Vital-Guard 450C Patient Monitor ® SpO2 2684-01-20 with Masimo SET Operation and Maintenance Manual User Responsibility This product will perform in conformity with the description thereof contained in this Operation and Maintenance Manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, IVY Biomedical Systems, Inc. recommends that a telephone call or written request for service advice be made to IVY Biomedical Systems, Inc. Service Department. This product or any of its parts should not be repaired other than in accordance with instructions provided by IVY Biomedical Systems, Inc. trained personnel. The product must not be altered without the prior written approval of IVY Biomedical Systems, Inc. Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction, which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than IVY Biomedical Systems, Inc. CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Ivy Biomedical Systems, Inc. has declared that this product conforms with the Eurpean Council Directive 93/42/EEC Medical Device Directive when its used in accordance with the instructions provided in the Operation and Maintenance Manual. Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, Connecticut 06405 (203) 481-4183 (800) 247-4614 FAX (203) 481-8734 www.ivybiomedical.com e-mail:ivybio@ivybiomedical.com The following are trademarks of Masimo Corporation: Masimo®, Masimo SET® and LNOP®. Covered by one or more of the following U.S. Patents: 5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830; 6,157,850 and international equivalents. U.S.A. and international patents pending. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. S450C-4May2010 2684-01-20 Rev.03 Declaration of Conformity Manufacturer: Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 Authorized Representative: Cavendish Scott Ltd. Starlings Bridge, Nightingale Road Hitchin, Herts, SG5 1FW, England Type of Equipment: Physiological Monitors Models: 450C We, Ivy Biomedical Systems, Inc., hereby declare that the devices mentioned above comply with the Swedish National Board of Health and Welfare Regulation and guidelines on medical devices LVFS 2003:11 (M) 28 October 1994 – transposing European Medical Devices Directive 93/42/EEC. Date of Validity: March 30, 2010 Classification: IIb Conformity Assessment Procedure: Notified Body: 10 Annex II Intertek SEMKO AB Name of Authorized Signatory: Position held in Company: Signature According to rule No. Notified Body No. Dick Listro Director of Regulatory 0413 This page is intentionally left blank. TABLE OF CONTENTS TABLE OF CONTENTS WARRANTY ............................................................................................................................................................... v INTRODUCTION ....................................................................................................................................................... 1 SAFETY ....................................................................................................................................................................... 2 Electrical ............................................................................................................................................................. 2 Explosion ............................................................................................................................................................. 2 Patient Connections ........................................................................................................................................... 3 MRI ..................................................................................................................................................................... 3 Pacemakers ......................................................................................................................................................... 3 Electrosurgery .................................................................................................................................................... 3 Defibrillation Protection .................................................................................................................................... 3 EMC .................................................................................................................................................................... 3 Electromagnetic Compatibility IEC 60601-1-2:2001 ..................................................................................... 4 Description of Warning Labels ......................................................................................................................... 8 For monitors used in Australia ......................................................................................................................... 8 MONITOR DESCRIPTION ....................................................................................................................................... 9 Classification....................................................................................................................................................... 9 Specifications .................................................................................................................................................... 10 Controls and Indicators ................................................................................................................................... 16 Display ............................................................................................................................................................... 20 Alarms ............................................................................................................................................................... 21 Priority Alarms Feature (If Present) .............................................................................................................. 24 Rear Panel......................................................................................................................................................... 24 Menu Structure ................................................................................................................................................ 25 The PATIENT SETUP Key......................................................................................................................... 26 The SYSTEM SETUP Key .......................................................................................................................... 27 MONITOR SETUP ................................................................................................................................................... 28 Adult/Neonate Modes ...................................................................................................................................... 28 Heart Rate Source ............................................................................................................................................ 29 Trace Speed ...................................................................................................................................................... 29 Set Time and Date ............................................................................................................................................ 29 Display Setup .................................................................................................................................................... 30 Data and Waveforms Color Setup .................................................................................................................. 30 Audio Setup ...................................................................................................................................................... 31 Display Limits ................................................................................................................................................... 31 Trend Displays.................................................................................................................................................. 31 Default Settings ................................................................................................................................................ 33 BATTERY OPERATION ......................................................................................................................................... 34 Internal Battery ................................................................................................................................................ 34 Status of the Battery ........................................................................................................................................ 34 Removing the Battery ...................................................................................................................................... 34 Vital-Guard 450C Operation and Maintenance Manual i TABLE OF CONTENTS RECORDER OPERATION ..................................................................................................................................... 35 Changing Paper ................................................................................................................................................ 35 Recorder Menus ............................................................................................................................................... 36 Recorder Modes ............................................................................................................................................... 36 Recorder Messages ........................................................................................................................................... 39 Example Printouts ............................................................................................................................................ 39 ECG MONITORING ................................................................................................................................................ 42 Safety Considerations ...................................................................................................................................... 42 Patient Connections ......................................................................................................................................... 43 ECG Waveform Amplitude ............................................................................................................................. 44 Heart Rate (HR) Alarm Limits ....................................................................................................................... 44 Lead Selection ................................................................................................................................................... 44 ECG Filter (Adult Mode Only) ....................................................................................................................... 44 ECG On/Off ...................................................................................................................................................... 45 Pacemakers ....................................................................................................................................................... 45 RESPIRATION MONITORING ............................................................................................................................. 46 Respiration Size ................................................................................................................................................ 46 Apnea Delay ...................................................................................................................................................... 47 Coincidence On/Off.......................................................................................................................................... 47 Respiration Rate (RR) Alarm Limits.............................................................................................................. 47 Respiration On/Off .......................................................................................................................................... 47 END TIDAL CO2 MONITORING........................................................................................................................... 48 General Description ......................................................................................................................................... 48 Preparation for Monitoring ............................................................................................................................ 53 Response Setting ............................................................................................................................................... 55 Compensation Settings ..................................................................................................................................... 56 Barometric Pressure ...................................................................................................................................... 56 N2O Compensation ........................................................................................................................................ 56 O2 Compensation ........................................................................................................................................... 56 Trace Scale Setting ........................................................................................................................................... 57 CO2 Alarm Limits ............................................................................................................................................ 57 Respiration Rate Alarm Limits ....................................................................................................................... 57 Respiration On/Off .......................................................................................................................................... 57 Gas Calibration ................................................................................................................................................ 58 INVASIVE PRESSURE MONITORING ................................................................................................................ 59 Pressure Transducer ........................................................................................................................................ 59 Connecting the Transducer ............................................................................................................................. 59 Zeroing the Transducer ................................................................................................................................... 60 Blood Pressure Scale ........................................................................................................................................ 60 Pressure Alarm Type ....................................................................................................................................... 61 Pressure Alarm Limits ..................................................................................................................................... 61 Expanded Pressure Scale ................................................................................................................................. 61 Alternate Pressure Site Labeling and Automatic Scale/Limit Adjustment Feature (If Present) .............. 62 MASIMO SET® PULSE OXIMETRY MONITORING ........................................................................................ 63 Overview ........................................................................................................................................................... 63 Principles of Operation .................................................................................................................................... 63 Pulse Oximetry Sensors ................................................................................................................................... 64 Monitoring Procedure ..................................................................................................................................... 64 SpO2 Alarm Limits........................................................................................................................................... 66 ii Vital-Guard 450C Operation and Maintenance Manual TABLE OF CONTENTS Response Mode Settings .................................................................................................................................. 66 Default Values .................................................................................................................................................. 66 Pulse Oximetry with ECG Off ........................................................................................................................ 67 Pulse Oximetry Considerations ....................................................................................................................... 67 NIBP MONITORING ............................................................................................................................................... 68 General Description ......................................................................................................................................... 68 NIBP Monitoring Considerations ................................................................................................................... 68 Cuff Placement ................................................................................................................................................. 69 Monitoring Procedure ..................................................................................................................................... 69 NIBP Graph ...................................................................................................................................................... 70 NIBP Messages ................................................................................................................................................. 71 Tabular Scrolling ............................................................................................................................................. 71 Clear Tabular Data .......................................................................................................................................... 72 NIBP Mode Select ............................................................................................................................................ 72 NIBP Alarm Settings........................................................................................................................................ 72 NIBP Calibration ............................................................................................................................................. 72 TEMPERATURE MONITORING .......................................................................................................................... 73 Temperature Alarms Description ................................................................................................................... 73 ALARM MESSAGES ............................................................................................................................................... 74 MONITOR TESTING............................................................................................................................................... 75 MAINTENANCE AND CLEANING ....................................................................................................................... 76 The Monitor ...................................................................................................................................................... 76 Patient Cables ................................................................................................................................................... 76 Reusable Pressure Transducer........................................................................................................................ 76 Cleaning and reuse of SpO2 sensors ............................................................................................................... 77 Reusable Temperature Probes ........................................................................................................................ 77 ETCO2 Sensor and Airway Adapter ............................................................................................................... 77 Preventive Maintenance .................................................................................................................................. 77 ACCESSORIES ......................................................................................................................................................... 79 ECG/Respiration .............................................................................................................................................. 79 EtCO2................................................................................................................................................................ 79 Invasive Pressure.............................................................................................................................................. 79 Non-Invasive Pressure (NIBP) ........................................................................................................................ 80 Temperature ..................................................................................................................................................... 80 Recorder............................................................................................................................................................ 80 SpO2 Reusable sensors ...................................................................................................................................... 81 SpO2 Disposable sensors ................................................................................................................................... 81 SpO2 Patient cables ........................................................................................................................................... 81 SpO2 Starter kits ............................................................................................................................................... 81 Disposal ............................................................................................................................................................. 81 REAR PANEL OUTPUTS ........................................................................................................................................ 82 Analog Output Connector ............................................................................................................................... 82 COM1 & COM2 Connectors .......................................................................................................................... 83 RJ45 Connector (option in place of COM2) .................................................................................................. 83 Configuration Menu ........................................................................................................................................ 84 Vital-Guard 450C Operation and Maintenance Manual iii TABLE OF CONTENTS TESTING AND TROUBLESHOOTING ................................................................................................................ 85 General .............................................................................................................................................................. 85 ECG Test ........................................................................................................................................................... 85 Pressure Test .................................................................................................................................................... 86 Respiration Test ............................................................................................................................................... 87 Temperature Test ............................................................................................................................................. 87 Pulse Oximeter Test ......................................................................................................................................... 87 EtCO2 Test ....................................................................................................................................................... 88 NIBP Test .......................................................................................................................................................... 88 Recorder Test ................................................................................................................................................... 88 Battery Test ...................................................................................................................................................... 89 Isolation and Leakage Tests ............................................................................................................................ 89 System Error Messages.................................................................................................................................... 90 Simplified Block Diagram................................................................................................................................ 91 REPLACEMENT PARTS ........................................................................................................................................ 92 Printed Circuit Boards .................................................................................................................................... 92 Modules and Assemblies .................................................................................................................................. 92 Fuses .................................................................................................................................................................. 92 Cables and Harnesses ...................................................................................................................................... 93 Labels ................................................................................................................................................................ 93 Software ............................................................................................................................................................ 93 DISASSEMBLY AND ASSEMBLY ....................................................................................................................... 94 Covers............................................................................................................................................................... 94 Printed Circuit Boards ................................................................................................................................... 95 450C Mother (5143) Board ........................................................................................................................... 95 EtCO2 Interface (5108) Board ...................................................................................................................... 95 EtCO2 Module .............................................................................................................................................. 95 Masimo SpO2 Module .................................................................................................................................. 95 Isolated Input (5144) Board .......................................................................................................................... 96 Front Panel ....................................................................................................................................................... 96 EOS Power Supply ........................................................................................................................................... 97 Recorder Assembly .......................................................................................................................................... 97 NIBP Module ................................................................................................................................................... 97 Battery Removal ............................................................................................................................................... 97 Display Assembly.............................................................................................................................................. 98 Speaker.............................................................................................................................................................. 98 BOARD LAYOUT DIAGRAMS ............................................................................................................................... A SCHEMATIC DIAGRAMS....................................................................................................................................... B iv Vital-Guard 450C Operation and Maintenance Manual WARRANTY WARRANTY All products manufactured by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment. All accessories supplied by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of 90 days from date of original shipment. If an examination by Ivy Biomedical Systems, Inc. discloses such products or component parts to have been defective, then our obligation is limited to repair or replacement (at our option). Fuses and batteries are not covered under this warranty. If products need to be returned to the manufacturer for repair or examination contact customer service personnel at IVY Biomedical Systems, Inc. to obtain the Return Authorization Number (RMA) and proper packing instructions. Vital-Guard 450C Operation and Maintenance Manual v WARRANTY This page is intentionally left blank. vi Vital-Guard 450C Operation and Maintenance Manual INTRODUCTION INTRODUCTION This manual is to provide information on the correct use of the Vital-Guard 450C patient monitor. It is up to the user to ensure that any applicable regulations regarding the installation and operation of the monitor are observed. The Information regarding circuit diagrams, board layouts and replacement parts is contained in the Operation and Maintenance Manual. For instructions on how to obtain the Operation Manual or the Operation and Maintenance Manual please contact customer service personnel at IVY Biomedical Systems, Inc. The model 450C is to be operated by qualified personnel only. Using This Manual We recommend that you read this entire manual before operating the equipment. This manual is written to include all parameters for a fully configured monitor. If the configuration of your monitor does not include all parameters, menu selections and display data for those parameters will not appear on your monitor. Use the Monitor Description section for general descriptions of controls and displays. For details on monitoring each parameter, refer to the section of the manual dealing with the appropriate parameter. NOTE: If the monitor beeps when you press a key, it indicates an invalid selection for the current mode or function. Boldface type is used in text to refer to the labeling on user controls. Special brackets [ selections used with the programmable keys. ] surround menu Manufacturer’s Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: • Assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the manufacturer • The electrical installation complies with all applicable regulations • The equipment is used in accordance with the instructions in this manual Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury. For technical and service information, please refer to the Vital-Guard 450C Operation and Maintenance Manual or contact: Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, Connecticut 06405 (203) 481-4183 or (800) 247-4614 e-mail: techline@ivybiomedical.com This manual explains how to set up and use the Model 450C. Important safety information relating to general use of the pulse oximeter appears in this manual. Other important safety information is located throughout the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE YOU OPERATE THE MONITOR. Vital-Guard 450C Operation and Maintenance Manual 1 SAFETY SAFETY Electrical This product is intended to be operated from a mains power source of nominally 100 to 230 V ~, 47-63 Hz, or from its internal battery. WARNING: To prevent electrical hazards to all personnel, this monitor must be properly grounded. Connect the monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electric code. WARNING: Do not under any circumstances remove grounding conductor from the power plug. WARNING: The power cable supplied with this equipment provides for this protection. Do not attempt to defeat this protection by modifying the cable or by using ungrounded adapters or extension cables. The power cord and plug must be intact and undamaged. To disconnect the equipment from the mains power unplug the power cord. WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer. WARNING: If there any doubt about the integrity of the protective earth conductor arrangement, operate the monitor on internal battery power until the AC power source protective conductor is fully functional. WARNING: Do not place the monitor in any position that may cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable, use only the handle on the monitor. WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to qualified service personnel. WARNING: To avoid electrical shock, disconnect the monitor from its power source before changing fuses. Replace fuses only with same type and rating (1.6ASB, Metric 5x20mm, 250V). WARNING: Do not clean monitor while it is on and/or plugged into a power source. WARNING: If unit is accidentally wet, discontinue use until dry and then test unit for proper operation before reuse on patient. WARNING: This unit uses a common isolation path for the ECG leads. Do not connect any non-isolated accessories to the ECG input when connected to a patient, as this may compromise the safety of the unit. When attached to other devices, insure that the total chassis leakage currents of all units do not exceed 300 μA. Explosion DANGER: Explosion hazard! Do not use this equipment in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environment or nitrous oxide. 2 Vital-Guard 450C Operation and Maintenance Manual SAFETY Patient Connections Patient connections are electrically isolated. For all connections use isolated probes. Don’t let patient connections contact other conductive parts, including earth. See instructions for patient connections in this manual. Carefully route patient cables to reduce the possibility of patient entanglement or strangulation. Leakage current is limited internally by this monitor to less than 10 μA. However, always consider cumulative leakage current that can be caused by other equipment used on the patient at the same time as this monitor. To ensure that the leakage current protection remains within the specifications, use only the patient cables specified in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death. If an alarm condition occurs while the alarms are set to off, the only alarm indication will be visual displays and symbols related to the alarm condition. MRI The model 450C should not be used within the magnetic field during Magnetic Resonance Imaging. Pacemakers Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance. Electrosurgery To avoid the potential of electrosurgery burns at monitoring sites, ensure proper connection of the electrosurgery return circuit as described by manufacturer’s instructions. If improperly connected, some electrosurgery units might allow energy to return through the ECG electrodes, SpO2 sensors, Pressure Transducers, EtCO2 sensors, and Temperature probes. To further reduce the potential of burns, locate the SpO2 sensors, Pressure Transducers, EtCO2 sensors, and Temperature probes as described in the manufacturer’s instructions. Defibrillation Protection This equipment is protected against 360 J discharge and electrosurgery potentials. The monitor is internally protected to limit current through the electrodes to prevent injury to the patient and damage to the equipment as long as the defibrillator is used in conformance with the manufacturer’s instructions. EMC This equipment has been certified to be protected to emissions and immunity according to IEC-60601-1-2. Vital-Guard 450C Operation and Maintenance Manual 3 SAFETY Electromagnetic Compatibility IEC 60601-1-2:2001 CAUTION: Medical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Operation Manual. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING: The model 450C should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Model 450C should be observed to verify normal operation in the configuration in which it will used. Accessories WARNING: The use of accessories other than those specified below may result in increased emissions or decreased immunity of the equipment. Part Number Description 590170 Three lead patient cable 590162 Set of three lead wires 590167 Five lead patient cable 590168 Set of five lead wires 590198 Set of three lead wires for prewired electrodes 590317 Low noise three lead patient cable 590318 Set of three radiotranslucent lead wires 590323 Low noise three lead patient cable with 1kohm resistors. The minimum amplitude or value patient physiological signal is 0.5 mV (AAMI EC-13 3.2.6.1). WARNING: The use of the Model 450C below the following amplitude values may cause inaccurate results: 4 Vital-Guard 450C Operation and Maintenance Manual SAFETY Guidance and manufacturer’s declaration – Electromagnetic emissions The Model 450C is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 450C should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Model 450C uses RF energy only for its internal CISPR 11 function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class A The Model 450C is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to the public low-voltage power Harmonic emissions Class A supply network that supplies buildings used for IEC 61000-3-2 domestic purposes. Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3 Vital-Guard 450C Operation and Maintenance Manual 5 SAFETY Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 450C is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 450C should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance level Electromagnetic environment – level guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete, discharge (ESD) or ceramic tile. If floors are IEC 61000-4-2 ±8kV air ±8kV air covered with synthetic material, the relative humidity should be at least 30%. Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be Transient/burst supply lines supply lines that of a typical commercial or IEC 61000-4-4 hospital environment. ±1 kV for ±1 kV for input/output lines input/output lines Surge ±1 kV differential ±250V Remove equipment that can cause IEC 61000-4-5 mode differential mode electrical disturbance from the vicinity of the input/output ±2 kV common ±2 kV common cables. mode mode Voltage dips, short <5 % UT <5 % UT Mains power quality should be interruptions, and (>95 % dip in UT) (>95 % dip in UT) that of a typical commercial or voltage variations for 0.5 cycle for 0.5 cycle hospital environment. If the user on power supply of the Model 450C requires input lines 40 % UT 40 % UT continued operation during power IEC61000-4-11 (60 % dip in UT) for (60 % dip in UT) mains interruptions, it is 5 cycles for 5 cycles recommended that the Model 450C be powered from an 70 % UT 70 % UT uninterruptible power supply. (30 % dip in UT) for (30 % dip in UT) 25 cycles for 25 cycles Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 6 <5 % UT (>95 % dip in UT) for 5 sec cycle 3 A/m <5 % UT (>95 % dip in UT) for 5 sec cycle Not applicable Not applicable Vital-Guard 450C Operation and Maintenance Manual SAFETY Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 450C is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 450C should assure that it is used in such an environment. Immunity test IEC 60601 test Complianc Electromagnetic environment – guidance level e level Portable and mobile RF communications equipment should be used no closer to any part of the Model 450C, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms d = 1.2 p Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m d = 1.2 p 80 MHz to 800 MHz d = 2.3 p 800 MHz to 2.5 GHz Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b Interference may occur in the vicinity of the equipment marked with the following symbol: NOTE 1 – At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 450C is used exceeds the applicable RF compliance level above, the Model 450C should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 450C. b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. Vital-Guard 450C Operation and Maintenance Manual 7 SAFETY Description of Warning Labels Attention, consult ACCOMPANYING DOCUMENTS before attempting to change power supply selection or carry out interconnections. Equipment connected should comply with IEC-60601-1 or IEC-950 with configuration to IEC-60601-1-1. ♥ Type CF applied part, Defibrillator proof. Equipotential earth connector adjacent to this symbol. Fuse type/rating. Output signal. ON Input signal. _______ Stand By (STBY) ♥ Type CF applied part. ∼ Alternate Current (AC) WEEE Compliance For monitors used in Australia For continued Defibrillation protection and proper Respiration monitoring use only patient cables with 1kΩ series resistors. It is important to use only patient cables with 1kΩ series resistors because the respiration circuit is tuned to operate with series resistors. For 3-lead configuration monitors, use 3-lead patient cable with 1kΩ series resistors. Ivy reorder no. 590197. For 5-lead configuration monitors, use 5-lead patient cable with 1kΩ series resistors. Ivy reorder no. 590207. 8 Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION MONITOR DESCRIPTION The Model 450C Patient Monitor is a color four-trace adult, pediatric, or neonatal monitor for: ECG Heart Rate Respiration - Impedance EtCO2 Two Invasive Pressures Two Temperatures Non-Invasive Blood Pressure (NIBP) Pulse Oximetry The Model 450C is available in several configurations, therefore, not all parameters are included in all monitors. The use of the Model 450C is restricted to one patient at a time. The monitor is intended for use in emergency room, recovery room, intensive care, and surgical applications and transport with 2.5 hours battery operation. The Model 450C is suitable for use in presence of electrosurgery. The Model 450C is not intended for use with any other physiological monitoring unit. An optional integral recorder is available. Recorder settings are made through the monitor menus. Battery operation consists of two rechargeable lead acid cells. The display has four traces available and alphanumeric displays for data, alarms, and user information, such as menus. The monitor automatically senses which devices are connected and acquires and displays data for the parameters being used. Data for parameters not being used is not displayed. Areas for display of those parameters are left blank. Classification (in accordance with IEC-60601-1) Protection against electric shock: Class 1 and internally power equipment Degree of protection against electric shock: Type CF applied part. Defibrillator proof: ECG Type CF applied part: SpO2, IBP, Temperature, NIBP, & EtCO2. Degree of protection against harmful ingress of water: Ordinary equipment IPX0 per IEC-60529 Methods of Maintenance and Cleaning: See page 72 Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anesthetic mixture Mode of operation: Continuous Vital-Guard 450C Operation and Maintenance Manual 9 MONITOR DESCRIPTION Specifications ECG Lead Selection: Standard Three-Lead: Five-Lead Option: ECG Amplitud range: 1 to 100 mm/mv Patient Cable: 6-Pin AAMI Standard Isolation: Isolated from ground related circuits by ≥4 kV rms, 5.5 kV peak CMRR: ≥90 dB with patient cable and 51 kΩ/47 nF imbalance Input Impedance: ≥20 MΩ at 10 Hz with patient cable Frequency Response Display, at 50 mm/sec: LI, LII, LIII, LI, LII, LIII, aVR, aVL, aVF, V Filtered: Diagnostic: 0.5 to 35 Hz 0.05 to 100 Hz Frequency Response X1000 Output: Filtered: Diagnostic: 0.5 to 35 Hz 0.05 to 100 Hz Input Bias Current: Any lead configuration <200 nA dc maximum Electrode Offset Potential: ± 0.5 V Noise: <20 µV peak-to-peak, referred to the input with all leads connected through 51 kΩ/47 nF to ground Defibrillator Protection: Protected against 360 J discharge. Leakage Current: <10 µA at 120 V ~, 60 Hz Electrosurgical Interference Protection: Standard Lead Fault Detection: Lead fault detection in any lead configuration with any of the leads open NOTE: The Phase Delay from patient electrode to rear panel outputs is < 3ms Cardiotach 10 Range: 15 to 300 bpm Accuracy: ±1% Resolution: 1 bpm Sensitivity: Adult: Neonate: Pacer Rejection Width: 0.1 to 2 ms at ±2 to ±700 mV Tall T Wave Rejection: Rejects T waves ≤R wave 300 µV peak 100 µV peak Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Temperature (Two Channels) Thermistor: YSI Series 400 or equivalent Range: 19°C to 45°C Accuracy: ±0.1°C from 25°C to 40°C Resolution: 0.1°C Isolation: Isolated from ground related circuits by ≥4 kV rms, 5.5 kV peak Leakage: <10 µA at 120 V ~, 60 Hz Respiration Excitation Current: <400 µA rms Excitation Frequency: 57 kHz Maximum Electrode Impedance: 4 kΩ Size Adjustment: Manual Respirotach Range: Neonate: Adult: 4 to 150 br/min 4 to 60 br/min Sensitivity Range: Neonate: Adult: 0.1 to 10 Ω, 4 to 150 br/min 0.3 to 10 Ω, 4 to 60 br/min Pace Pulse Rejection Width: 0.1 to 2 ms at ±2 to ±700 mV End Tidal CO2 Measurement Range: 0.0 to 100.0 Torr Reporting Range: –5.0 to 120.0 Torr Resolution: 0.1 Torr (0.01%) Bias: 0.0 to 40.0 Torr: 40.1 to 100.0 Torr: ±2.0 Torr Abs ±5.0% Relative Precision: 0.0 to 40.0 Torr 40.1 to 100 Torr <0.5 Torr (RMS) <1.0 Torr (RMS) CO2 Compensation: Local Barometric Pressure: 500 to 850 Torr (in whole units) 0 to 100% (in whole units) N2O 0 to 100% (in whole units) O2 Vital-Guard 450C Operation and Maintenance Manual 11 MONITOR DESCRIPTION MASIMO SET® Pulse Oximetry Range: Saturation (%SpO2) Pulse Rate (bpm) 1% - 100% 25 - 240 Accuracy: Saturation (%SpO2) – During no motion conditions Adults 70% - 100% ± 2 digits 0% - 69% unspecified Neonates 70% - 100% ± 3 digits Saturation (%SpO2) – During motion conditions Adults 70% - 100% ± 3 digits 0% - 69% unspecified Pulse (bpm) – During no motion conditions 25 to 240 ± 3 digits Pulse (bpm) – During motion conditions 25 to 240 ± 5 digits Resolution: Saturation (%SpO2) Pulse Rate (bpm) 1% 1 Non-Invasive Blood Pressure Measurement Technique: Oscillometric method determines mean arterial pressure (MAP), systolic, and diastolic pressure. Resolution: 1 mmHg Measuring Range: Systolic Mean Diastolic Pulse Rate 12 Adult (mmHg) 60–250 45–235 40–220 30 –180 Neonatal (mmHg) 40–130 35–105 20– 90 30 –240 Accuracy: Over the blood pressure measurement range stated above, for systolic and diastolic pressures treated separately, the mean difference of the paired measurement of the test system and the comparison system shall be ±5mmHg or less, with a standard deviation of 8mmHg or less. Inflation speed: At sea level <10 seconds. Maximum leak rate: 5 mmHg/3 min. Over pressure protector: (Maximum cuff pressure) Adult/Child Neonate 300mmHg 150mmHg Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Modes: Auto: Measurements are automatically repeated at timed programmed intervals of 1, 2, 3, 4, 5, 10, 15, 20, 30, or 60 minutes Stat: A series of consecutive measurements; the series lasts for 5 minutes. Manual: A single reading each time START is pressed. Alarms: High and low pressure alarms derived from the NIBP systolic, diastolic, or mean Invasive Pressure (Two Channels) Frequency Response: dc to 12 Hz Input Impedance: 500 kΩ Transducer Sensitivity: 50 µV/V/cm Hg Excitation Voltage: +5 V dc Zero: Auto pushbutton, ±150 mmHg Drift: 0.1 mmHg/oC Accuracy: ±2% of reading or ±1 mmHg, whichever is greater Isolation: Isolated from ground related circuits by ≥4 kV rms, 5.5 kV peak Test Waveform: 150/50 mmHg NOTE: Refer to the manufacturer’s documentation for technical specifications on any particular pressure transducer. Alarms Heart Rate: High and Low: 15 to 300 bpm in 5 bpm increments SpO2: High: 70 to 99% in 1% increments Low: 50 to 95% in 1% increments Asystole: R to R interval >6 seconds No Pulse: When triggering from pleth or invasive pressure, interval >6 seconds Lead Off: Detached lead or offset potential ≥0.5 V Check Leads: Electrode impedance is >4 kΩ Coincidence: When QRS and respiration triggers are synchronized for eight consecutive events Apnea: Absence of detectable respiration activity for 5, 10, 15,, or 20 seconds Vital-Guard 450C Operation and Maintenance Manual 13 MONITOR DESCRIPTION Alarms Resp Rate: High and Low: 5 to 150 br/min in 5 br/min increments Invasive Pressure: High and low; systolic, diastolic, or mean: -40 to 300 mmHg in 2 mmHg increments NIBP: High and low; systolic, diastolic, or mean: 10 to 300 mmHg in 2 mmHg increments For additional NIBP alarm conditions, see the NIBP Monitoring section of this manual. Trends NIBP: Last 200 readings, tabular Cardiorespirogram: Up to 4 minutes beat-to-beat heart rate and respiration Trend Waveforms: Up to 24 hours of heart rate, respiration rate, SpO2, and invasive pressure Review Trend: 6 hour view: Stored the last 24 hours of heart rate, respiration rate, SpO2 and IBP. Six hours of data are displayed per window. (1 pixel = 1 minute). 30 minute view: Stored the last 24 hours of heart rate, respiration rate, SpO2 and IBP. Thirty minutes of data are displayed per window. (1 pixel = 5 seconds). Real Time Clock Resolution: 1 minute Display: 24 hours Power Requirement: The real time clock keeps time if the monitor has power or not. The clock is powered by a dedicated battery whose life is minimum 4 years at a temperature of 25oC Test Mode ECG: 1 mV/100 ms @ 70 bpm Respiration: 70 br/min, coincidence check Invasive Pressures: 150/50 mmHg Temperatures: 40oC Type: Active Matrix TFT Color LCD Trace: Four Traces, moving bar Screen size (viewing area): Height: Width: Display 14 158.4 mm 211.2 mm Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Display Sweep Speed: 6.25, 12.5, 25, 50 mm/s Character Size: Large: Small: Recorder Writing Method: Number of Traces: Modes: Paper Speeds: Trends: Resolution: Frequency Response: Data Rate: 13x8 mm 4x3 mm Direct Thermal 2 Direct - Manual Recording Timed - Print button initiates a 30 second recording Delay - Recorder is activated by an alarm Auto - Parameters to be printed are selected based on the alarm CRG - Prints Cardiorespirogram Remote - Allows activation of a remote recorder 1 mm/s in CRG mode, 6.25, 12.5, 25 and 50 mm/s Printed as selected for the display NIBP tabular - prints up to 200 measurements as shown on the display Vertical - 200 dots/in. Horizontal - 600 dots/in. at ≤25 mm/s 400 dots/in. at >25 mm/s >100 Hz at 50 mm/s 400 samples/s/trace Mechanical Size: Height: Width: Depth: Weight: Basic unit: 12.8 lbs. (5.8 kgs.) Environmental Operating Temperature Range: 11.0 in. (28.0 cm) 11.1 in. (28.2 cm) 7.5 in. (19.1 cm) 15oC to 35oC Storage Temperature Range: -5oC to 55oC Relative Humidity: 0-90% non-condensing Power Requirements Voltage Input: 100 - 230 V ~; 47 - 63 Hz, +10% –15% Fuses Type and Rating: 1.6ASB, Metric 5x20mm, 250V Maximum ac Power Consumption: 145 VA Battery: Run Time: 2.5 hours – (NIBP measurement every 15 minutes and 30-second recorder print-out every 30 minutes) Charge Time: <12 hours Type: Replaceable sealed gel cell, DOT and IATA approved Vital-Guard 450C Operation and Maintenance Manual 15 MONITOR DESCRIPTION Controls and Indicators Setup Keys PATIENT SETUP SYSTEM SETUP ALARM SETUP EXIT Causes menu to be displayed for settings involving the parameters. Displays menus for general settings, such as display and recorder setup, adult/neonatal mode, and audio and clock settings. To set limits for all parameters To leave a menu and return to the normal display. See the Menu Structure section of this manual for a description of the menus. PROGRAMMABLE KEYS COLOR DISPLAY SETUP KEYS BASIC KEYS 16 Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Basic Keys Generates a 1 mV pulse at 70 bpm, respiration signal at 70 br/min, (coincidence check), invasive blood pressures at 150/50, and temperatures at 40°C displayed on the screen and sent to the rear panel. This key is used to verify that the monitor is functioning correctly. In TEST, heart rate is always computed from the generated ECG. Turns the alarm audio on and off. When off, the ALARMS OFF tag is displayed on the screen. Disables the audible and visual alarms for a two-minute period to allow the operator to perform procedures that would otherwise set off the alarms. This avoids the problem of turning off the alarms and forgetting to turn them back on. A message on the screen indicates when this function is active. Press the ALARM PAUSE key again to return the alarms to normal before the two minutes have expired. Respiration Size RESP SIZE The up and down arrows control the relative size of the respiration signal. Size ranges are from 0 to 100%. This controls both the display size and the trigger sensitivity. NOTE: If the respiration size is set for a very sensitive range, cardiac artifact can generate false triggers, causing a coincidence alarm. On When the monitor is either plugged into an AC power source or operating on batteries, the switch toggles from Stand By (off position) to ON providing power to the monitor’s electronic circuits. The monitor must be connected to an AC source to be able to charge the internal batteries. NOTE: To disconnect the monitor from the mains power unplug the power cord. Stand By NIBP Control Keys START STOP CYCLE Starts a single non-invasive blood pressure measurement in cycle off (manual mode) or repetitive measurements in cycle mode or stat mode. Measurements in any mode can be canceled by pressing STOP. Stops any non-invasive blood pressure measurements in cycle off (manual mode), automatic mode, or stat mode and cancels automatic or stat mode. Selects the NIBP mode of operation. Selections are: automatic cycle mode, stat mode or cycle off (manual mode). In the automatic cycle mode inflation intervals of 1, 2, 3, 4, 5, 10, 15, 20, 30 or 60 minutes can be selected. Vital-Guard 450C Operation and Maintenance Manual 17 MONITOR DESCRIPTION Programmable keys Each of the keys to the right of the display has a normal function, printed on the key, and several menu functions displayed on the screen in the setup mode. The normal functions are described below. Menu functions are described in the menu structure section of this manual. DISPLAY LIMITS Displays the current alarm limit settings. Press DISPLAY LIMITS again to return to normal display. FREEZE Stops the movement of the all waveforms on the display for closer evaluation. Press FREEZE again to resume movement. ALARM RESET Resets the audible and visual indicators for an alarm that has been activated. PRINT TREND 18 Starts a printout at the optional recorder. The recorder normally plots waveforms. To define the waveform printout, use the menus accessed by pressing the SYSTEM SETUP key. Displays Trend data. To define the trend display, see the trend display setup instructions. Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Side Panel Connector SpO2 ECG/RESP PRESS 1 PRESS 2 TEMP 1 TEMP 2 NIBP ETCO2 Vital-Guard 450C Operation and Maintenance Manual 19 MONITOR DESCRIPTION Display Waveform Display When the monitor is configured for all parameters, any of the following waveforms can be displayed: ECG Respiration Two Invasive Pressures (P1, P2) Pleth (Pulse Oximetry) EtCO2 Waveforms are updated with a moving bar at a rate of 6.25, 12.5, 25, or 50 mm/s, selected by the user. Waveform amplitudes are adjusted using the ECG Size selection in the menus and the RESP SIZE keys on the front panel. Invasive blood pressure scales are changed through the P1/P2 menu. A typical display is shown below. The display contains five zones, selectable through the menus. ZONE 1: Can only display the ECG waveform or no waveform (OFF) ZONE 2: Selectable to display waveforms of RESP, EtCO2, SpO2, P1, P2, or OFF ZONE 3: Selectable to display waveforms of RESP, EtCO2, SpO2, P1, P2, or OFF ZONE 4: Selectable to display waveforms of RESP, EtCO2, SpO2, NIBP, P1, P2, Zones 3 & 4 P1 EXPAND, Zones 3 & 4 P2 EXPAND, Zones 3 & 4 P1/P2 EXPAND, or OFF ZONE 5 (numeric only): Displays temperature readings with an area reserved to selectively display RESP, EtCO2, SpO2, or OFF If invasive pressure is being monitored, Zones 3 and 4 combined can display one or both pressures on a single expanded scale that is twice the height of the normal pressure scale. ZONE 1 ZONE 2 ZONE 3 PR=70 ZONE 4 TIME OF DAY ZONE 5 20 BATTERY INDICATOR Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Temperature data displayed in Zone 5 P1 displayed in Zone 3 and P2 displayed in Zone 4 PR=70 PR=70 Expanded P1 displayed in Zones 3 and 4 With NIBP Graph in Zone 4. PR=70 With PATIENT SETUP selections displayed PR=70 With SYSTEM SETUP selections displayed PR=70 NIBP Graph To display the NIBP graph, press the PATIENT SETUP key, select [NIBP], and select [DATA FORMAT] until it is set at GRAPH. The NIBP graph is shown in Zone 4 in one of the above illustrations. This oscillation profile assists the clinician in determining the validity of the NIBP measurement. An erratic or flat profile suggests that excessive motion or other artifact may have affected the measurement. A profile shaped like a bell curve represents a measurement not affected by motion or other artifact. Vital-Guard 450C Operation and Maintenance Manual 21 MONITOR DESCRIPTION Alphanumeric Data The following data appears on the display when the appropriate parameters are in use. Whenever possible, numeric data is displayed near related waveforms. When you select a display zone for a waveform, numeric data related to that waveform is also displayed in that zone. To display data without displaying the waveform, use Zone 5. Time of Day- At the lower right-hand corner of the display. Heart Rate- Upper left corner of the display with a symbol indicating the source of the heart rate. Respiration rate and flashing respiration indicator- To the left of the waveform. if the waveform is displayed. Otherwise, at the bottom of display in Zone 5. Respiration rate can be computed from either impedance or EtCO2. End Tidal CO2 (EtCO2 ) - To the left of the waveform if the waveform is displayed. Otherwise, at the bottom of display in Zone 5. Oxygen Saturation (SpO2) and pulse oximeter bar graph- To the left of the waveform if the waveform is displayed. Otherwise at the bottom of the display in Zone 5. Pressure Readings-one or two sets of readings- To the left of the waveform in the form: syst/dias (mean) Current NIBP Reading- At the lower left in the form: syst/dias (mean) Temperature- Three readings at the bottom of the display: Temp 1, Temp 2 and the difference between the two temperatures (∆ Temp). The data display is blank for any parameter not in use. Alarm Limits Display A numeric display of current alarm limits settings. The alarm limits appear just below the numeric value of the corresponding parameter. This display appears when the DISPLAY LIMITS key is pressed. Alarm Displays When an alarm setting has been exceeded, a flashing alarm tag appears on the screen, indicating which alarm has been triggered. Each alarm tag appears in the same location where the limits for that alarm are displayed. Trend Displays NIBP Trend: A tabular display of the readings at the time of each NIBP measurement. The latest five readings are displayed, and the display can be scrolled to view previous readings. CRG: Graphic Display of up to four minutes of beat-to-beat heart rate, SpO2 and respiration effort. Whenever EtCO2 is being monitored, the EtCO2 waveform is used for the respiration portion of the CRG. Trend: Graphic Display of up to 24 hours of averaged heart rate, SpO2, respiration rate, and pressure readings. Review Trend: Graphic and Numeric display of the most recent 24 hours of heart rate, SpO2, respiration rate, and pressure readings at two different views: 6 Hour View displays 6 hours of data per window; and 30 Minute View displays 30 minutes of data per window. Data can be moved under the cursor to obtain parameters readings at specific point in time. Numeric value of heart rate, SpO2, respiration rate, and invasive pressures is displayed over the cursor. 22 Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION Alarms The following is a list of alarms and ranges for which they can be set. When the alarm triggers, the alarm indicator flashes on the display and the audio alarm tone sounds. Pressing ALARM RESET turns off any alarms that have triggered. If the measurement returns to within the limits, the alarm turns off. The ALARM PAUSE key disables the alarms for two minutes or until ALARM PAUSE is pressed again. High heart rate: 15 to 300 bpm in 5 bpm increments Low Heart Rate: 15 to 300 bpm in 5 bpm increments High Resp Rate: 5 to 150 br/min in 5 br/min increments Low Resp Rate: 5 to 150 br/min in 5 br/min increments Temp High: 35ºC to 45ºC in 0.1ºC increments Temp Low: 35ºC to 45ºC in 0.1ºC increments NOTE: For additional Temp alarm conditions, see the Temperature Monitoring section of this manual. EtCO2 High: 10 to 100 Torr in 2 Torr increments EtCO2 Low: 10 to 100 Torr in 2 Torr increments NIBP High: Selectable systolic, diastolic, or mean 10 to 300 mmHg in 2 mmHg increments NIBP Low: Selectable systolic, diastolic, or mean 10 to 300 mmHg in 2 mmHg increments NOTE: For additional NIBP alarm conditions, see the NIBP Monitoring section of this manual. IBP High: Selectable systolic, diastolic, or mean; -40 to 300 mmHg in 2 mmHg increments IBP Low: Selectable systolic, diastolic, or mean; -40 to 300 mmHg in 2 mmHg increments NOTE: Invasive and non-invasive pressures can be set to alarm on systolic, diastolic, or mean. High SpO2: 50 to 100%in 1% increments Low SpO2: 50 to 100% in 1% increments Asystole: R-to-R interval >6 seconds No Pulse: When triggering from pleth or invasive pressure, the interval between heartbeats exceeds six seconds Lead Off: Detached lead or offset potential ≥0.5 V. The ALARM RESET key does not reset this alarm Check Leads: Electrode impedance is >4 kΩ Coincidence: When QRS and respiration triggers are synchronized for eight consecutive events Apnea: Absence of detectable respiration activity for 5, 10, 15, or 20 seconds, selectable. Vital-Guard 450C Operation and Maintenance Manual 23 MONITOR DESCRIPTION Priority Alarms Feature (If present) Note: Priority alarms may be enabled via the CONFIGURATION MENU (see operation and maintenance manual).This section applies only if priority alarms are PRESENT (default is ABSENT) There are two types of Priority alarms schemes. Scheme 1 prioritized the alarms into 3 groups while Scheme 2 prioritized the alarms into 4 groups. The table below describes the color and audio associated with each alarm and scheme. Priority High Medium SpO2 High Low Color Red Yellow N/A White SCHEME 1 Audio Type Rapid Beeps Slower Beeps N/A Longest Beeps SCHEME 2 Color Audio Type Red Siren Yellow Warble Light Blue Alternate tones White Tone The alarms are grouped as follows: High Priority: Asystole / No Pulse Apnea / No Resp Heart Rate (high/low) Medium Priority: Respiration rate (high/low) SpO2% (high/low). If Scheme 2 is selected this alarm becomes a separate priority. NIBP pressures (high/low) Invasive pressures (high/low) EtCO2 (high/low) InCO2 (high) Low Priority: Temperature (high/low) Miscellaneous alerts (i.e.: Coincidence) All non-physiological alerts (i.e.: Lead Off, Check Cuff, etc) Note: The Priority Alarm feature incorporated into the Vital-Guard 450C is intended to provide the user with a graded visual and audible indication of both the Patient’s and the Monitor’s status. It is the responsibility of the users to ensure that they use good clinical judgement to determine how they should respond to any alarm. Rear Panel The following are located on the rear panel. ANALOG OUTPUT: An analog output that can be used for connecting to an external device. Signals on this connector include ECG, respiration, invasive pressures, pleth, heart rate, SpO2, alarm out, remote recorder, and optional nurse call. Do not attempt to connect a cable to this connector without contacting your Biomedical Engineering Department or the Ivy Service Department. This is to insure the connection complies with leakage-current requirements of one of the following applicable standards: Underwriters Laboratories UL 2601-1, Canadian Standards Association CSA 601.1 No. M90 or Internal Electrotechnical Commission IEC 60601-1. The maximum non-destructive voltage that may be applied to this connector is 5 V dc. ECG X1000: A ¼-inch phone socket that can be used for connecting to an external device using the ECG waveform and LEAD OFF indicator. 24 Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION COM 1: A digital interface for network communication. COM 2 / RJ45: A digital interface for network communication. TELEMETRY ANTENNA: A BNC connector for the Telemetry System antenna. CAUTION: When the Telemetry option is selected and installed in the Model 450C due to the technical limitations inherent with all wireless communications, IVY Biomedical Systems, Inc. cannot guaranty that all signals transmitted via the antenna will be received by the appropriate receiver or receiving device. PEQ GROUND: Potential Equalization- Use this ground connection to ensure that no potential differences can develop between this equipment and the other electrical equipment. TELEMETRY ANTENNA COM 1 COM 2 / RJ45 ANALOG OUTPUT PEQ GROUND ECG X1000 OUTPUT MAINS POWER INPUT FUSES BEHIND THE PANEL Note: Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. ACCESSORIES (EQUIPMENT) – The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • use of the accessory in the PATIENT VICINITY; and • evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. Menu Structure Settings for all options for the Model 450C are made through a series of menus that appear at the right side of the display. You access the menus by pressing the PATIENT SETUP or SYSTEM SETUP key. The PATIENT SETUP key is for settings involving the parameters, while the SYSTEM SETUP key is for general monitor settings. When menus are displayed, if no key is pressed for a period of 30 seconds, the monitor returns to normal display. NOTE: If the monitor beeps when you press a key, it indicates an invalid selection for the current mode or function. Vital-Guard 450C Operation and Maintenance Manual 25 MONITOR DESCRIPTION The PATIENT SETUP Key Press PATIENT SETUP to display the main menu, which allows you to select ECG, RESP, SpO2, P1/P2, or NIBP menus. See the menu structure diagram below. When the main menu is displayed, press EXIT to return to normal display. PATIENT SETUP ECG/HR RESP/CO2 SpO2 NIBP INVASIVE BP SpO2 ALARM ON RESP IMPEDANCE RESP CO2 AVERAGING 8 SEC COINCIDENCE ON SENSITIVITY NORMAL APNEA DELAY 20 sec ECG ON ECG OFF RESPONSE NORMAL LEAD I HR SOURCE OXIMETRY ZERO SENSOR FILTER ON RESP OFF SPAN CHECK ECG SIZE 10 m m/mv SETTINGS PARAMETER P1 ZERO TRANSDUCER ALARM TYPE MEAN TRACE SCALE 0 TO 240 ALARM TYPE MEAN ALARM TYPE MEAN ALARM TYPE MEAN ALARM TYPE MEAN NEXT SETTING SCROLL SCROLL INITIAL CUFF 180 INITIAL CUFF 180 BAR PRESS 760 DATA FORMAT GRAPH DATA FORMAT ( NONE ) DEFAULT 760 MMHG DATA FORMAT NIBP TABLE DATA FORMAT IBP / TEMP TRACE SCALE 0 TO 50 SITE LABEL P1 PATIENTSETUP KEY SELECTION SpO2 ECG/HR SpO2 ALARM; ON, OFF AVERAGING:6, 8, 10, 12,14, 16 SEC SENSITIVITY: NORMAL, HIGH ECG: ON, OFF LEAD: I, II, III, aVR, aVL, aVF, V FILTER: ON, OFF ECG SIZE: 1 TO 100 m m/mV NIBP ALARM TYPE: MEAN, SYS, DIAS, OFF DATA FORMAT: NIBP TABLE, IBP/TEMP, GRAPH, NONE INITIAL CUFF: 50-250 mm Hg (ADULT) 50-150 mm Hg (NEONATE) RESP/CO2 RESP: IMPEDANCE, CO2, OFF COINCIDENCE: ON, OFF APNEA DELAY: OFF, 5, 10, 15, 20 s NO RESP DELAY: OFF, 5, 10, 15, 20 s. SETTINGS NEXTSETTING: BAR PRESS, N20, 02, NORMAL RESPONSE TRACE SCALE:0 TO 50, 0 TO 100 mmHg 26 INVASIVE BP 1&2 PARAMETER: P1, P2 ALARM TYPE: MEAN, SYS, DIAS, OFF TRACE SCALE: -30 TO 30, 0 TO 60, 0 TO 120, 0 TO 240, 0 TO 300 mmHg SITE LABEL: P1, ART1, CVP1, PA1, ICP1, UAC1, UVC1 P2, ART2, CVP2, PA2, ICP2, UAC2 & UVC2 Vital-Guard 450C Operation and Maintenance Manual MONITOR DESCRIPTION The SYSTEM SETUP Key Press SYSTEM SETUP to display the mode menu for setting audio volume, trace speed, display and recorder settings. When the mode menu is displayed, press EXIT to return to normal display. SYSTEM SETUP ALARM SETUP DISPLAY SETUP TREND SETUP RECORDER SETUP SET VOL/CLOCK MODE ADULT PARAMETER HR HIGH 140 MODE DIRECT TREND MODE 1 HOUR CONFIRM CLEAR TRACE SPEED 25 MM/SEC CHANNEL 1 ECG CLEAR TRENDS CANCEL ZONE 2 RESP/CO2 LOW 40 REVIEW TREND CO2 TREND ETCO2 SELECT MONTH HR VOL 40% < ---- < ---- ----> ----> VIEW IN (30 MIN) VIEW OUT (6 HOUR) ENTER PRINT PAGE PRINT PAGE SET CLOCK CANCEL 2 ALARM VOL 40% SYSTEM SETUP KEY SELECTION DISPLAY SETUP TRACE SPEED: 6.25, 12.5, 25, 50 mm/s ZONE 2: OFF, RESP/CO2, SpO2, P1, P2 ZONE 3: OFF, RESP/CO2, SpO2, P1, P2 ZONE 4: OFF, RESP/CO2, SpO2, NIBP, P1, P2 EXPANDED 3&4: P1, P2, P1/P2 ZONE 5: OFF, RESP, SpO2, NIBP TREND SETUP RECORDER SETUP MODE: DIRECT,TIMED,DELAY, AUTO, CRG, REMOTE CHANNEL 1: ECG, RESP/CO2, PLETH, P1, P2 CHANNEL 1: ECG, RESP/CO2, PLETH, P1, P2, OFF SET VOL/CLOCK HR VOL: OFF, 20, 40, 60, 80, 100% ALARM VOL: 20, 40, 60, 80, 100% SETCLOCK TREND MODE: CRG, 1, 8, 12, 24 hrs. CO2 TREND: ETCO2, RR SELECT: MONTH, DAY, YEAR, HOUR, MINUTE ALARM SETUP KEY SELECTIONS PARAMETER: HR, RR, SpO2, NIBP, P1, P2, ETCO2, INCO2, T1 & T2 (if active) Vital-Guard 450C Operation and Maintenance Manual 27 MONITOR SETUP MONITOR SETUP To setup the instrument for operation: 1. Plug the ac line cord into a power source providing the proper voltage. 2. Press the ON/STANDBY key at the bottom of the front panel to turn the unit on. 3. Connect the patient cable to the ECG/RESP connector on the right side panel. 4. If end tidal CO2 is to be monitored, connect the Sensor cable to the ETCO2connector on the right side panel. 5. If pulse oximetry is to be monitored, connect the sensor and the pulse oximetry cable to the SpO2 connector on the right side panel. 6. If NIBP is to be monitored, connect the NIBP hose to the NIBP connector on the right side panel. 7. If invasive pressure is to be monitored, connect the pressure transducer cable to the PRESS 1 or PRESS 2 right side panel connector. 8. If temperature is to be monitored, connect the temperature sensor cable to the TEMP 1 or TEMP 2 right side panel connector. Adult/Neonate Modes The Model 450C has mode settings for both adult/pediatric and neonatal monitoring. In general, the neonate mode is used for patients less than one year old. All other patients should be monitored using the adult mode. When monitoring NIBP, set the monitor to neonate mode whenever a neonatal cuff is being used. Select Adult or Neonate monitoring mode as follows: 1. Press the SYSTEM SETUP key to display the mode menu. 2. Use the [MODE] menu selection to select either ADULT or NEO. The current selection is displayed on the left side of the screen near the bottom. 3. Press EXIT to return to the normal display. 28 Vital-Guard 450C Operation and Maintenance Manual MONITOR SETUP Heart Rate Source Normally, heart rate is computed using the ECG waveform. If ECG is set to OFF, heart rate can be computed using the oximetry, P1, or P2 waveforms. 1. Press the PATIENT SETUP key. 2. Select [ECG/HR] and select [ECG], setting it to OFF. The [HR SOURCE] selection appears. 3. Use the [HR SOURCE] selection to select OXIMETRY, P1, P2, or NONE. Trace Speed 1. Press the SYSTEM SETUP key to display the mode menu. Then select [DISPLAY SETUP]. 2. Use the [TRACE SPEED] selection to select the trace speed. Selections are 6.25, 12.5, 25, and 50 mm/s. 3. Press EXIT to return to the normal display. Set Time and Date 1. Press the SYSTEM SETUP key to display the mode menu. Then select [SET VOL/CLOCK] and select [SET CLOCK] from the next menu. 2. The first setting is for MONTH. Use the 3. Press [SELECT] to move to the DAY setting. Use the setting. 4. Press [SELECT] to move to the YEAR setting. Use the setting. and keys to increase or decrease the year 5. Press [SELECT] to move to the HOUR setting. Use the setting. and keys to increase or decrease the hour 6. Press [SELECT] to move to the MINUTE setting. Use the minute setting. 7. When all date and clock settings are correct, select [ENTER] to enter the settings into the monitor’s memory. and keys to increase or decrease the month setting. Vital-Guard 450C Operation and Maintenance Manual and keys to increase or decrease the day and keys to increase or decrease the 29 MONITOR SETUP Display Setup 1. Press the SYSTEM SETUP key to display the mode menu. 2. Select [DISPLAY SETUP] to display the Zone Select menu. 3. Use the key next to each zone to select the display for the corresponding zone. Zone 5 is numeric only. Selections are as follows. Zone 1 Zone 2 Zone 3 Zone 4 Zone 5 ECG Off Resp/CO2 SpO2 (Pleth) P1 P2 Off Resp/CO2 SpO2 (Pleth) P1 P2 Off Resp/CO2 SpO2 NIBP P1 P2 P1 Expanded P2 Expanded P1/P2 Expanded Off Resp/CO2 SpO2 NIBP Each zone can also be set to off, except Zone 1, which is always ECG. Temperatures are displayed in a portion of Zone 5. NOTE: The above selections are available when the indicated parameters are included in the monitor’s configuration and are being used. 4. Press EXIT to return to the normal display. 5. To display expanded invasive pressure waveforms, use the Zone 4 setting. Data and Waveforms Color Setup 1. Turn the monitor OFF. 2. Simultaneously press the SYSTEM SETUP key and the ON/STANDBY button. 3. Use the 4. Press [CHANGE COLOR] to change the color. 5. Press [DEFAULTS] to reset the colors. 6. Press ON/STANDBY button twice to return to normal display. 30 and keys to change the parameter. Vital-Guard 450C Operation and Maintenance Manual MONITOR SETUP Audio Setup 1. Press the SYSTEM SETUP key to display the mode menu. 2. Select [SET VOL/CLOCK] to display the menu for setting HR and alarm volume. 3. Adjust the HR volume using [HR 4. Adjust the alarm volume using [ALARM 5. Press EXIT to return to the normal display. and ] keys. and ] keys. Display Limits To avoid clutter on the display, limits for parameter alarms are not displayed unless the Limits Display selection is set to ON. To enable or disable Limits Display, press the DISPLAY LIMITS key during normal display. Trend Displays The 450C monitor has a trend display showing heart rate, SpO2, P1, P2, and respiration rate. Time selections for this trend display are 1, 8, 12, and 24 hours. Another trend display is cardiorespirogram (CRG). The CRG displays the last four minutes of beat-to-beat heart rate, a compressed respiration signal, and SpO2 trend, if the SpO2 waveform is being displayed in the normal display. Trend Setup 1. Press the SYSTEM SETUP key. The mode menu appears. 2. Select [TREND SETUP] to display the trend selection menu. 3. Use the [TREND MODE] selection to select the trend mode: 1, 8, 12, or 24 hours or CRG. 4. Press EXIT to return to the normal display. Trend Display 1. To display the trend selected in the trend setup, press the TREND key. The trends appear on the display for the parameters selected in display setup. 2. Press TREND again to return to the normal display. NOTE: The monitor continuously accumulates trend data for all parameters in use. Any trend can be displayed by changing the setup in the menus. Vital-Guard 450C Operation and Maintenance Manual 31 MONITOR SETUP CRG Display 1 Hour Trend Display Review Trend Displays Review trend collects the most recent 24 hours of heart rate, SpO2, invasive pressures, and respiration rate. The monitor exhibits them at two different trend views: 1. The 6 Hour view trend displays 6 hours of data per screen (1 dot = 1 minute). 2. The 30 Minute view shows 30 minutes of data per screen (1 dot = 5 seconds). In either case, a cursor indicates the numeric value of the parameters. The data can be moved under the cursor to review the accumulated information at any specific time within the last 24 hours. NOTE: The 450C monitor is constantly gathering data of heart rate, SpO2, invasive pressures, and respiration rate to be used in the Review Trend. However, if the monitor is turned off the data will be erased. To access the Expanded Trend mode: 1. Press the SYSTEM SETUP key. The setup menu appears. 2. Select [TREND SETUP] to display the trend selection menu. 3. Select [REVIEW TREND] to enter the expanded trend display. 4. Press [←] or [→] to move the cursor a long the trend. 5. Select [VIEW IN/OUT] to toggle between 6 hour view and 30 minute view displays. 6. Press EXIT to return to the normal display. NOTE: The 450C monitor should be ON for at least one minute before Review Trend can be accessed. 32 Vital-Guard 450C Operation and Maintenance Manual MONITOR SETUP 6 Hour View 30 Minute View Clear Trend Data Use the following procedure to delete all trend data in memory (including NIBP tabular trend data) without turning power off. 1. Press the SYSTEM SETUP key. The mode menu appears. 2. Select [TREND SETUP] to display the trend selection menu. 3. Select [CLEAR TRENDS]. The selections [CONFIRM] and [CANCEL] appear. 4. Select [CANCEL] to abort the clear trends procedure. To clear the trend data, select [CONFIRM]. Default Settings User settings are stored in non-volatile memory. The monitor powers up with the same settings that were in effect when power was last turned off. To reset the monitor to the default settings press TEST key and ALARM RESET key simultaneously while applying power to the monitor by pushing the ON/STAND BY key. Default Settings System Setup Trace Speed: 25 mm/sec Displayed parameters: Zone 1: ECG Zone 2: RESP Zone 3: SpO2 Zone 4: NIBP Zone 5: Off Trend Mode: One hour Recorder: direct HR Volume: 40% Alarm Volume: 100% Monitoring Mode: Adult ECG Lead: I Filter: ON ECG size 10mm/mv HR limits (140-40) RESPIRATION Resp: Impedance Apnea delay: 20 sec Coincidence: ON RR limits (60-10) SpO2 SpO2 Alarm: ON Averaging: 8 sec Sensitivity: Normal Alarm limits (100-90) NIBP Cycle: OFF Data Format: NIBP table Alarm Type: Mean Alarm limits (160-80) TEMP (Both channels) Alarm limits: Off Vital-Guard 450C Operation and Maintenance Manual IBP 1 Alarm Type: Mean Alarm limits (120-60) Trace Scale: 0 to 240 mmHg Site Label: P1 IBP 2 Alarm Type: Mean Alarm limits (120-60) Trace Scale: 0 to 240 mmHg Site Label: P2 EtCO2 No Resp Delay: 20 sec Bar. Press: 760mmHg Trace Scale: 0 to 50 Alarm limits (50-300) 33 BATTERY OPERATION BATTERY OPERATION Internal Battery The model 450C is equipped with two internal batteries. This allows the monitor to operate for 2½ hours under its own power. In the event of a mains power failure, the model 450C will automatically switch to battery operation. A BAT indicator in the lower right corner of the display graphically displays the approximate remaining charge of the battery: full, 75 %, 50 %, 25 %. When the remaining battery charge is less than 20 minutes, the BAT indicator flashes the word LOW and an audio tone sounds every 15 seconds. The battery is continuously charged whenever the ac power is connected, even when the monitor is turned off. Charging time when the battery is fully discharged is 12 hours. If monitor is not in regular service, i.e. weekly use, to ensure maximum battery life, it is recommended that, at least once a month, the unit be run on battery until it turns itself off and then recharged. Remove the batteries if the monitor will not be in regular use for more than six months. Status of the Battery The model 450 has three LED’s (label as Charged, Charging and Battery Fault) to indicate the status of the battery. They are located in the bottom left corner of the faceplate. The following table shows the status of the battery depending on the action (ON, OFF or FLASHING) of the LED’s. Status of the Battery Charged LED Charging LED Battery Fault LED Battery Absent Pre-charge qualification Fast charging Maintenance charging *Charge Pending (Temperature out of range) **Fault OFF OFF OFF ON X X OFF FLASHING ON OFF X X ON OFF OFF OFF FLASHING ON *If the temperature of the battery exceeds 116 oF (47 oC) the battery will not charge and will remain in a Charge Pending status. **If Fault condition occurs replace the batteries immediately. Removing the Battery Refer to Disassembly and Assembly section of the Operation and Maintenance Manual to find out how to remove the batteries. WARNING: To avoid risk of fire, replace only with the same type battery (Ivy Part No. 110007). 34 Vital-Guard 450C Operation and Maintenance Manual RECORDER OPERATION RECORDER OPERATION Changing Paper Replace the roll of thermal paper as follows. 1. Press the paper eject button to open the door at the front of the recorder. Press Here If the door does not open completely, pull it toward you until it is completely open. 2. Reach in and remove the spent paper core by pulling it gently toward you. 3. Place a new paper roll between the two round tabs of the paper holder. 4. Pull some paper from the roll. Make sure the sensitive (shiny) side of the paper faces the print head. The shiny side of the paper normally faces inside the roll. 5. Align the paper with the pinch roller on the door. Print Head Pinch Roller Vital-Guard 450C Operation and Maintenance Manual 35 RECORDER OPERATION 6. Hold the paper against the pinch roller and close the door. Recorder Menus The recorder user interface is through the menu structure of the 450C. 1. Press the SYSTEM SETUP key to display the system menu. 2. Select [RECORDER SETUP] to display the recorder menu. NOTE: At the start of each printout, the printer produces a header consisting of the current readings for all parameters in use at the time of the printout, whether the parameter is displayed or not. Recorder Modes From the recorder menu, use (MODE) to select the printing mode to be used. Selections are DIRECT, TIMED, DELAY, AUTO, CRG, and REMOTE. The print mode is indicated in the lower right corner of the display. Direct To print in direct, press the PRINT key. Press PRINT again to stop printing. The plot is preceded by a header which contains all parameter readings and the time/date. The speed of the plot and vertical resolution are the same as the display. The plot is labeled with the speed of the plot in mm/s, the recorder mode, and the parameters. The following setup allows you to select which parameter is plotted in which channel of the recorder. If only one waveform is plotted or if the same waveform is selected for both channels, the recorder is scaled to use the entire 40 mm. If two different waveforms are selected, the recorder splits the plot into two 20 mm channels. 36 Vital-Guard 450C Operation and Maintenance Manual RECORDER OPERATION Use the following procedure to select the waveforms for each channel. 1. From the recorder menu, press the [CHANNEL 1] menu key to select the waveform to be printed on Channel 1. 2. Press the [CHANNEL 2] menu key to select the waveform to be printed on Channel 2. Selections for each channel are ECG, Respiration, ETCO2, SpO2 (Pleth), P1, and P2. Channel 2 can also be set to OFF. Whenever ETCO2 is being monitored, the ETCO2 waveform is used for respiration. Timed TIMED mode starts by pressing PRINT and prints for 30 seconds. The speed of the plot and vertical resolution are the same as the display. The plot is labeled with the speed of the plot in mm/s, the recorder mode, and the parameters. Delay Delay mode plots the 15 seconds before and 15 seconds after the occurrence of an alarm condition. The parameters printed are those selected as described in the Direct Mode section. The speed of the plot and vertical resolution are the same as the display. The plot is labeled with the speed of the plot in mm/s, the recorder mode, and the parameters. With no alarm, pressing PRINT starts a printout that includes the 15 seconds before and the 15 seconds after pressing the key. An asterisk marks the time when the key was pressed or the alarm occurred. The plot is preceded by a header which contains all parameter readings and the time/date. Whenever delay mode is enabled, REC DELAY is displayed in the lower right corner of the display. Auto Parameters to be printed are selected based on the alarm. The printout is the same as in delay mode except that when an alarm triggers the recorder, the parameters are selected automatically. If the recording is started by pressing the PRINT key, the selected parameters are printed. The following are the parameters printed for each type of alarm. Type of Alarm ASYSTOLE HR NO PULSE APNEA COINCIDENCE RR SpO2 NIBP IBP1 IBP2 Traces Printed Single-trace ECG Single-trace ECG, SpO2 (Pleth), P1, or P2 (based on HR source) Single-trace SpO2 (Pleth), P1, or P2 (based on HR source) ECG, Respiration ECG, Respiration ECG, Respiration ECG, SpO2 (Pleth) Single-trace ECG ECG, P1 ECG, P2 Vital-Guard 450C Operation and Maintenance Manual 37 RECORDER OPERATION CRG The recorder plots the CRG as two trend waveforms. The heart rate trend occupies the top half, and the compressed respiration occupies the lower half. If CRG is selected and respiration is not being monitored, HR only is printed. The trend is plotted at 1 mm/s. The plot is preceded by a header containing all the parameter readings and time/date. From the recorder menu, use [MODE] to select the CRG mode. While the recorder is in CRG mode, REC CRG is displayed in the lower right portion of the display. When menus are not displayed, press PRINT. The recorder then prints the real time CRG at 1 mm/s until you press PRINT again. Remote REMOTE mode will activate the recorder at a central station. Print Trend To print trends, select [PRINT TREND] from the [RECORDER SETUP] menu. The recorder prints the trends as they appear on the display. The trend is scaled to appear as it does on the display. The strip starts with a header, which contains the time and date and prints current readings for all measured parameters. Each trend is then plotted sequentially. The parameter, vertical scaling, and total time of the trend is printed with each trend. The vertical axis is printed at the start of the plot, and the horizontal time divisions are indicated. The resolution of the trend printout is: 1 hour 5 min/cm 8 hours 30 min/cm 12 hours 45 min/cm 24 hours 90 min/cm The contents of the trend buffers at the settings currently selected in the trend menu are printed. The system prints the selected trends sequentially. Once the contents of the print trend buffer have been printed, the recorder exits this mode. Print Review Trend To print Review trends: 1. Press the SYSTEM SETUP key and then select [TREND SETUP] from the setup menu. 2. Select [REVIEW TREND] to enter the Review trend mode. 3. Press [PRINT PAGE], the recorder will start printing. The resolution of the Review trend printout is: 6 Hour view View (6 hours): 30 Minute view (30 minutes): 0.5 hr / cm 2.5 min / cm The recorder prints the trends as they appear on the display. The trend is scaled to appear as it does on the display. The strip starts with a header, which contains the time and date and prints current readings for all measured parameters. Each trend is then plotted sequentially. The parameter, vertical scaling, and total time of the trend is printed with each trend. The vertical axis is printed at the start of the plot, and the horizontal time divisions are indicated. 38 Vital-Guard 450C Operation and Maintenance Manual RECORDER OPERATION Print NIBP Tab From [RECORDER SETUP] select [PRINT NIBP TAB] to print the entire contents of the tab buffer in columns as shown on the display. Recorder Messages The following are messages that appear on the display to indicate the status of the recorder. REC DIRECT: The recorder is ready to print in direct mode. REC DELAY: The recorder is set for delay mode. REC TIMED: The recorder is set for timed mode. REC REMOTE: The recorder is set for remote mode. DOOR OPEN: The recorder indicates that the door is open. PAPER OUT: The recorder is out of paper. REC ERROR: The monitor has detected a recorder failure. REC INOP: Low battery voltage. Insufficient battery charge to operate the recorder. REC HR: CRG is selected when respiration is not being monitored. HR only is printed. Example Printouts 5/11/99 Direct Mode: ECG on Channel 1 and Respiration on Channel 2 5/11/99 Direct Mode: ECG on Channel 1 and SpO2 (Pleth) on Channel 2 Vital-Guard 450C Operation and Maintenance Manual 39 RECORDER OPERATION 5/11/99 Direct Mode: ECG on Channel 1 and P1 on Channel 2 5/11/99 Direct Mode: ECG on Channel 1 and P2 on Channel 2 5/11/99 Direct Mode: ECG on Channel 1 and Channel 2 off 40 Vital-Guard 450C Operation and Maintenance Manual RECORDER OPERATION 5/11/99 Delayed Mode: ECG on Channel 1 and Channel 2 off 5/11/99 CRG Mode NIBP Table Vital-Guard 450C Operation and Maintenance Manual IBP/TEMP Table 41 ECG MONITORING ECG MONITORING When ECG monitoring, the display shows the ECG waveform, the heart rate, heart rate limits (if DISPLAY LIMITS is selected), lead selection, adult/neonate mode, and alarm indications. Also, a heart symbol, pulse, or BP symbol flashes each time a heartbeat is detected, depending on whether the rate is being triggered by the ECG, pleth, or blood pressure waveform. Safety Considerations Disposable products are intended for single-use only. Do not attempt to re-use these products. . For ECG connections use insulated probes. Don’t ECG Patient connections are electrically isolated Type CF let patient connections contact other conductive parts, including earth. See instructions for patient connections in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death. Leakage current is limited internally by this monitor to less than 10 μA. However, always consider cumulative leakage current that can be caused by other equipment used on the patient at the same time as this monitor. To avoid the potential of electrosurgery burns at ECG monitoring sites, ensure proper connection of the electrosurgery return circuit as described by manufacturer’s instructions. If improperly connected, some electrosurgery units might allow energy to return through the electrodes. Typical Electrode Placement during Surgical Procedure. Typical Electrode Placement. RA LA V RL RA LA RL LL LL Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance. For monitors used in Australia. For continued defibrillation protection and proper respiration monitoring use only patient cables with 1kΩ series resistors. Respiration circuit is tuned to operate with series resistors. 42 Vital-Guard 450C Operation and Maintenance Manual ECG MONITORING Patient Connections To ensure compliance with safety and performance specifications, always use the patient cables and leads supplied by Ivy. Other cables might not produce reliable results. NOTE: We recommend that you always use five-lead cables with monitors having the five-lead option. The use of many three-lead cables can cause poor quality signals and can inhibit the LEAD OFF alarm. When monitoring three leads, use the five-lead cable and remove the two unnecessary patient leads. Use only high quality silver/silver-chloride electrodes or equivalent. Use the following procedure for ECG monitoring: 1. Prepare each electrode site and apply the electrodes. 2. Connect the patient cable to the monitor’s right side panel ECG input. 3. Attach the leads to the electrodes. Model 450C monitors with five-lead option can accommodate both three- and five-lead configurations. 4. Use the procedures described in the following sections for alarm limit settings, lead selection, amplitude adjustment, and enabling or disabling the filter. See the menu diagram below. NOTE: For monitors designed to use both three- and five-lead cables, the LEAD OFF alarm tests only those leads that are relevant to the selected lead setting. PATIENT SETUP ECG/HR RESP/CO2 SpO2 NIBP INVASIVE BP ECG ON ECG OFF LEAD I HR SOURCE OXIMETRY FILTER ON ECG SIZE 10 m m/mv Vital-Guard 450C Operation and Maintenance Manual 43 ECG MONITORING ECG Waveform Amplitude Use the following procedure to adjust the amplitude (size) of the displayed ECG waveform. 1. Press the PATIENT SETUP key to display the main menu. Select [ECG/HR] to display the ECG menu. 2. Use the [ECG SIZE 3. Press EXIT to return to the normal display. and ] selections to adjust the ECG size. HR Alarm Limits 1. Press the ALARM SETUP key to display the alarm limits menu. 2. If necessary select [PARAMETER] to display HR limits. 3. Use the [HIGH and ] selections to set the high heart rate limit. 4. Use the [LOW and ] selections to set the low heart rate limit. Each time you press a key, the corresponding limit changes by 5 bpm. The current settings are shown on the display when the front panel DISPLAY LIMITS selection is on. 5. Press EXIT to return to the normal display. Lead Selection 1. Press the PATIENT SETUP key to display the main menu. Select [ECG/HR] to display the ECG menu. 2. Use the [LEAD] selection to set the lead selection. Available lead selections for five-lead ECG are I, II, III, aVR, aVL, aVF, and V. Selections for three-lead ECG are I, II, and III. If you select any other setting with only three leads connected, the monitor activates the LEAD OFF alarm. 3. Press EXIT to return to the normal display. ECG Filter (Adult Mode Only) 1. Press the PATIENT SETUP key to display the main menu. Select [ECG/HR] to display the ECG menu. 2. Use the [FILTER] selection to set the filter to on or off. The filter on indication is FILT; the filter off indication is DIAG (diagnostic). The filter sets the frequency response of the displayed waveform as follows: Filtered: Unfiltered (diagnostic): 0.5 to 35 Hz 0.05 to 100 Hz In neonate mode, the filter is always on. 3. 44 Press EXIT to return to the normal display. Vital-Guard 450C Operation and Maintenance Manual ECG MONITORING ECG On/Off The ECG can be turned off to monitor other parameters and not generate a LEAD OFF alarm. LEAD OFF is still functional for respiration. 1. Press the PATIENT SETUP key to display the main menu. Select [ECG/HR] to set the ECG to ON or OFF. 2. Press EXIT to return to the normal display. Pacemaker When a pacemaker has been detected, a P will start flashing in the heart symbol. Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance. Vital-Guard 450C Operation and Maintenance Manual 45 RESPIRATION MONITORING RESPIRATION MONITORING The monitor obtains the respiration signal through the same electrodes used for ECG. The lead selection does not affect the respiration signal. WARNING: This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death. CAUTION: Do not use patient cables with internal resistors for defibrillation protection when monitoring respiration. Use of such cables might cause erratic respiration readings. For proper respiration monitoring, cable capacitance between the RA and LA leads must be 400 ±100 pF. The following diagram shows the respiration menus. PATIENT SETUP ECG/HR RESP/CO2 SpO2 NIBP INVASIVE BP RESP IMPEDANCE RESP CO2 COINCIDENCE ON RESPONSE NORMAL APNEA DELAY 20 sec ZERO SENSOR RESP OFF SPAN CHECK SETTINGS Respiration Size The front panel up and down arrows control the relative size of the respiration signal. Adjust the size so that it is not so large that the peaks of the waveform are clipped on the display but large enough so that the signal triggers the rate counter. NOTE: The respiration detector requires the proper size setting to correctly detect respiration activity. 46 Vital-Guard 450C Operation and Maintenance Manual RESPIRATION MONITORING Apnea Delay 1. Press the PATIENT SETUP key to display the main menu. Select [RESP/CO2] to display the respiration menu. 2. Use [APNEA DELAY] to set the delay at 5, 10, 15, 20 seconds, or off. Once this alarm is triggered, it remains on until a respiration is detected or ALARM RESET is pressed. 3. Press EXIT to return to the normal display. Coincidence On/Off In some cases, the true respiration rate and heart rate are the same. If this condition occurs for some time, the coincidence alarm can become a nuisance. To avoid this problem, the audio and visual coincidence alarms can be turned off. Use the following procedure to enable or disable the coincidence alarm. 1. Press the PATIENT SETUP key to display the main menu. Select [RESP/CO2] to display the respiration menu. 2. Use the [COINCIDENCE] selection to turn the coincidence alarm on or off. 3. Press EXIT to return to the normal display. Respiration Rate Alarm Limits 1. Press the ALARM SETUP key to display the alarm limits menu. 2. Use the [PARAMETER] selection to display respiration rate (RR) limit settings. 3. Use the [HIGH and ] selections to set the high respiration rate limit. 4. Use the [LOW and ] selections to set the low respiration rate limit. Each time you press a key, the corresponding limit changes by 5 br/min. The current settings are shown on the display when the front panel DISPLAY LIMITS selection is on. 5. Press EXIT to return to the normal display. Respiration On/Off 1. Press the PATIENT SETUP key to display the main menu. Select [RESP/CO2] to display the respiration menu. 2. Use the [RESP] selection to turn respiration monitoring on or off. 3. Press EXIT to return to the normal display. Vital-Guard 450C Operation and Maintenance Manual 47 ETCO2 MONITORING END TIDAL CO2 MONITORING General Description The Ivy Model 450C monitor uses NonDispersive InfraRed (NDIR) gas measurement to determine CO2 gas concentration. The NDIR measurement method uses fixed (non-scanning) frequencies of infrared (IR) light. NDIR measurement is based on the phenomenon that higher gas concentrations in a given volume of gas in the path of an IR light signal create more absorption of the IR light. Therefore, higher concentrations of an IR absorbing gas create a measurably lower transmission of the IR light. Components The following components make up an NDIR instrument. See the illustration below. IR Source: A source of infrared light. The infrared light source actually produces a wide range of light at frequencies covering the IR band and extending in either direction into the visible and ultraviolet spectra. Sample Cell: The gas to be measured is transported into a sample cell with windows that allow the IR light to pass through the gas sample. The Sensor Head is mounted on the sample cell, called the Airway Adapter. The Airway Adapter has a constant volume and path length as seen by the Sensor Head. The Sensor Head and Airway Adapter windows are chosen for their non-IR absorbing quality. IR Filter: An optical bandpass filter is used to select a specific band of IR light centered on an exact wavelength. The optical IR filter’s center wavelength is chosen for the specific gas to be measured (CO2). The monitor also needs a reference channel which requires a second IR filter. IR Detector: A lead selenide IR detector converts the IR light transmitted through the sample cell into an output voltage. 48 Vital-Guard 450C Operation and Maintenance Manual ETCO2 MONITORING Sensor Head Components The diagram below represents the components of the Sensor Head. Sensor Head Case – The Sensor Head Case is sealed to control internal ambient CO2 concentration and to provide sufficient moisture resistance for cleaning. Hybrid Processing Board – The Hybrid Processing Board includes programmed control of: Lamp Power on/off Window Heating and Temperature Monitoring Detector Block Heating and Temperature Monitoring Multiplexing of Analog Signals Non-Volatile Memory containing all unit-specific data Bi-directional Digital Communications with the Signal Processing Board Vital-Guard 450C Operation and Maintenance Manual 49 ETCO2 MONITORING Lamp and Reflector Assembly – The lamp is pulsed on and off. Its collimated light beam travels through one Sensor Head Window, through the Airway Adapter containing the patient sample, through the second Sensor Head Window, and through the beam splitter. Heated Windows – The Sensor Head Windows are heated to reduce condensation. A thermistor monitors window temperature. Beam Splitter – The Beam Splitter directs part of the light falling on it to the CO2 IR Detector and the balance of the light to the Reference Channel Detector. IR Filters – An optical band pass filter is located in front of both IR Detectors. Each filter passes to its detector only the wavelength of light that is appropriate. IR Detectors – The IR Detectors convert the light falling on them into analog signals. The CO2 IR Detector’s output is relative to the CO2 concentration in the Airway Adapter, while the reference channel IR Detector is insensitive to CO2 concentration. Detector Preamplifier Board – The outputs of the IR Detectors are amplified and filtered. These analog signals are fed through the Hybrid Processing Board’s multiplexer to the Signal Processing Board. Heated Detector Block – The Detector Block is heated to stabilize the IR filter temperature. A thermistor monitors Detector Block temperature. 50 Vital-Guard 450C Operation and Maintenance Manual ETCO2 MONITORING To demonstrate the absorption of specific IR wavelengths by CO2 gas, the chart below shows the amount of IR transmission for various wavelengths of IR light through CO2. The CO2 filter passes infrared light in the range between 4.22 and 4.32 microns. The chart below shows that as the CO2 concentration increases from 2% to 10%, infrared light transmission decreases. IR light transmission is inversely proportional to the IR light absorption of the gas. By measuring how much light gets through the sample gas and the CO2 optical filter, we can calculate how much CO2 is present in the gas sample. Vital-Guard 450C Operation and Maintenance Manual 51 ETCO2 MONITORING Complications of NonDispersive InfraRed (NDIR) Monitoring IR Light Amplitude Changes – Changes in the output of the IR light source directly affect the IR detector’s voltage output for a given gas sample. In this monitor, the IR lamp pulses on and off. The on phase is created by a constant voltage, providing a consistent light output. A consistent IR lamp output is more important than a specific output level. Short and long term IR lamp amplitude changes are compensated for by use of a reference channel. A reference channel output change can be assumed to be non-gas related, and common to the CO2 channel. Software data processing compensates for IR lamp output changes. This same mechanism compensates for any other common mode source of signal degradation, such as light beam obscuration by patient secretions. Sample Gas Pressure Changes – Because a change in gas pressure in the Airway Adapter reduces the number of CO2 molecules in the IR path, without airway adapter pressure compensation, changes in gas pressure would appear as changes in CO2 concentration. Typically, the monitor measures CO2 only during the patient’s expired breath phase. At this time, airway adapter pressure is very close to local barometric pressure. The sensors are factory characterized and calibrated at sea level where local barometric pressure, and airway adapter pressure is 760 Torr. The system also has the ability to set the local barometric pressure into the monitor. The Sensor Head stores this pressure value and uses it to correct for the difference in airway adapter pressure between calibration time and normal use. Temperature Changes – Changes in the temperature of the IR filters, IR detectors, or sample gas (patient breath or calibration gas) directly affect the IR detector’s voltage output for a given gas sample. Each of these must be either held at a constant temperature or monitored for temperature compensation. During the expired phase, the patient’s breath is slightly lower than body temperature (about 34°C). This relatively constant temperature relieves the monitor of the need to control sample gas temperature or correct for its changes. Changes in sample gas flow rate can cause small sample gas temperature changes. The sensors are factory characterized and calibrated at 4.0 liters per minute. NOTE: When using bottled calibration gas for span calibration or troubleshooting, its temperature might not be 34°C. The difference between calibration gas temperature and 34°C can cause CO2 measurement errors. The IR filters and detectors are mounted on the Sensor Head’s detector block. Attached to the detector block is a thermoelectric heater strip and a thermistor. The heater temperature holds the Detector Block, IR Filters, and IR Detectors at a constant temperature (approximately 43°C). Multiple IR Absorbing Gases – N2O, water vapor, and anesthetic agents also absorb IR light and might be present in some applications. Each of these gases has different IR absorption characteristics, and choosing the correct CO2 and reference channel IR filters reduces the “cross gas interference” effect. Non-IR Absorbing Gases Present – The sample gas might also contain O2, N2O, or N2. Although O2 and N2 don’t absorb IR, they can create NDIR measurement problems via “collision line broadening.” The monitor uses assumed values for O2 and N2O and uses these values to compensate for “collision line broadening.” The default values are 21.0% O2 and 0.0% N2O. Different values can be entered and stored in the Sensor Head. NOTE: When using a calibration gas for span calibration or troubleshooting, O2 and N2O concentrations must also be entered. 52 Vital-Guard 450C Operation and Maintenance Manual ETCO2 MONITORING Zero Baseline and Span Calibration – The voltage output of the IR Detector has no absolute meaning until it is established what CO2 detector voltage represents 0.00% CO2 gas concentration and what other voltage represents full scale CO2 gas concentration (10.00%). The voltage level when the IR Lamp is off, known as the “dark level,” is the minimum voltage output of the IR Detector, and is used as the common reference for measuring all other IR Detector output voltages. When there is 0% CO2 in the sample gas, there is minimum IR absorption, and therefore, maximum IR transmission. This measurement is the maximum output voltage of the IR Detector, and is stored in the system at each Zero Calibration. All CO2 measurements are between these two values. The factory characterization of each unit includes the calculation of the system’s CO2 response curve. A field Span Calibration calculates simple multipliers that allow correction of long term component performance changes. Nonlinearity – As the IR Detector output voltage decreases with increasing CO2 gas concentration, some nonlinearities of NDIR technology must be managed. The nonlinearity of the system’s response curves was determined during its development. This nonlinearity is described in the resident CO2 response curve, and is automatically compensated for during data processing. Preparation for Monitoring Choosing an Airway Adapter Select one of the two Airway Adapters that are available. Use the Adult Airway Adapter for monitoring patients with endotracheal tube sizes greater than 4 cc. The Adult Airway Adapter is shown below. Use the Pediatric/Neonatal Airway Adapter for all other patients. The Pediatric/Neonatal Airway Adapter is shown below. Zeroing the Airway Adapter This procedure should be done at the start of monitoring or any time the message ZERO SENSOR is displayed on the monitor. Vital-Guard 450C Operation and Maintenance Manual 53 ETCO2 MONITORING 1. Insert the Airway Adapter into the Sensor as shown below. 2. Press the PATIENT SETUP key on the monitor to display the Main Menu, then select [RESP] so that CO2 is displayed. 3. Make sure that the Airway Adapter is exposed to room air and is not in the patient breathing circuit. Keep the Sensor and Airway Adapter away from all sources of CO2, such as ventilator exhaust and your own breath. 4. Select [ZERO SENSOR]. 5. After approximately 15 seconds, the message ZERO OK appears on the display. If an error message is displayed, either the Airway Adapter windows are occluded or the Sensor is defective. Replace the Airway Adapter and repeat the zeroing procedure. 6. Press the EXIT key to return to the normal display. Checking Sensor Calibration 1. Allow the sensor temperature to stabilize. 2. Place the sensor on the Span Check Cell attached to the sensor cable as shown below. Make sure that the sensor is fully seated on the cell. 3. Press the PATIENT SETUP key on the monitor to display the Main Menu, then select [RESP] so that CO2 is displayed. 54 Vital-Guard 450C Operation and Maintenance Manual ETCO2 MONITORING 4. Select [CHECK SPAN]. The test takes approximately 15 seconds. The message SPAN OK appears on the display. If SPAN FAIL appears, do not use the sensor. Have the sensor checked and calibrated by a biomedical engineer or contact Ivy Biomedical Systems, Inc. 5. Press the EXIT to return to the normal display. The Patient Airway Connection 1. Install the Sensor/Airway Adapter into the patient airway at the proximal end of the airway circuit between the endotracheal tube and the ventilator circuit wye. The Sensor cable should face away from the patient. 2. Connect the Sensor cable connector to the ETCO2 input on the monitor. 3. Verify the presence of a CO2 waveform on the monitor. Response Setting Three response settings are available on the Model 450C monitor, slow, fast, or normal. Use the following procedure to set the response. 1. Press the PATIENT SETUP key on the monitor to display the Main Menu, select [RESP/CO2], then select [RESP] so that CO2 menu is displayed. 2. Select [SETTINGS] to display next menu, then select [NEXT SETTING] until Response is shown. 3. Select [RESPONSE] until the desired response setting is displayed. 4. Press the EXIT key to return to the normal display. Vital-Guard 450C Operation and Maintenance Manual 55 ETCO2 MONITORING Compensation Settings As described earlier in this section, settings are available for entering barometric pressure. N2O, and O2 in case the actual values differ from the default settings, which were entered into the Sensor at the factory. Default settings are barometric pressure = 760 Torr, N2O = 0.0%, and O2 = 21.0%. If necessary, use the following procedures to change these settings. Barometric Pressure 1. Press the PATIENT SETUP key on the monitor to display the Main Menu, select [RESP/CO2], then select [RESP] so that CO2 menu is displayed. Then select [SETTINGS]. 2. Use the [BAR PRESS 3. To return to the default setting (760 Torr) select [DEFAULT]. 4. Press the EXIT key to return to the normal display. and ] selections to set the barometric pressure to the desired value. N2O Compensation 1. Press the PATIENT SETUP key on the monitor to display the Main Menu, select [RESP/CO2], then select [RESP] so that CO2 menu is displayed. Then select [SETTINGS]. 2. Select [NEXT SETTING] until N2O is displayed. 3. Use the [N2O 4. Press the EXIT key to return to the normal display. and ] selections to set the N2O to the desired value. O2 Compensation 1. Press the PATIENT SETUP key on the monitor to display the Main Menu, select [RESP/CO2], then select [RESP] so that CO2 menu is displayed. Then select [SETTINGS]. 2. Select [NEXT SETTING] until O2 is displayed. 3. Use the [O2 4. Press the EXIT key to return to the normal display. 56 and ] selections to set the O2 to the desired value. Vital-Guard 450C Operation and Maintenance Manual ETCO2 MONITORING Trace Scale Setting Two trace scale settings are available for waveform display, 0 to 50 and 0 to 100. Use the following procedure to set the trace scale. 1. Press the PATIENT SETUP key on the monitor to display the Main Menu, select [RESP/CO2], then select [RESP] so that CO2 menu is displayed. Then select [SETTINGS]. 2. Use the [TRACE SCALE] selection to select the desired trace scale setting. 3. Press the EXIT key to return to the normal display. CO2 Alarm Limits 1. Press the ALARM SETUP key to display the alarm limits menu. 2. If necessary select [PARAMETER] until ETCO2 is displayed. 3. Use the [HIGH and ] selections to set the high CO2 limit. 4. Use the [LOW and ] selections to set the low CO2 limit. Each time you press a key, the corresponding limit changes by 2 Torr. The current settings are shown on the display when the front panel DISPLAY LIMITS selection is on. 5. Press EXIT to return to the normal display. Respiration Rate Alarm Limits 1. Press the ALARM SETUP key to display the alarm limits menu. 2. Use the [PARAMETER] selection to display respiration rate (RR) limit settings. 3. Use the [HIGH and ] selections to set the high respiration rate limit. 4. Use the [LOW and ] selections to set the low respiration rate limit. 5. Press EXIT to return to the normal display. Respiration On/Off 1. Press the PATIENT SETUP key to display the main menu. Select [RESP/CO2], then select [RESP] to set respiration to OFF. 2. Press EXIT to return to the normal display. Vital-Guard 450C Operation and Maintenance Manual 57 ETCO2 MONITORING Gas Calibration The Sensor should never need to be calibrated. However, if hospital regulations require a periodic calibration, use the following procedure. 1. Make sure the Sensor has been operating for at least 30 minutes with no error conditions reported. 2. Zero the Sensor on an Adult Airway Adapter. See “Zeroing the Sensor” earlier in this section. 3. Press the PATIENT SETUP key on the monitor to display the Main Menu, select [RESP/CO2], then select [RESP] so that CO2 menu is displayed. The select [SETTINGS]. 4. Select [TRACE SCALE] and press TEST at the same time to display a “hidden” menu. 5. Introduce a 1.0 ±0.1 liter per minute flow of 5% ±0.1% CO2 balance Nitrogen into the Airway Adapter. The calibration gas should be held at a constant 34°C ±3°C. The flow of gas out of the Airway Adapter must be free and unobstructed. The reading should be 38 ±2 Torr. If 10% ±0.1% CO2 balance Nitrogen is available, check the accuracy with this. The reading should be 76 ±3 Torr. 6. Press the EXIT key to return to the normal display. 58 Vital-Guard 450C Operation and Maintenance Manual INVASIVE PRESSURE MONITORING INVASIVE PRESSURE MONITORING Model 450C monitors configured for invasive pressure monitoring have two channels available for monitoring pressure. Procedures and specifications are the same for both channels. These procedures refer primarily to P1, which uses the PRESS 1 connector (the lower pressure connector). Text in parentheses ( ) refers to P2. Pressure Transducer To ensure conformance with all safety and performance specifications, use only the recommended pressure transducers and cable. These are available from Ivy Biomedical Systems. Transducers are not to be immersed in liquid unless disconnected from the monitor. WARNING: Disposable transducers are for single use only. Do not attempt to re-use these products. WARNING: Disposable transducers and accessories identified as STERILE shall be handled in accordance to the manufacturer’s instructions. Connecting the Transducer 1. Connect the pressure cable to the PRESS 1 (PRESS 2) connector on the monitor’s side panel. 2. Make sure that the catheter tip is at the same height as the dome of the pressure transducer during both zeroing and monitoring. 3. If a continuous flow catheter flush system is used, fill the transducer dome and set the transducer at the desired level before zeroing. 4. Always do a final zeroing of the transducer after it is connected to the fluid system, positioned, and allowed to stabilize for a few minutes. 5. Always follow the instructions that come with the pressure transducer to ensure proper calibration and operation. Vital-Guard 450C Operation and Maintenance Manual 59 INVASIVE PRESSURE MONITORING Zeroing the Transducer If the pressure transducer has not been zeroed, the monitor displays the message ZERO TRANSDUCER. Use the following procedure to zero the transducer. See the menu diagram below. PATIENT SETUP ECG/HR PARAMETER P1 RESP/CO2 ZERO TRANSDUCER SpO2 ALARM TYPE MEAN NIBP TRACE SCALE 0 TO 240 INVASIVE BP SITE LABEL P1 1. Vent the pressure transducer to air 2. Press the PATIENT SETUP key to display the main menu. Select [INVASIVE BP] to display the pressure select menu. 3. Use the [PARAMETER] selection to select P1 or P2 for the transducer being zeroed. 4. Select [ZERO TRANSDUCER] to zero the transducer. Once the system has been correctly zeroed, the ZERO TRANSDUCER message disappears. If the transducer has an offset greater than ±150 mmHg or a varying signal, the monitor does not zero the transducer, and a tone sounds when you select [ZERO TRANSDUCER]. 4. Press EXIT to return to the normal display. NOTE: If Barometric Pressure changes then the transducer must be zero again. Blood Pressure Scale 1. Press the PATIENT SETUP key to display the main menu. Select [INVASIVE BP] to display the pressure select menu. 2. Use the [PARAMETER] selection to select P1 or P2 for the pressure channel being set. 3. Use the [TRACE SCALE] selection to select the scale. Selections are ±30, 60, 120, 240, and 300. 4. Press EXIT to return to the normal display. 60 Vital-Guard 450C Operation and Maintenance Manual INVASIVE PRESSURE MONITORING Pressure Alarm Type 1. Press the PATIENT SETUP key to display the main menu. Select [INVASIVE BP] to display the pressure select menu. 2. Use the [PARAMETER] selection to select P1 or P2 for the pressure channel being set. 3. Use the [ALARM TYPE] selection to select the pressure to be used to trigger the blood pressure alarm. Selections are systolic (SYS), diastolic (DIAS), MEAN, and OFF. 4. Press EXIT to return to the normal display. Pressure Alarm Limits 1. Press the ALARM SETUP key to display the alarm limits menu. 2. If necessary select [PARAMETER] to display P1 or P2 limits. If the alarm for P1 or P2 has been set to off, that selection does not appear in the [PARAMETER] selections. 3. Use the [HIGH and ] selections to set the high blood pressure limit. 4. Use the [LOW and ] selections to set the low blood pressure limit. Each time you press a key, the corresponding limit changes by 2 mmHg. The current settings are shown on the display when the front panel DISPLAY LIMITS selection is on. 5. Press EXIT to return to the normal display. Expanded Pressure Scale Use the following procedure to display one or both pressure waveforms on an expanded scale in Zones 3 and 4. 1. Press the SYSTEM SETUP key to display the mode menu. Then select [DISPLAY SETUP]. 2. Use the [ZONE 4] selection to select expanded pressure display. Selections are Zones 3 and 4 expanded P1, Zones 3 and 4 expanded P2, and Zones 3 and 4 expanded P1/P2. 3. Press EXIT to return to the normal display. Vital-Guard 450C Operation and Maintenance Manual 61 INVASIVE PRESSURE MONITORING Alternate Pressure Site Labeling and Automatic Scale/Limit Adjustment Feature (If present) NOTE: This feature must be enabled by setting the Pressure Site Labels option in the Configuration Menu (see service manual) to Present. When enabled, the user may select alternate labels by using the SITE LABELING soft key in the Invasive Pressure Setup menu. Labels for invasive blood pressures (P1 and P2) may be changed to one of several alternate labels at the users discretion. Site label selections for P1 are: P1, ART1, CVP1, PA1, ICP1, UAC1, and UVC1. Site label selections for P2 are: P2, ART2, CVP2, PA2, ICP2, UAC2 and UVC2. These labels will appear on both the screen, and the chart recorder printouts. When a pressure site label is changed, the alarm limits are also automatically adjusted to reflect that change. Limits are stored separately for each site label. The default limits are as follows (channel 2 defaults are the same as the channel 1 defaults). Note that one set of invasive pressure alarm limits is stored regardless of whether Adult or Neonatal mode has been selected. Site Label P1 ART1 CVP1 PA1 ICP1 UAC1 UVC1 SYS High Low 150 80 150 80 -10 10 150 80 20 4 100 40 20 4 DIAS High Low 100 50 100 50 -10 10 100 50 20 4 60 20 20 4 MEAN High Low 120 60 120 60 -10 10 120 60 20 4 70 30 20 4 In addition, pressure scales for waveforms and trends are automatically adjusted whenever the user changes pressure site labels. The default scale selections are as follows (again, P2 scales are the same choices as P1 scales): Site Label P1 ART1 CVP1 PA1 ICP1 UAC1 UVC1 Scale 0 to 240 mmHg 0 to 240 mmHg -30 to 30 mmHg 0 to 240 mmHg -30 to 30 mmHg 0 to 120 mmHg 0 to 60 mmHg PATIENT SETUP 62 ECG/HR PARAMETER P1 RESP/CO2 ZERO TRANSDUCER SpO2 ALARM TYPE MEAN NIBP TRACE SCALE 0 TO 240 INVASIVE BP SITE LABEL ART1 Vital-Guard 450C Operation and Maintenance Manual MASIMO SET® PULSE OXIMETRY MONITORING MASIMO SET® PULSE OXIMETRY MONITORING Overview Pulse oximetry allows you to continuously and no invasively monitor a patient’s hemoglobin oxygen saturation. The oximetry sensor contains two light emitting diodes (LEDs) that transmit specific wavelengths of light, which are received by a photodetector. Oxygen saturated blood absorbs light differently as compared to unsaturated blood. Thus the amount of light absorbed by blood can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood. The monitor displays this ratio as percent SpO2. Normal values typically range from 95 to 100% at sea level. Principles of Operation The Model 450C Pulse Oximeter is based on three principles: 1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry). 2. The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography). 3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse. The Model 450C Pulse Oximeter as well as traditional pulse oximetry determines SpO2 by passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared lightemitting diodes (LEDs) in oximetry sensors serve as the light sources, a photodiode serves as the photodetector. Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blood volume. This assumes that the blood flow in the region of the sensor passes entirely through the capillary bed rather than through any arterio-venous shunts. The traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean absorbance (DC) at each of two wavelengths, 660 nm and 940 nm. S(660) = AC(660)/DC(660) S(940) = AC(940)/DC(940) The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals: R = S(660)/S(940) The value of R is used to find the saturation SpO2 in a look-up table built into the oximeter’s software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies. Vital-Guard 450C Operation and Maintenance Manual 63 MASIMO SET® PULSE OXIMETRY MONITORING The Model 450C Pulse Oximeter assumes that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of noise during the pulse. The Model 450C monitor decomposes S(660) and S(940) into an arterial signal plus a noise component and calculates the ratio of the arterial signals without the noise: S(660) = S1 + N1 S(940) = S2 + N2 R = S1/S2 Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the saturation SpO2 in an empirically derived equation into the oximeter’s software. The values in the empirically derived equation are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies. The above equations are combined and a noise reference (N’) is determined: N' = S(660) - S(940) x R If there is no noise N' =0; then S(660) = S(940) x R which is the same relationship for the traditional pulse oximeter. The equation for the noise reference is based on the value of R, the value being seeked to determine the SpO2. The Model 450C software sweeps through possible values of R that correspond to SpO2 values between 1% and 100% and generates an N' value for each of these R values. The S(660) and S(940) signals are processed with each possible N' noise reference through an adaptive correlation canceller (ACC) which yields an output power for each possible value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete Saturation Transform (DSTTM) plot of Relative output power versus possible SpO2 value as shown in the following figure, where R corresponds to SpO2 = 97%. Relative The red light power range is 1mw to 3 mw. The infrared light power range is 0.7mw to 3mw. 64 Vital-Guard 450C Operation and Maintenance Manual MASIMO SET® PULSE OXIMETRY MONITORING The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO2 value. This entire sequence is repeated once every two seconds on the most recent four seconds of raw data. The Model 450C SpO2 therefore corresponds to a running average of arterial hemoglobin saturation that is updated every two seconds. WARNING: The pulse oximeter should NOT be used as an apnea monitor. WARNING: The pulse oximeter should be considered an early warning device. If a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. Caution: Use only sensors specified by Ivy Biomedical Systems, Inc. If you use sensors other than those manufactured by the Masimo corp., it might degrade performance and could damage the pulse oximeter. Caution: Tissue damage can be caused by incorrect application or use of the sensor. Check the sensor site frequently. Do not allow the sensor to remain on one site for a prolonged period of time, especially when monitoring neonates. Refer to the sensor’s specific instructions. Caution: Never attach a SpO2 sensor on a limb being monitored with a blood pressure cuff or a limb with restricted blood flow. Caution: A poorly applied sensor might give incorrect saturation values. Reapply the sensor. Caution: Choose a site with sufficient perfusion to ensure accurate oximetry values. Caution: Certain nail aberrations, nail polish, fungus, etc. might give inaccurate oximetry values Caution: Do not use the Model 450C Pulse Oximeter or sensors during Magnetic Resonance Imaging (MRI). Pulse Oximetry Sensors To ensure conformance with all safety and performance specifications, use only the recommended pulse oximetry sensors. Monitoring Procedure Use the following procedure for monitoring pulse oximetry: 1. Choose a site that is well perfused and provides proper alignment of the LEDs and receiving photodetector Select a site that has unrestricted blood flow Do not restrict blood flow when securing sensor with tape Select an appropriate sensor and apply it to the patient, following the directions for use provided with the sensor Do not select a site near potential electrical interference (electrical cords, for example). 2. Connect the cable to the monitor’s SpO2 input. 3. Plug the sensor into the extension cable. 4. Use the procedures described in the following sections for alarm limit settings, response mode settings, and enabling or disabling the SpO2 alarm. Vital-Guard 450C Operation and Maintenance Manual 65 MASIMO SET® PULSE OXIMETRY MONITORING PATIENT SETUP ECG/HR SpO2 ALARM ON RESP/CO2 AVERAGING 8 SEC SpO2 SENSITIVITY NORMAL NIBP INVASIVE BP SpO2 Alarm Limits 1. Press the ALARM SETUP key to display the alarm limits menu. 2. Use the [PARAMETER] selection to display SpO2 % limit settings. 3. Use the [HIGH and ] selections to set the high SpO2 % limit. 4. Use the [LOW and ] selections to set the low SpO2 % limit. Each time you press a key, the corresponding limit changes by 1 %. The current settings are shown on the display when the front panel DISPLAY LIMITS selection is on. 5. Press EXIT to return to the normal display. Response Mode Settings 1. Press PATIENT SETUP to display the menu. Select the [SpO2] to display the SpO2 menu.. 2. Use the [SpO2 ALARM] selection to set the Alarms on/off. 3. Use the [AVERAGING] selection to set the response time – 6, 8, 10, 12, 14 or 16 sec. 4. Use the [SENSITIVITY] selection to set the sensitivity level. (Options – Normal and High). The High sensitivity level should be used when the clinician wants to have absolute low perfusion performance of the Masimo SET® and is willing to sacrifice some sensor off detection capability. 5. Press EXIT to return to the normal display. Default Values The following defaults are set: 1. High SpO2 limit – set to 100. 2. Low SpO2 limit – set to 90. 3. Averaging – set to 8 sec. 4. Sensitivity – set to Normal. 66 Vital-Guard 450C Operation and Maintenance Manual MASIMO SET® PULSE OXIMETRY MONITORING Pulse Oximetry with ECG Off When you are monitoring oxygen saturation but not ECG, set the ECG/HR menu setting to OFF to inhibit unwanted LEAD OFF alarms. With these settings, the heart rate on the display is derived from the pulse waveform and has a flashing pulse symbol for each detected heartbeat. Use the following procedure to set ECG to OFF. 1. Press the PATIENT SETUP key to display the main menu. Select [ECG/HR] to display the ECG/HR menu. 2. Use the [ECG] selection to set ECG to off. When ECG is off, heart rate can be computed from the pleth waveform. NOTE: To set heart rate limits when using any heart rate source, use the ALARM SETUP menus as described in the ECG Monitoring section of this manual. Pulse Oximetry Considerations If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the Model 450C Pulse Oximeter for proper functioning. NOTE: The waveform displayed by the SpO2 signal is not proportional to the pulse volume. Inaccurate measurements may be caused by: • Incorrect sensor application or use • Significant levels of dysfunctional hemoglobin (e.g., carboxyhemoglobin or methemoglobin) – see note. • Intravascular dyes such as indocyanine green or methylene blue – see note. • Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material) • Excessive patient movement • Venous pulsations • Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line The Model 450C can be used during defibrillation, but the readings may be inaccurate for a short time. Loss of pulse signal can occur in any of the following situations: • The sensor is too tight • There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp or sunlight • A blood pressure cuff is inflated on the same extremity as the one with a SpO2 sensor attached • The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia • There is arterial occlusion proximal to the sensor • The patient is in cardiac arrest or is in shock NOTE: A pulse oximeter measures functional hemoglobin saturation. This is different to an arterial blood gas that measures fractional hemoglobin saturation. Differences can occur when significant levels of HbCO (carboxyhemoglobin), HbMET (methomoglobin) indocynanine green or methylene blue exist. Vital-Guard 450C Operation and Maintenance Manual 67 NIBP MONITORING NIBP MONITORING General Description The Model 450C uses the oscillometric method for measuring non-invasive blood pressure (NIBP). The monitor automatically inflates and then slowly deflates the pressure cuff. Pressure fluctuations from the arterial pulse are detected by the monitor and used to determine the systolic, diastolic, and mean pressure. The monitor displays numeric values for this measurement on the left side of the monitor. No waveform is displayed. For proper NIBP monitoring, use the accessories listed in the Accessories section of this manual. NIBP has three modes of operation: manual, automatic, and stat. Press the CYCLE key to set the desired mode. In manual mode, a single measurement is taken by pressing the START key. Automatic mode generates measurements at regular intervals until the STOP key is pressed. Intervals are programmable for 1, 2, 3, 4, 5, 10, 15, 20, 30, or 60 minutes. In STAT mode, pressing the START key initiates a series of measurements taken for a five-minute period. A tabular display shows data as it is measured at the time of each NIBP reading. The display contains columns for time of day; systolic, diastolic, and mean NIBP; peripheral pulse measured from the NIBP cuff; respiration rate; SaO2; invasive blood pressures and temperature. The latest four readings are displayed, and a scrolling procedure allows you to display previous readings. NIBP Monitoring Considerations • Do not use this device on a patient who has an artificial heart or lung. • Measurement might be impossible in case of continuous noise or when the patient’s pulse is highly irregular. • When this device is used to measure the blood pressure of critically conditioned patients, the pressures should be measured again by stethoscope or palpation if the indicated values are doubted. • Since the pulse rate is measured at a distal part of the body, it might be different from the rate computed from the ECG. • Use of the correct size cuff and proper wrapping help ensure accurate measurements. • Do not restrict or compress the external tubing. • Compression of the cuff or hose can cause noise, which might interfere with the measurement. • Try to keep the patient relaxed and quiet during the measurement. Muscle tension or talking can interfere with the measurement. • Check to be sure that use of the equipment does not result in prolonged impairment of the circulation of the patient. • The repeated use of the Short Term Automatic Mode (STAT MODE) for more than five minutes can caused tissue damaged. 68 Vital-Guard 450C Operation and Maintenance Manual NIBP MONITORING Cuff Placement Proper cuff size and placement are essential to assure accurate blood pressure measurement. The American Heart Association recommends that cuff sizes should be at a length-to-width ratio of about 2:1, ensuring that if the bladder width is 40% of the arm circumference, the bladder length will encircle 80% of the arm. Also, care should be taken to center the bladder directly over the brachial artery. Cuff too narrow Cuff proper width On the left, the bladder width is small for the arm, and full cuff pressure is never applied to the artery which can caused an erroneously high pressure result. On the right, the bladder width is adequate for the arm, and full cuff pressure is applied to the brachial artery. Cuffs for thighs are available for large patients or those where neither arm is available for cuff placement. Blood pressure measured at the thigh is typically 20-30 mmHg higher than blood pressure measured at the upper arm. Monitoring Procedure 1. Connect the air hose fitting to the NIBP connector on the monitor’s side panel. To remove move the sleve back and pull the air hose. Also connect the other end of the air hose to the cuff fitting. NIBP connector Air Hose Fitting Air Hose Fitting Cuff Fitting Neonate Sleve Monitor’s Side Vital-Guard 450C Operation and Maintenance Manual Cuff’s Side 69 NIBP MONITORING 2. Apply the cuff to the patient as follows. • Wrap the cuff snugly, with room between the cuff and arm for two fingers. If the cuff is wrapped too loosely, it cannot be inflated properly causing possible errors in measured values. • Wrap the bare arm when possible. If clothing oppresses the arm, measured values might not be reliable. The end of the cuff should fall inside the range marked on the inside of the cuff. If it doesn’t, use a different size cuff. Heart Cushion • Keep the cuffed part of the arm at the same level as the heart. If it is above the level of the heart the blood pressure measurement will be lowered. If it is below the heart level, the blood pressure will be raised (due to the physical weight of the blood). • Do not compress the cuff or the rubber hose externally. Compression of the cuff or the rubber hose will cause measurement error. Rest the arm on a cushion to prevent compression against the body. • Keep the patient as still as possible during the measurement. WARNING: Always check the mode setting before starting an NIBP procedure. Monitoring a neonate in adult mode can cause injury to the patient. 3. Select the NIBP monitoring mode as described in the following procedures. 4. Press the START key to initiate measurements. 5. Press STOP/DEFLATE to deflate the cuff and end all NIBP procedures. If the monitor cannot obtain a valid reading in manual mode, it displays a small number 1 near the NIBP mean value display and repeats the measurement. The monitor might try up to four measurements, depending on the problem, until a valid reading is obtained, displaying the number of tries after each measurement. After several unsuccessful tries, the monitor cancels the measurement and displays the CHK CUFF alarm message. NIBP Graph To display the NIBP graph, press the PATIENT SETUP key, select [NIBP], and select [DATA FORMAT] until it is set at GRAPH. The oscillation profile assists the clinician in determining the validity of the NIBP measurement. An erratic or flat profile suggests that excessive motion or other artifact may have affected the measurement. A profile shaped like a bell curve represents a measurement not affected by motion or other artifact. 70 Vital-Guard 450C Operation and Maintenance Manual NIBP MONITORING NIBP Messages If the monitor detects any problems with the measurement, one of the following messages is displayed. In most cases, the monitor attempts to get a good reading several times before displaying the message. The number of attempts is displayed near the NIBP readings. Alarm Messages CHECK CUFF: Check the cuff and hose connector for leaks. Check for patient movement and check the cuff for proper attachment. MOTION ARTIFACT: Check for patient movement. LOW INFLATION: Check for insufficient monitor pressure because of high blood pressure. ABNORMAL PULSE: Check for patient movement or arrhythmic patient. TIME EXCEEDED: Check the cause of obstructed air discharge, such as patient movement or bent or crimped hose. HIGH PULSE RATE: Check the cause of obstructed air discharge, such as patient movement or bent or crimped hose. OVER PRESSURE: Check for folded arm of patient or bent hose. WEAK PULSE: Check for improper attachment of cuff. CHECK CUFF HOSE: Check for improper cuff or improper attachment of cuff. CHECK CUFF SIZE: Check for neonatal cuff being used in ADULT mode. Non-Alarm Messages PRESS START: Indicates that you must press the NIBP START key to resume measurements. MVT (movement): Indicates that the monitor detected some patient movement during the measurement and the readings might be less reliable. INOPERABLE: The monitor has detected an NIBP failure. Tabular Scrolling Use the following procedure to scroll the tabular display to view previous readings. 1. Press the PATIENT SETUP key and select [NIBP] to display the NIBP menu. 2. Select [SCROLL displayed. 3. Press EXIT to return to normal display. The data selected remains on the display until the next NIBP reading or until the scrolling procedure is repeated. ] to scroll back or [SCROLL Vital-Guard 450C Operation and Maintenance Manual ] to scroll forward until the desired readings are 71 NIBP MONITORING Clear Tabular Data Use the following procedure to delete all tabular data in memory without turning power off. 1. Press the SYSTEM SETUP key then select [TREND SETUP]. 2. Select [CLEAR TRENDS] to delete all trend data in the monitor, including tabular data. 3. Select [CONFIRM] to proceed with clearing data or [CANCEL] to retain all data. NIBP Mode Select Press the CYCLE key in the front panel NIBP area repeatedly until the desired mode is displayed in the zone where NIBP values are displayed. Available modes are 1, 2, 3, 4, 5, 10, 15, 20, 30, or 60 minute automatic cycles, STAT, and OFF (MANUAL). NIBP Alarm Settings You must select one of the NIBP values (systolic, diastolic, or mean) to be used to trigger the NIBP alarm and then set up upper and lower alarm limits. NOTE:When the monitor alarms, there is a delay of <0.3s to the signal output connector for remote equipment. 1. Press PATIENT SETUP then select [NIBP] to display the NIBP menu. 2. Use [ALARM TYPE] to select the pressure to be used to trigger the NIBP alarm. (systolic). DIAS (diastolic), MEAN and OFF. 3. Press EXIT to return to the normal display. 4. Press ALARM SETUP. 5. Use the [PARAMETER] selection to select NIBP. 6. Use the [HIGH and ] selections to set the high NIBP limit. 7. Use the [LOW and ] selections to set the low NIBP limit. Selections are SYS Each time you press a key, the corresponding limit changes by 2 mmHg. The current settings are shown on the display when the front panel DISPLAY LIMITS selection is on. 8. Press EXIT to return to the normal display. NIBP Calibration 1. To enter the calibration mode, press TEST, ALARM RESET, and START at the same time. 2. Momentarily block the NIBP input and then attach the cuff to a manometer or other pressure measuring device. 3. Pump in pressure, and compare the manometer reading to the reading on the monitor display. 4. Press STOP/DEFLATE to exit the calibration mode. 5. With a cuff attached to the NIBP input, enter the calibration mode as described above. One minute after the monitor reaches a maximum pressure reading, leakage should be <5 mmHg/3 min. 72 Vital-Guard 450C Operation and Maintenance Manual TEMPERATURE MONITORING TEMPERATURE MONITORING Use only YSI Series 400 temperature probes or equivalent. Probes and cables are available from Ivy Biomedical Systems. WARNING: Disposable probes are for single use only. Do not attempt to re-use these products. 1. Connect the temperature cable to one of the TEMP connectors on the monitor’s side panel. 2. Locate the probe on the patient and wait for the probe temperature to stabilize. The temperature is displayed at the bottom of the screen. The label T1 refers to TEMP 1, the connector to the left; the label T2 refers to TEMP 2. When both temperature probes are connected to the monitor, the difference between the two temperatures (∆T) is displayed in Zone 5. Temperature Alarms Description Alarm limits for each of the two temperature channels may be set via the Alarm Setup menu, in the same manner as setting other limits. Temperature alarms may be set to off, (The default is off). Temperature alarm messages appear in the alarm overflow area (lower left corner of the screen). Temperature alarms are never latched, even if the latched alert option is enabled for other parameters. ALARM SETUP PARAMETER T1 HIGH 39.2 LOW 36.0 Vital-Guard 450C Operation and Maintenance Manual 73 ALARM MESSAGES ALARM MESSAGES The following is a list of alarms and ranges for which they can be set. When the alarm triggers, the alarm indicator flashes on the display and the audio alarm tone sounds. Pressing ALARM RESET turns off any alarms that have triggered. If the measurement returns to within the limits, the alarm turns off. The ALARM PAUSE key disables the alarms for two minutes or until ALARM PAUSE is pressed again. High heart rate: 15 to 300 bpm in 5 bpm increments Low Heart Rate: 15 to 300 bpm in 5 bpm increments High Resp Rate: 5 to 150 br/min in 5 br/min increments Low Resp Rate: 5 to 150 br/min in 5 br/min increments High ETCO2: 10 to 100 Torr in 2 Torr increments Low ETCO2: 10 to 100 Torr in 2 Torr increments NIBP High: Selectable systolic, diastolic, or mean 10 to 300 mmHg in 2 mmHg increments NIBP Low: Selectable systolic, diastolic, or mean 10 to 300 mmHg in 2 mmHg increments NOTE: For additional NIBP alarm conditions, see the NIBP Monitoring section of this manual. IBP High: Selectable systolic, diastolic, or mean; -40 to 300 mmHg in 2 mmHg increments IBP Low: Selectable systolic, diastolic, or mean; -40 to 300 mmHg in 2 mmHg increments NOTE: Invasive and non-invasive pressures can be set to alarm on systolic, diastolic, or mean. High SpO2: 50 to 100%in 1% increments Low SpO2: 50 to 100% in 1% increments Asystole: R-to-R interval >6 seconds No Pulse: When triggering from pleth or invasive pressure, the interval between heartbeats exceeds six seconds Lead Off: Detached lead or offset potential ≥0.5 V. This alarm is not reset by the ALARM RESET key Check Leads: Electrode impedance is >4 kΩ Coincidence: When QRS and respiration triggers are synchronized for eight consecutive events Apnea: Absence of detectable respiration activity for 5, 10, 15, or 20 seconds, selectable 74 Vital-Guard 450C Operation and Maintenance Manual MONITOR TESTING MONITOR TESTING Press and hold the TEST key to test the internal functions of the monitor. You should do this each time you begin monitoring a patient. The TEST function generates a 1 mV ECG pulse at 70 bpm, a respiration signal at 70 br/min and a coincidence check, which are displayed on the display and are available at the rear panel connector. The monitor also displays invasive pressure readings of 150/50 and temperature readings of 40°C. If these indications are not present, contact qualified service personnel. To test the visual and audio alarms turn on the monitor and press the ALARM PAUSE key. Check that the LEAD OFF messages is displayed on the ECG channel and the audio alarm is on. While pressing the TEST key check for the following sequence to happen: 1) LEAD OFF message disappear, 2) Monitor starts counting QRS, 3) HR<40 message appears on ECG channel, audio alarm is triggered, 4) RR<10 message appears on ECG channel, audio alarm is triggered, 5) A few seconds after the HR<40 message disappeared, a COINCIDENCE message is displayed on the Respiration channel. Stop pressing the TEST key and press ALARM OFF, all audio alarms should be silenced and visual alarms should be displayed. Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local or governmental regulations. In the event that internal adjustment or recalibration is necessary, refer to the Operation and Maintenance Manual for this equipment. Note: If no display is visible on the monitor, the monitor is inoperable. Contact qualified personal. When ECG input is >0.5 V, a inoperable condition is indicated by flashing LEAD OFF indicator on the display. Vital-Guard 450C Operation and Maintenance Manual 75 MAINTENANCE AND CLEANING MAINTENANCE AND CLEANING The Monitor When necessary, clean the exterior surfaces of the monitor with a cloth or swab dampened with a warm water and mild detergent solution. Do not allow liquids to enter the interior of the instrument. CAUTION: • Do not autoclave, pressure sterilize, or gas sterilize the monitor. • Do not soak or immerse in any liquid. • Use cleaning solution sparingly. Excessive solution can flow into the monitor and cause damage to internal components. • Do not touch, press or rub the display and covers with abrasive cleaning compounds, instruments, brushes, rough surface materials, or bring them into contact with anything that could scratch the display or the covers. • Do not use petroleum based or acetones solutions, or other harsh solvents, to clean the monitor. Patient Cables Do not autoclave the patient cables. Wipe the cables using a mild detergent solution. Never submerge the cables in any liquid or allow liquids to enter the electrical connections. Reusable Pressure Transducer 1. Remove the dome. 2. Clean the transducer as recommended by manufacturer. CAUTION: Do not immerse any part of the electrical connector of the transducer in the cleaning solution at any time. Examine the outer sheath of the cable for perforations. If the outer covering is damaged in any way, do not immerse the cable in the cleaning solution; this might result in moisture entering the transducer case, which is vented through the cable. WARNING: If liquids are permitted to enter the electrical connector, resistance between the electrical element and the transducer case should be checked to ensure that the leakage current is below acceptable levels for safe use on patients. 76 Vital-Guard 450C Operation and Maintenance Manual MAINTENANCE AND CLEANING Cleaning and Reuse of SpO2 Sensors Reusable sensors can be cleaned as follows: 1. Remove the sensor from the patient. 2. Clean the sensor as recommended by the manufacturer. NOTE: If the sensor fails to track the pulse consistently, the sensor might be incorrectly positioned. Reposition the sensor or choose a different monitoring site. CAUTION: Do not soak or immerse the sensor in any liquid solution. Do not sterilize any sensor by irradiation, steam, or ethylene oxide. Reusable Temperature Probes Clean the probes as recommended by the manufacturer. CAUTION: Probe plugs should not be immersed. CAUTION: Never boil the temperature probe. Autoclaving might cause the insulation to fail, and might also cause the probe to give inaccurate readings. EtCO2 Sensor and Airway Adapters The Sensor Head, Head Cables(s) and Airway Adapters should be cleaned as recommended by manufacturer. CAUTION Do not immerse the Head or Cables in cleaning solution or any other liquids. The Sensor Head can not be sterilized. Preventive Maintenance ECG & RESP Check that: • Cables and Leads are clean and intact. • The LEAD OFF message is displayed when the patient cable is connected, but the patient leads are not connected. Connecting the patient leads together should make the message disappear. SpO2 Check that: • Cables and Leads are clean and intact. • The probe is functioning (place it on a finger). Temperature Check that: • Temperature probe and cable are clean and intact. • Both channels are working (connect a temperature probe). Vital-Guard 450C Operation and Maintenance Manual 77 MAINTENANCE AND CLEANING Invasive Blood Pressure Check that: • Cables and pressure transducers are clean and intact. • The device recognizes cable connection (activated on the display). • The zeroing of transducers is working correctly. Non Invasive Blood Pressure Check that: • The cuff and hose are clean and intact. • A few seconds after turning the monitor on the message “PRESS START” appears in the NIBP zone. EtCO2 Check that: • The cable and sensor are clean and intact. • The probe is functioning. Connect the sensor to the monitor and verify the light on the head of the sensor turns on and the “WARMING UP” messages is displayed on the screen. 78 Vital-Guard 450C Operation and Maintenance Manual ACCESSORIES ACCESSORIES ECG/Respiration Standard Three-Lead Three-lead patient cable 590170 Patient leads 590162 Optional Five-Lead Five-lead patient cable 590167 Patient leads 590168 NOTE: For proper respiration monitoring, cable capacitance between the RA and LA leads must be 400 ±100 pF. For units used in Australia Three-lead patient cable with 1kΩ series resistors Patient leads 590197 590162 Five-lead patient cable with 1kΩ series resistors Patient leads 590207 590168 ETCO2 Adult Airway Adapter 590186 Pediatric/Neonatal Airway Adapter 590188 ETCO2 Sensor with Span Chech and one Adult Airway Adapter 2315-00-01 Invasive Pressure Pressure transducer reusable 590252 Cable for reusable pressure transducer 590251 Disposable transducer domes (Box of 50) 590253 Disposable pressure transducer (Box of 10) 590016 Cable for disposable pressure transducer 590235 Vital-Guard 450C Operation and Maintenance Manual 79 ACCESSORIES Non-Invasive Pressure (NIBP) Disposable Cuffs Neonatal Cuff, bladderless (3–6 cm) 590239 Neonatal Cuff, bladderless (6–11 cm) 590240 Neonatal Cuff, bladderless (8–15 cm) 590241 Child Small Cuff, full bladder (13–20 cm) 590267 Adult Small Cuff, full bladder (18–26 cm) 590268 Adult Cuff, full bladder (26–35 cm) 590269 Reusable Cuffs Infant Cuff (8–14 cm) 590270 Child Cuff (13–20 cm) 590271 Adult Small Cuff (18–26 cm) 590272 Adult Cuff (26–35 cm) 590273 Adult Large Cuff (32–42 cm) 590274 Adult Thigh Cuff (42–50) 590275 Cuff Hoses For use with all disposable cuff (yellow hose). 2686-00-01 For use with all reusable cuffs (black hose). 2689-00-01 Temperature Reusable temperature probe – rectal/esophageal 590003 Reusable temperature probe – skin 590005 Reusable cable for YSI disposable probes 590000 Disposable temperature probe YSI Series 400 or equivalent 590001 Disposable skin temperature probe 590002 Recorder Recorder Paper, box of 10 rolls 80 590035 Vital-Guard 450C Operation and Maintenance Manual ACCESSORIES SpO2 Reusable Sensors Adult LNOP DC-1 Finger Sensor, Reusable 590227 SpO2 Disposable Sensors Neonatal LNOP-Neo, Disposable Sensor, Box of 20 590223 Pediatric LNOP-Pdt, Slender Digit Disposable Sensor, Box of 20 590222 Neonatal Pre-term LNOP-NeoPt, Disposable Sensor, Box of 20 590224 Adult LNOP-Adt, Disposable Sensor, Box of 20 590221 SpO2 Patient Cables Patient Cable, 8 ft PC08 with LNOP Sensor Connector 590220 Patient Cable 12 ft PC12 with LNOP Sensor Connector 590230 SpO2 Starter Kits Starter Kit with 2 LNOP-Adt and 2 LNOP-Pdt sensors, and 12’ PC12 sensor cable 590225 Starter Kit with 2 LNOP-Neo and 2 LNOP-NeoPt sensors, and 8’ PC08 sensor cable 590226 Starter Kit with Adult LNOP-DC1 finger sensor, reusable and PC08 sensor cable 590228 Disposal Disposal of devices or consumables must be done in accordance with local, state, and federal laws and regulations. WEEE Directive 2002/96/EC.- Do not dispose of WEEE products in general waste. At the end of life of product contact IVY Biomedical Systems, Inc. customer service for return instructions. Vital-Guard 450C Operation and Maintenance Manual 81 REAR PANEL OUTPUTS REAR PANEL OUTPUTS Analog Output Connector Pin Signal Output 1 ECG X1000 1 V = 1 mV input 0.5 to 40 Hz filtered 0.05 to 100 Hz diagnostic (Adult Mode only) 2 ECG Adult: Neonate: 3 RESPIRATION 2.5 V peat-to-peak maximum (±1.25 V), variable with front panel control 4 IBP1 10 mV/mmHg, 0 mmHg = 0 mV ±50 mV (after Auto-Zero) 5 IBP2 10 mV/mmHg, 0 mmHg = 0 mV ±50 mV (after Auto-Zero) 6 PLETH Waveform, 1.2 V peak-to-peak maximum. No sensor = +0.6 V 7 HEART RATE 16.6 mV/bpm, 300 bpm max, 60 bpm = 1 V, 120 bpm = 2 V, 300 bpm = 5 V 8 SpO2 50 mV/% SpO2 100% max, 100% = 5 V 9 No Connection 10 GROUND Ground 11 EtCO2 50 mV/mmHg 12 ALARM OUT High +5 V (>2.4 V) when an alarm is present 13 GRAPH OUT Relay closure for remote recorder 14 GRAPH COM 15 UNIT ON 16 NURSE CALL 17 N.C. COMMON 18 LEAD OFF ALARM 19-25 No Connection X1000 (1 V = 1 mV input) X2000 (1 V = 0.5 mV input) 38mmHg = 1.90 ± 50 mV Relay closure for Nurse Call option High +5 V (>2.4 V) when a lead off alarm is present For the mating connector, use Ivy P/N 188505, 25-pin plug for 22-26 AWG wire. Use RFI/EMI shielded cable clamp, Ivy P/N 210032, 15-conductor shielded cable, Ivy P/N 600005, and a ferrite bead, Ivy P/N 150025, at the monitor end of the cable. 82 Manual Vital-Guard 450C Operation and Maintenance REAR PANEL OUTPUTS COM 1 & COM 2 Connectors Pin Signal Output 1 No Connection 2 RECEIVE DATA Not Used 3 TRANSMIT DATA RS-232 ±9 V (±5 V min.) 4 Not Used 5 SIGNAL GROUND 6 Not Used 7 REQUEST TO SEND Not Used 8 CLEAR TO SEND Not Used 9 Not Used Reference for COM 1 signals For the mating connector, use Ivy P/N 179004, 9-pin receptacle for 22-26 AWG wire. Use RFI/EMI shielded cable clamp, Ivy P/N 210030, and 5-conductor shielded cable, Ivy P/N 600002. RJ45 Connector (option in place of COM 2) Pin Signal 1 TRANSMIT DATA 2 SIGNAL GROUND 3 RECEIVE DATA 4 Not Used 5 Not Used 6 SIGNAL GROUND 7 Not Used 8 Not Used Vital-Guard 450C Operation and Maintenance Manual RJ45 VIEWED FROM REAR OF MONITOR 1 83 REAR PANEL OUTPUTS Configuration Menu To access the configuration menu hold both the TEST button and the EXIT button in while switching the power ON. Use the arrow keys ( ⇑ ⇓ ) to scroll to the function to be changed. Use the CHANGE OPTION key to select the desired option. CAUTION: Configuration is carefully preset at the factory based on which parameters and options have been installed. Extreme care should be taken when altering any of these settings and all users should be informed of changes Configuration Menu FUNCTION ECG 3 LEAD 60Hz OPTIONS 3 LEAD 50Hz 5 LEAD 60Hz 5 LEAD 50Hz RESP ABSENT IMPEDANCE CO2 IMP + CO2 SpO2 ABSENT NELLCOR MP204 MASIMO NELLCOR MP405 NIBP ABSENT COLIN TEMP ABSENT SINGLE DUAL INVASIVE BP ABSENT SINGLE DUAL RECORDER ABSENT PRESENT COM 1 ABSENT HTS820TC HTS820 COM2/ETHERNET ABSENT CPC REV C ANSAR REV B AUDIO OFF FEATURE ABSENT PRESENT LATCHING ALARMS ABSENT PRESENT PRIORITY ALARMS ABSENT SCHEME 1 INITIAL LIMITS DEFAULTS STORED TEMP UNITS DEGREES F DEGREES C KPA MMHG ABSENT PRESENT KPA MMHG PERCENT 3.0 KHZ 3.5KHZ 4.0KHZ NONE ONE HOUR PERMANENT DATE FORMAT MM/DD/YYYY DD/ MM/YYYY KEYPAD TYPE 17 KEYS 20 NO LIGHT PRESSURE UNITS PRESSURE SITE LABELS CO2 UNITS ALARM TONE TAB RETENTION 84 Manual THERMALINK SCHEME 2 TWO HOUR 20 + LIGHT Vital-Guard 450C Operation and Maintenance TESTING AND TROUBLESHOOTING TESTING AND TROUBLESHOOTING General Press and hold the TEST key to test the internal functions of the monitor. You should do this each time you begin monitoring a patient. The TEST function generates a 1 mV ECG pulse at 70 bpm, a respiration signal at 70 br/min and a coincidence check, which are displayed on the display and are available at the rear panel connector. The monitor also displays invasive pressure readings of 150/50 and temperature readings of 40°C. If these indications are not present, continue with troubleshooting procedures. Under normal operation, no internal adjustment or recalibration is required. Safety tests and internal adjustments should be done by qualified personnel only. Safety checks should be performed at regular intervals or in accordance with local or governmental regulations. ECG Test Equipment Required ECG Simulator (Fogg Model M310 or equivalent) Initial Settings for the Test HR high alarm limit HR low alarm limit Lead select Filter ECG Size Alarms 150 50 I ON 10 mm/mV ON (ALARMS OFF message not displayed) Test Procedure 1. 2. Connect the patient cable and simulator to the monitor and set the simulator as follows: • Heart rate of 80 bpm • Amplitude of 1.0 mV Observe the following on the monitor display: • ECG Lead I is displayed with an amplitude of approximately 10 mm and is noise free Press FREEZE to check the waveform if necessary. • Heart rate of 80 ±1 bpm • The heart next to the heart rate indicator flashes with every QRS complex displayed. Vital-Guard 450C Operation and Maintenance Manual 85 TESTING AND TROUBLESHOOTING 3. Verify that ECG Leads I, II, III, aVR, aVL, aVF, and V display properly as shown below. 4. Check the LEADS OFF alarm by removing one lead at a time from the simulator. 5. Change the heart rate on the simulator to 40 bpm. Notice the following: 6. • The HR <50 message appears on the display. • Heart rate value of 40 ±1 bpm is displayed. Press ON/OFF. Notice the following: • Audible alarm stops • Alarms Off message is displayed. 7. Press ON/OFF. The Alarms Off message goes off. 8. Set the simulator heart rate to 200 bpm. The HR >150 message is displayed, and an audible alarm sounds. 9. Set the simulator to 80 bpm. Pressure Test Equipment Required Transducer Simulator (Fogg Model BP48C or equivalent) Test Procedure 1. Press and hold the monitor's TEST button. The monitor's pressure reading should be 150/50. 2. Connect the simulator output to the monitor's pressure input. 3. Set the simulator output to 0 mmHg. 4. Zero the pressure channel. 5. Set the simulator to 100 mmHg output. 6. Set the monitor's blood pressure range to 120. 7. Check for the proper level on the monitor's display. 8. Repeat for the second pressure channel. 86 Vital-Guard 450C Operation and Maintenance Manual TESTING AND TROUBLESHOOTING Respiration Test Equipment Required Respiration Simulator (Fogg Model M98 or equivalent) Test Procedure Connect the BLACK (LA) and RED (LL) leads to the black simulator terminal. Connect the WHITE (RA) lead to the white simulator terminal. 1. Set the monitor to NEONATAL mode and the front panel RESP SIZE to 50%. 2. Set the simulator as follows: Power: Rate: Variation: Toggle Switch: Base Impedance: ON 50 br/min 0.5 Ω NORM. 1 kΩ The triggering should be consistent and the rate should be 50 ±1 br/min. 3. Set the monitor to ADULT mode. Check for the displayed amplitude to drop approximately 50%. The triggering should be consistent and the rate should be 50 ±1 br/min. 4. Turn the simulator power off. Set the APNEA DELAY to 20 seconds. The respiration must not trigger. Check for an APNEA alarm in 20 seconds. Temperature Test Equipment Required Temperature Simulator (Fogg Model TP-69 or equivalent) Test Procedure 1. Connect the SERIES 400 TEMPERATURE OUTPUT of the simulator to the monitor's TEMP input. 2. Set the output of the simulator to 37°C. The monitor's temperature reading should be 37°C ±0.1°C. 3. Check the monitor's output at 20°C and 40°C. 4. Repeat for the second temperature channel. Pulse Oximeter Test Equipment Required Sensor with cable Test Procedure 1. Connect the patient cable to the monitor and the sensor to your finger. 2. Check for waveform, SpO2 reading, pulse rate, bar indicator, and audio tone. Vital-Guard 450C Operation and Maintenance Manual 87 TESTING AND TROUBLESHOOTING ETCO2 Test Equipment Required EtCO2 sensor with cable. Test Procedure 1. Make sure the EtCO2 waveform is displayed in either zone 2, 3, or 4. 2. Check for the NO SENSOR message to be displayed. 3. Plug in the EtCO2 sensor and place the airway adaptor on it. The sensor should illuminate and the display should indicate that the sensor is warm-up. Warm-up should conclude in 3-5 minutes. 4. Through the RESP/CO2 menu, zero the sensor and check for the ZERO OK message to be displayed. 5. Remove the airway adaptor from the sensor and make sure the OFF AIRWAY message is displayed. 6. Place the span check cell on the sensor. Through the RESP/CO2 menu run the SPAN CHECK test, and wait for the SPAN OK message. 7. With the span check cell still on the sensor, check for the EtCO2 value and waveform to be within the percentage value of the Barometric Pressure (760mmHg) printed on the span check cell. (Span Check Value = %value * 760/100) NIBP Test Equipment Required Cylinder, such as bottle or coffee can NIBP cuff, hose, and Y-connector Manometer or other pressure measuring device Test Procedure 1. To enter the calibration mode, press TEST, ALARM RESET, and START at the same time. 2. Momentarily block the NIBP input and then attach the cuff to a manometer or other pressure measuring device. 3. Pump in pressure, and compare the manometer reading to the reading on the monitor display. 4. With a cuff attached to the NIBP input, enter the calibration mode as described above. One minute after the monitor reaches a maximum pressure reading, leakage should be <5 mmHg/3 min. Recorder Test Use the following procedure to verify that the recorder is operating properly. 1. Set the recorder to print ECG and respiration waveforms and set the recorder to TIMED mode. 2. Press PRINT and then press and hold the TEST key for at least 30 seconds. 88 Vital-Guard 450C Operation and Maintenance Manual TESTING AND TROUBLESHOOTING The recorder prints waveforms that match the waveforms on the display. The recorder continues printing for 30 seconds and then stops. Battery Test 1. Disconnect the power cord from the monitor so that it is operating on battery. 2. In approximately 30 seconds, the battery indicator should appear in the lower right corner of the display. 3. Connect the power cord. Verify that the charging light starts flashing (pre-charged qualification) and that after a few minutes either one of the following conditions occur: the charging light stays on (fast charging) or the charged led goes on (maintenance charging). 4. If the fault light goes on replace the battery immediately. Isolation and Leakage Tests Use a leakage tester or use the ac voltage range on a digital voltmeter to measure across a 1 kΩ resistor as shown below. CAUTION: Be careful to connect the circuit below only between the measurement points indicated in the following instructions. Do not connect this circuit directly across line voltage. Full line voltage would damage the measurement circuit and could possibly damage the monitor and/or the digital voltmeter. DMM A.C. VOLTS 0.015µf 1kΩ TO CIRCUIT BEING MEASURED 1. Measure between a known ground and the monitor’s ground post on the rear panel. With the line cord properly grounded, with the ground removed, and with the line cord reversed, the readings should be <100 µA. 2. With the line cord grounded, measure between shorted patient leads and the hot side of the ac line. The reading should be <10 µA. Vital-Guard 450C Operation and Maintenance Manual 89 TESTING AND TROUBLESHOOTING System Error Messages Numeric messages might appear in the lower right corner of the display if the processor detects a problem with the monitor. If a message appears, contact Ivy Biomedical Systems Service Department. When you call, have the following information available: Model Number Serial Number Numeric Error Message Procedure being performed when the message appeared System Error Messages & Solutions Error 90 Meaning Solution 1 The EPROM checksum test has failed. Replace U57 (2600-00-04) on Mother Board (5143-0001) board or replace U53 (2601-00-04) on Mother Board (5143-00-01) board or replace Mother Board (5143-0001). 2 The static RAM test has failed. Replace Mother Board (5143-00-01). 3 The non-volatile (clock chip) RAM test has failed. Replace Lithium Battery (330115) or replace Mother Board (5143-00-01). 4 An undefined interrupt has been detected. Replace Mother Board (5143-00-01) 5 A system timing error has been detected. Replace Mother Board (5143-00-01) 6 No DSP data has been received. Replace Mother Board (5143-00-01). 7 A DSP communication error (framing, overrun, etc) has been detected. Replace Mother Board (5143-00-01) 8 Bad DSP data has been received (ie: a bad header byte). Replace Mother Board (5143-00-01) 9 An unknown error has been detected. Replace Mother Board (5143-00-01) Vital-Guard 450C Operation and Maintenance Manual TESTING AND TROUBLESHOOTING Simplified Block Diagram ECG & RESP MUX A/D DSP Uart ECG Temp 1 Temp 2 ISOLATED INPUT BOARD Resp Press 1 Serial Inputs Press 2 Analog & COM ports Temp & Pressure Recorder Processor SpO2 EtCO2 NIBP 90-230VAC 47-63 Hz SpO2 Module EtCO2 Module Front Panel SpO2 Power Video Generator Display EtCO2 Power NIBP Module Mains Filter Power Supply Battery Charger BAT 1 BAT 2 450C Mother Board (5143-00-01) Vital-Guard 450C Operation and Maintenance Manual 91 REPLACEMENT PARTS REPLACEMENT PARTS Printed Circuit Boards Part Ivy Part Number 450C Monitor Mother Board Isolated Input Board (ECG/RESP, 2Temps & 2Press) Isolated Input Board (ECG/RESP) Isolated Input Board (ECG/RESP & 2Temps) Isolated Input Board (ECG/RESP & 2Press) EtCO2 Interface Board 5143-00-01 5144-00-01 5144-01-01 5144-02-01 5144-03-01 5108-00-01 Modules and Assemblies Part Ivy Part Number Replacement Battery EOS Power Supply 60W Masimo Sp02 Module (MS-3) Colin M2000 NIBP Module EtCO2 Signal Processor Board EtCO2 Power Board LSI Telemetry Transmitter Module Kit Ethernet Module Color Display Recorder Rubber Feet Pneumatic Hose for NIBP Window Speaker Assembly Fan Assembly Rear Enclosure (Rear bezel) Front Bezel Handle 110007 580025 580022 580024 580011 580012 580016 580026 570013 380004 680010 560000 2457-00-13 2616-00-10 2620-00-10 2566-00-11 2565-00-11 2570-00-11 Fuses CAUTION: To ensure safety and reliability, always replace fuses with the type specified. Part Power Entry Module (2) Mother Board – F1 Mother Board – F2, F3 & F4 92 Manual Description Ivy Part Number 1.6ASB, 5x20mm 5ASB, ASSY, SMT. 3/8ASB, ASSY, SMT 290021 290503 290502 Vital-Guard 450C Operation and Maintenance REPLACEMENT PARTS Cables and Harnesses Part Ivy Part Number Masimo Internal Sp02 Cable Andros Internal EtCO2 Cable EtCO2 Signal Power Supply Harness Assembly EtCO2 Signal Interface Harness Assembly Backlight Inverter NIBP Interface Ribbon Recorder Interface Ribbon COM 1 & COM 2 Interface Ribbon Telemetry Interface Ribbon Power Supply Input Power Entry Module Display Interface Ribbon Analog Output Interface Ribbon Horizontal Front Panel Vertical Front Panel Harness Interface Ribbon 2451-01-01 2317-01-01 2335-00-01 2336-00-01 2470-01-10 2609-00-10 2608-00-10 2614-00-10 2611-00-10 2612-00-01 2613-00-01 2615-00-10 2619-00-10 2605-00-10 2577-00-10 2466-00-10 Labels Part Ivy Part Number Front Panel Label, Vertical Front Panel Label, Horizontal Ivy Model Number Label (Masimo) Rear Panel Label Input Connector Label (ECG/Resp, NIBP, Sp02, 2Temp, 2Press, EtCO2) Input Connector Label (ECG/Resp, NIBP, Sp02, 2Temp, 2Press) Input Connector Label (ECG/Resp, NIBP, Sp02 , 2Temp) Input Connector Label (ECG/Resp, NIBP, Sp02 , 2 Press) Input Connector Label (ECG/Resp, NIBP, Sp02) 2458-00-10 2596-00-10 2599-01-10 2598-00-10 2597-01-10 2597-03-10 2597-05-10 2597-07-10 2597-09-10 Software Part Mother Board – U57 Mother Board – U53 Mother Board – U26 Mother Board – U98 Description Ivy Part Number 450C Program (1 of 2) 450C Program (2 of 2) DSP software 450C Video 2600-00-04 2601-00-04 2636-00-04 2634-00-04 Vital-Guard 450C Operation and Maintenance Manual 93 DISASSEMBLY AND ASSEMBLY DISASSEMBLY AND ASSEMBLY Covers WARNING: To prevent equipment damage and possible personal injury, always remove the power cord from the instrument. 1. Remove the four screws that secure the back half frame to the front half frame (front bezel). 2. Carefully unplug the following harnesses from the 450C mother board: Power harness, ground connector, COM1 & COM2 harness, ECGX1000, ANALOG OUTPUT harness, NIBP harness, Recorder harness, SpO2 Connector, EtCO2 connector (if available) and Ethernet connector (if available). The monitor should be open in two, the front half and the back half. Attached to the front half is the Mother board (5143-00-01), the color display and both horizontal and vertical faceplates. The back half contains the batteries, NIBP pump, Analog and digital outputs, the EOS power supply and the isolated input board (5144-00-01). Rear Panel Outputs Fan NIBP Pump Batteries Handle EOS Power Supply Back Half Frame Ethernet Module 450C Mother Board EtCO2 Interface Board Isolated Input Board EtCO2 Module SpO2 Module Front Half Frame Speaker 94 Color Display Vital-Guard 450C Operation and Maintenance Manual DISASSEMBLY AND ASSEMBLY Printed Circuit Boards 450C Mother (5143) Board 1. Open the monitor as describe in the previous section. 2. Take the front half of the monitor and remove the three screws (located at each corner of the 5143 board) that hold the board to the front half. 3. Disconnect the front panel interface ribbon cable and the speaker harness. EtCO2 Module Interface (5108) Board The EtCO2 module interface board is mounted on the Mother board next to the SpO2 module and the EtCO2 module. 1. Open the monitor as described above. 2. Disconnect the EtCO2 signal interface harness and EtCO2 power supply harness from J204 and J202 on the EtCO2 mother interface board. 3. Remove the three nylon screws that hold the EtCO2 interface board and carefully pull it up to release it from the Mother board. EtCO2 Module The EtCO2 module is mounted on the Mother board next to the SpO2 module. 1. Open the monitor as described above. 2. Disconnect the EtCO2 signal interface harness and EtCO2 power supply harness from J204 and J202 on the EtCO2 module. 3. Remove the three screws that hold the EtCO2 module to the Motherboard. Masimo SpO2 Module The Masimo module is attached to the 5143 board (the module is approximately at the middle of the 5143 board). 1. Open the monitor as described above. 2. Unplug the ribbon cable from the Masimo module. 3. Remove the three nylon screws that secure the module. Vital-Guard 450C Operation and Maintenance Manual 95 DISASSEMBLY AND ASSEMBLY Isolated Input Board NOTE: The screws securing the side panel to the monitor are covered by an adhesive label with the identification for the connectors on the panel. To gain access to the screws, you should carefully lift the label to expose the screws. If the label is damaged, it can be replaced by ordering Ivy P/N 2597-01-10. 1. Remove the four screws that secure the front half (front bezel) and back half of the monitor and unplug all the ribbon cables and harnesses from the 450C motherboard. 2. Remove the nuts from the outside of the temperature jacks (if present) and peel the adhesive label. 3. Unscrew the EtCO2 input connector (if present) and remove it from the monitor’s frame. 4. Remove the four screws that secure the isolated input board to the monitor’s frame. 5. Remove the two screws that hold the SpO2 input cable and pull it out from the monitor’s frame. Front Panel Use the following procedure to replace the horizontal front panel assembly. 1. Remove the four screws that secure the front half (front bezel) and back half of the monitor and unplug all the ribbon cables from the 450C motherboard. 2. Take out the three screws that secure the motherboard to the front half and carefully remove the board. 3. Carefully disconnect the 18 pin Interface ribbon cable and the speaker harness from the motherboard. 4. Disconnect the 10-pin ribbon cable that connects the vertical and horizontal faceplates. 5. Remove the four hex nut that hold the horizontal front panel to the front bezel (front half). 6. Pull the horizontal front panel out. CAUTION: Do not bend any pins when removing the front panel connector from the Mother Board. Bent pins might require replacement of the Mother Board. Use the following procedure to replace the vertical front panel assembly. 1. Remove the four screws that secure the front half (front bezel) and back half of the monitor and unplug all the ribbon cables from the 450C motherboard. 2. Take out the three screws that secure the motherboard to the front half and carefully remove the board. 3. Carefully disconnect the 18 pin Interface ribbon cable and the speaker harness from the motherboard. 4. Disconnect the 10-pin ribbon cable that connects the vertical and horizontal faceplates. 5. Remove the two hex nut that hold the vertical front panel to the front bezel (front half). 96 Vital-Guard 450C Operation and Maintenance Manual DISASSEMBLY AND ASSEMBLY 6. Pull the vertical front panel out. CAUTION: Do not bend any pins when removing the front panel connector from the Mother Board. Bent pins might require replacement of the Mother Board. EOS Power Supply 1. Open the monitor as described above. 2. Remove the Isolated Input Board. 3. Remove the four screws that secure the EOS Power Supply to the monitor’s back frame. 4. Disconnect the connectors from the EOS Power Supply, including the ground wire connector. Recorder Assembly 1. Open the recorder door and remove the paper from the recorder. 2. Loosen the two captive Philips-head screws inside the recorder housing. 3. Pull the Recorder Assembly straight out from the monitor. NIBP Module The NIBP module is mounted in the back half frame of the unit under the NIBP mounting bracket. 1. Remove the four screws that secure the front half (front bezel) and back half of the monitor and unplug all the ribbon cables and harnesses from the 450C motherboard. 2. Remove the recorder (if present) as described above. 3. Remove the two hex-nut that hold the ground points over the NIBP mounting bracket and remove all ground wires. 4. Remove the four screws (located to the sides of the bracket) that secure the NIBP mounting bracket to the back half frame and take the bracket out; the NIBP pump is attached to it. 5. Once the bracket is out, remove the four screws placed at each corner of the bracket and release the NIBP pump. Battery Removal The batteries are secure to the back half frame of the monitor by the Battery bracket. The Battery bracket has to be removed to replaced the batteries. 1. Remove the four screws that secure the front half (front bezel) and back half of the monitor and unplug all the ribbon cables and harnesses from the 450C motherboard. Vital-Guard 450C Operation and Maintenance Manual 97 DISASSEMBLY AND ASSEMBLY 2. Unplug the wires at the batteries terminals. 3. Remove the four screws that hold the battery bracket to the unit. Two screws are located on the rear panel and the other two are in the bottom of the back half frame. 4. Remove the battery bracket and the batteries. Display Assembly The Display Assembly is mounted on the front half frame under the motherboard. To remove the Display Assembly follows the next steps: 1. Remove the four screws that secure the front half (front bezel) and back half of the monitor and unplug all the ribbon cables from the 450C motherboard. 2. Remove the motherboard as described previously. Unplug the speaker harness and the front panel ribbon cable from the motherboard. 3. Remove the four screws that hold the display to the front half frame and lift the display up. NOTE: When installing back the display, the screws must be tight at 60 lb/in 4. Remove the four screws that secure the Display Power Supply to the front bezel. NOTE: The Display Assembly and Display Power Supply must be replaced as a pair. Speaker 1. Open the monitor as described in the first section of this chapter. 2. Remove the Mother Board and unplug the speaker harness. 3. Pull the speaker out from its location. 98 Vital-Guard 450C Operation and Maintenance Manual BOARD LAYOUT DIAGRAMS BOARD LAYOUT DIAGRAMS 1. EtCO2 Interface Board 5108-00-02 2. 450C Monitor Mother Board (front) 5143-00-02 3. 450C Monitor Mother Board (back) 5143-00-02 4. Isolated Input Board (solder side) 5144-00-02 5. Isolated Input Board (connector side) 5144-00-02 Vital-Guard 450C Operation and Maintenance Manual A BOARD LAYOUT DIAGRAMS This page is intentionally left blank. Vital-Guard 450C Operation and Maintenance Manual SCHEMATIC DIAGRAMS SCHEMATIC DIAGRAMS 1. EtCO2 Module Interface Board 2. 450C Monitor Mother Board a. 5143 Main b. Analog c. Bypass d. COMM e. Color CPU Main f. DSP Processor g. DSP Power Supply h. ECG Front End i. Ethernet Power Supply j. Glue k. CPU Memory l. Power Supply m. Resp n. SpO2 Power Supply o. Temp Pressure Front End p. Video FPGA 3. Isolated input board Vital-Guard 450C Operation and Maintenance Manual 5108-00-01 5143-00-01 (1 of 16) (2 of 16) (3 of 16) (4 of 16) (5 of 16) (6 of 16) (7 of 16) (8 of 16) (9 of 16) (10 of 16) (11 of 16) (12 of 16) (13 of 16) (14 of 16) (15 of 16) (16 of 16) 5144-00-01 B SCHEMATIC DIAGRAMS This page is intentionally left blank. Vital-Guard 450C Operation and Maintenance Manual 7 6 5 4 3 2 ISOLATED RXD_B VCC 4 D VCC 5 RN1 6 1K C U5 CNY17-3 7 RN1 8 1K ET_RES B++ E7 2 D1 L1 25UH C3 + C2 100UF 25V IGET C4 1500UF 25V + .0068UF 1KV CD 2252-00-10 T1 2 . SB5100 R6 620 OHM 2W 5% 3 4 R14 150 OHM 10W 5% H.S. . 1 64KHz E5 C9 1UF MP C8 100UF 25V 730MA D H.S. Q4 1G IRF540 D2 MBR350 + Q1 2 2N3906 C10 .1UF MP R2 10K .047UF MP 8 7 6 5 REF R_MID GND-F GND-S IGET COLLECTOR COMP V+ R_TOP 10000PF NPO R4 1 2 3 4 + C6 22UF TANT 3 Q2 S R8 6.98K 3 Q 7 DIS 6 THR R10 10K U7 ICM7555 TR R13 1K C7 2 C5 1000PF NPO 47PF NPO R11 10K CV 5 R9 10K 2 2N3903 B Q3 3 U6 CNY17-3 C11 D 4 C1 2 IGET TP2 1 IGET 5 2 B 2 2N3903 3 3 R12 100 OHM B++ 3 4 U2 BNX002-01 1 1 1 +5VIET TP1 1 IGET E4 4 2 4 VCC E3 8 5 IGET 3 RN1 4 1K 9 RN1 10 1K R 2 1K C +5VIET E2 U4 CNY17-3 R3 R5 2K E1 V+ +5VIET TXD_B V- +5VIET J204 173011 2 IGET +5VIET 1 +5VIET 1 RN1 2 1K 5 IGET 1 2 3 1 5 U3 CNY17-3 R1 2K 4 J202-4 D VCC TTL RECEIVE DATA TTL TRANSMIT DATA TTL EXTERNAL RES J202-3 DATE 8-28-97 11-4-97 6-25-99 8-9-02 NON-ISOLATED 2336-00-01 J202-1 J202-2 BY GP GP GP GP 1 D 1 REVISIONS DESCRIPTION REVISED PER ECN 691. REVISED PER ECN 709. REVISED PER ECN 957. REVISED PER ECN 1201. REV 01 02 03 04 1 8 R7 10K E6 D_GND D DGND TP3 33.2K U1 LT1431CN8 IVY BIOMEDICAL SYSTEMS INC. A NOTES: 1. ALL RESISTORS ARE 1/4W, 1% U.O.S. Title ETCO2 MODULE INTERFACE BOARD ASSEMBLY 2. LAST USED: Size 3. NOT USED: B Date: 8 7 6 5 A 11 BUSINESS PARK DRIVE BRANFORD, CT. 06405 (203) 481-4183 4 3 Document Number Rev 04 5108-00-01 (-03 SCHEMATIC) Thursday, March 10, 2005 2 Sheet 1 of 1 1 REVISIONS REV DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP 18 19 20 21 22 23 24 +6.5V TP50 PRESS_TEST + 3 - 2 +5VI 11 SLF7032T-101MR45-2 from TDK 1.5V R297 10K L8 -6.5V 1 temp1_plus +6.5V 13 V- 4 GND 5 V+ D R299 10K 2 I 100UH SMT U87A MAX327CSE IN 1 1M R300 1.2K .1% 50PPM R301 2.8K .1% 50PPM 100UH SMT + C181 6.8UF TANT 20V 3528 C182 .1UF CER 0805 I +6.5V I I 7 AV = 100 8 9 16 L9 temp1_neg R298 1.82K .1% 50PPM 12 1 I C178 .1UF CER 0805 +6.5V C179 .1UF CER 0805 -6.5V S R296 3 1 3 2 Q32 MMBF4393 PRES_TEST U86A TL034ACD 4 +5_Vref DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 40C_sel 20C_sel temp_cal# 40C_sel 20C_sel temp_cal# Vcc Out1 3 In2 Out2 6 In3 Out3 11 In4 Out4 14 In1 2 7 10 15 Gate1 Gate2 Gate3 Gate4 4 Latch I R302 2 - C180 1UF MP 2824 1.5V TP11 TEMP 1 5 3 + 10K 6 U89 4 1 8 AD621AR Temp Scaling 15 deg C = -3.5V 45 deg C = 4.21V I R304 931 OHM .1% 50PPM R303 9.31K .1% 50PPM temp1_out 25.7mV/deg C -6.5V R305 GND 10K I R306 9.31K .1% 50PPM U88 DS1640S 5 + C217 1UF TANT 16V 3216 I I I I 1.5V L10 temp2_plus +5VI U87D MAX327CSE 6 S PRESS_EN IN 8 R312 1 PRESS_EN 10K temp2_neg 100UH SMT U87B MAX327CSE 100UH SMT C193 .1UF CER 0805 100UH SMT L13 3 S 14 15 2 R318 12 + 13 - 40.2K C190 .22UF MP 2824 6 U92 AD621AR 7 8 AV = 100 press_1 14 10 S TP14 PRESS 2 R322 10 + 9 - 40.2K C195 .22UF MP 2824 I R323 22M 5% SG2+ SG2+ C201 .1UF CER 0805 100UH SMT L15 100UH SMT In3 Out3 11 In4 Out4 14 2 7 10 15 Gate1 Gate2 Gate3 Gate4 4 1 2 2 Latch 8 C185 1UF MP 2824 1.5V 6 418 temp2_out 25.7mV/deg C U91 AD621AR Temp Scaling 15 deg C = -3.5V 45 deg C = 4.21V I R315 931 OHM .1% 50PPM R314 9.31K .1% 50PPM TP12 TEMP 2 5 2 - -6.5V R317 GND I U90 DS1640S 10K R319 9.31K .1% 50PPM + C218 1UF TANT 16V 3216 I 3 3 4 4 5K 5 5 12K press_2 press_2 C229 .1UF CER 0805 6 U86C TL034ACD 6 34.872K 7 7 8 8 12K 9 9 34.872K 10 10 195K 90.1875K C230 .1UF CER 0805 R324 332K R326 143K I 4 1 5 C200 .1UF CER 0805 2 3 6 +6.5V R328 499K R329 499K I U86B TL034ACD 5 + 6 - 7 R325 1K 1.5V C198 .33UF NPO 0805 +6.5V U93 AD621AR +5VI AV = 100 +6.5V C202 .1UF CER 0805 9 7 3 + 10K I 7 8 C199 .1UF CER 0805 Out2 I R311 I -6.5V R327 22M 5% + SG2- L14 C197 .1UF CER 0805 - SG2- I In2 6 AV = 100 +5_Vref +5VI C196 .1UF CER 0805 1 I 11 D U87C MAX327CSE I 3 +6.5V I I I R321 499K Vcc Out1 In1 5 9 R320 499K 40C_sel 20C_sel temp_cal# 8 16 I RN1 435023 R307 1.82K .1% 50PPM 12 +5_Vref press_1 U86D TL034ACD Av = 3.906 +6.5V C194 .1UF CER 0805 I I IN SG1+ C192 .1UF CER 0805 TP13 PRESS 1 9.775mV = 1mmHg I 4 1 5 L12 C191 .1UF CER 0805 + SG1+ SG1- R316 22M 5% - SG1- C189 .1UF CER 0805 -6.5V + C186 6.8UF TANT 20V 3528 C187 .1UF CER 0805 D I IN R313 22M 5% C188 .1UF CER 0805 R309 2.8K .1% 50PPM L11 2 +5VI I R308 1.2K .1% 50PPM 1 Q33 MMBT3904LT1 C183 .1UF CER 0805 +6.5V C184 .1UF CER 0805 16 D R310 10K 3 7 100UH SMT NOTES: +5VI +5_Vref +5_Vref 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. I 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IGND I I -6.5V -6.5V IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 Title Temp Pressure Front End Size D Date: Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 15 of 16 1 +12V 5 D41 MBRS340T3 Vin +5VREF Switch 1 2 Feedback Q35 CMPT3906 3 1 2 2 U78 LM2587S-ADJ C168 120UF TANT 20V SIZE-R + D42 8 11 4 Comp 3 VO +15VI_SpO2 + C166 6.8UF TANT 35V 7343 I MBRS340T3 10 1 + C169 120UF TANT 20V SIZE-R D43 T5 2604-00-10 Gnd 2 MBRS340T3 U80 LM3411M5-5.0 VI VO R348 10K R279 5 1K C171 .1UF CER 0805 2 5 D TP18 DGND 4 Out Comp IN 1 GND 2 -15VI_SpO2 C170 6.8UF TANT + 35V 7343 NC 3 TP46 +5VI_SpO2 I +5VI_SpO2 + C172 180UF TANT 16V SIZE-R LOW ESR TP47 IGND_SpO2 TP48 IGND_SpO2 1 U81 CNY17-3SM 4 3 U79 LM2990S-15 3 C173 .1UF CER 0805 TP45 -15VI_SpO2 1 U12-14 R347 49.9K 9 4 5 D VI MBRS340T3 7 2 R278 4.02K D40 BZT52-C16 16V C204 .22UF MP 100V 2220-N GND R346 680 OHM 2W SMT + 12 C167 180UF TANT 16V SIZE-R LOW ESR TP44 +15VI_SpO2 U77 LM2940IMP-15 D39 GND F2 3/8ASB DGND IGND_SpO2 I D R280 10K 2 VCC Vcc R281 1 VCC 2 C174 .1UF CER 0805 Iso_SaO2_Xmitt 3 5 GND R283 499 OHM D VCC Grounded 1K U82 HCNW2601-300 6 SaO2_Xmitt Q28 CMPT3906 3 8 7 R282 2K I Isolated 2 R284 10K R285 1K 1 Q29 CMPT3906 VCC 2 3 SaO2_Rec U83 HCNW2601-300 8 7 R286 1K 6 3 GND 5 Iso_SaO2_Rec C175 .1UF CER 0805 R287 499 OHM I D VCC 2 R288 10K R289 1K U84 HCNW2601-300 1 Q30 CMPT3906 VCC 2 3 SaO2_Rts REVISIONS 8 7 6 3 GND 5 REV R290 1K Iso_SaO2_Rts C176 .1UF CER 0805 R291 499 OHM 18 19 20 21 22 23 24 DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 I D VCC NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2 R292 10K 1K 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 1 Q31 CMPT3906 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. U85 HCNW2601-300 3 R293 SaO2_Reset 2 8 7 R294 1K 6 3 5 Iso_SaO2_Reset C177 .1UF CER 0805 IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: MARK TUCCILLO 9/5/01 R295 499 OHM CHK: APR: GP 9/5/01 RAM 9/5/01 Title SpO2 Power Supply I D Size C Date: Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 14 of 16 REVISIONS REV 18 19 20 21 22 23 24 R240 4.99K +5VI 1 resp_high 100K 680PF NPO 0805 R251 R250 T4 2637-00-10 8 2 DS6 BA-CMS-90 R257 10K C152 5 * RA 0 OHM 0805 449008 .0068UF 1KV CD C147 R255 4.99K 7 3 U70 7 OPA228U C150 100PF NPO 0805 R260 1K I +5VI * R262 49.9K 3 Q27 MMBT3904LT1 I .1UF CER 0805 R258 402 OHM .1% 25PPM .1UF CER 0805 200K 7 3.32K inc# 7 1 3 + 2 -U74 D36 MMBD1503A I R263 6 R268 100K I R272 4.02K .01UF MP 2824 R271 R273 2K 49.9K .5% 25PPM I R275 1.82K .1% 50PPM C155 .1UF CER 0805 I 8 3 + 6 2 -U76 OPA228U 4 8 I 5 + C154 .1UF CER 0805 -5VI I .1UF CER 0805 7 6 - 3 + C160 .1UF CER 0805 1 I -5VI 6 5 3 4 2 3 1 8 R355 100K 4 -5VI R261 200K U72A LT1112S8 +5VI 10K I 3 2 C161 C162 .01UF MP 2824 I 1 4 L INC U/D W CS H GND 2M 2.2UF MP 4036 R274 2 - C163 D37 MMBD1503A R270 I .1UF MP 2824 +5VI R265 200K U75B LT1112S8 10M R269 121K .5% 25PPM C157 +5VI C159 C158 330PF NPO 0805 3 u/d# R378 R264 49.9K R267 I 2 R266 49.9K .5% 25PPM C156 .1UF CER 0805 1 49.9K .5% 25PPM OPA228U u/d# offset_cs# 1 2 7 +5VI 4 R379 R354 100K 8 Vcc -5VI 6 5 3 +5VI 10K 7 1 -5VI L INC U/D W CS H GND U71 DS1804Z-050 base_imp 4 TP10 BASE IMP Vcc 1 2 7 gain_cs# C153 .1UF CER 0805 4 8 PATIENT CABLES WITH 1K SERIES RESISTORS. U73 8 DS1804Z-100 10K C228 .01UF CER 0805 U101 TLE2061ACD 6 2 R369 1K u/d# +5VI 3 +5VI sclock0 R391 I R256 +5VI R259 1 I * SPECIAL FOR ACCOMMODATING I +5VI C149 -5VI I 10K 442049 I + C144 68UF TANT 16V 7343 R254 10K .1% 50PPM 680PF NPO 0805 C151 470K R249 49.9K 249 OHM -5VI C146 2 6 1000PF NPO 0805 3 .0068UF 1KV CD C148 680PF 3KV CD I I 2 LA .1UF CER 4 0805 R253 49.9K R248 + C145 D35 MMBZ5234B R252 1K C143 C220 .33UF CER NPO 0805 C139 .033UF MP 2824 R247 1M - -5VI 100PF NPO 0805 I I +5V_Ref 40.2K .5% 25PPM TP43 ZERO_ADJ C137 I .1UF CER 0805 C141 6.8UF TANT 20V 3528 + 15PF NPO 0805 shield_dr R244 2K + C140 6.8UF TANT 20V 3528 C142 resp_low U69B LT1112S8 R242 470K C138 -5VI I C215 4 R246 1K 7 6 - I 1 U69A LT1112S8 2 - R245 1K TP42 RESP_OSC .1UF CER 0805 8 3 + 5 + 470K 2 R243 TP8 RESP LOW R241 3 C136 I TP9 RESP HIGH DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 Try LT1881 as a replacement for the 1112 D34 MMBD4148SE R239 100K DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP R276 resp_test U75A LT1112S8 .1UF CER 0805 40.2K 150K R277 15K C165 I D38 MMBD4148 C164 33UF TANT 10V 7343 I I I Try LT1468 as a replacement for the 1028 +5V_Ref +5V_Ref +5VI +5VI -5VI NOTES: -5VI TP15 IGND 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. Iso_GND I IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: MARK TUCCILLO 9/5/01 Title Size D Date: CHK: APR: GP 9/5/01 RAM 9/5/01 Resp Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 13 of 16 REVISIONS R198 Mot MBRS360T3 1 6 5 18 19 20 21 22 23 24 MBRS340T3 + 5 C110 33UF TANT 35V SIZE-R Vin 4 Switch 7 MBRS340T3 8 R392 150 OHM 2W 5% Q17 IRF7205/SO R199 20K 2 Feedback 12V_Switcher Q18 MMBT3904LT1 Gnd .1 OHM 1W 2512 R206 46.4K C112 33UF TANT 35V SIZE-R + L5 27UH SMT D23 MMBD4148 R204 2K Battery_Pos + R203 261K 2 3 C111 .1UF CER 0805 R200 + C115 470UF 16V ALUM Thermistor_Neg R389 0 OHM R205 604K + C116 470UF 16V ALUM + C117 470UF 16V ALUM C118 470UF 16V ALUM R211 1K 1 Q19 MMBT3904LT1 R208 100K 1 2 Rec_GND 1 TP41 BAT_GND JP6 Pump_GND 8 R210 .39 OHM 1W 2512 7 D44 MBRS340T3 6 TP40 BAT (-) t t TP22 REC_GND Q40 IRF7205/SO 5 2 RT1 33K Vcc_BC C113 6.8UF TANT 20V 3528 RT2 3.3K 2 + Battery_Neg 2 1 VO 1 R207 249 OHM 3 VIN C114 1UF TANT 16V 3216 + R387 0 OHM TP38 Vcc_BC R209 100K 2 GND 8 Vcc_BC 3 4 Rec_GND U62 LM2931M-5.0 DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 D22 MBRS340T3 R202 1K 1 R201 1.2K U61 LM2587S-ADJ L4 68UH SMT DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP TP39 VBATT Vbat Comp 3 + 4 22UH SMT C109 180UF TANT 16V SIZE-R LOW ESR D21 3 D20 2 L3 REV 3.52K 1 TP49 EOS_OUT Switcher_GND Thermistor_Pos TP2 +12V +12V U63 Vcc R333 120K R212 20K D28 CMPD6263 TP51 BC_TMR Vcc_BC ac R334 100K Switcher_off R222 100K 1 2 3 4 5 6 7 8 R221 20K R217 121K C121 1000PF NPO 0805 C123 .01UF CER 0805 C122 .01UF CER 0805 C124 .1UF CER 0805 R335 T3 Q4435-B Vcc_BC 16 15 14 13 12 11 10 9 3. R213 49.9K R214 10K R215 10K D24 11 +12V_HD TP4 -12V MBRS340T3 D25 D26 BZT52-C16 16V MBRS340T3 .10 2 + D27 C119 180UF TANT 16V SIZE-R LOW ESR -12V MBRS340T3 4 R216 200K R383 20K bq2031SN TMTOLED2/DSEL FLOAT LED1/TSEL Bat MOD Vcomp Vcc Icomp Vss IGsel COM SNS LED3/QSEL TS TPWM 2 Switch R218 402 OHM R219 402 OHM R220 402 OHM 5 R224 1K + Power_On_Led Vin Gnd 1 2 1 U64 LM2587S-12 + 3 Bat_Maintence_LED 2K -12V L6 100UH SMT Output Feedback Comp C126 120UF TANT 20V SIZE-R U65 LM2575S-12 C125 120UF TANT 20V SIZE-R Vin Feedback 4 ON/OFF 5 + C120 180UF TANT 16V SIZE-R LOW ESR GND 3 C127 .22UF NPO 0805 Bat_Charging_LED Common_LED + 3 - 2 1 R385 49.9K Q20 IRF7205/SO R375 1 HD_GND Q41 CMPT3906 3 R377 5 6 7 HD_GND 10K 100K 8 JP7 R223 3.01K R376 U99A LM393M 2 R336 1 49.9K Q34 MMBT3904LT1 4 4 2 3 2 1 3 8 Battery_Fault_LED 100K Vbuss 8 7 6 5 -12V 1 2 12V_BM 3 Q21 IRF7205/SO 4 D29 MBRS340T3 U66 LM2676S-5 D30 2 MMBD4148 R225 10K C129 .1UF CER 0805 R332 10K R227 3 GND ON/OFF TP20 DGND 4 7 D31 MBRS340T3 Vcc C131 150UF TANT 10V SIZE-C JP8 3 8 D Q 13 Q 12 R228 1 Q23 MMBT3904LT1 10K 2 CLK R 11 S 2 9 10 14 6 S VD 7 R VS 4 3 2 1 2 3 2 3 Q TP3 VCC L7 33UH SMT U67B CD4013BM DGND DGND R230 100K R231 10K + C133 1UF TANT 16V 3216 10K Q26 MMBT3904LT1 + NOTES: + OP AMP - R337 100K 8 2 7 x1 3 - 4 C135 .1UF CER 0805 CLK 1 1 MMBD4148 R234 1 R237 316K 3 Q Vsw D33 1 C134 1UF TANT 16V 3216 C132 .33UF NPO 0805 R232 10K 1 Q25 CMPT3906 D 3 D32 MMBD4148 U67A CD4013BM 4 5 6 7 8 R229 200K Q24 IRF7205/SO R233 100K 5 + C128 .01UF CER 0805 6 Feedback Cb Q22 CMPT3906 1 10K On_Off C130 120UF TANT 20V SIZE-R R226 200K 2 + C219 6.8UF TANT 20V 3528 Input + U68 LTC1541CMS8 6 R338 100K 7 R235 732K 5 R236 100K + 5 - 6 U99B LM393M 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. + C203 1UF TANT 16V 3216 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: R238 100K Title Size D Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 Power Supply Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 12 of 16 REVISIONS DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. REVISED PER ECN 1274. GP REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP REV 18 19 20 21 22 23 24 DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 VCC VCC GND cs0 cs0 cs1 cs1 lbwe lbwe ubwe ubwe a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 a14 a15 a16 a17 ubre ubre pcs8-8 pcs8-8 nv_wr nv_wr d[0..15] d[0..15] 12 11 10 9 8 7 6 5 27 26 23 25 4 28 29 3 2 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 16 GND U55 CY7C1009-20VC U54 CY7C1009-20VC U53 lbre lbre O0 O1 O2 O3 O4 O5 O6 O7 13 14 15 17 18 19 20 21 d0 d1 d2 d3 d4 d5 d6 d7 CE OE 22 24 cs0 lbre VPP PGM NC 1 31 30 VCC a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 a14 a15 a16 a17 12 11 10 9 8 7 6 5 27 26 23 25 4 28 3 31 2 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 16 GND VCC 32 D0 D1 D2 D3 D4 D5 D6 D7 13 14 15 17 18 19 20 21 d0 d1 d2 d3 d4 d5 d6 d7 CS1 CS2 22 30 cs1 WE OE 29 24 lbwe lbre NC 1 VCC 32 VCC VCC A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 pcs8-8 lbre nv_wr 20 22 27 26 E1* G* W* E2 11 12 13 15 16 17 18 19 d8 d9 d10 d11 d12 d13 d14 d15 GND U58 CY7C1009-20VC U57 a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 a14 a15 a16 a17 12 11 10 9 8 7 6 5 27 26 23 25 4 28 29 3 2 16 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 GND O0 O1 O2 O3 O4 O5 O6 O7 13 14 15 17 18 19 20 21 d8 d9 d10 d11 d12 d13 d14 d15 CE OE 22 24 cs0 ubre VPP PGM NC 1 31 30 VCC VCC a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 a14 a15 a16 a17 32 12 11 10 9 8 7 6 5 27 26 23 25 4 28 3 31 2 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 13 14 15 17 18 19 20 21 d0 d1 d2 d3 d4 d5 d6 d7 CS1 CS2 22 30 cs1 WE OE 29 24 lbwe lbre NC 1 VCC 32 VCC 16 GND U59 CY7C1009-20VC d8 D0 D1 D2 D3 D4 D5 D6 D7 13 14 15 17 18 19 20 21 CS1 CS2 22 30 cs1 WE OE 29 24 ubwe ubre NC 1 VCC 32 d9 d10 d11 d12 d13 d14 d15 a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 a14 a15 a16 a17 VCC SOCKET 32 PIN 12 11 10 9 8 7 6 5 27 26 23 25 4 28 3 31 2 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 16 GND D0 D1 D2 D3 D4 D5 D6 D7 13 14 15 17 18 19 20 21 d8 d9 d10 d11 d12 d13 d14 d15 CS1 CS2 22 30 cs1 WE OE 29 24 ubwe ubre NC 1 VCC 32 VCC a18 a[0..20] a18 Vcc U60 SN74AHC1G04DCK 5 VCC A Y GND 2 3 a[0..20] 16 D0 D1 D2 D3 D4 D5 D6 D7 28 DQ0 DQ1 DQ2 DQ3 DQ4 DQ5 DQ6 DQ7 14 BATTERY A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 Vcc FT 10 9 8 7 6 5 4 3 25 24 21 23 2 Vss 1 a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 12 11 10 9 8 7 6 5 27 26 23 25 4 28 3 31 2 a18 SOCKET 32 PIN U56 M48T58SOH28 a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 a14 a15 a16 a17 4 NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: Size C Date: CHK: MARK TUCCILLO 9/5/01 Title APR: GP 9/5/01 RAM 9/5/01 CPU Memory Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 11 of 16 REVISIONS DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. REVISED PER ECN 1274. GP REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP REV pcs2_8 pcs1_8 spare_in_1 a17 a16 pcs8_8 pcs5_8 pcs4_8 a19 ac DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 fp_1 VCC fp_2 a18 a0 18 19 20 21 22 23 24 spare_in_3 host_a18 ac host_a0 GND fp_2 host_a19 fp_1 VccINT host_a17 host_a16 ~PIN001 GND GND pcs8_8 pcs5_8 pcs4_8 VCCIO pcs2_8 pcs1_8 spare_in_1 11 10 9 8 7 6 5 4 3 2 1 84 83 82 81 80 79 78 77 76 75 spare_in_3 a9 spare_out_1 spare_out_0 25_MHz r/w siz0 3_6864MHz kojak_light 64_KHz a14 cs2 ac ac fp_0 fp_1 fp_2 fp_3 fp_0 fp_1 fp_2 fp_3 3_6864MHz 25_MHz as VCCIO host_a9 spare_out_1 spare_out_0 16_MHz r/w GJND siz0 3_6864MHz kojak_light 64KHz host_a14 cs2 VCCIO spare_in_2 1_843MHz host_a13 fp_0 cs3 GND U52 2635-00-04 LC Color Glue ~PIN002 pcs0-8 GND lbwe lbre clock_wr alarm_out spare_out_4 VCCIO ubwe ubre host_d4 sao2_res graph_out rec_res GND etco2_res leads_off nibp_res dac_wr ecg_gain 74 73 72 71 70 69 68 67 66 65 64 63 62 61 60 59 58 57 56 55 54 pcs0_8 lbwe lbre nv_wr alarm_out spare_out_4 ubwe VCC ubre d12 sao2_res graph_out rec_res etco2_res lead_off nibp_res ecg_gain pcs0_8 pcs1_8 pcs2_8 pcs3_8 pcs5_8 pcs8_8 VCC d11 d10 d9 d8 pcs3_8 d14 d15 d13 spare_in_0 spare_in_1 spare_in_2 spare_in_3 a10 spare_out_2 a15 cs2 cs3 cs2 cs3 spare_in_0 spare_in_1 spare_in_2 spare_in_3 fp_3 a12 a11 r/w siz0 as r/w siz0 as a20 spare_out_3 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 3_6864MHz 25_MHz spare_in_2 1_8MHz a13 fp_0 cs3 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 host_a20 spare_out_3 fp_3 host_a12 host_a11 VCCIO host_a10 spare_out_2 host_a15 GND VCCINT host_d6 host_d7 host_d5 GND host_d3 host_d2 host_d1 host_d0 pcs3_8 VCCIO as pccs0_8 pccs1_8 pccs2_8 pccs3_8 pccs5_8 pccs8_8 ecg_gain ecg_gain lbwe ubwe lbre ubre lbwe ubwe lbre ubre nv_wr nv_wr 1_8MHz 1_8MHz kojak_light kojak_light a[0..20] a[0..20] rec_res sao2_res nibp_res etco2_res rec_res sao2_res nibp_res etco2_res d[0..15] d[0..15] graph_out alarm_out lead_off graph_out alarm_out lead_off spare_out_0 spare_out_1 spare_out_2 spare_out_3 spare_out_4 VCC VCC spare_out_0 spare_out_1 spare_out_2 spare_out_3 spare_out_4 64_KHz GND NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 64_KHz IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. Title 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. Size C Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 GLUE Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 10 of 16 REVISIONS REV Grounded 18 19 20 21 22 23 24 Isolated F4 3/8ASB DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. REVISED PER ECN 1274. GP REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 TP36 +5VI_E +12V C103 180UF TANT 16V SIZE-R + D17 BZT52-C16 16V R188 4.02K D18 ether_iso_+5V MBRS340T3 5 1 D19 MBRS340T3 5 Switch 1 4 4 ether_IGND 8 I T2 2532-00-10 Comp Feedback D TP37 E_GND + 7 Vin DGND C104 180UF TANT 16V SIZE-R LOW ESR 2 Gnd U47 3 LM2587S-ADJ D U48 LM3411M5-5.0 U12-14 +5VREF R189 5 1K C105 .1UF CER 0805 2 Q37 CMPT3906 4 Out Comp IN 1 GND 2 NC 3 U49 CNY17-3SM 4 R352 10K 1 3 1 C106 .1UF CER 0805 5 2 R351 49.9K D I VCC VCC 2 R190 10K U50 HCNW2601-300 VCC 2 R191 Q15 CMPT3906 3 8 7 R192 2K 1 ether_iso_txd 1K 6 ether_txd C107 .1UF CER 0805 3 5 GND R193 499 OHM D I VCC 2 R194 10K 1K U51 HCNW2601-300 1 Q16 CMPT3906 VCC 3 ether_rxd R195 2 8 7 R196 1K 6 3 GND 5 ether_iso_rxd C108 .1UF CER 0805 R197 499 OHM NOTES: D 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. I 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. OPTIONAL THIS CIRCUITRY IS FOR THE ETHERNET OPTION IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: Title Size C Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 Ethernet Power Supply Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 9 of 16 REVISIONS REV +6.5V TP6 SHIELD_DR U36A TL062ACD R126 shield_dr 3 -6.5V D11 MMBD1503A I U42C LT1058SW R140 10K .1% 50PPM leads0 leads1 leads2 R141 10K .1% 50PPM 1 R342 22M 5% 10 D3 11 S3 R159 22M 5% I R160 10K .1% 50PPM RA_ref R163 10K .1% 50PPM leads0 leads1 leads2 3 C101 220PF NPO 0805 13 D4 S4 V 5K MELF 1W 200K AVL = LA - 0.5(LL + RA) ON AVF = LL - 0.5(LA + RA) ON ON V = V - 0.33(LA + RA + LL) INH A B C U42A LT1058SW 418 U40 AD621AR 100K 2.2UF MP 4036 R151 178K R150 1.62M C95 1000PF NPO 0805 +5VI R166 24.9K R144 9.31K .1% 50PPM U41A LT1057S8 1 + 8 - 7 -6.5V I C93 .1UF MP 2824 R147 R148 9.31K .1% 50PPM 2.49K C98 C96 .22UF MP 2824 R168 10K 7 D4 6 S4 In4 8 TP7 ECGX1000 5 ecgX1000 U41B LT1057S8 I I R157 +5VI R156 32.4K R374 20 OHM +6.5V +5VI R158 10K 5 + 2 U45A 4 LM339AM C99 I .01UF MP 2824 R164 21.5K R165 11K -6.5V +5VI diag_bw\ I R176 10K 7 + U45B 6 - 5 R178 24.9K 3 680PF NPO 0805 165K .1% 50PPM I 9 + 14 U45C 8 LM339AM 11 + 13 U45D 10 LM339AM 4 I R155 1.65K .1% 50PPM +5VI I LL_Lead R145 6 1 R177 2 10K A Vcc B D15 MMBD4148 Y GND 4 R171 32.4K R169 1 pacer_det 10K LM339AM U46 SN74AHC1G08DCK 3 -5VI I MAX327CSE U37D I -5VI 2 U44C MAX327CSE U44B MAX327CSE 1 1 3 -5VI 5 6 C102 220PF NPO 0805 DS4 BA-CMS-90 ON ON ON 15 D2 14 S2 In2 16 10 D3 11 S3 In3 9 3 5K MELF 1W ON ON ON LL_ref R181 22M 5% R184 6 11 10 9 D16 MMBD1503A 2 *R183 ON ON V +5VI R180 22M 5% * R182 ON AVF U44D MAX327CSE R172 200K I R179 22M 5% AVL -6.5V -6.5V 8 In4 AVR = RA - 0.5(LA + LL) -6.5V .1UF MP 2824 1 2 6 III = LL - LA ON 3 X I 4 3 R175 7 OFF ON U43 CD4051BCM 7 3 +6.5V -5VI R343 22M 5% ON ON C94 1 C100 1 1 I leads0 leads1 leads2 X0 X1 X2 X3 X4 X5 X6 X7 -5VI 2 R170 22M 5% 200K R162 10K .1% 50PPM D14 MMBD1503A 2 DS3 BA-CMS-90 R161 10K .1% 50PPM 13 14 15 12 1 5 2 4 R149 100K 4 16 U37C MAX327CSE +5VI R167 22M 5% OFF ON I 5 2 - U39A LT1112S8 3 + 2 - IVCC 9 In3 ON AVR +6.5V 7 3 + 8 16 15 II = LL - RA III ECGX10 VDD 14 LEAD MIX +6.5V R143 100K C92 .01UF MP 2824 U42D LT1058SW C97 220PF NPO 0805 I = LA - RA OFF 7 I RA_Lead I INH A B C 6 - +6.5V -5VI OFF ON 16 R139 10K .1% 50PPM -5VI 1 V OFF ON U39B LT1112S8 5 + VSS 200K R138 10K .1% 50PPM D13 MMBD1503A 2 LL ON OFF 3 X U38 CD4051BCM VEE 5K MELF 1W R137 10K .1% 50PPM X0 X1 X2 X3 X4 X5 X6 X7 8 5K MELF 1W LA_ref 6 11 10 9 3 R154 13 14 15 12 1 5 2 4 +5VI 2 RA ON II 3 I LA I 6 R136 22M 5% MAX327CSE U37B VDD S2 VSS 14 16 In2 VEE D2 8 15 CONF IVCC 7 R341 22M 5% 3 *R153 5K MELF 1W 1 1 LA_Lead * R152 5K MELF 1W 2 10 DS2 BA-CMS-90 LL 4 3 2 1 C91 220PF NPO 0805 R146 22M 5% *R174 -6.5V TP25 IGND +6.5V -5VI 11 R142 22M 5% * R173 I I R131 953 OHM .1% 50PPM I RA 6 12 1 1 12 DS1 BA-CMS-90 5 - 2 2 3 R135 200K + 3 3 2 3 *R134 5K MELF 1W R128 4.75M Q14 DTC114 2 1 D12 MMBD1503A R132 22M 5% * R133 100K 3 2 5K MELF 1W 7 + LA Q13 CMPT3906 1 R353 R130 22M 5% 2 DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 2 R127 100K R129 22M 5% CHANGE THE "5K MELF 1W" RESISTORS TO "499 OHM MELF 1W" No. 449012 10 PLACES. 3 - DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP +5VI R340 22M 5% PATIENT CABLES WITH 1K SERIES RESISTORS. + 18 19 20 21 22 23 24 - * SPECIAL FOR ACCOMMODATING 1 1K C90 .1UF CER 0805 +5VI 8 ecg_test U36B TL062ACD 7 U42B LT1058SW +6.5V I I V_Lead 13 I Vcc 2 D1 3 S1 MAX327CSE Vss Gnd U37A I In1 4 1 5 V_ref I -6.5V +6.5V +6.5VI +6.5V +5VI IVCC +5VI RL NOTES: 13 * R185 *R186 R187 5K MELF 1W 5K MELF 1W 200K DS5 BA-CMS-90 Vcc I D1 3 S1 MAX327CSE Vss Gnd U44A In1 4 1 -5VI 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. -6.5VI 5 RL_ref I 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. -5VI 2 -6.5V IVY BIOMEDICAL SYSTEMS INC. -6.5V I 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 Iso_GND I DWN: Title Size D Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 ECG Front End Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 8 of 16 REVISIONS DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. REVISED PER ECN 1274. GP REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP REV F3 500mASB Grounded Isolated +12V R372 10K Q36 CMPT3906 C76 .1UF CER 0805 C77 .1UF CER 0805 C78 .1UF CER 0805 C79 .1UF CER 0805 1 R349 10K 3 Q38 CMPT3906 3 1 C75 .1UF CER 0805 DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 R373 806 OHM 2 2 R371 2 OHM 1W 2512 5% C74 .1UF CER 0805 18 19 20 21 22 23 24 R366 -6.5VI 3 0 OHM 2512 U31 LM2990S-5.0 2 VIN TP31 +6.5VI D7 BZT52-C16 16V 4 Feedback 2 1 TP34 IGND TP23 IGND 7 4 IGND 8 Comp D10 Gnd + C83 100UF TANT 16V 7343 TP32 -6.5VI I U33 LM2931M-5.0 + 8 MBRS340T3 VIN VOUT 2 3 6 7 3 R367 0 OHM 2512 C214 470UF 16V ALUM 1 +5VI + C84 6.8UF TANT 35V 7343 TP24 +5VI I R121 3.01K +6.5VI 3 R120 3.01K 1 Q10 FMMT617TA 2 Q11 CMPT3906 TP35 ISO_+5_VREF 3 1 R122 10K R368 +5_Vref 0 OHM 0805 R123 10K I U34 R124 1K C88 .1UF CER 0805 2 I 5 U32 LM2587S-ADJ C80 + 6.8UF TANT 35V 7343 TP17 IGND + U35 CNY17-3SM 5 Out 4 Comp C85 .33UF NPO 0805 PS_Synch IN 1 GND 2 NC 3 3 Switch C82 100UF TANT 16V 7343 2 1 5 C86 Q12 MMBT3904LT1 1 + LM3411M5-5.0 C87 6.8UF TANT 20V 3528 47PF NPO 0805 R125 20K C89 470PF NPO 0805 2 Vin DGND 1 -5VI NC NC D9 MBRS340T3 MBRS340T3 3 4 5 5 D8 T1 2532-00-10 GND GND GND GND R119 4.02K TP33 -5VI 1 + 4 C81 180UF TANT 16V SIZE-R LOW ESR VOUT GND 1 Q39 MMBT3904LT1 1K 2 R350 I I NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: Title Size C Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 DSP Power Supply Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 7 of 16 REVISIONS REV ecgX1000 press_1 press_1 press_2 press_2 10K R96 A4 A5 A6 A7 A11 DMS 16MHZ 3 15 23 35 VCC VCC VCC VCC WR- 10K R98 10K R99 IRQE 10K R100 13 21 20 ls1 ls2 MUX0 MUX1 MUX2 19 18 8 mux0 mux1 mux2 LA_REF RA_REF LL_REF V_REF RL_REF 25 33 7 11 34 la_ref ra_ref ll_ref v_ref rl_ref LEADS_OFF0 LEADS_OFF1 29 16 sel_20 press_test 10 22 30 42 IRQL1 10K R102 IRQ1 GND GND GND GND IDG 10K R103 DIAG_BW 14 diag_bw 24 PRESS_EN IRQ1 ECG_TEST 27 ecg_test TEMP_CAL_SEL HI_LO_SEL 41 26 temp_cal sel_40 PCS6 PCS7 PCS8 PCS9 28 9 31 32 pcs6 pcs7 pcs8 pcs9 4MHZ 12 4MHz RFS0 10K R105 3 15 16 17 18 19 20 21 22 23 24 25 26 27 d11 d12 d13 d14 d15 d16 d17 d18 d19 d20 d21 d22 d23 PRESS_EN IRQ0 10K R104 ls0 WRRDpcs6 4MHz IRQL0 10K R101 IVCC 7 11 10 8 12 13 DB0 DB1 DB2 DB3 DB4 DB5 DB6 DB7 DB8 DB9 DB10 DB11 DB12 VIN 1 VREF 2 1 AVCC 4 V- 5 + 3 - 2 R91 4.99K U21A TLE2062ACD 4 IVCC -6.5VI + -5VI C225 10UF TANT 10V 3528 I DVCC AZ CAL 28 6 9 ad_az ad_cal + C226 10UF TANT 10V 3528 U23 ADG426BRS 28 D 2 18 3 NC EN RS pcs9 13 WR D11 D10 D9 D8 14 15 16 17 A3 A2 A1 A0 I 19 20 21 22 23 24 25 26 11 10 9 8 7 6 5 4 ecgX1000 resp_high base_imp ecgX10 la_lead ra_lead ll_lead IVCC I -6.5VI rl_ref press_en press_test press_test v_ref v_ref ls0 ls0 diag_bw ecg_test sel_40 temp_cal temp_cal sclk0 sclk0 sel_20 sel_20 resp_test C227 resp_test ls0 ls0 ls1 14 4 5 6 7 8 9 10 11 DB7 DB6 DB5 DB4 DB3 DB2 DB1 DB0 VDD WR 649K Isolated resp_low 3 SOCKET 32 PIN IDG O0 O1 O2 O3 O4 O5 O6 O7 13 14 15 17 18 19 20 21 CE OE 22 BMS24 RD- IVCC d8 d9 d10 d11 d12 d13 d14 d15 16 IVCC R110 402K 1 31 30 VPP PGM NC I C59 1UF MP 2824 CEXT 7 REXT/CEXT 9 10 11 ecg_test VCC VCC A B CLR Q 5 Q 12 resp_test IVCC R112 1 U26 2636-00-04 IDG 8 7 R113 2K VCC 2 C60 .1UF CER 0805 IDG Q8 CMPT3906 dsp_txd dsp_txd 1K U27 HCNW2601-300 6 3 5 GND R114 499 OHM IRQ1 IRQ0 DR1 sclk0 TFS0 RFS0 IRQL1 IRQ2 IRQE IRQL0 R111 10K 2 IDG Grounded U19A 74HCT221D 6 3 R339 10K 15 Vcc IVCC A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 2 VREF GND d8 12 11 10 9 8 7 6 5 27 26 23 25 4 28 29 3 2 OUT2 ls2 resp_high 8 a0 a1 a2 a3 a4 a5 a6 a7 a8 a9 a10 a11 a12 a13 d16 d17 d18 d11 d10 d9 VCC 32 d15 d14 d13 d12 1 ls1 R109 U24 AD7524JR 75 74 73 72 71 70 69 68 67 66 65 64 63 62 61 60 59 58 57 56 55 54 53 52 51 OUT1 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 IDG IVCC GND 100 OHM U25 ADSP-2184BST-160 13 16 3 2 OUT 16MHz D15 D14 D13 D12 GND D11 D10 D9 Vdd GND D8 D6/IWR D6/IRD D5/IAL D4/IS GND Vdd D3/IACK D2/AD15 D1/AD14 D0/AD13 BG EBG BR EBR WR- 16 RFB GND a3 100 a2 99 a1 98 a0 97 96 95 94 PF0 93 PF1 92 91 90 89 PF2 88 87 86 85 d23 84 d22 83 d21 82 d20 81 80 d19 79 d18 78 d17 77 d16 76 Vcc 4 Y3 EMC60S5B-016 A4/AD3 A5/AD4 GND A6/AD5 A7/AD7 A8/ID7 A9/ID8 A10/AD9 A11/AD10 A12/AD11 A13/AD12 GND CLKIN XTAL Vdd CLKOUT GND Vdd WR RD BMS DMS PMS IOMS CMS A3/AD2 A2/AD1 A1/AD0 A0 PWDACK BGH PF0[MODE A] PF1[MODE B] GND PWD Vdd PF2[MODE C] PF3 FL0 FL1 FL2 D23 D22 D21 D20 GND D19 D18 D17 D16 IVCC IRQE+PF4 IRQL0+PF5 GND IRQL1+PF6 IRQ2+PF7 DT0 TFS0 RFS0 DR0 SCLK0 Vdd DT1 TFS1 RFS1 DR1 GND SCLK1 ERESET RESET EMS EE ECLK ELOUT ELIN EINT 1 2 3 a6 4 a7 5 a8 6 a9 7 a10 8 a11 9 a12 10 a13 11 12 13 14 15 16 17 18 WR- 19 RD- 20 BMS- 21 DMS- 22 PMS- 23 IOMS-24 CMS- 25 CS d15 d14 d13 d12 d11 d10 d9 d8 IDG a4 a5 12 ls2 + IVCC pcs8 - d[23..8] R364 10K R363 100PF NPO 0805 U21B TLE2062ACD 6 7 5 DR1 ll_ref sel_40 a[13..0] 4 ra_ref diag_bw R108 100K 13 Q la_ref ll_ref ecg_test R107 100K Q ls1 ra_ref IRQ2 R106 100K A B CLR press_en la_ref IVCC REXT/CEXT rl_ref ls1 I PF0 PF1 PF2 CEXT v_lead temp_1 temp_2 press_1 press_2 TFS0 10K R344 1 2 3 pacer_det S1 S2 S3 S4 S5 S6 S7 S8 S9 S10 S11 S12 S13 S14 S15 S16 IDG IDG 14 C58 .1UF MP 2824 15 R90 100K 8 IVCC WR RD CS CLKIN EOC INT U19B 74HCT221D +6.5VI TP5 ANALOG IN U22 ADC1241 LEADS0 LEADS1 LEADS2 IVCC RD- ad_az ad_cal 1 38 39 40 37 1 43 5 IOMS16MHz BMS- 10K R97 a4 a5 a6 a7 a11 36 17 Vdd temp_2 temp_2 DMS- D0 D1 D2 D3 Vss PMS- 10K R95 2 44 6 4 AGND temp_1 temp_1 10K R94 DSP_GLUE AD_AZ AD_CAL d16 d17 d18 d19 DGND pacer_det pacer_det -5VI 3 resp_low IOMS- 1 1 I 14 10K R93 resp_low 2 +6.5VI C57 .1UF CER 0805 U20 2529-00-04 v_lead v_lead CMS- 2 1K ll_lead ll_lead 10K R92 +5V_Ref D6 MMBD1503A IVCC R386 ra_lead ra_lead C224 10UF TANT 10V 3528 I la_lead la_lead IVCC + ecgX10 GND base_imp ecgX10 27 resp_high 12 resp_high DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 3 ecgX1000 base_imp DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP 18 19 20 21 22 23 24 I IVCC DGND VB 1 5 RS 7 TP30 RESET\_DSP R345 10K key RESET 1 3 5 7 9 11 13 2 4 6 8 10 12 14 IDG IRQ2 pcs7 d15 d14 d13 d12 d11 3 8 VO PFO D IDG d10 d9 d8 WR- pcs6 GND INTRN CEN D7 D6 D5 D4 D3 NC D2 D1 NC D0 WRN VCC RDN RXD TXD MP0 MP1 NC NC A2 A1 A0 X1/CLK X2 RESET IVCC IVCC U29 SCC2691AC1A28 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 RD- R115 10K 2 WDI J17 EZ-ICE IVCC R116 a2 a1 a0 2 U30 HCNW2601-300 JP5 C62 .1UF CER 0805 -6.5VI C63 .1UF CER 0805 C64 .1UF CER 0805 C65 .1UF CER 0805 C66 .1UF CER 0805 C67 .1UF CER 0805 C205 .1UF CER 0805 C206 .1UF CER 0805 C207 .1UF CER 0805 IVCC IVCC 2 4 A Y +5V_Ref IVCC C70 .1UF CER 0805 C71 .1UF CER 0805 C72 .1UF CER 0805 C73 .1UF CER 0805 IDG 5 dsp_rxd R118 499 OHM D I OUT 3 Y4 1.8432MHZ SMT 2 C69 .1UF CER 0805 3 C68 .1UF CER 0805 I R117 2K C61 .1UF CER 0805 dsp_rxd NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. 4 U100 SN74AHC1G04DCK IGND +5V_Ref R365 100 OHM Vcc +6.5VI +5VI 5 IDG GND -6.5VI IRQE -5VI Vcc +6.5VI GND GND -5Vi 8 7 6 3 TP16 IDG JP4 VCC Q9 CMPT3906 VCC RESET PS_Synch 1 1K 3 PFI 6 VCC 4 GND 2 IDG U28 MAX690A-CSA IDG 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: Title +5VI -5Vi Size D Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 DSP Processor Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 6 of 16 REVISIONS REV VCC VCC ac rec_res sao2_res nibp_res etco2_res spare_out_0 spare_out_1 spare_out_2 spare_out_3 spare_out_4 graph_out alarm_out lead_off rec_res spo2_res nibp_res etco2_res graph_out alarm_out lead_off graph_out alarm_out lead_off 8 d[0..15] Y2 EMC60S5B-048 D clock cs2 ds siz0 siz1 as r/w nv_wr clear blue[0..5] clock hsynch vsynch dot_clock cs2 ds siz0 siz1 as r/w D VCC 144 143 142 141 140 139 138 137 136 135 134 133 132 131 130 129 128 127 126 125 124 123 122 121 120 119 118 117 116 115 114 113 112 111 110 109 irq3 D reset GND VCC DSACK1 DSACK0 A0 A31/IACK7 A30/IACK6 A29/IACK5 A28/IACK4 GND VCC A27/IACK3 A26/IACK2 A25/IACK1 A24 D15 D14 D13 GND D12 GND VCC D11 D10 D9 D8 D7 D6 D5 D4 GND VCC D3 D2 D1 D0 RMC R/W SIZ1 SIZ0 DS AS BGACK BG BR BERR HALT RESET GND CLKOUT VCC XFC VCC EXTAL VCCSYN XTAL GND MODCK VCC IPIPE IFETCH BKPT FREEZE TIN1 TOUT1 TGATE1 TCK TMS TDI TDO VCC GND CS0/AVEC CS1/IRQ2 CS2/IRQ2 IRQ3 CS3/IRQ4 GND VCC IRQ5 IRQ6 IRQ7 DONE2 DACK2 DREQ2 DONE1 DACK1 DREQ1 X1 GND VCC X2 SCLK CTSB RTSB TXDB RXDB TXRDYA RXRDYA CTSA RTSA GND VCC TXDA RXDA TIN2 TOUT2 TGATE2 U17 MC68340FE25 POWERED BY MOTOROLA iack3 108 107 106 105 104 103 102 101 100 99 98 97 96 95 94 93 92 91 90 89 88 87 86 85 84 83 82 81 80 79 78 77 76 75 74 73 cs0 cs1 cs2 irq3 cs3 pcs4_8 irq6 ubre ubwe irq5 irq6 irq7 done2 dreq2 done1 dreq1 1_843MHz 1 3 5 7 9 VB PFO 5 RS 7 Q7 CMPT3906 irq6 3 2 WDI 8 GND VCC 6 1 D irq7 R84 1K done1 3 pcs5_8 done2 D reset cts_b rts_b rxd_b txd_b pcs4_8 txd_a rts_a rxd_a cts_a iack3 irq6 txd_e rts_e rxd_e cts_e ubre ubwe audio_a audio_b sinen souten d[0..15] rec_txd rec_rxd cts_d rts_d txd_d rxd_d cts_d rts_d txd_d rxd_d cts_c rts_c txd_c rxd_c cts_c rts_c txd_c rxd_c cts_b rts_b rxd_b txd_b cts_b rts_b rxd_b txd_b txd_a rts_a rxd_a cts_a txd_a rta_a rxd_a cts_a txd_e rts_e rxd_e cts_e txd_e rta_e rxd_e cts_e audio_a audio_b filter_clka filter_clkb a[0..20] ecg_gain ECG RESP IBP1 IBP2 PLETH HR SpO2 ecg_aout resp_aout ibp1_aout ibp2_aout pleth_aout hr_aout spo2_aout pcs1-8 ECGX1000 pcs2-8 pcs5-8 speaker+ cs_hires_dac speaker- ecgX1000 ecg_gain audio_a audio_b D lbwe ds lbwe ds Battery speaker+ speakeretco2_aout ETCO2 a3 a2 a1 a8 irq3 ether_rxd ether_txd 3MHz analog Battery a7 a6 a5 a4 a10 a9 a13 a12 a11 a16 a15 a14 a18 a17 a21 a20 2 irq5 1 cts_c rts_c txd_c rxd_c pcs0-8 ether_rxd ether_txd a0 +5VREF +5VREF Battery Battery analog VCC VO r/w VCC irq3 PFI cts_d rts_d txd_d rxd_d a[0..21] TP29 RESET\ 4 dsack1 VCC +12V dsp_txd dsp_rxd 2 4 6 8 10 U18 MAX690A-CSA a[0..20] -12 ds a19 D J16 TEST cs_hires_dac D pcs1_8 pcs2_8 pcs5_8 cs_hires_dac berr 3MHz VCC 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 VCC irq5 comm FC3 FC2 FC1 FC0 VCC GND A23 A22 A21 A20 A19 A18 A17 VCC GND A16 A15 A14 GND A13 A12 A11 VCC GND A10 A9 A8 A7 A6 A5 A4 VCC GND A3 A2 A1 25_MHz ether_cts ether_rxd ether_txd ether_rts GND d3 d2 d1 d0 d11 d10 d9 d8 d7 d6 d5 d4 d12 porta1 porta0 d15 d14 d13 iack3 porta2 iack5 porta4 dsack1 dsack0 a0 porta7 r/w VCC pcs0_8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 irq7 D d[0..15] d[0..15] porta0 porta1 porta2 porta4 porta7 hsynch vsynch dot_clock comm GND pcs3_8 blue[0..5] hsynch vsynch dot_clock video d[0..15] D br berr halt reset dsack1 red[0..5] blue[0..5] audio_a_clk audio_b_clk glue r/w siz1 siz0 ds as bgack eow_int A[0..21] cs_hires_dac hd[0..15] VCC intack7 porta0 porta1 porta2 porta4 porta7 sof_int green[0..5] red[0..5] 25_MHz 25_MHz memory a[0..20] spare_in_1 spare_in_2 spare_in_3 0 OHM 0805 VCC VCC kojak_light R362 5 green[0..5] +12 fp3 64KHz rec_res sao2_res nibp_res etco2_res OUT red[0..5] DGND fp2 64KHz 1_843MHz 64_KHz 1_8MHz kojak_light fp_0 fp_1 fp_2 fp_3 fp1 a[0..20] green[0..5] intack7 reset VCC fp0 lbwe ubwe lbre ubre intack5 intack7 AGND ac fp0 fp1 fp2 fp3 iack5 GND cs2 cs3 DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 video VCC +5VDC 3_6864MHz cs2 cs3 ecg_gain lbwe ubwe lbre ubre ecg_gain lbwe ubwe lbre ubre nv_wr VCC cs0 cs1 pcs8-8 GND 3MHz cs0 cs1 4 25_MHz r/w siz0 memory pcs0_8 pcs1_8 pcs2_8 pcs4_8 pcs5_8 pcs8_8 pcs0_8 pcs1_8 pcs2_8 pcs4_8 pcs5_8 pcs8_8 GND as 25_MHz r/w siz0 ac VCC glue as 18 19 20 21 22 23 24 DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP R72 10K R75 10K R78 10K R81 10K R85 10K R87 10K dreq1 dreq2 bgack br berr halt R73 10K R74 10K R76 10K R77 10K R79 10K R82 10K R86 10K R88 10K reset dsack0 dsack1 VCC +12V -12 -12V 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. DGND DGND D +12 -12V 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. bypass <Value> VCC +12V R83 10K NOTES: A VCC R80 10K D -12V AGND AGND A 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: Title Size C Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 COLOR CPU MAIN Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 5 of 16 REVISIONS REV VCC VCC U13 SCC2691AC1A28 15 16 17 18 19 20 21 22 23 24 25 26 27 28 d15 d14 d13 d12 d11 VCC 5 d10 d9 d8 Vcc A Y R51 10K R52 10K DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 R53 10K ether_rxd ether_txd ether_cts ether_rts a3 a2 a1 VCC 2 1 4 GND 3 20 13 14 10 17 8 VCC T1IN T2IN U14 MAX233ACWP T1OUT 5 T2OUT 18 R1OUT R2OUT R55 10K R56 10K C1+ C1VVV+ R1IN R2IN 4 19 C2+ C2+ C2C2- 12 15 11 16 GND GND 9 6 rts_e txd_e txd_e rts_e rxd_e rxd_e cts_e txd_a rts_a txd_a rts_a rxd_a cts_a rxd_a cts_a cts_e VCC R57 10K 2 1 3 20 13 14 10 17 8 VCC 7 R54 10K T1IN T2IN U15 MAX233ACWP 5 T1OUT 18 T2OUT R1OUT R2OUT C1+ C1VVV+ R1IN R2IN 4 19 C2+ C2+ C2C2- 12 15 11 16 GND GND 9 6 VCC d[0..15] a[0..20] d[0..15] U16 82C684CJ/44 a[0..20] VCC R356 10K r/w pcs0-8 irq3 iack3 d8 d9 d10 d11 d12 d13 d14 d15 7 8 9 10 11 12 13 14 D0 D1 D2 D3 D4 D5 D6 D7 a1 a2 a3 a4 a5 35 34 33 32 31 A1 A2 A3 A4 A5 r/w pcs0-8 15 16 R/W CE irq3 iack3 21 20 19 1 43 5 6 INTRN IACK DTACK SEL RESET CLK X2 28 38 IEI RDN VCC reset 3_MHz reset 3MHz R58 10K R59 10K R60 10K R61 10K R62 10K R63 10K R64 10K R65 10K R66 10K R67 10K R68 10K R69 10K R70 10K R71 10K RXD A TXD A RTS A CTS A 39 40 41 36 RXD B TXD B RTS B CTS B 4 3 42 37 rxd_b txd_b rts_b cts_b RXD C TXD C RTS C CTS C 27 26 25 30 rxd_c txd_c rts_c RXD D TXD D RTS D CTS D 17 18 24 29 rxd_d txd_d rts_d cts_d TIMER 1 TIMER 2 2 22 VCC DGND 44 23 rxd_b txd_b rts_b cts_b rxd_c txd_c rts_c cts_c rxd_d txd_d rts_d cts_d audio_a audio_b audio_a audio_b VCC VCC 5 +5VDC 8 R361 100 OHM OUT GND 2 VCC RDN RXD TXD MP0 MP1 NC NC A2 A1 A0 X1/CLK X2 RESET R50 10K 3 RESET lbwe VCC VCC 4 U102 SN74AHC1G04DCK GND INTRN CEN D7 D6 D5 D4 D3 NC D2 D1 NC D0 WRN 1 2 3 4 5 6 7 8 9 10 11 12 13 14 7 irq6 pcs4_8 18 19 20 21 22 23 24 VCC lbre DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP Y1 3.6864MHZ SMT NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. GND 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: MARK TUCCILLO 9/5/01 Title Size C Date: CHK: APR: GP 9/5/01 RAM 9/5/01 COMM Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 4 of 16 REVISIONS REV VCC 18 19 20 21 22 23 24 DGND VCC +12 D DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 AGND +12 -12 A -12 +12 +12 +12 +12 +12 +12 C28 + C29 4.7UF TANT .1UF CER 16V 3528 0805 C30 .1UF CER 0805 C31 .1UF CER 0805 C32 .1UF CER 0805 C33 .1UF CER 0805 C36 C35 + .1UF CER 4.7UF TANT 0805 16V 3528 -12 -12 C37 .1UF CER 0805 C38 .1UF CER 0805 C39 .1UF CER 0805 C40 .1UF CER 0805 VCC VCC C46 + C47 4.7UF TANT .1UF CER 16V 3528 0805 VCC C52 .1UF CER 0805 A VCC VCC VCC -12 VCC VCC VCC VCC C41 .1UF CER 0805 VCC C48 .1UF CER 0805 VCC C53 .1UF CER 0805 C42 .1UF CER 0805 VCC C49 .1UF CER 0805 VCC C54 .1UF CER 0805 C43 .1UF CER 0805 VCC C50 .1UF CER 0805 VCC C55 .1UF CER 0805 +12 C34 .1UF CER 0805 C44 .1UF CER 0805 VCC NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. C45 .1UF CER 0805 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. VCC 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. C51 .1UF CER 0805 VCC IVY BIOMEDICAL SYSTEMS INC. C56 .1UF CER 0805 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: D MARK TUCCILLO 9/5/01 Title Size A Date: CHK: APR: GP 9/5/01 RAM 9/5/01 BYPASS Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 3 of 16 C13 R14 10K .1UF CER 0805 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 R15 VCC 100K 8 R16 2 1 +5VREF U4A 3 TL062ACD 100K +5VREF C209 .1UF CER 0805 R19 R20 1M 100K 13 12 11 10 9 8 7 6 DB0 DB1 DB2 DB3 DB4 DB5 DB6 DB7 pcs5-8 16 15 14 CS! RD! BUSY! VREF 2 AIN BOFS 4 3 R21 18 VDD AGND U4B R24 5 Battery R27 49.9K 17 A R29 100K 5 filter_clka AGND Vout 8 2 V+ V- 7 3 NC NC 6 4 Vin CLK 5 filter_clkb C17 d8 d9 d10 d11 d12 d13 d14 d15 a1 14 13 12 11 10 9 8 7 6 lbwe pcs1-8 16 15 17 VDD DB0 DB1 DB2 DB3 DB4 DB5 DB6 DB7 DA/DB 2 3 4 OUT A RFB A VREF A 13 12 C19 R28 14 C20 .1UF CER 0805 R25 1 AGND DGND A 33.2K 6.8UF TANT 35V 7343 20 19 18 OUT B RFB B VREF B 1 SHUTDOWN Vo2 8 2 BYPASS GND 7 3 +IN Vdd 6 4 -IN Vo1 -12 5 2 3 4 A QRS C23 100PF NPO 0805 A A 1 A U8 LM4861M R30 100K C212 .1UF CER 0805 R31 100K U7A TL034ACD +12 TP27 SPEAKER (-) TP28 SPEAKER (+) C213 .1UF CER 0805 ALARM speakerspeaker+ A d[0..15] R32 a[0..20] 10K 10K AGND 10 VREF 19 VDD 18 8 U7C TL034ACD A VCC D d8 d9 d10 d11 d12 d13 d14 d15 20 19 18 17 16 15 14 13 DB0 DB1 DB2 DB3 DB4 DB5 DB6 DB7 a1 a2 a3 24 23 22 A0 A1 A2 pcs2-8 21 WR VOUT 1 VOUT 2 VOUT 3 VOUT 4 VOUT 5 VOUT 6 VOUT 7 VOUT 8 VDD VSS VREF DGND ds pcs5-8 R37 R38 20K C25 .1UF CER 0805 20K R41 D 10K lbwe lbwe A pcs1-8 pcs1-8 9 10 + pcs5-8 1 10 11 12 +12 -5VREF +5VREF R36 D 10K -12 2 VIN 4 GND VOUT U12B TL034ACD ecgX1000 8 U12C TL034ACD 5 + 6 - 7 C210 .1UF CER 0805 6 R390 499 OHM ecg R39 12 + 13 - 10K 14 C27 100K A R40 10K R42 A A +5VREF TP1 10K .1% 50PPM .1UF CER 0805 R44 10K .1% 50PPM +5 U12D TL034ACD C26 .1UF CER 0805 R43 pcs2-8 pcs2-8 ETCO2 IBP1 IBP2 PLETH HR SpO2 U11 AD680JR +5 .033UF MP 2220 VCC cs_hires_dac RESP IBP1 IBP2 PLETH HR SpO2 C24 - ds cs_hires_dac RESP ETCO2 9 8 7 6 5 4 3 2 R35 10K 7 U7B TL034ACD 11 9 2 5 2 3 A 4 1 6 U10 AD7228ACR R34 OUT1 10K + RFB 20 ds cs_hires_dac - DGND 17 16 + 3 R33 +5VREF WR CS - DB0 DB1 DB2 DB3 DB4 DB5 DB6 DB7 DB8 DB9 DB10 DB11 + 15 14 13 12 11 10 9 8 7 6 5 4 - U9 AD7545AKSW d2 d3 d4 d5 d6 d7 d8 d9 d10 d11 d12 d13 C18 .1UF CER 0805 A 40.2K A C22 220PF NPO 0805 D VCC 6.8UF TANT 35V 7343 R26 + 24.9K A WR CS + R23 100K U7D TL034ACD Battery audio_b 1 VCC D C21 .1UF CER 0805 D audio_a C16 .1UF CER 0805 A 5 A DGND Vin R17 100K 11 1 CLK 5 4 6.8UF TANT 20V 3528 U6 AD7528ACR 100K VCC 6 A A 6 VCC CLK 7 NC 10K TL062ACD 7 8 V- NC + filter_clkb filter_clkb d8 d9 d10 d11 d12 d13 d14 d15 Vout V+ 3 A R22 4.02K U5 AD7574JN filter_clka AGND 2 R18 1K -12 A 1 + A 4 A C15 .1UF CER 0805 U3 LTC1069-7CS8 VCC C14 +12 C208 .1UF CER 0805 filter_clka U2 LTC1069-7CS8 - 18 19 20 21 22 23 24 DATE + DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP - REVISIONS REV 1 U12A TL034ACD +12 C211 .1UF CER 0805 A A R45 100K R46 100K R47 ecg_gain MMBD4148 D5 MMBD4148 1 100K G +12 +12 1 R48 100K VCC TP21 AGND R49 100K NOTES: -12 A -12 AGND DGND -12 A D ECG S +12 vdd ECGX1000 Q6 MMBF4393 3 Q5 CMPT3906 VCC +5 VCC D 2 D4 2 +5VREF 3 +5VREF 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. Title 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. Size C Date: MARK TUCCILLO 9/5/01 CHK: APR: GP 9/5/01 RAM 9/5/01 ANALOG Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 2 of 16 pacer_det cts_c txd_c +12V nibp_gnd Battery_Pos Pump_GND +12V Vcc FB3 +12V_HD Vbuss Vcc HD_GND DGND dsp -12V -5VI 13 4 Switcher_off 12 5 11 6 10 7 9 8 CONNECT TO MOUNTING HOLE D rec_res sinen souten rec_rxd rec_txd A temp1_plus temp1_neg temp1_out temp2_out IGND 40C_sel 20C_sel temp_cal# -5VI -6.5VI 9 8 10 7 11 6 12 5 13 4 14 3 15 2 J10 COM 1 7 5 3 1 7 5 3 1 D D R358 1K 332 OHM R359 1K A 301 OHM C216 100PF 6KV CD alarm_out lead_off + C5 4.7UF TANT 16V 3528 Vcc SpO2 Power Supply VCC E1 DGND C8 10UF TANT 10V 3528 + TP19 DGND C9 10UF TANT 10V 3528 C12 10UF TANT 10V 3528 + ether_iso_rxd ether_iso_+5V ISOLATED D1 MMBD4148 R11 10K +5VREF NON ISOLATED 3 1 8 R12 Ethernet Power Supply 1 Q3 MMBT3904LT1 10K 4 3 10 6 11 5 12 4 13 3 14 2 15 1 16 J13 ANALOG OUT CONNECTOR 1 3 5 7 9 11 13 15 17 19 21 23 25 2 4 6 8 10 12 14 16 18 20 22 24 26 10 6 11 5 12 4 13 3 14 2 15 A 16 graph_com 6 Vbuss E6 7 A +12V Vcc E5 9 7 SF5 MEA8020T10R0 JP1 CHASSIS_GND E4 8 1 E3 9 A 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 A 8 + Vcc D SpO2 ISOLATED + + E2 D ether_txd ether_rxd ETHERNET ISOLATED C10 4.7UF TANT 16V 3528 etco2 3 NON ISOLATED C6 4.7UF TANT 16V 3528 + A SaO2_Xmitt SaO2_Rec SaO2_Rts SaO2_Reset +5VREF ISOLATED C11 4.7UF TANT 16V 3528 +12V E7 D ecgX1000_out ecg_out resp ibp1 ibp2 pleth hr SaO2 D D3 MMBD4148 5 2 graph 4 +12V 6 K1 390005 G6K-2F-Y-DC12 6 Alarm Out 7 3 1 8 3 D2 MMBD4148 7 5 2 4 3 Iso_SaO2_Xmitt Iso_SaO2_Rec Iso_SaO2_Rts Iso_SaO2_Reset IGND_SpO2 J24 ECGX1000 OUT R13 1 Q4 MMBT3904LT1 10K 2 TRANSMIT DATA RECEIVE DATA CTSRESET INPUT- A graph_out 2 D -15VI_SpO2 graph Battery Ethernet Power Supply ether_IGND ether_iso_txd D 1 2 3 + J14 SaO2 INTERFACE DGND 2 4 6 8 10 12 J12 BEDSIDE WIRELESS INTERFACE (B.W.I.) Vcc SF4 MEA8020T10R0 etco2_aout resp_aout ibp1_aout ibp2_aout pleth_aout hr_aout spo2_aout cpu_main Vbuss 1 3 5 7 9 11 J9 DISPLAY 191501 C3 .15UF 63V MP 2824 C4 .15UF 63V MP 2824 J8 KOJAK LIGHT D 0 OHM A 100UH SMT R360 C7 4.7UF TANT 16V 3528 +15VI_SpO2 R380 100UH SMT R357 1 2 3 D ECGX1000 SaO2Wform RespWform ecg_aout txd_b rxd_b etco2_res 64KHz Vbuss Vcc SF10 ACH3218-472 L1 ecgX1000 ether_rxd ether_txd Vcc D D NON ISOLATED FRONT END ISOLATED +5VI_SpO2 + C1 10UF TANT 10V 3528 C2 .1UF CER 0805 2 4 6 8 D I 1 2 3 4 5 6 7 8 9 10 11 12 13 14 0 OHM 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 line_enable rxd_d txd_d rts_d spo2_res J15 ETHERNET blue0 blue1 blue2 blue3 blue4 blue5 R382 Vcc J11 COM 2 L2 +12V green0 green1 green2 green3 green4 green5 D 1 SF3 MEA8020T10R0 D 2 4 6 8 temp_press SpO2 Power Supply red0 red1 red2 red3 red4 red5 SF11 ACH3218-101 D rxd_e txd_e DSP Power Supply -6.5V IGND ISOLATED temp2_plus temp2_neg Q2 IRF7205/SO D dot_clock hsynch vsynch 17 +5_Vref +5VI +6.5V SG2+ SG2- 1 R10 10K red[0..5] green[0..5] blue[0..5] 16 +12V Q1 MMBT3904LT1 Q42 MMBT3904LT1 1 D rta_e cts_e DGND R5 10K J6 DISPLAY BACKLIGHT D 100K rxd_a txd_a DSP Power Supply +12V 1 2 3 J21 FAN D temp_press I 1 2 3 D kojak_light red[0..5] green[0..5] blue[0..5] dot_clock hsynch vsynch +6.5VI +5VI U1 SP720AB R9 10K Vbuss R384 dsp SF9 ACH3218-472 R7 10K Vcc +12V_Rec J7 SPEAKER rta_a cts_a I R8 10K 16 15 14 13 12 11 10 9 V+ IN IN IN IN IN IN IN 2 1 2 3 speaker- AGND -12V D R6 10K speaker+ DGND ISOLATED press_1 press_2 R4 470K Vcc 5 VCC IN IN IN IN IN IN IN -V 1 porta7 porta4 porta2 porta1 porta0 cts_d rts_b rts_c cts_b SG1+ SG1- R3 470K 6 -12V 1 2 3 4 5 6 7 8 3 +12V I SF7 ACH3218-472 SF2 MEA8020T10R0 2 Vcc PS_Synch +5_Vref Vbuss 470K Vcc +12V PRES_TEST PRESS_EN RDBK0 Vcc R1 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 DATE 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 J3 RECORDER fp3 fp2 fp1 fp0 SF8 ACH3218-472 I D D Battery J19 RESP ADJ Resp R2 470K 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 7 1 2 3 4 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Vcc 8 Iso_GND u/d# offset_cs# inc# gain_cs# 2 14 dsp_txd dsp_rxd press_test press_en press_1 press_2 sel_40 sel_20 temp_cal 15 D dsp_txd dsp_rxd resp_high resp_low base_imp temp_1 temp_2 resp_high resp_low base_imp Common_LED On_Off Power_On_Led Bat_Maintence_LED Bat_Charging_LED Battery_Fault_LED Vcc 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 cts_c rxd_c txd_c nibp_res +5VI +5V_Ref +6.5VI RA 1 D VCC IGND -6.5VI -5Vi PS_Synch +5VI +5V_Ref sclock0 resp_test D J4 FRONT PANEL D 16 ac +5VREF sclk0 resp_test Resp SF6 ACH3218-472 8 D ac DGND diag_bw ecg_test LA 7 9 1 2 Vcc ecgX1000 ecgX10 ll_lead la_lead ra_lead v_lead shield_dr 6 10 cpu_main pacer_det LL LA RA RL V shield_dr IGND +5_VREF sg1+ sg2+ temp1_2 temp2_2 A NON ISOLATED la_ref ra_ref ll_ref v_ref rl_ref J5 ISOLATED INPUTS 2 4 6 8 10 12 14 16 18 20 22 24 5 11 18 ls0 ls1 ls2 1 3 5 7 9 11 13 15 17 19 21 23 4 12 -12V ecg_front_end LL LA RA RL V shield_dr IGND +5_VREF sg1sg2temp1_1 temp2_1 Power Supply 3 13 17 150014 diag_bw ecg_test +5VI +6.5VI V -5VI -6.5VI Iso_GND FB5 J20 210062 J23 THERMISTOR 2 14 18 RL 1 2 3 15 17 FB4 150014 Thermistor_Pos Thermistor_Neg TP26 GND 1 3 150014 Vbuss +12V ecgX1000 ECGX10 LL_Lead LA_Lead RA_Lead V_Lead 1 2 3 4 5 6 Battery_Neg 12V_Switcher Switcher_GND 16 2 RA J2 POWER F1 5ASB 18 LA 2 4 6 8 10 12 14 16 DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. REVISED PER ECN 1274. GP REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP 18 19 20 21 22 23 24 18 LA_ref RA_ref LL_ref V_ref RL_ref LL FB2 1 3 5 7 9 11 13 15 REV D 18 FB1 150014 nibp_res rxd_c +12V nibp_gnd SF1 MEA8020T10R0 Rec_GND 17 J1 NIBP shield_dr 150014 REVISIONS Power Supply leads0 leads1 leads2 17 ecg_front_end D K2 390005 G6K-2F-Y-DC12 D 1 8 7 5 2 4 K3 390005 G6K-2F-Y-DC12 Graph Out NOTES: 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. Title 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. Size MARK TUCCILLO 9/5/01 CHK: GP 9/5/01 APR: RAM 9/5/01 5143 Main Document Number 5143-00-01 (-03 SCHEMATIC) Date: Friday, May 27, 2005 Sheet 1 Rev 24 D of 16 8 7 6 5 4 3 2 1 REVISIONS DESCRIPTION REVISED PER ECN 691. REVISED PER ECN 709. REVISED PER ECN 957. REVISED PER ECN 1201. REV 01 02 03 04 BY GP GP GP GP DATE 8-28-97 11-4-97 6-25-99 8-9-02 D D 2336-00-01 J202-1 2 VCC D VCC 5 RN1 6 1K C 7 RN1 8 1K IGET ET_RES E4 B++ E7 3 2 R12 100 OHM B++ D1 L1 25UH C3 + C2 100UF 25V IGET C4 1500UF 25V + .0068UF 1KV CD 2252-00-10 T1 2 . SB5100 R6 620 OHM 2W 5% 3 4 R14 150 OHM 10W 5% H.S. . 1 64KHz E5 C9 1UF MP C8 100UF 25V 730MA D H.S. Q4 1G IRF540 D2 MBR350 2 2N3903 + Q1 2 2N3906 C10 .1UF MP R2 10K .047UF MP 8 7 6 5 REF R_MID GND-F GND-S IGET COLLECTOR COMP V+ R_TOP 10000PF NPO R4 1 2 3 4 + C6 22UF TANT 3 Q2 S R8 6.98K 3 Q 7 DIS 6 THR R10 10K U7 ICM7555 TR R13 1K C7 2 47PF NPO R11 10K CV 5 R9 10K C5 1000PF NPO 2 2N3903 B Q3 3 U6 CNY17-3 C11 D 4 C1 2 IGET TP2 1 IGET 5 2 B 3 4 U2 BNX002-01 1 1 1 +5VIET TP1 3 2 4 U5 CNY17-3 1 C +5VIET VCC E3 4 5 IGET 3 RN1 4 1K 9 RN1 10 1K 8 1K 4 2 R3 R5 2K E2 R +5VIET 1 2 3 RXD_B U4 CNY17-3 V+ +5VIET J204 173011 E1 TXD_B V- 1 +5VIET 1 RN1 2 1K IGET +5VIET 5 IGET 1 5 U3 CNY17-3 R1 2K 1 J202-4 4 J202-3 1 VCC TTL RECEIVE DATA TTL TRANSMIT DATA TTL EXTERNAL RES J202-2 R7 10K E6 D_GND D DGND TP3 33.2K U1 LT1431CN8 IVY BIOMEDICAL SYSTEMS INC. A NOTES: 1. ALL RESISTORS ARE 1/4W, 1% U.O.S. Title ETCO2 MODULE INTERFACE BOARD ASSEMBLY 2. LAST USED: Size 3. NOT USED: B Date: 8 7 6 5 A 11 BUSINESS PARK DRIVE BRANFORD, CT. 06405 (203) 481-4183 4 3 Document Number Rev 04 5108-00-01 (-03 SCHEMATIC) Thursday, March 10, 2005 2 Sheet 1 of 1 1 Video Add va[0..16] Video Data vd[0..15] Wave Add wa[0..14] Wave Data wd[0..7] Host Data Host Add sof_int eow_int clear GND VCCINT VCCIO clock dsack1 green5 green3 blue3 blue2 blue4 green4 GND VCCINT VCCIO blue5 va14 va10 va11 va12 R370 100 OHM 25_MHz dot_clock va13 wa6 A1 hsynch va5 wa12 wa7 wa8 VCCIO GND wa9 GND Data0 wd6 A15 A6 A14 A10 A11 A4 A5 VCCIO hd11 hd10 hd15 hd14 vd2 vd1 vd6 vd5 vd9 vd12 vd11 vd15 wd3 wd2 dclk U95 EPF6016QC208-2 vga_fpga vramadd13 RESERVED RESERVED RESERVED hd0 hd2 hd3 hd6 hd8 GND VCCIO hd9 hd12 hd13 video_data0 video_data3 video_data4 video_data7 video_data8 video_data10 video_data13 video_data14 wave_data0 wave_data1 nconfig GND VCCIO nstatus wave_data4 wave_data5 wave_data7 host_add3 host_add13 host_add12 host_add9 host_add0 host_add8 RESERVED host_add2 RESERVED RESERVED RESERVED GND VCCIO RESERVED host_add7 audio_a line_enable RESERVED RESERVED RESERVED vram_add8 A16 A17 green0 wram_we green1 green2 host_add20 host_add18 ^nCE GND VCCINT VCCIO host_add16 host_add17 green0 cs_wform_ram sof_int eow_int zone_inc reserved reserved reserved vert_wave_time reserved reserved reserved clear GND VCCINT VCCIO clock RESERVED RESERVED RESERVED RESERVED RESERVED dsack0 RESERVED RESERVED green5 green3 blue3 blue2 blue4 green4 GND VCCINT VCCIO MSEL blue5 vramadd14 vramadd10 25MHz vramadd11 vramadd12 53 54 55 56 57 58 59 60 61 GND 62 VCCIO 63 hd9 64 hd12 65 hd13 66 vd0 67 vd3 68 vd4 69 vd7 70 vd8 71 vd10 72 vd13 73 vd14 74 wd0 75 wd1 76 77 GND 78 VCCIO 79 nstatus 80 wd4 81 wd5 82 wd7 83 A3 84 A13 85 A12 86 A9 87 A0 88 A8 89 90 A2 91 92 93 94 GND 95 VCCIO 96 97 A7 98 audio_a_clk 99 100 101 102 103 104 GND VCCINT VCCIO 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 hd0 hd2 hd3 hd6 hd8 wram_we green1 green2 A20 A18 wave_add14 wave_add11 wave_add10 vram_add9 hd1 hd5 hd4 hd7 VCCIO GND hd11 hd10 hd15 hd14 video_data2 video_data1 video_data6 video_data5 video_data9 wave_data12 wave_data11 wave_data15 wave_data3 wave_data2 dclk VCCIO GND data0 wave_data6 host_add15 host_add6 host_add14 host_add10 host_add11 host_add4 host_add5 wram_cs wave_add9 RESERVED RESERVED RESERVED RESERVED VCCIO GND RESERVED wave_add6 host_add1 hsynch vram_add5 wave_add12 wave_add7 wave_add8 208 207 206 205 204 203 202 201 200 199 198 197 196 195 194 193 192 191 190 189 188 187 186 185 184 183 182 181 180 179 178 177 176 175 174 173 172 171 170 169 168 167 166 165 164 163 162 161 160 159 158 157 VCCIO GND wa14 wa11 wa10 va9 hd1 hd5 hd4 hd7 U94 CY7C199-12VI wa0 wa1 wa2 wa3 wa4 wa5 wa6 wa7 wa8 wa9 wa10 wa11 wa12 wa13 wa14 wave_add13 vram_add3 vram_add4 vram_cs host_add19 vsync CONF_DONE VCCIO VCCINT GND host_add21 vram_add2 cs_hires_dac vram_add16 vram_add15 vram_add1 wave_add0 wave_add2 wave_add5 wave_add4 wave_add3 wave_add1 RESERVED RESERVED intack7 VCCIO VCCINT GND intack5 host_cs3 ds siz0 as vram_rd siz1 r/w vram_rd red5 blue1 blue0 red0 red1 red2 red3 VCCIO VCCINT GND red4 audio_b vram_add0 vram_add6 vram_add7 156 155 154 153 152 151 150 149 148 147 146 145 144 143 142 141 140 139 138 137 136 135 134 133 132 131 130 129 128 127 126 125 124 123 122 121 120 119 118 117 116 115 114 113 112 111 110 109 108 107 106 105 wa13 va3 va4 vram_cs A19 vsynch conf_done VCCIO VCCINT GND A21 va2 cs_hires_dac va16 va15 va1 wa0 wa2 wa5 wa4 wa3 wa1 10 9 8 7 6 5 4 3 25 24 21 23 2 26 1 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 14 DGND 12 11 10 9 8 7 6 5 27 26 23 25 4 28 3 31 2 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 16 GND D0 D1 D2 D3 D4 D5 D6 D7 11 12 13 15 16 17 18 19 CE OE WE 20 22 27 wd0 wd1 wd2 wd3 wd4 wd5 wd6 wd7 wram_we VCC VCC 28 U96 CY7C1009-20VC va0 va1 va2 va3 va4 va5 va6 va7 va8 va9 va10 va11 va12 va13 va14 va15 va16 intack7 VCCIO VCCINT GND intack5 cs2 ds siz0 as siz1 r/w vram_we red5 blue1 blue0 red0 red1 red2 red3 D0 D1 D2 D3 D4 D5 D6 D7 13 14 15 17 18 19 20 21 CS1 CS2 22 30 WE OE 29 24 NC 1 VCC vd0 vd1 vd2 vd3 vd4 vd5 vd6 vd7 vram_we vram_cs VCC 32 VCCIO VCCINT GND red4 audio_b_clk va0 va6 va7 U97 CY7C1009-20VC va0 va1 va2 va3 va4 va5 va6 va7 va8 va9 va10 va11 va12 va13 va14 va15 va16 va8 line_enable line_enable 12 11 10 9 8 7 6 5 27 26 23 25 4 28 3 31 2 A0 A1 A2 A3 A4 A5 A6 A7 A8 A9 A10 A11 A12 A13 A14 A15 A16 16 GND D0 D1 D2 D3 D4 D5 D6 D7 13 14 15 17 18 19 20 21 CS1 CS2 22 30 WE OE 29 24 NC 1 VCC vd8 vd9 vd10 vd11 vd12 vd13 vd14 vd15 vram_we vram_cs VCC 32 audio_a_clk audio_a_clk audio_b_clk blue[0..5] blue[0..5] green[0..5] green[0..5] audio_b_clk blue[0..5] green[0..5] red[0..5] R330 10K hd[0..15] A[0..21] clear clock cs2 intack5 intack7 hd[0..15] Data0 dclk nstatus conf_done A[0..21] clear clock siz1 as r/w ds 1 2 3 4 intack5 VCC Data DCLK OE nCS VCC VCC nCASC GND r/w ds dot_clock 25_MHz 8 7 6 5 NOTES: 8 PIN 25_MHz sof_int sof_int eow_int 1. LAST USED: C230, D44, DS6, E7, F4, FB5, J24, JP8,K3, L15, Q42, R392, RT2, SF11, T5, TP51,U103, Y4. eow_int cs_hires_dac cs_hires_dac dsack1 dsack1 2. NOT USED: C221,J18,J22,JP2,JP3,R89,R388. VCCINT 3. ALL RESISTORS ARE 1/10W, SIZE 0805 UNLESS OTHERWISE SPECIFIED. siz0 IVY BIOMEDICAL SYSTEMS INC. REVISIONS GND vsynch dot_clock siz1 as hsynch vsynch SOCKET VCCIO intack7 red[0..5] hsynch VCC U98 2634-00-04 cs2 VCC siz0 R331 10K REV 18 19 20 21 22 23 24 DESCRIPTION BY FOR REVISION LEVEL HISTORY REV-00 THRU REV-17 REFER TO ECN 1274 IN THE ENGINEERING RECORD FILES. GP REVISED PER ECN 1274. REVISED PER ECN 1275. GP REVISED PER ECN 1289. GP REVISED PER ECN 1290. GP REVISED PER ECN 1326. GP REVISED PER ECN 1354. GP REVISED PER ECN 1432. GP DATE 11 BUSINESS PARK DRIVE BRANFORD, CT., 06405 USA (203) 481-4183 DWN: MARK TUCCILLO 9/5/01 6-11-03 6-11-03 6-25-03 6-25-03 3-4-04 4-13-04 5-27-05 Title Size C Date: CHK: GP 9/5/01 APR: RAM 9/5/01 VIDEO FPGA Document Number Rev 24 5143-00-01 (-03 SCHEMATIC) Friday, May 27, 2005 Sheet 16 of 16 4 3 2 1 J3 PRESSURE 1 J4 PRESSURE 2 J2 ECG F E D C B A 5 A B C D E F J5 TEMP 1 6 A B C D E F J6 TEMP 2 2 1 7 2 1 8 D D I FB6 150013 I FB5 FB4 FB3 FB1 FB7 FB8 FB10 FB9 FB11 150010 (FB-7 THRU FB-11) FB2 150013 FB15 150010 150013 23 21 19 17 15 13 11 9 7 5 3 1 C3 .1UF CER 0805 C1 .1UF CER 0805 C4 .1UF CER 0805 I I B I FB14 150013 FB12 150010 J1 170514 ISOLATED INPUTS 24 22 20 18 16 14 12 10 8 6 4 2 FB18 150010 B LA TEMP2_2 150013 150013 FB19 LL TEMP2_1 FB16 C FB13 I 150010 RA TEMP1_2 FB17 RL TEMP1_1 V C2 .1UF CER 0805 SHIELD_DR 5V SG1- SG2- SG1+ SG2+ C I IVY BIOMEDICAL SYSTEMS INC. 11 BUSINESS PARK DRIVE BRANFORD, CT. 06405 (203) 481-4183 A A Title ISOLATED INPUT BOARD (ECG/RESP,2P & 2T) REVISIONS DESCRIPTION REVISED PER ECN 1219. REVISED PER ECN 1220. REVISED PER ECN 1221. REV 01 02 03 8 7 BY GP GP GP 6 5 DATE 12-16-02 12-16-02 12-16-02 4 Size A Document Number Date: Monday, December 16, 2002 Rev 5144-00-01 (-03 SCHEMATIC) 3 Sheet 2 1 03 1 of 1