BM3 OperatiBM3 BM5 Operation Manual Patient Monitor Operator’s Manual Rev 1.0 BM5 Operation Manual Table of Contents 1. THE BASICS .................................................................................5 1.1 CE Marking Information .......................................................................................... 7 1.2 How to Reach Us ..................................................................................................... 8 Warranty ...............................................................................................................................9 1.3 General precaution .................................................................................................. 10 Warning, Caution, Note .........................................................................................................10 General precaution on Environment .....................................................................................11 General precaution on Electrical safety .................................................................................12 1.4 Components ............................................................................................................. 24 Overview of the product ........................................................................................................24 Features of the Product ........................................................................................................24 Features of Main body ..........................................................................................................26 1.5 Operation .................................................................................................................. 32 Front panel ...........................................................................................................................32 Control key ...........................................................................................................................32 1.6 Power ON .................................................................................................................. 34 1.7 Battery Power ON .................................................................................................... 35 1.8 User Interface Features .......................................................................................... 37 Features of Screen ...............................................................................................................37 Selection of Menu .................................................................................................................38 Features of Menu ..................................................................................................................38 2. MORE MENU ................................................................................43 2.1 ALARM ...................................................................................................................... 46 ALL LIMITS ...........................................................................................................................47 ALARM PRINT ......................................................................................................................48 ALARM VOLUME .................................................................................................................48 ALARM LEVEL .....................................................................................................................49 ARRHYTH LEVEL ................................................................................................................50 BM5 Operation Manual 2.2 ADMIT ....................................................................................................................... 51 CHANGE ADMIN INFO ........................................................................................................51 DISCHARGE ........................................................................................................................52 HEIGHT ...............................................................................................................................53 WEIGHT ............................................................................................................................53 2.3 TREND ...................................................................................................................... 54 GRAPHIC TREND ...............................................................................................................54 TABULAR TREND ...............................................................................................................56 2.4 SETUP ...................................................................................................................... 58 DISPLAY ..............................................................................................................................58 USER SERVICE ..................................................................................................................60 MAKER SERVICE ................................................................................................................61 3. ECG ...............................................................................................63 3.1 Introduction ............................................................................................................. 65 Position of ECG Connector and Probe Cable .......................................................................65 How to attach the electrode ................................................................................................67 Position of 5 and 3 Lead ......................................................................................................68 3.2 ECG Parameter Window ......................................................................................... 70 3.3 ECG Parameter setting menu ................................................................................ 71 LEAD SELECT .....................................................................................................................71 ALARM LIMIT ......................................................................................................................72 QRS VOLUME .....................................................................................................................73 ECG SIZE ............................................................................................................................73 ANALYSIS SETTING ...........................................................................................................74 4. SpO2 .............................................................................................. 79 4.1 Introduction ............................................................................................................. 81 Position of SpO2 Connector and Probe Cable ......................................................................81 4.2 SpO2 Parameter Window ........................................................................................ 82 4.3 SpO2 Parameter setting Menu ............................................................................... 83 Rate Volume ........................................................................................................................83 Alarm Limit ..........................................................................................................................84 BM5 Operation Manual 5. RESPIRATION ..............................................................................85 5.1 Introduction ......................................................................................................... 87 Position of RESPIRATION Connector and Probe Cable .................................................87 5.2 RESPIRATION Parameter Window .................................................................. 88 5.3 RESPIRATION Parameter Setting Menu ......................................................... 89 Respiration Size ..............................................................................................................89 Alarm Limit ..................................................................................................................90 6. NIBP ..............................................................................................91 6.1 Introduction .......................................................................................................... 93 Position of NIBP Connector and CUFF ...........................................................................93 6.2 NIBP Parameter Window ................................................................................... 95 6.3 NIBP Parameter setting Menu .......................................................................... 96 Alarm Limit ......................................................................................................................96 CUFF SIZE .....................................................................................................................97 INTERVAL TIME .............................................................................................................97 7. IBP................................................................................................... 99 7.1 Introduction .......................................................................................................... 101 Position of IBP Connector and Accessory ............................................................................ 101 7.2 IBP Parameter Window ........................................................................................ 104 7.3 IBP Parameter setting Menu ............................................................................... 105 CHANGE NAME ................................................................................................................ 105 SCALE ............................................................................................................................... 105 ALARM LIMITS ..................................................................................................................107 SETTINGS ........................................................................................................................ 109 ZERO ................................................................................................................................111 8. EtCO2 ........................................................................................... 113 8.1 Introduction .......................................................................................................... 115 Position of EtCO2 Connector and Accessory ........................................................................ 115 8.2 EtCO2 Parameter Window ................................................................................... 117 BM5 Operation Manual 8.3 EtCO2 Parameter setting Menu ........................................................................... 118 ALARM LIMITS ..................................................................................................................118 STANDBY ......................................................................................................................... 119 SETTINGS ........................................................................................................................ 119 SCALE ............................................................................................................................... 120 CALIBRATION ...................................................................................................................122 9. TEMPERATURE ...........................................................................124 9.1 INTRODUCTION .................................................................................................. 126 Position of Temperature Connector and Probe Cable .....................................................126 9.2 Temperature Parameter Window ..................................................................... 127 9.3 Temperature Parameter Setting Menu ............................................................ 128 ALARM LIMIT .................................................................................................................128 UNIT SELECT ................................................................................................................129 10. PRINTING ...................................................................................130 10.1 Printing ............................................................................................................... 132 Printer and thermal paper ...............................................................................................132 Function and setup Menu ...............................................................................................133 10.2 Changing Paper ............................................................................................... 134 11. MESSAGE LIST .........................................................................137 12. FACTORY DEFAULTS ..............................................................141 13. TROUBLE SHOOTING ..............................................................151 14. SPECIFICATION ........................................................................163 1. THE BASICS 1.1 CE Marking Information 1.2 How to Reach Us Warranty 1.3 General Precaution Warning, Caution, Note General Precaution on Environment General Precaution on Electric Safety 1.4 Components Overview of the Product Features of the Product Features of Main body 1.5 Operation Front panel Control key 1.6 Power ON 1.7 Battery Power ON 1.8 User Interface Features Features of Screen Selection of Menu Features of Menu BM5 Operation Manual 1.1 CE Marking Information TÜV LIST 1. Electrical Safety EN60601-1 2. EMC EN60601-1-2 3. Performance NIBP EN1060-1, EN1060-3 4. ECG test EN60601-2-27 5. NIBP test EN60601-2-30 6. SpO2 test ISO9919 7. Performance test For Temperature 12470-4 8. Patient monitoring safety EN/IEC60601-2-49 9. IBP test EN/IEC60601-2-34 10. EtCO2 test EN/ISO 21647 Rev 1.0 1. THE BASICS 7 BM5 Operation Manual 1.2 How to Reach Us The following are telephone numbers and addresses for contacting various service, product supplies and sales personnel Product and Bionet America.,Ltd. Purchase Inquiry 2691 Dow Ave. Suite B Tustin, CA 92780 Sales dept. Toll Free: 1-877-9bionet Direct: 714-734-1760 Fax : 714-734-1761 E-mail : sales@bionetus.com Service call & Technical For any technical questions or problems on the equipment, call; Tel: –714-734-1760 support E-mail : support@bionetus.com Web site of URL : http:// www.bionetus.com Bionet In the event of a malfunction or failure, contact Service Dept. Of Bionet America, INC along with the model name, serial number, date of purchase and explanation of failure. If you need the circuit diagram, component list, description and calibration instruction etc. you can contact us and we will provide you with it. Rev 1.0 1. THE BASICS 8 BM5 Operation Manual Warranty y This product is manufactured and passed through strict quality control and through inspection. y Warranty period is 2 years. y Warranty repair or replacement will be made by Bionet Service Center at no charge for warranty period if properly used under normal conditions in accordance with the instructions for use. y Manufacturer or sales agency takes no responsibility for any kind of damage or breakdown that is caused by misuse and failure to maintain the equipment. y Consequential and incidental damages are not recoverable under this warranty Rev 1.0 1. THE BASICS 9 BM5 Operation Manual 1.3 General precaution Warning, Caution, Note Terms are defined as listed below in operation manual. Users should operate the equipment according to all the Warnings and Cautions. Warning To inform that it may cause serious injury or death to the patient, property damage, material losses Caution To inform that it may cause no harm to life but may lead to injury Note To inform that it is not dangerous but important for proper installation, operation, and maintenance of the equipment Rev 1.0 1. THE BASICS 10 BM5 Operation Manual General Precaution on Environment Do not keep or operate the equipment in the environment listed below. Avoid placing in an area exposed to moisture. Do not touch the equipment with wet Avoid exposure to direct sunlight. hands . Avoid placing in an area where there is a high variation of temperature. Operating temperature ranges from 10°C to 40°C Operating humidity Ranges from 30% to 85%. Do not use or store in the vicinity of an Electric heater. Avoid placing in an area where there is Avoid excessive excessive humidity or shocks or vibration. poor ventilation. Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. Avoid inserting dust and especially metal material into the equipment. Do not open or disassemble the Power off when equipment. Bionet the equipment is America accepts no not fully installed. responsibility for Otherwise, unauthorized equipment could tampering, service, or be damaged. repair. Rev 1.0 1. THE BASICS 11 BM5 Operation Manual General Precaution on Electric Safety Warning Check the items listed below before operating the equipment 1. Be sure that AC power supply line is appropriate to use. (AC 100 - 240V) 2. Be sure that the power adapter is the one supplied from Bionet. (DC 18V, 2.5A) 3. Be sure that all cables are properly and firmly fixed. 4. Be sure that the equipment is properly grounded.(Otherwise, noise could result.) 5. The equipment should not be placed in the vicinity of electric generators, X-rays, broadcasting apparatus to eliminate the risk of electric noise during operation. This may cause incorrect results. Rev 1.0 1. THE BASICS 12 BM5 Operation Manual WARNINGS Accidental Spills To avoid electric shock liquids must not be allowed to enter the device. If liquids have entered the device, take it out of service and have it checked by a Service Technician before it is used again. Accuracy If the accuracy of any value displayed on the monitor, central station, or printed on a graph strip is questionable, determine the patient’s vital signs by alternative means. Verify that all equipment is working and connected correctly. Alarms Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Alarm is divided into two types, alarm for the patient’s condition and alarm for the product’s condition. The patient’s alarm sounds when the diagnostic functions (ASYSTOLE, VTAC/VFIB,VTAC) are detected to be outside the normal range. Each alarm sound differs in order and volume according to the severity of HIGH, MEDIUM, LOW message. The machine will sound an alarm with a corresponding message on the display if it detects any problems. For example, if sensors, probes or modules are intentionally disconnected by the operator the equipment gives “LOW” alarm sound and “LEAD FAULT” message. After connecting the monitor to the central station, verify the function of the alarm system. Rev 1.0 1. THE BASICS 13 BM5 Operation Manual WARNINGS Before Use Before putting the system into operation visually inspect all connecting cables for signs of damage. Damaged cables and connectors must be replaced immediately. Before using the system, the operator must verify that it is in correct working order and operating condition. Before using the system, be sure that the equipment is restricted to one patient at a time. Periodically, and whenever the integrity of the product is in doubt, test all functions. Cables Route all cables away from patient’s throat to avoid possible strangulation. Conductive Connections Extreme care must be exercised when applying medical electrical equipment. Many parts of the main/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the insulated patient input of the device. Such contact would bridge the patient’s insulation and cancel the protection provided by the insulated input. In particular, there must be no contact of the neutral electrode and ground. Defibrillation Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result. Discharge to Clear Patient Data When admitting a new patient, you must clear all previous patient data from the system. To accomplish this, disconnect patient cables(if you use a Tram module be sure the module is locked in place in the Tram-rack housing), then do a discharge. Rev 1.0 1. THE BASICS 14 BM5 Operation Manual WARNINGS Disconnection From Mains When disconnecting the system from the power line, remove the plug from the wall outlet first. Then you may disconnect the power cord from the device. If you do not observe this sequence, there is a risk of coming into contact with line voltage by inserting metal objects, such as the pins of lead wires, into the sockets of the power cord by mistake. Disposal The equipment shall be disposed in accordance with all federal, state, and local laws.. Explosion Hazard Do not use this equipment in the presence of flammable anesthetics, vapors or liquids. Interfacing Other Equipment Devices may only be interconnected with each other or to parts of the system when it has been determined by qualified biomedical engineering personnel that there is no danger to the patient, the operator, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices the user must contact the manufacturers concerned (or other informed experts) for proper use. In all cases, safe and proper operation should be verified with the applicable manufacturer’s instructions for use, and system standards IEC 60601-1-1/EN 60601-1-1 must be complied with. Rate Meters Keep pacemaker patients under close observation. Rate meters may continue to count the pacemaker rate during cardiac arrest and some arrhythmias. Therefore, do not rely entirely on rate meter alarms. Site Requirements For safety reasons, all connectors for patient cables and sensor leads (with the exception of temperature) are designed to prevent inadvertent disconnection, should someone pull on them. Do not route cables in a way that they may present a stumbling hazard. For devices installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient. Rev 1.0 1. THE BASICS 15 BM5 Operation Manual WARNINGS Intra cardiac Application When applying devices intra cardinally, electrically conductive contact with parts connected to the heart (pressure transducers, metal tube connections and stopcocks, guide wires, etc.) must be avoided in all cases. To prevent electrical contact, we recommend the following: ·Always wear isolating rubber gloves, ·Keep parts that are conductively connected to the heart isolated from ground, ·If possible, do not use tube fittings or stop cocks made of metal. During intra cardiac application of a device, a defibrillator and pacemaker whose proper functioning has been verified must be kept at hand. Leakage Current Test When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personal before using with patients. Patient Ambulation A Patient must be assisted if ambulating with a roll-stand mounted monitor. Power Supply The device must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect the monitor from the power line and operate it on battery power, if possible. All devices of a system must be connected to the same power supply circuit. Devices which are not connected to the same circuit must be electrically isolated when operated (electrically isolated RS232 interface). Protected Lead wires Only use protected lead wires and patient cables with this monitor. The use of unprotected Lead wires and patient cables creates the potential for making an electrical connection to ground or to a high voltage power source which can cause serious injury or death to the patient. Rev 1.0 1. THE BASICS 16 BM5 Operation Manual CAUTIONS Accessories (Supplies) To ensure patient safety, use only parts and accessories manufactured or recommended by BIONET. 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 60601-1 medical electrical system standards. Accessories (Equipment) The use of ACCESORY 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 ACCESORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. Accessories Connection Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 601-1 for medical equipment). Furthermore all configurations shall comply with the system standard EN 60601-1-1:1993. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 601-1-1:1993. If in doubt, consult the technical service department or your local representative. Battery Power If a device equipped with an optional battery pack will not be used or not be connected to the power line for a period of over six months, remove the battery. Rev 1.0 1. THE BASICS 17 BM5 Operation Manual CAUTIONS Before Installation Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility. Defibrillator Precaution Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and lead wires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation. Disposables Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur. Disposal All equipment and accessories must be disposed of in accordance with local and federal laws. Electrocautery Precautions To prevent skin burns, apply electrocautery electrodes as far as possible from all other electrodes, a distance of at least 15 cm/6 in. is recommended. EMF Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMF requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Also, keep cellular phones to other telecommunications equipment away from the monitor. Rev 1.0 1. THE BASICS 18 BM5 Operation Manual CAUTIONS Instruction for Use For continued safe use of this equipment, it is necessary that the instructions are followed. However, instructions listed in this manual in no way supersede established medical practices concerning patient care. Loss of Data Should the monitor at any time temporarily lose patient data, the potential exists that active monitoring is not being done. Close patient observation or alternate monitoring devices should be used until monitor function is restored. If the monitor does not automatically resume operation within 60 seconds, power cycle the monitor using the power on/off switch. Once monitoring is restored, you should verify correct monitoring state and alarm function. Maintenance Regular preventive maintenance should be carried out annually (Technical inspections). You are responsible for any requirements specific to your country. MPSO The use of a multiple portable socket outlet (MPSO) for a system will result in an enclosure leakage current equal to the sum of all individual ground leakage currents of the system if there is an interruption of the MPSO protective ground conductor. Do not use an additional extension cable with the MPSO as it will increase the chance of the single protective earth conductor interruption. Negligence BIONET does not assume responsibility for damage to the equipment caused by improperly vented cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on such walls. Rev 1.0 1. THE BASICS 19 BM5 Operation Manual NOTES Power Requirements Before connecting the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit’s label. If this is not the case, do not connect the system to the power line until you adjust the unit to match the power source. In U.S.A, if the installation of this equipment will use 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit. Restricted Sale U.S.A federal law restricts this device to sale by or on the order of a physician. Supervised Use This equipment is intended for use under the direct supervision of a licensed health care practitioner. Ventilation Requirements Set up the device in a location which affords sufficient ventilation. The ventilation openings of the device must not be obstructed. The ambient conditions specified in the technical specifications must be ensured at all times. ·Put the monitor in a location where you can easily see the screen and access the operating controls. ·This product is protected against the effects of cardiac defibrillator discharges to ensure proper recovery, as required by test standards. (the screen may blank during a defibrillator discharge but recovers within seconds as required by test standards.) Reference Literature Medical Device Directive 93/42/EEC EN 60601-1/1990 +A1: 1993 +A2 : 1995 : Medical electrical equipment. General requirements for safety EN 60601-1-1/9. 1994 +A1 12.95: General requirements for safety. Rev 1.0 1. THE BASICS 20 BM5 Operation Manual CLEANING Please follow the methods mentioned below to avoid unnecessary damage or contamination to the Equipment. In the event that harmful (unauthorized) materials are used for cleaning, the damaged or contaminated Equipment shall not be serviced without charges regardless of warranty period. Caution Please check carefully the unit and sensors, after cleaning the Equipment. Do not use any Equipment that is worn out or damaged At least once a month, clean and wipe off the frame by using a soft cloth after wetting it with lukewarm water and alcohol. Do not use lacquer, thinner, ethylene, or oxides, which could be harmful to the Equipment. Make sure both cables and accessories are free of dust or contaminants, and wipe them off with soft cloth wetted with lukewarm water(40°C/104°F), and at least once a week, clean them by using clinical alcohol. Do not submerge the accessories in any liquid or detergent. Also, make sure no liquid penetrates into the Equipment or probe. Rev 1.0 1. THE BASICS 21 BM5 Operation Manual Caution Always dispose of single use probes according to local procedures for handling biological hazardous waste. Caution There is back-up battery on board inside system. Please dispose of only in accordance with federal, state, and local laws. CR2032 3.0Volt battery Caution Check the electrodes of batteries before changing them Rev 1.0 1. THE BASICS 22 BM5 Operation Manual Classifications The BM5 patient monitor is classified, according to IEC 60601-1 as: Type of protection against electric shock : Degree of protection against CF-ECG, Temp, Resp. electric shock : BF-NIBP, SpO2, EtCO2, Degree of protection against Ordinary equipment(enclosed equipment without harmful ingress of water : protection against ingress of water) Degree of safety of Not suitable application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide : II : Class II equipment CF : Type CF applied part BF : Type BF applied part Not suitable : Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Rev 1.0 1. THE BASICS 23 BM5 Operation Manual 1.4 Components Overview of the Product BM5 monitor is a product used for monitoring the biological vital signs of an animal. Main functions of the product include displaying information such as ECG, respiration, SpO2, NIBP and temperature on its LCD screen and monitoring parameters, and alarming. It also prints out waves and parameters via a printer. Features of the Product BM5 is the small-size multi-functional monitoring equipment for a patient designed for portability. It features devices for auto power supply (DC 11V-16V) and DC power supply (DC 18V) as well as installing its handle to the bed. And, In case of using the optional capnography station, direct AC(100~240V, 50/60Hz) input is available. The equipment also measures major parameters such as ECG, SpO2, NIBP, IBP, EtCO2, temperature, respiration and pulse, displaying it on a 10.4-inch color LCD screen. It also enables users to check waves and parameters and other vital signs of a patient via the 58mm thermal printer and monitor the patient by the remote-controlled alarm system. An optional central monitoring system is available by linking devices used for separate patients so that one can monitor several patients at a time. Rev 1.0 1. THE BASICS 24 BM5 Operation Manual Features of the Product 1. Main body of BM5 Monitor 1 EA 2. 3-Lead Patient Cable (3CBL-400,3WIRE-400) 1 EA 3. Disposable electrodes (ECGSENS-400) 10 EA 4. NIBP extension tube (3m, NBPCBL-400) 1 EA 5. Reusable Adult NIBP cuff (25-35 cm, ACUFF-400) 1 EA 6. SpO2 sensor extension cable (2m, SPCBL-400) 1 EA 7. Reusable SpO2 sensor (SPASENS-400) 1 EA 8. DC Power Adaptor with Power Cord (18VDC/2.5A, KA1803F52) 1 EA 9. Operator’s Manual 1 EA Optional Products 1. Reusable Temperature Probe (Surface/Skin, TEMPSENS-400) 1EA 2. Thermal Printer (PRN-400) 1Set 3. Chart Paper (PAPER-400) 1EA 4. IBP Transducer Set (Disposable/Reusable) 1SET 5. EtCO2 Disposable Kit (Neonate/Pediatric/Adult, Intubated/Non-intubated) 1EA 6. Capnography Station(EtCO2) 1Set Warning In order to avoid electrical shock, do not open the cover. Disassembling of the equipment should be done only by the service personnel authorized by Bionet Co., Ltd. Warning Users must pay attention on connecting any auxiliary device via LAN port or nurse calling. Always consider about summation of leakage current, please check if the auxiliary device is qualified by IEC 60601-1, or consult your hospital biomedical engineer Rev 1.0 1. THE BASICS 25 BM5 Operation Manual Features of Main Body Rev 1.0 1. THE BASICS 26 BM5 Operation Manual Rev 1.0 1. THE BASICS 27 BM5 Operation Manual Rev 1.0 1. THE BASICS 28 BM5 Operation Manual Rev 1.0 1. THE BASICS 29 BM5 Operation Manual Equipment Symbols ATTENTION : Consult accompanying documents TYPE CF APPLIED PART : Insulated (floating) applied part suitable for intentional external and internal application to the patient including direct cardiac application. "Paddles" outside the box indicate the applied part is defibrillator proof. Medical Standard Definition : F-type applied part(floating/insulated) complying with the specified requirements of IEC 60601-1/UL 2601-1/CSA 601.1 Medical Standards to provide a higher degree of protection against electric shock than that provided by type CF applied parts. TYPE BF APPLIED PART : I Insulated (floating) applied part suitable for intentional external and internal application to the patient excluding direct cardiac application. "Paddles" outside the box indicate the applied part is defibrillator proof. Medical Standard Definition : F-type applied part (floating/insulated) complying with the specified requirements of IEC 60601-1/UL 2601-1/CSA 601.1 Medical Standards to provide a higher degree of protection against electric shock than that provided by type BF applied parts. Equip potentiality PRINTER RS-232, Serial port LAN port Rev 1.0 1. THE BASICS 30 BM5 Operation Manual AUX CONNECTOR DC INPUT INDICATOR BATTERY OPERATION INDICATOR DC INPUT CONNECTOR NIBP Temperature Function Power on Power off Respiration Rev 1.0 1. THE BASICS 31 BM5 Operation Manual ECG Heart Pulse EtCO2 Gas Input EtCO2 Gas Output Rev 1.0 1. THE BASICS 32 BM5 Operation Manual 1.5 OPERATION Front Panel The front panel of this product consists of an LCD screen and five function keys and one trim knob. Control key 1. Power key Switches on and off the power. 2. Function Key Switches between internal screen and external monitor. 3. NIBP GO/STOP Key Manually completes measuring blood pressure when this key is pressed with the cuff placed around the arm. 4. Printing GO/STOP Key Prints out the waves selected from the menu until the key is pressed to stop. 5. ALARM Key Stops alarm sound. First press stops the current alarm for one minute Second press stops the all alarm for five minutes. Third press makes the alarm back to the original setting. 6. Trim Knob Key This key is used to select menu items by turning it clock or counterclockwise to move cursors. Rev 1.0 1. THE BASICS 33 BM5 Operation Manual Comment [dk1]: Fix Spelling error: clock not clock Fix spelling – should be clock not clock Replace anticlockwise counterclockwise Rev 1.0 And replace anticlockwise with counterclockwise with ALARM PRINT: OFF ALARM VOLUME: 50% PREV ALARM ARRHYTH MENU LEVEL LEVEL MAIN ALL MENU LIMITS 1. THE BASICS 34 BM5 Operation Manual 1.6 POWER ON DC POWER DC Power LED is lighted on when the DC Power is plugged into the inlet at the back of the product. A press of power key makes the machine ready for use. In case of adding Capnography Station In case of adding Capnography Station, AC power (100~240Vac, 50/60Hz) can be provided with the the equipment directly, since the power supply function is built into the Capnography Station. Rev 1.0 1. THE BASICS 35 BM5 Operation Manual Note If the DC Power adaptor is connected to the equipment, the green DC LED indicator is turned on. Through this indication, you can check the status of power supply to the equipment. Rev 1.0 1. THE BASICS 36 BM5 Operation Manual 1.7 BATTERY POWER ON Power can be supplied by battery, enabling a portable use or a use during DC/AC power failure. Operation Battery Power LED is lighted on when the machine is in use. 1. Battery power lasts normally one to two hours. 2. Battery is automatically charged when the machine is connected to DC Power Supply. Battery LED is lighted on after blinking. 3. As for the battery, GP220AAH(12V-2200mAh, NiMH) of GP Batteries is recommended. 4. Battery condition is displayed on the screen in the following 10 images Battery Information: SDI18653S1PMXZ(11.1V - 2400mA, Li-ion) for Main Body SDI18653S2PMXZ (11.1V - 4800mA, Li-ion) for Capnography Station SDI18653S1PMXZ(11.1V - 2400mA, Li-ion) Rev 1.0 SDI18653S2PMXZ (11.1V - 4800mA, Li-ion) 1. THE BASICS 37 BM5 Operation Manual 5. When the battery power is low, the message of ‘Low Battery’ is displayed. The power is automatically cut off after 5 minutes from the appearance of the message. Warning Check the electrodes of batteries before changing them 6. Battery condition : In case of disconnection or damage on battery, the indication appears as below. 7. Automotive Power “CAR” appears rather than the battery symbols when the vehicle power (12V~16V) is used. CAR Display of automobile power Caution Battery is not charged while the automobile power is used. In this case, the battery condition is not indicated. Rev 1.0 1. THE BASICS 38 BM5 Operation Manual 1.8 User Interface Features Features of Screen Real-Time wave window: Displays measured results in up to three waves. Menu select windows: Menus appear when they are activated. Parameter windows: Measured and setup data are displayed in five windows. Rev 1.0 1. THE BASICS 39 BM5 Operation Manual Selection of Menu When the Trim Knob Key is turned, menus are selected in the order indicated above. The above screen shows that the MORE menu is selected. The menus move to the right in the order of MORE MENU -> ECG -> SpO2 -> RESP -> NIBP -> TEMP. An inactivated window is not displayed. Features of Menu MORE Menu Window One can set up or change functions by selecting “More”menu. MAIN ALARM ADMIT TREND MENU SETUP Rev 1.0 1. THE BASICS 40 BM5 Operation Manual Parameter Window This window displays a measured parameter, function setup, and the boundary of parameter values. Selection of Menu by Using Trim Knob Key A right-hand turn makes a movement in a clockwise direction. A left-hand turn makes a movement in an counterclockwise direction. A selection is made by pressing the Trim Knob Key. ALARM PRINT: OFF ALARM VOLUME: 50% PREV ALARM ARRHYTH MENU LEVEL LEVEL MAIN ALL MENU LIMITS Selection of Menu with Arrows Upward Movement: Turns the Trim Knob Key to the left. Downward Movement: Turns the Trim Knob Key to the right. Selection is made by pressing the Trim Knob Key. One comes out of the menu after the selection. MAIN MENU WAVE FORM2: OFF > OFF SPO2 RESP WAVE FORM1: ECG II PREV MENU Rev 1.0 1. THE BASICS 41 BM5 Operation Manual Word String Menu The following figure shows the screen where the word sequence menu is activated within the word sequence correction menu. Here, the cursor moves over the words when the Trim Knob Key is turned in the clockwise direction. MAIN MENU SET UNIT NAME PREV MENU MAIN MENU SET UNIT NAME PREV MENU The above figure shows how the cursor moves on the screen. The cursor moves according to the direction the Trim Knob Key is turned. Press the Trim Knob Key if you want to change a letter currently on the screen. MAIN MENU SET UNIT NAME A PREV MENU The above figure shows how the cursor is selected to change a letter. Right-hand turning of the Trim Knob Key makes it possible to select in the order of 0-9, A-Z, and a blank, while left turning makes the movement in the opposite direction. Once a letter or a number is selected, the screen comes back to the condition where the same Rev 1.0 1. THE BASICS 42 BM5 Operation Manual process of selection can be made. One may move to the menu item in the left of the screen to end the process, which is completed by pressing Trim Knob Key. After completion, the screen comes back to the earlier picture. Square Selection Menu Whenever the square moves, a selected letter or a number is highlighted displaying its value. ALARM VOLUME: 20% MAIN MENU OFF 10% > 20% 30% 40% 50% PREV MENU 60% 70% 80% 90% 100% Operation Menu The set up value changes without a selection when the menu is moved. ALARM PRINT: ON ALARM VOLUME: 50% PREV ALARM ARRHYTH MENU LEVEL LEVEL MAIN ALL MENU LIMITS ALARM PRINT: OFF ALARM VOLUME: 50% PREV ALARM ARRHYTH MENU LEVEL LEVEL MAIN ALL MENU LIMITS Rev 1.0 1. THE BASICS 43 2. MORE MENU 2.1 ALARM ALL LIMITS ALARM PRINT ALARM VOLUME ALARM LEVEL ARRHYTH LEVEL 2.2 ADMIT CHANGE ADMIN INFO DISCHARGE HEIGHT WEIGHT 2.3 TREND GRAPHIC TREND TABULAR TREND 2.4 SETUP DISPLAY USER SERVICE MAKER SERVICE BM5 Operation Manual Additional setups are made for each parameter function. One can make an overall setup for the entire monitor system. ALARM : Sets up information for all alarms of each parameter. ADMIT : Corrects or sets up information of each patient. TREND : Enables to store waves of each parameter, and see them by times. SETUP : Sets up system functions such as time, date, color, AC filter, etc. MAIN ALARM ADMIT TREND MENU SETUP Rev 1.0 2. MORE MENU 47 BM5 Operation Manual 2.1 ALARM Alarm is divided into two types, alarm for the patient’s condition and alarm for the product’s condition. The patient’s alarm sounds when the diagnostic functions (ASYSTOLE, VTAC/VFIB, VTAC) are detected. Each alarm sound differs in order and volume according to the levels of HIGH, MEDIUM, LOW, MESSAGE. Alarm HIGH -5 ≡ MEDIUM -3 ≡ Alarm ≡ text LOW -1 ≡ Alarm ≡ text ≡ Alarm ≡ text MESSAGE text ≡ : Alarm sound ≡ Alarm text ≡ : Number flashes : Waves are printed out : Alarm Lamp blinking Alarm for the Product The machine gives alarm sounds for its system with a related message flashing. LOW Rev 1.0 -1 ≡ Alarm Text ≡ 2. MORE MENU 48 BM5 Operation Manual ALL LIMITS The machine enables one to see and change the limits of alarm for all parameter functions. ALL LIMITS > RETURN UNITS LOW HIGH BPM 50 150 % 90 100 SPO2-R BPM 50 150 RESP RPM 10 30 RESP-A SEC 0 20 NIBP-S mmHg 80 200 NIBP-M mmHg 40 140 NIBP-D mmHg 20 120 30.0 42.0 ALARM PRINT: OFF ALARM VOLUME: OFF PREV ALARM ARRHYTH MENU LEVEL LEVEL HR SPO2 TEMP Rev 1.0 MAIN ALL MENU LIMITS 2. MORE MENU 49 BM5 Operation Manual ALARM PRINT With an ON/OFF setup, the related information is printed out whenever an alarm is given. LIMITS ALARM PRINT: OFF ALARM VOLUME: OFF PREV NUESE CALL: ALARM ARRHYTH MENU OFF LEVEL LEVEL MAIN ALL MENU ALARM VOLUME Volume of each alarm can be adjusted in 10 steps. MAIN MENU ALARM VOLUME: 50% OFF 10% 20% 30% 40% PREV MENU Rev 1.0 60% 70% 80% 90% 100% >50% 2. MORE MENU 50 BM5 Operation Manual ALARM LEVEL Priority of each parameter alarm can be set up. PARAMETER ALARM LEVELS > RETURN Rev 1.0 ALARM LEVEL HR MEDIUM NIBP MEDIUM SPO2 LOW RESP MESSAGE RESP-A MESSAGE TMEP MESSAGE SPO2-R MESSAGE LIMITS ALARM PRINT: OFF ALARM VOLUME: OFF PREV NURSE CALL: ALARM ARRHYTH MENU OFF LEVEL LEVEL MAIN ALL MENU 2. MORE MENU 51 BM5 Operation Manual ARRHYTH ALARM LEVEL One can set up priorities when he or she uses the alarm for the diagnostic function. ARRHYTHMIA ALARM LEVELS > RETURN Rev 1.0 ALARM LEVEL ASYSTOLE HIGH VTAC / VFIB HIGH VTAC HIGH ALARM PRINT: OFF ALARM VOLUME: OFF PREV ALARM ARRHYTH MENU LEVEL LEVEL MAIN ALL MENU LIMITS 2. MORE MENU 52 BM5 Operation Manual 2.2 ADMIT ADMIT menu is used to register and unregister the patient. In this menu, you can save and delete the patient’s information and change the unit of weight and height. You must admit a patient to save the measured data to the equipment. And, you must discharge the patient when you finish monitoring the patient, cause the caregiver may be confused with the remaining data measured from the previous patient. CHANGE ADMIT INFO In this function one can set up information of a patient including LAST and FIRST NAMES (up to 11 letters each), SEX (MALE, FEMALE), DATE OF BIRTH, WEIGHT, HEIGHT, and PATIENT ID (up to 11 digit numbers). CHANGE ADMIT INFORMATION > RETURN ALARM LEVEL LAST NAME FIRST NAME PATIENT ID SEX MALE BIRTH DATE 1 – JAN – 2000 AGE 0 HEIGHT 160.0 CM WEIGHT 50.0 KG CHANGE ADMIT INFO MAIN MENU Rev 1.0 PREV HEIGHT: WEIGHT: MENU CM KG DISCHARGE 2. MORE MENU 53 BM5 Operation Manual ADMIT It operates the trend and alarm functions in discharge status. You must set the status of ADMIT to YES before measuring new patient. Under this status, the measured data is stored to the equipment. CHANGE ADMIT INFO MAIN MENU PREV HEIGHT: WEIGHT: MENU CM KG MAIN ADMIT ADMIT MENU > NO YES PREV HEIGHT: MENU CM DISCHARGE After you finish the measurement, you must set the status of DISCHAGE to YES to delete all measured data from the equipment. Patient’s information and all set up values are changed to basic values. And, the message “ALL ALARMS OFF ADMIT PATIENT TO ACTIVE ALARMS” is displayed on the screen. CHANGE ADMIT INFO MAIN MENU Rev 1.0 PREV HEIGHT: WEIGHT: MENU CM KG DISCHARGE 2. MORE MENU 54 BM5 Operation Manual MAIN DISCHARGE MENU > NO YES PREV HEIGHT: MENU CM HEIGHT Patient’s height is set up in the units of Cm/Inches. CHANGE ADMIT INFO MAIN MENU PREV HEIGHT: WEIGHT: MENU CM KG DISCHARGE WEIGHT The patient’s weight is set up in the units of Kg/LBS. CHANGE ADMIT INFO MAIN MENU Rev 1.0 PREV HEIGHT: WEIGHT: MENU CM KG DISCHARGE 2. MORE MENU 55 BM5 Operation Manual 2.3 TREND TREND is stored in Wave Data and Numerical Data. Storage is made within 1 minute and the capacity of data storage is 24 hours. VIEW OLDER : Moved to the earlier data VIEW NEWER : Moved to the new data PAGE DOWN : Moved to a different parameter PAGE UP : Moved to a different parameter GRAPHIC TREND Wave Data can be stored and seen according to sections. GRAPHIC TREND 31-JAN-2099 23:30 100 HR 30 22:00 Rev 1.0 22:10 23:20 MAIN VIEW VIEW MENU OLDER NEWER PREV PAGE PAGE MENU DOWN UP TIME PERIOD: 30MINS 2. MORE MENU 56 BM5 Operation Manual TIME PERIOD Select a time period for viewing the displayed trends. GRAPHIC TREND 31-JAN-2099 23:30 300 HR 20 22:00 Rev 1.0 22:10 MAIN VIEW MENU OLDER PREV PAGE MENU DOWN 23:20 TIME PERIOD 30MINS > 30MINS 60MINS 90MINS 3HRS 6HRS 12HRS 2. MORE MENU 57 BM5 Operation Manual TABULAR TREND One can see the stored data in the time interval previously set up. TABULAR TREND 31-JAN-2099 24:30 31-JAN 22:00 31-JAN 31-JAN 31-JAN 31-JAN 22:30 23:00 23:30 24:00 HR 120 125 130 130 130 SPO2 95 90 90 90 90 SPO2-R 120 125 125 125 125 RESP 10 15 20 25 25 NIBP-S 80 85 90 90 90 NIBP-M 40 45 50 50 50 NIBP-D 20 26 30 35 35 36.5 36.5 36.5 36.5 36.5 TEMP ALARM MAIN VIEW VIEW MENU OLDER NEWER TIME PERIOD: 30MINS PREV MENU Rev 1.0 2. MORE MENU 58 BM5 Operation Manual TIME PERIOD Select TIME PERIOD to choose the time interval between each of the displayed columns of data. TABULAR TREND 31-JAN-2099 24:30 31-JAN 22:00 31-JAN 31-JAN 31-JAN 31-JAN 22:30 23:00 23:30 24:00 HR 120 125 130 130 130 SPO2 95 90 90 90 90 SPO2-R 120 125 125 125 125 RESP 10 15 20 25 25 NIBP-S 80 85 90 90 90 NIBP-M 40 45 50 50 50 NIBP-D 20 26 30 35 35 36.5 36.5 36.5 36.5 36.5 TEMP ALARM MAIN VIEW MENU OLDER TIME PERIOD: 30MINS 1MIN 5MINS 15MINS PREV MENU Rev 1.0 > 30MINS 1HR 2. MORE MENU 59 BM5 Operation Manual 2.4 SET UP DISPLAY It is a menu required to set up a display. PRINTER A menu used to set up the function of printer. (More details in Chapter 8) USER SERVICE A menu used to set up the name of device and detail. MAKER SERVICE A menu used to set up the product’s default value. MAIN MENU DISPLAY USER PRINTER SERVICE PREV DEMO: MAKER MENU OFF SERVICE DISPLAY : Selects the parameter to be displayed on the screen. SET PARA : Sets up or corrects wave speed. SET SWEEP : Sets up or corrects time. SET TIME COLOR SELECT : Sets up or corrects date. SET DATE MAIN SET SET MENU PARA TIME PREV MENU Rev 1.0 : Selects the color of waves. COLOR SELECT: COLOR SET DATE 2. MORE MENU 60 BM5 Operation Manual SET PARA One can select the parameters to be displayed on the screen. PARAMETER WINDOW SET > RETURN WINDOW ON/OFF ECG ON SPO2 ON RESP ON NIBP ON TEMP ON MAIN SET SET MENU PARA TIME COLOR SELECT: COLOR PREV MENU SET DATE SET SWEEP You can control the speed of waves displayed on screen. Default is 25mm/s. MAIN SET MENU PARA PREV SET SWEEP 25mm/s > 6.25mm/s 12.5mm/s 25mm/s 50mm/s MENU Rev 1.0 2. MORE MENU 61 BM5 Operation Manual SET TIME MAIN SET MENU TIME 10 : 58 : 01 PREV MENU COLOR SELECT One can select a wave color from GREEN/COLOR. MAIN SET SET MENU PARA TIME COLOR SELECT: GREEN PREV MENU SET DATE SET DATE MAIN SET MENU DATE 06-DEC-2001 PREV MENU Rev 1.0 2. MORE MENU 62 BM5 Operation Manual USER SERVICE The user can set up the device name, bed number and patient’s type(adult/neonate). MAIN MENU SET UNIT NAME PREV MENU SET BED NUMBER SYSTEM AC FILTER: 60HZ ADMIT TYPE: ADT SET UNIT NAME Input the unit name of a patient. SET BED NUMBER Input the bed number SYSTEM Confirm software version and change IP address Rev 1.0 2. MORE MENU 63 BM5 Operation Manual AC FILTER The user may need to set up a value required to eliminate noise that might occur from the differences of frequency. (Default frequency is 50Hz and 60Hz.) MAIN MENU SET UNIT NAME PREV MENU SET BED NUMBER SYSTEM AC FILTER: 50HZ ADMIT TYPE: ADT ADMIT TYPE Configure the environment of the device in discharge status. ADT : ADULT NEO : NEONATE MAKER SERVICE A menu used by the manufacturer of the product. Rev 1.0 2. MORE MENU 64 3. ECG 3.1 Introduction Position of ECG Connector and Probe Cable How to Attach the Electrode Position of 5 and 3 Lead 3.2 ECG Parameter Window 3.3 ECG Parameter Setting Menu LEAD SELECT ALARM LIMIT QRS VOLUME ECG SIZE ANALYSIS SETTING BM5 Operation Manual 3.1 INTRODUCTION It calculates the heart rate with 3 or 5 leads ECG signal acquisition and performs the alarm according to the setting limit. Colors and Standards of Cables AHA AHA IEC IEC Color code Label Color code Label Right arm White RA Red R Left arm Black LA Yellow L Right leg Green RL Black N Left leg Red LL Green F V1(precordial) Brown V(V1) White C(C1) Leadwire AHA American Heart Association (U.S.A. Standard) IEC International Electro technical Commission (European Standard) Position of ECG Connector and Probe Cable ECG Connector & Cable Rev 1.0 3. ECG 68 BM5 Operation Manual Note The signal input is a high-insulation port and it is defibrillator proof Note The maintenance is performed every 3 months Note Don’t use this device with high frequency surgical equipment The insulated input ensures patient safety and protects the device during defibrillation and electro surgery. Use only the electrodes listed in the SEC 12. SPECIFICATION “Accessories - BM5”. Electrodes for diagnostic use may vastly compromise recovery time and stability after defibrillation. Do not connect any electrode to metal parts or ground. Rev 1.0 3. ECG 69 BM5 Operation Manual How to attach the electrode 1. Electrodes have been placed on the patient following proper skin preparation. Note When using “snap” leadwires, attach leadwires to electrodes first, then apply electrode to the patient. This prevents the gel from spreading and becoming ineffective as you attach the snaps to the electrodes 2. Lead wires are attached to electrodes in the patient. Note Shall use only the CE certified disposable electrode 3. Lead wires are connected to patient cable and patient cable is connected to the monitor. 4. Verify the V-lead label is correct if using a 5-leadwire patient cable. 5. ECG setup is adjusted, if necessary. Follow detailed procedures within this chapter. Rev 1.0 3. ECG 70 BM5 Operation Manual Position of 5-Lead Position of 3-Lead Rev 1.0 3. ECG 71 BM5 Operation Manual Position of the NEONATAE Electrode Rev 1.0 3. ECG 72 BM5 Operation Manual 3.2 ECG Parameter Window Note ECG Wave Display is always on when the cable is connected Rev 1.0 3. ECG 73 BM5 Operation Manual 3.3 ECG Parameter Setting Menu A setup window appears at lower part of the screen when the Trim Knob Key is pressed in the ECG Parameter Window. Selection is made by pressing the Trim Knob Key, while movement across the menu is performed by turning the key either clock or counterclockwise. MAIN MENU LEAD SELECT: ALARM LIMIT II ECG SIZE X1 QRS VOLUME: OFF ANALYSIS SETTING LEAD SELECT Selection for display is made from channels from I to V MAIN MENU LEAD SELECT: LEAD II I >II III Rev 1.0 by moving the Key left or right aVR aVL aVF V 3. ECG 74 BM5 Operation Manual ALARM LIMIT 1. Move the mark to select RETURN or HR, and press. 2. If pressed at HR, move to LOW, and press. 3. Checking the color changing, move right or left to select the value to set up, and press. 4. Press at HIGH. Checking the color changing, move again to select the value to set up, and press. Move to HR, and press again. (You may decide to perform in the LOW →HIGH order, which produces same result.) 5. Select RETURN to get out of the window. ECG ALARM LIMIT > RETURN HR UNITS LOW HIGH BPM 50 150 ALARM QRS VOLUME: OFF MAIN LEAD SELECT: MENU II ECG SIZE X1 Rev 1.0 LIMIT ANALYSIS SETTING 3. ECG 75 BM5 Operation Manual QRS VOLUME Move the KEY to select a volume rate from OFF to 100%, and press. After selection, the user can get out of the window. MAIN MENU QRS VOLUME: OFF > OFF 10% 20% 30% 40% 60% 70% 80% 90% 100% 50% ECG SIZE ECG SIZE can be selected from X0.5, X1, X2 and X4. Press the key at the desired value in MENU. MAIN MENU ECG SIZE: X1 X 0.5 >X1 QRS VOLUME: OFF X2 X4 ANALYSIS SETTING Rev 1.0 3. ECG 76 BM5 Operation Manual ANALYSIS SETTING If one selects ANALYSIS SETTING, there appears three menus. ECG FILTER : One may select from three frequency types for WAVE FILTER. MONITOR 0.5Hz ~ 40Hz MODERATE 0.5Hz ~ 25Hz MAXIMUM 5Hz ~ 25Hz MAIN MENU ECG FILTER: MONITOR > MONITOR MODERATE MAXIMUM PREV MENU PACE ARRHYTH Rev 1.0 : Sets up ON/OFF to indicate that the patient has a pacemaker. : Sets up ON/OFF to indicate detection of diagnosis (Asys, VTAC/VFIB and VTAC). 3. ECG 77 BM5 Operation Manual WARNINGS FALSE CALLS False low heart rate indicators or false a systole calls may result with certain pacemakers because of electrical overshoots. MONITERING PACEMAKER PATIENTS Monitoring of pacemaker patients can only occur with the pace program activated. PACEMAKER SPIKE An artificial pacemaker spike is displayed in place of the actual pacemaker spike. All pacemaker spikes appear uniform. Do not diagnostically interpret pacemaker spike size and shape. PATIENT HAZARD A pacemaker pulse can be counted as a QRS during a systole in either pace mode. Keep pacemaker patients under close observation. RATE METERS Keep pacemaker patients under close observation. Rate meters may continue to count the pacemaker rate during cardiac arrest and some arrhythmias. Therefore, do not rely entirely on rate meter alarms. Rev 1.0 3. ECG 78 BM5 Operation Manual CAUTION FDA POSTMARKET SAFETY ALERT The United States FDA Center for Device and Radiological Health issued a safety bulletin October 14, 1998. this bulletin states “that minute ventilation rate-adaptive implantable pacemakers can occasionally interact with certain cardiac monitoring and diagnostic programmed rate.” The FDA further recommends precautions to take into consideration for patients with these types of pacemakers. These precautions include disabling the rate responsive mode and enabling an alternate pace mode. For more information contact: Office of Surveillance and Biometrics, CDRH, FDA 1350 Packard Drive, Mail Stop HFZ-510 Rockville, MD 20850 U.S.A NOTE ECG monitoring with patients in non-invasive trans coetaneous pacemakers may not be possible due to large amounts of energy produced by these devices. Monitoring ECG with an external device may be needed. Rev 1.0 3. ECG 79 BM5 Operation Manual WARNINGS VENTRICULAR ARRHYTHMIAS The arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect a trial or supra ventricular arrhythmias. Occasionally it may incorrect identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information in conjunction with other clinical findings. SUSPENDED ANALYSIS Certain conditions suspend arrhythmia analysis. When suspended, arrhythmia conditions are not detected and alarms associated with arrhythmias do not occur. The messages which alert you to the conditions causing suspended arrhythmia analysis are : ARR OFF, ARRHYSUSPEND, LEADS FAIL, ALARM PAUSE, ALL ALARMS OFF, and DISCHARGED. Trouble shooting Problem : Inaccurate heart rate and/or false a systole Solution : Check ECG signal from patient: 1. Check/adjust lead placement. 2. Check/perform skin preparation. 3. Check/replace electrodes. Check amplitude of ECG waveform: 1. Select ECG parameter label. 2. Select DISPLAY LEAD. 3. Scroll through all ECG leads and check for 0.5mV amplitude at normal (1X) size. (at least 0.5mV amplitude is required for QRS detection.) for borderline signals, validate on a graph. 4. If amplitudes are low, electrodes may need to be repositioned or replaced. Rev 1.0 3. ECG 80 BM5 Operation Manual Problem : False ventricular calls Solution : Check ECG signal from patient: (the chest lead may exhibit polarity changes which may occasionally cause an inaccurate call.) 1. Check/adjust lead placement. 2. Check/perform skin preparation. 3. Check/replace electrodes. (if chest lead is a problem, move the chest lead to another chest position or leg position.) Problem : Inaccurate pacemaker detection Solution : Use pacemaker processing: 1. Select ECG parameter label. 2. Display the lead of ECG with the greatest amplitude in the top waveform position. 3. Select ANALYSIS SETTINGS. 4. Select DETECT PACE. Rev 1.0 3. ECG 81 4. SpO2 4.1 Introduction Position of SpO2 Connector and Probe Cable 4.2 SpO2 Parameter Window 4.3 SpO2 Parameter setting Menu ALARMLIMIT RATE VOLUME BM5 Operation Manual 4.1 INTRODUCTION It performs alarm function according to the setting value, detecting SpO2 in the way of transmitting the red and infrared rays into the capillary vessel to take the pulsation. It performs automatic calibration on POWER ON. The measurement method is fractional saturation. Position of SpO2 Connector and Probe Cable SpO2 connector SpO2 Sensor & Extension Cable The recommended application time for continual probe use is 3 days. After this time, remove and clean probe. The material of the finger probe is non-toxic. The wavelength and the energies of the light are safe. We made functional safety tests(include alarm) according to EN 865 Rev 1.0 4. SpO2 84 BM5 Operation Manual 4.2 SpO2 Parameter Window Note SPO2 WAVE SIZE is changed automatically Caution Waveforms and measurements are affected by strong electromagnetic interference. Rev 1.0 4. SpO2 85 BM5 Operation Manual 4.3 SpO2 Parameter setting Menu ALARM LIMIT Menu in which SpO2 limits are set up RATE VOLUME Menu in which RATE VOLUME is set up MAIN ALARM MENU LIMIT RATE VOLUME: OFF RATE VOLUME Move the KEY to select the volume from OFF to 100%. When the SPO2 volume rate is set, it turns OFF automatically. MAIN MENU PREV MENU Rev 1.0 RATE VOLUME: OFF > OFF 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 4. SpO2 86 BM5 Operation Manual ALARM LIMIT 1. Move the mark to select from RETURN, SpO2 or SpO2-R, and press. 2. After pressing at SpO2, move the cursor right or left to LOW, and press. 3. Once the color is changed, move the cursor again to the selected value and press. 4. Place the cursor to HIGH and press, when the color changes, move the cursor again to select the targeted value, and press. Finally move to SpO2 and press. (You may decide to perform the process in the opposite order, LOW to HIGH, to have the same result.) 5. After pressing at SpO2-R, move the cursor right or left to LOW, and press. 6. Once the color is changed, move the cursor again to the selected value and press. 7. Place the cursor to HIGH and press, when the color changes, move the cursor again to select the targeted value, and press. Finally move to SpO2-R and press. 8. With the selection of RETURN the user gets out of the menu. SPO2 ALARM LIMIT > RETURN UNITS LOW HIGH % 90 100 SPO2-R BPM 50 150 MAIN ALARM MENU LIMIT SPO2 Rev 1.0 RATE VOLUME: OFF 4. SpO2 87 5. RESPIRATION 5.1 Introduction Position of RESPIRATION Connector and Probe Cable 5.2 RESPIRATION Parameter Window 5.3 RESPIRATION Parameter Setting Menu ALARM LIMIT RESP SIZE BM5 Operation Manual 5.1 INTRODUCTION Respiration via ECG Lead II electrode makes the skin area of the chest enlarged, causing changes in the resistance of skin. Through this it calculates respiration value per minutes and performs the alarm function according to limit value. Position of Detected Lead II Position of Respiration Connector and Probe Cable Respiration Connector Respiration Probe Cable Rev 1.0 5. RESPIRATION 90 BM5 Operation Manual 5.2 Respiration Parameter Window Rev 1.0 5. RESPIRATION 91 BM5 Operation Manual 5.3 Respiration Parameter Setting Menu : Menu to set up alarm during respiration limit Alarm Limit Respiration Speed : Menu to set up Wave Display Respiration Size MENU : Menu to set up Wave Display RESP SIZE: X2 ALARM LIMIT Respiration Size The user sets up the size of waves from X2 to X10. Once selection is made by moving the cursor, the user gets out of the menu. MENU ALARM LIMIT Rev 1.0 RESP SIZE : X2 > X2 X4 X6 X8 X 10 5. RESPIRATION 92 BM5 Operation Manual ALARM LIMIT 1. Move the mark to select RETURN, RESP or RESP-A, and press. 2. After a press in RESP, move the cursor right or left to LOW, and press. 3. After the color changed, move the cursor right or left to the selected value, and press. 4. Place the cursor to HIGH, and press. When the color has changed, move the cursor again to select the value, and press. Move to the RESP and press again. (You may decide to perform the process in the opposite order, LOW to HIGH, to have the same result.) 5. Once RESP-A is pressed, move to LOW and press. 6. When the color has changed, move the cursor to select the value, and press. 7. A press in the HIGH position, the color changes. Then move the cursor to select the value and press. Move again to RESP-A, and press. 8. Select RETURN to get out of the window. RESP ALARM LIMIT > RETURN UNITS LOW HIGH RESP BPM 10 30 RESP-A SEC 0 20 MAIN ALARM MENU LIMIT RESP SIZE: X2 CHANGE EtCO2 CHANGE EtCO2 When CAPNOGRAPHY STATION is equiped, this menu is used to change the measurement mode from Respiration to EtCO2. Rev 1.0 5. RESPIRATION 93 6. NIBP 6.1 Introduction Position of NIBP Connector and CUFF 6.2 NIBP Parameter Window 6.3 NIBP Parameter setting Menu ALARM LIMIT CUFF SIZE INTERVAL TIME BM5 Operation Manual 6.1 INTRODUCTION WARNING Noninvasive blood pressure monitoring is not recommended for patients with hypotension, hypertension, arrhythmias or extremely high or low heart rate. The software algorithm cannot accurately compute NIBP on patients with these conditions Automatic noninvasive blood pressure monitoring uses the oscillometric method of measurement. This function is to measure minimum, maximum and average blood pressure by using air pressure. Position of NIBP Connector and CUFF NIBP connector NIBP CUFF Rev 1.0 6. NIBP 96 BM5 Operation Manual Note As the value of NIBP can vary according to the age and sex of a patient, the user needs to set up right data in parameter Menu before measurement. Make sure that tubes between the cuff and the monitor are not kinked or blocked. The air pad should be exactly over the branchial artery. Tubing is immediately to the right or left of the branchial artery to prevent kinking when elbow is bent. The maintenance is performed every 2 years. Check the following list so that devise operates properly and safely at all times. 1. Check for proper cuff size. 2. Check for residual air left in the cuff from a previous measurement. 3. Make sure cuff is not too tight or too loose. 4. Make sure cuff and heart are at same level, otherwise hydrostatic pressure will offset the NIBP value. 5. Minimize patient movement during measurement. 6. Watch for pulses paradox us. 7. Check for leak in cuff or tubing. 8. Patient may have a weak pulse. Rev 1.0 6. NIBP 97 BM5 Operation Manual 6.2 NIBP Parameter Window The text in the graphic does not describe the NIBP button POWER OFF When power is cut off during pressure, air runs out of the CUFF automatically. Rev 1.0 6. NIBP 98 BM5 Operation Manual 6.3 NIBP Parameter Setting Menu ALARM LIMIT : Used to set up an alarm limit CUFF SIZE INTERVAL : Used to select a CUFF SIZE : Used to select intervals of blood pressure MAIN ALARM MENU LIMIT CUFF SIZE: ADT INFLATION SET: 170mmHg INTERVAL: OFF ALARM LIMIT 1. Move the mark to select one from RETURN, NIBP-S, NIBP-M, or NIBP-D, and press. 2. Press the key at NIBP-S, and move to LOW, and press again.(The user gets the same result regardless of the LOW-HIGH, or HIGH-LOW order.) 3. When the color has changed, move it again to select a target value, and press. 4. Press the key at HIGH. When the color has changed, move to the right to select a target value, and press. 5. Set up or revise the values of NIBP-M and NIBP in the same way as above. 6. With the selection of RETURN, the user can get out of the window. NIBP ALARM LIMIT Rev 1.0 > RETURN UNITS LOW HIGH NIBP-S mmHg 80 200 NIBP-M mmHg 40 140 NIBP-D mmHg 20 120 6. NIBP 99 BM5 Operation Manual MAIN ALARM MENU LIMIT CUFF SIZE: ADT INFLATION SET: 170mmHg INTERVAL: OFF CUFF SIZE The user can select a CUFF between ADULT, PEDIATRIC and NEONATAL. MAIN ALARM MENU LIMIT CUFF SIZE : ADT > ADT PED NEO INFLATION SET( ) The user can set the inflation pressure before measuring NIBP. You can provide the patient with more comfortable feeling and shorter measurement time, if you use this function. And, the available setting ranges are different according to the patient type. ADT (ADULT) MODE: 80, 100, 120, 140, 160, 180, 200, 220, 240 mmHg PED (PEDIATRIC) MODE: 80, 100, 120, 140, 160, 180, 200 mmHg NEO (NEONATE) MODE: 60, 80, 100, 120 mmHg The default set values are followed. ADT: 160mmHg PED: 100mmHg NEO: 80mmHg INTERVAL TIME This menu is used for selecting intervals for the measurement of blood pressure by using a CUFF. Move the Rev 1.0 mark to select a target interval from 1 minute to 8 hours. 6. NIBP 100 BM5 Operation Manual Rev 1.0 MAIN INTERVAL: MENU OFF > OFF 15MINS 1MIN 20MINS 2MINS 30MINS 3MINS 1HR 4MINS 2HRS 5MINS 4HRS 10MINS 8HRS 6. NIBP 101 102 7. IBP 7.1 Description IBP Connectors & Accessories 7.2 IBP Data Window 7.3 IBP Data Setting CHANGE NAME (Configuration of measuring position) SCALE (Configuring size of measurement waveform) ALARM LIMITS (Maximum / Minimum Alarming Values) SETTINGS (Various Settings) ZERO (Zero-Point Setting) BM5 Operation Manual 7.1 Description IBP has an alarm function based on the maximum & minimum alarm values configured by measuring the systolic, diastolic and mean blood pressure values with signal processing of electric signals which are transformed from changes in impedance components according to the changes of blood flow in vessels. IBP Connectors & Accessories IBP connector IBP ACCESSARY MEDEX Kit is used for IBP MONITORING KIT. Reusable Pressure Transducers Cartridges and Monitoring kit Rev 1.0 7. IBP 105 BM5 Operation Manual Rev 1.0 7. IBP 106 BM5 Operation Manual Disposable Pressure Transducers Cartridges and Monitoring kit Rev 1.0 7. IBP 107 7.2 IBP Data Window Different data windows are displayed on the screen according to the measuring positions. Rev 1.0 7. IBP 108 7.3 IBP Data Setting Labels for measuring positions are described on each menu. CHANGE NAME: Menu to set measuring position SCALE: Menu to set size of measurement waveform on screen. LIMITS: Menu to set alarming range. SETTING: Menu for processing various pressure signals. ZERO: Menu to set zero-point of Transducer. MAIN MENU CHANGE NAME ART ART SCALE: 30 ART LIMITS ART ZERO SETTING ART CHANGE NAME (Setting Measuring Position) It performs the name changing function for a measuring position to monitor. The setting positions are ART, FEM, PAP, RAP, LAP, UAP, UVP, CVP, ICP and OTHER. MAIN MENU Rev 1.0 CHANGE NAME ART > ART UAP FEM UVP PAP CVP RAP ICP LAP OTHER 7. IBP 109 List & Description of IBP Measurement Parameter Label Parameter Window, Scales Menu Window or Alarm Limits Pop-up Menu will appear according to the Labels. IBP displays the measuring positions based on 10 labels shown in the below table. The below table shows the names for each label and the descriptions to be displayed on the Parameter Window. Select ‘OTHER’ for a measuring position not in the listed positions. LABEL DESCRIPTION DISPLAY VALUE ART Arterial Pressure - Systolic, Diastolic and Mean FEM Femoral Pressure - Systolic, Diastolic and Mean PAP Pulmonary Artery Pressure - Systolic, Diastolic and Mean CVP Central Venous Pressure - Mean LAP Left Arterial Pressure - Mean RAP Right Arterial Pressure - Mean ICP Intracranial Pressure - Mean OTHER Other (OTHER) - Mean UAP Umbilical Artery Pressure - Systolic, Diastolic, and Mean UVP Umbilical Venous Pressure - Mean SCALE (Setting size of measurement waveform) You can set the pressure range for measurement waveform on this menu. The selectable values mean the maximum blood pressure range value that can be shown in a waveform. MAIN MENU Rev 1.0 ART SCALE: 160 300 200 > 160 100 80 60 30 7. IBP 110 Alarm Limits for ART Alarm limits vary according to measuring positions. The settable alarm range for systolic pressure, diastolic pressure and mean pressure is - 50 ~ 350mmHg. ART LIMITS > RETURN UNITS LOW HIGH ART-S ART-M mmHg mmHg 80 40 200 140 ART-D ART-R mmHg BPM 20 50 120 150 ART SCALE: 30 ART MAIN MENU Rev 1.0 CHANGE NAME ART LIMITS ART ZERO SETTING ART 7. IBP 111 The below table shows the settable values of standard alarm limits and scales of parameters for label setting. Parameter Adult Low High ART-S 80 200 ART-D 20 120 ART-M 40 140 ART-R 50 FEM-S Neonatal Low High 40 100 20 60 30 70 150 90 200 80 200 40 100 FEM-D 20 120 20 60 FEM-M 40 140 30 70 FEM-R 50 150 90 200 UAP-S 80 200 40 100 UAP-D 20 120 20 60 UAP-M 40 140 30 70 UAP-R 50 150 90 200 PAP-S -50 350 -50 350 PAP-D -50 350 -50 350 PAP-M -50 350 -50 350 CVP -50 350 30 -50 350 30 RAP -50 350 30 -50 350 30 LAP -50 350 30 -50 350 30 UVP -50 350 30 -50 350 30 ICP -50 350 30 -50 350 30 OTHER -50 350 160 -50 350 160 Rev 1.0 Scale 160 160 160 60 7. IBP Scale 100 100 100 60 112 IBP SETTING (Setting Various Functions) Other menus are to be applied for special functions to process pressure signals in various ways. BP FILTER: OFF MAIN MENU CAL. TRANSDUC PREV MENU Setting three labels of ART, FEM and UAP displaying PULSE-RATE among labels, the functions of PULSE-RATE DISPLAY and DISCONNECT ALARM will be added. BP FILTER: OFF MAIN MENU PULSE RATE: OFF CAL. TRANSDUC DISCONN ALARM: OFF PREV MENU BP FILTER: It filters waveforms by selecting three frequency bands. OFF 0Hz ~ 40Hz 12Hz 0Hz ~ 12Hz 20Hz 0Hz ~ 20Hz Generally recommended for monitoring Used for processing waveform components of higher frequency. Pressure value can be increased with this filter. MAIN MENU PREV BP FILTER: OFF CAL. TRANSDUC > OFF 12Hz 20Hz MENU Rev 1.0 7. IBP 113 BM5 Operation Manual PULSE RATE: Setting display of blood pressure pulse rate. CAL. TRANSDUC: A function to adjust a Transducer error on the monitor. MAIN MENU PREV MENU BP FILTER: OFF CAL. TRANSDUC DISCONN ALARM: OFF ADJUST TO MMHG 100mmHg A function to adjust an error value based on the other index manometer. How to Adjust 1. Select a menu by pressing the knob switch key. 2. Measure blood pressure along with another index manometer. 3. Compare the measured values of ‘mmHg’ for both manometers. 4. Adjust the error value on the parameter menu screen by turning knob switch. 5. Terminate the menu by pressing the knob switch key again. DISCONN ALARM: (Alarm function for disconnection) DISCONN ALARM MENU will be displayed when measurement label is set for ART, FEM and UAP. This function will be activated upon the following two conditions. 1. In case MEAN PRESSURE is not higher than 25mmHg. 2. In case the Disconnect Alarm is set ‘ON’. Medium alarm sound will be generated when the DISSCONNECTED ALARM is activated, and the alarm message “DISCONNECTED” will be displayed on the parameter screen. Rev 1.0 7. IBP 114 BM5 Operation Manual Troubleshooting for a case the measured value is different from the expected value Description In case there are air bubbles in tubes In case an extension tube is connected In case of using blood pressure transducer with a different sensitivity For other cases Action to Take Remove the air bubbles Remove the extension tube Check position of transducer Perform zero-point adjustment ZERO ART: (Zero-point Adjustment) Use ZERO option to set the zero-point of Transducer. Procedures (Zero reference) 1) Close the transducer stopcock on the patient’s side. 2) Open the venting stopcock on the air side. 3) Press the knob switch on the monitor panel. 4) Draw a line with the current input data in IBP area of WAVE WINDOW according to the Wave Base Line. And accord the wave line with the data. 5) Set the data as ‘0’ on the parameter screen. 6) Check if Zero reference is carried out. (Check the pressure parameter on the message window.) 7) Close the venting stopcock on the air side. 8) Open the transducer stopcock on the patient side. The pressure value should be displayed on the pressure parameter screen in a few seconds. Troubleshooting for a case that blood pressure value is not displayed on screen Description In case of ‘out of measurement range’ situation In case blood pressure transducer is damaged Rev 1.0 Action to Take Check the measurement conditions. Replace the damaged transducer with new one 7. IBP 115 BM5 Operation Manual Warning All parts, except Transducer, should not be conductive. Otherwise discharge of energy may induce a shock to operators during cardioversion. Note z Check if there is a scratch on the catheter balloon before using. z Do not reuse disposable parts and accessories. z Do not use Saline packs with passed expiration dates. z Do not use pressure measurement kits in torn packages. z Remove all air in the saline pack by squeezing it. Otherwise it may cause errors in blood pressure band and may go into the blood vessels. Rev 1.0 7. IBP 116 8. EtCO2 8.1 INTRODUCTION Position of EtCO2 Connector and Accessory EtCO2 ACCESSORY 8.2 EtCO2 Parameter Window 8.3 EtCO2 Parameter Setting Menu Rev 1.0 7. IBP 117 Rev 1.0 7. IBP 118 BM5 Operation Manual 8.1 Introduction ETCO2(End-Tidal CO2) is a device to see the concentration of end-tidal carbon dioxide, which uses a method of measurement based on the non-dispersed IR absorption of CO2 using IR ray by sampling a certain part of respiration through pipe during respiration. EtCO2 connector position and accessory EtCO2 connector Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 119 BM5 Operation Manual EtCO2 ACCESSORY EtCO2 monitoring accessory uses the Microstream™ accessory of Oridion Company. Intubated Filter Line® Products FilterLine H Set XSO4624 - Adult/Pediatric FilterLine H Set 006324 - Infant/Neonate FilterLine Set XS04620 - Adult/Pediatric Non-Intubated Filter Line® Products Smart CapnoLine Plus™ CapnoLine™ H NIV Line™ Nasal Filter Line® Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 120 BM5 Operation Manual 8.2 EtCO2 Parameter Window S: Display of apnea setting time in second unit Upper/lower limit value of alarm: Display of alarm setting range value for concentration of CO2 EtCO2: Display of concentration value of carbon dioxide RR: Display of the number of respirations per minute FIO2: Display of concentration value of carbon dioxide during inspiration Note EtCO2 waveform is always displayed if cable is connected. Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 121 BM5 Operation Manual 8.3 EtCO2 Parameter Setting Menu ALARM LIMITS: A menu to set the alarm limit STANDBY: A menu to set the power saving status of EtCO2 module SCALE: A menu to set the screen scale of measured waveform SETTINGS: A menu to handle the information of EtCO2 signal ALARM LIMITS MAIN MENU SETTINGS WAVEFORM SCALE: 30 CHANGE RESP ART LIMIT(Upper/lower limit value of alarm) Upper/lower limit value of alarm differs depending on the position of measurement. The basic setting range of alarm setting value for EtCO2, FiO2, RR, APNEA. ALARM > RETURN LIMITS UNITS LOW HIGH EtCO2 mmHg 30 50 FiO2 mmHg 0 4 AWRR BPM 8 30 APNEA SEC 0 20 MAIN ALARM MENU LIMITS SETTINGS WAVEFORM SCALE: 30 CHANGE RESP Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 122 BM5 Operation Manual The following table shows standard alarm limit of parameter and setting value of scale when setting the label. Parameter Adult Low High EtCO2 0 98 FiO2 0 20 AWRR 0 100 APNEA 0 40 Rev. 1.0 Neonatal Scale 40 Low High 0 98 0 20 0 100 0 40 8. Concentration of end-tidal CO2 (EtCO2) Scale 40 123 WAVEFORM SCALE (Measured waveform scale setting) This sets the range of measured waveform versus pressure. Selectable numerical value means the maximum pressure range value that is shown with waveform. Pressing the knob switch key and then selecting the desired range value displays the selected pressure range value below the upper dotted line among two dotted lines in the left middle of wave window. MAIN MENU ALARM LIMITS WAVEFORM SCALE: 40 > 40 50 60 80 100 CHANGE RESP (Menu conversion) In case of a model provided with capnography station, pressing the above menu converts EtCO2 menu into RESP menu. SETTINGS (Various setting) Different menus are applied to provide menu and information for handling the EtCO2 module. MAIN MENU APNEA ALARM OFF MODULE SETUP MODULE RESET PREV MENU APNEA ALARM: This performs a function to set the display of apnea message alarm. This displays a “apnea” message at the center of parameter window as shown in the figure below with apnea alarm on in case of apnea until the set apnea period is passed through. Rev 1.0 7. IBP 124 BM5 Operation Manual With apnea alarm off, measured values are displayed instead of message. MODULE SETUP: This sets the basic information display and environmental information of EtCO2 module. EtCO2 module contains equipment version information, module setup, and calibration date. S/W VER: Software version information of EtCO2 module H/W VER: Hardware version information of EtCO2 module DEVICE VER: EtCO2 module self serial number information BTP: This is a function to compensate the error between the pressure value of actual CO2 and the value of measured CO2 when EtCO2 module measures the signal, which can be selected with ON/OFF. PEAK PICKING MODE: This is a function to search the maximum EtCO2 and the minimum FiO2 within a certain section and display it on the screen, which is selected among NOP/ BREATH TO BREATH/ 10SEC/ 20SEC/ 30SEC. PATIENT: Measurement can be performed by selecting ADULT / NEONATE depending on measured patient group. CAL. DATE: This shows the information on the date of finally having executed calibration. Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 125 BM5 Operation Manual MODULE INFO SET > RETURN CONTENTS SW VER 2.00 HW VER DEVICE VER BTP 2.00 SN12345 ON PEAK NOP PATIENT ADULT CAL. DATE 2006- 06-26-09 MAIN MENU APNEA ALARM OFF MODULE MODULE SETUP RESET PREV MENU MODULE RESET: This is a function for initialization during functional error in EtCO2 module. CALIBRATION Calibration should be performed to compensate accuracy of EtCO2. Calibration function is located in the following route. MORE MENU Æ MAKER SERVICE Æ CALIBRATE AND TEST Æ EtCO2 SETUP Æ EtCO2 CAL. Goods to be prepared: Calibration Gas 5% CO2 Calibration Filter “T” Piece Connector Setting Method 1. Connect “T” piece connector and calibration filter with calibration gas tank. 2. Connect calibration filter with equipment. 3. Select menu by pressing the knob switch key. Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 126 BM5 Operation Manual 4. Inject gas by pressing the switch on the calibration gas tank simultaneously with “CALIBRATION START.” 5. Inject gas continuously until a message “CALCULATING” appears. 6. When calibration has been normally performed, a message “CALIBRATION DONE- O.K.” is displayed. Rev. 1.0 8. Concentration of end-tidal CO2 (EtCO2) 127 Warning If defibrillation is performed while doing CO2 monitoring, remove the CO2 FilterLine from patient Getting in touch with sensor cable without removing the FilterLine can result in serious electrical burn, shock, or injury due to electric discharge energy. Note In the following monitoring conditions, the measured values may be inaccurate. Read the measured values carefully. 1. When using this in an environment of nitrous oxide gas of high concentration 2. When using this in an environment where abrupt temperature change takes place 3. When using this in an environment with severely high humidity. Caution z The measured values may be inaccurate when using this equipment for patients who have very fast or irregular respiration. z When measuring CO2 from the patient under anesthesia, check it when gas mixture comes in. Otherwise, the measured result values may be inaccurate. z When using a anesthesia machine that uses a volatile anesthetic, CO2 values may be inaccurate. Rev 1.0 7. IBP 128 9. TEMPERATURE 9.1 INTRODUCTION Position of Temperature Connector and Probe Cable 9.2 Temperature Parameter Window 9.3 Temperature Parameter Setting Menu ALARM LIMIT UNIT SELECT BM5 Operation Manual 9.1 INTRODUCTION This function is used to indicate the changes of resistance generated by the changes of temperature in numbers. The function involves the process of transferring the changes into electrical signals. Position of Temperature Connector and Probe Cable Temperature connector Probe Cable Note Temperature probe is correctly positioned and fixed so as not to disconnect on the patient. Temperature cable is attached to the monitor Rev 1.0 8. TEMPERATURE 131 BM5 Operation Manual 9.2 Temperature Parameter Window Automatic calibration is performed upon power on. Note The minimum measuring time required to obtain accurate readings at the specific body site is at least 3 minutes Rev 1.0 8. TEMPERATURE 132 BM5 Operation Manual 9.3 Temperature Parameter Setting Menu MAIN ALARM MENU LIMIT UNITS SELECT: ALARM LIMIT 1. Move the mark to select either RETURN or TEMP, and press. 2. After pressing the cursor at TEMP, move it to LOW, and press. 3. When the color has changed, move the cursor again to select a target value, and press. 4. Move the cursor to HIGH and press. After the color has changed, move the cursor again to select a target value, and press. (One may choose HIGH first to get the same result.) 5. Select RETURN to get out of the menu. TEMPERATURE ALARM LIMIT >RETURN UNITS TEMP Rev 1.0 MAIN ALARM MENU LIMIT LOW HIGH 30.0 42.0 UNITS SELECT: 8. TEMPERATURE 133 BM5 Operation Manual UNIT SELECT The user can select here a temperature unit, either Celsius or Fahrenheit. Rev 1.0 MAIN ALARM MENU LIMIT UNITS SELECT: 8. TEMPERATURE 134 10. PRINTING 10.1 Printing Printer and Thermal Paper Function and Setup Menu 10.2 Changing Paper BM5 Operation Manual 10.1 Printing Printer and Thermal Paper A printer is used to print data onto thermal paper, this product is offered as an option. Size of the thermal paper roll: 580mm wide x 380mm(x15m) in diameter Any thermal paper of same size can be used for the printer. Side View of the PRINTER Rev 1.0 8. PRINTING 137 BM5 Operation Manual Function and Setup Menu MAIN SPEED MENU 25mm/S PREV WAVE FORM2: OFF MENU WAVE FORM1: ECGII WAVE FORM3: OFF 1. Press the PRINT Key for continuous printing. 2. Select Printing Speed (25mm/sec or 50mm/sec) MORE MENU SETUP PRINTER SPEED 25mm/S,50mm/S 3. A PRINT TEST can be made in SELF TEST. 4. Set up ALARM PRINT in the MORE menu to activate auto print on alarm. MORE MENU ALARM ALARM PRINT ON 5. Data is printed in a selected wave form along with personal information of the patient. (Printed in 3 waves). MORE MENU Rev 1.0 SETUP PRINTER ECG, WAVE FORM2, WAVE FORM3 8. PRINTING 138 BM5 Operation Manual 10.2 Changing Paper 1 Open the window of the printer. 2 Insert the paper roll offered with the product into the printing unit. Place the roll in a proper way so that the printed paper can roll out upwards. 3 Press the printer window until it is properly shut. Inaccurate shutting may cause failure in printing. Rev 1.0 8. PRINTING 139 11. MESSAGE LIST Parameter Message ECG LEAD FAULT CHECK PROBE LEAD FAULT SpO2 PULSE SEARCH POOR SIGNAL LOST PULSE Explanation Cable is not properly connected. Patient’s finger is off the probe. Defective or damaged probe. Cable is not properly connected. Detection of a repeatable pulse has ceased Searching signal is delayed. Signal is missing while normal measuring. RESP LEAD FAULT APNEA INFLATION FAILURE CHECK CUFF NIBP OVER PRESSURE DEFLATION FAILURE OVER TIME CUFF PRESSURE MEASUREMENT ERROR TEMP LEAD FAULT ALARM VOL.OFF ALARM APNEA gives an alarm. Cuff hose is not properly connected. Cuff pressure is excessively high. Cuff tube is blocked, preventing deflation. Measure time exceeds the preset Level. Measurement error, Signal saturated. Cable is not properly connected. Alarm volume is off. SILENCED Alarm key is pressed once. ALARM PAUSE 5MIN Alarm key is pressed twice. PRINT NO PAPER SETUP LOW BATTERY Rev 1.0 Cable is not properly connected. No paper in the printer. Battery is low. Need recharging. 10. MESSAGE LIST 142 12. FACTORY DEFAULTS 1. Adult-ICU Mode 2. Neonate-ICU Mode BM5 Operation Manual 1. Adult-ICU Mode Alarm level High Asystole 0 Vfib/VTac 0 V Tach 0 Medium HR 0 NIBP 0 IBP1 0 IBP2 0 SpO2 Low Message 0 SpO2-Rate 0 RR 0 RR-Apnea 0 T(ْ C) 0 Parameter Limits Low High HR 50 150 NIBP-S 80 200 NIBP-M 40 140 NIBP-D 20 120 SpO2 90 100 SpO2-Rate 50 150 RR(RESP) 10 30 RR-Apnea 0 20 30.0/42.0 86.0/107.6 IBP1-S 80 200 IBP1-M 40 140 IBP1-D 20 120 T( ْ C/ْ F) Rev 1.0 11. FACTORY DEFAULTS 146 BM5 Operation Manual IBP1-R 50 150 IBP2-S -50 350 IBP2-M -50 350 IBP2-D -50 350 IBP2-R 50 150 Display Patient Age Adult Color format Color Primary ECG II Arrhythmia Off Detect Pace Off Print Waveform2 Off Print Waveform3 Off Alarm Print On NIBP Auto Off NIBP Cuff Size Adult RR(RESP) Lead II Alarm Volume 50% QRS Volume Off Pulse Volume Off ECG Lead Fault Low Alarm SpO2 Probe Off Low Alarm Units for Height cm Units for Weight kg Temperature Units NIBP Limit Type ECG Filter Rev 1.0 ْ C Systolic Monitor 11. FACTORY DEFAULTS 147 BM5 Operation Manual 2. Neonate-ICU Mode Alarm level High Asystole 0 Vfib/VTac 0 V Tach 0 RR-Apnea 0 Medium HR 0 NIBP 0 SpO2 Low Message 0 SpO2-Rate 0 RR 0 T( ْ C) 0 Parameter Limits Low High HR 90 200 NIBP-S 40 100 NIBP-M 30 70 NIBP-D 20 60 SpO2 88 100 SpO2-Rate 90 200 RR(RESP) 15 100 RR-Apnea 0 15 30.0/42.0 86.0/107.6 T( ْ C/ْ F) Rev 1.0 11. FACTORY DEFAULTS 148 BM5 Operation Manual Display Patient Age 0~2 years Color format Color Primary ECG II Arrhythmia Off Detect Pace Off Print Waveform2 Off Print Waveform3 Off Alarm Print On NIBP Auto Off NIBP Cuff Size Neonate RR(RESP) Lead II Alarm Volume 50% QRS Volume Off Pulse Volume Off ECG Lead Fault Low Alarm SpO2 Probe Off Low Alarm Units for Height cm Units for Weight kg Temperature Units NIBP Limit Type ECG Filter Rev 1.0 ْ C Systolic Monitor 11. FACTORY DEFAULTS 149 13. TROUBLE SHOOTING 1. Noise in ECG 2. SpO2 malfunction 3. Temp malfunction 4. NIBP malfunction 5. Abnormality in NIBP measurements 6. IBP malfunction 7. Abnormality in IBP measurements 8. Failure in battery recharge 9. Failure in battery recharge 10. Power failure 11. Periodic noises 12. Print failure BM5 Operation Manual 1. Noise in ECG - Gel is dry - Electrodes do not stick well to skin The patient’s skin is extremely dry Yes Apply ECG gel or water to the area of contact then use the electrode No The electrode is in poor condition Yes Replace the electrodes (Use CE compatible products) No The cable(lead wire) is disconnected Yes Replace lead wires No Repair the ECG B/D Rev 1.0 12. TROUBLE SHOOTING 152 BM5 Operation Manual 2. SpO2 malfunction Connectors of the equipments are in bad condition? The extension cables Yes Replace extension cables are disconnected No The Finger probe is Yes Replace the finger probe in bad condition? No Repair the SpO2 B/D 3. Temp malfunction The probe is in bad condition? Yes Replace the probe No Repair the Temp B/D Rev 1.0 12. TROUBLE SHOOTING 153 BM5 Operation Manual 4. NIBP malfunction Are leaks from the hose Yes Replace the hose of cuff connector of cuff No Repair the NIBP B/D 5. Abnormality in NIBP measurements The patient moved Yes while measuring Make sure the patient remains still during diagnosis No The measurements Yes Loosen the cuff during diagnosis appear lower No There is a delay in measuring Yes Tighten the cuff during diagnosis No Repair the NIBP B/D Rev 1.0 12. TROUBLE SHOOTING 154 BM5 Operation Manual 6. IBP malfunction The extension cables Yes Replace extension cables are disconnected No The transducer is Yes Replace the transducer cable in bad condition? No Repair the IBP B/D 7. Abnormality in IBP measurements The transducer is zeroing? Yes Replace the extension cable or transducer cable No Repair the IBP B/D Rev 1.0 12. TROUBLE SHOOTING 155 BM5 Operation Manual 8. EtCO2 malfunction Connectors of the equipments are in bad condition? The Filter Line set Yes Replace Filter Line set are disconnected No The module is Yes Return to activate mode in standby mode? No Repair the EtCO2 Module 9. Failure in battery recharge ( the battery does not fully recharge in 6 hours or more) The output voltage of Yes Replace the adapter (the battery will not be changed the adapter is 18V at the rate lower than 17V) No The battery voltage is lower than 5V Yes Replace the battery No Repair the power B/D Rev 1.0 12. TROUBLE SHOOTING 156 BM5 Operation Manual 10. Power failure The adapter connector Yes Replace the adapter is in bad condition No The output voltage of the Yes Replace the adapter adapter is lower than 18V No Repair the power B/D “Admit” has been Yes Exit the “admit:” function (No data will be stored during battery selected in the menu discharge) No The Digital B/D (dig) Battery has been lower than 3V Yes Replace the battery (3volt) No Repair the Dig B/D Rev 1.0 12. TROUBLE SHOOTING 157 BM5 Operation Manual 11. Periodic noises Yes All alarm has been turned off No Display lead fault Yes message appears Turn functions not in use off (Mode-Display-Set Para) No The printer function abnormally Yes Replace the printer No Repair the accompanying Equipment Rev 1.0 12. TROUBLE SHOOTING 158 BM5 Operation Manual 12. Print failure The paper tray cover Yes Shut the cover tight is properly shut No The printing face of paper has been reversed Yes Reverse the paper face No Repair the printer and printer B/D Rev 1.0 12. TROUBLE SHOOTING 159 14. SPECIFICATION General Features Main Body Specifications Power Adaptor Specifications Capnography Station Specifications Graphical and Tabular Trends Performance Specifications Accessories BM5 Operation Manual Technical Specification General Features Ease of use · Battery operation · Optional integrated strip chart recorder · Carrying handle with bed-rail hook Customization · Tabular and Graphical Trends · Compatible with Nell or reusable and disposable SpO2 sensors Special Features · Direct DC input for transport needs · LAN data export interface Monitor Environmental Specifications · Operating Temperature 15°C to 30°C (59°F to 86°F) · Storage Temperature - 10°C to 60°C (14°F to 140°F) · Operating/Storage Humidity 20% to 95% RH, non-condensing · Operating Altitude 70(700) to 106Kpa(1060mbar) Main Body Specifications Display · 10.4” color TFT LCD (800 x 600) Dimension · 270(W) x 250(H) x 184.5(D) mm · Weight : 4.0kg including Capnography Station Indicators · Up to 5 waves (ECG, SpO2, Respiration or EtCO2, IBP1, IBP2) · Categorized alarms (3 priority levels) · Visual alarm · Heart rate tone · Battery status · External power LED Interfaces · DC input connector 18Vdc, 2.5A · DC output connector : 3.3Vdc, 1A Max Rev 1.0 12. SPECIFICATION 164 BM5 Operation Manual · Defib. Sync. Output connection support : 0 to 5V pulse( pulse width : 100 ± 10ms) · RS232C connection support · Nurse Call System connection support · LAN digital output for transferring data to an external computer · VGA output connector Battery · Battery Type Li-Ion ( 12Vdc, 2400mAh ) · Operating Time 2hours typical (fully charged battery) Thermal Printer(Option) · Speeds 25, 50 mm/sec · Paper Size : 56mm x 1500mm Power Adaptor Specifications · Input : AC 100-240V (50/60Hz) · Output : DC 18V, 2.5A Capnography Station Specifications (Option) Dimension · 270(W) x 60(H) x 172(D) mm Functions · End Tidal CO2 Gas Monitoring · Battery : Li-Ion( 12Vdc, 4800mAh ), 3 hours operating time (fully charged battery) · Built-in Power Adaptor Interface · AC Input : 100~240Vac, 50/60Hz, 1.2A Graphical and Tabular Trends Tabular Trends · Memory Storage 24 hours · Data Interval 1MIN, 5, 15, 30, 1HR · Tabular Format One table for all variables Graphical Trends · Memory Storage 24 hours · Display Period 30MINS, 60, 90, 3HRS, 6, 12 Rev 1.0 12. SPECIFICATION 165 BM5 Operation Manual Performance Specifications ECG Performance Specifications · Leads 3 leads / 5leads(Option) · Heart Rate Range 30 to 300bpm · Heart Rate Accuracy ±3bpm · Bandwidth 0.5 to 40Hz · Display Sweep Speeds 6.25, 12.5, 25, 50mm/sec · ECG Size (Sensitivity) 5, 10, 20, 40mm/mV · Lead-Off Detection with display indicator · Pacemaker Detection Mode Indicator on waveform display, user selectable · Differential Input Impedance > 5 MΩ · Common Mode Rejection Ratio > 90 dB at 50 or 60 Hz · Input Dynamic Range ± 5 mV AC · Defibrillator Discharge <4s SpO2 Performance Specifications · % Saturation Range 0% to 100% · Pulse Rate Range 30 to 254bpm · SpO2 Accuracy 70% to 100% ± 2 digits, 0% to 69% unspecified · Pulse Rate Accuracy ±2bpm · Sensor : red light ( 660nm, 2mW ), infrared light ( 905nm, 2-2.4mW) Respirations Performance Specifications · Range : 5 to 120 breaths/min · Accuracy : ±3 breaths/min · Display Sweep Speeds : 6.25, 12.5, 25, 50 mm/sec NIBP Performance Specifications · Technique Oscillometric · Measurement Modes: - Manual Single measurement - Auto Repetitive measurement ( 1, 2, 3, 4, 5, 10, 15, 20, 30minutes, 1, 2, 4, 8hours ) · Cuff Pressure Display 0 to 300 mmHg · Blood Pressure Measurement Range: - Systolic Pressure Range Adult : 40 to 270mmHg Pediatric : 40 to 200mmHg Neonatal : 40 to 135mmHg - Diastolic Pressure Range : Adult : 10 to 210mmHg Rev 1.0 12. SPECIFICATION 166 BM5 Operation Manual Pediatric : 10 to 150mmHg Neonatal : 10 to 95mmHg - Mean Pressure Range : Adult : 20 to 230mmHg Pediatric : 20 to 165mmHg Neonatal : 20 to 105 mmHg · Deviation of measured pressure : Average deviation : less than ±5mmHg Temperature Performance Specifications · Range 15°C to 45°C (59°F to 113°F) · Accuracy ± 0.1°C · Compatible with YSI Series 400 Temperature Probes Invasive Blood Pressure Performance Specification · Position : Arterial, femoral artery, pulmonary arterial, central, venous, right atrial, left atrial, intracranial, and others · Blood Pressure Measurement Range: 50 to 300mmHg · Accuracy : ±1mmHg ± 1digit (-50 mmHg <= IBP < 100mmHg) ±1% ± 1digit (100mmHg <= IBP <= 300mmHg) · Heart Rate Range 0 to 300 beats/min · Sensitivity : 5µV/V/mmHg EtCO2(Option) Performance Specification · Method Side Stream · CO2 Measurement Range 0 ~ 99mmHg · Respiration Measurement Range : 0 ~ 150bpm · Accuracy : 0 ~ 40mmHg, ±2mmHg 41 ~ 76mmHg, ±5% 77 ~ 99mmHg, ±10% · Resolution : 1mmHg · Apnea alarm : YES Accessories Standard Accessories · 3-lead patient cable (3 CBL-400, 3WIRE-400) · Electrodes (ECGSENS-400) · NIBP extension tube (3m, NBPCBL-400) Rev 1.0 1EA 10EA 1EA 12. SPECIFICATION 167 BM5 Operation Manual · Reusable adult cuff (25-35 cm, ACUFF-400) 1EA · SpO2 sensor extension cable (2 m, SPCBL-400) 1EA · Reusable SpO2 sensor (SPASENS-400) · DC adapter (18VDC/2.5A, KA1803F52) 1EA 1EA Optional Accessories · Temperature probe Surface/Skin, reusable (TEMPSENS-400) 2EA · Rolls of paper (PAPER-400) · 5-lead patient cable (5CBL-400,5WIRE-400) 1SET 1SET · IBP Reusable pressure transducer set · IBP Disposable pressure transducer set · EtCO2 Disposable kit Rev 1.0 1SET 1SET 1EA 12. SPECIFICATION 168 Product Warranty Product Name Patient Monitor Model Name BM5 Approval No. Approval Date Serial No. Warranty Period Two years from date of purchase Date of Purchase Customer Hospital : Address : Name : Tel : Sales Agency Manufacturer Thank you for purchasing BM5. This product is manufactured and passed through strict quality control and thorough inspection. Bionet Co., Ltd Overseas Dept. : #11F, E&C DREAM TOWER Ш, 197-33, Guro-Dong, Guro-Gu, Seoul, South Korea Tel : +82-2-6300-6418 / Fax : +82-2-6300-6454 Bionet America.,Ltd. 2691 Dow Ave. Suite B Tustin, CA 92780 Sales dept. Toll Free: 1-877-9bionet Direct: 714-734-1760 Fax : 714-734-1761 E-mail : sales@bionetus.com European Sales Representative : MGB Endoskopische Gerate GmbH Berlin Schwarzschildstr. 6, 12489 Berlin, Germany TEL : +49(30)63927010 / FAX : +49(30)63927011 After Sales Service Center : #11F, E&C DREAM TOWER Ш, 197-33, Guro-Dong, Guro-Gu, Seoul, South Korea Tel : +82-2-6300-6419 / Fax : +82-2-6300-6499 Bionet Co., Ltd Model Name : BM5