Apex Medical iCH auto&plus Service Manual Model No.: 9S-007100/9S007200 Model No.: 9S-007000 Please read the instruction manual before use. Table of Contents: Chapter 1 Introduction 1.1 General Information 1.2 Intended Use Chapter 2 Product Description 2.1 Warnings, Cautions, and Notes 2.2 Specification 2.3 Appearance 2.4 Functional Operation Chapter 3 Diagnosis 3.1 Diagnosis Procedure 3.2 Error & Warning Message Check Table 3.3 Device Failure Check Table Chapter 4 Repair and Replacement 4.1 Repair Procedure 4.2 Exploded Figure 4.3 The Disassembly and Reassembly Procedure of Components 4.4 Pressure Calibration Procedure 4.5 Download the Compliance Meter and Total Meter Data Chapter 1 Introduction This manual should be used for initial set up of the system and saved for reference purpose. 1.1 General Information Obstructive Sleep Apnea (OSA) is a condition that an intermitted and repetitive obstruction of the upper respiratory tract causes a complete (apnea) or partial (hypopnea) block of breathing airflow during sleep. The syndrome varies depending on the degree of relaxation of the tongue and soft palate muscle. The most common treatment for OSA is Continuous Positive Airway Pressure (CPAP). CPAP devices can deliver a constant air pressure into your upper airway via a nasal mask. This constant air pressure can keep your airway open during sleep, therefore prevents the OSA. This device is a micro-processor controlled continuous positive airway pressure device. It features the illuminated, menu-driven LCD display, universal power supply, and ramp time adjustment. The ramp time adjustment and ultra quiet operation ensure you to fall asleep comfortably while air pressure slowly build up to treatment level. The user compliance meter records the total system’s operating time for physician’s reference. The system has been tested and successfully approved to the following standards: EN EN EN EN EN 60601-1 60601-1-2 55011 Class B 61000-3-2 Class A 61000-3-3 For US and CANADA only E228589 53DG Medical Equipment- CPAP with respect to electrical shock, fire and mechanical hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No. 601.1 UL Le produit à été testé avec des équipements médicaux et respecte les normes 606UL 60601-1 & CAN/CSA C22.2 No.601.1. prévenant les choc électrique, le feu et les risques de blessures physiques. 011 AN D CA N/C SA C2 2.2 NO .60 1.1 UL EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving device. - Increase the separation between the equipment. - Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer or field service technician for help. This system has been tested and compliance to the following volunteer standards: FDA 1.2 Intended Use This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA). Cautions: Some patients might have pre-existing contraindications for CPAP therapy, or might experience some potential side effects of using CPAP device, please consult your physician if you have any questions concerning your therapy. NOTE: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. 2. Product Description Components including: (1) Main device (2) Water chamber (3) Switching adapter (4) Detachable power cord (5) User manual (6) Flexible air tubing with 1.8 m length (7) Full face or nasal mask and headgear straps (Optional, Always use CE certified and 510(k) cleared mask for CPAP) (8) Carrying bag (optional) (7) SD card and USB cable Note 1: ONLY for Physician or Technician to download data. Patient should not use this function. Note 2: Only applicable for devices with SD card slot. Note 3: Please use SD card (smaller than 2GB) which comply with SDHC standard. Before using it, please format it to FAT16 to ensure correct data collection. CAUTION – Patient should not connect the device to the personal computer for Data downloading. This may cause the CPAP system failure 1. 2. 3. 4. 5. LCD Display Up & Down Button Start/Standby Button Menu Button SD Card Slot/mini-USB Connector 6. Air Filter 7. Heater Platform 8. Heater Indicator 9. Heater Control knob 10. Air Outlet 11. Power Socket 12. Air Outlet of the Water Chamber 13. Fill Line 14. Water Chamber 2.1 Warnings, Cautions, Notes WARNING: This machine should be used only with special masks (or connectors) recommended by the manufacturer of the machine, or by your physician or respiratory therapist. A mask should not be worn unless the machine is turned on and operating properly. The vent hole associated with the mask should never be blocked for proper exhaling purpose. If the vent hole is blocked, the machine will stop and show message “Error 002”, after cooling down, please re-connect the power cord to reset the machine. WARNING: When the device is not in operation, oxygen may accumulate within the device enclosure, and it may create the risk of fire. This warning applies to most of the CPAP models. WARNING: This device SHOULD NOT be used if the room temperature is warmer than 35°C (95°F) to prevent the temperature of air delivered to nasal mask over 40°C (104°F). WARNING: This device SHOULD NOT be used in the vicinity of a flammable anesthetic mixture in combination with oxygen or air and nitrous oxide. WARNING: Recommended operating atmospheric condition is above sea level up to 5000 feet. Recalibration is required above 5000 feet. CAUTION: At low pressures, some exhaled gas may remain in the mask and be re-breathed. CAUTION: CAUTION: CAUTION: Make sure the environment around the machine is dry and clean. Dust and foreign particles may affect the treatment. Keep the air inlet on the back of the machine clear to prevent overheating and damage of the device. Do not place the machine near a source of hot or cold air. Extreme cold or hot environment may damage user's respiratory airway. Do not connect the device to the personal computer for data downloading during the treatment. This may cause the system failure. If there is a possibility of electro-magnetic interference with mobile phones, please increase the distance between devices or turn off the mobile phone. 2.2 Specifications Auto: Power Supply AC 100-240VAC, 50/60Hz, 2-1A Power Adapter Skynet ,Type : SNP-A069 or CINCON Electronics Co. Ltd., Type, TR60M24-21E03 Pressure Range 4-20 cmH2O (adjustable in 0.5 cmH2O increment) Initial Pressure 3-19 cmH2O (adjustable in 0.5 cmH2O increment) Maximum Pressure 5-20 cmH2O (adjustable in 0.5 cmH2O increment) Minimum Pressure 4-19 cmH2O (adjustable in 0.5 cmH2O increment) Ramp Time 0-45 minutes (adjustable in 5-minute increment) Ramp Starting Pressure 3-19 cmH2O (adjustable in 0.5 cmH2O increment) Operating Altitude up to 8,000 ft (2,438 m) when the pressure is set at 4-18 cmH2O but limit to 5,000ft (1,524m) when the pressure is set at 18.5 - 20 cmH2O Dimensions (W x D x H) 16.5 x 19.7 x 17.6 cm Weight 1.14 kg Sound Level 30 dBA at 10 cmH2O, 1 meter distance Water Capacity: 300ml Heater Settings: 1 to 6 from 40°C-70°C Pressure Drop: 0.2cmH2O @ 60LPM Humidity Output: Temperature Environment Humidity ≥ 10 mgH2O/L (Ambient temperature: 23°C ± 2°C & Relative humidity: 60% ± 15%) Operating: +5°C to +35°C (+41°F to +95°F) Storage: -15°C to 50°C (+5°F to +122°F) Operating: 15%RH to 95%RH non-condensing Storage: 10%RH to 90%RH non-condensing Class II Type BF, Applied Parts Mask Not suitable for use in the presence of a flammable anesthetic mixture IPX0: Enclosed equipment without protection against ingress of water Continuous operation. Classification: Note: the manufacturer reserves the right to modify the specification without notice. Plus: Item Power Supply Specifications AC 100-240VAC, 50/60Hz, 2-1A Power Adapter Skynet ,Type : SNP-A069 or CINCON Electronics Co. Ltd., Type, TR60M24-21E03 Pressure Range 4 –20 cmH2O (adjustable in 0.5 cmH2O increment) Ramp Time 0 – 45 minutes (adjustable in 5-minute increment) Ramp Starting Pressure 3 cmH2O to therapy pressure (adjustable in 0.5 cmH2O increment) Operating Altitude up to 8,000 ft (2,438 m) when the pressure is set at 4-18 cmH2O but limit to 5,000ft (1,524m) when the pressure is set at 18.5 - 20 cmH2O Dimensions (W x D x H) 16.5 x 19.7 x 17.6 cm Weight 1.14 kg Sound Level 30 dBA at 10 cmH2O, 1 meter distance Water Capacity: 300ml Heater Settings: 1 to 6 from 40°C-70°C Pressure Drop: 0.2cmH2O @ 60LPM Humidity Output: Temperature Environment Classification: Humidity ≥ 10 mgH2O/L (Ambient temperature: 23°C ± 2°C & Relative humidity: 60% ± 15%) Operating: +5°C to +35(C (+41°F to +95°F) Storage: -15℃ to 50℃ (+5°F to +122°F) Operating: 15%RH to 95%RH non-condensing Storage: 10%RH to 90%RH non-condensing Class II Type BF, Applied Parts Mask Not suitable for use in the presence of a flammable anesthetic mixture IPX0: Enclosed equipment without protection against ingress of water Continuous operation. Note: the manufacturer reserves the right to modify the specification without notice. BF symbol, which indicated this product is according to the degree of protecting against electric shock for type BF equipment. Attention, should read the instructions. Attention, should read the instructions. Class II Disposal of Electrical & Electronic Equipment (WEEE): This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment. For more detailed information about the recycling of this product, please contact your local city office, household waste disposal service or the retail store where you purchased this product. Fill line Air flow direction Authorized representative in the European community Manufacturer 2.3 Appearance Figure 2-1 are the features of iCH auto&plus. There are a 22 mm outer diameter air outlet in front of iCH auto&plus and the control panel with four buttons consists of START/STANDBY, MENU, UP, and DOWN buttons. There is 1 DC power socket at the side of iCH auto&plus, and 1 air inlet with air filter at the back of iCH auto&plus. Bottom enclosure of CPAP can also be found with warning labels, electrical specifications, and some labels of certification. Figure 2.3.1 Figures of iCH auto&plus 9S-007000 Airflow Outlet In front of iCH auto&plus, there is an air outlet with outer diameter of 22 mm and can connect to one end of 1.8 meter tube. The nasal mask connects to the other end of the tube that composes the ventilator circuits. Air filter An anti-microbial filter is inserted in the air filter area (replacement filter can be provided by provider.). The air filter should be cleaned at least once every two weeks or more often if this device is operated in a dusty environment and replaced with a new one every six months. CAUTION: Dirty air filter may cause high operating temperatures that affect device performance. Ensure the air filter is cleaned and fitted at all times. 1. Remove the dirty filter from the enclosure on the rear of the device. 2. Wash the filter in warm water with a mild detergent, and rinse with water. Allow the filter to air dry completely before reinstalling. Do not use a filter that is not completely dry. If the filter is torn, replace it. 3. Reinstall the filter. Figure 2.3.2 Disassembling the Water Chamber 1. Turn the device off and allow the heater and water to cool. If necessary, disconnect the flexible tubing from the water chamber. 2. Place thumb on the top of the water chamber and tip it upward as shown in Figure 2.3.3. Remove the water chamber from the system. 3. Unlock the water chamber by pull the tab as shown in Figure 2.3.3. Remove the chamber lid from the base. Figure 2.3.3 Power socket The DC power socket is for main power cord inserts. There are four buttons for controlling and setting the device including START/STANDBY button, MENU button, UP button, and DOWN button. Detail description for each button is following. START/STANDBY To start the treatment, simply press the "START/STANDBY" button. To stop the treatment, press the "START/STANDBY" button again. The display will switch between [STANDBY] and Therapy Pressure [ XX.X cmH2O] in cmH2O unit. MENU Press the "MENU" button to enter the setting mode when device is in standby mode. The adjustment setting includes mode selection, ramp time selection, ramp starting pressure, therapy pressure adjustment, alarm ON/OFF, clock alarm and clock setting, compliance meter, and total operating meter. When each setting's value has been changed, press "MENU" for confirmation and press "MENU" again for next setting selection. Please refer to 2.4 Function Description section for detailed information. UP Press the "UP" button to select the increasing value. DOWN Press the "DOWN" button to select the decreasing value. 2.4 Functional Operation The features for the functions of iCH auto&plus are described below: (1) Ramp Time (only CPAP mode) Ramp time function allows the user to fall asleep with a lower, more comfortable pressure and helps them gradually become accustomed to increasing treatment pressure. The first selection of pressing "MENU" is [Ramp XX MIN]. When the "MENU" setting is in [Ramp XX MIN] mode, press "UP" or "DOWN" button to set the preferred ramp time and press "MENU" for confirmation. There are 10 adjustable levels, 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45 minutes. (2) Ramp Starting Pressure (only CPAP mode) Press "MENU" button to select [Ramp P XX.X] menu, press "UP" or "DOWN" button to set the preferred ramp starting pressure and press "MENU" for confirmation. The ramp starting pressure can be changed from 3 cmH2O to “Therapy Pressure – 1” cmH2O. For example, if your therapy pressure is 10 cmH2O, the maximum ramp starting pressure you can select is 9 cmH2O. (3) Therapy Pressure (only CPAP mode) Press "MENU" button to select [P XX.XcmH2O] menu, you can view the current pressure setting displayed in cmH2O unit. Therapy pressure is adjustable only by the provider, a respiratory therapist or physician. NOTE: The therapy pressure is to only be prescribed by a physician. (4) Initial Pressure (only APAP mode) Press "MENU" button to select [Init. XX.XcmH2O] menu, you can view the current pressure setting displayed in cmH2O unit. Initial pressure is adjustable only by the provider, a respiratory therapist or physician. NOTE: The initial pressure is to only be prescribed by a physician. (5) Maximum Pressure (only APAP mode) Press "MENU" button to select [Max. XX.XcmH2O] menu, you can view the current pressure setting displayed in cmH2O unit. Maximum pressure is adjustable only by the provider, a respiratory therapist or physician. NOTE: The maximum pressure is to only be prescribed by a physician. (6) Minimum Pressure (only APAP mode) Press "MENU" button to select [Min. XX.XcmH2O] menu, you can view the current pressure setting displayed in cmH2O unit. Minimum pressure is adjustable only by the provider, a respiratory therapist or physician. NOTE: The minimum pressure is to only be prescribed by a physician. (7) Total Meter(only debug mode) 9 Plug the DC Power Cable and Press "MENU" and "POWER" button before the Standby mode, it will get into the debug mode, and press the "UP" button to see the Total Meter [TM XXXX.X hr], the total compliance meter records the total number of hours that the device has been active. It will clear the Total Meter when you press the "UP" twice. The meter should only be re-set by the provider, a respiratory therapist or by a physician. (8) Compliance Meter Press "MENU" button to select [CM XXXX.X hr] menu, the compliance meter records the total therapy hours for the device. The compliance meter should be re-set only by the provider, a respiratory therapist or by a physician. (9) Alarm Press "MENU" button to select [Alarm on/off] menu, press "UP" or "DOWN" button to set the alarm on or off. When alarm is turned on, the audible alarm will activate with warning messages showed on the LCD display. Set alarm off for mute the audible alarm. (10) Clock Alarm Press "MENU" button to select [Clock Alarm on/off] menu, press "UP" or "DOWN" button to set the clock alarm on or off. When clock alarm is set on, the display will show the time on the left side. Press "UP" or "DOWN" button to set the time to wake you up. Once the clock alarm is activated, press the start/standby button to mute the audible alarm. (11) Clock Press "MENU" button to select [Clock XX:XX] menu, press "UP" or "DOWN" button to set the current time. (12) Turn off the Device Remove the power cord from the electrical outlet, and disconnect power cord from the power socket on the back of device. NOTE: Once the setting is confirmed, press “MENU” button. Otherwise, the device will automatically go back to standby without saving the modification if no action is taken in 5 seconds. (13) Event Indication While the device is on standby mode, press UP" and "DOWN" button at the same time to see the latest one data of Apnea Index (AI), Hypopnea Index (HI) and Snoring Index (SI) on the display. Press "MENU" button to show each index in sequence. To go back to standby mode, press "START/STANDBY" button. NOTE: Once the device is re-started, all the indexes will be re-calculated. The whole data of these indexes are only seen by respiratory therapists or physicians by using Easy Compliance 3.1 playback software. Turn off the Device Remove the power cord from the electrical outlet, and disconnect DC power cord from the DC power socket on the side of device. Using the heated humidifier 1. Turn the control knob on the back of the device to power on the heater and the heater on indicator above the knob will be lit (orange light), as shown in Figure 2.4.1 Figure 2.4.1 2. Adjust the control knob to increase the humidity in the range of 1 to 6 (refer to diagram). 1 is minimum humidity, 6 is maximum humidity. The optimum setting is dependent on the ambient temperature and humidity of your room. Danger: In order to avoid the destruction or damages of the device or even the hazard of electric shock, when the water chamber is attached, DO NOT fill water from the outlet port of the water chamber. Users must fill water no more than the marking for maximum volume after the water chamber is removed from the device. Using the SD Card to Collect Data If physicians need to review the usage data, they may ask you to use the SD card to copy data from the device, and to return the card to them. Data that is copied to the SD Card is still stored and available on the device. 1. Insert the SD Card when the device is in standby mode. 2. Data copying starts automatically when the SD Card is inserted into the slot. 3. The [Card] message is displayed on the LCD while data is being copied. 4. The [OK Card ] message is displayed on the LCD when copying has finished. 5. Remove the SD Card and mail it to the clinician. 6. The SD Card should be stored in the plastic card case when not in use. The SD card does not need to be uninstalled for the device to work properly. CAUTION: Do not remove the SD card until [OK Card ] message is displayed on the LCD, or data copied to the card may be corrupted or missing. Flowchart of Menu settings Enter the user's menu mode by pressing the “MENU” button. Auto: CPAP Mode CPAP APAP Ramp (Ramp Time) Int. P (Initial Pressure) < 0 ~ 45 > min < 3.0 ~ 19.0 > cmH2O Ramp P (Ramp Starting Pressure) < 3.0 ~ 19.0 > cmH2O Max. P (Maximum Pressure) APAP Mode < 5.0 ~ 20.0 > cmH2O P (Therapy Pressure) Min. P (Minimum Pressure) < 4.0 ~ 20.0 > cmH2O < 4.0 ~ 19.0 > cmH2O Low P (Low Pressure Auto Off) < on/off > CM (Compliance Meter) < xxxx.x > hr Alarm < on/off > Clock Alarm < on/off > Clock < hh:mm > Clock Alarm <On> < hh:mm > Plus: Ramp (Ramp Time) < 0, 5, 10, 15, ……………., 45> min Ramp P (Ramp Starting Pressure) < 3, 3.5, 4, 4.5, ……………., 19> cmH2O P (Therapy Pressure) < 4, 4.5, 5, 5.5, ……………., 20> cmH2O Low P (Low Pressure Auto Off) < on/off > CM (Compliance Meter) < XXXX.X > hr Alarm Clock Alarm Clock < on/off > Clock Alarm <On> < hh: mm > < hh: mm > In each setting, when the preferred value has been selected, press "MENU" for confirmation and press "MENU" again to enter next selection. NOTE: For physicians, please refer to a separated “Physician’s Additional Instruction” page. Chapter 3 Diagnosis This chapter discusses the actions necessary to diagnose iCH auto&plus. It includes diagnosis procedure, Error Message Check Table, and Device Failure Check Table. 3.1 Diagnosis Procedure According to the troubleshooting flow chart below to find out the failed component. Using the procedure of components decomposing and reassembling described in chapter 4 to replace the failed component. After repair, perfoming the Function Test described in chapter 5 to verify the integrity of device. Failure Occurred Yes Did Device Display Found the problem according Error Messages? to Error Message Check Table No Problem Found Found the problem according Replace the defect components to Device Failure Check Table according to Chapter 4 Problem not found Fail Return the device to Apex Run the Function Test according Medical Corp. to Chapter 5 Pass Complete service Figure 3-1 Troubleshooting FloweChart 3.2 Error & Warning Message Check Table The Error & Warning Message may or may not be serious. If device appears to be a serious failure, device will display the error code in LCD display and hold itself to stop using. The Error & Warning Message Table can help technician to find out the problem. Problem Definition Message in LCD Device Status Possible Cause Action Error for abnormal system settings Error 001 Replace PCB. See PCB assembly Shut down PCB may be faulty. steps in the section 4.3.4 Error for flow 1.Airway outlet may generator failure be blocked. Clean airway outlet Error 002 2.Blower may be Replace Blower. See Blower Shut down faulty. assembly steps in the section 4.3.5 Replace PCB. See PCB assembly 3.PCB may be faulty. steps in the section 4.3.4 Error for abnormal Error for abnormal Replace PCB. See PCB assembly timer setting or timer Error 003 Shut down timer setting or timer steps in the section 4.3.4 failure failure. Out of system memory Download the memory data and Warn 001 Out of system Display only reset the meter. See download and memory. reset steps in the section 4.5. System memory is nearly full Warn 002 Download the memory data and Display only System memory is reset the meter. See download and nearly full reset steps in the section 4.5 SD card module SD card module Display only communication failure Warn 003 Ensure the SD card is inserted into the slot. failure Remove the SD Remove the SD card while data is communication Warn 004 Display only card while data is Abnormal Use; Provide correct operation Instructions for use being processed being processed SD card is full Warn Low Pressure: Pressure Sensor 005 Low P Display only 1. Standby Ensure the SD card has enough SD card is full capacity. Pressure sensor may Replace PCB. See PCB assembly steps in the section 4.3.4 be faulty. Error Air leakage@CPAP mode Air leakage@APAP mode 2. Standby 1.Might wear an unsuitable mask. Replace a suitable mask. 2.Mask might not be worn well. Wear mask well. 1.Might wear an 3. Default unsuitable mask. PWM @4cm 2.Mask might not be H2O worn well. Replace a suitable mask. Wear mask well. 3.3 Device Failure Check Table Some failures occurred but device did not display any error message in LCD. According to the sign of failure, technician can use the below table, Device Failure Check Table, to find out the problem. Problem Possible Cause Action 1. Incorrect Power Source. Use specified power input as section 2.2 2. Power Cord may be faulty. Replace Power Cord. Replace Power Module. See Power Module Power Loss 3. Power Module may be faulty. assembly steps in the section 4.3.6 Replace PCB. See PCB assembly steps in the 4. PCB may be faulty. section 4.3.4.2 Can’t Display Message 1. PCB may be faulty. Replace PCB. See PCB assembly steps in the section 4.3.4.2 Can’t Operate CPAP Replace PCB. See PCB assembly steps in the 1. PCB may be faulty. section 4.3.4.2 Compliance Meter display Replace PCB. See PCB assembly steps in the 1. PCB may be faulty. erroneous information section 4.3.4.2 1. Screw may loosed Tighten the screws Return device to Apex Medical service center to 2. The enclosure may be damaged or destroyed. repair Loud noise Replace Blower. See Blower assembly steps in 3. Blower may be faulty. the section 4.3.5 Replace PCB. See PCB assembly steps in the 4. PCB may be faulty. section 4.3.4.2 1. Airway outlet may be blocked.. Clean airway outlet Replace Blower. See Blower assembly steps in 2. Blower may be faulty. No airflow delivered the section 4.3.5 Replace PCB. See PCB assembly steps in the 3. PCB may be faulty. section 4.3.4.2 1. Ramp time function is in use. Adjust ramp time setting to proper value. 2. Air filter may be dirty. Clean or replace filter. See section 4.3.7 3. Air tube may be not connected properly. Reassemble air tube to device Incorrect air pressure Replace Blower. See Blower assembly steps in delivered 4. Blower may be faulty. the section 4.3.5 Replace PCB. See PCB assembly steps in the 5. PCB may be faulty. section 4.3.4.2 Integrated humidifier 1. Power cord not plug into a working DC outlet. Plug in the power cord to a working DC outlet. power on indicator not 2. Knob is not turned on See the figure 2.4.1 and turn the power on. light Replace PCB. See PCB assembly steps in the 3. PCB or indicator worn out section 4.3.4.1. Contact your local agent or EU representative for 4. Fuse blown out(heater plate) service. Contact your local agent or EU representative for 1. Heater plate over heating Heater on indicator not service. light at all Replace PCB. See PCB assembly steps in the 2. PCB indicator worn out section 4.3.4.1. Adjust the control knob to low temperature 1. The heater plate setting is too high. Condensation in mask or flexible tube setting. 2. The operating environment or position of Remove any air conditioner which may nearby the heated humidifier is not properly. The heated humidifier. Or keep room temperature up temperature close to mask or flexible tube is low. near 25℃。 Remove the water chamber from the heated 1. Assembly of water chamber is not proper or Water Leakage incorrectly. humidifier, pull out the water and reassemble the water chamber again, make sure water chamber closes securely, and fill the water till it reach fill line and check if it still leak or not. 2. Water chamber worn out. Replace a new water chamber. Chapter 4 Repair and Replacement This chapter provides the repair and replacement information for iCH auto&plus.-9S-007000 4.1 Repair Procedure After diagnosing the problem according as chapter 3, perform the suggesting repair and replacement procedure in this chapter. The exploded figure of iCH auto&plus is showed in section 4.2. The steps of disassembling and reassembling are described in section 4.3. 4.2 Exploded Figure The exploded figure of iCH auto&plus is shown below. Table 4.2.1 is the list of iCH auto&plus components. Table 4.2.2 is the list of iCH auto&plus water chamber components. Table 4.2.1 The components list of iCH auto&plus 24 Non-slip pad,silicone, black, HS(A)40 1 47 Panel cover, PC-122, transparency black 1 Rating label,9S-007100_iCH_plus(9S-007200_iCH_auto), 100-240V, 23 50/60Hz, APEX standard 1 46 ●LCM(black mask),9S-007000_iCH, with 24pin FPC 1 22 Bottom frame,iCH only, ABS. 94V-0, pantone426C, black 1 46 ●panel control board,9S-007000_iCH, with blue LED 1 21 Blower module top enclosure,iCH only, ABS, 94V-0, black 1 44 ●panel control board,9S-007000_iCH, Manual button 1 20 Blower module bottom enclosure,iCH only, ABS, 94V-0, black 1 43 ●panel control board,9S-007000_iCH, up and down button 1 19 foam,ESH(PU), 90*90*45mm, black 1 42 Electrical wire,red color, 1.25 terminal 3pin, 30mm 1 18 foam,PU, SM-55, 45*35*3t, with adhesive 3M467, black 1 41 Electrical wire,red color, 1 17 foam,PU, SM-55, 37*30*3t, with adhesive 3M467, black 1 40 Power button,9S-007000_iCH, Silicone, HS(A)30, black 1 16 Sensor tube,POM, 1 39 Front cover,iCH only, PC-V2, pantone 8403C 1 15 Silicone tube,φ2*φ4*12cm 1 38 washer,ID Ø1/8*OD Ø10*1.0t 2 14 Silicone tube,φ2*φ4*13cm 1 37 foam,PU, SM-55, 41.9*29.9*3t, black 1 13 Silicone tube,φ2*φ4*10cm 1 36 T shape frame,iCH only, ABS. 94V-0, pantone432C 2 35 Circle label,Ø6mm*0.254t, 2 12 L type tube, PP 3/32”,AP0909ELBP 1.25 terminal 2pin, 30mm Mylar 11 Blower air outlet tube,iCH only, high tension silicone, HS30 1 34 ●HH control board,9S-007000_iCH, w/SD+USB+HH 1 10 Blower air outlet tube sealing plate,SUS304, 1.0t, sandblasted surface 1 33 knob,iCH only, ABS. 94V-0, pantone432C, 1 9 ABIII blower,DC 24V, L80*W81*H51mm 1 32 Screw 3*8 15 8 Blower damper,silicone HS(A 14 1 31 screw3*20 6 7 ●Main control board,9S-007000_iCH_auto(plus) , DC 24V 1 30 SD/USB cover 1 6 FFC, 30pin, 25cm, EUNSUNG E129545 AWM 2896, 30V VW-1 1 29 Location pin,with SUS304 spring, wire diameter Ø0.5 mm 2 5 damper,silicone, HS(A)35, blue 4 28 Heated plate,9S-007000_iCH, 24V/24W, with fuse 1 4 Air filter,PU, MF-15, 21.5*18*7.5mm 1 27 ●Blue light control board,9S-007000_iCH, (PCB with Cable, 2 left wire= 32cm, right wire= 24cm) 3 Leader wire,white, 2.0 terminal 10pin*2, 1007 #26AWG, 50mm 1 26 spring,SUS304, wire diameter 1.0mm* L=13mm, 4.5 laps 2 menu button,9S-007000_iCH, Silicone, HS(A)30, black 1 25 1 Up & Down button,9S-007000_iCH, Silicone, HS(A)30, black 1 No. Description Q'ty DC power wire, red、 black, 1015 #20 AWG, 105℃ 600V, JST terminal 3pin*1, DC jack Ø5.5*1, L=17cm No. Description 2 1 Q'ty 5 Water chamber down enclosure, PC 1 4 Water chamber middle plate, PC 1 3 o-ring, silicone HS50, ψ2.3*L330mm 1 2 Water chamber top enclosure, PC 1 1 o-ring, silicone HS40, ψ21.82*ψ3.53, black 1 Level Description Quantity Table 4.2.2 The components list of iCH auto&plus water chamber 4.3 The Disassembly and Reassembly Procedure of Components Caution: Technician must read section 4.3.1 before disassembling and reassembling device. The required tools are listed in section 4.3.2. There are four sections to discuss steps of disassembly and reassembly. 4.3.1. Attention Points The below lists several attention points about disassembly and reassembly. 1. The technicians who execute the repair procedure must be trained by Apex Medical Corporation. 2. Turn off power and disconnect the power cord before executing repair procedure. 3. Technician must wear protective glove during repair procedure. 4. Be careful to connect each connector during reassembling according to the steps described below. 4.3.2. Tools Required The required tools are listed below: 1. Screwdriver 2. Gloves “T“ Shape Frame PCB Connet 4.3.3. Open the iCH auto&plus Cable HH PCB Front Enclosure Heater Connect Cable Silicon Outlet Tube Main PCB FFC Cable Blue Light Blower Module Figure 4.3.3.1 screws Figure 4.3.3.2 Figure 4.3.3.3 Blower cable Figure 4.3.3.4 PCB Cable Sensor DC Power Cable Silicon Tube Steps for disassembly: 1. Use the screwdriver to remove the two screws from bottom of iCH auto&plus, then remove the other two screws in the back of iCH auto&plus. 2. Separate Front Enclosure and disconnec the FFC Cable from the Front Rnclosure(Figure4.3.3.3). The Main PCB is screwed in the Blower Module and connects with Bottom Enclosure via three electric wires. 3. Remove the two screws in the Silicone Outlet Tube and disconnec the all cables, then take out the Blower Module from the Bottom Enclosule. Steps for reassembly: 1. Put the Blower Module back and make sure the Blower Module was put on the four Dampers. Make sure the HH Control Cable and Blue Light Cable must in front of the Outlet Tube. The 3 pin side of DC Power Cable must be pluged in Main PCB, and the 8 pin side of Heater Connect Cable must be pluged in HH PCB. The Blower Cable of Blower must be pluged in Main PCB. The Blue Light PCB cable must be pluged in Main PCB. 2. Put the FFC Cable back and cover the Front Enclosure. Make sure the all cables are arrange well. See the figure 4.3.3.4 3. Tighten four screws into each side of Front Enclosure. 4.3.4. PCB Replacement 4.3.4.1 HH PCB 4.3.4.2 Main PCB Figure 4.3.4.1.1 Steps for disassembly: 1. Open the iCH auto&plus. See Section 4.3.3 2. Disconnect the HH Cable from the connector of HH PCB on the “T“ Shape Frame and remove the two screws to replace the HH PCB. (figure 4.3.4.1.1) Steps for reassembly: 1. Place the HH PCB into the “T“ Shape Frame. Note: Replacement must be made in antistatic environment to prevent the PCB damage from the static electricity. Figure 4.3.4.2.1 Steps for disassembly: 1. Open the iCH auto&plus. See Section 4.3.3 2. Take out the Blower Module (see section 4.3.3). 3. Disconnect the Blower Cable from the Main PCB and PCB Connect Cable (Figure 4.3.4.2.1) and remove the three screws to replace the Main PCB. Steps for reassembly: 2. Use a screwdriver to tighten two screws into both side of the PCB. 3. Connect the Heater Cable to the connector of HH PCB. Figure 4.3.4.2.2 antistatic environment to prevent the PCB damage from the static electricity. Steps for reassembly: Figure 4.3.4.2.3 1.Use a screwdriver to tighten three screws into each side of the Main PCB. 2.Connect the Blower Cable to the connector of Main PCB and set the blower cable.(figure 4.3.4.2.3) 3.Connect the FFC Cable to the connector of Main PCB and place the FFC on top of the HH PCB. (figure 4.3.4.2.5) 4.3.4.3. Blue Light PCB Figure 4.3.4.2.4 Figure 4.3.4.2.5 Steps for disassembly: 1. See the figure 4.3.4.2.2 to set the blower cable. 2. Place the PCB into the Top Enclosure of Blower Module, and align the PCB with the mounting posts. Note: Replacement must be made in Figure 4.3.4.3.1 Steps for disassembly: 1.Remove the four screws to disassembly the “T“ Shape Frame and the Bottom Plate. (figure 4.3.4.3.1) 2. Disassembly the Aluminum Plate and remove the two screws of both side Blue Light PCB. (figure 4.3.4.3.1) Note: Replacement must be made in antistatic environment to prevent the PCB damage from the static electricity. Steps for reassembly: 1.Use a screwdriver to tighten two screws in both side of the Blue Light PCB. 2. Arrange the line into the Bottom Plate rip (see the figure 4.3.4.3.2), and put the Aluminum Plate and the “T“ Shape Frame back and tighten the four screws. Figure 4.3.4.4.2 Steps for disassembly: 1. Disconnect the LCM FPC and disassembly the Panel Button PCB.(see the figure 4.3.4.4.1 & 4.3.4.4.2) Steps for reassembly: Figute 4.3.4.3.2 4.3.4.4 Panel Button PCB Figure 4.3.4.4.3 Figure 4.3.4.4.1 1.Put the Panel Button PCB back and connect the LCM FPC into the connector. 4.3.5. Blower Replacement Steps for disassembly: 1. Remove the four screws to disassembly the Blower Module. See Section 4.3.5.1 2. Separate the Blower and the Silicone Outlet Tube. 3. Separate the Damper from the blower. Figure 4.3.5.1 Steps for reassembly: 1. Connect the Silicone Outlet Tube to the Blower and put the Blower back on the Foam. 2. Make sure the blower location pin is fix in the Foam. 3. Put the Damper back and arrangement the Blower control wire.(see the figure 4.3.5.2) Figure 4.3.5.2 Figure 4.3.5.3 4. Use a screwdriver to tighten four screws of the Blower Module 4.3.6. Air Filter Replacement Steps for disassembly : 1. Take out filter from the back of iCH auto&plus.(Figure 4.3.6.1) Caution: Replace a dirty or obstructive filter may cause higher temperature of the device or/and damage device. Steps for reassembly: Figure 4.3.6.1 1. Put new or clear filter into the iCH auto&plusi. Notes: Clean the filter by rinsing it in a steady stream of water. Allow filter air dry on a rack. Dot not expose it under sunlight. Caution: When replace the filter, it must be completely dry before use. 4.4 Pressure Calibration Procedure 4.4.1. Attention Points The iCH auto&plus must perfom the pressure calibration procedure after finishing any repair. Before performing the pressure calibration procedure, the technician must make sure that all required tools have to be calibrated. 4.4.2. Tool Required The required tools are listed below: 1. Personal Computer 1 PCS 2. USB Cables(A-type M to mini 5P) 1 PCS 3. Tube 4. Manometer(for CPAP Test Purpose) 1 PCS 1 PCS 4.4.3. Calibration Procedure The calibration procedure is described below: 1. Plug the DC Power Cord into the iCH auto or iCH plus. 2. Before the Standby appear. Press the two buttons ”UP” and “DOWN” at the same time, then you will get in the Pressure Calibration Mode. 3. Press “START“ key to start the Calibration. 4. See the pressure value on the manometer. Press “DOWN” key while the pressure value is higher than 10 cmH2O. In contrast, press “UP” key while the pressure value is lower than 10 cmH2O. 5. Press “MENU” key to check the flow sensor (the pressure will rise to 18cmH2O) and disconnect the DC Power Cord to leave the Calibration Mode. 6. Now, the iCH auto&plus will display Standby mode on LCD panel. 4.5 Download the Compliance Meter and Total Meter Data Please refer to Easy Compliance 3.0 CPAP Data Management Software instruction. If you need to re-set compliance meter & total meter, see section 2.4. NOTE – 1. When the warning message appears, contact your equipment provider to download the memory data and reset the meter. 2. When the compliance meter has been cleared, the total meter will also be cleared at the same time, and vice versa. CAUTION – Do not connect the device to the personal computer for data downloading during the treatment. This may cause the CPAP system failure. APEX Medical Corporation 9, Min Sheng St. Tu-Cheng, Taipei county, 236, Taiwan, R.O.C TEL:886-2-22683100 FAX-886-2-22686525 http://www.apexmedical.com.tw