FCC ID: 2AHD3-ICH2JP Bluetooth 4.0 Dongle

iCH Auto/English 1 iCH Auto with Bluetooth CPAP System Instruction Manual iCH Auto/English 2

Table of Content English Users manual................................................................ P. 1 APEX MEDICAL S.L. Elcano 9, 6a planta 48008 Bilbao. Vizcaya. Spain APEX MEDICAL CORP. No.9, Min Sheng St., Tu-Cheng, New Taipei City, 23679, Taiwan www.apexmedicalcorp.com Print-2016/All rights reserved iCH Auto/English 3 Model No.: 9S-007301 Please read the instruction manual before use. IMPORTANT SAFEGUARDS SAVE THESE INSTRUCTIONS READ ALL INSTRUCTIONS BEFORE USING WARNING 1. THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT. It may stop operating due to power 2. interruption without hazard to patient. If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use. Explanation of the Warning: When the device is not in operation and the oxygen flow is left on, oxygen delivered into the tubing may accumulate within the device and create a risk of fire. flame. 3. Oxygen is inflammable. Oxygen should not be used while smoking or in the presence of an open 4. Always ensure the device is generating airflow before the oxygen supply is turned on. Always turn 5. This device should not be used in the vicinity of a flammable anaesthetic mixture in combination off the oxygen supply before stopping the airflow from the device. with oxygen or air and nitrous oxide. 6. The airflow for breathing generated by this device may be as much as 7C (12.6F) higher than the room temperature. This device should not be used if the room temperature is warmer than 35C

(95F) to prevent the airflow temperature from exceeding 40C (104F) and causing irritation to your airway. If this device overheats, it will stop operating and show message Error 002 on the display. After cooling down to the proper temperature, the device can be restarted. 7. 8. This machine should be used only with masks (and connectors) recommended by the manufacturer, or by your doctor or respiratory therapist. A mask should not be used unless the CPAP machine is turned on and operating properly. The vent holes for the mask should never be blocked, to allow for proper exhaling. If the vent hole is blocked, the CPAP machine will stop and show message Error 002. After the machine cools down, please re-connect the power cord to reset the machine. 9. At low CPAP pressure, some exhaled gas may remain in the mask and be breathed in again. CAUTION 1. Make sure the area 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. An extremely cold or hot environment may damage the user's respiratory airway. 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. 3. Do not connect the device to the personal computer for data downloading during the treatment. 676038-0000 V1.1 This may cause a failure in the CPAP system. 4. To prevent from potential allergic reactions to mask used in the device, This machine shall be used only with masks (and connectors) recommended by the manufacturer. iCH Auto/English 4 iCH Auto/English 25 5. U.S. Federal law restricts this device to sale by or on the order of a licensed doctor. DANGER -To reduce the risk of electrocution:

1. Always unplug this product immediately after using. 2. Do not use while bathing. 3. Do not place or store product where it can fall or be pulled into a tub or sink. 4. Do not place in or drop into water or other liquid. 5. Do not reach for a product that has fallen into water. Unplug immediately. 6. If product falls into water or other liquids do not reach into the water or other liquids. Unplug immediately. WARNING -To reduce the risk of burns, electrocution, fire or injury to persons:

1. This product should never be left unattended when plugged in. 2. Close supervision is necessary when this product is used with or near children or invalids. Choking resulting from a child swallowing a small part that has become detached from the device or its accessories. 3. Use this product only for its intended use as described in this manual, do not use attachments not recommended by the manufacturer. 4. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water. Return the product to a service centre for examination and repair. 5. Keep the cord away from heated surfaces. 6. Never block the air openings of this product or place it on a soft surface, such as a bed or couch, where the air openings may be blocked. Keep the air opening free of lint, hair, and other similar particles. 7. Never drop or insert any object into any opening or hose. 8. Follow the national requirementfor disposing of the unit. 9. Do not operate the device before the mask and water chamber have been installed. 10. Disconnect the water chamber from the device when not in use, water entering the device may result in electric shock hazard or damage. 11. Do not use if water comes in contact with the device or enters the tubing. 12. This device is not for use with patients whose supraglottic airways have been bypassed. 13. Do not cover the device with blankets or clothes . 14. Do not remove water chamber while humidifier is heating. Do not touch the heater plate for 30 minutes after the device is disconnected from the mains. 15. No modification of this equipment is allowed. 16. Do not modify this equipment without authorization of the manufacturer. 17. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. 18. Do not leave long lengths of air tubing around the top of your bed. It could twist around your head or neck while you are sleeping and lead to strangulation. Recommended separation distances between portable and mobile RF communications equipment and this device This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 80 MHz to 800 MHz d 2.1=

P 800 MHz to 2,5 GHz d 3.2=

P P 2.1=

150 kHz to 80 MHz d 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 0.01 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters

(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. iCH Auto/English 24 iCH Auto/English 5 Compliance Electromagnetic Environment-Guidance Guidance and Manufacturers Declaration- Electromagnetic Immunity:

This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test IEC60601 test level 3Vrms150 kHz to 80 MHz outside ISM bandsa 3 V/m 80 MHz to 2.5 GHz Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3Vrms 3V/m 2.1=

3.2=

P P P 2.1=

150kHz to 80MHz 80MHz to 800MHz 800 MHz to 2.5G MHz Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d d d Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey c, should be less than the compliance level in each frequency ranged. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges. c) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 1. Introduction 1.1 General Information This manual should be used for initial set up of the system and saved for reference purpose. 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. 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 builds up to treatment level. The user compliance meter records the total systems operating time for physicians reference. The system has been tested and successfully approved to the following standards:

IEC/EN 60601-1 IEC/EN 60601-1-2 IEC/EN 61000-3-2 Class A IEC/EN 61000-3-3 CISPR 11 Group 1, Class B For US and CANADA only E348970 53DG Medical Equipment- CPAP WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008) The below description for is for Canada only Le produit t test avec des quipements mdicaux et respecte les normes ANSI/AAMI ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008). prvenant les choc lectrique, le feu et les risques de blessures physiques. iCH Auto/English 6 iCH Auto/English 23 Power frequency

(50/60Hz) magnetic field IEC61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to the application of the test level Federal Communication Commission Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:

. Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. FCC Caution: To assure continued compliance, any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. (Example - use only shielded interface cables when connecting to computer or peripheral devices). FCC Radiation Exposure Statement This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 0.5 centimeters between the radiator and your body. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. iCH Auto/English 22 iCH Auto/English 7 Appendix A: EMC Information Guidance and Manufacturers Declaration- Electromagnetic Emissions:

This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test Electromagnetic Environment-Guidance Compliance RF emissions CISPR 11 Group1 RF emissions CISPR 11 Class B The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network. Class A Complies Harmonic emissions IEC61000-3-2 Voltage fluctuations /

Flicker emissions IEC61000-3-3 Guidance and Manufacturers Declaration- Electromagnetic Immunity:

This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test Electromagnetic Environment-Guidance Compliance Electrostatic Discharge(ESD) IEC61000-4-2 Electrical fast transient/

burst IEC61000-4-4 Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11 IEC60601 test level 6kV contact 8kV air 2kV for power supply line 1kV for input/out line 1 kV line(s) to line(s) 2 kV line(s) to earth

<5 % UT(>95 %

dip in UT)for 0,5 cycle 40 % UT(60 % dip in UT)for 5 cycles 70 % UT(30 % dip in UT)for 25 cycles

<5 % UT(>95 %

dip in UT)for 5 sec Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of this device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery. 6kV contact 8kV air 2kV for power supply line 1kV for input/out line 1 kV line(s) to line(s)

<5 % UT(>95 %

dip in UT) for 0,5 cycle 40 % UT(60 % dip in UT) for 5 cycles 70 % UT(30 % dip in UT) for 25 cycles

<5 % UT(>95 %

dip in UT) for 5 sec EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices to the IEC/EN 60601-1-2. 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 to an outlet on a circuit different from that to which the other device(s) are

- Consult the manufacturer or field service technician for help. connected. 1.2 Intended Use This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated heated humidifier is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience. Cautions: Some patients might have pre-existing contraindications for CPAP therapy, or might experience some potential side effects of using a CPAP device. Please consult your doctor if you have any questions concerning your therapy. NOTE: Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. 1.3 Contraindications Studies have shown that the following pre-existing conditions may contraindicate the use of CPAP therapy for some patients. Should you have any of these conditions, your physician will determine if CPAP therapy is appropriate for you.

Bullous lung disease

Pneumothorax

Pathologically low blood pressure due to or associated with intravascular volume depletion

Severe cardiac arrhythmias or coronary artery disease

Stroke

Seizures

Penumocephalus has been reported in a patient using nasal Continuous Airway pressure iCH Auto/English 8 iCH Auto/English 21 2. Product Description 2.1 Unpacking the Contents Components include:

(1) Main CPAP device with integrated heated humidifier

(2) Power supply adapter and AC power cord

(3) User manual

(4) Flexible air tubing, 1.8 m length

(5) Carrying bag

(6) Bluetooth module 10. Servicing The iCH series systems are intended to provide safe and reliable operation according to the instructions provided by Apex Medical. Apex Medical recommends that the iCH system be inspected and serviced by authorized technicians if there is any sign of wear or concern with device function. Otherwise, service and inspection of the devices generally should not be required during the five year design life of the device. 11. Limited Warranty Apex Medical Corp. (hereafter Apex) gives the customer a limited manufacturer warranty on new original Apex products and any replacement part fitted by Apex in accordance with the warranty conditions applicable to the product in question and in accordance with the warranty periods from date of purchase as listed below. This warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects not related to material or workmanship. To exercise your rights under this warranty, please contact your local, authorized Apex dealer. NOTE: Warranty is only valid in the country of purchase. Product CPAP devices (including external power supply units) Water chamber Mask systems Disposable products Warranty period 2 years 6 months 6 months None CAUTION: Patient should not connect the device to a personal computer for data downloading. This may cause the CPAP system failure. To secure contents inside, the device and accessories are bundled in a paper packaged box. Unpack this box by removing the device and accessories and check for any damage, which may have occurred during shipping. If there are damages, please contact your dealer immediately. LCD Display 2.2 System Overview 1. 2. Up & Down Button 3. Start/Standby Button 4. Menu Button 5. Bluetooth module 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 4 8 9 10 11 14 1 2 3 5 6 7 12 13 20 iCH Auto/English 9 BF symbol, which indicated this product is according to the degree of protecting against electric shock for type BF equipment. 3. Installation 3.1 Disassembling the Water Chamber iCH Auto/English Symbols Attention, should read the instructions. Refer to instruction manual Attention, should read the instructions. Class II Protected against solid foreign objects of 12.5 mm and greater; Protected against vertically falling water drops. 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 9. NOTE, CAUTION, AND WARNING STATEMENTS NOTE: Indicates information that you should pay special attention to. CAUTION:

Indicates correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property. WARNING: Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury. 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 3-1. Remove the water chamber from the system. 3. Unlock the water chamber by pulling the tab as shown in Figure 3-2. Remove the chamber lid from the base. 3.2 Filling the Water Chamber Figure 3-1 Figure 3-2 1. Fill the chamber to the fill line with distilled water (approx. 300 ml), as shown in 2. Figure 3-3. If the silicon gasket has been removed, replace it securely on the top edge of the water chamber base. Otherwise, the device will not deliver air properly. 3. Position the water chamber on the heater plate and push the bottom forward to lock it in place, as shown in Figure 3-4. Make sure the silicon connector on the inlet connector fits securely over the CPAP device air outlet. CAUTION: Do not overfill the water chamber. Damage to the device may occur. CAUTION: Use only room temperature water; do not fill the chamber with hot or chilled water. CAUTION: Do not turn the heater on without the water chamber installed CAUTION: When installing the water chamber, do not allow water to spill into the device. CAUTION: Do not move the device when the chamber has water in it. Figure 3-3 Figure 3-4 10 iCH Auto/English 19 iCH Auto/English 3.3 Setting Up 1. Place the device on a flat surface and at a lower level than your sleeping position. 2. Connect one end of the air tubing firmly to the air outlet on the back of the device, as shown in Figure 3-5. 3. Connect the other end of the air tubing to the mask system. Put on the mask and headgear according to the mask instruction manual. 4. Plug the socket end of the AC power cord into the power supply adapter. Plug the pronged end of the AC power cord into a main electrical outlet. 5. Plug the power supply cords adapter connector into the power inlet on the right side of the device, as shown in Figure 3-6. 6. Once the power supply cords adapter connector is plugged into the power inlet, the CPAP system is in ready to operate position (STANDBY sign appears in LCD display) NOTE: The AC power cord also serves to disconnect the device. NOTE: Do not position the equipment so that it is difficult to operate the disconnecting device. Figure 3-5 Figure 3-6 8. Technical Specifications Item Power Supply Power Adapter Pressure Range Operating Altitude Dimensions (W x D x H) Weight Sound Level Water Capacity Heater Settings Pressure Drop Humidity Output:

Specifications 60W, DC 24V, 2.5A DELTA ELECTRONICS, Model No.: MDS-060BAS24 A Input: AC 100~240VAC, 50/60Hz 4 6.5 cmH2O (adjustable in 0.5 cmH2O increments) up to 8,000 ft (2,438 m) 16.5 x 19.7 x 17.6 cm 1.14 kg

< 28 dBA at 10 cmH2O, 1 meter distance 300ml 1 to 6 from 40C-70C 0.2cmH2O @ 60LPM 10 mgH2O/L

(Ambient temperature: 23C 2C & Relative humidity: 60% 15%) Temperature Operating: +5C to +35C (+41F to +95F) Environment Humidity Classification Storage: -15C to 50C (+5F to +122F) Shipping: -15C to 70C (+5F to +158F) Operating: 15%RH to 95%RH non-condensing Storage: 10%RH to 90%RH non-condensing Shipping: 10%RH to 90%RH non-condensing Class II Type BF, Applied Parts: Mask Not suitable for use in the presence of a flammable anaesthetic mixture IP21: Protected against solid foreign objects of 12.5 mm and greater;

Protected against vertically falling water drops. Continuous operation. Note: the manufacturer reserves the right to modify the specifications without notice. iCH Auto/English 18 iCH Auto/English 11 3. Flexible tube is blocked. 1. The heater plate setting is too 3. Unblock the flexible tube. 1. Adjust the control knob to low correctly. right. high. Condensation in mask or flexible tube Water Leakage 2. The operating environment or position of heated humidifier is not correct. The temperature close to mask or flexible tube is low. 1. Water chamber is not properly assembled. 2. Water chamber worn out. temperature setting. 2. Remove any air conditioner which may nearby the heated humidifier. Or keep room temperature up near 25C 1. Remove the water chamber from the heated humidifier, pour out the water and reassemble the water chamber again, making sure water chamber closes securely, and fill the water till it reaches fill line and check if it still leaks or not. 2. Replace with a new water chamber. Error / Warning Messages shown on LCD Message type Error:

Primary function cant execute. Definition Error for abnormal system settings Error for flow generator failure Error for abnormal timer setting or timer failure Error for flow sensor failure Error for heater failure (thermal fuse blows off) Out of system memory System memory is nearly full Warning:

Message in LCD Error 001 Error 002 Error 003 Error 004 Error 005 Warn 001 Warn 002 NOTE: When the warning message appears, contact your doctor or equipment provider to download the memory data and reset the meter. 4. Operation NOTE: Always read the operating instructions before use. 4.1 Control Panel Description Buttons on control panel and main use of the buttons:

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] or [ XX.X hPa] in cmH2O or hPa unit. MENU Press the "MENU" button to enter the setting mode when device is in standby mode. The adjustment setting includes alarm ON/OFF, clock alarm 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 4.3 Function Description section for detailed information. UP Press the "UP" button to increase the selected value. DOWN Press the "DOWN" button to decrease the selected value. iCH Auto/English 12 iCH Auto/English 17 4.2 Function Description Getting Started First time use. For first-time use, follow the steps below:

1. Make sure that your package contains a face or nasal mask with headgear. If not, your care provider can recommend the type of mask and headgear you must obtain 2. Attach tubing and mask (see Setup section). 3. Attach power cord to the unit and an electrical outlet (see Setup section). Unit will power-on automatically. 4. Press the START/STANDBY button Airflow to the mask will begin. 5. You can now place the Headgear and Mask over your head and face and begin treatment. 4.3 Menu Button - Option Description

(1) Pressure Unit The first selection of pressing "MENU" button is to set Pressure Unit [cmH2O / hPa] menu, press "UP" or "DOWN" button to set the preferred pressure unit and press "MENU" for confirmation. There are two pressure unit, cmH2O and hPa.

(2) Compliance Meter

(3) Alarm Press "MENU" button to select the [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 doctor. Press "MENU" button to select the [Alarm on/off] menu, and press "UP" or "DOWN" button to set the alarm on or off. When the alarm is turned on, the audible alarm will activate with warning messages shown on the LCD display. Set alarm off to mute the audible alarm.

(4) Clock Alarm Press "MENU" button to select the [Clock Alarm on/off] menu and press "UP" or "DOWN"

button to set the clock alarm on or off. When the 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.

(5) Clock Press "MENU" button to select the [Clock XX:XX] menu, press "UP" or "DOWN" button to set the current time. NOTE: If you set a new time that occurs in the past then the "Invalid Data" which does not exist for this new period would be erased.

(6) Turning off the Device Remove the power cord from the electrical outlet, and disconnect power cord from the power socket on the right side of the device. NOTE: Once the setting is confirmed, press the MENU button. Otherwise, the device will automatically go back to standby without saving the modification if no action is taken in 20 seconds. NOTE: Please follow national requirements to dispose of the unit properly. 6.4 Water Chamber 1. Turn the heater off and allow the heater and water to cool. 2. Disconnect the flexible tubing from the water chamber. Place thumb on the top of the water chamber and lift it to separate it from the system. Open the chamber and empty the remaining water. 3. Use a mild detergent to wash all the chamber parts. Rinse all the parts with clear water and allow them to air dry. 4. All items of the chamber are subject to normal wear and tear and may eventually be replaced. Replace the chamber parts if any damage is present. 7. Troubleshooting The table below lists troubleshooting solutions for the problems that may happen. If the problem persists, contact your equipment providers service agent. Possible Causes Solutions Problem No display Display code incorrect 1. The power cord is not connected 1. Ensure the power cord is 2. LCD failure or controlled PCB 2. Contact your equipment provider to the power socket. failure. connected. for repair. LCD failure or controlled PCB failure. Contact your equipment provider for Illuminator under LCD is not on Buttons do not work LED failure Button failure Air delivered is slow 1. During ramp time. 2. Filter is too dirty. 3. Flow generator failure. repair. Contact your equipment provider for repair. Contact your equipment provider for repair. 1. Check the ramp time setting 2. Change or clean the filter 3. Contact your equipment provider regularly. for repair. working AC outlet. 2. See Set up procedure and turn the power on. 3. Contact your local agent or EU representative for service. 4. Contact your local agent or EU representative for service. 1. Contact your local agent or EU representative for service. 2. Contact your local agent or EU representative for service. 1. Power cord not plugged into a 1. Plug in the power cord to a Integrated humidifier power on indicator not lit up working AC outlet. 2. Power switch is not turned on 3. PCB or indicator worn out 4. Fuse blown Heater on indicator not lit at all 1. Heater plate over heating 2. PCB indicator worn out There is no air flow through the mask 1. Device is not turned on or working 1. Check the power cord is correctly connected properly. 2. Flexible tubing is not connected 2. Reconnect the flexible tubing iCH Auto/English 16 iCH Auto/English 13 an authorized service agent. Do not drop any object into the air tube or air outlet. 6.2 Tubing and Mask The tubing and mask should be checked and cleaned regularly. Please refer to the cleaning instruction s that come with the accessories. 1. Disconnect the air tubing from the air outlet of the device. 2. Remove the air tubing and headgear straps from the mask. 3. Wash the mask system according to the instructions supplied with it. 4. Wash the air tubing in warm water using mild detergent. Rinse thoroughly, hang and allow to dry. 5. Before next use, assemble the mask and headgear according to the mask user instructions. 6. All items of the mask and air tubing are subject to normal wear and tear and may eventually be replaced. Replace the mask and the air tubing if they are damaged. CAUTION: Do not use bleach, chlorine-, alcohol-, or aromatic-based (including all scented oil moisturizing or antibacterial soaps to clean the cushion, mask or air tubing. These solu may cause hardening and reduce the life of the product. CAUTION: Do not wash or dry the mask or air tubing at a temperature above 70C (160F) WARNING: Do not use any cleaner containing fragrance or conditioners as they will leave a residue.

(7) Compliance Information Hold "UP" and "DOWN" button to read compliance information while in the standby screen. Press START/STANDBY button to go back to standby screen i. Period When entering the compliance information mode, the LCD screen should start blinking to allow you to select the period. Press "UP" or "DOWN" button to select the period from 1 day to 90 days. After selecting the period, press "MENU" to confirm. Press DOWN button to read more compliance information. ii. Usage Hours / Compliance Hours The Usage Hours [XXX hrs] records the therapy hours under the set time frame. Press MENU button to reselect the time frame, or press DOWN button to read more compliance information. iii. Average Compliance Hours per day The Average Compliance Hours per day [X.X hrs/d] records the average compliance hours per day over the different time frame. Press "UP" or "DOWN"

button to read last or next compliance information. iv. Days4 Hours The Days4 Hours [4 X.X d] records the cumulative number of days that exceeded 4 hours over the different time frame. Press "UP" or "DOWN" button to read last or next compliance information. v. AHI The [AHI XX.X] records the average Apnea Hypopnea Index (AHI) over the different time frame. Press "UP" or "DOWN" button to read last or next compliance information. WARNING: The mask must not be re-used by another person. This is to avoid the risk of vi. Average Pressure cross-infection. 6.3 Air Filter For an optimum operation of the device, the air filter can be cleaned by the user at least once every two weeks or more often if this device is operated in a dusty environment. It is recommended that the filter be replaced with a new one after 6 months of use; however, depending on the air quality, the replacement time may vary. 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. The [P XX.XcmH2O] or [P XX.XhPa] records the average pressure over the different time frame. Press "UP" or "DOWN" button to read last or next compliance information. vii. Average Leak Rate The [Leak XX.X lpm] records the average leak over the different time frame. Press

"UP" button to read last or next compliance information or press "MENU" to come back to the main menu. iCH Auto/English 14 iCH Auto/English 15 4.4 Flowchart of Menu settings 4.6 Using the heated humidifier Enter the user's menu mode by pressing the MENU button. APAP Pressure Unit

< cmH2O / hPa >

CM Alarm

(Compliance Meter)

< xxxx.x > hr In each setting, when the preferred value has been selected, press "MENU" for confirmation and press "MENU" again to enter next selection. Clock Alarm <On>

Clock Alarm

< hh:mm >

< hh:mm >

< on/off >

< on/off >

Clock 4.5 Flowchart of Compliance Information reading Period

(Time Frame)

< 1 d /7d / 30 d / 90 d>

Usage Hours

< xxx > hrs Average Compliance Hours per day

< x.x > hrs /d

4

(Days4hrs)

< xx > d

AHI

< xx.x >

P

Leak

(Average Pressure)

< xx.x > cmH2O/hPa

(Average Leak Rate)

< xx.x > lpm 1. Turn the control knob on the back of the device to turn on the heater and the heater on indicator above the knob will light up (orange light), as shown in Figure 4-1 Figure 4-1 2. Adjust the control knob to increase the humidity in the range of 1 to 6 (see 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 damage to 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 maximum mark after the water chamber is removed from the device. 5. Bluetooth Function With Bluetooth module, this device has Bluetooth function. You can pair the therapy device to a mobile device that has the APEX App. APEX App is an App which can help Obstrucitve Sleep Apnea patients enhance their sleep therapy experience. 5.1 Pairing with an enabled Mobile Device Follow the steps to manually pair with your mobile phone 1. Connect your Bluetooth module to the miniUSB port 2. 3. Open our APEX App and choose the APEX device on your mobile phone BT ON will be shown on the screen NOTE:Paring works best when your device and mobile device are in the same room NOTE:You can only pair your therapy device to one mobile device at any given time. 6. Cleaning & Maintenance 6.1 Device The device should be checked and dusted regularly (at least every 30 days). Wipe with a damp cloth and a mild detergent and keep it free from dust. If other detergent is used, choose one that will have no chemical effects on the surface of the plastic case. All parts should be air-dried thoroughly before use. Inspect the device and all circuit parts for any damage after cleaning and replace if necessary. WARNING: Dont try to open this device. Repairs and internal servicing should only performed by