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Summary of Contents for Apex Digital iX Series

  • Page 2 Version History: Revision Project Code Ver. Revised Content Note Date (ECR、Variation A~D) 2021.2 New release. New Release 2021.5 Add contents and revised Troubleshooting...
  • Page 3: Table Of Contents

    7-2 iX Fit / Sense Pressure Test ............................42 7-3 iX Auto Pressure Calibration ............................45 7-4 iX Auto Pressure Test ............................... 48 7-5 iX Series functional verification ............................ 51 Chapter 8. Reset Total Meter ................................. 56 Applicable Model: iX Sense / iX Fit ..........................56 Applicable Model : iX Auto ...............................
  • Page 4 Applicable Model: iX Auto (4G with Wi-Fi version) ....................61 Applicable Model: iX Auto(without 4G) ......................... 63 Applicable Model: iX Heating Humidifier ........................65 For customer optional purchase Accessory Parts < > ....................65 Applicable Model: iX Fit / Sense / Auto ........................65 Chapter 10.
  • Page 5: Chapter 1: Introduction & Intended Use

    CHAPTER 1: Introduction & Intended Use This device is intended to provide continuous positive airway pressure ( CPAP ) for the treatment of adult Obstructive Sleep Apnea ( OSA ) in spontaneously breathing patients weighing over 30 kg ( 66 lbs. ). It is for use in the home or hospital / institutional environment.
  • Page 6: Chapter 2: Warning & Cautions

    CHAPTER 2: Warning & Cautions 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.
  • Page 7 14. Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or permits spontaneous breathing can cause asphyxiation.  CAUTION – Reducing the risk of damage to the device. Mobile RF communications equipment can affect medical electrical equipment. Ensure that the SD card sealed cover and filter back cover are both closed whenever any of the accessories are not installed.
  • Page 8: Chapter 3: Theory Of Operation

    CHAPTER 3: Theory of Operation...
  • Page 9: Chapter 4: Maintenance

    CHAPTER 4: Maintenance 4-1. Cleaning of the Device The device should be checked and dusted regularly at least every 30 days. Pull out the plug from the device. Wipe the outside of device with a cloth dampened with water and mild detergent Device should be air-dried thoroughly before use.
  • Page 10: Replace Air Filter

    CAUTION  Do not use bleach, chlorine-, alcohol-, or aromatic-based, which including all scented oils, moisturizing or antibacterial soaps to clean the cushion, mask or air tubing. These solutions may cause hardening and reduce the life of the product.  Do not wash or dry the mask or air tubing at a temperature above 70°C (158°F) ...
  • Page 11: Chapter 5: Troubleshooting

    CHAPTER 5: Troubleshooting It is necessary to pass the verification from APEX headquarters and get the certificate. Any unauthorized servicing or repairing will void the warranty of the product Error Code Definition Solution 1. Do not remove the humidifier Remove the Humidifier during treatment during treatment.
  • Page 12 connect item to the connected IT-network). 3. Check for connection of FFC cable if above solutions do not work <refer to 6-3>. Ensure the cellular setting is on <refer to 7-5>. Replace a new 4G SIM card for testing if the signal still remains too weak.
  • Page 13 6-4>. Replace the 4G module board if the problem still remains <refer to 6-3>. Check for if there is any dirt grime or foreign debris on the 4G E100-004 SIM Card is not plug in module board. Re-plug 4G SIM card. Check if the heating humidifier connects...
  • Page 14 1. Check if flow sensor properly connects and check if any damage E101-05 Abnormal flow sensor on the flow sensor tube. 2. Replace the flow sensor tube <refer to 6-3>. 1. Replace the heating plate if the problem remains the same <refer to Humidifier Overheat ->...
  • Page 15 Low P icon Low Pressure Make sure the mask is properly fit on the user’s face. Check the condition of the tubing and connect it properly. Check if pressure & flow sensor tube connects properly. Check if any damage on the pressure &...
  • Page 16 might need to use a new SD card. 1. Device is not turned on or working Check the power cord is connected There is no air correctly properly. flow through 2. Heated tubing is not connected Reconnect the heated tubing correctly. the mask correctly.
  • Page 17 device. interfere by adding new item/disconnect item to the connected IT-network. Turn off Airplane Mode Re-plug and the device will automatically re-upload data.
  • Page 18: Chapter 6: Component Removal & Installation

    CHAPTER 6: Component Removal & Installation It is necessary to pass the verification from APEX headquarters and get the certificate. Any unauthorized servicing or repairing will void the warranty of the product. 6-1. Open the Top cover Applicable Model: iX Fit / iX Sense / iX Auto Disassembly Steps: ...
  • Page 19: Lcd Display

    6-2. LCD Display Applicable Model : iX Auto Disassembly Steps: 1. Remove the 4 screws under the bottom and top cover can be separated <Refer to 6.1>. 2. Squeeze both sides of the screen bracket and make 2 buckles under the screen separately. 3.
  • Page 20: Mainboard

    Mainboard 6-3. Applicable Model: iX Fit Disassembly Steps: 1. Remove the 4 screws under the bottom and top cover can be separated < Refer to 6.1 >. 2. Pull up the mainboard upward and disconnect all the cables from the mainboard (Heating Humidifier / Blower / DC cord).
  • Page 21: Applicable Model : Ix Sense

    Applicable Model : iX Sense Disassembly Steps: 1. Remove the 4 screws under the bottom and top cover can be separated <Refer to 6.1>. 2. Remove the Wi-Fi FFC cable. 3. Pull up the mainboard upward and disconnect all the cables from the mainboard (Heating Humidifier / Blower / DC cord/Sensor tube).
  • Page 22 3. Make sure the Wi-Fi Flat Flexible cable pass through the outer slot on the board and buckle up securely. 4. Check if the flow sensor tubes are properly connected. 5. Make sure the Wi-Fi FFC cable pass through the outer slot on the board. The connector should also be closed tightly.
  • Page 23: Applicable Model: Ix Auto

    Applicable Model: iX Auto Disassembly Steps: 1. Remove the 4 screws under the bottom and top cover can be separated <Refer to 6.1>. 2. Please remove the Wi-Fi FFC cable. 3. Pull up the mainboard upward and make sure the sensor tube should be separated from the device. 4.
  • Page 24 Assembly Steps: Before connecting the 4G module cable, the cable should be followed the direction of the groove as picture below 2. Connect the 4G module cable. While connecting the 4G module cable, please align the side that shows CON2. It should hear the sound of “click” after connecting. 3.
  • Page 25 5. Check the flow sensor tube should connect to the bottom. 6. Make sure the Wi-Fi FFC cables pass through the outer slot on the board and the FFC cable should be assembled under the LCD display. The connectors should be closed tightly. 7.
  • Page 26: Sd Module

    6-4. 4G & SD Module Applicable Model : IX Sense ( SD Module ) / IX Auto (4G/wireless+ SD Module ) Disassembly Steps: 1. Remove the 4 screws under the bottom and then the top cover can be separated <Refer to 6.1>. 2.
  • Page 27 7. The 4G and SD module board can be removed after loosening the 2 screws that beside the 4G module. While in the process of loosening the screws, use a needle-nose plier to hole the hex nuts and separate the components as picture below. Assembly Steps: ...
  • Page 28: Blower & Air Path Module

    Assembly Notes: 4G/wireless+ SD Module Make sure the direction of the front and back should be correct as picture below The Service BOM also provides the whole components as F697C01-0000 for iX Auto and F697C03-0000 for iX Sense <refer to Ch.9>. 6-5.
  • Page 29 5. After removing the non-slip pad, then remove the 2 screws. Remove the 5 screws from the cover of blow. Use fingertips to pull out the air path module from the inside out. Pull out the blower and air path module together from the bottom, and then separate these two components.
  • Page 30: Applicable Model : Ix Sense / Ix Auto

    Applicable Model : iX Sense / iX Auto Disassembly Steps: 1. Remove the 4 screws under the bottom and top cover can be separated <Refer to 6.1>. 2. Pull up the mainboard and make the mainboard separated from device <Refer to 6.3>. 3.
  • Page 31 5. After removing the non-slip pad, then remove the 2 screws. 6. Use fingertips to pull out the air path module from the inside out. 7. Remove the 5 screws on the top cover of blower. Make sure to tear off the yellow tape which is on the 4G module cable 8.
  • Page 32 Assembly Steps Applicable Model: IX Fit/ IX Sense / IX Auto For the Blower and Air path module assembly steps, it is suitable for all the IX series <The photos are for the reference only>. 1. Connect the air path module and blower together.
  • Page 33 2. Put the blower and the air path module together back to the blower box. 3. Press down the air path module and make sure to hear the “click” sound while assembling the air path module. 4. Tighten the 2 screws and replace the 2 non-slip pads.
  • Page 34 5. Please check the direction of the outlet fixed module. 6. Assemble the silicone fixed pad, which should be a short side facing downward. While loading the pad, pay attention to the cable arrangement, and it should be parallel. 7. Make sure there is no bend or curl on the silicone lip and the internal silicone tube should be parallel to align on the line as picture below;...
  • Page 35: Wifi Board

    10. Use cable-tie to tie up the cables and make sure to tighten the cable tie if the cable tie was cut. 6-6. WIFI Board Applicable Model : iX Sense / iX Auto Auto/Sense Disassembly Steps: 1. Remove the 4 screws under the bottom and top cover can be separated. <Refer to 6.1>. 2.
  • Page 36 5. Pull up the Wi-Fi board upward. Auto / Sense Assembly Steps: According to the disassembly steps, assemble the WI-FI board in a reverse order. 1. While assembling the Wi-Fi board, make sure that matte surface screw washer is on the top. 2.
  • Page 37: Dc Jack Cable

    DC Jack cable 6-7. Applicable Model : iX Fit / iX Sense / iX Auto Disassembly Steps: 1. Remove the 4 screws under the bottom and then the device can be separated <Refer to 6.1>. 2. Pull up the mainboard and make the mainboard separated from device <Refer to 6.3>. Pull out the blower and air path module together from the bottom cover...
  • Page 38: Heated Humidifier

    6-8. Heated Humidifier Disassemble Steps ( PCBA mainboard ) Remove 5 screws beside the board. Remove 3 cables, which are heated plate cable, heated tube cable, and heated communication cable. Assemble Steps: Connect the heated plate cable. While assembling the mainboard, make sure the 5 ribs should align to the 5 holes on the board, then connect the heated tube cable and heated communication cable.
  • Page 39 Connect the heated communication cable. While in the process of connecting, pay attention not to damage the cable. Fix 5 screws beside the board. Disassemble Steps (Heated Plate): Remove the 5 screws beside the board. Remove the cable on the heated humidifier mainboard.
  • Page 40 Remove the 2 non-slip pads under the device. After removing the non-slip pad, then remove the 2 screws. Pull out the heated plate. Please observe the condition of the springs and replace if it is rusty. Assemble Steps: 1. According to the disassembly steps, assemble in a reverse order. 2.
  • Page 41: Chapter 7. Performance Verification

    Chapter 7. Performance Verification 7-1. iX Fit / Sense Pressure Calibration Purpose: Please check the pressure of calibration after replacing any electronic components. Calibration Tool: CPAP Service Kit <refer to Ch. 10>. <The picture, iX Fit, is for reference only> Interface:...
  • Page 42 Calibration Step by Step: Steps Stage Description Reference simultaneously Plug in the adopter and long press the buttons together within Engineer Step 1. 2 seconds to get into the Engineer Mode. Mode <The picture is for reference only > While the screen displays “CALJB” and press the button to start the first calibration point and Step 2.
  • Page 43: Fit / Sense Pressure Test

    Long press the button and at the same time continue to press button to enter the third Step 6. Third Point calibration point. <The picture is for reference only> Adjust the pressure value by pressing the buttons until the pressure value on pressure meter shows 20.0 cmH The pressure error value should be in 20.0 ±...
  • Page 44 Interface: Test Steps: Step 1. Plug in the adopter than press the button and switch to the setting pressure mode Step 2. Long press buttons and continue to press the button and its display will start to blink. Step 3. Adjust the pressure value by pressing the buttons until the pressure value on the pressure test point 4.0 cmH O and press...
  • Page 45 Step 5. Pull out the air tube to check whether there is a Low P alarm after finishing the final pressure test point. Step 6. Press the button again and pressure test will be completely...
  • Page 46: Auto Pressure Calibration

    7-3 iX Auto Pressure Calibration Purpose: If you found the pressure is abnormal, please do the pressure calibration. Calibration Tool: CPAP Service Kit <refer to Ch. 10>. <The picture, iX Auto, is for reference only> Interface:...
  • Page 47 Calibration Step by Step: Steps Stage Description Reference Plug in the adopter and continue to long press Engineer Button within 3 seconds to enter Step 1. Mode Engineer Mode. <The picture is for reference only > Rotate the button to select menu calibration Start mode, and then press the "Dial"...
  • Page 48 After finishing the second calibration, press the Step 7. Third Point button into the third calibration point 20.0 cmH <The picture is for reference only> Adjust the pressure value by rotating the button until the pressure value on pressure meter shows 20.0 cmH The pressure error value should be in Step 8.
  • Page 49: Auto Pressure Test

    7-4 iX Auto Pressure Test Purpose: After finishing the pressure calibration, please perform the pressure test to verify the pressure calibration. CPAP Service Kit Test Tool: <The picture, iX Auto, is for reference only> Interface: Test Steps: Step 1: After plugging in the adopter and into the main screen, long press the button first and then press the button.
  • Page 50 Step 2: After selecting the Therapy Setting Mode, press the button to select mode. Rotate the right side and select from APAP mode into CPAP mode. Step 3: After selecting the CPAP Mode, rotate the button to the right to choose therapy pressure in 4.0 cmH Note: Remember to set your ramp time at 0 to save your test time.
  • Page 51 Step 5: Pull out the air tube to check whether there is a Low P alarm after finishing the final pressure test point.
  • Page 52: Series Functional Verification

    7-5 iX Series functional verification After replacing any electrical components, the following test processes will instruct you on verifying the functions to ensure the device works properly. WI-FI functions < applied for IX series 9S-010600 and 9S-010620 > Steps Description...
  • Page 53 Cellular communication functions < Only for iX series 9S-010620 > Steps Description Reference Plug the power connector into the rear of Step 1 the device. Press the Start Menu , and select the Step 2 Setting mode. Rotate the Dial to Cellular function and...
  • Page 54 Heated humidifier commutation functions Steps Description Reference Release the bottom pad from above Step 1 without pressing the button. Connect the device with heated humidifier horizontally. Note: Please make sure the humidifier is Step 2 inserted to device completely to reach desired performance.
  • Page 55 Auto only) displayed. <The picture is only for reference>. < SD card function applied for IX series 9S-015040 and 9S-010600> Steps Description Reference Plug the power connector into the rear of the device. Connect one end of the power...
  • Page 56 Buzzer function Steps Description Reference Plug the power connector into the rear of the device. Connect one end of the power cord into Step 1 the power supply unit and the other end into the power outlet. Press the Start Menu and go into the Setting Step 2 mode.
  • Page 57: Chapter 8. Reset Total Meter

    Chapter 8. Reset Total Meter Applicable Model: iX Sense / iX Fit Step 1: Plug in the adopter to the iX Sense. Step 2: Long press the button and button, and the LCD will turn into the Rest Total Meter. Step 3: Long press the buttons and continue to press the button.
  • Page 58: Chapter 9. Reset To Default Settings

    Chapter 9. Reset to Default Settings Applicable Model : iX Auto Step 1: Plug in the adopter and press the button and enter into Engineer Mode. Step 2: Rotate the button to select the menu Reset to Default, and then press the button to start the Reset to Default.
  • Page 59: Applicable Model: Ix Sense / Fit

    Applicable Model: iX Sense / Fit Step 1: Plug in the adopter to the iX Sense. Step 2: Long press the button and button within 2 second and press button 4 times to find “rESEi” mode. Step3: Long press the buttons first and then continue to press the button.
  • Page 60: Chapter 10. Service Bom

    Chapter 10. Service BOM Service Parts: Applicable Model: iX Fit Part name Part No. Description Picture Mainboard F697B05-0000 PCBA,9S-010500_iX Fit AB3+ Blower FB075027 DC Blower,24VDC, AB-III +, ( Sensorless ) Air path module F696B03-0000 Air path module Wire,NA, CEW04030024, CHERNG WEEI, Wire 694106-0000 50+-5mm, NA, 4P, 24AWG, NA, Molex...
  • Page 61: Applicable Model: Ix Sense

    Applicable Model: iX Sense Part name Part No. Description Picture Mainboard F697B04-0000 PCBA,9S-010540_iX Sense AB3+ Blower FB075027 DC Blower,24VDC, AB-III +, ( Sensorless ) Air path module F696B02-0000 Air path module Wire,NA, CEW04030024, CHERNG WEEI, Wire 694106-0000 50+-5mm, NA, 4P, 24AWG, NA, Molex 44432-0401, RoHS Wire,NA, YBO-004, SUNSHINE, DC Jack cable...
  • Page 62: Applicable Model: Ix Auto (4G With Wi-Fi Version)

    Hose Connector 691703-0000 Hose, ABS 765B Applicable Model: iX Auto (4G with Wi-Fi version) Part name Part No. Description Picture Mainboard F697B01-0000 PCBA,9S-010660_iX Auto AB5 Blower FB075028 DC Blower,24VDC, AB-V, ( Sensorless ) Air path Module F696B01-0000 Air path module Wire,NA, CEW04030024, CHERNG WEEI, Wire 694106-0000...
  • Page 63 4G / Wireless module F697B03-0000 PCBA,9S-010_iX, 4G Wireless, w/FW PCBA mainboard, w/SD &USB,( F697B01-0000+ PCBA,9S-010660_iX Auto, w/SD & USB, F697C01-0000 F697A03-0000+ (w/4G & CSA) F697B03-0000) LCD Module 674G01-0000 LCD Module O-ring 693402-0000 O-ring ,ψ7*ψ3ψ2, black Flow Sensor tube 693602-0000 Flow Sensor tube, Silicone, 50A Silicone Tube F695A01-0000 Silicone Tube, ψ2xψ4x12mm...
  • Page 64: Applicable Model: Ix Auto(Without 4G

    Applicable Model: iX Auto(without 4G) Part name Part No. Description Picture Mainboard F697B01-0000 PCBA,9S-010660_iX Auto AB5 Blower FB075028 DC Blower,24VDC, AB-V, ( Sensorless ) Air path Module F696B01-0000 Air path module Wire,NA, CEW04030024, CHERNG WEEI, Wire 694106-0000 50+-5mm, NA, 4P, 24AWG, NA, Molex 44432-0401, RoHS Wire,NA, YBO-004, SUNSHINE, 110+-5mm, DC Jack cable...
  • Page 65 LCD Module 674G01-0000 LCD Module O-ring 693402-0000 O-ring ,ψ7*ψ3ψ2, black Flow Sensor tube 693602-0000 Flow Sensor tube, Silicone, 50A F695A01-000 Silicone Tube Silicone Tube, ψ2xψ4x12mm Hose Connector 691703-0000 Hose, ABS 765B...
  • Page 66: Applicable Model: Ix Heating Humidifier

    Applicable Model: iX Heating Humidifier Part name Part No. Description Picture Heating plate F699A02-0000 Heating plate Module Humidifier Mainboard F697B02-0000 PCBA,9S-010800_iX Humidifier,w/FW Spring 695502-0000 Spring_Humidifier, sus304 Wire , NA, CEW04030025, CHERNG Wire 694103-0000 WEEI, 35+-3mm, NA, 4P, 24AWG, NA, Molex 44133-0400, RoHS F693D01-0000 Heated Humidifiers Heated Humidifiers...
  • Page 67 Non-slip pad, silicone, black, Non-slip pad 693401-0000 Adhesive 3M9448 SIM Card,-25~85℃, NA, NA, M2MP3FF, Vodafone, SIM CARD 694902-0000 15.1*12.1mm, 182.71mm, NA, 1.62~3.3V, RoHS SD card 694901-0000 SD Card F690A04-0000 Top cover Module_IX fit Top cover Module_IX fit 691204-0000 iX Sense/Fit, ABS 765B, Bottom cover, ABS 765B Pantone 5285 F690A03-0000...
  • Page 68 CPAP Tubing 698001-0000 CPAP tubing, Gray Color, 180cm Heated Tubing, Gray, ID 15mm Tubing, LENGTH 183cm, 22F CUFF, Heated Tubing< iX Auto for 698002-0000 with a NTC Sensor & a 4-PIN optional purchase only> Connector, Packed with IFU/Label in/on a PE BAG ◎...
  • Page 69: Chapter 10. Service Kit

    Chapter 10. Service Kit Purpose: Tools required for product verification. Part name Part No. Description Picture CEM Pressure Meter Self-Purchase CEM DT-8890A pressure meter Standard resistance QA provide Standard resistance Stopper without hole QA provide Stopper without hole Silicone tube QA provide Silicone tube ( 20 cm ) ◎...

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