XT Auto_Service_Manual

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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
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