Apex Digital 9S-007201 Manuel utilisateur

iCH Auto CPAP System

Instruction Manual

Table of Content

User’s manual ....................................................................... P. 1

Manual de Instrucciones

......................................................

P.25

Instructions d'utilisation ...................................................... P.55

Model No.: 9S-007201, 9S-007202

Please read the instruction manual before use.

English

Español

Français

iCH Auto/ English 1

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

interruption without hazard to patient.

2. 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.

3. Oxygen is inflammable. Oxygen should not be used while smoking or in the presence of an open

flame.

4. Always ensure the device is generating airflow before the oxygen supply is turned on. Always turn

off the oxygen supply before stopping the airflow from the device.

5. This device should not be used in the vicinity of a flammable anaesthetic mixture in combination with

oxygen or air and nitrous oxide.

6. The airflow for breathing generated by this device may be as much as 7°C (12.6°F) higher than the

room temperature. This device should not be used if the room temperature is warmer than 35°C (95°F)

to prevent the airflow temperature from exceeding 40°C (104°F) and causing irritation to your airway.

7. 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.

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.

2. If there is a possibility of electro-magnetic interference with mobile phones, please increase the

distance between devices or turn off the mobile phone.

3. Do not connect the device to the personal computer for data downloading during the treatment. 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.

5. U.S. Federal law restricts this device to sale by or on the order of a licensed doctor.

iCH Auto/ English 2

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.

iCH Auto/ English 3

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 builds 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:

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

The description below is for Canada only

Le produit à été testé avec des équipements médicaux et respecte les normes ANSI/AAMI

ES60601-1 (2005)+AMD 1 (2012) and CAN / CSA C22.2 No. 60601-1 (2014).. prévenant les choc électrique, le feu et les

risques de blessures physiques.

E348970

53DG

Medical Equipment- CPAP with integrated heated humidifier

AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL

HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI

ES60601-1 (2005)

, ANSI/AAMI ES60601-1 (2005) + AMD 1

(2012), CAN/CSA-C22.2 No. 60601-1 (2008) and

CAN/CSA-C22.2 No. 60601-1 (2014)

iCH Auto/ English 4

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

connected.

- Consult the manufacturer or field service technician for help.

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

 Pneumocephalus has been reported in a patient using nasal Continuous Airway pressure

iCH Auto/ English 5

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) SD card and USB cable

NOTE: Please use a SD card (smaller than 4GB) which complies with SDHC standard. Before

using it, please format it to FAT16 to ensure correct data collection.

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.

2.2 System Overview

1. LCD Display

2. Up & Down Button

3. Start/Standby Button

4. Menu Button

5. 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. Protruding tab and groove

14. Fill Line

15. Water Chamber

16. Buckle

5

6

7

8

9

10

11

1

2

3

4

12

15

14

16

13

iCH Auto/ English 6

3.

Installation

3.1 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 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

1. Fill the chamber to the fill line with distilled

water (approx. 300 ml), as shown in Figure 3-3.

2. Follow the steps to assemble the water chamber:

2.1 Insert the protruding tab into the groove

2.2 Put the top and bottom of the water chamber together

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.

4. Follow the steps to install the chamber correctly:

4.1 Position the water chamber on the heater plate

4.2 Tilt the water chamber, align with the air outlet (Figure

3-4, 3-5)

4.3 Push downwards until you hear a click (Figure 3-6)

4.4 Lock on the buckle to secure the chamber (Figure 3-7)

Fi

g

ure 3-2Fi

g

ure 3-1

Fi

g

ure 3-3

Figure 3-6

Fi

g

ure 3-5

Fi

g

ure 3-7

Figure 3-4

iCH Auto/ English 7

NOTE: 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.

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 3-8.

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 cord’s adapter connector into the power inlet on the right side of the

device, as shown in Figure 3-9.

6. Once the power supply cord’s 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.

Fi

g

ure 3-8

Fi

g

ure 3-9

iCH Auto/ English 8

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

cmH

2

O]

or

[ XX.X

hPa]

in cmH

2

O or hPa unit.

MENU

Press the

"MENU"

button to enter the setting mode when device is in standby mode. The

adjustment setting includes ramp time selection,

ramp starting pressure, therapy

pressure adjustment, 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 9

4.2 Function Description

Getting Started – First time use.

For first-time use, follow the steps below:

1. Make sure that your doctor or care provider has initialized and configured the appropriate

treatment values into the unit.

2. Make sure that your package contains a face or nasal mask with headgear. If not, your doctor

or care provider can recommend the type of mask and headgear you must obtain

3. Attach tubing and mask (see Setup section).

4. Attach power cord to the unit and an electrical outlet (see Setup section). Unit will power-on

automatically.

5. Use the

“MENU”

button to set the Current Time, Ramp Up Time, and Ramp Starting Pressure, (see

“MENU”

Button Section for description of these options).

Note that these values may have already been set by your doctor or care provider.

6. Press the

“START/STANDBY”

button – Airflow to the mask will begin.

7. 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

[cmH

2

O / hPa]

menu, press

"UP"

or

"DOWN"

button to set the preferred pressure unit and press

"MENU"

for confirmation.

There are two pressure unit, cmH

2

O and hPa.

(2) Ramp Time

Ramp time function allows user to fall into sleep with a lower, comfortable pressure and helps

users gradually get 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.

(3) 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 4 cmH

2

O / hPa to “Therapy Pressure – 1” cmH

2

O / hPa. For example, if your

therapy pressure is 10 cmH

2

O / hPa, the maximum ramp starting pressure you can select is 9

cmH

2

O / hPa.

(4) Therapy Pressure (only CPAP mode)

Press

"MENU"

button to select the

[P XX.XcmH

2

O]

or

[P XX.XhPa]

menu. You can view the

current pressure setting displayed in cmH

2

O or hPa unit. Therapy pressure is adjustable only by

the provider, a respiratory therapist or doctor.

NOTE: The therapy pressure is to only be prescribed by a physician.

(5) Maximum Pressure (only APAP mode)

Press

"MENU"

button to select

[Max. XX.XcmH

2

O]

or

[Max. XX.XhPa]

menu, you can view the

current pressure setting displayed in cmH

2

O or hPa unit. Maximum pressure is adjustable only by

the provider, a respiratory therapist or doctor.

NOTE: The maximum pressure is only to be prescribed by a doctor.

(6) Minimum Pressure (only APAP mode)

Press

"MENU"

button to select

[Min. XX.XcmH

2

O]

or

[Min. XX.XhPa]

menu, you can view the

current pressure setting displayed in cmH

2

O or hPa unit. Minimum pressure is adjustable only by

the provider, a respiratory therapist or doctor.

iCH Auto/ English 10

NOTE: The minimum pressure is only to be prescribed by a doctor.

(7) Initial Pressure (only APAP mode)

Press

"MENU"

button to select

[Init. XX.XcmH

2

O]

or

[Init. XX.XhPa]

menu. Here you can view

the current pressure setting displayed in cmH

2

O or hPa unit. Initial pressure is adjustable only by

the provider, a respiratory therapist or doctor.

NOTE: The initial pressure is only to be prescribed by a doctor.

(8) PVA (Pressure Variation Algorithm)

Press

"MENU"

button to select

[c on/off]

menu, you can view if the PVA function is enabled by

the provider, a respiratory therapist or physician. The PVA function delivers pressure relief upon

exhalation to improve comfort. If the PVA function is enabled, press

"UP"

or

"DOWN"

button to

adjust the comfort level. There are 3 adjustable levels of pressure relief that you feel while

exhalation. Level 1 provides small pressure variation; and level 3 provides higher pressure

variation.

(9) Low Pressure Auto Off (only CPAP mode)

Press

"MENU"

button to select

[LOW P on/off]

menu, you can view if the Low Pressure Auto Off

setting is enabled and the device will be automatically turned off while detecting a large leak for

3 minutes. This setting is adjustable only by the provider, a respiratory therapist or physician.

(10) Compliance Meter

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.

(11) Alarm

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.

(12) 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.

(13) 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.

(14) 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.

iCH Auto/ English 11

(15) 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. Days＞4 Hours

The Days＞4 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.

vi. Average Pressure

The

[P XX.XcmH

2

O]

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.

(16) Check Value

Press

"MENU"

button to select

[CHXXX]

menu, which displays a check value. Your care provider

may ask for this information

iCH Auto/ English 12

4.4

Flowchart of Menu settings

Enter the user's menu mode by pressing the “

MENU

” button.

In each setting, when the preferred value has been selected, press

"MENU"

for confirmation and press

"MENU"

again to enter next selection.

NOTE: For doctors, please refer to a separate “Doctor’s Additional Instructions” manual.

APAP

Mode

CPAP

Mode

Clock

< hh:mm >

Clock Alarm <On>

< hh:mm >

CM

(Compliance Meter)

< xxxx.x > hr

Alarm

< on/off >

APAP

Max. P

(Maximum Pressure)

< 5.0 ~ 20.0 > cmH

2

O / hPa

Min. P

(Minimum Pressure)

< 4.0 ~ 19.0 > cmH

2

O / hPa

Init. P

(Initial Pressure)

< 4.0 ~ 19.0 > cmH

2

O / hPa

Pressure Unit

< cmH

2

O / hPa >

C

(PVA Comfort Level)

< on/off >

CPAP

Ram

p

(Ramp Time)

< 0 ~ 45 > min

P

(Therapy Pressure)

< 4.0 ~ 20.0 > cmH

2

O / hPa

Ram

p

P

(Ramp Starting Pressure)

<4.0~19.0>cmH

2

O / hPa

Pressure Unit

< cmH

2

O / hPa >

Low P

(Low Pressure Shut Off)

< on/off >

C

(PVA Comfort Level)

< on/off >

PVA <On>

< 0, 1, 2, 3 >

PVA <On>

< 0, 1, 2, 3 >

Clock Alarm

< on/off >

Ram

p

(Ramp Time)

< 0 ~ 45 > min

iCH Auto/ English 13

4.5

Flowchart of Compliance Information reading

4.6

Using the heated humidifier

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

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.

NOTE: When the ‘Low P’ sign is displayed on the screen while large air leakage is detected,

heating will automatically stop with the heater indicator lights off. (e.g. removing the

Fi

g

ure 4-1

Period

(Time Frame)

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

Usa

g

e Hours

< xxx > hrs

＞4

(Days＞4hrs)

< xx > d

Avera

g

e Com

p

liance

Hours per day

< x.x > hrs /d

AHI

< xx.x >

P

(Average Pressure)

< xx.x >

cmH

2

O/hPa

Leak

(Average Leak Rate)

< xx.x > lpm



CH

(Check Value)

< xxx >



iCH Auto/ English 14

mask will stop the machine from operating.) If the air leakage problem is eliminated,

heater will resume again.

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.

4.7 Using the SD card

If doctors 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

[COPY] & [Card]

message is displayed on the LCD while data is being copied.

4. The

[End] & [OK]

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

[End] & [OK]

message is displayed on the LCD, or

data copied to the card may be corrupted or missing.

5. Cleaning & Maintenance

5.1 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: Don’t try to open this device. Repairs and internal servicing should only

performed by an authorized service agent. Do not drop any object into the air

tube or air outlet.

5.2 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.

iCH Auto/ English 15

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 oils),

moisturizin

g

or antibacterial soa

p

s to clean the cushion, mask or air tubin

g

. These soluti

o

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 70°C (158°F)

WARNING: Do not use any cleaner containing fragrance or conditioners as they will leave a residue.

WARNING: The mask must not be re-used by another person. This is to avoid the risk of

cross-infection.

5.3 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.

NOTE: Please follow national requirements to dispose of the unit properly.

5.4 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.

CAUTION: Dirt

y

air filter ma

y

cause hi

g

h o

p

eratin

g

tem

p

eratures that

affect device

p

erformance. 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 deter

g

ent, and rinse with

water. Allow the filter to air dr

y

com

p

letel

y

before reinstallin

g

. Do not

use a filter that is not completely dry. If the filter is torn, replace it.

3. Reinstall the filter.

iCH Auto/ English 16

6. Troubleshooting

The table below lists troubleshooting solutions for the problems that may happen. If the problem persists,

contact your equipment provider’s service agent.

Problem Possible Causes Solutions

No display 1. The power cord is not connected

to the power socket.

2. LCD failure or controlled PCB

failure.

1. Ensure the power cord is

connected.

2. Contact your equipment provider

for repair.

Display code incorrect LCD failure or controlled PCB failure. Contact your equipment provider for

repair.

Illuminator under LCD is

not on

LED failure Contact your equipment provider for

repair.

Buttons do not work Button failure Contact your equipment provider for

repair.

Air delivered is slow 1. During ramp time.

2. Filter is too dirty.

3. Flow generator failure.

1. Check the ramp time setting

2. Change or clean the filter regularly.

3. Contact your equipment provider

for repair.

Data can not be copied to

the SD card

1. SD card is full.

2. SD card is not inserted correctly.

3. Data on the SD card is corrupted.

1. Ensure the SD card has enough

capacity.

2. Ensure the SD card is inserted into

the slot.

3. Format the card.

Integrated humidifier

power on indicator not lit

up

1. Power cord not plugged into a

working AC outlet.

2. Power switch is not turned on

3. PCB or indicator worn out

4. Fuse blown

1. Plu

g

in the

p

ower cord to a workin

g

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.

Heater on indicator not lit

at all

1. Heater plate over heating

2. PCB indicator worn out

3. Large air leak is detected (e.g.

removing the mask will stop the

machine from operating.)

1. Contact your local agent or EU

representative for service.

2. Contact your local agent or EU

representative for service.

3. Check mask fit

There is no air flow

through the mask

1. Device is not turned on or working

correctly

2. Flexible tubing is not connected

right.

3. Flexible tube is blocked.

1. Check the power cord is

connected properly.

2. Reconnect the flexible tubing

correctly.

3. Unblock the flexible tube.

Condensation in mask or

flexible tube

1. The heater plate setting is too

high.

2. The operating environment or

p

osition of heated humidifier is not

correct. The temperature close to

mask or flexible tube is low.

1. Adjust the control knob to low

temperature setting.

2. Remove any air conditioner which

may nearby the heated humidifier.

Or keep room temperature up near

25°C

iCH Auto/ English 17

Water Leakage 1. Water chamber is not properly

assembled.

2. Water chamber worn out.

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 Definition

Message in LCD

Error:

Primary function can’t

execute.

Error for abnormal system settings

Error 001

Error for flow generator failure

Error 002

Error for abnormal timer setting or timer

failure

Error 003

Error for flow sensor failure

Error 004

Error for heater failure (thermal fuse

blows off)

Error 005

Error for pressure sensor failure

Error 006

Warning:

Out of system memory

Warn 001

System memory is nearly full

Warn 002

SD card module communication failure

Warn 003

Remove the SD card while data is being

processed

Warn 004

SD card is full

Warn 005

Inconsistent ID no. of device with SD card

Warn 006

NOTE: When the warning message appears, contact your doctor or equipment provider to

download the memory data and reset the meter.

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