Apex Digital XT Auto Manuel utilisateur

XT Auto

User’s Manual

CONTENTS

USER’S MANUAL 1

MANUAL DE INSTRUCCIONES 22

INSTRUCTIONS D'UTILISATION 45

MODEL NO.: 9S-005720

PLEASE READ THE MANUAL BEFORE USE

XT Auto/ English 1

IMPORTANT SAFEGUARDS – PLEASE MAKE THIS PRECAUTIONS LIST

AVAILABLE TO ALL USERS and PROVIDERS

READ ALL INSTRUCTIONS BEFORE USING THIS SYSTEM

WARNING –

1. THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT. It may stop operating due to power interruption but no

hazards 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’s enclosure and create a risk

of fire.

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

flame.

4. Always ensured the device is generating airflow before the oxygen supply is turned. 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 anesthetic 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 “Error 002” on the display. After cooling down

to proper temperature, the device can restart again.

8. This machine should be used only with masks (and connectors) recommended by the manufacturer,

or by your physician or respiratory therapist. A mask should not be used unless the CPAP machine is

turned on and operating properly. The vent holes associated with the mask should never be blocked

for proper exhaling purpose. If the vent hole is blocked, the CPAP machine will stop and show

message “Error 002”, after cooling 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 re-breathed.

XT Auto/ English 2

CAUTION –

1. 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.

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 the CPAP system failure.

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 physician.

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.

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 by, on, 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 center 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 their 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 on the unit or into the tubing.

8. When disposing the unit because of damage or failure, you must comply with the regulations of your

particular region or country for disposing such equipment

9. No modification of this equipment is allowed.

10. Do not modify this equipment without authorization of the manufacturer.

11. If this equipment is modified, appropriate inspection and testing must be conducted to ensure

continued safe use of the equipment.

12. 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.

XT Auto/ English 3

1. Introduction

This manual is provided to explain initial set up and operating instructions. This manual should be

stored in a safe location and be readily accessible for future reference.

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:

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

Below description is for Canada only

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

ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008). prévenant les choc électrique, le

feu et les risques de blessures physiques.

E348970

53DG

Medical Equipment - CPAP

WITH RESPECT TO ELECTRICAL SHOCK,

FIRE AND MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH ANSI/AAMI

ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No.

6060

1-1

(

2

008,

3

rd

ed

.

)

XT 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 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.

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.

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

XT Auto/ English 5

2. Product Description

Components including:

(1) Main CPAP device

(2) Detachable power cord

(3) User man ual

(4) Flexible air tubing with 1.8 m length

(5) Carrying bag

(6) 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 4GB) 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.

Menu Button

Start/Standby Button

LCD Display

Up Button

Down Button

Air Outlet

Power Socket

Air Filter

SD Card Slot / Mini-USB Connector

XT Auto/ English 6

3. Installation

3.1 Unpacking

To secure its contents inside, the CPAP device and accessories are bundled in a paper packaged box.

Unpack this box by removing the CPAP and its accessory and checking for any damage, which may

have occurred during shipping. If there are damages, please contact your dealer immediately.

3.2 Setting Up

1) Connect the power cord to CPAP device and plug into main

electrical outlet.

Once the power cord is plugged into the electrical outlet, the

device is in ready to operate position (“STANDBY” sign appears

in LCD display)

NOTE: The plug is also served to disconnect the

device.

2) Connect one end of the air tubing firmly to the air outlet of the

CPAP.

3) Connect the other end of the air tubing to the mask system.

Putting on the mask and headgear according to the mask

instruction manual.

XT Auto/ English 7

4. Operation

NOTE: Always read the operating instruction before use.

4.1 Control Panel Description

Buttons arrangement 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]

in cmH

2

O 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, initial pressure adjustment, maximum pressure adjustment,

minimum 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

4.2 Function Description section for detailed information.

UP

Press the

"UP"

button to increase the value.

DOWN

Press the

"DOWN"

button to decrease the value.

XT Auto/ English 8

4.2 Function Description

Getting Started – First time use.

For first-time use, follow the steps below:

1. Make sure that your physician 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

physician 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 been already set by your physician 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 Descriptions

The following items describe the options presented to you after you press the

“MENU”

button on the

control panel.

(1) Ramp Time

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 second

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 4 cmH

2

O to “Therapy Pressure – 1” cmH

2

O. For example, if your therapy

pressure is 10 cmH

2

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

2

O.

(3) Therapy Pressure (only CPAP mode)

Press

"MENU"

button to select

[P XX.XcmH

2

O]

menu, you can view the current pressure setting

displayed in cmH

2

O 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.XcmH

2

O]

menu, you can view the current pressure

setting displayed in cmH

2

O 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.

XT Auto/ English 9

(5) Maximum Pressure (only APAP mode)

Press

"MENU"

button to select

[Max. XX.XcmH

2

O]

menu, you can view the current pressure

setting displayed in cmH

2

O 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.XcmH

2

O]

menu, you can view the current pressure

setting displayed in cmH

2

O 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) 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.

(8) 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.

(9) 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.

(10) 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.

(11) 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.

(12) Clock

Press

"MENU"

button to select

[Clock XX:XX]

menu, press

"UP"

or

"DOWN"

button to set the

current time.

XT Auto/ English 10

(13) 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

automaticall

y

g

o back to standb

y

without savin

g

the modification if no action is taken in

20 seconds.

(14) Event Indication

While the device is on standby mode, press

UP"

and

"DOWN"

button at the same time to see the

latest 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: AI, HI, SI indexes of the last sleep session with over 15 minutes of usage is displayed.

Index data can be viewed by respiratory therapists or physicians by using Easy

Compliance playback software.

XT Auto/ English 11

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 physicians, please refer to a separated “Physician’s Additional Instruction” page.

Ramp

(Ramp Time)

< 0 ~ 45 > min

P

(Therapy Pressure)

< 4.0 ~ 20.0 > cmH

2

O

CM

(Compliance Meter)

< xxxx.x > hr

Ramp P

(Ramp Starting

Pressure)

Low P

(Low Pressure Shut Off)

< on/off >

Alarm

< on/off >

Clock Alarm

< on/off >

Clock

< hh:mm >

CPAP

Mode

Int. P

(Initial Pressure)

< 4.0 ~ 19.0 > cmH

2

O

Max. P

(Maximum Pressure)

< 5.0 ~ 20.0 > cmH

2

O

APAP

A

PAP

Mode

Min. P

(Minimum Pressure)

< 4.0 ~ 19.0 > cmH

2

O

Clock Alarm <On>

< hh:mm >

C

(PVA Comfort Level)

< on/off >

C

(PVA Comfort Level)

< on/off >

PVA <On>

< 0, 1, 2, 3 >

PVA <On>

< 0, 1, 2, 3 >

Ramp

(Ramp Time)

< 0 ~ 45 > min

XT Auto/ English 12

5. Adding a Humidifier

XT Auto CPAP device can be used with XT Heated

Humidifier (9S-006500) which is available from the

home care provider. The heated humidifier may

reduce nasal dryness and irritation by providing

adequate moisture and heat to the airflow. Please

refer to the XT heated humidifier (9S-006500)

instruction manual for complete setup

information.

NOTE: When XT Auto CPAP device is used with the heated humidifier, its power supply is from the

power socket outlet of the heated humidifier. Do not connect the power cord to CPAP

device and plug into main electrical outlet.

6. 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

[COPY] & [Card]

messages are displayed on the LCD while data is being copied.

4. The

[End] & [OK]

messages are displayed on the LCD when copying has finished.

5. Remove the SD Card and mail it to the clinician.

6. 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]

messa

g

es are dis

p

la

y

ed on the LCD,

or data copied to the card may be corrupted or missing.

XT Auto/ English 13

7. Cleaning & Maintenance

7.1 Cleaning the Main Unit

The main unit should be cleaned regularly (at least every 30 days). To clean the unit, wipe it down with a

damp cloth using a mild detergent. When selecting a cleaning agent, take precautions to choose one that

is not chemically abrasive to the surface of the plastic case. All parts should be air-dried thoroughly before

use. During storage, the unit should be kept in a dust-free location.

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

an authorized service agent. Don’t drop any subject into the air tube or air outlet.

7.2 Tubing and Mask

The tubing and mask should be checked and cleaned daily. Please refer to the cleaning

instruction packaged 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 nasal mask.

3. Wash the mask system according to the instructions supplied with it. Wash the air tubing in

warm water using mild detergent.

4. Rinsed thoroughly, hang and allow to dry.

5. Before next use, assemble the mask and headgear according to the mask user instructions.

6. All items of the mask and air tubing are subject to normal wear and tear and may eventually be

replaced. Replace the mask and the air tubing if they are damaged.

CAUTION: Do not use blench, chlorine-, alcohol-, or aromatic-based (including all

scented oils), moisturizing or antibacterial soaps to clean the cushion, mask,

air tubing. These solutions 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.

XT Auto/ English 14

7.3 Air Filter Maintenance

For an optimum operation of the device, the air filter can be cleaned by the user at least once every

two weeks or more often if this device is operated in a dusty environment. It is recommended that

the filter be replaced with a new one after 6 months of use; however, depending on the air quality,

the replacement time may vary.

CAUTION:

Dirt

y

air filter ma

y

cause hi

g

h o

p

eratin

g

tem

p

eratures that affect device

performance. Ensure the air filter is cleaned and fitted at all times.

1. Remove the dirt

y

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

reinstalling. Do not use a filter that is not completely dry. If the

filter is torn, replace it.

3. Reinstall the filter.

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

8. Troubleshooting

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

contact your equipment provider 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.

Illuminant under LCD is not

on

LED failure Contact your equipment provider for

repair.

Buttons disable 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.

XT Auto/ English 15

Error / Warning Messages show in LCD.

Message type Definition Message in LCD

Error:

Primar

y

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

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

Wrong firmware version of SD card module

Warn 007

SD card is damaged

Warn 008

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

the memory data and reset the meter.

XT Auto/ English 16

9. Technical Specifications

Item Specifications

Power Supply Universal power supply, AC100-240V, 50/60 Hz, 0.5-0.3A

Pressure Range 4-20 cmH

2

O (adjustable in 0.5 cmH

2

O increment)

Initial Pressure 4-19 cmH

2

O (adjustable in 0.5 cmH

2

O increment)

Maximum Pressure 5-20 cmH

2

O (adjustable in 0.5 cmH

2

O increment)

Minimum Pressure 4-19 cmH

2

O (adjustable in 0.5 cmH

2

O increment)

Ramp Time 0-45 minutes (adjustable in 5-minute increment)

Ramp Starting Pressure 4-19 cmH

2

O (adjustable in 0.5 cmH

2

O increment)

Operating Altitude up to 8,000 ft (2,438 m) when the pressure is set at 4-18 cmH

2

O

but limit to 5,000ft (1,524m) when the pressure is set at 18.5 - 20

cmH

2

O

Dimensions (W x D x H) 14.5 x 13.0 x 10.0 cm or 5.7” x 5.1” x 3.9”

Weight Approximately 800 g or 1.76 lb

Environment

Temperature Operating: +5°C to +35°C (+41°F to +95°F)

Storage: -15°C to 50°C (+5°F to +122°F)

Shipping: -15°C to 70°C (+5°F to +158°F)

Humidity Operating: 15%RH to 95%RH non-condensing

Storage: 10%RH to 90%RH non-condensing

Shipping: 10%RH to 90%RH non-condensing

Classification:

Class II

Type BF, Applied Parts: Mask

Not suitable for use in the presence of a flammable anesthetic mixture

IP21: Protected against solid foreign objects of 12.5 mm and greater;

Protected against vertically falling water drops.

Continuous operation.

Note: The manufacturer reserves the right to modify the specification without notice.

XT Auto/ English 17

Symbols

BF s

y

mbol, which indicated this

p

roduct, is accordin

g

to the de

g

ree of

p

rotectin

g

against electric shock for type BF equipment.

Attention, should read the instructions.

Refer to instruction manual

Class II

Attention, should read the instructions.

Protected against solid foreign objects of 12.5 mm and

g

reater; Protected a

g

ainst

vertically falling water drops.

Disposal of Electrical & Electronic Equipment (WEEE):

This

p

roduct should be handed over to an a

pp

licable collection

p

oint for the rec

y

clin

g

of

electrical and electronic equipment. For more detailed information about the rec

y

clin

g

of this

p

roduct,

p

lease contact

y

our local cit

y

office, household waste dis

p

osal service

or the retail store where you purchased this product.

Authorized representative in the European community

Manufacturer

RTCA/DO-160 Section 21 Category M Compliant

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