Apex Digital 9S-005720 Manuel utilisateur

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XT Auto
Users 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
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
mbol, which indicated this
roduct, is accordin
to the de
ree of
rotectin
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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