Apex Digital XT Fit User manual

XT Fit
User’s Manual

CONTENTS
USER’S MANUAL 1
MANUAL DE INSTRUCCIONES 20
INSTRUÇÕES DE UTILIZAÇÃO 39
INSTRUCTIONS D'UTILISATION 59
GEBRAUCHSANLEITUNG 79
DUTCH GEBRUIKERSHANDLEIDING 100
ITALIANO MANUALE DI ISTRUZIONI 119
MODEL NO.: 9S-005500
PLEASE READ THE MANUAL BEFORE USE

XT Fit /English 1
IMPORTANT SAFEGUARDS –PLEASE MAKE THIS
PRECAUTIONS LIST AVAILABLE TO ALL USERS and
PROVIDERS
READ ALL INSTRUCTIONS BEFORE USING THIS SYSTEM
WARNINGS:
1. THIS DEVICE IS NOT INTENDED FOR LIFE SUPPORT.
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.
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.

XT Fit /English 2
DANGER –Reducing 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 into or be pulled into a tub or sink.
4. DO NOT place or immerse the unit into water or other liquids.
5. DO NOT reach for the unit if it is immersed in water. Unplug the unit immediately.
WARNINGS - To reduce the risk of burns,electrocution, fire or injury:
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 purpose as described in this manual. DO NOT use auxiliary attachments that
are not approved by the manufacturer.
4. Never operate this product if it has a damaged cord or plug. If it is not working properly, or has been dropped,
damaged, or immersed in water, return the product to a service center for examination and repair.
5. Keep the cord away from hot surfaces and objects.
6. Never block the air outlets on this product. DO NOT place the unit on a soft surface such as a bed or couch, where
the air outlets may become obstructed. Keep the air outlets free of lint, hair, and other obstructive 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. For therapy pressure 4-18 cmH2O, the default pressure compensation is available for altitude from sea level up to
8000 feet; for therapy pressure 18.5-20 cmH2O, the default pressure compensation is available for altitude from
sea level up to 5000 feet.
10. No modification of this equipment is allowed.
11. Do not modify this equipment without authorization of the manufacturer.
12. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use
of the equipment.
13. 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 Fit /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 is an intermittent and reoccurring obstruction of the upper
respiratory tract, causing a complete (apnea) or partial (hypopnea) blockage of respiratory airflow during sleep.
The syndrome varies in degree, depending on the position of the tongue and soft palate muscle when in a relaxed
state.
The most common treatment for OSA is Continuous Positive Airway Pressure (CPAP). CPAP devices can deliver
constant air pressure into your upper respiratory tract via a nasal mask. This constant air pressure can keep your
airway open during sleep, preventing occurrences of OSA.
This unit is a CPAP device regulated by an internal micro-processor. It features a menu-driven LCD display,
universal power supply, and Ramp Time Adjustment. The Ramp Time Adjustment feature allows the unit to begin at
low pressures, allowing you to comfortably fall asleep. The unit will then gradually “ramp up” the pressure over a
configurable period of time until the appropriate therapy pressure is reached. This unit also has a Compliance
Meter that records patient usage data that can be reviewed by a physician at a later time.
The system has been tested and successfully approved for the following standard:
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
E348970
53DG
Medical Equipment - CPAP
WITH RESPECT TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI
ES60601-1:2005/(R)2012, CSA CAN/CSA-C22.2
NO. 60601-1:14

XT Fit /English 4
Below description is for Canada only
Le produit à été testé avec des équipements médicaux et respecte les normes ES60601-1:2005/(R)2012 and
CSA CAN/CSA-C22.2 NO. 60601-1:14. prévenant les choc électrique, le feu et les risques de blessures
physiques.
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices for IEC/EN 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation. This unit 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 unit.
Increase the distance between the conflicting equipment.
Connect the unit into an outlet that is on a different circuit than the other device(s).
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 Fit /English 5
2. Product Description
Components including:
1. Main CPAP device
2. Detachable power cord
3. User manual
4. Flexible air tubing with 1.8 m length, 22mm diameter (Optional).
5. Carrying bag (Optional)
6. Mask and headgear stapes
Menu Button
Start/Standby Button
LCD Display
Up Button
Down Button
Air Outlet
Power Socket
Air Filter

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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.

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3. Operation
NOTE: Always read the operating instruction before use.
4.1 Control Panel Description
Main control panel and button descriptions:
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
When the unit is in “Standby” mode, you can press the “MENU” button to enter the configuration
menus. The patient can adjust the “Ramp Up Time” (Ramp), Ramp Starting Pressure (Ramp P) and
Altitude Compensation (Alt). The three other options, Therapy Pressure (P), Compliance Meter
(CM), and Total Operating meter (TM) are to be set only by a physician or other care provider. To
confirm a change to a setting, you must press the “MENU” button again. Refer to section 4.2
(Menu Option Descriptions) for a detailed explanation.
UP
Press the “UP” button to the increasing values when adjusting configurations.
DOWN
Press the "DOWN" button to decrease values when adjusting configurations.

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4.2 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, Ramp Starting Pressure, and Altitude
Compensation (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 XX MIN)
The Ramp Time feature on this unit allows the patient to fall sleep at a lower, more comfortable pressure,
after which the unit will gradually ramp up to the appropriate therapy pressure. The first option of the
“MENU” button is the Ramp Time, which is the time (in minutes) it will take for the unit to “ramp” up to the
appropriate therapy pressure. Press the “UP” or "DOWN" buttons to set the preferred ramp time and
press “MENU” for confirmation. There are ten timing options; 0, 5, 10, 15, 20, 25, 30, 35, 40 and 45
minutes.
(2) Ramp Starting Pressure (Ramp P XX.X)
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 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 (P XX.XcmH2O)
The third option of the “MENU” button is the Therapy pressure displayed in units of cmH2O.
The Therapy pressure option should only be set by the equipment provider, a respiratory therapist or a
physician.
NOTE: The Therapy Pressure value itself should only be prescribed by a physician.

XT Fit /English 9
(4) Altitude Compensation (Alt XXX)
The fourth option of the “MENU” button is the Altitude Compensation option, used to adjust pressure in the
mask based on the altitude relative to sea level. Press the “UP” or "DOWN" buttons to select from eight
options (1 to 8) that correspond to a range of altitudes listed in the table below. The level should be set
relative to your elevation above sea level. Once the preferred option has been selected, press the “MENU”
button to confirm.
NOTE:
Users can operate XT Fit at wide range of altitude within 0~8000 ft (limit to 5000 ft if the pressure
is set at 18.5-20 cmH2O). The altitude function provides a method of accuracy pressure output at
high altitude. Users must follow the below table to select correct altitude setting depending on your
elevation above sea level, the device will automatically regulate airflow output to achieve targeted
pressure at high altitude. Otherwise, wrong altitude setting will cause inaccuracy pressure output.
There are eight altitude compensation levels. The level should be set depending on your elevation
above sea level. Below table is the comparison of altitude setting and altitude.
Altitude Setting
Altitude (Imperial)
Altitude (Metric)
1
0 ~ 1000 ft
0 ~ 304 m
2
1001 ~ 2000 ft
305 ~ 609 m
3
2001 ~ 3000 ft
610 m ~914m
4
3001 ~ 4000 ft
915 m ~1219m
5
4001 ~ 5000 ft
1220 m ~1524m
6
5001 ~ 6000 ft
1525 m ~1829m
7
6001 ~ 7000 ft
1830 m ~2134m
8
7001 ~ 8000 ft
2135 m ~2438m
(5) Total Meter (TM XXXXX.X)
Press "MENU" button to select [TM XXXXX.X hr] menu, the total meter records the total usage time of the
device.
(6) Compliance Meter (CM XXXXX.X)
Press "MENU" button to select [CM XXXXX.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.
(7) Session Counter (CM XXX 4hr)
Press "MENU" button to select [CM XXX 4hr] menu, the session counter displays the number of sessions
greater than four hours. Your home care provider may ask for this information. The session counter will be
erased once the compliance meter has been reset.
(8) Check Value (c XXX)
Press "MENU" button to select [c XXX] menu, which displays a check value. Your home care provider may
ask for this information.
(9) Turn off the Device
Remove the power cord from the electrical outlet, and disconnect power cord from the

XT Fit /English 10
power socket on the back ofdevice.
4.4 Flowchart of Menu settings
Enter the user's menu mode by pressing the “ MENU ” butt on.
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.
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 20 seconds.
Ramp
(Ramp Time)
P
(Therapy Pressure)
Alt.
(Altitude Compensation)
< 0, 5, 10, 15, ……………., 45> min
< 4, 4.5, 5, 5.5, ……………., 20> cmH2O
< 1, 2, 3, 4, 5, 6, 7, 8> if P set at 4-18 cmH2O
< XXXXX.X > hr
< 1, 2, 3, 4, 5> if P set at 18.5-20 cmH2O
Ramp P
(Ramp Starting Pressure)
< 4, 4.5, 5, 5.5, ……………., 19> cmH2O
CM
(Compliance Meter)
CM 4 hr
(Session Counter)
c
(Check Value)
< XXX >
< XXX >
< XXXXX.X > hr
TM
(Total Meter)

XT Fit /English 11
4. Adding a Humidifier
XT Fit 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 Fit 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.
5. Cleaning & Maintenance
6.1 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.
6.2 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. Use a mild detergent and prepare the detergent according to manufacturer's recommendations. Tubing and
mask can be washed and rinsed in warm water.
4. Rinse thoroughly and make sure they are completely dry before next use.
5. 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.

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CAUTION:
Do not use bleach, 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 (160°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.
6.3 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 for the filter to be replaced with a
new one after 6 months of use of the device; however, depending on the air environment, the replacement time
may vary.
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.
NOTE: Please follow national requirements to dispose the unit properly.

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6. Troubleshooting
The table below lists troubleshooting solutions for the problems that may happen. If the problem persists, contact
your equipment provider service agent.
Pro b lem
Pos si b le C a use s
Solu t ion s
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.
Error / Warning Messages show in 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
Warning:
Out of system memory
Warn 001
1. System memory is nearly full
2. Memory resetting problem
Warn 002
NOTE: When the warning message appears, contact your physician or equipment
provider to download the memory data and reset the meter.

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7. Technical Specifications
Item
Spec if icat i ons
Mode of Operation
Continuous
Pressure Range
4 –20 cmH2O (adjustable in 0.5 cmH2O increment)
Ramp Time
0 –45 minutes (adjustable in 5-minute increment)
Ramp Starting Pressure
4 to therapy pressure-1
Altitude Compensation
(Manual setting)
Level 1~8 for 0 ~ 8000 ft when the pressure set at 4-18 cmH2O.
Level 1~5 for 0 ~ 5000 ft when the pressure set at 18.5-20 cmH2O
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
Sound Level
28 dBA at 10 cmH2O, 1 meter distance
Power Input
AC100-240V, 50/60 Hz, 0.5-0.3A
Environment
Temperature
Operating: +5°C to +35°C (+41° F to +95° F)
Storage/Transport: -15ºC to +50ºC (+5° F to +122° F)
Humidity
Operating: 15%RH to 95%RH non-condensing
Storage/Transport: 10%RH to 90%RH non-condensing
Air Tubing
Flexible plastic, 1.8m (approx.)
Classification:
Class II
Type BF, Applied Parts Nasal 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.Continuous operation.
Note: The manufacturer reserves the right to modify the specification without notice.

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Symbols
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.
Refer to instruction manual
Attention, should read the instructions.
Class II
Protected against solid foreign objects of 12.5 mm and greater; Protected against vertically falling
water drops.
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.
Authorized representative in the European community
Manufacturer
RTCA/DO-160 Section 21 Category M Compliant

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8. NOTE, CAUTION, AND WARNING STATEMENTS
NOTE:
Indicate information that you should pay special attention to.
CAUTION:
Indicate correct operating or maintenance procedures in order to prevent damage to or destruction
of the equipment or other property.
WARNING:
Calls attention to a potential danger that requires correct procedures or practices in order to
prevent personal injury.
9. Servicing
The XT series systems are intended to provide safe and reliable operation according to the instructions provided
by Apex Medical. Apex Medical recommends that the XT system be inspected and serviced by authorized
technicians if there is any sign of wear or concern with device function. Otherwise, service and inspection of the
devices generally should not be required during the five year design life of the device.
10. Limited Warranty
Apex Medical Corp. (hereafter ‘Apex’) gives the customer a limited manufacturer warranty on new original Apex
products and any replacement part fitted by Apex in accordance with the warranty conditions applicable to the
product in question and in accordance with the warranty periods from date of purchase as listed below. This
warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects not related to
material or workmanship. To exercise your rights under this warranty, please contact your local, authorized Apex
dealer.
Product
Warranty period
CPAP devices
2 years
Water chamber
6 months
Mask systems
6 months
Disposable products
None

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Appendix A: EMC Information
Guidance and Manufacturer’s Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment specified below. The user of this device should make
sure it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment-Guidance
RF emissions
CISPR 11
Group1
The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment
RF emissions
CISPR 11
Class B
The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network
Harmonic emissions
IEC61000-3-2
Class A
Voltage fluctuations /
Flicker emissions
IEC61000-3-3
Complies
Warning:
1. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device
should be observed to verify normal operation in the configuration in which it will be used.
2.Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
3. Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the CPAP, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could result.
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of this device should make
sure it is used in such an environment.
Basic EMC standard
Immunity Test Levels
Compliance
Levels
Electromagnetic
Environment-Guidance
Professional
healthcare
facility environment
HOME HEALTHCARE
ENVIRONMENT
Electrostatic
Discharge (ESD)
IEC61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the
relative humidity should be at
least 30 %.
Electrical fast
transient/ burst
IEC61000-4-4
±2kV for power supply line
±1kV for input/output line
±2kV for power
supply line
±1kV for
input/output line
Mains power quality should be
that of atypical commercial or
hospital environment
Surge
IEC61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to
line(s)
± 1 kV line(s) to
line(s)
Mains power quality should be
that of atypical commercial or
hospital environment.