Apex Digital XT Fit Manuel utilisateur

XT Fit

CPAP System

Instruction Manual

Model No.: 9S-005500 Please read the instruction manual before use.

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

Manual de Instrucciones

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

P.20

Instructions d'utilisation ................................................ P. 40

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English

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.

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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 cmH

2

O, the default pressure compensation is available for altitude from

sea level up to 8000 feet; for therapy pressure 18.5-20 cmH

2

O, 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.

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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:

EN 60601-1

EN 60601-1-2

EN 61000-3-2 Class A

EN 61000-3-3

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 (2005,3rd ed.) and CAN / CSA C22.2

No. 60601-1 (2008)

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EMC Warning Statement

This equipment has been tested and found to comply with the limits for medical devices for EN

60601-1-2:2007. 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.

This system has been tested to comply with the following voluntary standards: FDA

1.2 Intended Use

This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of

adult Obstructive Sleep Apnea (OSA).

Cautions: Some patients might have pre-existing contraindications for CPAP therapy, or

might experience some potential side effects of using CPAP device, please consult

your physician if you have any questions concerning your therapy.

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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

5. Carrying bag

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 onto 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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4. 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 cmH

2

O] in cmH

2

O 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 3 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 (P XX.XcmH

2

O)

The third option of the “MENU” button is the Therapy pressure displayed in units of cmH

2

O.

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.

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(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 cmH

2

O). 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 XXXX.X)

The fifth “MENU” item is the Total Meter which displays the total number of hours that the

device has been “On” and delivering airflow. In other words, it is the time the

“START/STANDBY” button was pressed to begin airflow to the time the

“START/STANDBY” button was pressed again to stop airflow. This meter should only be

re-set by the equipment provider, a respiratory therapist or by a physician.

(6) Compliance Meter (CM XXXX.X)

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.

(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.

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(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

power socket on the back of device.

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.

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)

TM

(Total Meter)

< 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

< XXXX.X > hr

< 1, 2, 3, 4, 5> if P set at 18.5-20 cmH2O

Ramp P

(Ramp Starting Pressure)

< 3, 3.5, 4, 4.5, ……………., 19> cmH2O

CM

(Compliance Meter)

CM 4 hr

(Session Counter)

c

(Check Value)

< XXXX.X > hr

< XXX >

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5. 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.

6. 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.

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.

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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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7. 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.

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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8. Technical Specifications

Item

Specifications

Mode of Operation

Continuous

Pressure Range

4 –20 cmH

2

O (adjustable in 0.5 cmH

2

O increment)

Ramp Time

0 – 45 minutes (adjustable in 5-minute increment)

Ramp Starting Pressure

3 to therapy pressure

Altitude Compensation

(Manual setting)

Level 1~8 for 0 ~ 8000 ft when the pressure set at 4-18 cmH

2

O.

Level 1~5 for 0 ~ 5000 ft when the pressure 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

Sound Level

28 dBA at 10 cmH

2

O, 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: -15º C to +50º C (+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

9. 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.

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10. 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.

11. 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.

NOTE: Warranty is only valid in the country of purchase.

Product

Warranty period

CPAP devices

2 years

Water chamber

6 months

Mask systems

6 months

Disposable products

None

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Appexdix 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

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.

Immunity Test

IEC60601 test level

Compliance

Electromagnetic

Environment-Guidance

Electrostatic

Discharge(ESD)

IEC61000-4-2

±6kV contact

±8kV air

±6kV contact

±8kV 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/out

line

±2kV for power

supply line

±1kV for input/out

line

Mains power quality should be that

of atypical commercial or hospital

environment

Surge

IEC61000-4-5

±1kV for differential

mode

±2kV for common

mode

±1kV for differential

mode

Mains power quality should be that

of atypical commercial or hospital

environment.

Voltage dips, short

interruptions and voltage

variations on power supply

input lines

IEC61000-4-11

<5 % UT(>95 % dip

in UT)for 0,5 cycle

40 % UT(60 % dip

in UT)for 5 cycles

70 % UT(30 % dip

in UT)for 25 cycles

<5 % UT(>95 % dip

in UT)for 5 sec

<5 % UT(>95 % dip

in UT) for 0,5 cycle

40 % UT(60 % dip

in UT) for 5 cycles

70 % UT(30 % dip

in UT) for 25 cycles

<5 % UT(>95 % dip

in UT) for 5 sec

Mains power quality should be that

of atypical commercial or hospital

environment. If the user of this

device requires continued

operation during power mains

interruptions, it is recommended

that the device be powered from an

uninterruptible power supply or a

battery.

Power frequency

(50/60Hz) magnetic field

IEC61000-4-8

3 A/m

Power frequency magnetic fields

should be at levels characteristic of

atypical location in a typical

commercial or hospital

environment.

NOTE: U

T

is the a.c. mains voltage prior to the application of the test level

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