1. INTRODUCTION

1. INTRODUCTION

This manual should be used for initial set up of the system and for reference purposes.

1.1 GENERAL INFORMATION

This system is a high quality, affordable mattress system, suitable for the treatment and prevention of

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

 

 

 

pressure ulcers. This product has been tested and successfully approved for the following standards:

EN 60601-1

EN 60601-1-2

EN 55011 Class B

IEC61000-3-2

IEC 61000-3-3

Harmonic emissions

Class A

IEC61000-3-2

 

 

 

Voltage fluctuations /

 

Flicker emissions

Complies

IEC61000-3-3

 

 

 

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network.

FOR US AND CANADA ONLY

Medical Equipment-Air Pump

E245395

with respect to electrical shock, fire and

53DG

mechanical hazards only in accordance with

 

 

UL60601-1 AND CAN/CSA C22.2 NO.601.1

Le produit à été testé avec des équipements médicaux et respecte les normes UL 60601-1 & CAN/CSA C22.2 No.601.1. prévenant les choc électrique, le feu et les risques de blessures physiques.

1.2 INTENDED USE

This product is intended:

to help and reduce the incidence of pressure ulcers while optimizing patient comfort.

for long term home care of patients suffering from pressure ulcers.

for pain management as prescribed by a physician.

NOTE: This equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with pure oxygen or nitrous oxide.

NOTE: L’équipement ne peut être utilisé s’il y a risque de mélange d’un anesthésique inflammable avec l’air ou l’oxygène ou oxyde nitreux.

3

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

Compliance

 

Electromagnetic

 

 

 

 

 

test level

 

Environment-Guidance

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

±6kV contact

±6kV contact

Floors should be wood, concrete or

Electrostatic Discharge (ESD)

ceramic tile. If floors are covered

IEC61000-4-2

±8kV air

±8kV air

with synthetic material, the relative

 

 

 

 

 

 

humidity should be at least 30%.

 

 

 

 

 

 

 

 

 

±2kV for power

±2kV for power

Mains power quality should be that

Electrical fast transient/ burst

supply line

supply line

of a typical commercial or hospital

IEC61000-4-4

±1kV for input/out

±1kV for input/out

environment.

 

 

 

line

line

 

 

 

 

 

 

 

 

 

 

Surge

± 1 kV line(s) to

± 1 kV line(s) to

Mains power quality should be that

 

 

 

line(s)

line(s)

of a typical commercial or hospital

IEC61000-4-5

± 2 kV line(s) to earth

± 2 kV line(s) to earth

environment.

 

 

 

 

 

 

 

 

 

 

 

 

<5 % UT (>95 % dip

<5 % UT (>95 % dip

Mains power quality should be that

Voltage dips, short

in UT)for 0,5 cycle

in UT) for 0,5 cycle

of a typical commercial or hospital

40 % UT (60 % dip in

40 % UT (60 % dip in

environment. If the user of this

interruptions and voltage

UT)for 5 cycles

UT) for 5 cycles

device requires continued operation

variations on power supply

70 % UT (30 % dip in

70 % UT (30 % dip in

during power mains interruptions, it

input lines

IEC61000-4-11

UT)for 25 cycles

UT) for 25 cycles

is recommended that the device be

<5 % UT (>95 % dip

<5 % UT (>95 % dip

powered from an uninterruptible

 

 

 

 

 

 

in UT)for 5 sec

in UT) for 5 sec

power supply or a battery.

 

 

 

 

 

 

 

 

 

Power frequency

 

 

 

Power frequency magnetic fields

(50/60Hz) magnetic field

3 A/m

3 A/m

should be at levels characteristic of

a typical location in a typical

IEC61000-4-8

 

 

 

 

 

 

commercial or hospital environment.

 

 

 

 

 

 

 

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

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Drive Medical Design AS 5000 Introduction, Appendix A Emc Information, General Information, Intended Use, Emissions Test