Drive Medical Design AS 5000 Introduction, Appendix A Emc Information, General Information

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.

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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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