Filter
Top Products
3
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
pressure ulcers. This product has been tested and successfully approved for the following standards:
FOR US AND CANADA ONLY
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.
EN 60601-1
EN 60601-1-2
EN 55011 Class B
IEC61000-3-2
IEC 61000-3-3
Medical Equipment-Air Pump
with respect to electrical shock, fire and
mechanical hazards only in accordance with
UL60601-1 AND CAN/CSA C22.2 NO.601.1
E245395
53DG
12
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
Harmonic emissions
IEC61000-3-2
Class A
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network.
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 a typical 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)
± 2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
<5 % U
T
(>95 % dip
in U
T
)for 0,5 cycle
40 % U
T
(60 % dip in
U
T
)for 5 cycles
70 % U
T
(30 % dip in
U
T
)for 25 cycles
<5 % U
T
(>95 % dip
in U
T
)for 5 sec
<5 % U
T
(>95 % dip
in U
T
) for 0,5 cycle
40 % U
T
(60 % dip in
U
T
) for 5 cycles
70 % U
T
(30 % dip in
U
T
) for 25 cycles
<5 % U
T
(>95 % dip
in U
T
) for 5 sec
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of this
device requires continued operation
durin
g
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 3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical 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