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 |
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pressure ulcers. This product has been tested and successfully approved for the following standards:
EN
EN
EN 55011 Class B
IEC
Harmonic emissions | Class A | |
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Voltage fluctuations / |
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Flicker emissions | Complies | |
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The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public
FOR US AND CANADA ONLY
Medical
E245395 | with respect to electrical shock, fire and | |
53DG | ||
mechanical hazards only in accordance with | ||
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Le produit à été testé avec des équipements médicaux et respecte les normes UL
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 | |
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| ±6kV contact | ±6kV contact | Floors should be wood, concrete or | ||
Electrostatic Discharge (ESD) | ceramic tile. If floors are covered | ||||||
±8kV air | ±8kV air | with synthetic material, the relative | |||||
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| humidity should be at least 30%. | |
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| ±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 | |||||||
±1kV for input/out | ±1kV for input/out | ||||||
environment. | |||||||
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| line | line | |||
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Surge | ± 1 kV line(s) to | ± 1 kV line(s) to | Mains power quality should be that | ||||
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line(s) | line(s) | of a typical commercial or hospital | |||||
± 2 kV line(s) to earth | ± 2 kV line(s) to earth | environment. | |||||
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| <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 | |||||||
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 | |||||
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| in UT)for 5 sec | in UT) for 5 sec | power supply or a battery. | ||
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Power frequency |
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(50/60Hz) magnetic field | 3 A/m | 3 A/m | should be at levels characteristic of | ||||
a typical location in a typical | |||||||
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| commercial or hospital environment. | ||||
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NOTE: UT is the a.c. mains voltage prior to the application of the test level
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