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Classification, Environmental requirements, Warning – Power Plate pro7HC User Manual

Page 5: Patient

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Electromagnetic Compatibility (EMC)

Precautions

The pro7HC™ models are suitable for

use in all establishments, including

domestic establishments and those

directly connected to the public low-

voltage power supply network that

supplies buildings used for domestic

purposes. Both models have been tested

against, and have passed the applicable

requirements of relevant electromedical

standards, including EN 60601-1-2:2007.

The pro7HC™ models must emit

electromagnetic energy in order to

perform their intended function. Nearby

electronic equipment may be affected

by this emission. Similarly the pro7HC™

models may themselves be affected by

electromagnetic emissions from other

equipment in the vicinity.

The pro7HC™ models are intended for

use in the electromagnetic environment

specified below. The customer or user of

the pro7HC™ model should assure that

they are used in such an environment:

– Floors should be wood, concrete or

ceramic tile. If the floor is covered with

synthetic material, the relative humidity

in the room should be at least 30%.

– Mains power quality should be that

of a typical domestic, commercial or

hospital environment as appropriate.

– The pro7HC™ should not be used during

power mains interruptions

– Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical commercial

or hospital environment.

The pro7HC™ models are intended for

use in an electronic environment in which

radiated radio-frequency (RF) disturbances

are controlled.

The customer or user of the

pro7HC™model can help prevent

electromagnetic interference by

maintaining a minimum distance between

portable and mobile RF communications

equipment (transmitters) and the

pro7HC™ model as recommended below,

according to the maximum output power

of the communications equipment:

The adequate separation distance

to provide base immunity to RF

disturbances is 1.0m.

Retain this user manual for your future

reference.

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Classification

1. Class I equipment;
2. Type B applied part;
3. IPX0;
4. Not category AP / APG equipment;
5. Mode of operation: Non-continuous Operation : 9mins on/ 3hours off

Environmental Requirements




OPERATING CONDITIONS
Temperature: 10ºC to 40ºC
Humidity: 10% to 95% RH
Pressure altitude: Normal atmospheric

conditions/ 860-1060hPa

STORAGE AND SHIPPING CONDITIONS
Temperature: 10ºC to 40ºC
Humidity: 10% to 95% RH
Pressure altitude: Normal atmospheric

conditions/ 860-1060hPa

WARNING

The device is not suitable for use in the presence of flammable anesthetic mixtures

with air or with oxygen or nitrous oxide.

The device requires no calibration.

The device is not repairable and contains no user serviceable parts.

The user must check that the equipment functions safely and see that it is in proper

working condition before being used.

The manufacturer does not require such preventive inspections by other persons.

The plug is used to disconnect from the main supply. Do not position the machine

so that it is difficult to disconnect the main plug.

Warning: To avoid the risk of electric shock, this equipment must only be

connected to a supply main with protective earth grounding.

Patient

The machine is intended for use by a diverse patient population including:
• Adult men and woman who are medically cleared and able to undertake

physical exercises such as weight baring and ground reaction force type
exercise programs. In general this applies to healthy grownups (16+ years old).

• All others users should be cleared by their physician and only use the Power

Plate under medical supervision.