Bedienungsanleitung Compex Sport Elite 3.0 (Seite 17 von 22) (Englisch)

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STANDARDS

The Compex® Wired 3.0 complies with current medical standards.

The Compex® Wired 3.0 also complies with the IEC 60601-1 standard on general safety

requirements for electro-medical devices, the IEC 60601-1-2 standard on electromagnetic

compatibility, the IEC 60601-2-10 standard on particular safety requirements for nerve and muscle

stimulators, and the IEC 60601-1-11 standard on requirements for home use.

HOW TO GET HELP

To get assistance or answers to your questions, please contact: DJO, LLC

Toll Free: 1-877-266-7398 (877-COMPEX8)

DESCRIPTION OF DEVICE MARKINGS

The markings on the Compex® Wired 3.0 are your assurance of its conformity to the highest

applicable standards of medical equipment safety and electromagnetic compatibility. One or more

of the following markings may appear on the device:

Current international standards require that a warning be given concerning the application of

electrodes to the thorax (increased risk of cardiac fibrillation).

The Compex® Wired 3.0 also complies with Directive 2012/19/EU on waste electrical and

electronic equipment (WEEE).

The Compex® Wired 3.0 also complies with Directive 2011/65/EU & (EU) 2015/863& (EU)

2017/2102 on Restriction of Hazardous Substances (ROHS)

The Compex® Wired 3.0 also complies with regulation 1907/2006/EC on Registration, Evaluation,

Authorisation and Restriction of Chemicals (REACH)

Caution

This is an indication for protection

against ingress of water and

particulate matter. The mark IP22 on

your unit means: your unit is protected

against solid foreign objects of 12.5mm

dia and greater, meanwhile, protection

against vertically falling water drops

when ENCLOSURE tilted up to 15°

Manufacturer symbol: This symbol

shall be accompanied by the name and

address of the manufacturer.

Keep dry

Labeling statement: Council Directive

2012/19/EU concerning Waste

Electrical and Electronic Equipment

(WEEE) requires not to dispose of

WEEE as municipal waste. Contact

your local distributor for information

regarding disposal of the unit and

accessories.

Date of manufacture

NEMKO Certification U.S.

The stand-by button is multi-functional

Batch Number

Reference Number: Indicates the

manufacturer’s catalogue number so

that the medical device can be identified.

Serial number

LOT

REF

Refer to Instruction Manual/ Booklet

Class II Medical Device

Type BF Equipment

SYMBOL AND TITLE

Information essential for proper use shall be indicated by using the corresponding

symbols. The following symbols may be seen on the device and labeling.

OUTPUT WAVEFORM

Biphasic rectangular impulse with electrical mean equal zero (net zero DC).

All electrical specifications are given for an impedance of 500-1000 ohms per channel.

Channels: Four independent and individually adjustable channels that are electrically isolated

from each other and earthed.

UNIT CHARACTERISTICS

Body: plastic

Weight: 210g

Length: 140 mm

Width: 80 mm

Height: 25mm

Protection Rating: IP22

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Compex Sport Elite 3.0 Seite 17

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