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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
SN
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
