Empi Direct Tens - General Information

Direct TENS
™
5
• The product Direct TENS™ bears the CE marking CE-0473 (Notied Body: AMTAC Certication Services Limited)
showing that it complies with the Council Directive 93/42/EEC as amended concerning medical devices and fulls
the essential requirements of Annex I of this directive. It has an internal power source and is classied as IIa
equipment (MDD).
• The device has a type BF applied part.
• The device fulls the requirements of the standard EN 60601-1 “Medical electrical equipment, Part 1: General
requirements for safety” as well as the immunity requirements of the standard EN 60601-1-2 “Electromagnetic
compatibility - medical electrical equipment”.
• This manual is an integral part of the device and should be kept near the device at all times. Close observance of the
information given in this manual is a prerequisite for using the device as intended and for correct operation to
ensure user’s safety. Please note that information pertinent to several chapters is given only once.
Therefore, carefully read the manual once in its entirety.
• Using the device for purposes other than those described in this manual is not permitted.
• The safety information given in this manual is classied as follows:
• No part of this manual may be reproduced without written permission from DJO.
• Key to symbols used on the equipment
GENERAL INFORMATION...
Warning
Indicates a hazard. If not avoided, the hazard can
result in death or serious injury.
Caution
Indicates a potential hazard. If not avoided, the
hazard may result in minor injury and/or
product/property damage.
Caution, consult accompanying documents
Patient part type BF- Body oating
Device complies with the Council Directive 93/42/EEC
about medical devices, tested and approved by AMTAC
Certication Services Limited
Do not dispose with unsorted domestic waste
Manufacturer
DJO, LLC
1430 Decision Street
920181 Vista, CA
USA
Phone: +1-800-336-6569
Fax: +1-800-936-6569
MDSS GmbH
Schigraben 41
30175 Hannover
Germany
Phone: +49-511-6262-8630
Fax: +49-511-6262-8633
Manufacturer
DJO - LLC
1430 Decision Street
Vista - CA 92081
USA
0473
EC REP
EU Authorized Representative
MDSS GmbH
Schigraben 41
30175 Hannover
Germany
Storage temperature: from-20˚C to 45˚C
Max. relative humidity: 75%
Atmospheric pressure: from 700hPa to 1060hPa
Manufacturer
DJO - LLC
1430 Decision Street
Vista - CA 92081
USA
0473
EC REP
EU Authorized Representative
MDSS GmbH
Schigraben 41
30175 Hannover
Germany
Storage temperature: from-20˚C to 45˚C
Max. relative humidity: 75%
Atmospheric pressure: from 700hPa to 1060hPa
Manufacturer DJO - LLC 1430 Decision Street Vista - CA 92081 USA
0473
EC REP
EU Authorized Representative MDSS GmbH Schigraben 41 30175 Hannover Germany
Storage temperature: from-20˚C to 45˚C Max. relative humidity: 75% Atmospheric pressure: from 700hPa to 1060hPa
Supplied by EME Services Ltd