5
Direct TENS
™
• The product Direct TENS™ bears the CE marking CE-0473 (Notified Body: AMTAC Certification Services
Limited) showing that it complies with the Council Directive 93/42/EEC as amended concerning medical
devices and fulfils the essential requirements of Annex I of this directive. It has an internal power source
and is classified as IIa equipment (MDD).
• The device has a type BF applied part.
• The device fulfils 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 classified as follows:
• No part of this manual may be reproduced without written permission from DJO.
• Key to symbols used on the equipment
Warning
Indicates a hazard. If not avoided, the haz-
ard 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.
GENERAL INFORMATION
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