Draegerwerk and KGaA EASTM21 Inductive Tag Reader module User Manual title
Draeger Medical GmbH Inductive Tag Reader module title
Users Manual
Project file Module M21: 10.1 Instruction for use (IFU)
revision 03 Page 1 of 1
revision date 16.07.2007
release status released if signed
T:\Projekte\TCB USA\Draeger Medical AG & Co. KG\UVFEAST-MP02001\10.1 Instruction for use (IFU)-Rev3.doc
title 10.1 Instruction for use (IFU)
responsible
Gerd Wotha creating system
MS-Word
author
Gerd Wotha document type doc
filling
Design history file KM-tool tbd
filling name and path
I:\Techn Management\Projekte\Electronic_Accessory_Signature_System\DP-
Project\05-Qualification\CE & FCC Akte\CE-Akte\10 Device Labelling\10.1 IfU incl accessory
list\10.1 Instruction for use (IFU).doc
Released
name
Gerd Wotha
date
signature
1. Instruction for use of Medical device
1.1. Declaration of conformity
- A declaration of conformity according to R&TTE will be inserted to each instruction for use
of the Medical device which uses the Module M21.
1.2. General items
- M21 Reader Module is an integrated part within Draeger Medical devices. The
antennas are permanently connected to the M21 via connectors.
- M21 Reader Module has an operational manual. The programming of the Draeger
Medical device is based on this document. There is no user interface to the module.
1.3. Mandatory text
- Changes or modifications not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment
- The intended use of the M21 will be explained within each instruction for use of the
Medical device which uses the Module M21.
- Following text has to be content of the device IFU:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.