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.

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