Digitimer DS7A - EU Declaration and FDA Indications; EU Declaration of Conformity

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Operator's Manual DS7A - Constant Current Stimulator

EU Declaration of Conformity

File Ref: N:\Docs\Company\Manuals\DS7A\Issue-14\DS7A-iss14.odt Last Revised: February 1, 2017

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Warning & Caution5
Contact Addresses6
Purchase Information7
Product Registration8
- Why Register Your Purchase8
- How to Register Your Purchase8
- Product Announcement Mailing List8
- Table of Contents9
EU Declaration of Conformity12
FDA - Indications for Use13
Equipment Description14
Regulatory Statements14
- 60601-1:2006 + A1:2013 Classifications14
- Environmental14
Cleaning, Maintenance & Servicing14
Unpacking Your DS7A Stimulator15
Accessories15
Precautions & Warnings15
Product Intended Usage18
Indications for Use18
Explanation of Symbols Used on DS7A19
Front Panel Controls21
- Notes on Front Panel Controls22
Rear Panel Controls23
Insertion of DS7A Stimulus Output Connector24
Installation & Initial Check25
Stimulus Control26
- Pulse Duration' Control26
- Pulse Polarity' Control26
- Current Max.' Control and 'X1/X10' Range Switch26
- Volts Max.' Control27
- Out of Compliance' Indicator27
Trigger out Pulse Duration28
Maximum Stimulus Repetition Rates28
Specifications30
- Stimulus Output30
- Trigger30
- Indicators30
- External Fuses31
- Internal Fuses31
- Dimensions31
- Temperature31
- Other31
Stimulating Electrodes32
Mains Connection33
- Mains Plug Connections33
- Mains Plug Fuse33
- Mains Voltage Selector33
Trigger Polarity34
- Input Trigger34
- Output Trigger34
Explanation of Symbols Used on Accessories35
D185-Hb136
D185-Hb437
D185-Tcx - Trigger Cables38
D185-Fs139
Connection of DS7A to an EMG System40
- Introduction40
- Modes40
  - DS7A - Trigger-Out40
  - DS7A - Trigger-In40
- Setting up the EMG System41
- Artefact Rejection41
- Making Trigger Connections to the DS7A42
- Symbols Used in Connection with the Trigger42
- Description of Socket Function42
- Electrical Characteristics of Triggers43
- Trigger Pulse to Output Stimulus Relationship43
Bibliography44
- Appendix 1 .. DS7A Modification Record Status46
- New Instruments46
- The Modifications Made46
- Units that Have Been Modified after First Delivery46
Warranty Information57
- Limited Warranty57
- Obtaining Warranty Service57
- Product Change or Discontinuation57
- Digitimer Ltd58

Digitimer DS7A - EU Declaration and FDA Indications; EU Declaration of Conformity

Table of Contents