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Digitimer DS7A User Manual

Digitimer DS7A
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Digitimer
Constant Current Stimulator
DS7A (including DS7AH)
OPERATOR’S MANUAL
0120
The DS7A/DS7AH has been Listed for human use
in Europe, USA, Canada and other Countries.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Digitimer’ is a registered Trade Mark of Digitimer Limited

Table of Contents

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Digitimer DS7A Specifications

General IconGeneral
BrandDigitimer
ModelDS7A
CategoryAnalytical Instruments
LanguageEnglish

Summary

Product Registration and Information

Why Register Your Purchase

Explains the benefits of registering the product for updates and safety information.

How to Register Your Purchase

Details methods for registering the product, including online and mail-in options.

Product Announcement Mailing List

Information on joining mailing lists for product announcements and updates.

Warning and Safety Precautions

General Warnings

Critical safety advice emphasizing reading the manual before use.

Percutaneous Stimulation Definition

Clarifies the meaning of 'Percutaneous Stimulation' as skin-through stimulation.

Contact and Company Information

Manufacturer Details

Contact information for Digitimer Limited, the manufacturer.

International Representatives

Contact details for representatives in USA, Japan, and Germany.

Purchase Information

Device Specifications

Stimulus Output Parameters

Details current, pulse duration, polarity, and compliance ranges for stimulus output.

Trigger Input and Output

Describes trigger input options, output signals, and maximum trigger rates.

Indicators and Fuses

Information on unit indicators (LEDs) and external/internal fuse specifications.

Physical and Environmental Specifications

Covers dimensions, weight, temperature ranges, and power requirements.

EU Declaration and FDA Indications

EU Declaration of Conformity

Statement of conformity with EU directives for medical devices.

FDA Indications for Use

Details the intended use of the device as per FDA registration.

Equipment Description and Statements

Equipment Description

Overview of the DS7A Stimulator's features and capabilities.

Regulatory Statements

Classifications, environmental, and maintenance/servicing guidelines.

Unpacking and Accessories

Unpacking the DS7A Stimulator

Instructions on how to unpack the device and keep the packaging.

Available Accessories

Lists of standard and optional accessories like headboxes and cables.

Product Usage and Intended Purpose

Product Intended Usage

Defines the intended use of the DS7A Stimulator and limitations.

Indications for Use

Specifies the clinical applications for neurological monitoring and assessment.

Explanation of Symbols

Front Panel Symbols

Defines symbols found on the front panel of the DS7A Stimulator.

Rear Panel Symbols

Defines symbols found on the rear panel of the DS7A Stimulator.

Front Panel Controls Overview

Front Panel Control Descriptions

Detailed explanation of each control and indicator on the front panel.

Notes on Front Panel Controls

Important operational notes and interactions between front panel controls.

Rear Panel Controls

Stimulus Output Connector Insertion

Installation and Initial Checks

Stimulus Control Operations

Pulse Duration and Polarity Control

Setting pulse duration and selecting between normal, reverse, and alternating polarity.

Too-fast Warning and Cut-out

Behavior and reset procedure for excessive trigger rates in alternating mode.

Current Max and Range Settings

Adjusting output current levels using the dial and range switch.

Volts Max Control

Setting the maximum output voltage limit.

Out of Compliance Indicator

Indicates when voltage is insufficient for the selected current and impedance.

Maximum Stimulus Repetition Rates

Repetition Rate Limitations

Explains limits on repetition rates based on pulse duration and current.

Trigger Out Pulse Duration

Specifies the duration of the trigger output pulse.

Stimulating Electrodes

Mains Connection Procedures

Mains Plug and Wiring

Guidance on connecting the mains lead and ensuring proper grounding.

Mains Plug Fuse Requirement

Specifies the correct fuse rating for the mains plug.

Mains Voltage Selector

Instructions for setting the voltage selector based on local supply.

Trigger Polarity Settings

Input Trigger Configuration

Details on trigger input signal characteristics and configuration.

Output Trigger Signal

Describes the properties of the TTL trigger output signal.

Accessory Symbols and Identification

Specific Accessories

D185-HB1 Headbox

Description and connection of the D185-HB1 electrode headbox.

D185-HB4 Headbox

Description and connection of the D185-HB4 electrode headbox.

D185-TC Trigger Cables

Details on various trigger cables for connecting to recording systems.

D185-FS1 Foot Switch

Information on the medical-grade foot switch and its connection.

Connecting to an EMG System

Introduction and Trigger Modes

Explains the need for synchronization and two basic trigger modes.

EMG System Setup and Artefact Rejection

Guidance on EMG system settings and managing stimulus artefacts.

Trigger Connections and Characteristics

Trigger Symbols and Socket Functions

Defines trigger-related symbols and describes rear panel socket functions.

Trigger Electrical Characteristics

Details electrical properties of trigger inputs and outputs.

Trigger Pulse to Stimulus Relationship

Illustrates the timing relationship between trigger pulses and stimulus output.

Bibliography

DS7A Modification Record Status

New Instruments Status

Explanation of the 'Mod. State' for new units.

Units Modified After Delivery

Information on units that have undergone modifications post-manufacture.

Details of Recent Modifications

List of recent changes that affect the 'Mod. State' of the unit.

Appendix 2: DS7AH High Output Current

DS7AH Performance Differences

Compares the DS7AH's higher output current to the standard DS7A.

DS7AH Safety Considerations

Notes that safety features are maintained despite increased current output.

Appendix 3: Operational Tests

Appendix 4: Recurrent Testing Procedures

Test Procedure and Visual Inspection

Guidance on performing recurrent tests and visual checks on the DS7A.

Electrical and Functional Tests

Instructions for performing electrical safety tests and functional checks.

Evaluation, Documentation, and Normal Use

Analysis of test results and preparation for returning the unit to service.

Appendix 5: EMC Guidance and Declarations

Electromagnetic Emissions

Declarations and guidance on RF and harmonic emissions compliance.

Electromagnetic Immunity

Immunity test levels and guidance for ESD, transients, surges, and voltage variations.

Recommended Separation Distances

Guidelines for safe separation distances from RF communication equipment.

Appendix 6: Guidance on System Integration

Warranty Information

Limited Warranty Terms

Details the warranty period, coverage, and exclusions for the product.

Obtaining Warranty Service

Procedure for returning the product for warranty service.

Product Change or Discontinuation

Digitimer's right to change or discontinue products without notice.