Digitimer DS5 - Technical Annexes; Annex 1: Recurrent Testing; Test Procedures and Inspections

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DS5 Isolated Bipolar Constant Current Stimulator DS5 Operator's Manual 5.0

CHAPTER 4

TECHNICAL ANNEXES

ANNEX 1:- Recurrent Testing of the DS5

Recurrent testing of medical electrical equipment is often required as part of the equipment management

policy of hospitals or other responsible organisation. These tests may be required before the equipment is

put into service, or after fixed time intervals.

The international standard, IEC 62353 (Recurrent test and test after repair of medical electrical equipment),

suggests testing intervals. For equipment that applies electrical energy, to directly influence the function of

nerves or muscles, as the DS5 can, the suggested test intervals should be no more than 24 months.

Every DS5 supplied is extensively tested by Digitimer before delivery.

These instructions are meant as a guide to suitably qualified test personnel, with authority to perform these

tests on behalf of the responsible organisation for the equipment involved. They provide guidance to allow

the tests to be accomplished without causing damage to the equipment or exposing the test personnel to

risk. They cannot and must not replace the training and experience required for testing medical electrical

equipment.

Test Procedure

Before commencing the test procedure it is important to fully understand the operation of the DS5 by

reading the Operator's Manual.

The DS5 is a Class 1 device with Type BF applied parts.

There is no requirement, in any of these tests, to open the case of the DS5. All repair procedures should be

referred to Digitimer or a local distributor.

Visual Inspection

Visually check for any damage to the enclosure of the DS5. Also carefully check for damage to the supply

lead and any input or output cables.

Check that the voltage selectors on the rear panel are set to suit the local supply voltage.

Check that the 2 mains fuses, housed within the appliance coupler, are of the correct rating and type for the

local supply voltage.

Check for signs of contamination or fluid spill. If fluid has entered the enclosure refer the repair to Digitimer

or it’s local distributor.

Check that the tamper-evident seals on the rear of the DS5 are unbroken and un-disturbed. Evidence that

the enclosure has been opened may indicate the need for more extensive testing.

Electrical Tests

The electrical tests may be most easily accomplished using combination test equipment such as the Rigel