Digitimer DS5 - Precautions and Warnings; Patient Safety and Operational Hazards

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

Digitimer Limited makes no representation that the design, implementation, testing or manufacture of the

DS5 stimulator meets more than reasonable standards for use as a medical product. As stated in the

Digitimer Limited Warranty Statement, supplied with each product, “Digitimer Limited Expressly disclaims all

warranties to buyer except the limited warranty set forth therein, including without limitation to any and all

implied warranties of merchantability and fitness for a particular purpose.”

Precautions & Warnings

Operator’s Manual

Carefully study this Operator’s Manual before using the DS5 Bipolar Constant Current Stimulator.

Risks to Patient Safety



Stimulating electrodes should not be placed thoracically or trans-thoracically as this may increase

the risk of cardiac fibrillation. A warning to this effect is given on the outside of the DS5.



Care should be taken when selecting appropriate stimulating electrodes. If the current density of

the chosen electrode is greater than 2mA rms/cm

then the operator should pay extra attention to

stimulus parameters to ensure that the patient does not suffer burns at the stimulation site.



Simultaneous connection of a patient to the DS5 and high frequency surgical equipment may result

in burns at the site of stimulation and possible damage to the stimulator.



Operation of the DS5 in close proximity (e.g. 1m) to a shortware or microwave therapy equipment

may produce instability in the stimulator output.



The DS5 is not suitable for use in close proximity to extreme magnetic fields, such as those

generated by MRI scanners.

Patient Exclusion Criteria

Patients fitted with an implanted electronic device such as a cardiac pacemaker should NOT be subjected to

stimulation unless specialist medical opinion has been obtained.

Explosion and Fire

The DS5 must not be used in an explosive atmosphere or in the presence of flammable anaesthetic gasses.

High Voltages

Dangerous voltages are present within this unit. Do not remove covers, and refer servicing a Digitimer

representative.

WARNING

For Patient and Operator Safety, this manual

should be FULLY read and understood

before use of this product