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Indications:
PENS therapy is electrical stimulation of the nerves and nerve endings contained within the subcutaneous tissue intended for the symptomatic relief and management of chronic intractable neuropathic pain.
Contraindications:
Contraindications include; demand type cardiac pacemakers, caution with patients known to have heart disease, epilepsy, pregnancy, avoid transcranial stimulation, local infection, patients on anticoagulants, generalised septicaemia, non consenting. Safety has not been established for paediatric use. Possible adverse events include; possibility of infection at probe entry point, temporary increase in pain, bleeding at probe entry point, haematoma, peripheral misplacement may cause temporary neuroplaxis.
Warnings & Precautions:
The NeuroStimulator is to be operated by qualified personnel only. Do not modify the PENS therapy equipment in any way. Any modifications may compromise safety and efficacy. Before use this manual should be carefully read and understood.
Risk of Fire:
Do not use in the presence of flammable anaesthetics or flammable fluids such as skin prepping agents, flammable objects or in oxygen enriched atmospheres or in the presence of oxidizing agents to avoid the risk of ignition of these gases or dressings.
Risk of Burns to the Patient:
Position the return electrode pad as indicated by the manufacturer to avoid burns or interference with other equipment. Use only the PENS therapy return electrode cable and hospital grade return electrode pads.
Interference with Active Implants:
During stimulus output implanted devices such as demand type pacemakers may be affected. Qualified advice should be obtained as necessary to minimise the risk of injury from implanted device malfunction. Use in these circumstances is at the discretion of the physician. When the NeuroStimulator is in stimulus output mode, the conducted electrical fields may interfere with other electrical medical equipment.
The PENS therapy Probes must only be used with the Algotec Dual Intermediate Cable. Attempts to use it with other Intermediate Cables can result in electric shock to the patient or operator. Cables must be checked for insulation integrity prior to use to avoid the risk of burns to patient or user. Damaged probes or cables must be discarded.
The PENS therapy Probe and Connector Cable is STERILE and is intended for single use only. The Dual Intermediate Cable is non-sterile and is intended for limited re-use.
Do not attempt to use the NeuroStimulator. Never remove the cover of the NeuroStimulator as there is a potential for electric shock. Servicing should only be undertaken by authorised personnel.
The mains power cord of the NeuroStimulator must be connected to a properly grounded receptacle. Extension cords and adaptor plugs must never be used. Do not wrap instrument cables around metal objects as this may induce hazardous currents. Do not activate stimulus output until the Probe is properly positioned in the patient and the Return Electrode is in place.
The audio alert tones and activations lights are important safety features and should not be obstructed or disabled. The NeuroStimulator and PENS therapy Probes and accessories must be used by physicians familiar with PENS therapy technique only. Probe misplacement has the potential to cause injury.
Algotec relies on the physician to determine, assess and communicate to each individual patient all foreseeable risks of PENS therapy and to obtain informed consent as required. |
