Manufacturer
Xavant Technology Pty (Ltd)
Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd
Silverton, Pretoria, South Africa, 0184
Tel:
+27 (0) 12 743 5959
Fax:
+27 (0) 86 547 0026
E-mail: [email protected]
Web: www.xavant.com
Legal Representative in the EU
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Tel:
+31 70 345 8570
Fax:
+31 70 346 7299
Indications for use:
The STIMPOD NMS460 is a Transcutaneous Electrical Nerve Stimulation device
used for symptomatic relief and management of chronic intractable pain and/
or as an adjunctive treatment in the management of post-surgical pain, post
traumatic acute pain problems, as well as an adjunct for pain control due to
rehabilitation.
Contraindications:
• Known neurological disorders.
• Do not use this device on patients who have a cardiac pacemaker, implanted de-
fibrillator, or other implanted metallic or electronic device, because this may cause
electric shock, burns, electrical interference, or death.
• Do not use this device on patients whose pain syndromes are undiagnosed.
Warnings:
• Read the entire User Manual before attempting to use the device.
• Use of cables or accessories other than those supplied with the STIMPOD NMS460
may result in serious injury.
• Maintenance on this device may only be performed by the manufacturer or
persons explicitly authorized by the manufacturer.
• Do not use the STIMPOD NMS460 in close proximity to equipment that produces
strong electromagnetic fields, such as high frequency surgical equipment. The
cable leads could act as antennae and dangerous currents could be induced as
a result.
• The device should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
• The patient should avoid contact with metallic objects that are grounded, produce
an electrical conductive connection with other equipment and/or enable capacitive
coupling.
• The cables should be positioned in such a way that they do not contact either the
patient or other cables.
• Simultaneous connection of a patient to high frequency surgical ME equipment
and the STIMPOD NMS460 may result in burns and possible damage to the
stimulator.
• Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME
equipment may produce instability in the stimulator output.
• Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
• If battery acid has leaked into the device essential circuitry may have been
compromised. In the event of leakage the device must be returned to its
manufacturer for safety checks and possible repairs.
• Do not apply stimulation over the patient’s neck because this could cause severe
muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse
effects on heart rhythm or blood pressure.
• Do not apply stimulation over open wounds or rashes, or over swollen, red,
infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis,
varicose veins).
• Do not apply stimulation over, or in proximity to, cancerous lesions.
• Do not apply stimulation when the patient is in the bath or shower.
• Do not apply stimulation while the patient is sleeping.
• Do not apply the stimulation while the patient is driving, operating machinery,
or during any activity in which electrical stimulation can put the patient at risk of
injury.
• Do not apply stimulation when the leads are open circuited (e.g. when the
electrodes are held in the user’s hands).
• Do not remove electrodes when stimulation is being applied (to avoid unintended,
possibly hazardous, stimulation pathways).
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