Xavant STIMPOD NMS 410 Manual page 2

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: support@xavant.com
Web: www.xavant.com
Legal Representative in the EU
Emergo Europe
Prinsessegracht 20, 2514 AP The Hague
The Netherlands
Caution
Federal (US) law restricts this device to sale by or on the order of a physician.
Indications for use:
This product is a nerve stimulation device designed to be used by an anaesthetist during
•
General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular
Blocking Agent using non-invasive surface electrodes (not supplied) (NMS450X).
•
Regional Anaesthesia for the purpose of
• Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).
• Nerve locating using invasive electrodes/needles (not supplied).
Contraindications:
•
Infection of the puncture site.
•
Known neurological disorders.
•
Severe coagulation disorders.
2
Warnings:
•
Read the entire User Manual before attempting to use the device.
•
Use of cables or accessories other than those supplied with the STIMPOD 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 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.
•
Do not apply the STIMPOD to patients with implanted electrical devices, such as
cardiac pacemakers, without first consulting with an appropriate medical specialist.
•
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 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.
•
No modification of this equipment is allowed.
•
Do not modify this equipment without authorization of the manufacturer.
•
If this equipment is modified, appropriate inspection and testing must be conducted
to ensure continued safe use of the equipment.
Cautions:
•
Prior to changing the batteries be sure to switch off the device and remove all the
cables.
•
Remove elements which may adversely affect the connection between the
electrodes and the skin, e.g., dirt, hair, oil.
•
Ensure that ECG electrodes are not damaged or dried out.
•
Large current densities associated with failing ECG electrodes may cause superficial
burns.