3
•
The Stimpod is designed to be compatible with a standard ECG electrode, however,
for high currents the use of a dedicated NMT electrode such as the Xavant XT45008
is recommended.
•
Electrodes that have current densities exceeding 2mA/cm2 may require special
attention of the operator.
•
This product must be stored at 0 – 50°C.
•
This product must be transported in the carry case provided.
•
This product and all the accessories have been certified latex free.
•
Inspect all parts for any damage or manipulation. Never use any damaged or
manipulated part!
•
If an electrically conductive surface of the Stimpod device or its cables are exposed,
such electrically conductive surface may shock a person handling it. Do not use such
a device or accessory, please contact the manufacturer for repair.
•
The refractory period delay is set at a default value to prevent the user from
repeating stimulation while the nerve synapse is recovering from effects of the
previous stimulation. A refractory period of less than 12 seconds in TOF mode is not
advisable as measurements might not represent the effect of blocking agents on the
neuromuscular junction.
Application Specification:
•
The patient population includes patients of all ages, weight and nationality. Patient
health and state is described in contraindications, warnings and cautions.
•
The user must be a medical professional with knowledge of anatomy.
•
The use environment requirements of the device such as the medical practice and
operating room is described in the guidance and manufacturers declaration.
•
The device can be used on any part of the body except for limitation described in
warnings and cautions or identified in section 3 for the NMT mode.
Warranty:
•
The Stimpod (device only) carries a 24 Month Warranty against defects, provided that
the device was used in accordance with the operating instructions.
•
The cables included in the Stimpod Kit carry a 6 Month Warranty against defects,
provided that they were used in accordance with the operating instructions.
•
The Stimpod enclosure should not be opened under any circumstances. Opening
the unit will void the warranty.
STIMPOD (NMS 410/450X) conforms to the following
standards:
•
IEC 60601-1, IEC 60601-2-10
•
IEC 60601-1-2: CISPR 11 Group1 class A; IEC 61000-4-2; IEC 61000-4-3
•
ISO 13485, Directive 93-42-EEC
