8
Trigno™
System User’s Guide
Warnings and Precautions
Consult all accompanying documents for precautionary statements and
other important information.
Consult accompanying user’s guide for detailed instructions.
Keep the device dry. The ingress of liquids into the device may compromise
the safety features of the device.
Handle with care.
Sensitive electronic device. Avoid static discharges. Do not operate or store
near strong electrostatic, electromagnetic, magnetic or radioactive fields.
Interference from external sources may decrease the signal-to-noise ratio
or result in corrupted data.
Connect only to Delsys-approved devices.
Connecting a patient to high-frequency surgical equipment while using
Delsys EMG systems may result in burns at the site of the EMG sensor
contacts
Immediately discontinue device use if skin irritation or discomfort occurs.
Immediately discontinue device use if a change in the device’s
performance is noted. Contact Delsys technical support for assistance.
Delsys Inc. guarantees the safety, reliability, and performance of the
equipment only if assembly, modifications and repairs are carried out by
authorized technicians; the electrical installation complies with the
appropriate requirements; and the equipment is used in accordance with
the instructions for use.
Device contains a Lithium-Polymer battery. Do not damage, crush, burn,
freeze or otherwise mishandle the device. Recharge only with the
approved power supply and recharger.
Trigno Systems should be stored and operated between 5 and 50 degrees
Celsius due to the presence of an internal Lithium Polymer rechargeable
cell. Storing or operating the device, and consequently the cell, outside of
this temperature range may compromise the integrity and the safety
features of the cell.
Device Information
Complies with Requirements put forth by the Medical Device Directive
93/42/EEC. Class I device, Annex VII. Type BF device (IEC 60601-1)
Isolated device, (Class II, IEC 60601-1)
