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MicroPace StimLab - General Handling Precautions; Pre-use and During-use Precautions

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USER INSTRUCTION MANUAL
Page 4 of 49 ENGLISH
Use only supplied Stimulus Connection Box (MP3014) or optional Stimulus Multiplexer Box
(MP3086) components to connect Stimulator’s stimulus output to patient circuits.
The MP3014 and MP3086 components are over voltage protected by gas arrestors for
differential voltages > 350VAC. Exposing these components to unfiltered RF ablation energies
exceeding this limit (e.g. by direct connection to unfiltered RF Ablation energies > 150W or
ablating into > 300 Ohm loads may cause reduction of RF energy available for ablation and
overheating and a fire hazard within these components.
Warning: Do not stimulate via ablation electrode during delivery of RF Ablation energy.
To avoid possibility of unintended arrhythmia induction, do not stimulate myocardium via the
ablation electrode during application of RF energy. Efficacy and potential for adverse effects of
stimulation of heated myocardium in the process of ablation have not been established.
1.4 General Precautions in Handling Stimulator
Caution: Installation, Transport, and Storage.
To ensure reliable operation of the Stimulator, install it in a well-ventilated place away from
dust, excessive heat or humidity, direct sunlight and splashing liquids.
To ensure operator may see important error messages displayed during operation, install with
the front panel of the Stimulus Generator Unit visible to the Operator.
To avoid damage to the Stimulator, avoid exposure to chemical gases, excessive vibration,
impact, temperatures above 60 Deg. Celsius or ambient air pressures equivalent to above
10000m altitude during transport and handling.
To ensure that backup battery remains fully charged, store system between uses with the
Stimulus Generator Unit connected to mains power supply, switched on at the rear panel
switch.
Assembly and modification of this Medical System during the actual service life requires
evaluation to the requirements of IEC 60601-1:2005.
Caution: Precautions prior to use.
When turning on the SGU, ensure all LEDs illuminate during the Power On Self Test and no
error messages are displayed, else refer to Troubleshooting section below.
Ensure that all cables are properly installed and secured.
Ensure that the mains power supply is isolated and that attached equipment is also electrically
isolated and does not pose an electrical hazard.
If the Stimulator has been unused or may have been disconnected from mains power supply
for more than 1 month, charge backup battery by leaving connected to the mains supply in
Standby Mode overnight.
Do not use the Stimulator if any component appears damaged, computer appears to start up
abnormally, or error messages appear on the computer screen or Stimulator front panel. If in
doubt, contact the Distributor or Micropace directly.
Ensure that the Operator is trained thoroughly on how to switch the Stimulator to Backup
Manual mode or Emergency Fixed Rate Pacing modes.
To prevent custom software malfunction, do not install other software.
Caution: Precautions during use.

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