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Impulse Dymanics OPTIMIZER Smart System - Maintenance; Storage and Handling; Disposal; 35 Service and Warranty

Impulse Dymanics OPTIMIZER Smart System
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101
34.8 Maintenance
The OPTIMIZER Mini Charger does not contain any user serviceable parts. If the
OPTIMIZER Mini Charger is not operational, please contact your Impulse Dynamics
representative to obtain a replacement charger.
Warning: No modification of this equipment is allowed.
The battery inside the OPTIMIZER Mini Charger is expected to have a service life of 5
years. If the OPTIMIZER Mini Charger is unable to fully charge an OPTIMIZER Smart
IPG after the charger battery has been fully charged, please contact your Impulse
Dynamics representative to obtain a replacement charger.
34.9 Storage and Handling
The OPTIMIZER Mini Charger is designed to function normally after it has been
exposed (while being packaged for transport) to the following environmental extremes:
(1) -4°F to +140°F, (2) relative humidity 10% to 100% (with or without condensation),
(3) atmospheric pressure 500 hPa to 1060 hPa.
The OPTIMIZER Mini Charger should not be exposed to excessively hot or cold
conditions. Patients should be instructed not to leave the devices in their car or outdoors
for extended periods of time. The sensitive electronics can be damaged by temperature
extremes, particularly high heat. For proper operation, the Charger should not be used if
the ambient temperature is above 80°F. In addition, the recommended conditions for use
are relative humidity between 20% and 75%, and atmospheric pressure between 700 hPa
and 1060 hPa.
34.10 Disposal
If the OPTIMIZER Mini Charger is no longer needed by the patient and is returned,
please notify your Impulse Dynamics representative of its return.
Warning: DO NOT discard the OPTIMIZER Mini Charger in the trash. The
OPTIMIZER Mini Charger contains Lithium batteries as well as non-RoHS
components. If disposal of the OPTIMIZER Mini Charger is necessary,
properly dispose of the OPTIMIZER Mini Charger in accordance with local
regulations governing the disposal of such material.
35. SERVICE AND WARRANTY
For emergency assistance, Impulse Dynamics has professional technical staff on call around the
clock. If you require assistance, please contact your local Impulse Dynamics representative.
35.1 Limited Warranty Information
Impulse Dynamics warrants that all IPGs (including the respective firmware and
software) will be free from defects in workmanship and materials for a period of 24
months after the original implantation of the IPG (the “Warranty Period”).
If it appears that any IPG or part thereof appears to be defective in workmanship or
materials, or fails to conform to applicable specifications, Impulse Dynamics shall either
replace defective or non-conforming implantable components or repair or replace
defective or non-conforming non-implantable components. The warranty period for a
replaced or repaired IPG shall be the time remaining on the original warranty period or
nine months from delivery of the repaired or replaced IPG, whichever is longer.

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