Product Info

10001045 REV B 17
6 PRECAUTIONS
PRECAUTIONS. Instructions about the device patients and doctors should follow to avoid damage to the
device, so that it will function correctly and last longer.
6.1 Storage
Store the Senza
®
Bluetooth
®
Trial System components and accessories at the prescribed temperatures, whether
in transport or storage. Excessively hot or cold temperatures may damage the components, particularly high heat.
Devices should be kept in temperature regulated areas within the acceptable temperature range. Do not expose
the components to liquids or excessive moisture.
• The storage temperature range for the Trial Stimulator is 0°C to 45°C (32°F to 113°F).
• The storage temperature range for the Remote Control is -20°C to 60°C (-4°F to 140°F).
6.2 Operating Temperatures
• The operating temperature range for the Remote Control is 5°C to 40°C (41°F to 104°F).
• The operating temperature range for the Trial Stimulator is 5°C to 40°C (41°F to 104°F).
• Device surface temperatures may reach a couple of degrees above ambient conditions. Therefore at
40°C, the maximum operating surface temperature for the Patient Remote & Trial Stimulator may exceed
41°C, up to 43°C (109°F).
6.3 Sterilization
The Trial Stimulator and all implanted components are intended for single use only.
• Prior to opening the sterile package, inspect the sterilization indicator and the sterile package.
• Do not use the contents if the package is broken or torn, or if contamination is suspected because of a
defective sterile package seal.
• Do not use any component that shows signs of damage.
• Do not re-sterilize the package or the contents. There is risk of infection and device malfunction.
• Do not use if "Use by" date has passed.
• Do not re-use the Trial Stimulator or any of the implanted components.
6.4 Handling
Use care when handling the Senza
®
Bluetooth
®
Trial System’s components and accessories. Do not drop them or
submerge them in water. Do not impact the system components against hard surfaces and avoid rough handling.
Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the
devices on hard surfaces or in water or other rough handling, can permanently damage the components and
accessories.
6.4.1 Handling the Leads and Lead Extensions
Follow these guidelines when handling the leads or lead extensions: