Conditions of use and storage
Temperature for use: SYNSYS is designed for use in places where the ambient temperature is
between -10 and 40°C. In case of exposure to excessively low or high temperatures, your
device's operation may be altered.
Atmospheric pressure: 700 – 1060 hPa.
Air humidity (RH): 15% - 90%. No condensation
Storage and transport temperature: RH 15% - 90% with no condensation
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Long term (more than 1 week): between 0°C and 30°C
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Short term (less than one week): between -20°C and +60°C
Following storage at -20°C, wait for 16 minutes for the knee to become operational (≥ -10°C).
Following storage at 60°C, wait for 35 minutes for the knee to become operational (≤ 40°C).
For transport, switch off the SYNSYS and pack it properly. Avoid leaving the prosthesis in places
with excessive temperatures.
Preferably store the prosthesis in the vertical position.
Following prolonged storage, leave the prosthesis vertical for 2 hours, recharge the prosthesis,
test the brake and check that the vibrator is operating properly; dust off.
Regulatory information
This product is tested and certified compliant with Regulation (EU) 2017/745, and with
Class B under standards IEC 60601-1, 60601-1-2, 60601-1-4, 60601-1-11, ETSI EN 300-
328, EN 62311 and ISO 10328 - P6 - 125 kg.
The device complies with part 15 of the FCC regulations, and bears the CE marking
EN - 21