Össur RHEO KNEE XC Instrucciones De Uso página 11

PRODUCT SPECIFICATION INFORMATION
The device is tested and certified to comply with the IEC/EN60601- 1, standard of electrical safety of medical
devices and IEC/EN60601-1-2, electromagnetic compatibility for medical electrical devices and ISO 10328. The
company fulfills the requirements of ISO13485, MDD 93/42/EEC, and the device is CE marked accordingly.
ENVIRONMENTAL CONDITIONS
• Operating temperature: -10 °C to 40 °C (14 °F to 104 °F)
• Operating humidity: 0% - 100% relative humidity
• Storage temperature: 0 °C to 45 °C (32 °F to 113 °F)
• Storage humidity: 10% - 90% relative humidity (non-condensing)
CAUTION: If the unit is either used or stored in cold environment (below 0 °C) for a period of time, it can cause
reduced extension speed of the device. If the device will not regain its normal function again it must be sent in
for service to Össur.
WARNING: The device is not designed for use in presence of flammable gases or oxygen rich environments.
POWER SUPPLY INFORMATION
• The power supply provided with the unit is certified to comply with medical electrical equipment standards. It is
only safe to use Össur recommended power supplies.
• Input: 100–240 VAC
• Input frequency: 50–60 HZ
• Input current: 0.6A
• Output voltage: 24 VDC
• Output current: 1.0 A
• Operating temperature: 0 °C to 40 °C (32°F to 104°F)
• Operating humidity: 5% to 95% relative humidity (non-condensing)
• Manufacturer: UE Electronic
• Model No.: UE24WCP-240100SPA
ELECTROMAGNETIC COMPATIBILITY PRECAUTIONS
SAFETY PRECAUTIONS
Because of electromagnetic compatibility (EMC) special precautions need to be taken with the device:
• The device should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use is
necessary, the device should be checked to make sure it operates normally.
• The device can be susceptible to electromagnetic interference from portable and mobile RF communications
devices such as mobile (cellular) phones.
• The device can be susceptible to interference from other equipment, even if the equipment complies with
CISPR EMISSION requirements.
MAINTENANCE
The unit should be sent to Össur for repairs or service. No other company or individual is allowed to service or
repair the unit in any way.
Before sending the device for repairs or service, make sure that the operating instructions have been followed
accurately. Immediately after exposure to water the device may emit slight noise during use.
CLEANING
• Clean the knee with a damp cloth and mild soap or isopropyl alcohol when needed. Dry the product with a lint-
free cloth and allow it to dry fully.
• DO NOT use solvents stronger than isopropyl alcohol.
• DO NOT use compressed air to clean the knee, as it can cause the knee to malfunction and deteriorate
prematurely.
LIABILITY
The manufacturer recommends using the device only under specified conditions and for the intended purposes.
The device must be maintained and used according to the instructions for use. The manufacturer is not liable for
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