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8.0 Maintenance—for Medical Personnel
Attention!
Do not immerse the PRO Controller in any fluids.
Cleaning
Gently clean all exposed surfaces with a mild soap or alcohol. Do not use abrasive cleansers. To disinfect, wipe all
exposed surfaces with a 10% solution of bleach and water, or other suitable disinfectants. Do not immerse the device in
liquids. Store the CPM device in its box when not attached to the bed.
Operator Maintenance Between Patients
• Patient Kits for the device are for single patient use only and cannot be washed for reuse.
• Check the entire device for any visible evidence of damage such as bent components, cracked or broken covers,
frayed or damaged wires, etc. If any signs of damage are found, the device must be repaired before use.
• Ensure that all knobs and/or levers are usable and in place.
• Ensure that all moving components move freely as required.
• Check all displays and electronic controls for proper operation.
• Check all mechanical pivot and linkage points for smooth operation and secure mechanical connection. Make sure all
screws, nuts, bolts, rivets, pivot pins, and other fasteners are secure.
• Gently wipe clean all exposed surfaces with a soft cloth dampened with a mild soap solution or alcohol. Do not use
abrasive cleansers. To disinfect, wipe all exposed surfaces with a 10% solution of bleach and water, or other suitable
disinfectants.
• Ensure that all labels are present.
• Replace the Patient Kit.
• Verify that the device operates to its set limits over several complete cycles.
• For Range of Motion (ROM) settings verify device calibration by observing the ROM of the device while taking a
visual reading using a goniometer at the device's anatomic pivot points. Compare the ROM settings of the device
with the goniometer readings. ROM readings should be within +/- 5° of the set parameters. If the readings do not fall
within the set parameters, the device needs to be checked and recalibrated by a properly trained Service Technician.
Maintenance Every Six Months
• Repeat steps under "Maintenance Between Patients".
Maintenance Every Twelve Months
• Repeat "Maintenance Between Patients" procedures.
Maintenance Every Eighteen Months
• A full inspection of the device by a properly trained Service Technician is recommended every 18 months.
• Repeat steps "Maintenance Every Twelve Months".
• Fully inspect all internal and external mechanical and drive components, and repair or replace as necessary.
• Fully inspect all internal and external electrical components (including wire connectors and solder joints), and repair or
replace as necessary.
• Perform a complete recalibration and subsequent check of electronic and mechanical safety systems including
Reverse-On-Load function and Range of Motion controls.
• Complete a final check of the device in accordance with Otto Bock Final Inspection criteria. (These are available
through your Sales representative, Otto Bock Customer Service, or your local distributor.)
Sterilization
• This device does not require sterilization for use.
• Exposing the device to sterilization conditions will damage the device and may result in a potential hazard.
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