Specific Warnings; Residual Risk - Promeba ROLLED SPLINT PA-08 User Manual

USER GUIDE // ROLLED SPLINT PA-08
Review 2021/09

01.10 Specific warnings

1. Establish a maintenance program and periodic testing, identifying a reference employee.
The person to whom the ordinary maintenance of the device is entrusted must ensure the
basic requirements foreseen by the manufacturer in the user's manual.
2. Use only accessories/spare parts that are original or approved by Promeba, S.L. , when
carrying out any operation, to avoid causing any alteration or modification to the device,
otherwise we assume no responsibility for the proper functioning or damage resulting from
device to the patient or the operator and warranty will be considered void.
3. Never leave the patient unassisted on the device, because he may be injured.
4. Do not use bleach to disinfect the product. Use a hydroalcoholic based disinfectant and
wash with water.
5. The device and all its components, after washing, should be allowed to dry completely
before storing.
6. Keep clean as routine (incl. disinfect).
7. Follow procedures approved by Emergency Medical Services.
8. Avoid contact with sharp objects.
9. Use the Rolled Splint PA-08 only as described in this user's manual.
01.11 Residual risks
The residual risks listed below have been identified only with reference to the intended use
of the device:
1. Use by untrained personnel may result in injury to patient, operator, or third parties.
2. Inappropriate disinfection procedures can create a risk of cross infection.
3. Failure to comply with the warnings for operators can create risks.
4. Failure to read and understand the product instructions can result in injury to the patient
and operators.
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