Specific Warnings; Residual Risk; Reference Standards - Promeba PA-55 User Manual

USER GUIDE // HEAD IMMOBILIZER PA-55
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.
4. Never leave the patient unassisted on the device, because he may be injured.
5. Do not use bleach to disinfect the product. Use a hydroalcoholic based disinfectant and wash with
water.
6.The device and all its components, after washing, should be allowed to dry completely before
storing.
7. Keep clean as routine (incl. disinfect).
8. Follow procedures approved by Emergency Medical Services for immobilization and transportation
of the patient.
9. Follow procedures approved by Emergency Medical Services.
10. Avoid contact with sharp objects.
11. Use the Head immobilizer 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.

01.12 Reference standards

REFERENCE
TITLE OF DOCUMENT
(UE) 2017/745
Reglamento UE del 05 de Abril del 2017 sobre productos sanitarios
As a distributor or end user of the products manufactured and/or distributed by
Promeba, S.L., you are strictly obliged to know the legal provisions in force in the
country of destination of the goods, applicable to the devices to be supplied (including
the regulations relating to technical specifications and/or safety requirements) and,
therefore, understand the necessary requirements to ensure compliance of the products
themselves with all the legal requirements of the territory.
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