Promeba PA-190, User Manual

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USER GUIDE // PEDIATRIC IMMOBILIZATION SYSTEM PA-190
Review 2021/09
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.
01.13 Life span
If used as described in the following instructions, this device has a useful life of 10 years
from the date of purchase.
This useful life can be extended with annual reviews carried out by the manufacturer, which
uses specialized and authorized internal and external technicians.
In case these annual checks are not carried out, the device must be disposed of according
to the information in paragraph 01.4 and the manufacturer must be notified.
Only the manufacturer or an authorized center can extend the life of the device, if it meets
the safety requirements.
Promeba, S.L. will not accept any responsibility for malfunction or damage caused by the
use of devices that have not been checked by the manufacturer or authorized center, or that
have exceeded the maximum allowed useful life.
ODUCT DESCRIPTION
02
PRODUCT DESCRIPTION
02.1 Product Features
The Model is a device designed to aid in stabilizing and immobilizing a pediatric trauma patient.
The Pediatric Immobilization System is for professional use by a minimum of two trained operators.
02.2 Components
The Pediatric Immobilization System features include:
1. A plywood backboard with a removable nylon cover
2. An adjustable, color-coded restraint system
3. A head support, lifting handle, and cot attachment loops.
4. Included a carrying case, a Pediatric Immobilization System, and two head restraints.