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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. 

 

 

Содержание PA-190

Страница 1: ...USER GUIDE PEDIATRIC IMMOBILIZATION SYSTEM PA 190 Review 2021 09...

Страница 2: ......

Страница 3: ...ents of the operators 06 01 8 Intended purpose 06 01 9 General warnings 06 01 10 Specific warnings 09 01 11 Residual risk 09 01 12 Reference standards 10 01 13 Life span 10 02 PRODUCT DESCPRIPTION 10...

Страница 4: ......

Страница 5: ...manufacturer s serial number to identify a specific medical device Indicates the manufacturing date The symbol must be accompanied by a manufacturing Date yyyy mm adjacent to the symbol It is placed t...

Страница 6: ...nts of the operators Promeba s Pediatric immobilization system PA 190 is destined to professional use only The operators must be trained in efficient effective and safe patient transport 01 8 Intended...

Страница 7: ...other than described in this manual is forbidden 10 Do not alter or modify in any way the device any such interference could cause malfunctions and injury to the patient and or rescuer 11 The device m...

Страница 8: ...cluding 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...

Страница 9: ...ect 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...

Страница 10: ...d 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 mu...

Страница 11: ...Open the head support 7 Align the color coded restraints with the patients as follows Restraint Colour coded Area Chest restraint Red Even with patient s armpits Upper hip restraint Yellow Just above...

Страница 12: ...e the patient s chin if needed 13 Wrap the head support around the patient s head The slots in the head support should be in line with the patient s ears 02 3 3 Transport the Patient 1 Use an ambulanc...

Страница 13: ...t the backboard into the cover and close the cover flap 4 Attach the head support and the Pediatric Immobilization System and fasten the restraints 5 Slide the Pediatric Immobilization System into its...

Страница 14: ...E REGISTER The product must be used by trained personnel only having attended specific training for this device and not for similar products Keep this document at least 10 years from the end of life o...

Страница 15: ...as indicated by the manufacturer in this user s manual Keep this document at least 10 years from the end of life of the device DATE TYPE OF SERVICE Maintenance verification extension of useful life OP...

Страница 16: ...t The possession of this document does not entitle no license to these patents The information contained in this document does not affect or change the specifications or product specifications or warr...

Страница 17: ...product or incorrect installation of accessory parts not previously tested iii States or defects of the system in which the product is used or incorporated with the exception of other pro ducts Prome...

Страница 18: ...ta o la inexactitud de la informaci n aqu mencionada All rights reserved Variations can be done without notice Promeba S L is to be considered not responsible for damages caused by the lack or the wro...

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