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USER GUIDE // 

PEDIATRIC IMMOBILIZATION SYSTEM PA-190 

Review 2021/09

 

6

 

 

 

 

 

 

01.4  Demolition

 

 

When  the  devices  are  no  longer  suitable  for  use,  if  they  have  not  been  contaminated  by  any 
particular  agent,  they  can  be  disposed  of  as  normal  solid  waste,  otherwise,  follow  the  current 
demolition regulations.

 

 

 
 

01.5    Labelling

 

 

Each  product  incorporates  an  identification  label,  placed  on  the  device  itself  and/or  on  the  box.  It 
must  never  be  removed  or  covered.  This  label  includes  the  serial  number  and  the  product  code. 
Please keep these numbers so you can inform the dealer if necessary.

 

 

 
 

 
 
 

 
 

 
 
 

 
 
 

1.6 

Contraindications and adverse effects

 

 

The use of this device, if used as described in this manual, does not present any contraindications 
or collateral effects.

 

 

 
 

01.7      Physical requirements 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 purpose

 

 

 

The Model is a device designed to aid in stabilizing and immobilizing a pediatric trauma patient. 

 

01.9      General warnings

 

 

1. The product must be used by trained personnel only, having attended specific 
training for this device and not for similar products.

 

 

2.  At  least  every  6  months,  is  important  to  verify  if  updated  User  Manuals  are 
available or there is any change involving  your product. This information is freely 
available on the website

 http://www.promeba.com 

 

3.  Before  carrying  out  any  kind  of  operation  on  the  appliance  (training, 
installation,  use),  the  operator  must  carefully  read  the  enclosed  instructions, 
paying particular attention to the correct safety precautions and to the procedures 
to be followed for installation and for correct use.

 

 
 
 

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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