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USER GUIDE // 

PEDIATRIC IMMOBILIZATION SYSTEM PA-190 

Review 2021/09 

01 

INTRODUCTION

 

 

 

5

 

 

 

01 

INTRODUCTION 

 

01.1  Using of manual

 

 

The  manual  provides  using  and  maintenance  instructions  of  the  product  as  well  as  technical 
aspects, functioning, spare parts and safety.

 

It  is  recommended  before  the  operation  of  the  product  to  read  carefully  this  manual  in  order  to 
avoid damages caused by a misuse.

 

Do  not  lose  this  document.  It  should  be  accessible  to  any  doubt  that  could  appear  by  medical 
personnel. Remember that a good use and maintenance are necessary for the proper operation of 
the product.

 

 

 

01.2  Legend of Symbols

 

 

SYMBOL 

EXPLANATION / DESCRIPTION

 

 

MANUFACTURER  symbol.  This  symbol  is  accompanied  by  the  name  and  address  of  the 
manufacturer,  adjacent to the symbol  (PRODUCTOS  METÁLICOS  DEL  BAGÉS  S.L.,  Ctra. 
C-16 Km 59.5, 08650 - Sallent (Barcelona) - Spain). 

 

Indicates the manufacturer

’s reference number to identify the medical device.

 

         

PROMEBA, S.L. uses this symbol to set each internal reference for each configuration and 

business variant.

 

 

         

Indicates the 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 to inform that the product is a 

“Medical Device”.

 

 

CE symbol without the intervention of a Notified Organism, as a Medical Device classified as  
Class I according to the EU Regulation 2017/745 on Medical Devices.

 

 

         

Symbol for the Unique Device Identifier.

 

 

         

Symbol 

“See instructions for use or operating instructions”.

 

 

Symbol 

“caution”. This symbol is placed to warn of the need for the user to refer to important 

precautionary information in the operating instructions, such as warnings and cautions not 
otherwise found on the label.

 

 

Symbol 

“Caution”. For a general warning.

 

 

 

Warning, crushing of hands

 

 

 

 

-20ºC

 

+40ºC

 

Indicates the temperature limits. The upper and lower temperature limits should be indicated 
adja- cent to the horizontal lines.

 

 
 

01.3  Servicing request

 

 

For  information  of  the  correct  interpretation  of  the  instruction  manual,  the  use,  maintenance, 
installation and restoration of the product, please contact Promeba customer service: T. 93 837 12 
00,  email 

prom[email protected]

    or  write  to  PROMEBA,  S.L.  -  Ctra  C-16  Km  59.5  ·  08650 

Sallent (Barcelona) · SPAIN.

 

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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