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USER GUIDE // 

HEAD IMMOBILIZER PA-55 

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) - España). 

 

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.

 

Summary of Contents for PA-55

Page 1: ...USER GUIDE HEAD IMMOBILIZER PA 55 Review 2021 09...

Page 2: ......

Page 3: ...rators 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 09 01 13 Life span 09 02 PRODUCT DESCPRIPTION 10 02 1 Product Fe...

Page 4: ......

Page 5: ...turer 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 infor...

Page 6: ...operators Promeba Head immobilizer is destined to professional use only The operators must be trained in efficient effective and safe patient transport 01 8 Intended purpose It is mainly used for hos...

Page 7: ...an 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 must not...

Page 8: ...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 r...

Page 9: ...portation 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 Residu...

Page 10: ...f devices that have not been checked by the manufacturer or authorized center or that have exceeded the maximum allowed useful life 02 PRODUCT DESCRIPTION 02 1 Product Features 1 It is made of high de...

Page 11: ...rap through the upper fixing slots and the chin strap through the remaining lower fixing slots to immobilize the forehead and chin of the patient fasten using the Velcro 03 OPERATION 03 1 Transport 1...

Page 12: ...faults occur do not use the head immobilizer and contact customer support 03 3 2 Cleaning Recommendation Clean the surface using a moist sponge water and neutral soap Then rinse and dry thoroughly Do...

Page 13: ...ER 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 of the de...

Page 14: ...ated 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 OPERATIONS...

Page 15: ...ssession 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 warranties o...

Page 16: ...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 products Promeba S L de...

Page 17: ...a os causados por la falta 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 cause...

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