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USER GUIDE // 

ROLLED SPLINT PA-08 

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.

 

Summary of Contents for ROLLED SPLINT PA-08

Page 1: ...USER GUIDE ROLLED SPLINT PA 08 Review 2021 09...

Page 2: ......

Page 3: ...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 02 1...

Page 4: ......

Page 5: ...rer 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...

Page 6: ...cations or collateral effects 01 7 Physical requirements of the operators Promeba s Rolled splint PA 08 is destined to professional use only 01 8 Intended purpose Mainly used in hospitals ambulances s...

Page 7: ...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 in...

Page 8: ...e 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 req...

Page 9: ...because he may be injured 4 Do not use bleach to disinfect the product Use a hydroalcoholic based disinfectant and wash with water 5 The device and all its components after washing should be allowed...

Page 10: ...cturer 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...

Page 11: ...ly and follow the instructions to become familiar with the correct operation and maintenance of the splint Otherwise the company will not be responsible for the dangerous accidents If the patient has...

Page 12: ...ortation as shown by the box stacking 03 3 Maintenance 1 Inappropriate use and lack of maintenance can cause damage to people and objects 2 It is recommended that you check the surface of the Rolled s...

Page 13: ...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 devi...

Page 14: ...ted 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: ...ession 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 of...

Page 16: ...r 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 Promeba S L des...

Page 17: ...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 caused...

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