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USER GUIDE // 

ROLLED SPLINT PA-08 

Review 2021/09 

01 

INTRODUCTION

 

 

 

7

 

 

 

 

4.  In  the  case  of  any  doubts  as  to  the  correct  interpretation  of  the  instructions, 
please contact Promeba, S.L. for any necessary clarifications.

 

 

5. Do not allow untrained persons to help during the use of the device, because 
they could cause damage to the patient or to themselves.

 

 

6.  Periodically  check  the  device,  carry  out  the  prescribed  maintenance  and 
respect the life span indicated by the manufacturer in this user manual.

 

 

7.    Before  each  use  of  device  the  perfect  operating  state  of  the  device  must  be 
checked  as  specified in  the  instruction  manual.  If  any  damage  or  abnormalities 
which  could  in  any  way  influence  the  correct  functioning  and  the  safety  of  the 
device,  of  the  patient  and/or  of  the  user  are  detected,  the  device  must  be 
immediately removed from service and the manufacturer must be contacted.

 

 

8.  If  any  failure  or  incorrect  functioning  of  the  device  is  detected,  it  must  be 
immediately  substituted  with  a  similar  item  so  that  the  rescue  procedures  are 
guaranteed without any interruption.

 

 

9.  Use of the device in anyway 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 must not in any way be tampered with (modification, adjustment, 
addition,  replacement).  In  such  cases  all  responsibility  will  be  denied  for  any 
malfunctions or injuries caused by the appliance itself; moreover CE certification 
and product warranty will be considered void.

 

 

12.  Handle with care.

 

 

13.    Ensure  that  all  the  necessary  precautions  are  taken  in  order  to  avoid  the 
hazards that can arise as the result of contact with blood or body fluids.

 

 

14.  Register  and  store  with  these  instructions:  lot  number,  place  and  date  of 
purchase, first date of use, date of checks, name of users, any comments.

 

 

15.  When  the  device  is  being  used,  the  assistance  of  qualified  staff  must  be 
guaranteed.

 

 

16.    Do  not  store  the  device  underneath  any  heavy  objects  which  could  cause 
structural damage.

 

 

17.  Store in a cool, dry, dark place and do not expose to direct sun.

 

 

18.  Store and transport device in its original packaging.

 

 

19.    The  device  must  not  be  exposed  or  come  into  contact  with  any  source  of 
combustion or inflammable agents.

 

 

20.    Position  and  adjust  the  device  taking  care  not  to  cause  any  obstruction  to 
rescuers and or any other rescue equipment.

 

 
 

 
 

 

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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