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USER GUIDE // 

PEDIATRIC IMMOBILIZATION SYSTEM PA-190 

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 PA-190

Page 1: ...USER GUIDE PEDIATRIC IMMOBILIZATION SYSTEM PA 190 Review 2021 09...

Page 2: ......

Page 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...

Page 4: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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