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USER GUIDE // 

PEDIATRIC IMMOBILIZATION SYSTEM PA-190 

Review 2021/09

 

 

 

 

 

 
 

01.10    Specific warnings

 

 

1.  Establish  a  maintenance  program  and  periodic  testing,  identifying  a  reference  employee. 
The  person  to  whom  the  ordinary  maintenance  of  the  device  is  entrusted  must  ensure  the 
basic requirements foreseen by the manufacturer in the user

’s manual. 

 

2.  Use  only  accessories/spare  parts  that  are  original  or  approved  by  Promeba,  S.L.  ,  when 
carrying  out  any  operation,  to  avoid  causing  any  alteration  or  modification  to  the  device, 
otherwise  we  assume  no  responsibility  for  the  proper  functioning  or  damage  resulting  from 
device to the patient or the operator and warranty will be considered void.

 

 
3. Never leave the patient unassisted on the device, 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  to  dry  completely 
before storing.

 

 
6. Keep clean as routine (incl. disinfect). 

 

 
7.  Follow  procedures  approved  by  Emergency  Medical  Services  for  immobilization  and 
transportation of the patient.

 

 
8. Follow procedures approved by Emergency Medical Services.

 

 
9. Avoid contact with sharp objects. 
 
10. Use the Pediatric immobilization system PA-190 only as described in this user

’s manual.

 

 

 

01.11 Residual risks

 

 

The residual risks listed below have been identified only with reference to the intended use 
of the device:

 

 

1. Use by untrained personnel may result in injury to patient, operator, or third parties.

 

 
2. Inappropriate disinfection procedures can create a risk of cross infection.

 

 
3. Failure to comply with the warnings for operators can create risks.

 

 
4. Failure to read and understand the product instructions can result in injury to the patient 
and operators.

 

 

 

 

 

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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