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01 

INTRODUCTION    

05

 

01.1 

Using this manual   

05

 

01.2 

Legend of symbols    

05

 

01.3 

Servicing request    

05

 

01.4 

Demolition    

06

 

01.5 

Labelling   

06

 

01.6 

Contraindications and adverse effects   

06

 

01.7 

Physical requirements 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 

Product Features    

10

 

02.2 

Components    

10 

02.3      Use Method    

11 

 

03 

OPERATION   

13 

03.1 

Transport 

13

 

03.2 

Storage   

13 

03.3      Maintenance    

13 

  

 

 

04 

MAINTENANCE REGISTER  

14

 

 

05 

LEGAL NOTICES   

16

 

 

06 

PRODUCT WARRANTY   

17

 

 
 
 

 

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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