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USER GUIDE // 

ROLLED SPLINT PA-08 

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.

 

 
8. Avoid contact with sharp objects. 
 
9. Use the Rolled Splint PA-08 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 ROLLED SPLINT PA-08

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

Страница 2: ......

Страница 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...

Страница 4: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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