Arm Sling Immobilizer

  

 

Instructions For Use ( I F U )

- Trade Name: Healthy Arm Sling pouch é Immobilizer     

هيلثى أرم إسلينج  وز إيموبيليزر - Arabic Name :

- Registered Trade Name Of the Manufacturer :

   HEALTHY HEALTH CARE PRODUCTS

- Registered Place of Business (Address) :

  99 ELSEBAK ST. – MERILAND, HELIOPOLIS,

CAIRO, Egypt  

- Where Applicable:

   Home and Hospitals

Application:

* Put the semi flexed elbow into the cloth pouch including lower half of upper arm , elbow fore arm and hand

* Apply the long white strap around the back of the neck

* Put the sponge pad at back of the neck

* Fasten the strap into the metal clip to adjust the suspension level

* Put the thumb into its noose .

* Apply the second strap around the trunk

*  Fasten the second strap é the second metal clip for complete immobilization of upper limb

- How Determine the suitable size (Sizing)? :

* Use the sizing chart on the package to get the suitable size

 

  - Lot or Serial Number :

    MM / YY

- Sterility :

 The Device is supplied unsterile

- Single use or reusable :

The device is reusable unless it is teared or become redundant .

- The duration of use : for 3 months to 6 months

- Invasive or non invasive :

The device is non invasive

The device not introduced into human body orifices

The device not absorbed by human skin or locally dispersed  

- Intended Purpose :

Healthy Arm Slings are intended to elevate the upper limb to control oedema , and enhance healing and recovery following hand , wrist , forearm , elbow , upper arm , and shoulder surgery , trauma or casting.

- Indications :

* Shoulder dislocations

* Hemiplegia

* Upper limb trauma

* Upper limb casting

* Post operative ( operations in upper limb )  

- Precautions :

* Be sure of right size

* Be sure of sanitary conditions ( dry & clean )

* Reusable for not more than 6 months

* The device must not be teared or redundant

- Contra indications :  

* Teared or redundant device

- Device description :

* Immobilizer : a non-sterile, cotton 100 % Cloth pouch , é metal clips suspended from an overhead and shoulder support and second strap applied around the trunk for immobilization

- Suggested Training for users

The device needs no training for users

- Performance Characteristics :

* Non invasive

* Already used non sterile but can be sterilized either by Autoclave or by Ethylene Oxide or Gamma Radiation .

* Not rupture for proper strong tighten performance .

* Easy to use i . e easy to wear and easy to get off .

* Available sizes to suit all patients , both adults and children .

* Material in contact with the skin is cotton 100% ( the most safest material )

* Strong materials to ensure support

- Device specification :

* Support  Upper limb (  shoulder / upper arm / elbow/ forearm / wrist / Hand )

* Allows complete free movement when intended

* Breathable , for cool , comfortable and extended use  

* Completely washable and hygienic

- Special Facilities :

The device requires no , special facilities , special training or particular qualification of the user

- Device maintenance and calibration :

The device needs no , regular maintenance , no consumable components , and no necessary calibration or measurements

- Instructions for cleaning :

* Put the device in tape water with some detergent for a while

* Rinse the device è tape water to remove remnant for detergent

* Dry the device away from direct sunlight , in horizontal position

* No automatic washing machine

* No electric iron

- Other devices :

Not used together with other devices

- Circumstances in which the user should consult a health care professional :

Only if the device is teared , ruptured , redundant or dirt

           - Any serious incident , occurred in relation to the device should be reported to :

1- The manufacturer

2- SFDA 

- Date of issue : 04/2025