Arm Sling Collar and cuff

 

Instructions For Use ( I F U )

- Trade Name: Healthy Arm Sling Collar and Cuff   

   هيلثى أرم إسلينج كولار أند قف - 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:

* One loop is applied around the neck

* The second loop is applied around the wrist

* Fasten the 2 plastic clips to adjust level of suspension  

- How Determine the suitable size (Sizing)?

* Adjustable for any age    

- 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 elevation of 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 redundant or dirt device

- Device description :

* Collar and cuff : a non-sterile long roll of a foam core with cotton fabric covering and plastic clips used to fashion two loops one for round the neck and the other round the wrist ( collar and cuff )

- 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