Instructions For Use ( I F U )

- Trade Name :  Care hard collar with chin

   كير هارد كولار وز تشين  - 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 :

* Adjust height of the collar according to height of pt .neck

* Put the hard Collar while the Soft Velcro towards the right

* Round the Hard Collar around neck é the curvature for mandible ant.

* Adjust then fastening by Soft and rough Velcro

- How Determine the suitable size ( Sizing )?

* Measure neck circumference on Adam ś apple in cm

* Use the sizing chart on the package      

- 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 :

* Provide support to the head while limiting movement of and lightly stretch the cervical vertebrae .

- Indications :

- Painful neck due to cervical vertebrae or neck muscles lesions which include :

* Neck Strain

* Neck Trauma

* Inflammations ( cervical spondylitis , spondylosis and spondylithesis)

* Cervical disc herniation

* Post operative     

- 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

- Contra indications :  

* Teared device

- Device description :

* Hard é Chin piece : non sterile fabricated 2 plastic bands , perforated and its side in contact é the skin covered é spongy pad and fabricated leather in addition to Cotton 100% chin cup pad

- 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 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 hypoallergenic

* Strong plastic bands to ensure supports  

* Soft , breathable , stockinette covering

- Device specification :

* Support  the head and cervical spines

* Allows 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