Care Inguinal Hernia Truss ( Right )

 Instructions For Use ( I F U )

- Trade Name :  Care Inguinal Hernia Truss ( Right )          

كير أنجوينال هرنيا ترس( رايت(  - Arabic Name:  

- Registered Trade Name Of the Manufacturer :

   Healthy health care products

- Registered Place of Business ( Address ) :

  99 Al Sabak ST. – Meriland Heliopolis – Cairo – Egypt

- Where Applicable ? :

   Home and Hospitals

- Application :

 * Put the waist strap around the waist and close lightly

 * Adjust the occlusive mass on the opening of hernia at the groin 

 * Close the waist strap tightly  

 * Close the thigh straps tightly .

- How Determine the suitable size ( Sizing ) ? :

 * Measure waist circumference at upper edge of pelvic bones ( Iliac and pubic bones)

 * 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 :

Inguinal Hernia Trusses, are tightened around the groin and waist to close the opening / openings of inguinal hernia, so prevent intestinal contents from protrusion from these openings

- Indications :

Inguinal Hernia, right sided *

* Operable Cases pore operative only ( i.e Temporary )

* Postponed or inoperable cases ( for long periods )  

- 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 :

* Inflamed Hernia

* Inflamed Skin

* Teared or redundant device

- Device description :

non-sterile, cotton 100% strong elastic bandage like strap to be worn over one or both sides of the groin é adjustable waist band é smooth leather cover and metal buckle.

 

- 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

* Breathable , for cool , comfortable and extended use  

- Device specification :

* Support  the inguinal hernia opening in  anterior abdominal wall .

* 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