Sterile Hemovac drain

General Description

  • Drains systems are a common feature of post-operative surgical management and are used to remove drainage from a wound bed to prevent infection and the delay of wound healing.
  • A drain may be superficial to the skin or deep in an organ, duct, or a cavity such as a hematoma.
  • The number of drains depends on the extent and type of surgery.
  • A closed system uses a vacuum system to withdraw fluids and collects the drainage into a reservoir.
  • Closed systems must be emptied and measured at least once every shift and cleaned using sterile technique according to agency protocol.
  • Closed Wound Suction Unit is consists of 3 main components is Bellow container , Main tube & Drainage tube , this component is well fitted with each other to achieve negative pressure .

Ref .Code for Device Variants:

Intended Patient Population:

  • This product used some times after operation & for patients who had wide variety of different types of surgery as  :-
  • Plastic surgery including myocutaneous flap surgery.
  • Breast surgery (to prevent collection of blood and lymph).
  • Orthopedics procedures (associated with greater blood loss).
  • Chest drainage.
  • Chest surgery (with, for example, the associated risks of raised intrathoracic pressure and tamponade).
  • Infected cysts (to drain pus).
  • Pancreatic surgery (to drain secretions).
  • Biliary surgery.
  • Thyroid surgery (concern over hematoma and hemorrhage around the airway).
  • Neurosurgery (where there is a risk of raised intracranial pressure).
  • Nasogastric tubes.
  • Patient : Humans , Female , Male Aged: 65+ years , Middle Aged 45-64 years , Adult , 19-44  years, Adolescent: 13-18 years, 6-12 years  with a people who need medicine by determine concentration and have week vein can’t bear the Normal infusion ,children from 2-5 , infants less than 23 month.

Intended Purpose:

  • The product is used for close wound drainage or collection of fluid or blood from surgical wound (This will help healing and reduce infection; we will see fluid and blood in the drain. under negative pressure through a collection tube and collection device (bellow) with an option to operate one or two catheters simultaneously.
  • A burn, pressure ulcer, diabetic ulcer, chronic (long-lasting) wound, or injury. This therapy can help your wound heal faster and with fewer infections.
  • We do not use accessories with the product.

Instruction For Use  (IFU)

1-(a) Place the perforated tube in the wound with the help of curved needle, as (Fig 1&2) Ensure that the entire perforated part of the catheter is well within the wound to avoid any air leakage during drainage.

   (b) The length of the perforation should be reduced according to the size of the wound

   (c) Catheter is marked 5 cm from the last perforation to ascertain the depth of catheter in the wound.

2- Press the bellow container with both hands. (Fig. 3)

3- Connect the connecting tube (duly clamped off) to the bellow container. (Fig. 4)

4· Connect the perforated catheter with connecting tube (Fig. 5) and start drainage by releasing the clamp.

5- To re-charge the vacuum, start operation repeating instructions (2,3,4).

FOR USE OF TWO CATHETERS SIMULTANEOUSLY Remove protector cap provided at the “r connector and connect the spare perforated catheter with the “Y” connector as shown in (Fig. 6) and follow the rest of the directions as given above.

The Product Doesn’t Contain :

  • TSE species derived material in manufacturing process.
  • Medicinal substance & Animal Tissue
  • Human Blood Derivatives
  • Phthalates (DEHP Free)

Intended User:  Skilled Or Trained Personnel (In-Charge)

Surgeon will discuss with you before the operation whether you will need a hemovac drain and where it will be.

  • When the Hemovac drain is collecting less than 30cc (1oz.) of fluid in 24hours (unless otherwise directed by your surgeon), the drain is taken out by a nurse or doctor.
  • The drain should be emptied at least twice a day (at breakfast and bedtime) and when the container is fully expanded, or as directed by your surgeon.
  • If you, a family member, friend or neighbor is able to change your Hemovac dressing, you will be taught to do so by your surgeon.
  • It is important that you change the dressing as instructed. The most commonly used Hemovac dressing is a simple
  • Dry gauze dressing. Such dressings are changed daily and when the dressing leaks through or falls off.

Contraindications:

  • Malignancy of the wound.
  • Not to be used in patients with known hypersensitivity to any of the materials used.

WARNINGS:

  • Product is single use only. Re-use of the product can cause change in physical characteristics.
  • The product should be checked for any major complications i.e. in (bellow container , main tube , big C Clamp, Flexible tubing, S.S Needle , etc )
  • Do not re-sterile may increase the EO Residual in the product or physical property of the products may be change.
  • Visually inspect and carefully check the product and packaging before use. Improper transport and handling may cause structural/functional damage to device or packaging.
  • Transportation / Dispatch of the material should be done under covered & safe container to avoid any damage, rain & direct heat.
  • Discard after use. Do not recycle, clean or re-sterile.
  • Ensure proper disposal of product and packing after use.
  • Read instructions before use.
  • Check expiry date prior to use.
  • Call your doctor if you have: Pain, swelling, or fluid around the tube , Redness or warmth around the incision , Nausea (feeling sick to your stomach) and vomiting (throwing up) , Chills and fever , Fluid from the incision , Stitches holding the tube that become loose or infected , A tube that falls out , Fluid that has a bad smell , Drainage that changes colour from light pink to bright red .

Sterilization:

  • Hemovac Drain  is sterilized by Maramco for international trade .
  • EtO sterilization, biological indicator testing and aeration process are performed by Maramco for international trade
  • Sterilized by ETO (Ethylene oxide 70% and Carbon dioxide CO2 30%)

Shelf life:

  • Following sterilization the product has 5 years shelf life, provided that it is stored in the original packaging in recommended.
  •  Storage condition and that the packs are not damaged or opened or tampered with in any way.
  • Storage Condition the Temperature limit from 25°C to 30°C
  • Sterilized by ETO (Ethylene oxide 70% and Carbon dioxide CO2 30%)

Packaging:

  • The sets the below and suction tube are packed in Pouch consists of PET, PP & Medical Paper which maintains the integrity of the sets.

Packing:

 Each 30 pouch are packed in master carton.

Storage condition:

  • Shall be stored in cool & dry place.
  • Do not exposure to heat or direct sunlight.
  • the Temperature limit from 25°C to 30°C

Keep away from any source of ignition.