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Tracheostomy Tube

Instructions

Manual

Document no. IFU‐17‐R2/001 Issue Date: January 01, 2017

i

Contents

- Instruction for Use

a, Product Description b, Unpacking c, Operating Instructions d, Dimensions e, Warnings f, Clearning g, Sterlization - Manufacturer - Final Words

The operator must carefully read and understand this manual before using the product

h, Symbols

cGMP

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a, Product Description

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Fig 01

LUER Tracheal Tube

Fig 02 JACKSON Tracheal Tube

A

B

C

A

B

What is

Tracheostomy?

A tracheotomy is an opening (made by an incision) through the neck into the trachea (windpipe). A tracheotomy opens the airway and aids breathing.

A tracheotomy may be done in an emergency, at the patient's bedside or in an operating room. Anesthesia (pain relief medication) may be used before the procedure. Depending on the person's condition, the tracheotomy may be temporary or may be for long time.

What is Tracheostomy / Tracheal Tube?

A Tube which is inserted into the tracheostomy by a minor surgery. This tube remains fixed with the help of a small belt go around the neck holding the cannula. Tracheotomy tubes are available in several sizes and materials including semi-flexible plastic, rigidplastic, PVTor metal. These tubes are either disposable or reusable. They may have an inner cannula that is either disposable or reusable. The

tracheotomy tube may or may not have a cuff. Cuffed tracheal tubes are generally used for patients who have swallowing difficulties or who are receiving mechanical ventilation. Non-cuffed tracheal tubes are used to maintain the patient's airway when a ventilator is not needed. The choice of tube is based on your condition, neck shape and size and purpose of the tracheotomy. All tracheal tubes have an outer cannula (main shaft) and a neck plate (flange). The flange rests on your neck over the stoma (opening). Holes on each side of the neck plate allow you to insert tracheal tube ties to secure the tracheal tube in place. This tracheotomy tube is made of Stainless Steel.

Fig 01:

represents the Luer Tracheal Cannula, it only have two iner and outer cannula

Part A: Outer Cannula or Outer Tube Part B: Inner Cannula or Inner Tube

Fig 02:

Is the Chevalier Jackson or Jackson type Tracheal Cannula, it also have two in er and outer cannula with addition adopter. This adoptern helps the doctor while inserting into to tracheal small hole.

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b, Unpacking

After opening the packages, first of all it is necessary to check all pieces and parts. Check that they are all present and in perfect condition.

Each box contains the number of specified pieces mention on the box label; configure the quantity with the label specified quantity. Each piece is further packed and sealed in a poly bag. Open the poly bag and con -firm that it should contain the outer and inner cannula.

The packaging should be removed with adequate means and shall not be left at the mercy of irresponsible persons: the same is valid for tools used to remove packages (Scissors, Knives, etc,)

First of all it is necessary to choose the size of tube is required. It is some time depends upon the age and other factors as well. See Catalog The examiner should check the working of the tube, is it working smoothly and softly or not, unless it may cause of further injury to the patient.

Step 01:

Check the lever, is it working properly, rotate it, rotation should be smooth and soft.

Positions the lever for unlock.

GYNAMED Instruments offering two kinds of locking systems. You may also see the detail in our catalogue. Please mention which one do you need while placing order.

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Step 02:

1. Remove the inner cannula from the tube as it is shown in Fig.

Step 03:

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Step 04

Remove the adopter and drop the inner cannula into in the outer cannula, it should travel smoothly.

Step 05

1. Position the lever for lock the inner cannula.

If all the above process you had done, now you may go ahead for sterilization of the device.

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Sucon View 1.

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d, Dimensions

GYNAMED offering a veriety of tracheal cannula with different sizes and patterns. See our catalog or website: www.gynamed.com

Don t use or operate with the device, if it is damage.

Avoid repairing, if it is not working properly, immediately contact to your retailer or supplier.

Clean the Device before to use. This device is not sterilized. See the sterilization guide below.

Remember the tube is oiled by the manufacturer on the marked position.

Tubes made of metal steel must be removed before radiotherapy

Tracheotomy Tube isn’t sterilized by the manufacturer.

It is recommended to clean and sterilize the cannula before use.

Tracheotomy tube is oiled by the manufacturer on the dened posi-tion, (See illustration on left side) so make sure that after cleaning there

shouldn t be any sign of oil or lubricates, it may cause of infection.

Sterilization Process Guide

Manually Clean tube with a mild detergent (neutral soap, dish-washing liquid). Use soft brushes only (see catalog for brushes)

Disinfect tube by placing in boiling water for at least 15 minutes. Place tube with bent portion pointing downward to avoid air bub-bles formation (FIG 6.01)

Pour out water after 15 minutes. The tube should now be held only by the closure (FIG 6.02).

Brown and black spots are typical on silver. use commercially avail-able silver dip solution. Again carefully clean tube to remove any residues of the dip solution.

NOTE: Separatly sterilize inner and outer cannula.

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e, Warning

1. 2. 3. 4. 5.

f, Cleaning / Shelf Life and Sterilization

Oiled Posion

Fig 6.01

Fig 6.02

!

Stainless Steel made cannula will have complete marking eg, logo, article code reference, lot number etc. whereas German Silver cannula never have any kind of marking, it will be separately packed in individual air tight packing and label is past on it.

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REF 00.000000

EC REP

2

Latex

Gynamed Instruments product code. Gynamed Europe representative address: Mr. ISHFAQ AJMAL.

10/12, Childers Street, Hyder Park, York Shire, Doncaster, DN4-5DA, UK

ajmal@gynamed.com

Meeting the requirements of European Medical Devices Directive.

Single Use Latex Free

Don t Use, if the package received open.

2012/12

If remaine sealed

NON STERILE

!

Read manual before use

Product is Non Sterile by manufacturer

Expiry date or use before, YYYY/MM

Made by GYNAMED - Pakistan Product is made in Pakistan and produced by GYNAMED

LOT Product is Non Sterile by manufacturer

0 0 0 0 0 0 0 0 0 0 0 0 0

Bar Code Manufacturer:

GYNAMED Instruments

Small Industrial Estate, PO.Box 1714, Sialkot, Pakistan Tel: +92 52 3556286 Fax: +92 52 3560687,

www.gynamed.com, info@gynamed.com Manufacturing Date: YYYY/MM

Order No: Gynamed Internal Order number

h, Symbols

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i

Gynamed Instruments

Small Industrial Estate, Ghounse Puram Kacha Shahab Road, P.O.Box 1714, Sialkot, Pakistan

References

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