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GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon Button GB Gastrostomy Balloon Catheter Kit GB Gastrostomy Balloon Button Kit

GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

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Page 1: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

GB Gastrostomy Balloon CatheterGB Gastrostomy Balloon ButtonGB Gastrostomy Balloon Catheter KitGB Gastrostomy Balloon Button Kit

Page 2: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

2

GB Gastrostomy Balloon Catheter

GB Gastrostomy Balloon Button

The shape of the tip became milder to reduce the resistance caused

during insertion.

Milder-tip shape to reduce the resistance during insertion

New type The shape of the corner cut tip has

been changed.

Conventional type Conventional type

To the GB gastrostomy balloon catheter/balloon button, a replacement set has been added to enhance the line-up.

Page 3: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

3

Less water escapes from the balloon.Newly employed gas barrier type silicone balloonThe GB silicone balloon, which was developed with Phycon’s original technology, has been newly employed for the GB gastrostomy balloon catheter.It is a gas barrier type silicone balloon, of which the balloon inner pressure is excellently stable, and the feeding tube is controlled so that the escape of water is minimized.After inserting the balloon into the stomach, the apple shape of the balloon will protect the gastric wall from the catheter tip to minimize damage.

Data of the test for escape of water with the GB gastrostomy balloon(Compared with our products)

Less water escapes from the balloon.Newly employed gas barrier type silicone balloon

The Gas barrier type GB balloon is employed to reduce the escape of water from the balloon.

The balloon inflates in an apple shape to minimize the damage to the gastric wall.

The catheter tip is in a taper shape to enable smooth insertion.

Comparison of balloon change (with humidity of 80%)GB gastrostomy balloon

Conventional gastrostomy

Before start 1 week 2 weeks 3 weeks 4 weeks 5 weeks

GB gastrostomyWith humidity of 90%

GB gastrostomyWith humidity of 80%

Conventional gastrostomyWith humidity of 90%

Conventional gastrostomyWith humidity of 80%

Test body: GB gastrostomy balloon 20 Fr, 10 mLConventional type GB gastrostomy balloon 20 Fr, 10 mL

Water permeability test(Test equipment: EYELA incubator LTI-600SD)Experimental environment: Temperature: 37ºC/ Distilled water to be used

Page 4: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

1192312

1192314

1192316

1192318

1192320

1192322

1192324

1192418

1192420

1192422

1192424

4.0(12Fr)/M

4.7(14Fr)/M

5.3(16Fr)/M

6.0(18Fr)/M

6.7(20Fr)/M

7.3(22Fr)/M

8.0(24Fr)/M

6.0(18Fr)/L

6.7(20Fr)/L

7.3(22Fr)/L

8.0(24Fr)/L

3mL

4mL

5mL

10mL

255

1pc./ box

With X-ray contrast line Sterilized / for single use only

49510mL

Productcode

Size(mm)

Recommended volume of balloon

Total length(mm)

Colorcode

Packingunit

White

Green

Orange

Red

Yellow

Purple

Blue

Red

Yellow

Purple

Blue

GB gastrostomy balloon catheter (single item)

4

GB Gastrostomy Balloon Catheter

Characteristics● The feeding tube for the gastrostomy allows for a shorter

replacement interval to keep the conditions cleaner than the bumper type. Also, as it does not require any exclusive connection tube, if the funnel part is kept outside the clothing, the patient will not need to take off any clothing for the feeding tube connection, reducing the load to the patient and caretaker.

● As the catheter has an extracorporeal fixation plate and marking that will not directly contact the fistula part, it is easier to observe the fistula part, reducing the chance of buried bumper syndrome and gastric outlet obstruction.

● The feeding funnel has a shape that can handle two sizes with one point, allowing for easier prevention of nutritional supplement and drug infusion errors.

Employment of the funnel compliant to the connection error prevention measures

Fistula can be observed, and an extracorporeal fixation plate that reduces displacement is newly employed.

The s imple and compact design of the new infusion funnel has a shape that is compliant to the standard related to the connection with the enteral feeding route to prevent connection errors with the infusion line.

How to use the funnel

For the infusion of drugs To stop using

For the infusion of nutritional supplements

Remove the connector for the infusion of nutritional supplements

Remove the connector cap for the infusion of drugs.

Be sure to lock the funnel to stop using it

Newly employed fixation plate

Page 5: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

GB gastrostomy balloon button (single item)

1192221

1192223

1192225

1192231

1192233

1192235

1192241

1192243

1192245

1192247

1192251

1192253

1192255

1192257

1192259

1192275

1192277

1192279

4.7(14Fr)

4.7(14Fr)

4.7(14Fr)

5.3(16Fr)

5.3(16Fr)

5.3(16Fr)

6.0(18Fr)

6.0(18Fr)

6.0(18Fr)

6.0(18Fr)

6.7(20Fr)

6.7(20Fr)

6.7(20Fr)

6.7(20Fr)

6.7(20Fr)

8.0(24Fr)

8.0(24Fr)

8.0(24Fr)

12

17

24

12

17

24

12

17

24

34

12

17

24

34

44

24

34

44

4mL

5mL

10mL

10mL

10mL

1pc./ box

Productcode

Size(mm)

Recommendedvolume of balloon

Shaft length(mm)

Packingunit

With X-ray contrast line Sterilized / for single use only5

GB Gastrostomy Balloon Button

Characteristics

An apple-shaped GB silicone balloon is employed, which is soft on the gastric walls and newly developed with Phycon’s original technology.

● The compact wing part and wide gauge of the injection part enable easier tube-feeding control.

Straight type L type

One-touch insertion

The button inlet and built-in one-way valve are designed with wide gauges to allow for thick nutritional supplements to easily pass through and to prevent the back streaming of infusion.

Exclusive straight type and L type feeding tubes are attached. To connect them, just al ign the marks and rotate to set.

Attachment

Exclusive feeding/depressurization tube

Inner diameter: 3.5 mm Outer diameter: 5.5 mm Total length: 500 mm

Wide gauge type

Page 6: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

GB Gastrostomy Balloon Catheter KitGB Gastrostomy Balloon Button Kit

Application

Characteristics

Replacement set for the gastrostomy balloon catheter and button.Feeding tube related products, which are sterilized, are set in the order of operation.This shortens the time required for preparation and deployment, and allows for smooth replacement operation.

This is a set of a balloon catheter and a balloon button for the replacement of the feeding tube, which aims to infuse various nutritional supplements into and depressurize the gastric fistula of which the fistula formation has already been completed.

● This set contains the devices required for replacement such as a povidone-iodine cotton stick, glycerin, and a prefilled syringe so that the replacement operation can be started immediately.

6

Page 7: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

[ External view ] [ External view ]

Speci�cation Speci�cation

Contents of the GB gastrostomy balloon button kit

2

1

34

5

6

7

8

9

Contents of GB gastrostomy balloon catheter kit

Balloon catheter Balloon in�ating syringe (containing sterilized water) Syringe (for inspecting the balloon and suctioning the sterilized water of the balloon of the deployed catheter) Lubricant agent (glycerin) Cotton stick immersed with antiseptic solution (10% povidone-iodine cotton stick) Tweezers Gauze patch Stylet

…………………………………………………… 1pc.………… 1pc.

…………… 1pc.………………………………………… 1pc.

……………………………… 1pc.…………………………………………………………… 1pc.

……………………………………………………… 3pcs.……………………………………………………………… 1pc.

Balloon button Balloon in�ating syringe (containing sterilized water) Syringe (for inspecting the balloon and suctioning the sterilized water of the balloon of the deployed catheter) Lubricant agent (glycerin) Cotton stick immersed with antiseptic solution (10% povidone-iodine cotton stick) Tweezers Gauze patch Stylet Feeding / depressurization tube (L type / straight type)

…………………………………………………… 1pc.………… 1pc.

………… 1pc.………………………………………… 1pc.

……………………………… 1pc.…………………………………………………………… 1pc.

……………………………………………………… 3pcs.……………………………………………………………… 1pc.

…… 1pc.each

2

1

1

2

3

4

5

6

7

8

1

2

3

4

5

6

7

8

9

34

5

6

7

8

Funnel

Balloon lumenOne-way valve

Color code

StopperFixation plateBalloon

Catheter

Connector

Connector cap

Shaft lengthBalloon

1192612

1192614

1192616

1192618

1192620

1192622

1192624

1192718

1192720

1192722

1192724

4.0(12Fr)/M

4.7(14Fr)/M

5.3(16Fr)/M

6.0(18Fr)/M

6.7(20Fr)/M

7.3(22Fr)/M

8.0(24Fr)/M

6.0(18Fr)/L

6.7(20Fr)/L

7.3(22Fr)/L

8.0(24Fr)/L

3mL

4mL

5mL

10mL

255

1set./ box

With X-ray contrast line Sterilized/for single use only

49510mL

Productcode

Size(mm)

Recommended volume of balloon

Total length(mm)

Colorcode

Packingunit

White

Green

Orange

Red

Yellow

Purple

Blue

Red

Yellow

Purple

Blue

GB gastrostomy catheter (kit) GB gastrostomy button (kit)

1192521

1192523

1192525

1192531

1192533

1192535

1192541

1192543

1192545

1192547

1192551

1192553

1192555

1192557

1192559

1192575

1192577

1192579

4.7(14Fr)

4.7(14Fr)

4.7(14Fr)

5.3(16Fr)

5.3(16Fr)

5.3(16Fr)

6.0(18Fr)

6.0(18Fr)

6.0(18Fr)

6.0(18Fr)

6.7(20Fr)

6.7(20Fr)

6.7(20Fr)

6.7(20Fr)

6.7(20Fr)

8.0(24Fr)

8.0(24Fr)

8.0(24Fr)

12

17

24

12

17

24

12

17

24

34

12

17

24

34

44

24

34

44

4mL

5mL

10mL

10mL

10mL

1set./ box

Productcode

Size(mm)

Recommendedvolume of balloon

Shaft length(mm)

Packingunit

With X-ray contrast line Sterilized/for single use only

GB gastrostomy balloon catheter GB gastrostomy balloon button

7

Page 8: GB Gastrostomy Balloon Catheter GB Gastrostomy Balloon ... · (Test equipment: EYELA incubator LTI-600SD) Experimental environment: Temperature: 37ºC/ Distilled water to be used

(1) Carefully remove from the sterilized package and confirm that there is no damage with the product.

(2) Do not inflate the balloon with anything other than sterilized distillated water.

(3) The infusion amount described on the funnel is the recommended value.

(4) Do not grasp the balloon with forceps or the like.(5) Do not pull forcibly or modify the balloon, such as

creating a hole.(6) This product is only for single use. Do not reuse it.(7) After use, appropriately dispose of the product

according to the 10cal Law.(8) Be sure to read the package insertion before use.

・Nutrition Management Using Percutaneous Endoscopic Gastrostomy (PEG) (Jiro Kanie)

・Home-visit Nursing Care (Igaku Shoin) 13(4):299-307 1998/4 13(5):371-380 1998/5

・Problem and efficacy of Percutaneous Endoscopic Gastrostomy (PEG) in Hospitals for the Elderly (Jiro Kanie, Kazuhiko Kono, Takayuki Yamamoto, Hiroyasu Akatsu, Hiroshi Shimokata, Teruhisa Iguchi)

・Journal of Japan Society of Geriatrics 1998;35 (7) : 543-547 1998/7

Precautions for use Reference materials

(Y-0087)A.2009.2.5000CL Printed in Japan