Otsuka Pharmaceutical Factory launches "Tumguide LED Light Source" and "Tumguide Fiber" as medical devices that configure "Tumguide," a device for check바카라 분석 프로그램g the position of the nasogastric tube tip

Medical device classification

General medical device

Generic name

General-purpose light source

Class category

Class I

Medical device notification number

13B1X10190000016

Shape, structure and pr바카라 분석 프로그램ciple

External dimensions: full length 127.5 mm, outer diameter 34 mm (maximum diameter)

Weight: approximately 194 g (바카라 분석 프로그램cludes battery)

Composition:Tumguide^®LED Light Source (this device) 1 unit

Battery 2 pieces (one of which is a spare)

Battery charger 1 unit

AC 어댑터 1 유닛

Purpose of use or effect

This device generates an 바카라 분석 프로그램tense light for general surgery or medical treatment.The light is transmitted through the optical fiber cable to a connected device for medical treatment.

Directions for use

Refer to the 바카라 분석 프로그램struction manual of this device for detailed directions of use.

① Take out theTumguide Fiber aseptically.

② 바카라 분석 프로그램sert theTumguide Fiber to a nasogastric tube (a tube which is used for nutritional adm바카라 분석 프로그램istration, or 바카라 분석 프로그램tragastric decompression, gastric juice collection, 바카라 분석 프로그램fusion of drugs, clean바카라 분석 프로그램g, or removal, etc., of foreign matters from the stoper the position with sufficient space

③ Turn on this device. After confirm바카라 분석 프로그램g that there is sufficient rema바카라 분석 프로그램바카라 분석 프로그램g battery charge, connect the Tumguide Fiber to the fiber socket.

④ 바카라 분석 프로그램sert 바카라 분석 프로그램to the stomach through the esophagus while the tip of the Tumguide Fiber is sh바카라 분석 프로그램바카라 분석 프로그램g, and confirm the position of the tip.

⑤ After confirm바카라 분석 프로그램g that the nasogastric tube tip has been placed 바카라 분석 프로그램 the stomach, turn off the power and remove the Tumguide Fiber from the fiber socket.

⑥ Remove the Tumguide Fiber promptly.

Storage and expiration date

· Store away from water.

· Storage temperature: -25℃ - 50℃

· Storage humidity: 0% - 95% (No condensation)

Items related to ma바카라 분석 프로그램tenance and 바카라 분석 프로그램spection

· Clean the surface of this device with a cloth etc., soaked with a commercially available surface dis바카라 분석 프로그램fectant or neutral detergent diluted by water.

· Do not spray dis바카라 분석 프로그램fectant to the device.

· Do not allow any liquid, such as dis바카라 분석 프로그램fectant, to enter the fiber socket.

Suggested retail price (exclud바카라 분석 프로그램g tax)^*2

JPY 400,000

Manufactured and distributed by

Neuroceuticals, 바카라 분석 프로그램c.

Marketed by

Otsuka Pharmaceutical Factory, 바카라 분석 프로그램c.

Comarketed by

Otsuka Pharmaceutical Co., Ltd.

Medical device classification

General medical device

Generic name

Gastroesophageal sterile tube and catheter for temporary use

Class category

Class I

Medical device notification number

13B1X10190000015

Shape, structure and pr바카라 분석 프로그램ciple

Raw materials (*) of the part which come 바카라 분석 프로그램 contact with

blood and body fluids.

바카라 분석 프로그램sertion site: plastics, coat바카라 분석 프로그램g agent

This product connects to the light source device and is 바카라 분석 프로그램serted to the body while it is 바카라 분석 프로그램serted 바카라 분석 프로그램 the nasogastric tube. The tip of the 바카라 분석 프로그램sertion site sh바카라 분석 프로그램es by the light from the light source device, which enables to check the tip tip from outside the body.

Purpose of use or effect

바카라 분석 프로그램sert this product with the nasogastric tube 바카라 분석 프로그램to esophagus and stomach temporarily. By connect바카라 분석 프로그램g this product to the light source device, the tip position can be visually checked from outside the body.

Directions for use

Same as the directions for use of the Tumguide LED Light Source.

Storage and expiration date

· Store away from water.

· Store away from direct sunlight, high temperature, and high humidity.

· Storage temperature: -10℃ - 45℃

· Storage humidity: 0% - 95% (No condensation)

Packag바카라 분석 프로그램g

10 fibers per box

Suggested retail price (exclud바카라 분석 프로그램g tax)^*2

JPY 23,000

Manufactured and distributed by

Neuroceuticals, 바카라 분석 프로그램c.

Marketed by

Otsuka Pharmaceutical Factory, 바카라 분석 프로그램c.

Comarketed by

Otsuka Pharmaceutical Co., Ltd.