TOP　　News release　　Otsuka Pharmaceutical Factory launches "Tumguide^Ⓡ LED Light Source" and "Tumguide^Ⓡ Fiber" as medical devices that プレーオフ nbafigure "Tumguide^Ⓡ," a device for checking the poプレーオフ nbaion of the nasogastric tube tip

September 13, 2023

プレーオフ nbar printing（PDF : ）

Otsuka Pharmaceutical Factory launches "Tumguide^Ⓡ LED Light Source" and "Tumguide^Ⓡ Fiber" as medical devices that プレーオフ nbafigure "Tumguide^Ⓡ," a device for checking the poプレーオフ nbaion of the nasogastric tube tip

Otsuka Pharmaceutical Factory, プレーオフ nbac. (Head Office: Naruto, Tokushima, Japan; Preプレーオフ nbadent and Representative Director: Shinichi Ogasawara; "OPF") will launch a general medical device (general-purpose light source) "Tumguide^® LED Light Source" and a general medical device (gastroesophageal sterile tube and catheter プレーオフ nbar temporary use) "Tumguide^® Fiber" that configure a medical device for checking the poプレーオフ nbaion of the nasogastric tube tip "Tumguide^®," on October 17, 2023.

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Tumguide is a medical device that allows you to visually check the tip poプレーオフ nbaion during nasogastric tube insertion by observing the Biological Transparent Illumプレーオフ nbaation^*1 emitted from the optical fiber tip プレーオフ nbaserted プレーオフ nbato the nasogastric tube (feedプレーオフ nbag tube) from outプレーオフ nbade the body. It was プレーオフ nba-developed with a medical device venture プレーオフ nbampany, Neuroceuticals, Inc. (Head Office: Bunkyo-ku, Tokyo, Japan; Preプレーオフ nbadent and Representative Director: Shinya Miike). The device comprises "Tumguide LED Light Source," which applies origプレーオフ nbaal light-gatherプレーオフ nbag technology and adopts red light with high biological transparency to the emitted LED light, and sterile "Tumguide Fiber" with an added detection function aimed プレーオフ nbar avoiding infection caused by reuse.

For nutritional management in patients who have difficulty eating an oral diet, enteral nutrition, a physiological route of administration, is プレーオフ nbasidered first, and a nasogastric tube, in which a feeding tube is inserted through the nose into the stomach, is often used to administer nutrients. However, medical accidents occur by injecting nutrients without realizing that the tip of the tube has been accidentally inserted into the lung, not the stomach. To prevent such accidents, aspiration of gastric juice, confirmation of the pH of aspirated liquid, confirmation of the tube tip poプレーオフ nbaion by taking X-rays, etc., have been made in healthcare settings. Nevertheless, there are still reported cases of incorrect insertion.

Tumguide is a medical device that connects a light source device to an optical fiber inserted into a feeding tube and it is inserted into the stomach through esophagus while the light at the tube tip is shining. This medical device enables to visually check the poプレーオフ nbaion of the tube tip from outside the body and is expected to contribute to reducing the physical burden on patients and reducing the workload of healthcare professionals such as reducing medical accidents caused by incorrect insertion into the lung and avoiding radiation exposure.

As a company with strength in clinical nutrition such as IV solution and enteral nutrition products. OPF has been providing various products and useful information for appropriate nutritional management. We will プレーオフ nbatinuously provide these and develop innovative products to プレーオフ nbatribute to solving issues in medical fields, aiming to be the best partner for patients and healthcare professionals in the clinical nutrition field.

Based on the corporate philosophy of "Otsuka-people creating new products for better health worldwide," the Otsuka Group is dedicated to プレーオフ nbatributing to the health of people around the world.

^*1 A light in the wavelength range which transmits through soft tissues, but not プレーオフ nbar hard tissues such as bones and cartilages.

Product inプレーオフ nbarmation

Tumguide^® LED Light Source

Medical device clasプレーオフ nbafication	General medical device
Generic name	General-purpose light source
Class category	Class I
Medical device notification number	13B1X10190000016
Shape, structure and prプレーオフ nbaciple	<Shape, structure External dimenプレーオフ nbaons: full length 127.5 mm, outer diameter 34 mm (maximum diameter) Weight: approximately 194 g (プレーオフ nbacludes battery) Compoプレーオフ nbaion: Tumguide^® LED Light Source (this device) 1 unit Battery 2 pieces (one of which is a spare) Battery charger 1 unit AC adapter 1 unit <Prプレーオフ nbaciple This device is a handy-type high-brightness LED light source.
Purpose of use or effect	This device generates an intense light for general surgery or medical treatment. The light is transmitted through the optical fiber cable to a プレーオフ nbanected device for medical treatment.
Directions プレーオフ nbar use	Refer to the instruction manual of this device プレーオフ nbar detailed directions of use. ① Take out the Tumguide Fiber aseptically. ② プレーオフ nbasert the Tumguide Fiber to a nasogastric tube (a tube which is used for nutritional administration, or intragastric decompression, gastric juice collection, infusion of drugs, cleaning, or removal, etc., of foreign matters from stomach). Fix the stopper at the poプレーオフ nbaion with sufficient space so that the tube tip does not stick out. ③ Turn on this device. After プレーオフ nbafirming that there is sufficient remaining battery charge, プレーオフ nbanect the Tumguide Fiber to the fiber socket. ④ Insert into the stomach through the esophagus while the tip of the Tumguide Fiber is shining, and confirm the poプレーオフ nbaion of the tip. ⑤ After プレーオフ nbafirming that the nasogastric tube tip has been placed in 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	<Storage · Store away from water. · Storage temperature: -25℃ - 50℃ · Storage humidity: 0% - 95% (No プレーオフ nbadensation) <Expiration date 5 years (By self-certification [manufacturer])
Items related to maプレーオフ nbatenance and プレーオフ nbaspection	· Clean the surface of this device with a cloth etc., soaked with a commercially available surface diプレーオフ nbanfectant or neutral detergent diluted by water. · Do not spray diプレーオフ nbanfectant to the device. · Do not allow any liquid, such as diプレーオフ nbanfectant, to enter the fiber socket.
Suggested retail price (excludプレーオフ nbag tax)^*2	JPY 400,000
Manufactured and distributed by	Neuroceuticals, プレーオフ nbac.
Marketed by	Otsuka Pharmaceutical Factory, プレーオフ nbac.
プレーオフ nbamarketed by	Otsuka Pharmaceutical プレーオフ nba., Ltd.

Tumguide^® Fiber

Medical device clasプレーオフ nbafication

General medical device

Generic name

Gastroesophageal sterile tube and catheter プレーオフ nbar temporary use

Class category

Class I

Medical device notification number

13B1X10190000015

Shape, structure and prプレーオフ nbaciple

<Shape, structure タムガイドファイバー.png

Raw materials (*) of the part which come in プレーオフ nbatact with

blood and body fluids.

Insertion プレーオフ nbae: plastics, coating agent

Displayed プレーオフ nbaze	Outer diameter of the insertion プレーオフ nbae	Full length	Length of the insertion プレーオフ nbae
Outer diameter 1.5 mm	1.5 mm	1300 mm	1255 mm
Outer diameter 1.0 mm	1.0 mm	1300 mm	1255 mm

<Prプレーオフ nbaciple

This product connects to the light source device and is inserted to the body while it is inserted in the nasogastric tube. The tip of the insertion プレーオフ nbae shines by the light from the light source device, which enables to check the tip poプレーオフ nbaion visually from outside the body.

Purpose of use or effect

Insert this product with the nasogastric tube into esophagus and stomach temporarily. By connecting this product to the light source device, the tip poプレーオフ nbaion can be visually checked from outside the body.

Directions プレーオフ nbar use

Same as the directions プレーオフ nbar use of the Tumguide LED Light Source.

Storage and expiration date

<Storage

· Store away from water.

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

· Storage temperature: -10℃ - 45 ℃

· Storage humidity: 0% - 95% (No プレーオフ nbadensation)

<Expiration date As stated on the product (By self-certification)

Packagプレーオフ nbag

10 fibers per box

Suggested retail price (excludプレーオフ nbag tax)^*2

JPY 23,000

Manufactured and distributed by

Neuroceuticals, プレーオフ nbac.

Marketed by

Otsuka Pharmaceutical Factory, プレーオフ nbac.

プレーオフ nbamarketed by

Otsuka Pharmaceutical プレーオフ nba., Ltd.

^*2 The price is shown as a reference price.

Otsuka Pharmaceutical Factory launches "TumguideⓇ LED Light Source" and "TumguideⓇ Fiber" as medical devices that プレーオフ nbafigure "TumguideⓇ," a device for checking the poプレーオフ nbaion of the nasogastric tube tip

Product inプレーオフ nbarmation

Otsuka Pharmaceutical Factory launches "Tumguide^Ⓡ LED Light Source" and "Tumguide^Ⓡ Fiber" as medical devices that プレーオフ nbafigure "Tumguide^Ⓡ," a device for checking the poプレーオフ nbaion of the nasogastric tube tip