Gima TELE-LARYNGOSCOPE diam. 8 x 170 mm User guide

®

Tian Song

Focusing Laryngoscope

Operating Manual

ZHEJIANG TIANSONG MEDICAL INSTRUMENT CO., LTD

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

I

 Production License No., Product Registration No. and Implementation of standards of the

enterprise

——Zhejiang Food and Drug Administration Production No 20100200

——Zhejiang Food and Drug Administration No 2014 No 2220774

— This product has passed the Certification of Medical Devices Quality Management System

which meets the demand of GB/T 19001-2016idt ISO 9001:2015 and YY/T 0287-2017idt ISO

13485:2016

Certification No：04719Q10763R6M、04719Q10000879

— This product has passed the Certification of EC Medical Devices Quality System which

meets the demand of EN ISO 13485:2016

Certification No.: CE—0197 SX 60123619 0001

CE—0197 HD 60123618 0001

 After-sales service

— Repair guide: After-sales service department of Zhejiang Tiansong Medical

Instrument Co., Ltd requires the product which needs repairing should meet the

demand of Warranty Statement. We will repair the product and do an overall check as

well. We provide free service if the product is before the limited period and paid service

if it is out of the guarantee scope or exceeds the limited period.

— If you want to buy our products or have consultation, please contact with our Sales

Department.

— Tel: [phone]; Fax:[phone]

We have set up offices all over the provinces and cities in China to do service, try best to

make sure the customers believe us, their contacts would be known if you phone our

Sales Department.

— After-sales Tel: [phone]

— After-sales service company: Zhejiang Tiansong Medical Instrument Co., Ltd

Address: No. 168 Jianduan Road, Tonglu Economic & Technical Development Zone,

Hangzhou 311501, Zhejiang, China

Zip Code: 311501

Website: www.zj-tiansong.com; www.chinaendoscope.cn

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

I

Content

Symbol Description------------------------------------------ -----1

Operator qualify ------------------------------------------------1

1. Product usage-------------------------------------------------2

2. Main structure------------------------------------------------2

3. Main feature, specification and the configuration- ------------2

4. Applying field------------------------------------------------2

5. Using Method--------------------------------------------------2

6. Attention-----------------------------------------------------3

6.1 Warning and attention----------------------------------------3

6.2 Cleaning, disinfection and sterilization---------------------5

7. Contraindication （ only for reference） -----------------------7

8. Maintenance and repair ---------------------------------------7

9. Marking and signal--------------------------------------------9

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

1

Symbol description

In this manual we use the symbols as below:

Warning: mean the potential harm, if not avoid, may lead to die

or the strong result.

Attention: mean the potential harm, if not avoid may lead middle

or light result, also use as unsafe operation or potential harm.

Operator qualifies

The products operator should be the specialist or the medical affairs under

the specialist’ s supervision; they should be passed the fully special

clinical focusing laryngoscope training. All the using method and the

contraindication are only for reference.

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

2

laryngoscope

1. Product usage

Focusing laryngoscope is mainly used with larynx instruments for

larynx inspection and operation.

2. Main structure

Focusing laryngoscope is mainly composed of lens body, eyepiece casing,

light pencil joint， focusing part and handle.

3. Main feature, specification and configuration

Item No.

1

2 Laryngoscope D0101 90°

3

4 Laryngoscope D0112 70°
5 Laryngoscope D0105 70°

6

7 laryngoscope D0104.1 70°
8 Light guide cable T5012 1800mm

Note： The focusing laryngoscope can be operated with larynx instruments,

please phone for details.

Name Serial No.

Focusing

laryngoscope

Focusing

laryngoscope

Focusing

laryngoscope

D0103 70°

D0102 90°

D0110 70°

Specification

4. Applying field

Focusing laryngoscope is used with larynx instruments for larynx

inspection and operation.

5. Using Method

1. Lay the front point of disinfected laryngoscope into 40° C distilled

water to prepare for use.

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

3

2. Insert fiber-optic light cable into the hole of light source and

adjust light to the lowest degree. Then connect another end of fiber-optic

light cable with laryngoscope. Finally turn on light source, if necessary,

adjust light degree and focus the endoscope until the image is clear.

6. Attention

6.1 Warning and Attention

1) Attention： Before using the focusing laryngoscope, please

read the manual carefully and accessories manual.

2) Warning： The operator should be the certain qualification,

and after the training and with the good operating skill. Before

the operation, they should read the relative document include the

technique, relative disease and the harm.

3) Warning：If the sterilizing not totally, and the sterilizing

liquid over the term or not sterilizing not follow the general

requirement, all that case will possibly lead to intercross

infection. Especially for the contagion and the cancer patient, must

disinfect in time!

4) Attention ： Please check the inserted part of focusing

laryngoscope if there are some roughened surface, acuity edge or

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

4

the prominence on the instrument.

5) Attention：Focusing laryngoscope is the important guarantee

of observation and diagnosis. Be careful when using. Always be mild,

step by step, can’ t push by force, bump and bend.

6) Warning ： Whenever discovering the anomaly of focusing

laryngoscope, he should immediately stop using it and extract slowly.

It would be harmful to patients if operating with faulted focusing

laryngoscope.

7) Warning： Do not ever directly look at the cold light source,

fiber optic cable or endoscope light, which would damage the eyes.

8) Attention ： Focusing laryngoscope is a kind of reusable

medical devices. The long-term usage or improper maintenance will

cause the aging of the reused focusing laryngoscope and the

instruments. Please make sure every part of the focusing

laryngoscope is safe and reliable before using.

9) Attention： Before using the focusing laryngoscope, please

check it if it is rough or has sharp outshoot. Once they were found,

the operator should immediately stop using the focusing

laryngoscope. Otherwise it will hurt the patient.

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

5

6.2 Cleaning, disinfection and sterilization

 Cleaning

Attention： The products are not disinfected and sterilized

before the transportation. So that, before you first time use, you should

do the cleaning, disinfecting and sterilizing as below.

1） Before disinfection, please discharge the cable from the focusing

laryngoscope, and give the endoscope a thorough clean-up. Please

separate the endoscope and other components when cleaning.

2） A fter using the focusing laryngoscope, it should be thoroughly

washed with flowing water immediately to remove blood, mucus and

other residue material. Then drying it.

3） About the focusing laryngoscope after drying, it should be soaked

in a dedicated multi-enzyme cleaning lotion to prevent organic

matter and protein coagulating, the soaking time of multi-enzyme

lotion refers to the manual, and rinse under running water.

4 ） Focusing laryngoscope after washing, please dry it, to be

disinfected.

 Disinfection and sterilization

1> Ethylene oxide sterilization

——Mini ethylene oxide sterilizer relative condition

Ethylene oxide sterilizer gas concentration… 600mg/L～ 800mg/L

Temperature……………………………………….……37℃～63℃

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

6

Relative humidity…………………………….………40%-80%

Sterilizing time…………………………………………1h-6h

2> Glutaraldehyde sterilization

--- Put the cleaned and dry focusing laryngoscope to the 2%

Glutaraldehyde vessel, cover and after 10 hours, take out by aseptic

technique, clean it by aseptic water, then aseptic dry.

Note: The Glutaraldehyde must with the valid concentration the

valid term, if not please change in time

3> The other sterilizing method under the ministry of health

Attention：

1 ） Openness concretion, hepatitis, AIDS patient or the pathogen

carrier should use the special focusing laryngoscope, patient and the

focusing laryngoscope should do the strictly sterilization, and the

sterilizing vessel also should be separately strictly from the other

patient. If using the special focusing laryngoscope is difficult, also

should do the sterilizing or high-level disinfecting.

2 ） The focusing laryngoscope sterilized by the chemo sterilant,

firstly should be cleaned by aseptic water t o clean the rest disinfector.

 Sterilization and disinfection of other parts

1） The surgical instruments used with focusing laryngoscope should be

sterilized after cleaning.

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

7

2） Ethylene oxide sterilization can also be used, the methods and notes

refer to the sterilization of focusing laryngoscope.

3） S terilization by soaking in 2% glutaraldehyde for 10h, all parts

should be soaked in disinfectant, all channels should be filled with

disinfectant。

4） F iber optic cable and other accessories can be disinfected by 75%

alcohol cloth to wipe both sides, or adopt disposable sterile plastic

cover to achieve the purpose of isolation disinfection, but the contact

part should still be disinfected by alcohol.

Note: All the clean, disinfecting and chemical method, steps

and the technical parameters are only for reference. The detail should

be accord with the operating manual.

7. Contraindication (Only for reference)

If the throat inspection is not clear, the laryngoscopy is very

suitable for the following symptom.

1. Resection of vocal cord polyp

2. Resection of vocal nodules

3. Removal of hypopharynx or laryngeal foreign body

4. Resection of vocal cord cyst

8. Maintenance and Repair

Note: The products are cannot repaired by customer. Please do

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

8

not disassemble, modify or try to maintain, otherwise that will do harm

to the patient or the operator, even damage the focusing laryngoscope.

The focusing laryngoscope should be use carefully and lightly, avoid

damaging the surface. Should be kept well.

1) When finish the operation, please clean in time and keep them well,

even when you do the disinfecting, also should rudely, cannot disinfected

by random. Disinfecting strictly follow the regulation avoid damagement.

2) If the focusing laryngoscope will be no use for long time, they

should be put in the pneumatic drying place, checked every one to two weeks,

be careful not to mould and rust.

3) Fiber optic cable cannot be over-bending, the radius of curvature

shall be not less than 5cm, in order to avoid damage to optical fiber.

4) Focusing laryngoscope removal, storage should be handled with care,

no bump, collision, extrusion, etc.

Note： Focusing laryngoscope is a kind of reusable medical

devices

Using condition: Environment temperature: 10℃～40℃

Relative humidity: 30%～ 75%

Air pressure： 700KPa～ 1060KPa

Storing condition: Environment temperature: -20℃～+60℃

Relative humidity: 10%～ 80%

Air pressure： 500KPa～ 1060KPa

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

9

Please store them to the no corrosiveness and the well-ventilated room,

the sterilized focusing laryngoscope should be kept according to the

requirement for the asepsis.

From the date of the factory, product does not work within 12 months because

of quality issues, we will repair for free, replace parts or products,

life-long maintenance.

The following situations is not in the scope of warranty, we will provide paid

service:

1) Human factors, e.g. using improperly, bump, choosing wrong disinfection method

and maintenance;

2) Broken lens;

3) Demolition by self;

All kinds of the products can be updated or improved. If the

configuration change, forgive us inform further.

9. Marking and signal

1）Tian Song®---------------------------------- Company registered brand

2 ） “ A0013 ” and so on--------------------------------Product series

number

3） Series code： The first two number is the year, next two is the month,

then the work number, the last two is the quantity of this lot number.

For example:05071120, it means the production date is July,2005, work

number is 11, and the quantity of this lot number is 20

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China

Tian Song® Focusing Laryngoscope operating manual

Company: Zhejiang Tiansong Medical Instrument Co., Ltd

Tel: [phone] Fax: [phone]

10

72021 / D0104.1

Zhejiang Tiansong Medical Instrument Co., Ltd.

Lotus NL B .V.

M-72021-GB-Rev.3.02.20

0197

No. 168, Jianduan Road, Tonglu Economic & Technical Development Zone,
Hangzhou 311501, P.R. China

Koningin Julianaplein 10, 1 e Verd, 2595AA,
The Hague, Netherlands

Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, China