Tian Song®
Sinuscope
Operating Manual
ZHEJIANG TIANSONG MEDICAL INSTRUMENT CO., LTD
Tian Song® Sinuscope operating manual
- 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: +86(0)571-6424187864241388; Fax:+86 (0)571-64241818We 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: +86(0)571-64241168— After-sales service company: Zhejiang Tiansong Medical Instrument Co,. LtdAddress: No. 168 Jianduan Road, Tonglu Economic & Technical Development Zone, Hangzhou 311501, Zhejiang, ChinaZip Code: 311501Website: www.zj-tiansong.com; www.chinaendoscope.cn
Company: Zhejiang Tiansong Medical Instrument Co., Ltd IAddress: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
Content
Symbol Description ———————————- 1Operator qualify ————————————– 11. Product usage ————————————– 22. Main structure ————————————- 23. Main feature, specification and the configuration — 23.1 Main feature ———————————– 23.2 Products configuration ———————- 24. Applying field ———————————– 35. Using Method ———————————– 35.1 Preoperative preparation ——————– 35.2 Steps ——————————————— 46. Attention —————————————– 56.1 Warning and attention ———————— 56.2 Cleaning, disinfection and sterilization —- 77. Contraindication only for reference ——— 108. Maintenance and repair ———————— 109. Marking and signal —————————— 12
Company: Zhejiang Tiansong Medical Instrument Co., Ltd IAddress: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
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 qualifyThe products operator should be the specialist or the medical affairs under the specialist’s supervision; they should be passed the fully special clinical Sinuscope training. All the using method and the contraindication are only for reference.
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 1Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
1. Product usage
Sinuscope is mainly used for sinus inspection and operation.
2. Main structure
Sinuscope is mainly composed of lens body, light pencil joint, eyepiece casing and light guide cable. The construction features are as follows:
3. Main feature, specification and configuration
3.1 Main feature
| Item | Name | Sinuscope |
| Out diameter | Φ4mm（utmost deviation+5%) |
| Working length | ≥175mm |
| Field Of View | 60°, 90°（utmost deviation-5%) |
| Direction of view | 0°（utmost deviation ±5°）
30°（utmost deviation ±5°） 70°（utmost deviation ±5°） 45°（utmost deviation ±5°） |
| Magnification | ＞1x (L=10mm) |
| Resolution | ≥9.92Lp/mm(L=10mm) |
| Illumination | ＞5000Lx(L=10 mm) |
The product meets the demand of GB 9706.1GB 9706.19.
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 2Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
3.2 Configuration
| Item | Name | Item No. | Specification |
| Sinuscope | Endoscope | B0110 | 0°Φ 4×175mmWide angle |
| Endoscope | B0112 | 30°Φ 4×175mmWide angle | |
| Endoscope | B0113 | 70°Φ 4×175mmWide angle | |
| Endoscope | B0016 | 45°Φ 4×175mmWide angle | |
| Endoscope | B0120 | 0°Φ 4×175mmWide angle, Autoclave | |
| Endoscope | B0122 | 30°Φ 4×175mmWide angle, Autoclave | |
| Endoscope | B0123 | 70°Φ 4×175mmWide angle, Autoclave | |
| Endoscope | B0016.1 | 45°Φ 4×175mmWide angle, Autoclave | |
| Endoscope | B0040 | 0°Φ 4×175mm | |
| Endoscope | B0042 | 30°Φ 4×175mm | |
| Endoscope | B0043 | 70°Φ 4×175mm | |
| Endoscope | B0044 | 45°Φ 4×175mm |
4. Applying field
Sinuscope is used for sinus lumen examination and operation.
5. Using Method
5.1 Preoperative preparation
Attention : During the use of Sinuscope, it may occur Sinuscope’s failure (such as unclsinus imaging of lens body) or a subsidiary of equipment failure (such as the cold light bulb lighting failure), resulting in the loss of equipment’s function. Therefore, we suggest preparing spare equipment and parts before the operation to prevent any eventuality.
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 3Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
- Realize the patient’s state of illness, clsinus the purpose of inspection;
- Explained to the patients about the state of illness, inform relating matters to inspection, and get the patient’s consent;
- Prepare the necessary preoperative examination, such as hsinust, liver and renal function measurement;
- Sinusnestly do a good preparatory work of Sinuscope, cold light source and other accessories in order to check whether its function is good.
Required inspection items
- Definition of endoscopic imaging, on outer surface whether there are sharp edges, corner.
- Whether the connection of endoscope and light guide cable is good, as well as the light guide cable and cold light source.
- Whether the cold light source works well. When connecting you should confirm if the temperature of insert part is over 41 and electrical security is good;
5.2 Steps
1) Anesthesia: Generally, without anesthesia, but to infants and those who cannot cooperate, you can use proper sedative hypnotics drug in order to facilitate the operation.
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 4Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
2) Body posture: After total anesthesia, flat lie and head slant.
3) Connect the endoscope with cable and light source, open the light source and adjust to proper lighteness.4) The patient’s head position should be fixed during examination, doctor can sit or stand on the right side, hold Sinuscope gently to insert the nasal cavity.
6. Attention
6.1 Warning and Attention
1) Attention : Before using the Sinuscope, 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!
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 5Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
4) Attention: Please check the inserted part of Sinuscope if there is some roughened surface, acuity edge or the prominence on the instrument.
5) Attention : Sinuscope 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 Sinuscope, he should immediately stop using it and extract slowly. It would be harmful to patients if operating with faulted Sinuscope.
7) Warning: The temperature of Sinuscope will increase to 41 ºC to 50 ºC because of the light irradiation. The surface temperature over 41 ºC would lead to mucosa burning. Therefore, the operator need to use the smallest illumination, the shortest time and the most appropriate distance for observation. Fixed-point observation should be avoided as far as possible, do not let the Sinuscope close mucosal for too long time.
8) Warning: Before and after using of Sinuscope, please try to refrain from the use of lighting. Persistent lighting will rise the temperature of objective lens, resulting in burn of patients or
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 6Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
operators.
9) Warning: If the Sinuscope uses endoscopic annex with energy, then the patients will increase leakage current.
10) Warning: Do not ever directly look at the cold light source, fiber optic cable or endoscope light, which would damage the eyes.
11) Attention: Sinuscopy set is a kind of reusable medical devices. The long-term usage or improper maintenance will cause the aging of the reused Sinuscope and the instruments. Please make sure every part of the Sinuscope is safe and reliable before using.
12) Attention: Before using please put the front part of disinfected endoscope in the distilled water about 40 ºC in order to avoid the fog which will affect the observation.
6.2 Cleaning, disinfection and sterilization
6.2.1 Cleaning
- 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 Sinuscope,
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 7Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
and give the endoscope a thorough clean-up. Please separate the endoscope and other components when cleaning.
2) After using the Sinuscope, it should be thoroughly washed with flowing water immediately to remove blood, mucus and other residue material. Then drying it.
3) About the Sinuscope 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) Sinuscope after washing, please dry it, to be disinfected.
Attention: Bending of the endoscope should be avoided, do not spin to loose or remove eyepiece cover (except special products), do not put heavy on the endoscope or drop or rough dispose. Avoid cleaning endoscopes with ultrasonic.
6.2.2 Disinfection and sterilization
- Ethylene oxide sterilization
—-This is the preferred method for the endoscope which can not bsinus pressure steam sterilization methods.
—-Mini ethylene oxide sterilizer relative conditionEthylene oxide sterilizer gas concentration…600mg/L∼800mg/L
Temperature ………………………………………….37ºC∼63ºC
Relative humidity ………………………………….. 40%-80%
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 8Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
Sterilizing time…………………………………………1h-6h
- Glutaraldehyde sterilization
—-Put the cleaned and dry endoscope 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
- The other sterilizing method under the ministry of health
Attention:
1) Openness concretion, hepatitis, AIDS patient or the pathogen carrier should use the special Sinuscope, patient and the Sinuscope should do the strictly sterilization, and the sterilizing vessel also should be separately strictly from the other patient. If using the special Sinuscope is difficult, also should do the sterilizing or high level disinfecting.
2) The Sinuscope sterilized by the chemosterilant, firstly should be cleaned by aseptic water to clean the rest disinfector.
- Sterilization and disinfection of other parts
1) The surgical instruments used with Sinuscope should be sterilized after cleaning.
2) Ethylene oxide sterilization can also be used, the methods and notes refer to the sterilization of Sinuscope
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 9Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
3) Sterilization by soaking in 2% glutaraldehyde for 10h, all parts should be soaked in disinfectant, all channels should be filled with disinfectant.
4) Fiber 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)
Sinuscopy doesn’t have absolute contraindication. But to infants and those who can not cooperate, you can use proper sedative hypnotics drug in order to facilitate the operation.
8. Maintenance and Repair
Note: The products are can not repaired by customer. Please do not disassemble, modify or try to maintain, otherwise that will do harm to the patient or the operator, even damage the Sinuscope.
The Sinuscope 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,
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 10Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
even when you do the disinfecting, also should rulely, can not disinfected by random. Disinfecting strictly follow the regulation avoid damagement.
2) If the Sinuscope 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 can not be over-bending, the radius of curvature shall be not less than 5cm, in order to avoid damage to optical fiber.
4) Sinuscopic removal, storage should be handled with care, no bump, collision, extrusion, etc.
Note: Sinuscopy set is a kind of reusable medical devices
Using condition: Environment temperature: 10°C∼40°CRelative humidity: 30%∼75%Air pressure:700KPa∼1060KPa
Storing condition: Environment temperature: -20°C∼+60°CRelative humidity: 10%∼80%Air pressure: 500KPa∼1060KPa
Please store them to the no corrosiveness and the well-ventilated room, the sterilized Sinuscopy set 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.
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 11Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
Tian Song® Sinuscope operating manual
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 ysinus, 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.
72010 / B0040 – 72011 / B0042 – 72012 / B0043 – 72013 / B0044
Zhejiang Tiansong Medical Instrument Co., Ltd.No. 168, Jianduan Road, Tonglu Economic & Technical Development Zone,Hangzhou 311501, P.R. China 
0197
Lotus NL B.V.Koningin Julianaplein 10, 1 e Verd, 2595AA,The Hague, Netherlands
M-72010-GB-Rev.3.02.20
Company: Zhejiang Tiansong Medical Instrument Co., Ltd 12Address: No.168 Jianduan Road, TongLu Economic&Technical Development Zone, Hang Zhou 311501, Zhejiang, ChinaTel: +86 571 6424138864241878 Fax: +86 571 64241818
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