Biportal Endoscopy, Bone Biopsy Needle - Dragon Crown
Instructions for DRAGON CROWN models including: DCZJ-, DCZJ-, DCZJ Spinal Endoscope, DCZJ, Spinal Endoscope, Endoscope
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DocumentDocumentINSTRUCTION FOR USE
Spinal Endoscope
Dragon Crown Medical Co., LTD Registered Address: No.109 Shunhua Road, High-Tech Development Zone, Jinan, Shandong, 250101, China. Production Address: B1, F1, F4, F5, F6, F7, F8 and East House, Engineering & Technology Center Bldg., No.978 Tianchen Road, High-Tech Development Zone, Jinan, Shandong, 250101, China. Tel+86-531-81217461; Fax+86-831-81217299 Website: www.dcvertebrae.com Revision:SGL/CE-07-H A/1 Date: Jul.,9,2024
1. Product name Spinal Endoscope 2. Specifications and models DCZJ- , DCZJ- 3. Product Performance Spinal Endoscope is a rigid tube endoscopic instrument designed by the company for minimally invasive surgery according to clinical needs. Its characteristic is that under the premise of less trauma, through the medical camera, the surgical field of view is transmitted to the monitor, with high conductivity optical fiber, so that the surgical field has enough illumination, the doctors complete the operation by observing the image on the monitor screen, and use special instruments. Because the endoscope will enlarge the surgical field of view, making the operation safer.
This product belongs to the application part (whole) of BF type equipment, waterproof class is IPX7, no physiological effect risk. It is clinically used with medical cameras and cold light sources that meet the national Class I BF safety requirements.
BF() IPX7BF The Spinal Endoscope should be used by a trained doctor , and the operator should read the IFU carefully before use and be familiar with the use of the Spinal Endoscope. This product can be reused.
4. The main structure of the product The Spinal Endoscope consists of an eyepiece cover, a mirror body and an optical fiber interface. The schematic diagram of product structure is as follows:
DCZJ- 3.0×105
DCZJ- 2.7×150/2.7×180
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5. Indications
DCZJ- 6.3×125/6.3×181/ 6.9×181/10.0×125
All types of intervertebral disc herniation and prolapse; Spinal stenosis; Intervertebral foramen stenosis; Intervertebral space infection; Discogenic low back pain and so on.
6. Contraindication Mental patients. Pregnant women and others unfit for surgery. 7. Patient target group Those who need to use this product for surgery are evaluated by doctors.
8. Warning
(1) Type III Spinal Endoscope 6.3*181/6.3*125/6.9 has a circular instrument channel with diametric 3.7mm, 3.75mm and 4.1mm respectively. Users should pay attention to the selection of suitable instruments.
(2) The liquid used in clinical operation, cleaning and sterilization of this product includes: normal saline, routine injection liquid, purified water for cleaning, alcohol, multi-enzyme lotion or cleaning solution for endoscope; Do not use disinfectants containing peracetic acid, phenol, chlorine-containing components without anti-corrosion protection, and various adhesives or liquids that may cause corrosion to stainless steel.
(3) Due to the high temperature of the tube outlet, do not place the endoscope on heat-sensitive materials (such as covering cloth, etc.) to avoid burning or even burning.
(4) When used in combination with a high-performance light source, the temperature of the light emitting part of the Endoscope may exceed 41ºC, causing burns at the surgical site. Therefore, direct contact between the Spinal Endoscope and the tissue should be avoided. If possible, increase the flushing of the operating area and promptly suction out the generated steam with a negative pressure suction tube.
(5) Damage to the endoscope will cause blurred images, and continued operation may cause harm to the patient, so the operation should be stopped and changed to open surgery or other measures.
(6) There is potential electromagnetic interference between the device and other devices. Please try to stay away from other electronic devices when using.
(7) Optical accessories fade due to X-ray radiation, which can cause damage to the endoscope. Using CT or X-ray and endoscope at the same time can lead to danger. Because the magnetic field can cause movement/migration or heat, some metals of the endoscope can be dangerous in the examination, so such patients should not use MRI scans. The optical and electrical medical instruments of endoscopes can be damaged by magnetic forces. The metal of the endoscope can cause side effects and visual interference. Using MRI and endoscope at the same time can be dangerous.
(8) Modification of the device is not permitted.
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(9) At no time should you look directly at light from cold light sources, optical cables or endoscopes with your eyes, which can damage your eyes.
(10) The F-type application part is provided by the insulation between the supply device and the optical beam delivery outlet. (11) Before each use, or after changing the viewing mode/setting, check to ensure that the image viewed through the endoscope
is live (and not a stored image). (12) This device does not have automatic cleaning function. (13) Do not stretch the nerve or contact the meninges during the use of this product. 1. 6.3*181/6.3*125/6.9 3.7mm3.75mm 4.1mm 2. 3. () 4. 41ºC , 5. 6. 7. X CT X / MRI MRI 8. 9. 10.F 11./() 12. 13..
9. Safety tips
(1) In order to protect the endoscope from loss of function, prepare a spare endoscope before each use. (2) Before each use, it is necessary to check the part of the Spinal Endoscope and endoscope accessories inserted into the
human body, and there must be no rough surface, sharp edges and sharp edges or protrusions, incomplete or loose parts that may cause safety hazards. (3) Before each use, the Spinal Endoscope and related Spinal Endoscope auxiliary equipment must be checked for optical or mechanical damage. Do not use damaged Spinal Endoscopes. (4) When the high-frequency instrument is used, the current conducting part should be in the field of view and in contact with the specified position, and the high-frequency current conducting part can be powered on only when the distance between the high-frequency current conducting part and the end of the endoscope or the working sleeve is more than 10mm. Please refer to the use instructions of the high-frequency instrument manufacturer. (5) When using high-frequency devices, it should be noted that the leakage current of the patient may be accumulated. The maximum rated repeat peak voltage of the device used by the user is 1000V, and a higher repeat peak voltage should not be used. (6) High-frequency isolation and/or insulation are provided by the high-frequency accessories and/or equipment used for interconnection.
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(7) When a type III Spinal Endoscope is used, an instrument that can pass through the instrument channel on the Spinal Endoscope must be used, where the surgical forceps should be introduced or removed visually from the instrument channel of the mirror when the mouth of the forceps is closed. If larger tissue is clamped, it can be removed from the working cannula along with the endoscope.
(8) Do not use high frequency devices in the presence of flammable anesthetics, excessive gas injection, high concentration explosive gases, inert gases or laser assisted gases to avoid gas embolism.
(9) When the endoscope device is used with accessories, other ME devices and/or non-ME devices within the scope of the endoscope application configuration, there should be no similar design resulting in incorrect links to avoid the risk of simultaneous use.
1. 2. 3. 4. 10mm 5. 1000V, 6. ()() 7. 8. 9. ME/ ME
10. Usage method
(1) Operating conditions Temperature range: 5 ~ 40; Relative humidity range: 80%; Atmospheric pressure range: 70kPa ~ 106kPa. Free of corrosive gases and well-ventilated interior. 54080%70kPa106kPa (2) Check The Spinal Endoscope must be checked before each use: Check the product: make sure it is free from rust, indentation, scratch, bending, deformation and broken lens. Check the image quality: the text about 30mm from the end of the objective lens should be clearly seen through the optical tube. 30mm
(3) Clinical Use
a. According to surgical requirements, the posterior (interlaminal) approach of the spine was generally selected for DCZJ-II 3.0×105, DCZJ-III 2.7×150,6.3×125, and 10.0×125, and DCZJ-III 2.7×150,2.7×180,6.3× 181. 6.9×181 spinal lateral posterior approach was selected, DCZJ-III 2.7×150 anterior cervical approach was selected, and after X-ray positioning,
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percutaneous puncture was performed to expand step by step, and finally the working cannula was placed to complete the establishment of the working channel. DCZJ- 3.0×105DCZJ- 2.7×150,6.3×125 10.0×125 () DCZJ- 2.7×1502.7×1806.3×1816.9×181 DCZJ- 2.7×150 X b. DCZJ- 3.0×105 and DCZJ-III 2.7×150,2.7×180 intervertebral disc lenses should be stuck on the entry frame first and then fitted on the working sleeve, and the position and height should be determined before fixing the frame; Type III Spinal Endoscopes 6.3× 125,6.3 × 181,6.9 ×181 and 10.0×125 can be directly inserted into the working tube, and the normal saline is connected to the flushing valve on the scope to adjust the appropriate water flow. DCZJ- 3.0×105 DCZJ- 2.7×150,2.7×180 6.3×1256.3×1816.9×18110.0×125 c. Connect the endoscope to the camera lens port and the optical fiber, and fasten it firmly. d. Turn on the camera, cold light source, and monitor switch (If you need to adjust the white balance, point the white paper or gauze without reflective, press the white balance button for 5 seconds), rotate the focus ring on the camera, adjust the focus length until the image is clear, and rotate the camera to adjust the direction of the image. ( 5 ) e. In use, if there is blood or other tissue in the lens, water can be flushed into the working tube or the Spinal Endoscope can be removed and wiped to ensure a clear image. When taking out, it should be slowly pulled out, do not exert too much force.
11. Spinal Endoscope cleaning, sterilization and maintenance
(1) The Spinal Endoscope is provided in a non-sterile state, and must be cleaned and sterilized before use.The cleaning process does not require disassembly.
. (2) Processing restrictions and constraints: the damaged disc scope can not continue to use; Spinal Endoscopes that have
reached the limit of times of use should not be used any longer. (3) Initial treatment: the pollutants on the surface of the Spinal Endoscope should be initially removed under running tap
water within 30 minutes after use, and the water stains on the surface of the Spinal Endoscope should be wiped clean; If the disc scope cannot be handled immediately, it should be kept damp during transport, covered with a wet towel or placed in a tray with running water. 30 (4) Transport and container: should be equipped with Spinal Endoscope tray transported to the special work area for processing; Contaminated and uncontaminated Spinal Endoscope should be transported separately to avoid human and environmental contamination.
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(5) Cleaning agent and cleaning tools: It is recommended to use a multi-enzyme cleaning agent with a concentration of 0.5%, special soft brush, soft cloth, and dust-free cloth. Multi-enzyme cleaners are used in accordance with the manufacturer's instructions for use.
0.5% (6) Cleaning / a. Clean the Spinal Endoscope with purified water for at least 3 minutes to remove residual substances such as blood and
tissue. Use a soft cloth to remove any remaining dirt from the Spinal Endoscope scope. (processing temperature: 15 ~ 30). 3min (1530) b. Check the end of the Spinal Endoscope for damage, and make sure that the lens at the end is intact and firmly in the proper position, and check whether it has exceeded the number of uses. c. Prepare 0.5% medical multi-enzyme low-foam detergent diluted with purified water in a suitable container, so that the whole Spinal Endoscope can be completely soaked for 20min (processing temperature: 25~30). 0.5% 20min( 25~30) d. After soaking, wash the whole Spinal Endoscope with a soft brush and the lumen with a special soft brush for at least 2min to remove all visible contaminants (processing temperature: 25~30). 2min 25~30 e. All parts of the Spinal Endoscope should be thoroughly cleaned with purified water (at least 30s), and the lumen should be thoroughly washed with a high-pressure water gun (at least 20s) (processing temperature: 15 ~ 30). ( 30s)( 20s)(1530) f. Wipe the end with a dust-free cloth until the dirt is completely removed. g. Rinse the entire Spinal Endoscope with purified water for at least 60 seconds until visible dirt and cleaning agent are completely removed (processing temperature: 15 ~ 30) 60 (1530) h. First drain all water, and then completely dry the Spinal Endoscope end and all surfaces with a soft and absorbent cloth. Use a pressure air gun to blow out any remaining water traces on the Spinal Endoscope surface and inside the channel cavity (do not use compressed air on the Spinal Endoscope end). () i. Place in a drying oven at 80 ° C (set temperature) for at least 30min and ensure that the Spinal Endoscope is dry before moving to the next step. 80() 30min j. Check the entire Spinal Endoscope for dirt under a magnifying glass. If dirt is still present, repeat the entire cleaning process. (7) Inspection and maintenance: After cleaning, the Spinal Endoscope must be checked, and the inspection should be thorough.
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Check the product: to ensure that it is free from rust, indentation, scratch, bending, deformation and broken lens. Check the image quality: the text about 30mm from the end of the objective lens should be clearly seen through the optical tube. 30mm (8) Sterilization a. The sterilization of the Spinal Endoscope should be put into a special disinfection box, and then the sterilization box
should be double-wrapped with a standard non-woven fabric or a moisture-proof surgical sterile bag. Or follow the rules of your local medical institution. b. Can use steam sterilizer (Shandong Xinhua Medical Equipment Co., LTD.; Model MOST-T; Volume 80L). The sterilization parameters were temperature 134, pressure 201.7kPa-229.3kPa, sterilization time 4min, and drying time 30 minutes. It is the responsibility of the user to ensure that the sterilization procedure has achieved the specified sterilization effect. Note: The sterilizer in the manual is recommended. If the user changes the sterilizer, the sterilizer should be verified by himself. 1 2 (MOST-T80L) 134 201.7kPa-229.3kPa 4min30min (9) Storage: sterilized products should be classified, stored in the sterile goods storage area in separate racks . The ambient temperature should be < 24, relative humidity should be less than 70%, medical non-woven packaging products are valid for no more than 180 days. Or follow the rules of your local medical institution. 2470% 180
12. Maintenance, storage and transportation
1) The Spinal Endoscope is a precise optical instrument, and must be used with care to avoid collision between other instruments and the mirror tube, especially the mirror tube is very sensitive to bending pressure, and too much force may cause damage to the optical components and make it impossible to use.
2) The surface of the Spinal Endoscope can not be wiped with hard objects, and high care should be taken when cleaning the Spinal Endoscope to avoid bending the mirror tube under pressure, and to prevent impact and fall, resulting in losses.
3) The Spinal Endoscope should be stored in the atmospheric pressure range of 70kPa ~ 106kPa, the temperature of -20~ 45, the relative humidity is not more than 80%, no corrosive gas and good ventilation room; Transport conditions are atmospheric pressure range 70kPa ~ 106kPa, temperature -20~ 45, relative humidity is not more than 80%.
4) In order to avoid damage to the endoscope in transit, we recommend using the original packaging during delivery and repair.
5) The disposal of equipment and packaging materials and accessories shall comply with the relevant national environmental protection regulations. 1.
2.
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3. 70kPa106kPa -20~ 45 80 70kPa106kPa -20~ 45 80
4. 5.
13. High-frequency service parameter 1) Operation mode: Cutting, clotting, cutting/clotting mix. 2) Output frequency: 1.7MHz ~ 4.0MHz. 3) Maximum output power: 120W. 4) Maximum output voltage: cutting, cutting/coagulation mode 600V, coagulation mode 300V. 5) Warning: Avoid using explosive gases in areas where high-frequency endoscope attachments are used. 6) Safety type: BF type. 7) Anti-fluid level: IPX7.
1. / . 2. 1.7MHz ~ 4.0MHz 3. 120W 4. / 600V, 300V 5. 6. BF 7. IPX7
14. Date of Manufacture, & Expiration Date Date of Manufacture: See product label Lifetime: 5 years Number of repetitions: 100 times Note: The service life and the number of repeated use of the first to achieve the first. 100
15. Complications/Side Effects /
a. Nerve root injury
b. Infection
16. Graphic symbol interpretation:
BF type application part
Handle with care
Caution
Be afraid of rain
Model number
Date of manufacture
Sterilization parameter Batch Code
Temperature limit
Humidity limitation
Use by date
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The atmospheric pressure limit
Manufacturer
Consult instructions for use
Serial number
Company Name :Lotus NL B.V. Company Address:Konin gin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlan ds.
Tel+31644168999
E-mailpeter@lotusnl.com
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