Detail
- Endoscope adopts imported stainless steel material
- Endoscope adopts German optic glass,light fiber and light cone
- Adopt the patented technology of rod optical lens,clear field of view
- With directional markings and sapphire lenses;
- The low temperature plasma sterilization endoscope can be chosen.
- The operation instruments adopt imported stainless steel material,no coating,good anti-corrosion function
- Stainless steel valve,easy for maintenance,avoid damaging
Product specification & Matching list
Matching list
| Endoscope | Scope sheath | Puncture needle | Blunt obturator | Optical cable |
| J0500G | G4500 | G4520 | G4540 | U8724 |
| G4500X | G4520X | G4540X | ||
| J0530G | G4503 | G4502 | G4540 | |
| G4503X | G4502X | G4540X | ||
| J0570G | G4507 | G4520 | G4540 | |
| G4507X | G4520X | G4540X | ||
| J0500E | G4500 | G4520 | G4540 | |
| G4500X | G4520X | G4540X | ||
| J0530E | G4503 | G4502 | G4540 | |
| G4503X | G4502X | G4540X | ||
| J0570E | G4507 | G4520 | G4540 | |
| G4507X | G4520X | G4540X | ||
| J2500C | G4510XA | G4530XA | G4550XA | |
| J2530C | G4513XA | G4530XA | G4550XA | |
| J2500 | G4510X | G4530X | G4550X | |
| J2530 | G4513X | G4530X | G4550X | |
| J2570 | G4517X | G4530X | G4550X |
1 Intended purpose
The device is used for observation during diagnostic and therapeutic arthroscopic surgical procedures in the knee and shoulder.
1.1 Medical Indications
Based on the judgment of an experienced surgeon, the following list includes some of the primary indications for using the arthroscope and is by no means exhaustive.
Knee Joint:
• Meniscus repair and resection
• Knee osteoarthritis
• Knee joint cartilage injuries
• Knee trauma and fractures
Shoulder Joint:
• Adhesive capsulitis
• Diagnosis and repair of rotator cuff injuries
• Surgical treatment of pelvic lip injuries
• Surgical treatment of shoulder instability
1.2 Contraindications
• Joints have fibrous stiffness or rigidity;
• There are lesions around the joints;
• Have a serious systemic infection;
• Patient in such poor general condition that they cannot tolerate this examiner;
• The arthroscope is contraindicated for use when, in the opinion of a qualified physician, such use would create a condition that would be dangerous for the patient.
2 Intended Patient Populations
The product is suitable for any patients with the above disease or medical condition except for those with contraindications.
3 Intended Users
The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.
4 Warning
1) Please read the instructions for use carefully before use.
2) Any serious incidents related to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient are established.
3) The operator must have certain qualifications. 2-3 years of conventional joint site surgery experience are generally required. Rigorous training and proficiency in the skills of operation are also necessary. Before the operation, consult the medical literature about the techniques, complications, and hazards.
4) Strict, sterile operation. Do not cross-use.
5) To avoid injury caused by rough surfaces, sharp edges, and protrusions, please check the inserting part of the arthroscope before use.
6) The surgery should be operated on carefully and gently to avoid injury or damage to the patients and the equipment during the operation.
7) Making emergency preparedness before surgery in case of emergency.
8) Do not use a tourniquet or fixator long-term during surgical operations; otherwise, the patient may be injured.
9) Postoperative healthcare should be adequate, and postoperative percutaneous aspiration should be performed if necessary; otherwise, patients may develop abnormal conditions, such as edema.
10) When the light exit window of the endoscope transmits the high-energy radiation light, the temperature of the light exiting portion may exceed 41 °C, which will cause high-temperature harm to the front portion of the light exit window. In order to meet clinical needs, we propose that the operation time be as short as possible and the light source brightness be as low as possible.
11) If the surface temperature of the arthroscope exceeds 41 °C, it may cause burns to the contact site of the patient, so if the doctor feels the surface temperature of the arthroscope exceeds body temperature, he should stop using it immediately. If the cooling fan or light-insulated glass fails, replace it with the standby light source or take other emergency measures quickly.
12) No matter the direct sight or connection to the video, please adjust the light source to the least illumination intensity so that the endoscope can get the best illuminating performance. The higher the light intensity of the light source, the bigger the heat output the terminal for the endoscope creates.
13) Before and after the arthroscope examination, please do not use the illumination. Consistent illumination will make the objective tip of the endoscope temperature rise and then burn the patient or the user.
14) After connecting to the cold light source, the endoscope will have a high illuminating temperature through the light cable. Users and patients should not look directly at the endoscope illuminating section so that damage to the eye can be avoided.
15) If the endoscope loses its function, for example, when the observed image is seriously unclear or invisible, stop using it or replace it with the backup endoscope.
16) Whether for direct view or video combination, always adjust the light source to the minimum brightness required to achieve the best endoscopic field of view illumination effect. The higher the intensity of the light source, the greater the amount of heat generated at the end of the endoscope.
17) The Arthroscope can be used in combination with HD camera systems, cold light sources, HF generators, and HF surgical equipment that comply with the following standards: EN 60601-1:2006/A2:2021, EN IEC 60601-2-2:2018, and EN 60601-2-18:2015. HF surgical equipment is typically used to achieve hemostasis, tissue dissection, or ablation during arthroscopic procedures.
18) To avoid distraction from other devices or other equipment, the cold light source power line should be connected to the power unit when the arthroscope operates. Also, users should note the EEG machine, patient monitor, diasonograph, X-ray machine, and heart pacemaker, especially the electromagnetic interference from the device checking the body's biological signal.
19) Apply the suggestion of other medical electrical equipment.
20) When using endoscopic equipment with other medical electrical equipment, a suggestion should be made to avoid potential safety hazards under unified use.
21) The Arthroscope is intended for use in the arthroscopy operating rooms of medical institutions, which are classified as professional healthcare facility environments.
22) Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC). This device is to be used only for the purposes described in this document and has to be installed, set up, and operated in compliance with the EMC guidelines.
23) Using the product with other equipment which are not approved by the manufacturer may result in an increase of electromagnetic emissions and electromagnetic interference and the compliance with the stipulated limit values are not guaranteed anymore.
24) Use of this equipment adjacent to or stacked with other equipment should be avoidedbecause it could result in improper operation. If such use is necessary, this equipment andthe other equipment should be observed to verify that they are operating normally.
25) Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
26) Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the arthroscope, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
27) NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
5 Precautions
1) Keep endoscopes clean and dry when they are not in use. The exterior of the endoscope is made of stainless steel, but it is not completely rustproof.
2) Bending the endoscope or using the endoscope as a lever or pry bar may result in lens damage and render the scope unusable.
3) Contact with a surgical laser beam may damage the endoscope surface and internal optics.
4) There is no guarantee that instruments selected solely based on maximum insertion portion width and working length will be compatible in combination.
5) There is no guarantee that instruments selected solely using this minimum instrument channel width will be compatible in combination.
6) Do not use this product in flammable environments.
7) Arthroscopes and its accessories are the applied part.
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