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5. Do not a�ach, insert or remove components during opera�on of the handpiece. Place
the mode lever on Safe posi�on before inser�ng or removing the product.
6. Do not contact the cut surface when blade is a�ached to the handpiece. Sharp surface
can cause injury.
7. A�er use, properl y dispose the blade used together according to the regula�on and
procedure of the hospital.
8. Do not re-sterilize and reuse disposable blade. Re-steriliza�on standard for disposabl e
products has not been established, and reusing such products can reduce pe rformance,
safety and sterility of the product.
c. Precau�ons
If the device is used in disregard of the warnings, it may lead to so� �ssue burns, bone loss
and/or infec�on of the procedural area due to metal debris or spla�er resul�ng from high speed.
1. During a cu�ng procedure, stem disloca�on should be performed enough not to interfere
with the rota�on of EZX sha�.
If the device repeatedly makes abnormal noise or fric�on during cu�ng, stop the opera�on
immediately and check the affected area and the device.
2. Remove so� �ssues around the cup before performing the procedure. If possible, remove
so� �ssues un�l the edge of the targeted cup is clearly shown.
3. During the opera�on, maintain a 90° angle between the sha� and the liner.
4. This device cannot be used on the cup where pins and spikes are also used. If pins, spikes,
or screws cannot be removed in the cup, do not use this device.
5. Do not use for removing cups that are non-hemispheric.
6. Do not use the blade to cut cups, pins, or screws.
7. Do not subject the device to strong impact such as bending, breaking, or twis�ng as it
may bend or break blades or connectors.
8. Always be careful when removing blades as they are very hot a�er use.
9. This product must be used according to the intended purpose.
10. Be careful in handling the device. When the device is dropped on the floor or damaged,
immediately return it to the place of purchase for service.
11. The product must be used with equipment and accessories tested and approved according
to the medical device standards of the manufacturer. The product may not
func�on properly with other products or violate the medical device standards.
12. When the product, its components and other products used together are not used,
stored and managed as described in Instruc�on for use, or repaired and altered by a
person not authorized by the manufacturer, they are excluded from free warranty service.
13. Do not arbitrarily alter the product since none of its parts can be repaired by the user.
14. Check whether all components are accurately and safety a�ached and perform func�on
test before use.
15. Wash and sterilize all equipment and components as described in Instruc�on for use.
16. Do not disassemble the product or apply lubricant since the product is provided with
complete sealing. It can be excluded from free warranty service.
17. Check whether blade is bent, blunt or otherwise damaged before use. When it is
damaged,dispose it instead of trying to straighten or sharpen it.
18. Completely wash and inspect the components as described in User Manual a�er use.
19. Since the product can be damaged, components must be a�ached as designated.
20. Do not let blade to contact other surgical instruments. Blade and instruments can be
damaged.
21. Compared to non-cement acetabular cu�ng, cemented acetabular cup cu�ng may
take longer and/or cause overhea�ng. Keep moisture and irriga�on with saline solu�on
during the cu�ng process.
F. Complica�ons
Complications related to Brasseler EZX are very rare, but when they occur, they can be
serious. Most complica�ons are related to surgery techniques and possible complica�ons
would be, not limited to;
- Pa�ent burn or thermal necrosis
- Paralysis by wrong opera�on
- Frostbite, hematoma in target site etc. by infec�on
- Injury by wrong opera�on or cracked chip of blade
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