Medtronic MIDAS REX series Bedienerhandbuch Seite 5

WARNING
1. It is important that the Electric Bone Mill operator be familiar with this manual, its precautions, procedures and safety issues.
2. This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test.
However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive
equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the
source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
3. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this Guide.
4. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
5. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased
immunity of this unit.
6. A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested
to ensure that it is functioning in accordance with Medtronic specifications.
7. Always inspect the components before and after use for any damage. If damage is observed, do not use the damaged part until
it is repaired or replaced.
8. DO NOT operate the Midas Rex™ Electric Bone Mill base without the bowl and cap secured in place.
9. Verify reusable device was sterilized prior to use. If not sterilized, do not use.
10. Achieve electrical grounding reliability with proper connections. Connect the Bone Mill to hospital grade receptacles only.
11. DO NOT operate the Midas Rex™ Electric Bone Mill in the presence of flammable anesthetics. Avoid potential ignition or
explosion of gases.
12. Take care to process bone to the desired partical size. DO NOT over process bone.
13. The Midas Rex™ Electric Bone Mill bowl, cap, and spatula are provided STERILE and are intended for SINGLE PATIENT
USE ONLY. DO NOT RESTERILIZE THESE COMPONENTS. MEDTRONIC ASSUMES NO LIABILITY FOR PRODUCTS
WHICH HAVE BEEN RESTERILIZED BY HEALTH CARE FACILITIES. In discarding the disposables, follow health-care
facility guidelines on proper disposal of contaminated materials.
14. Disconnect power to the Midas Rex™ Electric Bone Mill base before cleaning the unit to avoid electrical shock.
15. After each procedure, properly clean all reusable system components.
16. Sterilizing and drying the Midas Rex™ Electric Bone Mill Base before storing decreases the likelihood of cross-contamination.
17. All service must be performed by Medtronic-qualified personnel only.
18. DO NOT operate the Midas Rex™ Electric Bone Mill before following proper cleaning and sterilization protocols.
19. Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
20. DO NOT come in contact with the interior of the disposable bowl or cap during the milling of bone.
21. DO NOT operate the Midas Rex™ Electric Bone Mill in the presence of Magnetic Resonance Imaging Devices.
22. DO NOT operate the Bone Mill without eye wear protection.
23. DO NOT use any other components except for Medtronic Midas Rex™ Electric Bone Mill disposables.
24. Do not use accessory if package is opened or damaged. A broken seal offers no protection against cross-contamination.
25. No modification of this equipment is allowed.
26. To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
PRECAUTION
1. The addition of any liquid to the milling process should be administered in small volume to prevent leakage.
2. Improper sterilization or overloading of the Midas Rex™ Electric Bone Mill can lead to permanent motor damage.
3. The Midas Rex™ Electric Bone Mill must not be overloaded. DO NOT process more that 10 cc of bone at one time. The
maximum starting size of the pieces should not exceed 1.5 cc. Additional bone graft may be processed in separate batches or
loads.
4. DO NOT use Midas Rex™ Electric Bone Mill Disposables to process more than 6 bone pieces approximately 1.5 cm3 in size at
one time.
5. DO NOT use Midas Rex™ Electric Bone Mill Disposables to process more than a total of 40 cc of bone during any one surgical
procedure.
6. DO NOT immerse and/or soak the Bone Mill Base or Console.
7. DO NOT use chlorine based or corrosive cleaning agents such as bleach, acetone, solutions containing glutaraldehyde, etc.
8. The equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary,
the equipment should be observed to verify normal operation in the configuration in which it will be used.
9. Take care when placing base unit on a surgical drape, that the base is in a stable position and that the cable is safely routed.
10. DO NOT obstruct access to the power cord connection at the rear of the console.
MIDAS REX™ ELECTRIC BONE MILL MIDAS REX™ ELECTRIC BONE MILL
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