3
INDICATION FOR USE
The Micro Handpiece is an accessory to the FMS VUE Fluid Management and Tissue Debridement System. The FMS VUE Fluid
Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring,
shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
CONTRAINDICATIONS
Do not use the Micro Handpiece with systems other than the FMS VUE.
WARNINGS
•
This equipment may be operated only by arthroscopic surgeons. The surgeon using this device must be trained in arthroscopic
surgical procedures, be aware of the risks associated with those procedures, and have current knowledge of technological advances
in surgical products and techniques.
•
Prior to use, check the system components for damage. Check the cable integrity carefully. If there are signs of damage, do not use.
•
Failure to follow all applicable instructions may result in serious surgical consequences to the patient.
•
Do not wrap handpiece cable around metal objects. Wrapping cables around metal objects may induce currents that could lead to
electric shock, fire and/or injury to patient or surgical personnel.
•
This device has been tested and found in compliance with limits of medical devices according IEC 60601-1-2 2007 standard. These
limits are designed to provide reasonable protection in a typical medical installation, against harmful interference when devices are
located in close proximity. If the pump is causing harmful interference with other devices, turn the main power off, then on again to
determine if it is causing the interference, relocate the system or separate it from other devices. If you cannot resolve the problem
contact DePuy Customer Service at 1-800-382-4682. In the European Union, contact your local affiliate.
•
Disconnect the device from the pump when cleaning or inspecting.
•
Do not insert anything other than approved DePuy Mitek burrs and blades into the distal end of the handpiece.
PRECAUTIONS
•
Electrical safety testing should be performed by a biomedical engineer or other qualified person.
•
Read the instructions, cautions, and warnings provided with all FMS VUE System accessories before use. Your sales representative
can advise which accessories are used with these systems.
INSTRUCTIONS FOR USE
Refer to the following manual for instructions for using the handpiece with the FMS VUE system:
•
FMS VUE Operator’s Manual (Ref. IFU-110665)
HANDPIECE CLEANING AND STERILIZATION
CAUTION:
These guidelines do not guarantee that the device is sterile after the procedure. The institution is responsible for
sterility assurance validation.
Automated Cleaning
Clean and sterilize before and after each use:
1. Place the protective cap securely onto the shaver handpiece connector.
2. Leave the suction toggle in the open «MAX» position. Soak soiled instruments per manufacturer’s instructions (minimum of
15 minutes) in the enzymatic solution. Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any
hard-to-reach areas, textured surfaces, or crevices. Rinse the instrument thoroughly with warm tap water
.
3. Carry out five (5) to and fro motions with a swab-type brush on all surfaces, paying particular attention to lumens, holes and
spring loaded retractable features. Immerse the instrument in the neutral pH cleaning solution to avoid aerosol generation. Actuate
moveable mechanisms, such as hinges, box locks, or spring-loaded/retractable features.
4. Actuate and/or retract moveable parts while rinsing:
The Locking System: (Inner and Outer parts) Open and close the locking system to ensure that it is free of foreign bodies.
The Suction Port: Pass running water through the suction port, with the suction toggle switch in the fully open position.
The Suction Toggle: Open and close the suction toggle several times. Rinse the inner and outer parts thoroughly.
5. Check for remaining debris and remove as needed.
6. Carry out a second soaking bath in a pH-neutral detergent prepared in accordance with the manufacturer’s instructions for a
minimum of 15 minutes in an ultrasound bath.
7. Rinse with deionized water for 30 seconds.
