Transcript
SHAVER - SYSTEM 52.300.00/SET
Operating Manual NO. 11
________________________________________ MAT GmbH&Co.KG Friedrich-Wöhler-Str. 10 D-78576 Emmingen / Germany Tel.: +49 7465 / 909 188; Fax.: +49 07465 / 909024 E-Mail:
[email protected] ; www.mat-medical.com
Version 10.2007
This manual contains proprietary information subject to the copyright law. All rights are protected. Without the express written approval of MAT GmbH&Co.KG the reproduction by photocopy, microfilm or other methods or the circulation of this manual, whether fully or in part, is not permitted.
Intended use The Shaver-System 52.300.00/SET has been designed especially for use in arthroscopic surgery. It is intended for the resection of fibrous and cartilage tissue in joints, and shall be operated by trained personnel only.
Dear customer Please read this manual carefully before putting the equipment to use for the first time. This will prevent damages that may otherwise occur due to faulty connections or incorrect operation. Use this shaver system only for the purpose described in this Operating Manual. We assume no liability for damages resulting from any misuse of the instrument. Follow all safety precautions! Keep the operating manual available for all personnel. This Operating Manual provides no detailed description of endoscopic or any other special treatment procedures!
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CONTENTS
1. Introduction ........................................................................................................................................................... 4 2. Technical specifications ....................................................................................................................................... 5 3. Safety information and inspection ....................................................................................................................... 6 4. System description ............................................................................................................................................ 7-9 5. Set up ................................................................................................................................................................. 10 6. Operation ....................................................................................................................................................... 11-12 7. Cleaning and sterilisation .............................................................................................................................. 13-14 8. Malfunctions................................................................................................................................................... 15-16 9. Shipping and storage .......................................................................................................................................... 16
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1. Introduction The Shaver-System 52.300.00/SET is designed for arthroscopic surgical procedures. It is intended for the resection of fibrous and cartilage tissue in joints. The Shaver-System consists of the electronic controlled control unit, the handpiece and the footswitch. The Shaver-System includes: - Control unit - Shaver- Handpiece - Footswitch - Power cord
52.300.00 52.300.05 52.300.10
Optional Accessories: - Drill- Handpiece - Saw- Handpiece
52.301.05 52.301.10
The components of the system are designed and intended to be operated exclusively as a unit. Direction and speed of rotation of the cutting tool can be selected by the surgeon either by means of the footswitch or directly at the control unit. The cutting tool has the RPM steps in clockwise, counterclockwise or oscillation mode. ATTENTION
This device is to be used only under the supervision of a trained and licensed surgeon. This device should not be used by untrained personnel or used for indications other than those described in this Operating Manual.
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2. Technical specifications Control unit 52.300.00 • Width: • Height: • Depth: • Weight: • Power input: • Capacity: • Fuses: • Protection Class: • Type: • Operating mode: • Water Protection: • EN-Class: • Connections: Shaver- Handpiece 52.300.05 • Length: • Weight: • Speed Range: • Oscillating Cycle: • Operating mode: •
Length of cable:
323 mm 118 mm 267 mm 4 kg 100-240 V AC 50 / 60 Hz 100 VA 2 x T 6,3A I B continuous IP X0 2a Handpieces, Footswitch
165 mm 475 g 1000/1500/2000/2500/3000/5000/8000 rpm +10% 0.3 -1,2 s intermittent mode – 3 minutes ON / 3 minutes OFF (at max speed) 3m
Drill- Handpiece 52.301.05 • Length: • Weight: • Speed Range: • Operating mode: • Length of cable:
165 mm 840 g 150/300/600/900/1100 rpm +10% intermittent mode 3m
Saw- Handpiece 52.301.10 • Length: • Weight: • Speed Range: • Operating mode: • Length of cable:
190 mm 450 g 20.000 rpm +10% intermittent mode 3m
Footswitch 52.300.10 • Width: • Height: • Depth: • Weight: • Mode of operation: • •
Water Protection: Length of cable:
Power cord:
266 mm 20 mm 209 mm 1400 g clockwise, counterclockwise, oscillation, speed level adjustment, handpiece- choice IPX8 3m 230 V, 10 A, 3-pole
If you request circuit diagrams, component part list, descriptions, calibration instructions or other information please contact the manufacturer.
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3. Safety information and inspection Please read through these operating instructions carefully before working with Shaver-System. These instructions cover the handling and operation of the Shaver-System . The Shaver-System complies with the relevant Health and Safety requirements, is designed according to the latest state of the art technology, and is safe to operate. This equipment can be dangerous if operated by untrained personnel and / or if used incorrectly. No interference is known to occur between this Shaver-System and any other equipment used in the OR. There is no contraindication noticed as long as the Shaver-System is used correctly. If any component of the Shaver-System fails or appears to malfunction please contact the manufacturer. WARNING
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
This equipment has passed testing for EMI / RFI radiation, and susceptibility; however, if not installed and used in accordance with the instructions, interference to other devices in the near vicinity may occur. The following designations are used in these operating instructions to indicate safety information: ATTENTION
Damage to equipment may occur in the absence of full compliance with the operating instructions indicated with this designation.
NOTE
More effective and easier work is possible when the instructions marked with this designation are followed.
To ensure the fully functional condition of the Shaver-System it is essential to perform an inspection after receiving the unit. Carefully unpack the unit and inspect the housing for scratches, indentations and other signs of physical damage. If the Shaver-System is in perfect physical condition, perform a first functional test by following the sections Set up and Operation. In case of an instrument failure please contact the manufacturer.
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4. System Description Control unit - front panel: 1. ON/OFF power switch 2. LCD - display 3. Handpiece – choice button 1-2-3 (version with 3 handpiece sockets) 4. Speed button RPM 5. Counterclockwise rotary direction button REV 6. Clockwise rotary direction button FWD 7. Connection socket HANDPIECE 1 8. Connection socket HANDPIECE 2 (version with 3 handpiece sockets) 9. Connection socket HANDPIECE 3 (version with 3 handpiece sockets) 10. Connection socket FOOTSWITCH
2
7
3
8
9
4
5
6
1
10
Control unit - rear panel: 28. Power supply socket 29. Equipotential bonding pin 30. Equipotential bonding plate 31. Nameplate
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Shaver - Handpiece: Compatible with Arthrex/Linvatec Shaver Blade Connection! 11. Cutting attachment lock 12. Suction control 13. Suction connection 14. Connecting cable 15. Handpiece connector 16. Protective cap
11 12
15
13
14
Drill - Handpiece 17. Chuck 18. Cannulation 19. Key for chuck
18 17
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Saw - Handpiece 20. Saw blade chuck
20
16
Footswitch: 21. Counterclockwise rotary direction switch REV 22. Clockwise rotary direction switch FWD 23. Oscillation switch OSC 24. Switch SPEED 25. Handpiece – choice switch 1-2-3 26. Connecting cable 27. Connector
26
27
24
25
23 21
22
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5. Set up - Take the control unit out of its packaging and place it in its intended location. NOTE
Set up the control unit so that it is not more than 3 m from the operating location of the handpiece.
ATTENTION
Never place containers with liquid on the control unit or in its immediate vicinity!
- Plug the power cord into the power supply socket (28) on the rear side of the control unit. - Plug the power cord into a properly grounded socket outlet. - Insert the footswitch connector (27) into socket (10) of the control unit NOTE
Align the red marker for the insertion position of the connector with red marker on socket.
- Take sterile handpiece. - Remove the protective cover (16) from connector and insert the connector (15 ) of the handpiece into chosen socket (7,8,9) of the control unit using light pressure. NOTE
Align the red marker for the insertion position of the connector with red marker on socket .
- Connect the suction hose to the suction connection (13) and to the vacuum pump. NOTE
Before start-up all connecting cables and power cord of the Shaver System must be inspected externally for visible damage such as cracks, fractures, crushing, wear etc.
ATTENTION
Only use handpieces und footswitches which have been developed by MAT GmbH&Co.KG specially for the Shaver System 52.300.00/SET.
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6. Operation Control unit Switch on Shaver-System using the power switch ON/OFF ( 1 ). After it is switched on the LCD display signals “No piece”. Press the button 1 2 3 to choice the Handpiece (version with 3 handpiece sockets) socket and insert the handpiece connector into the chosen socket. The handpiece is recognized and appears on the display. On the display appears also optimal rotary speed setting and the active (chosen) HANDPIECE socket. The shaver is ready to operate. To set the required speed press the RPM button. Pressing the button FWD causes the cutting tool to be driven clockwise. Pressing the button REV causes the cutting tool to be driven counterclockwise. To set the oscillation mode, simultaneously press the button REV and FWD. Messages on the control unit: Text
Description
NO-PIECE
P1
No handpiece in the socket 1
NO-PIECE
P2
No handpiece in the socket 2
NO-PIECE
P3
No handpiece in the socket 3
SAW
Saw- Handpiece connected
SHAVER
Shaver- Handpiece connected
DRILL
Drill- Handpiece connected
FWD
Motor is moving forward
REV
Motor is moving in reverse
OSC
Motor is oscillating
RPM
Speed (rotation per minute)
ACTIVE
Footswitch or unit button active but no handpiece connected
INACTIVE
No function
Footswitch Insert the footswitch connector in the socket FOOTSWITCH on the control unit. With the switch speed ( 24 ) adjust the required speed. Press the switch 1 2 3 to choice the handpiece socket. Pressing the blue switch ( 22 ) causes the cutting tool to be driven clockwise. Pressing the yellow switch ( 21 ) causes the cutting tool to be driven counterclockwise. Press the oscillating switch ( 23 ) to set the oscillation mode. Press the black switch (25) to choice the handpiece (version with 3 handpiece sockets) Set the direction or speed only with connected handpiece, otherwise occurs the message “active”.
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Shaver- Handpiece Rotate the attachment lock ( 11 ) to unlock position (turning counterclockwise). Insert correctly the required blade into cutting attachment lock. Rotate attachment lock to locked position (turning clockwise). Removal is accomplished by reversing instructions. Connect the handpiece cable connector to the chosen socket on the control unit. The console will recognize the handpiece type and display available options for the operator to adjust. Adjust the flow volume with the suction control ( 12 ). Move the suction control switch to the “Max” on the handpiece body (fully opened) to obtain the maximum flow volume. The suction can be adjusted between the “Max” and “Min” settings to achieve appropriate level. ATTENTION
Under no circumstances immerse the handpiece in a liquid for cooling!
ATTENTION
Use cutting tools only in fluid medium, otherwise there is danger of blockage and overheating!
ATTENTION
The handpiece should not be used continuously at full load to prevent overheating. The working cycle should last max. 3 minutes followed by a cool down phase to allow the handpiece to return to room temperature. If fluid is flowing through the handpiece, the cool down phase will be greatly reduced.
Drill- Handpiece The drill handpiece is equipped with a chuck. A corresponding key is enclosed. Guide pins etc. can be placed using the cannulation feature. The speed can be adjusted in five steps by using the RPM button on the front panel of the control unit or the footswitch speed button ( 24 ). The corresponding setting is shown on the display. Available RPM settings are: 150, 300, 600, 900 and 1100 rpm.
Drill direction is selected with the FWD ( 22 ) or REV ( 21 ) footswitch button, or with the corresponding button on the front panel of the control unit. The oscillate function OSC is disabled for the drill. ATTENTION
The handpieces should not be used continuously at full load to prevent overheating. The working cycle should last 3 minutes at max. RPM setting, followed by a cool down phase to allow the drill to return to room temperature.
Saw- Handpiece The saw- handpiece operates at a speed of 20.000 cycles per minute. This preprogrammed setting cannot be changed. In the chuck of the oscillating saw may be used MAT GmbH&Co.KG or another compatible blade. Activate the saw by selecting the FWD, REV or OSC footswitch button or FWD, REV on the front panel of the control unit. ATTENTION
The handpieces should not be used continuously at full load to prevent overheating. The working cycle should last 3 minutes maximum, followed by a cool down phase to allow the handpiece to return to room temperature.
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7. Cleaning and sterilization Cleaning Control Unit - Clean and disinfect the console with a commercially available surface disinfectant. Always comply with the instructions issued by the manufacturer of the disinfectant. ATTENTION
Never clean the console jacks with liquid cleaners. Remove dust, if necessary, with dry compressed air.
Shaver- Handpiece - Remove any shaver blades - Prior to sterilization, seal off the handpiece connector with protective cover - Open the suction control fully - Clean the shaver handpiece with an enzymatic cleaner without subsequent acid neutralization - Clean the suction control connection with a cleaning brush - Rinse the handpiece thoroughly after cleaning under lukewarm water - Disinfect the handpiece with a commercially available disinfectant. Always comply with the instructions issued by the manufacturer of the disinfectant ATTENTION
Never allow the handpiece connector to have any contact with liquids. Remove dust or moisture, if necessary, with dry compressed air. Only dry connectors may be plugged into the console.
ATTENTION
Never place the shaver handpiece in Cidex or other aldehyde disinfectant solution.
Drill- und Saw- Handpiece - Remove saw blade or drill - Prior to sterilization, seal off the handpiece connector with protective cover - Clean the handpiece with an enzymatic cleaner without subsequent acid neutralization - Rinse the handpiece thoroughly after cleaning under lukewarm water - Disinfect the handpiece with a commercially available disinfectant. Always comply with the instructions issued by the manufacturer of the disinfectant ATTENTION
Never allow the handpiece connector to have any contact with liquids. Remove dust or moisture, if necessary, with dry compressed air. Only dry connectors may be plugged into the console.
ATTENTION
Never place the shaver handpiece in Cidex or other aldehyde disinfectant solution.
Footswitch - Clean the footswitch with an enzyme cleaner without subsequent acid neutralization. - Rinse the footswitch thoroughly after cleaning under lukewarm water - Disinfect the footswitch with a commercially available disinfectant. Always comply with the instructions issued by the manufacturer of the disinfectant
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ATTENTION
Never allow the footswitch connector to have any contact with liquids. Remove dust or moisture, if necessary, with dry compressed air. Only dry connectors may be plugged into the console.
Sterilization Sterilization does not eliminate the need for proper cleaning and disinfection of handpiece and cables prior to sterilization. Sterilization capabilities, cleaning, disinfecting, handling and storage of handpiece are the responsibility of qualified facility/user personnel. Handpiece that is provided non-sterile, may be sterilized by one of the following methods: Gravity displacement cycles : • 134°C: exposure time 18 minutes (min) • 121°c. exposure time 60 minutes Prevacuum cycle: • 134°C: 5 minutes Sterilizers vary in design and performance characteristics, so cycle parameters should be verified against the sterilizer manufacturer`s instructions for the specific sterilizer and load configuration being used. It is the duty of the user to perform appropriate validation tests. Cooling – the device must be adequately cooled, after being removed from the sterilizer. It should not be touched during the cooling process. Do not place the device on a cold surface or immerse in a cold fluid. ATTENTION
After autoclaving the handpiece is very hot. Careless handling can result in burns. After sterilization in the autoclave let the handpiece cool down slowly, never use cold water to cool the handpiece; this can damage the electronic components and seals. Liquid on the cable connector of the handpiece can cause damage to the device. Before connecting the handpiece ensure that the jacks are clean und dry.
The following special instructions are to be observed when sterilizing certain handpieces. ATTENTION
Shaver- Handpiece Open the suction control completely to ensure proper circulation. Do not sterilize the shaver – handpiece with shaver blades attached.
ATTENTION
Drill- Handpiece Open the chuck completely to ensure proper circulation. Do not sterilize the drill– handpiece with tolls or pins installed.
ATTENTION
Saw- Handpiece Do not sterilize the saw– handpiece with the saw blade attached.
The multi-use shaver- or saw blades, drill and tools sterilize always comply with the instructions issued by the manufacturer. Do not resterilize the one way products.
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8. Malfunctions In case of any functional problem with the unit please check the list below. If the problems persist, disinfect the shaver system and send it to MAT GmbH&Co.KG using the original packaging. Please enclose a brief explanation of the detected malfunction.
Malfunction
Corrective action
1.No system messages when
- Check the power supply - Check the power cord - Check power switch - Send in for repairs
the control unit is switched on 2.Cutting tool does not operate
- Not inserted properly – insert the shaver blade so that it engages and close the locking mechanism fully - Damaged – replace shaver blade
3.Handpiece does not work - Check connecting cable, send for repair if necessary - Check whether the connector is plugged in to the correct socket – choose the socket - Liquid in connector or socket – dry thoroughly - Connector damaged – send in for repair - Foot switch defective – operate device using console unit and send the footswitch for repair - Fault in handpiece – send in for repairs 4.No suction - Suction connection clogged – rinse with a siringe - Suction control closed - Suction control damaged – send in for repairs
5.System runs with the control unit but not with the footswitch - Check connector from footswitch to control unit - Liquid in connector or socket – dry thoroughly - Footswitch defect – send in for repairs
Replacing the fuses: -
Disconnect the device from the AC mains Open the fuse tray in the AC inlet Replace the fuses with the proper values as noted on the rear panel Push the fuse holder back into the AC inlet ATTENTION
Always use fuses with the correct values
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MAT GmbH&Co.KG assumes a warranty to the first purchaser for a twelve month period with regard to defects or failure of its medical devices. All defective products covered by the warranty are repaired or replaced free of charge by MAT GmbH&Co.KG. Warranty claims will not be accepted if: - the unit is damaged as a result of force majeure or negative environmental influences (like moisture, electrical interferences, etc.); - the unit has been opened or repaired by non-authorized service stations or other personnel; - sterilisation regulations have not been complied with. - when the unit is changed in any way or repairs are performed by any party other than MAT GmbH&Co.KG.
9. Shipping and storage Save all containers and packing material, they will be required if it becomes necessary to return the equipment to manufacturer. Claims under warranty are invalid when the equipment has been incorrectly packed. Operation condition: Temperature: Relative Humidity:
+10°C to +50°C 30% to 75%
Storage: Temperature:
-10°C to +50°C
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Symbol Explanation
!
Attention Symbol: Read this accompanying documentation before operating this equipment
Electrical Ground Symbol
b
Proof Typ B
Handopiece
∠
Footswitch
FWD
REV
Oszillation
Speed
Сє 1253
European Certification Symbol
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