OSCAR
OSCAR Pro User Manual Rev A Nov 2020
User Manual
64 Pages
Preview
Page 1
USER MANUAL
Keep this leaflet: you may need to read it again. Discard previous versions Important information - please read prior to use
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CONTENTS
0. IMPORTANT INFORMATION UPON DELIVERY
7
0.1. FIRST VERIFICATION UPON DELIVERY
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0.2. DEVICE PARTS IDENTIFICATION
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0.2.1. Sales Configuration
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0.3. SYMBOL EXPLANATION
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0.4. SPECIFICATIONS
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0.5. ELECTRICAL SAFETY STATEMENT
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0.6. ELECTROMAGNETIC COMPATIBILITY (EMC) STATEMENTS
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0.7. SUMMARY OF SAFETY INFORMATION
16
0.7. 1. Warnings
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0.7. 2. Precautions
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1. FIRST POWER ON
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2. CLINICAL INFORMATION
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2.1. INTENDED USE
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2.2. INDICATIONS
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2.3. CONTRAINDICATIONS
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2.4. INTENDED USERS
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2.5. DISCLAIMER
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2.6. POSSIBLE ADVERSE EVENTS
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3. PRODUCT DESCRIPTION
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3.1. PRINCIPLE OF OPERATION
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3.2. SYSTEM OVERVIEW
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4. SYSTEM SETUP
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4.1. INSTALLATION OF GENERATOR
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4.2. ASSEMBLY AND CONNECTION OF HANDSET, PROBE AND ACCESSORIES
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4.3. FOOTSWITCHES
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4.4. SYSTEM INITIALIZATION AND USE
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5. OSCAR PRO™ GENERATOR MENU FUNCTIONS MAP
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5.1. STATUS BAR
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5.2. ON SCREEN HELP
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5.3. SETTINGS
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5.3.1. Language settings
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5.3.2. System settings
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CONTENTS
5.4. SURGICAL FUNCTIONS
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5.4.1. Cement Removal
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5.4.2. Cementless Prosthesis Removal
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5.4.3. Osteotomy
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5.5. SELECT CHANNEL & PROBE SCAN
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5.5.1. Selecting a channel
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5.5.2. Cementless Prosthesis Removal
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5.5.3. Enabling the footswitch
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5.5.4. Switching channels
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5.6. OPERATE
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5.6.1. Activating ultrasound
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5.6.2. Starting/Stopping irrigation
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5.6.3. Switching handset/channel
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5.6.4. Probe changes during surgery
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5.7. END OF USE
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5.7.1. Switching off the generator user interface
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5.7.2. Purging the irrigation tube
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5.7.3. Turn off the generator
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6. SYSTEM & MAINTENANCE AREA
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6.1. RESET
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7. CONNECTION AREA
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7.1. COPYING OR SENDING THE DATA LOG
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7.1.1. Copy Data Log onto USB
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7.1.2. Sending the data log via Wi-Fi
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7.2. ADMIN AREA
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8. AUDIBLE AND VISIBLE FEEDBACK SUMMARY
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9. INSTRUCTIONS FOR PROCESSING AND REPROCESSING
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9.1. WARNINGS
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9.2. LIMITATIONS ON REPROCESSING
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9.3. POINT OF USE
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9.4. CONTAINMENT AND TRANSPORTATION
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9.5. CLEANING AND STERILIZATION
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9.5.1. Disconnection and Disassembly
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9.5.2. Cleaning
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CONTENTS
9.5.3. Maintenance, inspection and function testing
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9.5.4. Packaging
56
9.5.5. Sterilization
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9.5.6. Deviations from Cleaning and Sterilization Instructions
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9.6. STORAGE
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10. TROUBLESHOOTING
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10.1. EVENTS
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10.1.1. Non-blocking events
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10.1.2. Blocking events
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10.2.1. Touchscreen frozen
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11. SERVICE & REPAIR
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11.1. CHANGING FUSES
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11.2. SERVICE & REPAIR ACTIVITIES
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12. DISPOSAL
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FIGURE 1 LOADING PAGE
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FIGURE 2 FIRST POWER ON - LANGUAGE SETTING
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FIGURE 3 FIRST POWER ON - DATE/TIME SETTING
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FIGURE 4 SURGICAL FUNCTION MENU
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FIGURE 5 AWAITING HANDSET CONNECTION
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FIGURE 6 READY TO SCAN
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FIGURE 7 INTERCONNECTION DIAGRAM FRONT VIEW
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FIGURE 8 INTERCONNECTION DIAGRAM REAR VIEW
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FIGURE 9 HANDSET MAIN PARTS
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FIGURE 10 OSCAR PRO™ DIAGRAMMATIC VIEW
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FIGURE 11 OSCAR PRO™ INSTRUMENT TRAY
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FIGURE 12 HANDSET HORN POSITION
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FIGURE 13 HANDSET HOLDER FOR PROBE COUPLING
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FIGURE 14 HANDSET-PROBE COUPLING
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FIGURE 15 HANDSET HANDLE POSITION
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FIGURE 16 IRRIGATION NOZZLE ATTACHMENT
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FIGURE 17 IRRIGATION TUBE ROUTING
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FIGURE 18 IRRIGATION TUBE POSITIONING
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FIGURE 19 PLUGGING THE HANDSET CABLE INTO THE HANDSET
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CONTENTS
FIGURE 20 CLIPPING IN THE TUBE & HANDSET CABLE
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FIGURE 21 HANDSET CABLE PLUG
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FIGURE 22 LINING UP THE CABLE CONNECTOR AND THE RECEPTACLE
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FIGURE 23 FOOTSWITCH CONNECTION
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FIGURE 24 LOADING PAGE
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FIGURE 25 USER MANUAL REFERENCE
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FIGURE 26 SURGICAL FUNCTION MENU
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FIGURE 27 SELECT CHANNEL
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FIGURE 28 PROBE SCAN
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FIGURE 29 ENABLING THE FOOTSWITCH
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FIGURE 30 OPERATE
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FIGURE 31 IRRIGATION
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FIGURE 32 STATUS BAR
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FIGURE 33 ON SCREEN HELP EXAMPLE
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FIGURE 34 SETTINGS - LANGUAGE PAGE
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FIGURE 35 SETTINGS PAGE
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FIGURE 36 SURGICAL FUNCTION MENU PAGE
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FIGURE 37 SELECT CHANNEL PAGE
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FIGURE 38 PROBE SCAN PAGE
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FIGURE 39 OPERATE PAGE
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FIGURE 40 OPERATE PAGE - DETAILS
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FIGURE 41 POWER OFF ICON
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FIGURE 42 CONFIRM IRRIGATION LINE PURGE
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FIGURE 43 MAIN SWITCH OFF
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FIGURE 44 SYSTEM & MAINTENANCE AREA ICON
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FIGURE 45 MAINTENANCE AREA PAGE
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FIGURE 46 CONFIRMING RESET
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FIGURE 47 ACCESS TO MAINTANCE AREA
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FIGURE 48 CONNECTION PAGE AREA
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FIGURE 49 DATA TRANSFER SUCCESSFUL
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FIGURE 50 WIFI CONNECTIVITY PAGE
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FIGURE 51 DATA TRANSFER SUCCESSFUL
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FIGURE 52 ACCESS TO ADMINISTRATOR AREA
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FIGURE 53 POWER OFF
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CONTENTS
FIGURE 54 MESSAGES AT POWER OFF
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FIGURE 55 MAIN SWITCH OFF
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FIGURE 56 POWER CABLE DISCONNECTION
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FIGURE 57 EQUIPOTENTIAL CABLE DISCONNECTION
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FIGURE 58 HANDSET CABLE DISCONNECTION FROM GENERATOR
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FIGURE 59 HANDSET CABLE DISCONNECTION FROM HANDSET
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FIGURE 60 WATER IRRIGATION DISCONNECTION
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FIGURE 61 HANDSET HANDLE DISCONNECTION
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FIGURE 62 PROBE DISASSEMBLY
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FIGURE 63 REMOVAL OF IRRIGATION TUBE FROM PUMP
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FIGURE 64 DISCONNECTION OF IRRIGATION TUBE FROM GENERATOR
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FIGURE 65 DISASSEMBLY OF HANDSET HORN ENCLOSURE
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FIGURE 66 DISASSEMBLY OF HANDSET BUTTON LEVER
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FIGURE 67 INSTRUMENT TRAY COMPOSITION
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FIGURE 68 EVENT ICON EXAMPLE
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FIGURE 69 WARNING ICON EXAMPLE
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FIGURE 70 ERROR ICON EXAMPLE
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FIGURE 71 ERROR ICON EXAMPLE
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FIGURE 72 REPLACEMENT OF MAIN FUSES
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USER MANUAL
0. IMPORTANT INFORMATION UPON DELIVERY Section 0 and Section 1 of this Manual contain important information for the identification, handling and first power on of the OSCAR PRO™. Conventions on Warnings and Precautions WARNING
Disclosure of residual risk after all possible mitigations applied by Orthofix.
PRECAUTION
Prescription of risk mitigation to be adopted by user to minimise exposure to hazard.
NOTE
Useful information to allow efficient use of the system.
0.1. FIRST VERIFICATION UPON DELIVERY Conventions on Warnings and Precautions PRECAUTION
In case of visible damage to packaging or device upon delivery, do not use the device and contact the manufacturer for assistance or replacement.
PRECAUTION
After receiving OSCAR PRO™, transport and store the device in its dedicated transport case. Using different container may result in damage, malfunction or failure before or during use.
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USER MANUAL
0.2. DEVICE PARTS IDENTIFICATION
O4CABLE
Part #
Code
Description
1
OS4000*
OSCAR PRO GENERATOR
2
O4BEAM
OSCAR PRO HOLDER FOR WATER BAG L459mm
3
PERISTALTIC PUMP, embedded in the generator
4
2000972
STERILE KIT FOR PERISTALTIC PUMP
4
800001
STERILE KIT FOR PERISTALTIC PUMP US
5
O4HAND*
OSCAR PRO UNIVERSAL HANDSET
6
PROBE, various models, provided separately
7
O4CABLE
OSCAR PRO UNIVERSAL HANDSET CABLE
8
O4UHH
OSCAR PRO UNIVERSAL HANDSET HANDLE
9
O4FOOT-W*
OSCAR PRO FOOTSWITCH FOR IRRIGATION
10
O4FOOT-U*
OSCAR PRO FOOTSWITCH FOR ULTRASOUND
11
OSCAR PRO MAIN LEAD, various models
12
SPAN7mm SPANNER 7mm
13
SPAN8/9mm SPANNER 8/9mm
14
O4HOLD
OSCAR PRO HANDSET HOLDER
15
O4IPL200
OSCAR PRO SLAP HAMMER
16
O4TRAY-02
OSCAR PRO LID TRAY
17
O4TRAY-01
OSCAR PRO BASE TRAY
* Component of the device: OSCARPRO – ULTRASOUND MEDICAL SYSTEM
USER MANUAL 0.2.1. Sales Configuration SINGLE USE STERILE ITEMS The following items codes are provided in single, sterile packaging configuration. The packaging consists of double pouch inner packaging with a cardboard FSC outer box. Part # 99-O4SL09D06 99-O4SL18D06 99-O4SL09D08 99-O4SL18D08 99-O4SL27D08 99-O4SL09D10 99-O4SL18D10 99-O4PL09D06 99-O4PL18D06 99-O4PL09D08 99-O4PL18D08 99-O4PL27D08 99-O4PL09D10 99-O4PL18D10 99-O4HL18D06 99-O4HL18D08 99-O4EXP 99-O4AL09DNA 99-O4PSFB8 99-O4OL09B10 99-O4CL09B10 99-O4FL08B06 99-O4SCL08B04 99-O4EL09B06
Description - Single use probes OSCAR PRO TITANIUM CEMENT SCRAPER L90MM D6MM STERILE OSCAR PRO TITANIUM CEMENT SCRAPER L180MM D6MM STERILE OSCAR PRO TITANIUM CEMENT SCRAPER L90MM D8MM STERILE OSCAR PRO TITANIUM CEMENT SCRAPER L180MM D8MM STERILE OSCAR PRO TITANIUM CEMENT SCRAPER L270MM D8MM STERILE OSCAR PRO TITANIUM CEMENT SCRAPER L90MM D10MM STERILE OSCAR PRO TITANIUM CEMENT SCRAPER L180MM D10MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L90MM D6MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L180MM D6MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L90MM D8MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L180MM D8MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L270MM D8MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L90MM D10MM STERILE OSCAR PRO TITANIUM CEMENT PIERCER L180MM D10MM STERILE OSCAR PRO TITANIUM CEMENT HOE L180MM D6MM STERILE OSCAR PRO TITANIUM CEMENT HOE L180MM D8MM STERILE OSCAR PRO TITANIUM CEMENT PLUG EXTRACTOR L180MM STERILE OSCAR PRO TITANIUM CURVED CEMENT PIERCER L90MM STERILE OSCAR PRO TITANIUM FLAT CEMENT PIERCER L90MM STERILE OSCAR PRO TITANIUM FLAT BLADE SMOOTH L90MM W10MM STERILE OSCAR PRO TITANIUM CURVED BLADE SMOOTH L90MM W10MM STERILE OSCAR PRO TITANIUM FLAT BLADE SMOOTH L80MM W6MM STERILE OSCAR PRO TITANIUM CURVED BLADE SERRATED L80MM W4MM STERILE OSCAR PRO TITANIUM OSTEOTOME WEDGE TIP L90MM W6MM STERILE
The Irrigation Kit (irrigation tube + nozzle) is provided in single, sterile packaging configuration. The packaging consists of a double pouch inner packaging with a cardboard FSC outer box.
Part # 2000972 8000001
Description STERILE KIT FOR PERISTALTIC PUMP STERILE KIT FOR PERISTALTIC PUMP US
The above Part # are manufactured by: EMOTEC S.R.L. - VIA MAESTRI DEL LAVORO, 5 – 41036 MEDOLLA (MO) ITALY C.F. E P. IVA 02578710366 - TEL. : +39 0535 / 53060 - FAX: +39 0535 / 52629 - E-MAIL: EMOTEC@ EMOTEC.IT DISTRIBUTED BY:
MULTIPLE USE, NON STERILE ITEMS The following items are sold individually packed. Description Part # OSCAR PRO UNIVERSAL HANDSET O4HAND* OSCAR PRO UNIVERSAL HANDSET HANDLE O4UHH OSCAR PRO HANDSET HOLDER O4HOLD OSCAR PRO SLAP HAMMER O4IPL200 SPANNER 7 MM SPAN7MM SPANNER 8/9MM SPAN8/9MM OSCAR PRO UNIVERSAL HANDSET CABLE O4CABLE* OSCAR PRO FOOTSWITCH FOR ULTRASOUND O4FOOT-U* OSCAR PRO FOOTSWITCH FOR IRRIGATION O4FOOT-W* OSCAR PRO Main lead: OSCAR PRO MAIN LEAD EU O4POWEU or OSCAR PRO MAIN LEAD US O4POWUS or OSCAR PRO MAIN LEAD UK O4POWUK A sterilization tray is available to sterilize multiple use instruments.
O4TRAY - OSCAR PRO INSTRUMENT TRAY EMPTY The tray can accommodate reusable and re-processable instruments, as per the following configuration: Description Q.ty Part # OSCAR PRO UNIVERSAL HANDSET HANDLE 2 O4UHH OSCAR PRO HANDSET HOLDER 2 O4HOLD OSCAR PRO UNIVERSAL HANDSET 2 O4HAND OSCAR PRO SLAP HAMMER 1 O4IPL200 SPANNER 7MM 2 SPAN7MM SPANNER 8/9MM 2 SPAN8/9MM OSCAR PRO UNIVERSAL HANDSET CABLE 2 O4CABLE
OSCAR PRO Instrument Tray spare part: O4TRAY-01 O4TRAY-02
Orthofix Srl - Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy Telephone +39 045 671 9000 - Fax +39 045 671 9380
OSCAR PRO Base tray OSCAR PRO Lid tray
A dedicated transport case for the instrument tray is available and sold separately; the transport case includes a custom foam in a non-sterile configuration.
OINSTFLY1 - OSCAR INSTRUMENT FLIGHT CASE The OSCAR PRO generator is provided within a dedicated transport case, including one water bag holder.
OS4000* - OSCAR PRO GENERATOR Q.ty Part #
1 1 1
OGENFLY2 O4BEAM
Description OSCAR PRO GENERATOR OSCAR PRO GENERATOR FLIGHT CASE OSCAR PRO HOLDER FOR WATER BAG L459MM
The OGENFLY2 transport case is designed to also accomodate the following items, as per below configuration:
OGENFLY2 - OSCAR PRO GENERATOR FLIGHT CASE Q.ty Part #
1
Irrigation Kit
9
1 1
O4POWEU O4POWUS O4POWUK O4FOOT-U O4FOOT-W
Description OSCAR PRO main lead: OSCAR PRO MAIN LEAD EU OSCAR PRO MAIN LEAD US OSCAR PRO MAIN LEAD UK OSCAR PRO FOOTSWITCH FOR ULTRASOUND OSCAR PRO FOOTSWITCH FOR IRRIGATION
OSCAR PRO Generator spare parts: Part # OGENFLY2 O4BEAM
Description OSCAR PRO GENERATOR FLIGHT CASE OSCAR PRO HOLDER FOR WATER BAG L459MM
* Component of the device: OSCARPRO – ULTRASOUND MEDICAL SYSTEM
10 USER MANUAL
0.3. SYMBOL EXPLANATION
APPENDIX 1
Markings
Symbol
Description Model number Batch code Follow instruction for use
0123
CE marking in conformity to applicable European Medical Device Directives/Regulations Date of manufacture
Manufactured By
VOLTAGE: 115-240 V 50-60 Hz
Supply AC Voltage Supply AC Frequency
POWER: 250 VA
Input Power
28kHz 150W
Output Power
T5A H 250V 5x20mm
Fuse Details Supply Power ON Supply Power OFF Disposal. In accordance with the WEEE 2012/19/UE Directive, the product and all its parts (cable, batteries, accessories, etc.) may not be treated as domestic waste. For further information regarding disposal, contact the appropriate department of your local council or the manufacturer service personnel. Warning: counterrotating rollers. Do not operate with open cover. On peristaltic pump embedded in the generator: Flow direction of irrigation liquid.
FOR INTERMITTENT USE ON/OFF
10 | 20 s Output connector Type B Applied Part Equipotential From left to right: Ultrasound - Footswitch connections - Irrigation Wi-Fi connectivity USB port (for mass storage NOT connected to other devices, network or power supply) Caution
USER MANUAL
Stand-by Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Temperature limitation 90%
Humidity limitation
10 % 1060hPa
Atmospheric Pressure limitation 500hPa
Non-sterile Caution Consult instructions for use
FRAGILE
Fragile Ultrasound Irrigation Locking – Unlocking direction
0.4. SPECIFICATIONS APPENDIX 2
Technical Specification
Symbol
Description
Dimensions:
Generator
377 mm(width) x 180 mm(height) x 415 mm(depth)
Weight:
Generator
9.1 Kg.
Transport case (loaded with generator) and accessories
19.5 Kg
Handset
0.8 Kg
Transport case (loaded with handset, probes, accessories)
11.9Kg
Fuse Type
T5A H 250V 5x20mm
Power Supply input
115 – 240 V
Power Consumption
250 VA
Output – Frequency of operation
28kHz (Channel I and II)
Output - Accuracy of frequency display
1%
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Output power
150 W
Volume Adjustment
53 dbA - 88 dBa
Mode of operation
Intermittent Use ON | OFF (Channel I & II) 10s | 20s
Electrical Classification
Generator Class I - generator has a protective earth connection Handset probes: Type B (patient applied parts are at earth potential)
Power Supply Switch
Mean to isolate equipment circuits electrically from the supply mains on all poles simultaneously Transmission and receiving frequencies [bandwidth]
Maximum output
2.4GHz 801.11b [2400~2483.5 MHz]
12.95mdBm
19.72 mW
2.4GHz 801.11g [2400~2483.5 MHz]
12.89mdBm
19.45 mW
2.4GHz 801.11n HT20 [2400~2483.5 MHz]
12.78mdBm
18.97 mW
2.4GHz 801.11n HT40[(2400~2483.5 MHz]
10.28mdBm
10.67 mW
Wireless: Radio-frequency specifications
Handset materials
Handset enclosure: Aluminum alloy Handset transducer: Titanium alloy + Piezoelectric ceramic + Silicone rings
Ingress protection
Generator: IPX0 Handset: autoclavable
Environment for transport and storage
Environment for use
Other Accessories
Temperature: Humidity: Atmospheric pressure:
-40°C to +50°C | -40 °F to +122 °F 10% to 90% 500hPa to 1060hPa
Temperature: Humidity: Atmospheric pressure:
10°C to 30°C | +50 °F to +86 °F 30% to 75% 700hPa to 1060hPa
Transport cases for the generator (GENERATOR FLIGHT CASE) and for the instrument tray (INSTRUMENT FLIGHT CASE). Reference section 9.5 for details of reprocessing.
Items to be sterilised (moist heat sterilisation)
Detachable parts
O4HAND OSCAR PRO UNIVERSAL HANDSET O4CABLE OSCAR PRO UNIVERSAL HANDSET CABLE O4UHH OSCAR PRO UNIVERSAL HANDSET HANDLE O4HOLD OSCAR PRO HANDSET HOLDER SPAN7MM SPANNER 7 MM SPAN8/9MM SPANNER 8/9MM O4IPL200 OSCAR PRO SLAP HAMMER O4TRAY OSCAR PRO INSTRUMENT TRAY See section 3.2 for identification. O4HAND-05 O4HAND-04
HANDSET HORN ENCLOSURE HANDSET BUTTON LEVER
OSCAR PRO™ has been designed and built in accordance with ISO 13485 Quality Assurance standard for medical devices and Part 820 of the Title 21 of the Code of Federal Regulations of the USA.
USER MANUAL
0.5. ELECTRICAL SAFETY STATEMENT The equipment complies with EN 60601-1 and IEC 60601-1. The verification of electrical safety according to EN 60601-1 and IEC 60601-1 is performed by Orthofix before delivery and is valid until the date specified in the dedicated label on the back panel of the generator. The generator is provided with a receptacle for connection of a POTENTIAL EQUALIZATION CONDUCTOR conforming to requirements of EN 60601-1 (ref. Figure 8 and symbol in section 0.3). Warnings and Precautions WARNING
The electrical safety label is valid if all parts of the system are used, transported and stored according to the instructions of this manual. After the expiry date of electrical safety, Orthofix is not responsible for malfunctioning, damage to the device, environment or other objects, or harm to users or patient, that may be related to the loss of electrical safety.
PRECAUTION
To avoid the risk of electric shock, this equipment must be connected to a grounded power supply. Appropriate system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the generator. Never pull on the power cord to remove it from the receptacle.
The product is covered by worldwide patents covering all international markets. Orthofix will provide circuit diagrams, component parts lists and descriptions on request. However, Orthofix does not designate any part of the equipment as user-repairable.
0.6. ELECTROMAGNETIC COMPATIBILITY (EMC) STATEMENTS This equipment has been tested and found to comply with the limits for a medical device. However, should interference occur, try the following measures: 1. Turn equipment off and on to confirm the source of the interference. 2. Increase separation between this equipment and other devices. 3. Connect this equipment to a power socket different from that to which the other devices are connected. 4. Consult medical physics department. 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 manual. Portable and mobile RF communications equipment can affect medical electrical equipment. Warning WARNING
Orthofix has no clinical evidence to confirm the safety of using OSCAR PRO™ on a patient or a health care professional (HCP) fitted with a cardiac pacemaker. Even if no adverse effects have been reported in this regard, the choice to use OSCAR PRO™ in this situation is at the HCP’s discretion.
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Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions
OSCAR PRO™ is intended for use in the electromagnetic environment specified below. The customer or the user of OSCAR PRO should assure that it is used in such an environment. Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The OSCAR PRO™ must emit electro-magnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations /flicker emissions IEC 61000-3-3
Complies
OSCAR PRO™ is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Table 2 Guidance and manufacturer’s declaration - electromagnetic immunity
OSCAR PRO™ is intended for use in the electromagnetic environment specified below. The customer or the user of OSCAR PRO should assure that it is used in such an environment. IMMUNITY test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic discharge (ESD) IEC 61000-4-2
8kV contact 2kV, ± 4kV, ± 8kV, ± 15kV air
8kV contact 2kV, ± 4kV, ± 8kV, ± 15kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
± 2kV for power supply lines ± 1kV for signal lines
Main power quality should be that of a typical commercial or hospital environment.
Electrical fast transient/burst IEC 61000-4-4
± 2kV for power supply lines ± 1kV for signal lines ± 1kV line to line ± 2kV line to earth
± 1kV differential mode ± 2kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5s
<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5s
Main power quality should be that of a typical commercial or hospital environment. If the user of OSCAR PRO™ requires continued operation during power main interruptions, it is recommended that OSCAR PRO™ be powered from an uninterruptible power supply.
Power frequency (50/60Hz) magnetic field IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment
Surge IEC 61000-4-5
NOTE UT is the a.c. main voltage prior to application of the test level
Main power quality should be that of a typical commercial or hospital environment.
USER MANUAL
Table 3 List of Cables Item
Length
Type
Handset Cable
3.0 m
Shielded 4-conductor
Power cord
3.0 m
Unshielded 3-conductor
Precautions PRECAUTION
The use of accessories, handsets and cables other than those provided with OSCAR PRO™ may result in increased emissions and reduced immunity of the device. Such issues may result in user and/or patient harm. Use only Orthofix branded equipment and accessories.
Table 4 Guidance and manufacturer’s declaration - electromagnetic immunity
OSCAR PRO™ is intended for use in the electromagnetic environment specified below. The customer or the user of OSCAR PRO should assure that it is used in such an environment. IMMUNITY test
IEC 60601 test level
Compliance level
Conducted RF IEC 61000-4-6
3Vrms 150kHz to 80MHz
3Vrms
Radiated RF IEC 61000-4-3
3V/m 80MHz to 2.5GHz
3V/m
Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of OSCAR PRO™, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P, 80MHz to 800MHz d = 2.3√P, 800MHz to 2.3GHz where P is the maximum power output rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol.
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which OSCAR PRO™ is used exceeds the applicable RF compliance level above, OSCAR PRO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,such as re-orienting or relocating OSCAR PRO. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. a
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Table 5 Recommended separation distances between portable and mobile RF communications equipment and OSCAR
OSCAR PRO™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of OSCAR PRO™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and OSCAR PRO™ as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter
Separation distance according to frequency of transmitter 150kHz to 80MHz d = 1.2√P
80MHz to 800MHz d = 1.2√P
800MHz to 2.5GHz d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
0.7. SUMMARY OF SAFETY INFORMATION Please read this section of the manual carefully. It contains a summary of all precaution, warning and caution statements contained in the manual. However, the user is advised to read the entire manual and operate the device only in accordance with all of the instructions contained herein. Servicing of this device should only be performed by qualified technicians authorised by Orthofix. There are no service controls accessible to the user.
0.7.1. Warnings CONTEXT
INFORMATION
Preparation
The electrical safety label is valid if all parts of the system are used, transported and stored according to the instructions of this manual. After the expiry date of electrical safety, Orthofix is not responsible for malfunctioning, damage to the device, environment or other objects, or harm to users or patient, that may be related to the loss of electrical safety.
Use
Orthofix has no clinical evidence to confirm the safety of using OSCAR PRO™ on a patient or an health care professional (HCP) fitted with a cardiac pacemaker. Even if no adverse effects have been reported in this regard, the choice to use OSCAR PRO™ in this situation is at the HCP’s discretion.
Use
Portable and mobile RF communication equipment can affect medical electrical equipment. If RF equipment is necessary, monitor the OSCAR PRO™ for appropriate function during the procedure.
Use
During use, warning messages may be displayed on the screen in relation to a specific event or machine status. Refer to section 10 of this manual for the meaning of each message.
Use
In case of excessive load, the OSCAR PRO™ warns the user with specific luminous and acoustic signals. See section 8 and section 10.
Reprocessing
Single use devices MUST NOT BE REUSED, as they are not designed to perform as intended after the first usage. The used probes MUST BE discarded after the surgical procedure. Do not attempt to reuse or re-sterilise any single-use items.
Reprocessing
Personnel working with contaminated medical devices must follow safety precautions as per the healthcare facility’s procedures.
Reprocessing
Take care when handling handsets with probes attached, some edges are serrated and sharp.
Reprocessing
DO NOT USE detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions. Their use will damage the devices and may cause device failure during use.
Reprocessing
Contact with saline solutions should be kept to a minimum.
USER MANUAL
Reprocessing
The use of ultrasonic washers is not permitted for cleaning the ultrasonic generator, the handsets, the main lead and the footswitches with their pneumatic tubes.
Reprocessing
The ultrasonic generator, main lead and footswitches with their pneumatic tubes must not be immersed in cleaning solution.
Reprocessing
Sterilisation of the ultrasonic generator, main lead and footswitches with their pneumatic tubes is not permitted.
Reprocessing
During washing, avoid contact between devices because movement could cause damage to devices and the washing efficacy could be reduced.
Reprocessing
Do not include additional devices or instruments in the sterilisation tray. Sterility is not guaranteed if the sterilisation tray is overloaded.
Maintenance
Use only USB mass storage devices with no connection with other devices and no connection to power supply. Failing to comply with this restriction may expose the hospital network to security violation and compromise the integrity of the device.
0.7.2. Precautions CONTEXT
INFORMATION
Preparation
In case of visible damage to packaging or devices upon delivery, do not use the device and contact the manufacturer for assistance or replacement.
Preparation
After receiving OSCAR PRO™, transport and store the device in its dedicated transport case. Using different containers may result in damage, malfunction or failure before or during use.
Preparation
Handle handsets, probes and cables with care, as inappropriate treatment may affect the safety and performance of the unit. Before use it is recommended that the cables are inspected for damaged insulation. Damaged cables should be replaced before further use of the system.
Preparation
The OSCAR PRO™ generates high voltages within the generator itself and the connected handset. To avoid injury, the generator should be never be operated before ensuring that its cover is properly closed and has not been tampered with. Do not attempt to remove or disassemble the cover. There are no userserviceable parts inside the generator. All servicing should only be performed by an authorised Orthofix representative. No modification of this equipment is required nor allowed.
Preparation
In conditions of incorrect use or insufficient maintenance, electrical medical devices may present a residual risk of unexpected shutdown, electric shock or fire. Follow use instructions and ordinary maintenance instructions to prevent occurrence of those issues. This manual shall be kept in close proximity to the system for easy referral when needed.
Preparation
Adequate air circulation is needed to cool electronic components inside of the generator. Do not block the cooling fan at the generator rear or the air vents on the generator bottom. Do not place the generator on a towel, foam or other soft surface since the material may block the air vents. Blocking these vents may cause the generator to overheat and malfunction or create a shock hazard. A clear drape can be used to protect the generator front panel but do not cover the pump housing or other generator sections.
Preparation
This device is considered medical electrical equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this operator's manual.
Preparation
OSCAR PRO™ must not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, the generator should be observed to verify normal operation.
Preparation
Connecting the generator to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or create a shock or fire hazard. In case of fuse replacement, ensure that the correct fuses are used (refer to section 11).
Preparation
To avoid the risk of electric shock, this equipment must be connected to a grounded power supply. Appropriate system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the generator. Never pull on the power cord to remove it from the receptacle.
Preparation
The use of accessories, transducers and cables other than those specified may result in increased emissions and reduced immunity of the device. Such issues may result in user and/or patient harm. Use only Orthofix branded equipment and accessories.
Preparation
Allow the devices to reach room temperature before use.
Preparation
When inserting the irrigation line in the pump, make sure that the intended flow direction matches the indication arrow on the pump cover.
Use
Improper connection of the handset cable may present a shock hazard. Confirm that the handset connector is dry prior to plugging it in.
Use
Ensure that the software status bar, positioned in the right corner of the header, is continuously blinking as feedback that the Graphic User Interface is operational.
Use
When enabling the irrigation function, verify that no spillage is occurring along the entire line from the water bag to the handset.
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Use
Do not lift or drag the handset by the handset cable, as this may damage both the handset and the cable. Never pull on the handset cable to remove it from the connector.
Use
The use of accessories which are not OSCAR PRO™ original components may result in decreased system performance or failure of the device. Such issues may result in user and/or patient harm. Use only Orthofix branded equipment and accessories.
Use
This device should only be used by qualified surgeons who are (1) suitably trained in the arthroplasty revision surgery procedures that are to be carried out and (2) trained in the specific use of ultrasonic surgical instruments intended for use during arthroplasty revision.
Use
DO NOT use this equipment in the presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide to prevent fire ignition.
Use
OSCAR PRO™ must not be used adjacent to or stacked with other electrical equipment that may interfere with its normal functionality or decrease its immunity. Minimum distances to other electrical medical devices or electrical appliances are stated in the EMC information provided in this operator's manual.
Use
In case of high loads and prolonged use, in exceptional cases beyond the recommended 10s duty cycle, the handset may accumulate heat up to 45°C. Overheating may affect the user and might reduce the handset transducer's life. For this reason, audible and visible alarms inform the user when the system is approaching this condition. Proceed by changing the handset in use or by reducing the active time of the duty cycle in favour of the cooling time, until the temperature limit returns within the acceptable range.
Use
DO NOT operate pump with pump cover in raised position. Rollers might pinch loose clothing or fingers, resulting in personal injuries.
Use
During use, the probe for cement removal may reach a temperature up to 120°C, depending on the use. Irrigation, either manual or assisted by the OSCAR PRO™ irrigation function, must be used whenever temperature control is deemed necessary to limit overheating effects such as bone necrosis around the cemented area. See section 5.6 of this manual and the operative technique for specific indications.
Use
During use, the probe for bone cutting may reach a temperature above 47°C. Irrigation, either manual or assisted by the OSCAR PRO™ irrigation function, must be used to limit overheating effects such as necrosis of bone or other surrounding tissues. See section 5.6 of this manual and the operative technique for specific indications.
Use
To ensure effective cooling, the irrigation flow shall be directed on the tip of the probe by adjusting the direction of the dedicated irrigation nozzle.
Use
Follow the appropriate sequence of steps to shut down the generator: first, select the power off option from the menu function and then, once the procedure is complete, including pump cleaning if necessary, the user can proceed with the switch off by pressing the ON|OFF switch positioned in the rear panel of the generator.
Use
During bone cutting, bone necrosis may result if the probe is not moved relative to the bone. A continuous probe motion is recommended in order to minimise contact duration with the ultrasonic tip and minimise heat build-up. In this instance a more frequent intermittent use must be applied.
Use
Extra care should be taken when operating the energised probe in the vicinity of nerves.
Use
Do not operate OSCAR PRO™ Probes on the surgical site simultaneously with laser equipment or high frequency surgical equipment. The combined effect may lead to device damage and patient injury.
Reprocessing
All reusable handset parts and accessories must be properly decontaminated, cleaned and sterilised before each use as per the instructions contained in this manual. Failure to do so may lead to infections, which can result in serious harm or death.
1. FIRST POWER ON The tasks in this section allow you to: • Configure the system with your language preference. • Set the local date/time. • Verify the basic integrity of the generator interface, handset cables and handsets before installation in the operating theatre. Precautions PRECAUTION
Allow the devices to reach room temperature before use.
PRECAUTION
In conditions of incorrect use or insufficient maintenance, electrical medical devices may present a residual risk of unexpected shutdown, electric shock or fire. Follow use instructions and ordinary maintenance instructions to prevent occurrence of those issues. This manual shall be kept in close proximity to the system for easy referral when needed.
1. Position the OSCAR PRO™ Generator on a flat surface. Precautions PRECAUTION
Adequate air circulation is needed to cool electronic components inside of the generator. Do not block the cooling fan at the generator rear or the air vents on the generator bottom. Do not place the generator on a towel, foam or other soft surface since the material may block the air vents. Blocking these vents may cause the generator to overheat and malfunction or create a shock hazard. A clear drape can be used to protect the generator front panel but do not cover the pump housing or other generator sections.
USER MANUAL
2. Connect the generator to the power supply using the power cord provided. Precautions PRECAUTION PRECAUTION
PRECAUTION
OSCAR PRO™ must not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, the generator should be observed to verify normal operation. Connecting the generator to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or create a shock or fire hazard. In case of fuse replacement, ensure that the correct fuses are used (refer to section 11). The OSCAR PRO™ generates high voltages within the generator itself and the connected handset. To avoid injury, the generator should never be operated before ensuring that its cover is properly closed and not tampered with. Do not attempt to remove or disassemble the cover. There are no user-serviceable parts inside the generator. All services should only be performed by an authorized Orthofix representative. No modification of this equipment is required nor allowed.
3. Using the main power switch located on the back of the generator, turn the system ON (position “I”). 4. A loading page appears on the touchscreen showing the progress of the system start-up.
Figure 1 LOADING PAGE 5. Select your preferred language from the ones listed. The system interface, messages, errors and help section will be presented in the selected language until any system reset. The reset procedure will return the system to the default configuration. Reset procedure described in section 6.
Figure 2 FIRST POWER ON - LANGUAGE SETTING 6. Now, the user can adjust the date and time settings. Setup local date/time using the [+] and [-] symbols. The date/time settings will remain in use until the next system reset. The reset procedure will revert back to the system’s default configuration.
Figure 3 FIRST POWER ON - DATE/TIME SETTING
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7. Touch the Continue button to complete the configuration. The Surgical Functions menu appears. CHECK1. Verify that the system’s clock displays the correct time and date on the bar at the bottom of the page. CHECK2. Verify that the dashes in the top right corner are lit up and they are changing brightness in sequence.
Figure 4 SURGICAL FUNCTION MENU 8. After touching one of the options in the Surgical Functions menu, the generator surges for Handset connection.
Figure 5 AWAITING HANDSET CONNECTION 9. Position the Instrument Tray on a table. Precautions PRECAUTION PRECAUTION
Handle handsets, probes and cables with care, as inappropriate treatment may affect the safety and performance of the unit. Before use it is recommended that the cables are inspected for damaged insulation. Damaged cables should be replaced before further use of the system. Do not lift or drag the handset by the handset cable, as this may damage both the handset and the cable. Never pull on the handset cable to remove it from the connector.
10. Connect a Handset Cable to a Handset and connect the Handset Cable to the socket beside the “I” symbol on the front panel of the Generator. CHECK3. After completing the connection, the box “CHANNEL 1” on the screen should turn from faded to light blue. NOTE: Do not press the activation button on the handset as indicated on the screen, as no scan is possible without a probe connected to the horn. If pressed accidentally, continue to follow the sequence after the scan ends. 11. Unplug the Handset Cable from CHANNEL 1 and repeat step 10 with a different Handset Cable and Handset on CHANNEL 2 (symbol “II” on the front panel of the Generator).
Figure 6 READY TO SCAN
12. Unplug the Handset Cable from CHANNEL 2. 13. Touch the Home icon to return to the Surgical Functions menu. 14. Touch the On-Off icon to switch the interface off. 15. Turn the main power switch off (position “O”). 16. In the event that one or more of CHECK 1, CHECK 2 or CHECK3 fail, contact an Orthofix agent for assistance. The first power ON procedure ends with the above steps. In order to test additional functionalities and/or verify additional hardware components (probe connection and scan, footswitches connection and activation, peristaltic pump activation) in a functional setting, proceed with section 4. This section provides the steps for connecting and putting the complete system into operation. Details on each OSCAR PRO™ Generator software menu are provided in section 5.