Orthofix Oscar Manual

PQ OSC E 09/18 (Part 1/3)
EN
OSCAR  ULTRASONIC
ARTHROPLASTY REVISION  2
DE
OSCAR REVISION VON ENDOPROTHESEN
MITULTRASCHALL  49
IT
OSCAR ARTROPLASTICA DI REVISIONE
AULTRASUONI  17
NO
OSCAR ULTRASONISK
ARTROPLASTIKK REVISJON  112
ES
OSCAR ARTROPLASTIA DE REVISIÓN
PORULTRASONIDOS  65
FI
OSCAR ULTRAÄÄNILAITE TEKONIVELIEN
UUSINTALEIKKAUKSIIN  96
NL
OSCAR REVISIE ULTRASONE
ARTHROPLASTIEK  127
DA
OSCAR ULTRASONISK
ARTHROPLASTIK REVISION  81
FR
OSCAR REPRISE D'UNE ARTHROPLASTIE
PARULTRASONS  33
PT
OSCAR REVISÃO DE ARTROPLASTIA
DE ULTRASSOM  143
0123
ORTHOFIX Srl
Via Delle Nazioni 9 - 37012 Bussolengo (Verona) - Italy
Telephone [phone] - Fax [phone]

2
Instruction leaet - Please read prior to use.
OSCAR
ultrasonic arthroplasty revision
INDICATIONS FOR USE
OSCAR is intended to be used for cutting and removal of bone and acrylic bone cement in orthopaedic applications.
Warnings and Cautions
• Handle the acoustics (handset and probes) with care. Do not attempt to modify the acoustics. Damage or changes can affect the ability to attain resonance and reduce
the effectiveness of the device. Do not use if damage is suspected.
• Sparks may be produced if the probes touch anything metal while activated.This equipment is not to be used in the presence of flammable gases or liquids.
• Use only genuine OSCAR accessories to assure compatibility and compliance with the requirements of 60601-1-2 in terms of emissions and immunity.
• The use of unofficial accessories (
Handsets and cables ), which are not OSCAR original components may increase emission or decrease immunity of the OSCAR System.
• 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.
• OSCAR system must not be used adjacent to or stacked with other equipment.
• The probes may become hot during use. Do not allow the probes to contact tissue following use.
• Do not allow the probes to contact tissue between activations, in case accidental activation should occur.
• Care should be taken when operating in the vicinity of nerves.
• To avoid the risk of electric shock, this equipment must only be connected to a grounded power supply.
Warnings -In Use
• Do not operate OSCAR in the presence of flammable gases or liquids and an environment rich with oxygen.
• Single use probes should not be reprocessed under any circumstances.
• As no clinical evaluation is available, Orthofix Srl is unable to confirm the safety of use of the OSCAR where a patient or an operator of the unit has been fitted with
a cardiac pacemaker. It is, therefore, left to the clinician’s discretion as to the use of the OSCAR in this situation. However no adverse effects have been reported.
• Please take care of the handsets, probes and cables as rough treatment may affect the safety and performance of the unit.
• The use of handsets or probes not supplied as part of the OSCAR system may damage the generator and create a safety hazard for the operator and patient.
• Avoid allowing an energised probe to come into contact with any metal surface.
• Avoid touching or holding the probes when the handset is energised.
• The generator may be shutdown (disconnected) by use of the switch on the rear panel.
• Wherepossible, avoidallowingprobestobecome stuck incementas thismay cause thegeneratorthermal triptooperate.Howeverifthis situationoccursrefertosection
Problems and Solutions: Removal of probe stuck in cement.
• Do not allow an energised probe to come into firm contact with skin or muscle, as this will cause a friction burn. Skin should be protected with a dry swab.
• Do not over tighten the probes to the handsets.
• The use of accessories, transducers and cables other than those specified, with the exception of the products sold by Orthofix Srl as replacement parts for OSCAR
(see Appendix 0 for full listing), may result in increased emissions or decreased immunity.
• Servicing and maintenance activities shall be conducted in the absence of a patient.
• OSCAR should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary OSCAR should be observed to verify normal operation
in the configuration in which it will be used.
• To avoid the risk of electric shock, this equipment must only be connected to a grounded power supply.
EN

3
• Mains Isolation is achieved by use of the double pole switch located on the rear panel.
• No modification of this equipment is allowed.
• Do not use OSCAR simultaneously with laser equipment or high frequency surgical equipment.
SAFETY PRECAUTIONS AND EQUIPMENT CARE
OSCAR Handset Cement Remover
Intensive useof Cement Removal Handset can causewarming of handset body.In such situations the user is advised either to increase the cooling time allowed, or to use
a second Cement Removal Handset. In case of intensive use these are the potential temparature reachable by handsets:
• Cement Removal Handset (normal condition): 55°C
• Osteotome Handset (normal condition): 47°C
• Cement Removal Handset (single fault condition): 64°C
OSCAR Bonecutter Single Use Probe
This probe should only be used with an OSCAR Bonecutter system.
Theprobehasa screw thread fitting thatcouplesto the handsetin thesame manner as all OSCARprobes.Thiscouplingshould be tightenedusingan 8mmspanner/wrench.
This probe has been designed to be single use only. It is not designed to be reused in any way whatsoever.
The probe is supplied STERILE.
STERILE. By irradiation. As indicated on the package label.
• Do not use if packaging is open or damaged.
• Probe damage may occur should it come into contact with any metal surface whilst activated. Should this happen, remove the probe and replace with a new one.
• Do not use an energised probe and the endoscope simultaneously.This may damage the probe and endoscope.
• Do not allow an energised probe to come into firm contact with skin or muscle, as this will cause a friction burn. Skin should be protected with a dry swab.
• Do not over tighten the probes to the handsets.
• If a probebecomes damaged during a procedure and needs replacing, it is mostimportant not toget talcum powder,blood or any formof contamination on the mating
surfaces.This will cause them to become eroded and materially affect the ultrasonic conduction of the waveguide, making it less efficient.
• If the probe is reused, there is a risk that it may be worn which will result in poor performance or it may even fatigue which may lead to probe fracture.
After use the probe should be disposed of.The handset should be cleaned and sterilised as instructed in this document.
OSCAR Single Use Probe
This probe should only be used with an OSCAR system.
Theprobehas a screwthreadfitting thatcouples tothe handset in the same manner as all OSCAR probes.Thiscouplingshould be tightenedusing a 7mm spanner/wrench.

4
Single Use probes may require the addition of a reducer/extension bar in order to function effectively.The table below MUST be followed when connecting probes to an OSCAR
handset. Failure to follow these coupling instructions is likely to result in damage to the handset.
Use with Extension/Reducer Bars.
Probe ID Probe Name OHR2000
Reducer bar
OHRE2000SU
OHRE2002SU
Short Extension Bar
OHRE2001SU
OHRE2003SU
Long Extension Bar
Use without Exten-
sion/Reducer Bar OHE2000 StandardExtensionBar
OHP218FSU 8mm Flat Piercer YES NO NO NO NO
OHP2080SU 8mm Piercer NO YES YES NO NO
OHS2080SU 8mm Scraper NO YES YES NO NO
OHP2062SU Slim 6mm Piercer NO NO NO YES NO
OHP2100SU 10mm Piercer NO YES YES NO NO
OHS2100SU 10mm Scraper NO YES YES NO NO
OHS2062SU Slim 6mm Scraper NO NO NO YES NO
OHA2030SU Acetabular probe NO NO NO YES YES (Optional)
OHH2062SU 6mm Hoe Probe NO NO NO YES NO
OHH2081SU 8mm Hoe Probe NO NO NO YES NO
EXP2681SU Extraction Probe NO NO NO YES YES (Optional)
The probe has been designed to be Single Use only. It is not designed to be re-used in any way whatsoever.
The probe is supplied STERILE.
STERILE. By irradiation. As indicated on the package label.
Do not use if packaging is open or damaged.
• Avoid allowing an energised probe to come into contact with any metal surface.
• Do not use an energised probe and the endoscope simultaneously.This may damage the probe and endoscope.
• Wherepossible, avoid allowing probes to become stuck incement asthis maycause thegeneratorthermal trip to operate.However, if thissituation occurs, referto theOSCAR
User Manual section - Problems and Solutions - removal of probe stuck in cement.
• Do not allow an energised probe to come in firm contact with skin or muscle, as this will cause a friction burn. Skin should be protected with a dry swab.
• Do not over tighten the probes to the handsets.
• If a probe becomes damaged during a procedure and needs to be replaced, it is most important not to get talcum powder, blood or any form of contamination on the mating
surfaces of the probeand handset.This willcause themto becomeerodedand materiallyaffect theultrasonic conductionof the waveguide,making it less efficient.
• If the probe is reused, there is a risk that it may be worn which will result in poor performance or it may even fatigue which may lead to probe fracture.
• After use the probe should be disposed of.The handset should be cleaned and sterilised as instructed in this document.

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Scratches on Probes
OSCAR probes are susceptible todamage if forced into contact with metal (e.g. screw, retractor, or part of the prosthesis) whenactive.The consequence of scratching a probe
is to raisethe mechanicalstress inthe region ofthe scratch (a“stress raiser”)when the probeis vibrating. If thestress is raisedsufficiently there isa risk of the probe suffering metal
fatigue and cracking. Fatigue failure is more likely if the stress raiser is close to one of the fixed points of maximum mechanical stress in the vibrating probe.
Replace any probe which has a scratch in the regions indicated below, if the scratch is deep enough to be detected by sliding a fingernail over it.
• Long Probes (eg. 6, 8, 10mm piercers, 6, 8mm scrapers)
Scratches at the midpoints of the two thinnest straight sections of the shaft
• Short Probes (e.g. 10mm scraper, groover)
Scratches at the midpoint of the thinnest straight section of the shaft
• Acetabular Scratches near the head where the curvature is tightest
Note 1: Scratched probes may be returned to the manufacturer for assessment and polishing if no other damage is evident.
Note 2: Single use probes, due to their smaller distal stem section are more vulnerable to fatigue failure related to surface impact damage. This is more likely in the case
of prosthesis removal instruments when metal contact is unavoidable. However the flat osteotomes are designed to be used so that theflat faces rub against the
prosthetic stem and distal contact is avoided.This method of application also avoids damage to the serrated edges
Damage or Wear on Piercer and Scraper Cutting Heads
The curved flange on the cutting head of most probes will eventually become blunt.The lifetime depends on the amount of use but efficient cement cutting is generally
reduced significantly after approximately 30 revisions. In addition to this part of the flange may break off if it has worn down, especially on the piercer probes that have
holes in the flange.
• Replace any probe for which the rear facing cutting edge is clearly rounded
• Replace any probe on which more than 25% of the flange circumference is missing
• Replace any piercer probe which has“lost”one or more of the holes in the flange
Damage or Wear on Cables
Before use it is recommended that the cables are inspected for damaged insulation. Damaged cables should be replaced before further use of the system.
Irrigation During Cement Removal
Irrigation of the bone canal following a period of cement removal is important for two reasons. Firstly, it clears the canal of cement debris and secondly it maintains safe
operatingtemperatures.It isrecommendedthatirrigation,in theform ofpulsed lavageormanual irrigation,isused intermittentlyfollowing use of the scrapersor groover
probes and that the frequency of irrigation is more frequent when using the piercer probes.
It is recommended that irrigation is used more frequently in the following instances:
1. Cement removal in the upper extremity limbs
2. Knee revisions
3. Cases of femoral cortices which are particularly thin
Donot irrigateduringultrasonic energy application, thiswill compromisethe speedof removaland efficacy of transmission.Thedesign ofthe OSCAR probesisspecifically
aimed at achieving rapid heating and transference of the softened cement. Cooling during an energy cycle will delay this action and reduce the energy available.
Notes: If possible chilled saline should be used Refer to video material of OSCAR use

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Irrigation During Cementless Revision
It is important to maintain a steady flow of saline around the prosthetic stem during insertion of the flat osteotomes, particularly when cutting cortical bone.This helps
to keep the metal on metal interface cool and lubricated whilst the active edges of the osteotome are cutting bone.
CLEANING AND STERILISING PROCEDURES (BEFORE AND AFTER USE)
These instructions apply to the Oscar reusable devices only. All these reusable system components are provided clean but not sterile.
These reprocessing instructions were written in accordance with ISO17664 and have been validated by Orthofix in compliance with international standards. It is the
responsibility of the health care facility to ensure that the reprocessing is performed in accordance with instructions and to perform validation and routine monitoring of
the process. Any deviation from these instructions is responsibility of the health care facility in charge of reprocessing.
Warnings
• The personnel that works with contaminated medical devices must follow safety precautions as per the procedure of the healthcare facility;
• Cleaning solutions with a neutral pH are recommended;
• DO NOT use ultrasonic washing;
• DO NOT sterilize OSCAR generator or screen;
• All reusable devices must be thoroughly manually pre-cleaned before automated washing in order to remove soiling that accumulates in recesses;
Limitations and restrictions on reprocessing
• End of life is normally determined by wear and damage due to use;
• Carefully inspect instruments between uses to verify proper functioning;
• Damaged instruments should be repaired or replaced to prevent potential patient injury and loss of metal fragments into the surgical sites;
• Scratches or dents can result in breakage or malfunction;
• Products labeled for Single Use only must not be reused regardless any reprocessing;
Point of use
• It is recommended that reusable devicesare reprocessed as soon as is reasonably practicable following use;
• Wipe down all components (including the generator) and remove any surplus body soiling;
• Ensure probes, cables, endcaps and shrounds are disconnected from the handsets (ref. to disassembly diagram figure 1);
• Don’t use a fixating detergent or hot water as this can cause the fixation of residue which may influence the result of the reprocessing process.
Containment and transportation
• Follow hospital protocols when handling contaminated and bio-hazardous materials. Used instruments should be covered to minimize the risk of cross contamination;
• All used surgical instruments must be regarded as contaminated.Their handling, collection and transportation must be strictly controlled to minimize any possible risks
to patients, personnel and any area of the healthcare facility.
Preparation for decontamination
• Disassemble the devices where applicable (please refer to figure 1);
• Prepare the cleaning solution. Orthofix recommends the use of a pH-neutral enzymatic cleaning agent. Please refer to detergent’s manufacturer datasheet for
concentration of the solution, required time and temperature.
Cleaning: Manual
• Soak the single components in the cleaning solution for at least 5 minutes;

7
• When cleaning, fully submerge the instruments in the cleaning solution;
• Thoroughly scrub the single components in the cleaning solution with a soft brush until all visible soiling is removed. Metal brushes should be avoided. Clean
cannulations and holes using an appropriate brush ensuring that the full depth of the feature is reached;
• Rinse the single components in running tap water for at least 2 minutes. Ensure that running water passes through cannulations, and that blind holes are repeatedly
filled and emptied;
• Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer for at least 5 minutes. Do not exceed 140°C (285°F).
Cleaning: Automated
• When the devices to be cleaned have lumens or present complexity, a preliminary manual cleaning may be required;
• Use a validated, properly maintained and calibrated washer disinfector;
• Place all the instruments into washer baskets.
• Place heavier devices in the bottom of the baskets.
• Connect cannulations to the proper injector jets.
• Wherever possible, all parts of disassembled devices should be kept together in one container.
• Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer.
Orthofix recommends that cycle steps are at least as follows:
• Prewash at low temperatures;
• Main wash at 40-60°C for at least 5 minutes;
• Rinse with demineralized water;
• Thermal disinfection at 90-95°C for at least 1 minute;
• Rinse the components in sterile or freshly prepared purified water;
• Carefully hand-dry using absorbent, non-shedding cloth or industrial dryer. Do not exceed 140°C (285°F).
Maintenance, inspection and testing
• All instruments and product components must be visually inspected under good light for cleanliness. If some areas are not clearly visible, use a 3% hydrogen peroxide
solution to detect the presence of organic residuals. If blood is present, bubbling will be observed;
• All instruments and product components must be visually inspected for any signs of deterioration that may cause failure during use (such as cracks or damage to
surfaces) and functions tested before being sterilized. If a component or instrument is believed to be faulty, damaged or suspect, it must NOT BE USED;
• Inspect cables for wear and damage, ensuring that no cracks, tears, or other damage is found;
• Check to see probes have a continuous cutting edge and are free of nicks.
Packaging:
• Wrap the tray before sterilization with an approved sterilization wrap (a FDA-cleared sterilization wrap is recommended in US) or insert it into a rigid sterilization
container in order to prevent contamination after sterilization;
• Do not include additional systems or instruments in the sterilization tray. Sterility cannot be guaranteed if the sterilization tray is overloaded;
• The total weight of a wrapped instrument tray should not exceed 10 kg.
Sterilization:
• Steam sterilization is recommended. Gas plasma, dry heat and EtO sterilization must be avoided as they were not validated for Orthofix products;
• Sterilization must be at least two hours prior to use to allow the equipment to cool and stabilize;
• Handsets are NOT to be submerged in water to expedite cooling;
• DO NOT sterilize the generator or screen;
• Use a validated, properly maintained and calibrated steam sterilizer;
• The steam quality must be appropriate for the process to be effective;

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• DO NOT exceed 137°C (278°F);
• DO NOT exceed 18 minutes of exposure temperature;
• DO NOT exceed 2 bars as maximum autoclave pressure;
• DO NOT stack trays during sterilization;
• Sterilize by steam autoclaving, utilizing a fractioned pre-vacuum cycle or gravity cycle according to the table below:
Steam sterilizer type Pre-vacuum Pre-vacuum (not recommended for use in US)
Minimum exposureTemperature 132° C (270° F) 134° C (273° F)
Minimum exposureTime 4 minutes 3 minutes
Drying Time 30 minutes 30 minutes
Storage:
Store the sterilized instrument in the sterilization packaging in a dry and clean environment at room temperature. The handset should not be stored or transported
with the probes attached.
A
C
E
D
B
E
D
C
A: Switch
B: Horn
C: Connector End Cap
D: Shroud
E: End Cap
Figure 1 DO NOT REMOVE THIS COMPONENT - DOING SO WILL DAMAGE THE PRODUCT
Generator & Footswitch
The generator and footswitch may be cleaned with a cloth moistened with Isopropyl Alcohol after use.
After Use
Turn off the equipment, remove the power cord plug from the power Socket (net) and disconnect the handset cable from the Handset and the Generator. Take care
when handling handsets with probes attached - some edges are serrated and sharp. Detach all probes from handsets using two spanners. If the probe is single use,
dispose of in a“sharps”bin.
Probe Cleaning (after use)
(Cement Removal Consumable Probes ONLY)
After surgical use it is necessary to remove all traces of PMMA from each reusable type instrument head by manual cleaning (scrubbing), prior to sterilisation.

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OSCAR Cleaning System
Alternatively, the OSCAR cleaning system (Figure 2) is designed for use in the“sluice”room and consists of a small trolley mounted
enclosure containing an ultrasound generator with timing control circuit and a cleaning cell.
Note - Ensure that all pins and sockets on ends of handsets and handset cables are dry then re-assemble the cables, shrouds and
each contaminated probe to the handset.
Insert a new cleaning cell in the OSCAR cleaning equipment. Each handset with its contaminated probe is connected via the
handset cable to the socket at the rear of the enclosure. As with connection to the generator, the red dot on the handset cable must
be aligned with the red dot on the connection at the rear of the cleaning system. The probe is then inserted into the cleaning cell
when it is automatically energised by special circuitry incorporated in the apparatus. It is held in place in this way until the cleaning
cycle is complete. A short cycle, (15 seconds) and long cycle, (30 seconds) are selectable to provide optimum cleaning conditions.
Should traces of cement remain after removal from the cell, the operation may be repeated until visual inspection of the cement
removal head indicates that cleaning is complete.
After each cleaning Session the cleaning cells shall be discarded to avoid contamination build up.
Replacement cells are supplied with sealed ends; the seals are broken as the first revision instrument is inserted.
Storage of Equipment Between Cases
Donot operateOSCARin the presenceofflammable gases.Itis recommendedthat; betweencases,the handsetsand cables arestored,in alargeautoclavetrayand again,
care should be taken to ensure that the cable is not kinked close to the connector. In this situation it is much easier to coil the cable when the handset is disconnected.
Maintenance
There are no user-serviceable parts in OSCAR.
Any damage to the handsets or cables should be reported and the components returned to Orthofix Srl for repair or replacement at the earliest opportunity.
Fuse Replacement
To replace rear fuses, first disconnect generator from supply mains.The fuse drawer may be extracted by inserting a small flat bladed screwdriver into the slot adjacent to
the On/Off switch. Ensure that the replacement fuse is of the correct type (see Appendix 1).
Disposal
All SINGLE USE probes must be disposed of following standard Theatre procedures, ideally in an appropriately sized‘sharps’bin after use. The generator, handset and
footswitch may be returned to the manufacturer for safe disposal at their end of life.
Precautions During Surgical Procedure
The handset instruments are machined from a special titanium alloy and the profile of each instrument is carefully controlled to minimise the likelihood of metal fatigue
and to ensure that it functions correctly throughout its expected life of up to six months. It is important to ensure that the instrument tip does not touch any metal
component whilst the handset is engaged. Even a brief contact with a screw, retractor, or part of the prosthesis can result in serious damage and impair the performance
of the instrument. Sparks may sometimes be seen if the probe tip comes into contact with metal.The back scraper will lose its sharp cutting edge if it is in contact with
hard cortical bone. Cracks in the piercer head will reduce its cutting efficiency, although it will still function. If a probe becomes damaged during a procedure it is possible
to replace it by unscrewing it from the distal part of the horn using a 9mm spanner. While replacing a probe in this way it is most important not to get talcum powder,
blood or any form of contamination on the mating surfaces as this will cause them to become eroded and materially affect the ultrasonic conduction of the wave guide,
making it less efficient. Cables should not be compressed during cement removal as this can cause fracture of the components of the cable.
Any damage to the probes or cables should be notified and the components returned to local Distributor at the earliest opportunity.
Figure 2

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APPENDIX 0 Replacement parts
EN
Code Description
OMC300EU
OMC300UK
OMC300US
Power Supply Cable Europe
Power Supply Cable United Kingdom
Power Supply Cable United States
OH300/2 Cement Removal Handset
OHB300/2 Osteotome Handset
CH300 Cable
ORFS300 Footswitch
APPENDIX 1 Markings on the OSCAR Front and Back Panels
EN
Symbol Description
Model OS3000 Model Number
Follow instruction for use
Date of Manufacture Manufacturer by
SN Serial Number
Alternating Current
Voltage 230V Supply ACVoltage
50 - 60 Hz Supply AC Frequency
POWER 175W Input Power
150W Output Power

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Fuse Details
Supply Power On
Supply Power off
Handset activation“ON”/ “OFF”(push button)
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.
+50°C
-40°C
Temperature limitation
10%
100%
Humidity limitation
1060hPa
500hPa
Atmospheric pressure limitation
Caution
Type B Applied Part
INTERMITTENT USE
ON/OFF 10/20s Channel I & II
Footswitch Connection
Output Connector
Equipotential Connection
Volume MIN MAX
NON STERILE
Consult instructions for Use
Expiry date (year-month)
Do not use if package is opened or damaged
Single use. Do not reuse
STERILE. Sterilised by irradiaton
STERILE. Sterilised by moist Heat

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APPENDIX 2 Technical Specication
Dimensions: Caseframe: 457mm (width) x 140mm (height) x 355mm (depth)
Weight: Caseframe: 7.5kg
Transport case (loaded with caseframe): 15kg
Handsets Cement removal / Osteotome: 0.8kg
Transport case (loaded with handsets, probes, accessories): 13.6kg
Fuse Type: 2 x T5A H 250V, 5 x 20mm
Power supply input 230V ac
Power consumption 175W
Output - Frequency
ofoperation 28kHz (Channel I & I)
Output - Accuracy
offrequency display ±1%
Output power 150W
Mode of operation Intermittent use 10s ON / 20s OFF (Channel I & II)
Electrical classications: Generator: Class 1 ( generator has a protective earth connection)
Handsets and probes:Type B (patient applied parts are at earth potential)
Handset Titanium, stainless steel enclosure, silicone and viton components, with sealed switch and cable connector suitable for autoclave sterilisation.
Connecting cable provided with earthed screen.
Ingress protection Generator: IPX0
Environment for transport
& storage
Temperature: -40ºC to +50ºC
Humidity: 10% to 100%
Atmospheric pressure: 500hPa to 1060hPa
Environment for use Temperature: 0ºC to +30ºC Humidity: 30% to 75%
Atmospheric pressure: 700hPa to 1060hPa
OSCAR 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.The equipment
complies with BSEN60601-1.The product is covered by worldwide patents covering all international markets.
Orthofix Srl will provide on request, circuit diagrams, component parts lists and descriptions. However, Orthofix Srl do not designate any part of the equipment as user repairable.

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Appendix 3: Electromagnetic Interference
This equipment has been tested and found to comply with the limits for a medical device.
However should interference occur, the user can 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.
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
OSCAR is intended for use in the electromagnetic environment specified below.
The customer or the user of OSCAR should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1 OSCAR uses RF energy only for its internal function. Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11 Class A
OSCAR 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.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations
/flicker emissions
IEC 61000-3-3 Complies

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Table 2
Guidance and manufacturer’s declaration - electromagnetic immunity
OSCAR is intended for use in the electromagnetic environment specified below.
The customer or the user of OSCAR 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
±6kV contact
±8kV air ±6kV contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1kV for signal lines
±2kV for power supply lines
±1kV for signal lines Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV line to line
±2kV line to earth
±1kV differential mode
±2kV common mode Mains power quality should be that of a typical commercial or hospital environment.
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
Mains power quality should be that of a typical commercial or hospital environment. If the user of OSCAR
requires continued operation during power mains interruptions, it is recommended that OSCAR be powered
from an uninterruptible power supply.
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment.
NOTE UTis the a.c. mains voltage prior to application of the test level

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Table 3
Guidance and manufacturer’s declaration - electromagnetic immunity
OSCAR is intended for use in the electromagnetic environment specified below.
The customer or the user of OSCAR should assure that it is used in such an environment.
IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150kHz to 80MHz
3V/m
80MHz to 2.5GHz
3Vrms
3V/m
Portable and mobile RF communications equipment should be used no closer to any part of OSCAR, 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,ashould be less than
the compliance level in each frequency range.b
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 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a 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 andTV 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 in the location
in which OSCAR is used exceed the applicable RF compliance level above, OSCAR should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating OSCAR.
b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m

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Table 4
Recommended separation distances between portable and mobile RF communications equipment and OSCAR
OSCAR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of OSCAR can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment and OSCAR 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
m
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 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people

17
Foglietto illustrativo - Leggere attentamente prima dell'uso.
OSCAR
Revisione protesica a ultrasuoni
INDICAZIONI PER L'USO
OSCAR è concepito per essere utilizzato nelle applicazioni ortopediche per il taglio e la rimozione di tessuto osseo e cemento osseo acrilico.
Avvertenze e precauzioni
• Maneggiare con cautela i componenti acustici (manipolo e sonde). Non tentare di modificare i componenti acustici. Eventuali danni o modifiche potrebbero
compromettere l'esito della risonanza e ridurre l'efficacia del dispositivo. Non utilizzare in caso di sospetto danneggiamento.
• Il contatto tra una sonda e una superficie metallica potrebbe generare scintille. Non utilizzare l'apparecchiatura in presenza di liquidi o gas infiammabili.
• Utilizzare solo accessori OSCAR originali per garantire la compatibilità e la conformità ai requisiti della normativa 60601-1-2 in termini di emissioni e immunità.
• L'uso di accessori non ufficiali (
manipoli e cavi ), che non sono quindi componenti OSCAR originali, può aumentare le emissioni e ridurre l'immunità del sistema OSCAR.
• Questo dispositivo deve essere utilizzato esclusivamente da chirurghi opportunamente formati (1) all'esecuzione del tipo di procedure a cui il dispositivo
è destinato e (2) all'uso specifico di strumenti chirurgici a ultrasuoni previsti per l'uso durante la revisione protesica.
• Non collocare il sistema OSCAR vicino o sopra ad altre apparecchiature.
• Le sonde potrebbero scaldarsi durante l'uso. Evitare il contatto tra sonde e tessuto in seguito all'utilizzo.
• Evitare il contatto tra sonde e tessuto tra un'attivazione e l'altra, in quanto potrebbero verificarsi attivazioni accidentali.
• Prestare particolare attenzione durante l'utilizzo in prossimità dei nervi.
• Onde evitare il rischio di shock elettrico, l'apparecchiatura deve essere collegata esclusivamente a fonti di alimentazione con messa a terra.
Avvertenze d'uso
• Non utilizzare OSCAR in presenza di liquidi o gas infiammabili o di liquidi e un ambiente a elevata concentrazione di ossigeno.
• Le sonde monouso non devono essere riutilizzate in nessun caso.
• In mancanza di opportune valutazioni cliniche, Orthofix Srl non fornisce alcuna garanzia di sicurezza in merito all'impiego di OSCAR nei casi in cui il paziente o
l'operatore del dispositivo siano portatori di pacemaker cardiaco. Pertanto, la decisione di ricorrere o meno all'utilizzo di OSCAR in situazioni simili è lasciata alla
totale discrezione del medico.Tuttavia non sono stati segnalati effetti indesiderati.
• Maneggiare con cautela manipoli, sonde e cavi, in quanto un utilizzo inadeguato potrebbe compromettere la sicurezza e le prestazioni dell'unità.
• L'utilizzo di manipoli o sonde non fornite con il sistema OSCAR potrebbe danneggiare il generatore e comportare un rischio per la sicurezza dell'operatore e del paziente.
• Impedire che una sonda carica entri in contatto con una superficie in metallo.
• Evitare di toccare o prendere in mano le sonde quando il manipolo è carico.
• È possibile spegnere (scollegare) il generatore utilizzando l'interruttore posto sul pannello posteriore.
• Se possibile, evitare che le sonde rimangano incastrate nel cemento, in quanto ciò potrebbe far scattare l'interruttore termico del generatore. Se tale problema
dovesse verificarsi comunque, fare riferimento alla sezione Problemi e soluzioni: Rimozione di una sonda incastrata nel cemento.
• Impedire che una sonda carica entri in stretto contatto con la pelle o il muscolo, in quanto ciò potrebbe provocare una bruciatura da sfregamento. La pelle deve
essere protetta mediante un tampone asciutto.
• Non serrare eccessivamente le sonde ai manipoli.
• L'utilizzo di accessori, trasduttori e cavi diversi da quelli specificati, fatta eccezione per i prodotti venduti da Orthofix Srl come parti di ricambio per il sistema OSCAR
(vedere Appendice 0 per un elenco completo), potrebbe causare un aumento delle emissioni o una riduzione dell'immunità del sistema stesso.
• Gli interventi di assistenza e manutenzione devono essere eseguiti in assenza di pazienti.
• Non collocare il sistema OSCAR vicino o sopra ad altre apparecchiature. Se tale disposizione risultasse assolutamente necessaria, controllare che il sistema OSCAR
funzioni normalmente nella configurazione in cui verrà utilizzato.
IT

18
• Onde evitare il rischio di shock elettrico, l'apparecchiatura deve essere collegata esclusivamente a fonti di alimentazione con messa a terra.
• Per isolare la rete elettrica, utilizzare l'interruttore bipolare posto sul pannello posteriore.
• Non è consentito apportare modifiche all'apparecchiatura.
• Non utilizzare il sistema OSCAR contemporaneamente con apparecchiature laser o apparecchiature elettriche ad alta frequenza.
MISURE DI SICUREZZA E MANUTENZIONE DELL'APPARECCHIATURA
Manipolo OSCAR per la rimozione del cemento
Unuso intensivodelmanipolo per la rimozione del cementopuò causarneil surriscaldamento. In tal caso, siconsiglia diaumentareil tempodi raffreddamento consentito
oppure di utilizzare un altro manipolo per la rimozione del cemento. Di seguito sono riportate le possibili temperature raggiunte dai manipoli in caso di uso intensivo:
• Manipolo rimozione cemento (condizione normale): 55°C
• Manipolo per osteotomia (condizione normale): 47°C
• Manipolo rimozione cemento (condizione di guasto singola): 64°C
Sonda monouso taglia ossa OSCAR
Questa sonda deve essere utilizzata esclusivamente con un sistema taglia ossa OSCAR.
La sonda è dotata di un raccordo con filettatura a vite che consente l'associazione con il manipolo come avviene per tutte le sonde OSCAR. Questo raccordo deve
essere serrato utilizzando una chiave da 8mm.
Questa sonda è esclusivamente monouso e non deve pertanto essere riutilizzata in alcun modo.
La sonda viene fornita STERILE.
tramite irradiazione in base all'indicazione riportata sull'etichetta della confezione.
• Non utilizzare se la confezione è aperta o danneggiata.
• Potrebbero verificarsi danni alla sonda in caso entri in contatto con superfici metalliche quando attiva. In tal caso, rimuovere la sonda e sostituirla con una nuova.
• Non utilizzare contemporaneamente una sonda carica e l'endoscopio, in quanto potrebbero verificarsi danni a entrambi i componenti.
• Impedire che una sonda carica entri in stretto contatto con la pelle o il muscolo, in quanto ciò potrebbe provocare una bruciatura da sfregamento. La pelle deve
essere protetta mediante un tampone asciutto.
• Non serrare eccessivamente le sonde ai manipoli.
• Se una sonda subisce danni durante una procedura e deve essere sostituita, è estremamente importante evitare contaminazioni delle superfici di contatto con
talco, sangue e altre sostanze contaminanti, che potrebbero provocare l'erosione delle superfici stesse e interferire materialmente con la propagazione delle onde
ultrasonore della guida d'onda, compromettendone l'efficienza.
• Se la sonda viene riutilizzata, sussiste il rischio di usura che potrebbe a sua volta causare prestazioni scarse o persino una rottura per fatica della sonda.
Dopo l'uso, le sonde devono essere smaltite. Il manipolo deve essere pulito e sterilizzato come da istruzioni riportate nel presente documento.
Sonda monouso OSCAR
Questa sonda deve essere utilizzata esclusivamente con il sistema OSCAR.
La sonda è dotata di un raccordo con filettatura a vite che consente l'associazione con il manipolo come avviene per tutte le sonde OSCAR. Questo raccordo deve
essere serrato utilizzando una chiave da 7mm.

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Alle sonde monouso potrebbe dover essere aggiunta una barra di riduzione/estensione per poter funzionare in modo efficace. È NECESSARIO seguire quanto riportato
nella tabella seguente quando si collegano le sonde a un manipolo OSCAR. Se non si seguono queste istruzioni di raccordo potrebbero verificarsi danni al manipolo.
Uso con barre di estensione/riduzione.
ID sonda Nome sonda OHR2000
Barra di riduzione
OHRE2000SU
OHRE2002SU
Barra di estensione
corta
OHRE2001SU
OHRE2003SU
Barra di estensione
lunga
Uso senza barra di
estensione/riduzione
OHE2000
Barra di estensione
standard
OHP218FSU Perforatore piatto da 8mm SÌ NO NO NO NO
OHP2080SU Perforatore da 8mm NO SÌ SÌ NO NO
OHS2080SU Raschiatore da 8mm NO SÌ SÌ NO NO
OHP2062SU Perforatore sottile da 6mm NO NO NO SÌ NO
OHP2100SU Perforatore da 10mm NO SÌ SÌ NO NO
OHS2100SU Raschiatore da 10mm NO SÌ SÌ NO NO
OHS2062SU Raschiatore sottile da 6mm NO NO NO SÌ NO
OHA2030SU Sonda acetabolare NO NO NO SÌ SÌ (facoltativa)
OHH2062SU Sonda Hoe da 6mm NO NO NO SÌ NO
OHH2081SU Sonda Hoe da 8mm NO NO NO SÌ NO
EXP2681SU Sonda da estrazione NO NO NO SÌ SÌ (facoltativa)
Questa sonda è esclusivamente monouso e non deve pertanto essere riutilizzata in alcun modo.
La sonda viene fornita STERILE. Il metodo di sterilizzazione può essere:
La sonda viene fornita STERILE.
tramite irradiazione in base all'indicazione riportata sull'etichetta della confezione.
Non utilizzare se la confezione è aperta o danneggiata.
• Impedire che una sonda carica entri in contatto con una superficie in metallo.
• Non utilizzare contemporaneamente una sonda carica e l'endoscopio, in quanto potrebbero verificarsi danni a entrambi i componenti.
• Se possibile, evitare che le sonde rimangano incastrate nel cemento, in quanto ciò potrebbe far scattare l'interruttore termico del generatore. Se tale problema
dovesse verificarsi comunque, fare riferimento alla sezione del Manuale utente OSCAR Problemi e soluzioni - Rimozione di una sonda incastrata nel cemento.
• Impedire che una sonda carica entri in stretto contatto con la pelle o il muscolo, in quanto ciò potrebbe provocare una bruciatura da sfregamento. La pelle deve
essere protetta mediante un tampone asciutto.
• Non serrare eccessivamente le sonde ai manipoli.
• Se una sonda subisce danni durante una procedura e deve essere sostituita, è estremamente importante evitare contaminazioni delle superfici di contatto della
sonda e del manipolo con talco, sangue e altre sostanze contaminanti, che potrebbero provocare l'erosione delle superfici stesse e interferire materialmente con
la propagazione delle onde ultrasonore della guida d'onda, compromettendone l'efficienza.
• Se la sonda viene riutilizzata, sussiste il rischio di usura che potrebbe a sua volta causare prestazioni scarse o persino una rottura per fatica della sonda.
• Dopo l'uso, le sonde devono essere smaltite. Il manipolo deve essere pulito e sterilizzato come da istruzioni riportate nel presente documento.

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Presenza di gra sulle sonde
Le sonde OSCAR in attività potrebbero danneggiarsi in caso di contatto con superfici metalliche (ad es. viti, retrattori o parti di protesi). La presenza di un graffio sulla
sonda comporta un aumento della tensione meccanica nell'area interessata dal graffio ("sollecitatore di tensione") quando la sonda vibra. Se la tensione raggiunge
livelli molto elevati, vi è il rischio che il metallo si logori, con conseguente rottura per fatica. Le probabilità di una rottura per fatica sono più elevate se il sollecitatore di
tensione si trova in prossimità di uno dei punti fissi di massima tensione meccanica della sonda in funzione.
Sostituire le sonde che presentano un graffio nelle regioni indicate di seguito nel caso in cui il graffio in questione sia abbastanza profondo da poter essere individuato
passandovi sopra l'unghia.
• Sonde lunghe (ad es. perforatori da 6, 8, 10mm, raschiatori da 6, 8mm)
Graffi nei punti centrali delle due sezioni dritte più sottili del corpo della sonda
• Sonde corte (ad es. raschiatore da 10mm, scanalatrice)
Graffi nel punto centrale della sezione dritta più sottile del corpo della sonda
• Sonda acetabolare Graffi in prossimità della testa, dove la curvatura è più pronunciata
Nota 1: le sonde che presentano graffi devono essere restituite al produttore per la valutazione e la levigatura, in mancanza di altri danni evidenti.
Nota 2: a causa delle dimensioni ridotte della sezione dello stelo distale, le sonde monouso sono più soggette alla rottura per fatica correlata ai danni da urto della
superficie. Questo problema riguarda soprattutto lo strumentario per la rimozione delle protesi, dove il contatto con le superfici in metallo è inevitabile.
Tuttavia gli osteotomi piatti sono progettati per essere applicati in modo tale che le superfici piatte entrino i contatto con lo stelo della protesi, evitando il
contatto distale. Questo metodo di applicazione consente inoltre di evitare di danneggiare i bordi seghettati
Danneggiamento o usura delle teste di taglio di perforatori e raschiatori
La flangia curva presente sulla testa di taglio della maggior parte delle sonde tende a smussarsi con il tempo. La sua durata dipende dall'utilizzo, ma generalmente
l'efficacia di taglio del cemento risulta notevolmente ridotta dopo circa 30 revisioni. Inoltre, una parte della flangia rischia di rompersi in seguito a usura, soprattutto
nel caso delle sonde per perforazione, che presentano fori sulla flangia.
• Sostituire le sonde la cui lama posteriore risulta arrotondata
• Sostituire le sonde in cui oltre il 25% della circonferenza della flangia risulta mancante
• Sostituire le sonde perforatore in cui uno o più fori della flangia risultano mancanti
Danneggiamento o usura dei cavi
Prima dell'uso, si raccomanda di ispezionare i cavi per assicurarsi che l'isolamento non sia danneggiato. I cavi danneggiati devono essere sostituiti prima di continuare
a utilizzare il sistema.
Irrigazione durante la rimozione del cemento
L'irrigazione del canale osseo in seguito alla rimozione del cemento è importante per due motivi: Consente di rimuovere i residui di cemento dal canale e mantiene le
temperature operatorie entro i limiti di sicurezza. Si raccomanda di ricorrere periodicamente all'irrigazione, sotto forma di lavaggio a impulsi o irrigazione manuale,
dopo avere utilizzato raschiatori o sonde scanalatrici e di aumentare la frequenza dell'irrigazione quando si utilizzano le sonde per perforazione.
Si raccomanda di aumentare la frequenza di utilizzo dell'irrigazione nei seguenti casi:
1. Rimozione di cemento nell'arto superiore
2. Revisioni di ginocchio
3. Casi di corticali femorali particolarmente sottili