Orthofix Ltd
Ultrasonic Arthroplasty Revision Instruction leaflet
392 Pages

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EN
Instruction leaflet - 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. • Where possible, avoid allowing probes to become stuck in cement as this may cause the generator thermal trip to operate. However if this situation occurs refer to section 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. 2
• 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 use of Cement Removal Handset can cause warming 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. The probe has a screw thread fitting that couples to the handset in the same manner as all OSCAR probes. This coupling should be tightened using an 8mm spanner/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 probe becomes damaged during a procedure and needs replacing, it is most important not to get talcum powder, blood or any form of 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. The probe has a screw thread fitting that couples to the handset in the same manner as all OSCAR probes. This coupling should be tightened using a 7mm spanner/wrench.
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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. OHRE2000SU OHRE2002SU Short Extension Bar
OHRE2001SU OHRE2003SU Long Extension Bar
Probe ID
Probe Name
OHR2000 Reducer bar
Use without Extension/Reducer Bar
OHE2000 Standard Extension Bar
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) NO
OHH2062SU
6mm Hoe Probe
NO
NO
NO
YES
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. • Where possible, avoid allowing probes to become stuck in cement as this may cause the generator thermal trip to operate. However, if this situation occurs, refer to the OSCAR 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 probe and handset. 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. 4
Scratches on Probes OSCAR probes are susceptible to damage if forced into contact with metal (e.g. screw, retractor, or part of the prosthesis) when active. The consequence of scratching a probe is to raise the mechanical stress in the region of the scratch (a“stress raiser”) when the probe is vibrating. If the stress is raised sufficiently there is a 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 • Short Probes • Acetabular
(eg. 6, 8, 10mm piercers, 6, 8mm scrapers) Scratches at the midpoints of the two thinnest straight sections of the shaft (e.g. 10mm scraper, groover) Scratches at the midpoint of the thinnest straight section of the shaft 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 the flat 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 operating temperatures. It is recommended that irrigation, in the form of pulsed lavage or manual irrigation, is used intermittently following use of the scrapers or 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 Do not irrigate during ultrasonic energy application, this will compromise the speed of removal and efficacy of transmission. The design of the OSCAR probes is specifically 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 5
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; 6
• 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 exposure Temperature
132° C (270° F)
134° C (273° F)
Minimum exposure Time
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. C
A
E D
E D
B
A: Switch B: Horn C: Connector End Cap D: Shroud E: End Cap
Figure 1
C
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.
Figure 2
Storage of Equipment Between Cases Do not operate OSCAR in the presence of flammable gases. It is recommended that; between cases, the handsets and cables are stored, in a large autoclave tray and 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. 9
Replacement parts
APPENDIX 0
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 Description
Symbol Model OS3000
Model Number Follow instruction for use Date of Manufacture
SN
Manufacturer by Serial Number Alternating Current
10
Voltage 230V
Supply AC Voltage
50 - 60 Hz
Supply AC Frequency
POWER 175W
Input Power
150W
Output Power
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
Temperature limitation -40°C
100%
Humidity limitation
10% 1060hPa
Atmospheric pressure limitation 500hPa
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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Technical Specification
APPENDIX 2 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 classifications:
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: Humidity: Atmospheric pressure:
-40ºC to +50ºC 10% to 100% 500hPa to 1060hPa
Environment for use
Temperature: Humidity: Atmospheric pressure:
0ºC to +30ºC 30% to 75% 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
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations /flicker emissions IEC 61000-3-3
Complies
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.
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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)
±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%.
±2kV for power supply lines
±2kV for power supply lines
IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge
±1kV for signal lines
±1kV for signal lines
±1kV line to line
±1kV differential mode
IEC 61000-4-5
±2kV line to earth <5% UT (>95% dip in UT) for 0.5 cycle
±2kV common mode <5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 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 5s
3A/m
3A/m
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60Hz) magnetic field
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
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 magnetic fields should be at levels characteristic of a typical commercial or hospital environment.
IEC 61000-4-8 NOTE UT is 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 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
Conducted RF
3Vrms
IEC 61000-4-6
150kHz to 80MHz
3Vrms
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).
Radiated RF
3V/m
IEC 61000-4-3
80MHz to 2.5GHz
3V/m
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should 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 2 These 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 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 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.
150kHz to 80MHz d = 1.2√P
Separation distance according to frequency of transmitter m 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
Rated maximum output power of transmitter
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
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