Civco AccuCARE EX3 Stepper User manual

EQUIPMENT:
EX3™ STEPPER
ACCUCARE™
REFERENCE GUIDE

EX3™ Stepper English
EX3™ STEPPER
Symbol Title of Symbol Description of Symbol
Manufacturer
(ISO 15223-1, 5.1.1) Indicates the medical device manufacturer.
Authorized Representative in the European
Community (ISO 15223-1, 5.1.2) Indicates the Authorized Representative in the European Community.
Date of manufacture
(ISO 15223-1, 5.1.3) Indicates the date when the medical device was manufactured.
Batch code
(ISO 15223-1, 5.1.5) Indicates the manufacturer’s batch code so that the batch or lot can be identified.
Catalog number
(ISO 15223-1, 5.1.6) Indicates the manufacturer’s catalogue number so that the medical device can be identified.
Serial number
(ISO 15223-1, 5.1.7) Indicates the manufacturer's serial number so that a specific medical device can be identified.
Type B applied part
(IEC 60417, 5840)
Indicates a type B applied part complying with relevant section of the technical standard IEC
60601-1 for safety of medical electrical equipment.
Electrical equipment waste
(BS EN 50419)
Identifies product that is subject to the European Union's Waste Electrical and Electronic
Equipment (WEEE) 2012/19/EU Directive for recycling of electronic equipment.
Consult instructions for use
(ISO 15223-1, 5.4.3) Indicates the need for the user to consult the instructions for use.
European Conformity
(EU MDR 2017/745, Article 20)
Indicates manufacturer declaration that the product complies with the essential requirements of
the relevant European health, safety and environment protection legislation.
Medical Device
(MedTech Europe Guidance: Use of Symbols
to Indicate Compliance with the MDR)
Indicates the product is a medical device.
Quantity
(IEC 60878, 2794) To indicate the number of pieces in the package.
GENERAL EQUIPMENT INFORMATION
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
nBefore use, you should be trained in ultrasonography. For instructions on the use of your transducer, see your system's user guide.
nPrior to use, read and understand all instructions and warnings.
nPrior to use inspect device for signs of damage, if damage is evident do not use.
nEquipment is not to be modified without CIVCO authorization.
nStepper is designed and validated for use with CIVCO accessories. For stabilizers, template grids, drapes, and other accessories, visit
www.CIVCO.com.
nStepper is packaged non-sterile and is reusable. To avoid possible patient contamination, ensure stepper is properly cleaned and disinfected before
each use. See reprocessing section for instructions on how to properly clean and disinfect.
nFor illustration purposes only, equipment may be shown without a drape. Always place a drape over the equipment to protect patients and users from
cross-contamination.
nIf the product malfunctions during use or is no longer able to achieve its intended use, stop using the product and contact CIVCO.
nReport serious incidents related to the product to CIVCO and the competent authority in your Member State, or appropriate regulatory authorities.
INTENDED USE
The equipment is intended to hold and manipulate ultrasound imaging probes, and report position, during prostate brachytherapy, cryotherapy,
transperineal template-guided biopsy, and/or fiducial marker placement procedures (including volume determination of the prostate gland), and/or the
application of radionuclide source(s) into the body during brachytherapy.
INDICATIONS FOR USE
Prostate - Diagnostic imaging and minimally invasive puncture procedures.
Surgical (Prostate) - Diagnostic imaging and puncture procedures.
PATIENT POPULATION
Equipment is for use in adult males with suspected or diagnosed prostate cancer.
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English EX3™ Stepper
INTENDED USERS
Equipment should be used by clinicians medically trained in ultrasound imaging. User groups may include, but are not limited to: Physicists, Radiation
Oncologists, Surgeons and Urologists.
PERFORMANCE CHARACTERISTICS
nStepper allows for incremental longitudinal and rotational movement of the ultrasound transducer to achieve its intended purpose.
nStepper includes a quick mounting, secure connection to CIVCO stabilizers to ensure stability of the ultrasound transducer.
nStepper directly reports angular and linear position to Treatment Planning Software.
NOTE: For a summary of clinical benefits for this product, visit www.CIVCO.com.
ELECTRICAL SAFETY SPECIFICATIONS
Device Specification Specification
Classification Type B
Protection Against Ingress of Water Ordinary Protection
Longitudinal Position Step accuracy of +/- 0.5mm through full range of motion
Rotational Position Accuracy of +/- 1 degree through full range of motion
PRIOR TO USE
nThe user is responsible for ensuring the application and use of the device does not compromise the patient contact rating of any equipment used in the
vicinity of, or in conjunction with, the system.
nThe use of accessory equipment and/or hardware not complying with the equivalent product safety and EMC requirements of this product may lead to
a reduced level of safety and/or EMC performance of the resulting system. Consideration relating to the choice of accessory equipment used with this
product shall include:
lThe use of the accessory in the patient vicinity.
lEvidence the safety certification of the accessory has been performed in accordance with the appropriate IEC 60601-1 and/or IEC 60601-1-1
Harmonized National Standards.
lEvidence the EMC certification of the accessory has been performed in accordance to the IEC 60601-1-2 Harmonized National Standards.
nObserve all safety precautions recommended by the accessory equipment manufacturer in the user documentation provided with the equipment.
nKeep this manual with device for reference as required.
oBK Medical 8558, 8658, 8848, E14CL4b
oBest® Sonalis™®TRT TriView
oGEHealthcare ERB, E7C8L
oHitachi Aloka Medical C41L47RP,
CL4416R1, EUP-U533, UST-672-5/7.5
oMindray ELC13-4U/E/s
oSiemens Endo-PII
oTerason 8B4S
I. Grid platform
II. Cradle latch
III. Cradle
IV. Longitudinal movement detent adjustment knob
V. Drum locking knob
VI. Longitudinal movement knob
VII. Rotary scale drum
VIII. Grid rail
IX. Rotational movement detent knob
X. Grid rail locking knobs
XI. Carriage
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EX3™ Stepper English
ATTACHING STEPPER TO STABILIZER
1. Slide stepper interface plate into stabilizer interface plate. Secure by tightening stepper quick connect knob.
I. Stepper interface plate
II. Stepper quick connect knob
III. Stabilizer interface plate
PLACING PROBE IN STEPPER AND OPTIMIZING INSERTION PROFILE
NOTE: For GEHealthcare ERB transducer: Transducer handle must be removed.
1. Open the cradle latch.
2. Place and orient transducer into the cradle.
3. Close cradle latch and tighten knob.
4. Loosen grid rail locking knobs and pull back on grid rail so grid platform is out of the way for initial transducer positioning.
NOTE: nFree longitudinal movement achieved by fully disengaging longitudinal movement detent knob by turning counterclockwise. Enable stepping
function by turning knob clockwise until tight.
nFree rotation of cradle achieved by disabling rotational movement detent knob by turning counterclockwise. Enable rotational detent by
turning knob clockwise until tight.
DEVICE INSPECTION
1. EX3 Stepper should hold transducer securely, allow smooth rotation and precise movement along longitudinal axis of the transducer.
FUNCTIONAL PREUSE CHECKS
WARNING
nPrior to each use perform the following checks to ensure optimal stepper performance.
1. Rotate longitudinal movement knob to ensure carriage moves freely through full range of linear travel and performs stepping function.
2. Rotate cradle to ensure movement through full range of rotational travel.
3. Rotate vertical adjustment knob, grid rail locking knobs, and horizontal adjustment knobs to ensure movement through full range of rotational travel.
4. If carriage, cradle or knobs do not move freely, apply lubricant that complies with hospital policies and procedures. Super Lube®Multi-Purpose
Synthetic Grease with Syncolon®(PTFE) is recommended.
NOTE: nIf horizontal adjustment knob does not move freely, lubricate surface areas of adjustment slide block.
nIf carriage does not move freely, lubricate outer edge of index drum.
CONNECTING TO A COMPUTER
WARNING
nDo not use a USB hub.
nThe EX3 Stepper should only be connected to an IEC 60950-1 approved computer.
nThe computer is not to be used in the patient treatment environment.
1. To transmit information on probe position connect USB 2.0 cable from EX3 Stepper directly to computer with validated treatment planning software.
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English EX3™ Stepper
2. To safely terminate operation, remove USB 2.0 cable from computer.
I. EX3 Stepper
II. USB 2.0 Cable
III. Computer
Validated Treatment Planning Software
MIM Software™ MIM Symphony™
Varian VariSeed™ version 3.0 and higher
Varian Vitesse™ version 8.0.2 and higher
NOTE: Refer to treatment planning software manufacturer for version compatibility.
ADJUSTING THE STEPPER AND STABILIZER
1. Grasp handles of FAM and loosen locking control knob on stabilizer.
For Micro-Touch®Stabilizer: Adjust weight by turning weight adjustment knob on stabilizer to achieve desired feel to equipment.
2. Obtain satisfactory transducer position and starting image, tighten locking control knob on stabilizer. After stabilizer is locked into position, locking
control knob should not be used until removal from the patient.
3. Use FAM to optimize position of probe.
4. Install sterile drape and grid, position grid platform appropriately and secure with grid rail locking knobs. Refer to Sterile Drape and Template Grid
instructions for use.
5. To manually set longitudinal scale, loosen drum locking knob and position rotary scale drum at zero. Tighten drum locking knob to secure.
WARNING
nBefore using assembled equipment, verify needle position is correctly aligned with grid display on the ultrasound monitor. If needle position is not
correctly aligned with display, adjust grid platform.
nIf locking control knob on stabilizer will not hold unit securely in place, please contact CIVCO.
nLongitudinal and rotational scales are for reference only.
ADJUSTING AND SECURING GRID PLATFORM
1. Loosen Vertical Adjustment Screws with the provided hex wrench(3/32"). Align needle with the grid display on ultrasound monitor by turning the
Vertical Adjustment Knob until the vertical needle position is correctly aligned with display.Tighten Vertical Adjustment Screws.
2. Loosen Horizontal Adjustment Screw with the provided hex wrench (3/32"). Align needle with the grid display on ultrasound monitor by turning the
Horizontal Adjustment Knob until the horizontal needle position is correctly aligned with display. Tighten Horizontal Adjustment Screw.
I. Vertical Adjustment Screws
II. Vertical Adjustment Knob
III. Horizontal Adjustment Screw
IV. Horizontal Adjustment Knobs
V. Adjustment Slide Block
WARNING
nStepper is required to be cleaned and disinfected any time grid platform is readjusted and secured to ensure exposed areas of the grid platform are
properly decontaminated prior to use. See Reprocessing section for instructions.
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EX3™ Stepper English
REPROCESSING
WARNING
nUsers of this product have an obligation and responsibility to provide the highest degree of infection control to patients, co-workers and themselves.
To avoid cross-contamination, follow infection control policies established by your facility.
nSee your system's user guide for reprocessing transducer between uses.
nThese procedures for reprocessing have been validated for effectiveness and compatibility. Equipment could be damaged or cross-contaminated due
to improper reprocessing.
nDo not soak or immerse posterior section of the EX3 Stepper that contains the electrical components.
nDo not place in a mechanical washer.
nDo not use ethylene oxide or autoclave to sterilize.
DISASSEMBLING EX3 STEPPER FOR REPROCESSING (REQUIRED IF USING IMMERSION CLEANING METHOD)
1. Place EX3 Stepper onto flat surface.
2. Loosen hold screws (2) by turning counterclockwise until top cover can be lifted vertically.
I. Hold Screws
II. Top Cover
3. Rotate EX3 Stepper, loosen hold screws (2) by turning counterclockwise until bottom cover can be removed. Ensure USB cord is disengaged from cover.
I. Bottom Cover
II. Hold Screws
4. Loosen interface screws (2) by turning counterclockwise.
5. Pull location lock finger and rotate posterior section 20 degrees to disengage.
I. Interface Screws
II. Posterior Section
III. Location Lock Finger
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English EX3™ Stepper
WARNING
nBe certain to place the posterior section in a dry place until prepared to engage it with the anterior section.
nMake certain all cables have remained in their respective connectors or modular jacks before attempting to assemble the EX3 Stepper.
ANTERIOR SECTION ONLY
CLEANING - IMMERSION AND WIPING ARE BOTH VALIDATED FOR CLEANING. CHOOSE EITHER METHOD.
IMMERSION
1. Prepare an enzymatic detergent solution, such as Enzol®Enzymatic Detergent, at manufacturer's recommendation.
2. Fully immerse anterior section of EX3 Stepper in prepared enzymatic detergent solution. Soak for 3 minutes.
3. After soak time, brush entire surface for 1 minute. Ensure all crevices and grooves are brushed.
4. Dispose of used enzymatic detergent solution and prepare a new enzymatic detergent solution, such as Enzol®Enzymatic Detergent, at manufacturer's
recommendation.
5. Allow EX3 Stepper to soak in new enzymatic detergent for 3 minutes.
6. Remove EX3 Stepper from enzymatic detergent solution and rinse under running tap water for a maximum of 1 minute, but not less than 50 seconds.
7. Dry EX3 Stepper with a soft, clean, lint-free cloth.
NOTE: nIf there is residual water inside the stepper, compressed air may be used at a maximum of 150 psi to remove remaining water.
nProlonged exposure of anodized aluminum and nylon to Enzol®Enzymatic Detergent may cause slight discoloration of surfaces.
WIPING
1. Using a clean germicidal wipe with at least 55% isopropyl alcohol and 0.5% quaternary ammonium, such as Super Sani-Cloth® Germicidal wipe,
wipe surfaces to remove gross soil.
nEnsure all crevices and grooves have come into contact with wipe.
2. Using a new, clean germicidal wipe with at least 55% isopropyl alcohol and 0.5% quaternary ammonium, such as Super Sani-Cloth® Germicidal
wipe, wipe surfaces until visibly wet.
DISINFECTION
1. Unfold a clean germicidal wipe with at least 55% isopropyl alcohol and 0.5% quaternary ammonium, such as Super Sani-Cloth®Germicidal wipe,
and thoroughly wet surface.
2. Allow treated surface to remain wet for no more than 2 minutes. Use additional wipe or wipes, if necessary, to ensure continuous 2 minutes wet
contact time.
3. Once 2 minute wet contact time has been reached, allow surfaces to air dry.
POSTERIOR SECTION NON-ELECTRICAL COMPONENTS ONLY
nTop Cover
nBottom Cover
nHold Screws
nLongitudinal Movement Knob
WARNING
nDo not soak or immerse the posterior section of EX3 Stepper containing electrical components.
CLEANING AND DISINFECTION
1. Using a clean germicidal wipe with at least 55% isopropyl alcohol and 0.5% quaternary ammonium, such as Super Sani-Cloth® Germicidal wipe,
wipe surfaces to remove gross soil.
nEnsure all crevices and grooves have come into contact with wipe.
2. Using a new, clean germicidal wipe with at least 55% isopropyl alcohol and 0.5% quaternary ammonium, such as Super Sani-Cloth® Germicidal
wipe, wipe surfaces until visibly wet.
3. Allow treated surface to remain wet for no more than 2 minutes. Use additional wipe or wipes, if necessary, to ensure continuous 2 minutes wet
contact time.
4. Once 2 minute wet contact time has been reached, allow surfaces to air dry.
ASSEMBLING EX3 STEPPER AFTERREPROCESSING (REQUIRED IF IMMERSION CLEANING METHOD WAS USED)
1. Connect posterior section at 20 degree angle to anterior and rotate into place. Ensure location lock finger has fully engaged.
WARNING
nEnsure interface screws are fully tightened to prevent gear slippage and corresponding errors in positioning when advancing the stepper.
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EX3™ Stepper English
2. Tighten interface screws (2) by turning clockwise. If interface screws do not move freely, apply lubricant that complies with hospital policies or
procedures. Super Lube® Multi-Purpose Synthetic Grease with Syncolon®(PTFE) is recommended.
I. Interface Screws
II. Posterior Section
III. Location Lock Finger
IV. Index Drum
3. Rotate EX3 Stepper, place bottom cover over posterior section and tighten bottom hold screws (2) by turning clockwise. Ensure USB cord strain relief
groove is aligned with notch in cover.
I. Bottom Cover
II. Hold Screws
4. Rotate EX3 Stepper. Place top cover over posterior section, aligning locating tabs on top and bottom covers.
5. Tighten hold screws (2) by turning clockwise.
I. Hold Screws
II. Top Cover
6. EX3 Stepper is now assembled. Perform pre-use checks to ensure device is functioning properly.
ELECTROMAGNETIC COMPATIBILITY (EMC)PRECAUTIONS
NOTE: nEX3 Stepper needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information
provided in this document.
nPortable and mobile RF communications equipment can affect the EX3 Stepper. Recommended separation distances between the EX3
Stepper and RF communications equipment are provided in Table 4.
nFor EMC problems not described within this section, contact CIVCO at 319.248.6757, 800.445.6741.
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English EX3™ Stepper
CAUTION
Certain parts of the EX3 Stepper must be free to move by design. Electrostatic Discharge can occur to these electrically ungrounded parts and disrupt operation
of electronic components inside the EX3 Stepper. The user is cautioned to follow operating precautions within this section.
WARNING
nThe EX3 Stepper is intended for use by healthcare professionals only. This equipment may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the EX3 Stepper or shielding the location.
nImmunity Level Justification: This device requires special precautions regarding Electrostatic Discharges (ESD). This device is compliant to +/- 4kV
ESD immunity level. Static discharges to the EX3 Stepper can occur and cause the position indicators to disconnect. If the device loses connection,
then an error message will be shown on the display and the encoder position will be disabled. If this occurs the operator must return the EX3 to the
starting position and reinitialize the control program to continue. The procedure can then be restarted.
To reduce the chance of an ESD error occurring, observe the following precautions:
lPrior to operating the EX3 Stepper, touch the base of the stepper and procedure table. This should reduce any static buildup and reduce
chances of an electrostatic discharge.
lSynthetic fabrics and carpets are electrical insulating materials and hold static charge on their surfaces. Use of these materials should be
minimized where the EX3 Stepper will be used.
lVery low levels of humidity also contribute to static charge buildup. The EX3 Stepper should be used in a temperature/humidity controlled
environment where at least 20% relative humidity is maintained.
nUse of replacement parts not provided by CIVCO may result in increased emissions or decreased immunity of the EX3 Stepper.
nThe EX3 Stepper should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the EX3 Stepper should be
observed to verify normal operation in the configuration in which it will be used.
TABLE 1
GUIDANCE AND MANUFACTURER'S DECLARATION -ELECTROMAGNETIC EMISSIONS
The EX3 Stepper is intended for use in the electromagnetic environment specified below. The customer or the user of the EX3 Stepper should assure that it is
used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1 The EX3 Stepper 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
The EX3 Stepper 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
Not Applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not Applicable
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EX3™ Stepper English
TABLE 2
GUIDANCE AND MANUFACTURER'S DECLARATION -ELECTROMAGNETIC IMMUNITY
The EX3 Stepper is intended for use in the electromagnetic environment specified below. The customer or the user of the EX3 Stepper 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
±6 kV contact
±8 kV air
±4 kV contact
±8 kV air
Prior to operating the EX3 Stepper, touch the base of the stepper and
procedure table. Synthetic fabrics and carpets should be minimized.
Relative humidity should be at least 20%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output lines
Not Applicable Mains power quality should be that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
Not Applicable 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 5 sec
Not Applicable Mains power quality should be that of a typical commercial or
hospital environment.
If the user of the EX3 Stepper requires continued operation during
power mains interruptions, it is recommended that the EX3 Stepper be
powered from an uninterruptible power supply or a battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A / m 3 A / m Power frequency magnetic fields should be at levels characteristic of a
typical location in 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
The EX3 Stepper is intended for use in the electromagnetic environment specified below. The customer or the user of the EX3 Stepper 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
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
Portable and mobile RF communications equipment should be used no closer
to any part of the EX3 Stepper, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
d= 1,2 m 150 kHz to 80 MHz
d= 1,2 m 80 MHz to 800 MHz
d= 2,3 m 800 MHz to 2,5 GHz
where Pis the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and dis 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: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: 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 location in which the EX3 Stepper is used
exceeds the applicable RF compliance level above, the EX3 Stepper should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the EX3 Stepper.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTE: Above immunity levels apply to essential functions monitored during test. All functions described in this section are considered essential functions.
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EX3™ Stepper English
TABLE 4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EX3STEPPER
The EX3 Stepper is intended for use in an electronic environment in which radiated RF disturbances are controlled. The customer or the user of the EX3
Stepper can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the EX3 Stepper 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)
(m)
(W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d= 1.2 d= 1.2 d= 2.3
0,01 0.12 0.12 0.23
0,1 0.37 0.37 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: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
STORAGE AND DISPOSAL
WARNING
nDispose of single-use components as infectious waste. Reprocess reusable components after each use according to instructions for use.
NOTE: nDevice should be stored to keep all components together and secure.
nFor questions or to order additional CIVCO products, please call [phone] or 1-800-445-6741 or visit www.CIVCO.com.
nAll product to be returned must be in its original packaging. Contact CIVCO for further instructions as needed.
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Hrvatski Koračni motor EX3™
12
KORAČNI MOTOR EX3 ™
Simbol Naslov simbola Opis simbola
Proizvođač
(ISO 15223-1, 5.1.1) Ukazuje na proizvođača medicinskog uređaja.
Ovlašteni predstavnik u Europskoj zajednici (ISO 15223-1,
5.1.2) Ukazuje na ovlaštenog predstavnika u Europskoj zajednici.
Datum proizvodnje
(ISO 15223-1, 5.1.3) Ukazuje na datum kada je medicinski uređaj proizveden.
Šifra serije
(ISO 15223-1, 5.1.5) Ukazuje na šifru serije proizvođača da bi se serija ili skup mogli identificirati.
Kataloški broj
(ISO 15223-1, 5.1.6)
Ukazuje na kataloški broj proizvođača, tako da se medicinski proizvod može
identificirati.
Serijski broj
(ISO 15223-1, 5.1.7)
Ukazuje na serijski broj proizvođača, tako da se specifičan medicinski proizvod
može identificirati.
Primijenjeni dio tipa B
(IEC 60417, 5840)
Označava primijenjeni dio tipa B koji je sukladan s relevantnim dijelom tehničke
norme IEC 60601-1 za sigurnost medicinske električne opreme.
Električni otpad
(BS EN 50419)
Označava proizvod koji podliježe Direktivi Europske unije o otpadnoj električnoj i
elektroničkoj opremi (OEEO) 2012/19/EU za recikliranje elektroničke opreme.
Proučite upute za uporabu
(ISO 15223-1, 5.4.3) Ukazuje na potrebu da korisnik prouči upute za uporabu.
Europska sukladnost
(EU MDR 2017/745, Članak 20.)
Ukazuje na izjavu proizvođača da proizvod udovoljava osnovnim zahtjevima
relevantnog europsko zakonodavstvo za zdravlje, sigurnost i zaštitu okoliša.
Medicinski uređaj
(Smjernice MedTech Europe: uporaba simbola kojima se
ukazuje na usklađenost s pravilima o medicinskim
proizvodima)
Ukazuje na to da je proizvod medicinski uređaj.
Količina
(IEC 60878, 2794) Za ukazivanje na broj dijelova u paketu.
OPĆE INFORMACIJE O OPREMI
OPREZ
Prema saveznom zakonu Sjedinjenih Američkih Država ovaj uređaj može prodavati samo liječnik ili se to može činiti prema njegovom nalogu.
UPOZORENJE
n
Prije upotrebe morate biti obučeni za obavljanje ultrazvuka. Pogledajte korisnički vodič za sustav za upute o upotrebi pretvornika.
n
Prije upotrebe s razumijevanjem pročitajte sve upute i upozorenja.
n
Prije upotrebe provjerite ima li na uređaju znakova oštećenja. U slučaju vidljivih oštećenja nemojte upotrebljavati uređaj.
n
Nisu dozvoljene preinake opreme bez CIVCO odobrenja.
n
Koračni motor namijenjen je i validiran za upotrebu s dodatnim priborom tvrtke CIVCO. Za stabilizatore, rešetke predložaka, pokrivače i ostali
dodatni pribor posjetite www.CIVCO.com.
n
Koračni motor pakiran je kao nesterilan i za višekratnu upotrebu. Kako biste izbjegli kontaminaciju pacijenta, osigurajte pravilno čišćenje i
dezinfekciju koračnog motora prije upotrebe. Za upute o pravilnom čišćenju i dezinfekciji proučite odjeljak o obradi.
n
Oprema se može prikazati bez pokrivača samo u svrhe ilustracije. Uvijek postavite pokrivač preko opreme kako biste zaštitili pacijente i korisnike
od prijenosa infekcije.
n
Ako tijekom uporabe dođe do neispravnog rada proizvoda ili se više ne može postići namjeravana uporaba, prestanite upotrebljavati proizvod i
obratite se tvrtki CIVCO.
n
Prijavite ozbiljne incidente u vezi s proizvodom tvrtki CIVCO i nadležnom tijelu u vašoj državi članici ili odgovarajućim regulatornim tijelima.
NAMJENA
Ova je oprema namijenjena za držanje i rukovanje sondama za ultrazvučno snimanje te za javljanje položaja tijekom brahiterapije prostate, krioterapije,
transperinealne biopsije vođene predloškom i/ili postupke postavljanja fiducijalnog markera (uključujući određivanje volumena prostate) i/ili primjenu izvora
radionuklida u tijelu tijekom brahiterapije.
INDIKACIJE ZA UPOTREBU
Prostata - Dijagnostičko snimanje i minimalno invazivni postupci punkcije.
Kirurški (Prostata) - Dijagnostičko snimanje i postupci punkcije.
POPULACIJA PACIJENATA
Oprema je namijenjena upotrebi kod odraslih muškaraca kod kojih postoji sumnja na rak prostate ili je isti utvrđen.

Koračni motor EX3™ Hrvatski
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PREDVIĐENI KORISNICI
Opremu mogu upotrebljavati liječnici koji su medicinski osposobljeni za uporabu ultrazvuka. Grupe korisnika mogu između ostalog uključivati: liječnike,
radijacijske onkologe, kirurge i urologe.
KARAKTERISTIKE UČINKOVITOSTI
nKoračni motor omogućuje uzdužno i rotacijsko kretanje ultrazvučnog pretvornika u malim koracima kako bi postigao svoju svrhu.
nKoračni motor uključuje brzu montažu, sigurno spajanje sa stabilizatorima CIVCO radi osiguravanja stabilnosti ultrazvučnog pretvornika.
nKoračni motor izravno prijavljuje kutni i linearni položaj Softveru za planiranje liječenja.
NAPOMENA: Sažetak kliničkih prednosti ovog proizvoda potražite na www.CIVCO.com.
SPECIFIKACIJE ELEKTRIČNE SIGURNOSTI
Specifikacija uređaja Specifikacija
Klasifikacija Tip B
Zaštita od prodira vode Uobičajena zaštita
Uzdužni položaj Preciznost koraka od +/- 0,5 mm čitavim rasponom kretanja
Rotacijski položaj Preciznost od +/- 1 stupanj čitavim rasponom kretanja
PRIJE UPORABE
nKorisnik se mora pobrinuti da primjena i upotreba ovog proizvoda ne ugrozi stopu kontakta pacijenta s opremom koja se koristi u blizini ili zajedno sa
sustavom.
nUpotreba dodatne opreme i/ii hardvera koji nije sukladan s ekvivalentnom sigurnosti proizvoda i EMC zahtjevima ovog proizvoda može dovesti do
smanjene razine sigurnosti i/ili EMC učinkovitosti posljedičnog sustava. Razmatranje odabira dodatne opreme koja se upotrebljava s ovim
proizvodom uključuje:
lUpotrebu dodatne opreme u blizini pacijenta.
lDokaz da je sigurnosna certifikacija dodatne opreme provedena u skladu s odgovarajućim Usklađenim nacionalnim normama IEC 60601-1
i/ili IEC 60601-1-1.
lDokaz da je EMC certifikacija dodatne opreme provedena u skladu s Usklađenim nacionalnim normama IEC 60601-1-2.
nPridržavajte se svih sigurnosnih mjera opreza koje preporučuje proizvođač dodatne opreme u korisničkoj dokumentaciji koja se isporučuje uz
opremu.
nDržite ovaj priručnik uz uređaj kao referencu u slučaju potrebe.
oBK Medical 8558, 8658, 8848, E14CL4b
oBest® Sonalis™®TRT TriView
oGEHealthcare ERB, E7C8L
oHitachi Aloka Medical C41L47RP,
CL4416R1, EUP-U533, UST-672-5/7.5
oMindray ELC13-4U/E/s
oSiemens Endo-PII
oTerason 8B4S
I. Rešetkasta platforma
II. Zasun podloge
III. Podloga
IV. Gumb za podešavanje zapirača uzdužnog kretanja
V. Gumb za zaključavanje bubnja
VI. Gumb za uzdužno pomicanje
VII. Bubanj rotacijske skale
VIII. Tračnica rešetke
IX. Gumb zapirača rotacijskog kretanja
X. Gumbi za zaključavanje tračnice rešetke
XI. Kolica

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PRIČVRŠĆIVANJE KORAČNOG MOTORA ZA STABILIZATOR
1. Gurnite ploču sučelja koračnog motora u ploču sučelja stabilizatora. Pričvrstite zatezanjem gumba za brzo spajanje koračnog motora.
I. Ploča sučelja koračnog motora
II. Gumb za brzo spajanje koračnog
motora
III. Ploča sučelja stabilizatora
POSTAVLJANJE SONDE U KORAČNI MOTOR I OPTIMIZACIJA PROFILA UMETANJA
NAPOMENA: Za pretvornik GEHealthcare ERB: ručka pretvornika mora se skinuti.
1. Otvorite zasun na podlozi.
2. Postavite i usmjerite pretvornik u podlogu.
3. Zatvorite zasun na podlozi i zategnite gumb.
4. Popustite gumbe za zaključavanje tračnice rešetke i povucite tračnicu rešetke unatrag kako rešetkasta platforma ne bi smetala pri prvom
postavljanju pretvornika.
NAPOMENA: nSlobodno uzdužno kretanje postiže se potpunim otpuštanjem gumba zapirača uzdužnog kretanja okretanjem u smjeru suprotnom
od kretanja kazaljki na satu. Uključite koračnu funkciju okretanjem gumba u smjeru kazaljki na satu dok ga dobro ne zategnete.
nSlobodno okretanje podloge postiže se onemogućavanjem gumba zapirača rotacijskog kretanja okretanjem u smjeru suprotnom od
kretanja kazaljki na satu. Uključite rotacijski zapirač okretanjem gumba u smjeru kazaljki na satu dok ga dobro ne zategnete.
PREGLED UREĐAJA
1. Koračni motor EX3 treba čvrsto držati pretvornik, omogućavati nesmetano okretanje i precizno kretanje po uzdužnoj osi pretvornika.
FUNKCIONALNE PROVJERE PRIJE UPOTREBE
UPOZORENJE
n
Prije svake upotrebe provedite sljedeće provjere kako biste osigurali optimalan rad koračnog motora.
1. Okrećite gumb za uzdužno kretanje kako biste osigurali nesmetano kretanje kolica čitavim linearnim putem i provođenje njihove koračne funkcije.
2. Okrećite podlogu kako biste osigurali kretanje čitavim rotacijskim putem.
3. Okrećite gumb za okomito podešavanje, gumbe za zaključavanje tračnice rešetke te gumbe za vodoravno podešavanje kako biste osigurali
pomicanje čitavim rasponom rotacijskog kretanja.
4. Ako se kolica, podloga ili gumbi ne pomiču slobodno, nanesite sredstvo za podmazivanje koje je usklađeno s bolničkim politikama i procedurama.
Preporučuje se višenamjensko sintetičko mazivo Super Lube®koje sadrži Syncolon®(PTFE).
NAPOMENA: nAko se gumb za vodoravno podešavanje ne pomiče slobodno, podmažite površinske dijelove kliznog bloka za podešavanje.
nAko se kolica ne pomiču slobodno, podmažite vanjski rub indeksacijskog bubnja.
POVEZIVANJE S RAČUNALOM
UPOZORENJE
n
Nemojte upotrebljavati USB čvorište.
n
Koračni motor EX3 smije se povezivati samo s računalom odobrenim standardom IEC 60950-1.
n
Računalo nije namijenjeno upotrebi u okruženju za liječenje pacijenata.
1. Za prijenos informacija na položaj sonde spojite USB 2.0 kabel sa koračnog motora EX3 izravno s računalom s validiranim softverom za planiranje
liječenja.

Koračni motor EX3™ Hrvatski
15
2. Da biste na siguran način prekinuli rad, izvadite USB 2.0 kabel iz računala.
I. Koračni motor
EX3
II. USB 2.0 kabel
III. Računalo
Softver za planiranje validiranog liječenja
MIM Software™ MIM Symphony™
Varian VariSeed™
Varian Vitesse™
NAPOMENA: Proučite upute proizvođača softvera za planiranje liječenja za usklađenost verzija.
PODEŠAVANJE KORAČNOG MOTORA I STABILIZATORA
1. Primite ručke FAM-a i popustite kontrolni gumb za zaključavanje na stabilizatoru.
Za stabilizator Micro-Touch®:Podesite težinu okretanjem gumba za podešavanje težine na stabilizatoru kako biste postigli željeni osjet opreme.
2. Postignite zadovoljavajući položaj pretvornika i početnu sliku, zategnite gumb za kontrolu zaključavanja na stabilizatoru. Nakon što se stabilizator
zaključa u svom položaju, gumb za kontrolu zaključavanja ne smije se koristiti do vađenja iz pacijenta.
3. Upotrijebite FAM za optimizaciju položaja sonde.
4. Postavite sterilni pokrivač i rešetku, smjestite rešetkastu platformu na odgovarajući način i pričvrstite je gumbima za zaključavanje tračnice rešetke.
Proučite upute za upotrebu sterilnog pokrivača i rešetke predloška.
5. Da biste ručno postavili uzdužnu skalu, popustite gumb za zaključavanje bubnja i postavite bubanj rotirajuće skale na nulu. Zategnite gumb za
zaključavanje bubnja da biste ga pričvrstili.
UPOZORENJE
n
Prije upotrebe sastavljene opreme provjerite da je položaj igle ispravno poravnat s prikazom rešetke na ultrazvučnom monitoru. Ako položaj igle
nije ispravno poravnat s prikazom, podesite rešetkastu platformu.
n
Ako kontrolni gumb za zaključavanje na stabilizatoru ne drži uređaj čvrsto na mjestu, molimo kontaktirajte CIVCO.
n
Uzdužne i rotacijske ljestve služe samo kao referenca.
PODEŠAVANJE I PRIČVRŠĆIVANJE REŠETKASTE PLATFORME
1. Popustite vijke za okomito podešavanje pomoću priloženog šesterokutnog odvijača (3/32"). Poravnajte iglu s prikazom rešetke na ultrazvučnom
monitoru okretanjem gumba za okomito podešavanje dok se okomit položaj igle ne poravna ispravno sa prikazom.Zategnite vijke za okomito
podešavanje.
2. Popustite vijke za vodoravno podešavanje pomoću priloženog šesterokutnog odvijača (3/32"). Poravnajte iglu s prikazom rešetke na ultrazvučnom
monitoru okretanjem gumba za vodoravno podešavanje dok se vodoravan položaj igle ne poravna ispravno sa prikazom. Zategnite vijak za
vodoravno podešavanje.
I. Vijci za okomito podešavanje
II. Gumb za okomito podešavanje
III. Vijak za vodoravno podešavanje
IV. Gumbi za vodoravno podešavanje
V. Podešavanje kliznog bloka
UPOZORENJE
n
Koračni motor potrebno je očistiti i dezinficirati prilikom svakog podešavanja i pričvršćivanja rešetkaste platforme kako bi se osigurala pravilna
dekontaminacija izloženih područja rešetkaste platforme prije upotrebe. Za upute proučite odjeljak Obrada.

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PRERADA
UPOZORENJE
n
Korisnici ovog proizvoda obavezni i odgovorni su pružiti najvišu razinu kontrole infekcije za pacijente, suradnike i njih same. Slijedite pravila
kontrole infekcije vaše ustanove kako bi se spriječio prijenos infekcija.
n
Pogledajte korisnički priručnik sustava za prenamjenu pretvornika između upotreba.
n
Ovi postupci za ponovnu obradu validirani su na učinkovitost i usklađenost. Oprema se može oštetiti ili se na nju može prenijeti infekcija uslijed
neispravne ponovne obrade.
n
Nemojte močiti ili uranjati stražnji dio koračnog motora EX3 koji sadrži električne dijelove.
n
Nemojte stavljati u mehaničku perilicu.
n
Nemojte upotrebljavati etilen oksid ili autoklav za sterilizaciju.
RASTAVLJANJE KORAČNOG MOTORA EX3 RADI OBRADE (OBAVEZNO AKO KORISTITE METODU ČIŠĆENJA
POTAPANJEM)
1. Postavite koračni motor EX3 na ravnu površinu.
2. Popustite vijke za pričvršćivanje (2) okretanjem u smjeru suprotnom od smjera kretanja kazaljki na satu dok ne budete u stanju okomito podignuti
gornju navlaku.
I. Vijci za pričvršćivanje
II. Gornja navlaka
3. Zakrenite koračni motor EX3, popustite vijke za pričvršćivanje (2) okretanjem u smjeru suprotnom od kretanja kazaljki na satu dok ne budete u stanju
skinuti donju navlaku. Pobrinite se da se USB kabel odvoji od navlake.
I. Donja navlaka
II. Vijci za
pričvršćivanje
4. Popustite vijke sučelja (2) okretanjem u smjeru suprotnom od smjera kretanja kazaljki na satu.
5. Povucite prst za zaključavanje lokacije and zakrenite stražnji dio za 20 stupnjeva da biste ga odvojili.
I. Vijci sučelja
II. Stražnji dio
III. Prst za zaključavanje lokacije

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UPOZORENJE
n
Obavezno stavite stražnji dio na suho mjesto dok ne budete spremni prikopčati ga u prednji dio.
n
Pobrinite se da su svi kabeli u svojim priključcima ili modularnim utičnicama prije nego krenete sastavljati dio koračnog motora EX3.
SAMO PREDNJI DIO
ČIŠĆENJE - POTAPANJE I BRISANJE ODOBRENE SU METODE ČIŠĆENJA. ODABERITE BILO KOJU OD TIH METODA.
POTAPANJE
1. Pripremite otopinu enzimatskog deterdženta, kao što je enzimatski deterdžent Enzol®, prema preporukama proizvođača.
2. Potpuno uronite prednji dio koračnog motora EX3 u pripremljenu otopinu enzimatskog deterdženta. Namačite tri minute.
3. Nakon proteka vremena namakanja očetkajte čitavu površinu u trajanju od jedne minute. Pobrinite se da očetkate sve otvore i udubljenja.
4. Odložite upotrijebljenu otopinu enzimatskog deterdženta i pripremite otopinu enzimatskog deterdženta sa suptilizinom, kao što je enzimatski
deterdžent Enzol®, prema preporukama proizvođača.
5. Pustite koračni motor EX3 da se namače u novom enzimatskom deterdžentu tri minute.
6. Izvadite koračni motor EX3 iz otopine enzimatskog deterdženta i isperite pod tekućom vodom iz slavine u trajanju od najviše jedne minute, no ne
manje od 50 sekundi.
7. Osušite koračni motor EX3 mekanom, čistom krpom koja ne ostavlja dlačice.
NAPOMENA: nAko u koračnom motoru ima zaostale vode, za njezino uklanjanje smije se koristiti komprimirani zrak pod maksimalnim tlakom od
150 psi.
nProduženo izlaganje anodiziranog aluminija i najlona enzimatskom deterdžentu Enzol®može uzrokovati blagu promjenu boje
površina.
BRISANJE
1. Germicidnom maramicom s najmanje 55 %-tnim izopropilnim alkoholom i 0,5%-tnim kvartarnim amonijem, npr. maramicom Super Sani-Cloth®,
očistite vidljivu prljavštinu s površina.
nPobrinite se da krpom prebrišete sve otvore i udubljenja.
2. Novom, čistom germicidnom maramicom s najmanje 55 %-tnim izopropilnim alkoholom i 0,5%-tnim kvartarnim amonijem, npr. maramicom Super
Sani-Cloth®, temeljito namočite površine.
DEZINFEKCIJA
1. Odmotajte čistu maramicu s najmanje 55 %-tnim izopropilnim alkoholom i 0,5%-tnim kvartarnim amonijem, npr. germicidnu maramicu Super Sani-
Cloth®, i temeljito namočite površinu.
2. Pustite obrađenu površinu da bude mokra u trajanju od najviše dvije minute. Ako je potrebno, upotrijebite dodatnu maramicu ili više njih kako biste
osigurali kontinuirano vrijeme mokrog kontakta od dvije minute.
3. Nakon proteka vremena mokrog kontakta od dvije minute pustite da se površine osuše na zraku.
SAMO NEELEKTRIČNI DIJELOVI STRAŽNJEG DIJELA
nGornja navlaka
nDonja navlaka
nVijci za pričvršćivanje
nGumb za uzdužno pomicanje
UPOZORENJE
n
Nemojte močiti ili uranjati stražnji dio koračnog motora EX3 koji sadrži električne dijelove.
ČIŠĆENJE I DEZINFEKCIJA
1. Germicidnom maramicom s najmanje 55 %-tnim izopropilnim alkoholom i 0,5%-tnim kvartarnim amonijem, npr. maramicom Super Sani-Cloth®,
očistite vidljivu prljavštinu s površina.
nPobrinite se da krpom prebrišete sve otvore i udubljenja.
2. Novom, čistom germicidnom maramicom s najmanje 55 %-tnim izopropilnim alkoholom i 0,5%-tnim kvartarnim amonijem, npr. maramicom Super
Sani-Cloth®, temeljito namočite površine.
3. Pustite obrađenu površinu da bude mokra u trajanju od najviše dvije minute. Ako je potrebno, upotrijebite dodatnu maramicu ili više njih kako biste
osigurali kontinuirano vrijeme mokrog kontakta od dvije minute.
4. Nakon proteka vremena mokrog kontakta od dvije minute pustite da se površine osuše na zraku.
SASTAVLJANJE KORAČNOG MOTORA EX3 NAKON OBRADE (OBAVEZNO AKO JE KORIŠTENA METODA
ČIŠĆENJA POTAPANJEM)
1. Spojite stražnji dio s prednjim pod kutom od 20 stupnjeva i zakrenite u svoje mjesto. Pobrinite se da je prst za zaključavanje lokacije posve
pričvršćen.
UPOZORENJE

Hrvatski Koračni motor EX3™
18
n
Provjerite jesu li vijci sučelja dobro zategnuti kako biste spriječili skliznuće opreme i posljedične pogreške pri postavljanju prilikom pomicanja
koračnog motora.
2. Zategnite vijke sučelja (2) okretanjem u smjeru kazaljki na satu. Ako se vijci sučelja ne pomiču slobodno, nanesite sredstvo za podmazivanje koje je
usklađeno s bolničkim politikama ili procedurama. Preporučuje se višenamjensko sintetičko mazivo Super Lube® koje sadrži Syncolon®(PTFE).
I. Vijci sučelja
II. Stražnji dio
III. Prst za zaključavanje lokacije
IV. Indeksacijski bubanj
3. Zakrenite koračni motor EX3, postavite donju navlaku preko stražnjeg dijela i zategnite donje vijke za pričvršćivanje (2) okretanjem u smjeru kazaljki
na satu. Provjerite je li žlijeb za smanjenje naprezanja USB kabela poravnat s urezom na navlaci.
I. Donja navlaka
II. Vijci za
pričvršćivanje
4. Zakrenite koračni motor EX3. Postavite gornju navlaku preko stražnjeg dijela, poravnavajući jezičce za lociranje na gornjoj i donjoj navlaci.
5. Zategnite vijke za pričvršćivanje (2) okretanjem u smjeru kazaljki na satu.
I. Vijci za pričvršćivanje
II. Gornja navlaka
6. Koračni motor EX3 je sada sastavljen. Provedite provjere pred upotrebu kako biste se uvjerili da uređaj ispravno funkcionira.
MJERE OPREZA VEZANE UZ ELEKTROMAGNETSKU KOMPATIBILNOST (EMK)
NAPOMENA: nKoračni motor EX3 zahtijeva posebne mjere opreza vezano uz EMK te ga je potrebno instalirati i pustiti u rad u skladu s
informacijama o EMK-u navedenima u ovom dokumentu.
nPrijenosna i mobilna RF komunikacijska oprema može utjecati na koračni motor EX3. Preporučena udaljenost između koračnog
motora EX3 i RF komunikacijske opreme navedena je u Tablici 4.
nZa EMC probleme koji nisu opisani u ovom odjeljku obratite se CIVCO na 319.248.6757, 800.445.6741.