Prior To Use - Civco ACCUCARE Manual Del Usuario

EX3 Stepper
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.
Device Specification
Classification
Protection Against Ingress of Water
Longitudinal Position
Rotational Position

PRIOR TO USE

The 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
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vicinity of, or in conjunction with, the system.
The use of accessory equipment and/or hardware not complying with the equivalent product safety and EMC requirements of this product may lead to
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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:
The use of the accessory in the patient vicinity.
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Evidence the safety certification of the accessory has been performed in accordance with the appropriate IEC 60601-1 and/or IEC 60601-1-1
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Harmonized National Standards.
Evidence the EMC certification of the accessory has been performed in accordance to the IEC 60601-1-2 Harmonized National Standards.
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Observe all safety precautions recommended by the accessory equipment manufacturer in the user documentation provided with the equipment.
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Keep this manual with device for reference as required.
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BK Medical 8558, 8658, 8848
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®
Best Sonalis™ TRT TriView
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GE Healthcare ERB
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Hitachi Aloka Medical C41L47RP,
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EUP-U533, UST-672-5/7.5
Siemens Endo-PII
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Terason 8B4S
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I. Grid platform
II. Cradle latch
III. Cradle
IV. Longitudinal movement detent adjustment knob
V. Drum locking knob
VI. Longitudinal movement knob
ATTACHING STEPPER TO STABILIZER
1. Slide stepper interface plate into stabilizer interface plate. Secure by tightening stepper quick connect knob.
Specification
Type B
Ordinary Protection
Step accuracy of +/- 0.5mm through full range of motion
Accuracy of +/- 1 degree through full range of motion
VII. Rotary scale drum
VIII. Grid rail
IX. Rotational movement detent knob
X. Grid rail locking knobs
XI. Carriage
I. Stepper interface plate
II. Stepper quick connect knob
III. Stabilizer interface plate
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English