Intended Users; Performance Characteristics; Prior To Use - Civco EX3 Manual De Instrucciones

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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

Stepper allows for incremental longitudinal and rotational movement of the ultrasound transducer to achieve its intended purpose.
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Stepper includes a quick mounting, secure connection to CIVCO stabilizers to ensure stability of the ultrasound transducer.
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Stepper directly reports angular and linear position to Treatment Planning Software.
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NOTE: For a summary of clinical benefits for this product, visit www.CIVCO.com.
ELECTRICAL SAFETY SPECIFICATIONS
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
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the 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
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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:
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, E14CL4b
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®
Best® Sonalis™ TRT TriView
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GE Healthcare ERB, E7C8L
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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
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
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EX3™ Stepper