Intended Use - Civco C-Qual Guía De Referencia

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INTENDED USE

Device is intended to achieve a desired set- up for a breast- patient for radiotherapy and diagnostics.
CAUTION
Federal (United States) law restricts this device to sale by or on the order of a physician.
WARNING
Do not use if device appears damaged.
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Do not use device with MRI scanner.
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Verify all angles of treatment and attenuation characteristics prior to treating patients.
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Ensure all accessories are attached securely prior to treatment.
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Do not allow patient to reposition themselves.
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Ensure patient remains still for duration of setup and treatment.
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Do not use Lok-Bar™ to secure positioning devices.
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When positioning patient for first time, use setup sheet to record all adjustments. Setup sheet is available at WWW.CIVCORT.COM.
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Verify patient position with completed setup sheet prior to treatment.
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Do not exceed patient weight of 330 lbs. (150 kg).
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To prevent damage, grasp both the tilting board and lower board when handling.
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Do not reposition device with patient on it.
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Verification image should be taken to confirm patient position prior to treatment.
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Only use CIVCO compatible accessories.
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This product is manufactured with carbon fiber, and rough handling may cause damage resulting in fibers coming off. If this happens, stop using the product to prevent
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fibers from getting in contact with the patient's or user's skin.
NOTE: If any serious incident occurs in relation to device, incident should be reported to manufacturer. If incident occurred within the European Union, also report to the
competent authority of the Member State in which you are established.
ATTACHING C- QUAL™
WARNING
Lok-Bar™ is a positioning device only, do not use to secure patient.
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1. Snap Lok- Bar™ at appropriate longitudinal position. Ensure Lok- Bar™ is secure.
2. Place C- Qual™ onto Lok- Bar™ pins carefully to prevent damage. Ensure C- Qual™ and Lok- Bar™ are secure.
ADJUSTING C- QUAL™
NOTE: When positioning patient for the first time, use C- Qual™ setup sheet to record all adjustments.
1. Pull lock to unlock tilting board from lower board.
I. Upper Board
II. Lock
III. Lower Board
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I. Overlay
II. Lok- Bar™
III. Lok- Bar™ Pins
IV. Prodigy™ Buttons
V. C- Qual™
C-Qual™