Civco Radiotherapy HipFix Referenzhandbuch Seite 5

HipFix® System
INTENDED USE
Device is intended for patient fixation.
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Devices are used to aid in the support and positioning of patients during an MRI.
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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 Lok-Bar™ to secure positioning devices.
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Ensure sliding clamps are retracted and covered prior to patient dismount.
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When positioning patient for first time, use setup sheet to record all adjustments. Setup sheet is available
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at WWW.CIVCORT.COM.
Verify patient position with completed setup sheet prior to treatment.
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Verify all angles of treatment and attenuation characteristics prior to treating patients.
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Do not reposition device with patient on it.
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Ensure device is secure prior to use.
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Ensure device/patient does not move for duration of set-up and treatment.
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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.
MRI SAFETY INFORMATION
MTPLVCMR, MTPLVC04MR: Device is MR safe.
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MTPLVC04MR: MR image quality may be compromised if the area of interest is relatively close to
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the small positioner cover plate, large positioner cover plate, or Lok- Bar™ hole. In non- clinical
testing, the image artifact extends 41.3mm in axial GRE images, 7.2mm in sagittal GRE images, and
MR Safe
3.6mm in sagittal SE images near the small positioner cover plate; 27.0mm in axial GRE images and
19.9mm in sagittal GRE images near the large positioner cover plate; and 11.9mm in axial GRE
images and 6.5mm in sagittal GRE images near the Lok- Bar™ hole; when imaged with a spin echo
or gradient echo pulse sequence and 3.0 T MRI System.
USING HIPFIX® SYSTEM
1. Fasten floating width retainers to pelvic board (Ball driver not included).
2. Place pelvic board onto Lok- Bar™ pins (refer to Lok-Bar™ instruction, ensure MR Lok-Bar™ is used in MR
environments).
3. Store device in a flat position to avoid potential warping.
USING VAC- LOK™ WITH HIPFIX® SYSTEM (OPTIONAL)
1. Attach optional Vac- Lok™ indexing notches.
a. Attach Sliding clamp to indexing notch.
b. Attach indexing notch to pelvic board using socket screws.
2. Attach split- leg Vac- Lok™ bag to HipFix® system, ensuring pins on Vac- Lok™ bag fit in indexing notches (refer
to Vac-Lok™ instruction).
USING THERMOPLASTICS
1. Insert reloadable frame into indexing notches. Ensure sliding clamps are locked (refer to Thermoplastic
instruction).
2. Gently mold material to contours of treatment area.
3. Allow thermoplastic to cool completely before releasing from attachment base.
REPROCESSING
WARNING
Users of this product have an obligation and responsibility to provide the highest degree of infection control
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to patients, co-workers and themselves. To avoid cross-contamination, follow infection control policies
established by your facility.
1. Wipe all surfaces with common germicidal or antiseptic wipe, such as alcohol.
MAINTENANCE
NOTE: Inspect device prior to use for signs of damage and general wear.
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