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Vac-Lok™ Cushions
INTENDED USE
The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy
including electron, photon, and proton treatments. The device is also used during image acquisition to support
treatment planning.
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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Verify all angles of treatment, attenuation characteristics and WET values prior to treating patients. Refer
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to Technical Data Sheet at WWW.CIVCORT.COM for WET values.
Do not reposition device with patient on it.
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Remove sharp objects from patient and treatment area to avoid puncturing.
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Ensure Vac-Lok™ bag is deflated to proper vacuum prior to each use.
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Never leave patient unattended on flaccid (inflated) Vac-Lok™ cushion.
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Do not use Lok-Bar™ to secure positioning devices.
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Ensure cushion is not over-inflated to avoid bursting or difficulty in positioning patient.
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Nylon fabric Vac-Lok™ cushions may become soiled if not covered with sheet.
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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
Non- clinical testing and scientific rationale has demonstrated that the Vac- Lok™ Cushion is MR
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Conditional. A patient with this device can be safely scanned in an MR system meeting the
following conditions:
Static magnetic field of 1.5 T and 3.0 T
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MR
Maximum spatial field gradient of 2,000 gauss/cm (20 T/m)
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Conditional
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4
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W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the device is expected to produce a maximum
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temperature rise of less than 0.4°C after 15 minutes of continuous scanning.
In non- clinical testing, the image artifact caused by the device extends up to 82mm from the
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Vac- Lok™ valve with stem when imaged with a spin echo pulse sequence and 3.0 T MRI System.
NOTE:
Vac- Lok™ cushion should be flaccid prior to positioning patient on it.
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Ensure integrity of Vac- Lok™ cushion is not compromised during daily handling.
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Place female valve connector onto cushion valve to let air into Vac- Lok™ cushion without using
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pump.
USING VAC- LOK™ CUSHIONS
1. Place appropriate Vac- Lok™ cushion onto tabletop.
Vac- Lok™ F- Series cushion: place onto Lok- Bar™ pins (refer to Lok-Bar™ instruction).
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Cushions with multiple indexing points: attach cushion with one fixed locking feature and one Slide
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Guide Lok- Bar™.
2. Smooth Vac- Lok™ cushion to evenly disperse beads.
3. Attach vacuum hose to cushion valve.
WARNING
Locate valve away from region of interest to prevent image artifacts.
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4. Place sheet over cushion.
5. Position patient onto Vac- Lok™ cushion. Distribute beads around anatomical regions to be immobilized.
6. Evacuate air from Vac- Lok™ cushion while forming around anatomical regions until desired level of vacuum is
achieved.
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. Remove visible contaminants using a soft damp cloth.
2. Wipe dry with lint- free cloth or allow to air dry.
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