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Respiratory Pump and Gauge
INDICATIONS FOR USE
The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and
proton treatments, and simulation including CT and MR image acquisition.
INTENDED USE
The device is part of a system intended to immobilize, position and reposition patients undergoing stereotactic radiation
therapy including SBRT.
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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Ensure clearance is maintained between Body Pro-Lok™ system and all linac or imaging equipment before using
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system.
When positioning patient for first time, use setup sheet to record all adjustments. Setup sheet is available at
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WWW.CIVCORT.COM.
Verify patient position with completed setup sheet prior to treatment.
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Pressure indication is for reference only.
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Inspect device prior to use for signs of damage and general wear.
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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
Device is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the
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following conditions:
Static magnetic field of 1.5 T and 3.0 T
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Maximum spatial field gradient of 51,700 gauss/cm (517 T/m)
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MR
Conditional
BODY PRO-LOK™ RESPIRATORY BELT
1.
Attach respiratory gauge and pump to respiratory belt.
2.
On gauge, use range A through H for respiratory belt inflation.
3.
Inflate respiratory belt until desired respiratory restriction is achieved.
4.
Prior to imaging or treatment, remove gauge and pump from respiratory belt.
NOTE:
Note all indexed positions and acceptable pressure range on setup sheet.
COMFORTCARE™ CUSHION
1.
Use range 1 through 8 on respiratory gauge for ComfortCare™ cushion inflation.
2.
Inflate ComfortCare™ cushion to distribute pressure and improve patient comfort.
3.
Prior to imaging or treatment, remove pump and gauge from cushion.
NOTE:
Record all patient specific settings on setup sheet.
REPROCESSING
WARNING
Users of this product have an obligation and responsibility to provide the highest degree of infection control to
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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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