KLARITY SBRT System, Instructions For Use

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Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
info@klaritymedical.com
www.klaritymedical.com
To be used by a qualified medical professional
IFU.BP.001.08 9/20/21
Store below
35˚C (95˚F)
35˚C
Keep in a
cool and dry
environment
Lotus NL B.V
Koningin Julianaplein 10, le Verd, 2595AA
The Hague, Netherlands
T: +31645171879 (English)
T: +31626669008 (Dutch)
EC REP
Klarity SBRT System
INSTRUCTIONS FOR USE
GENERAL INFORMATION
The Klarity
®
SBRT System is a medical device used for precise
positioning and immobilization of patients undergoing radiation therapy
treatments for tumors outside the CNS that require either a single high
dose radiation treatment or a few fractionated radiation treatments.
PRODUCT DESCRIPTION
The Klarity
®
SBRT System is designed to be simple to use, highly
indexable, and easily adjustable. The standard system has a
streamlined design to allow for quick and easy set up with accurate
reproducibility. Advanced indexing options are included in the standard
system for treatments requiring high conformity and detail. Both
standardized and customized indexing options are available in the form
of Masks, Klarity Cushions™, and Vacuum Bags providing strong
support, comfort, and accurate positioning.
STORAGE AND CLEANING
Store in a clean, dry place away from direct sunlight. Wipe thoroughly
with a neutral antiseptic cleaner. Allow to dry thoroughly before next use.
INSTRUCTIONS FOR USE
BASEPLATE
The Klarity SBRT Board (R624-SCF1
)
can be attached to a
couch top using standard indexing bars at the top and
bottom of the board. Six holes are provided at both ends
so the board can be secured in three different positions:
in the Middle of the couch top, adjusted Left, or adjusted
Right.
The Klarity SBRT System has a variety of positioning and indexing
options for optimal patient set up and comfort. There are three
regions in which positioning takes place; the upper body, the lower
body, and the belly (for breath restriction).
UPPER BODY
WingSpan™ Baseplate : The Klarity WingSpan™ Baseplate (R632-BTCF)
indexes to the SBRT Baseplate using one of the two SBRT Board
Indexing Bars (RE-15CF) provided with the SBRT System and includes an
adjustable T-grip handle that allows therapists to position patients’ arms
effectively and comfortably. The WingSpan™ Baseplate also features
indexing points for optional headrests, as well as two black pegs near
the middle of the board that allow for the SBRT Full Body Vacuum Bag
(R7641-25BC) to be indexed directly to it.
T-Grip Handle:
The handle has 12 indexing options (1-12) for the
proximity to the patient’s head and six (A-F) for the height of the
handles. To index the handle to the board, first make sure the locking
mechanism on the base is lifted, then slide the inverted T-shaped block
PARTS INCLUDED
R624-SCF1 Klarity SBRT Baseplate – Carbon Fiber
R632-BTCF WingSpan Baseplate
R7641-25BC SBRT Full Body Vacuum Bag
R624-SCF1-1 Belly Bridge
R624-SCF1-5 Respiratory Belt
R624-SCF1-2 Knee Bridge
R7131-5NLT Knee Bridge Vacuum Bag
R624-SCF1-3 Knee Positioner Device
R624-SCF1-4 Foot Positioner Device
R634-LE
Knee and Foot Positioner Cushions:
Knee Positioner Cushion (1), Knee Elevation Block (1),
and Foot Positioner Cushion (1)
RE-15CF SBRT Board Indexing Bars (2)
R624-SCF1-5 Respiratory Belt