KLARITY MR SBRT System Instructions For Use

Klarity MR SBRT System
INSTRUCTIONS FOR USE
GENERAL INFORMATION
The Klarity MR 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 MR 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.
PARTS INCLUDED
R624-SGF1 Klarity SBRT Baseplate – Fiberglass
R632-BTGF
R7641-25BC SBRT Full Body Vacuum Bag
R624-SGF1-1
R624-SGF1-2
R7131-5NLT
R624-SGF1-3
R624-SGF1-4
Knee and Foot Positioner Cushions:
Knee Positioner Cushion (1), Knee Elevation Block (1),
R634-LE and Foot Positioner Cushion (1)
RE-15GF MR SBRT Board Indexing Bars (2)
To be used by a qualified medical professional
IFU-B-011
MR WingSpan Baseplate
Belly Bridge
Knee Bridge
Knee Bridge Vacuum Bag
Knee Positioner Device
Foot Positioner Device
35˚C
Keep in a
cool and dry Store below
environment
35˚C (95˚F)
INSTRUCTIONS FOR USE
BASEPLATE
The Klarity MR SBRT Board (R624-SGF1
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
MR WingSpan™ Baseplate : The Klarity MR WingSpan™ Baseplate
(R632-BTGF) indexes to the SBRT Baseplate using one of the two MR
SBRT Board Indexing Bars (RE-15GF) 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
under the overhangs (the green arrow should be pointing up, away from
the patient's head), align the green line on the base of the handle with
the lines of the desired indexing location, and engage the locking
mechanism. To adjust the height of the handle, disengage the locking
mechanism, either pull the handle up or push it down to the desired
height, and reengage the locking mechanism.
Head Rests: The optional foam (R511) or Silverman (R507) headrests
(sold separately) can both be used with the MR WingSpan™ Baseplate.
The foam headrest simply sits in the shallow recess in the middle of the
EC REP
Lotus NL B.V
Koningin Julianaplein 10, le Verd, 2595AA
The Hague, Netherlands
T: +31645171879 (English)
T: +31626669008 (Dutch)
)
can be attached to a
Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
info@klaritymedical.com
www.klaritymedical.com