KLARITY SBRT System User manual

!
Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
[email protected]
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: [phone] (English)
T: [phone] (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

!
Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
[email protected]
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: [phone] (English)
T: [phone] (Dutch)
EC
REP
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 WingSpan™ Baseplate. The foam
headrest simply sits in the shallow recess in the middle of the
WingSpan™ Baseplate, while Silverman headrests can be indexed using
the white pins to the sides of the recess.
SBRT Full Body Vacuum Bag:
The patient’s torso can be immobilized
from below using the large vacuum bag (R7641-25BC) included in the
Klarity SBRT system. It has indexing locations at the bottom and top of
the bag. The top location indexes directly onto the WingSpan™
Baseplate and should be done first, while the bottom location indexes to
the board using one of the two SBRT Board Indexing Bars (RE-15CF)
provided with the system. With the patient in place, remove air from the
bag and form it around the patient.
NOTE
: If an optional headrest is being used, index the vacuum bag over
top of the headrest.
LOWER BODY
Knee and Foot Positioner:
The Knee and Foot Positioner includes the
Knee Positioner Device, the Foot Positioner Device, and their respective
cushions.
Knee Positioner Device:
The Knee Positioner Device (R624-SCF1-3)
indexes to the SBRT board using the two locking clips on either side. To
index, first make sure both clips are in the “Unlocked” position and
place the device at the foot of the board with the clips toward the feet
and hanging off the end. Slide the device up the board making sure that
the clips go around the lip of the
board. Move the device to the
desired location, using the
windows and indicator lines
above the locking clips for precise
locating, and move the switch on
both clips to the locked position.

!
Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
[email protected]
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: [phone] (English)
T: [phone] (Dutch)
EC
REP
Foot Positioner Device:
The Foot Positioner Device (R624-SCF1-4)
indexes to the SBRT board in the same manner as the Knee Positioner
Device, with one small difference; this time the clips will go on first and
be pointed toward the head so that the device is open to the rest of the
board.
NOTE:
The Knee Positioner Device must be indexed first, then the Foot
Positioner Device.
Knee and Foot Positioner Cushions:
The Knee and Foot Positioner
Cushions (R634-LE) index to the Knee Positioner and Foot Positioner
devices. Simply match up the channel on the cushions with the raised
bars on the positioning devices and set them down. Make sure the Foot
Positioner Cushion has the foot cups pointed up towards the body, so
the patient’s feet sit inside them. The elevation blocks for the Knee
Positioner also have pegs on the raised bar for indexing to the Knee
Positioner Cushion. Simply fit the pegs into the holes in the channel on
the bottom of the next cushion. The Knee Positioner Cushion should be
oriented, so the long side is toward the feet and the short side is toward
the head.
Knee Bridge:
The Knee Bridge (R624-SCF1-2) indexes to the SBRT
board using locking clamps similar to the those on the Knee Positioner
and Foot Positioner Devices; however, they can be indexed starting at
any point and don’t need to be slid on from the foot of the board. With
the clamps in the “Unlocked” position and the green arrow on top
pointing towards the head, place the bridge on the board in the desired
location (usually this will line up with the crest of the Knee Positioner
Cushion) and engage the locking mechanism of the clamps. The Knee
Bridge is also height-adjustable with 5 height options (A-E). With the
bridge attached to the board, undo the clips on the sides of the bridge
and pull up or push down on it to change to the desired height, then
reengage the clips.
Knee Bridge Vacuum Bag:
The Knee Bridge Vacuum Bag (R7131-5NLT-
O) indexes to the Knee Bridge. Start with some air in the vacuum bag, so
it is easy to manipulate and will fit inside the arch of the bridge, with
both locking pins on the top of the bridge disengaged (pulled up). Fit the
holes in the indexing bar on the vacuum bag onto the indexing pegs and
locking pins on the underside of the bridge and push down on the

!
Klarity Medical Products, LLC
600 Industrial Parkway
Heath, OH 43056
T: 740.788.8107 F: 740-788-8109
[email protected]
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: [phone] (English)
T: [phone] (Dutch)
EC
REP
locking pins to engage them and lock the cushion in place. With the
patient in place, remove air from the bag and form it around the patient.
BELLY
Belly Bridge:
The Belly Bridge (R624-SCF1-1) is height adjustable and
indexes to the SBRT board using locking clamps just like the Knee
Bridge, as shown above. As with the Knee Bridge, the green arrow on top
should be pointed towards the head of the board.
Belly Compression Paddle:
The belly bridge comes with a Belly
Compression Paddle which is used to restrict respiratory movement and
is adjustable both laterally and vertically. The paddle is triangular and
should be attached to the bridge so that the single corner of the triangle
points to the patient’s head, while the other two corners are pointed
towards the patient’s feet. To adjust the paddle laterally, loosen the set
screw on the top of the bridge, shift the paddle assembly to the desired
location using the indicator line and indexing scale, and retighten the set
screw. To adjust the paddle vertically, turn the gear on the paddle
assembly. Note the window with the indicator line that shows the
paddles exact vertical location on another indexing scale.
Respiratory Belt:
The Respiratory Belt (R624-SCF1-5) is another device
to restrict the movement due to breathing.
It indexes to the SBRT board using the same style of locking clips as the
Knee Positioner and Foot Positioner Devices; however, due to its flexible
nature, the clips do not need to be slid on from the foot of the board.
After the patient is in place, index the loosened belt to the board, then
tighten it using the Velcro strap on top. Attach the sphygmomanometer
and inflate the belt to the desired amount, then detach the
sphygmomanometer. Note the indexing scale on the strap to allow for a
reproducible fit.
Thorax Mask:
The optional SBRT thorax mask (R323-B2436) is another
method of breath restriction. It indexes to the SBRT board using
expansion pins and the indexing holes on the sides of the board. For
heating instructions please refer to the Klarity Mask literature.
!