qfix kVue CT Overlay Product Manual

PRODUCT GUIDE
& USER MANUAL
RT-4550KVGEC, RT-4550KVGEL, RT-4550KVGER,
RT-4550KVPBR, RT-4550KVSS1, RT-4550KVSS2,
RT-4550KVSS3, RT-4550KVSS4, RT-4550KVSS5,
RT-4550KVTAQ, RT-4550KVTAQ2, & RT-4450KVPH01
kVue™ CT Overlay
Advena Limited
Tower Business Centre, 2nd Flr
Tower Street, Swatar, BKR 4013
Malta
Made in the USA by
Qfix
440 Church Rd,
Avondale, Pennsylvania, USA
+1 484-720-6053 www.Qfix.com
EN English
DA Danish (Dansk)
DE German (Deutsch)
ES Spanish (Español)
FR French (Français)
IT Italian (Italiano)
Japanese (日本語版)
JA
EN: English
GENERAL PRECAUTIONS
WARNING STATEMENTS
! WARNING ! NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED. IF ANY PART
OF THIS DEVICE EXPERIENCES A CATASTROPHIC LOAD, APPEARS DAMAGED OR
FUNCTIONS IMPROPERLY, DISCONTINUE USE IMMEDIATELY AND CONTACT QFIX
AT +1 484-720-6053 OR TECHSUPPORT@QFIX.COM.
! WARNING ! THE ONETOUCH™ IS A PRECISION MECHANISM AND IS ONLY FOR USE
WITH APPROVED QFIX KVUE DEVICES. UNAPPROVED NON-QFIX DEVICES THAT
HAVE NOT BEEN VALIDATED BY QFIX MAY NOT BE SAFE FOR USE AND WILL VOID
WARRANTY IF USED.
SERIOUS INCIDENTS
Please report any serious incidents (e.g. incidents which result in or have the potential to
result in death or serious injury) to both Qfix and your country's Competent Authority.
Qfix | 440 Church Road | Avondale, Pennsylvania 19311 USA |
kVue CT Overlay on
Canon Aquilion®
UK Responsible Person
QServe Group UK, Ltd.
49 Greek Street
Soho, London W1D 4EG
United Kingdom
Raditec Medical AG
Schlossberg 5a
5454 Bellikon
Switzerland
2002600_ML_1 / 2024-08
Kazakh (Қазақша)
KK
NL Dutch (Nederlands)
RO Romanian (Română)
RU Russian (Русский)
SV Swedish (Svenska)
Chinese (简体中文)
ZH
PRODUCT GUIDE AND USER MANUAL – 2002600_IFU, kVue CT Overlay_ML
ADDITIONAL WARNINGS
• The kVue CT will not work with certain panels with all inserts, such as those with a
beam limiter.
• Pinch points may exist and are properly marked on the KVue CT Overlay.
• Attention is necessary when moving the Couch and CT Insert into the Gantry Bore
to ensure that pinch point risk to hands and fingers are avoided. If cradle is retracted
from the bore of the machine with the cradle in its lowest position, it may be
possible to damage the front end eccentric cams.
• The unit must be inspected periodically for damage and atypical wear.
• Use of this product in a manner not specified in the User Manual may be unsafe and
is not recommended.
• Use of unapproved devices or attachments may be unsafe and is not recommended.
! CAUTION ! LOCATING BARS USED IN CT SCANS MAY CAUSE ARTIFACTING. MOVE
LOCATING BAR OUTSIDE REGION OF INTEREST IF NECESSARY.
LOAD RATING
DO NOT exceed 249 kg (550 lbs) or the lowest of the kVue CT Overlay, kVue, and CT
weight limit.
! NOTE ! When combined with the OEM couch base, the load rating is the lower of the
two safe working loads. The kVue CT Overlay load should NOT exceed the original
couch base manufacturer's specifications. Refer to the product literature provided by
the original manufacturer.
WARNING LABELS & DESCRIPTIONS
Refer to Qfix.com for a listing of symbols and their definitions.
LOAD RATING
249 kg
<
DO NOT exceed 249 kg (550 lb) uniformly distributed load.
(550 lb)
PINCH POINTS
Pinch points may exist and are indicated by one of these symbols.
INTENDED USE
This device is intended to immobilize, position and reposition patients undergoing
radiation therapy.
! NOTE ! United States Federal law restricts this device to sale by or on the order of a
physician.
PATIENT TARGET GROUPS
Patients undergoing radiation therapy or diagnostic imaging procedures.
INTENDED USERS
The intended user for the products is a person qualified in accordance with the
requirements of the regulatory region.
FEATURES
DESCRIPTION
The kVue CT is a CT simulator that allows kVue Inserts to be placed directly into the CT.
The dosimetric properties of your couch top can now be taken into account in the
Treatment Planning Software (TPS). The kVue CT is available in many CT makes and
models.
RT GATING CAMERA
Location for mounting RT Gating Camera (Fig. 1).
Mounting
Holes
Fig. 1
+1 484-720-6053 | +1 610-268-0588 | www.Qfix.com