Bionix PBRT-6025-03 User manual

Prone Breast System
PBRT-6025-03
INSTRUCTIONS FOR USE
ENHANCED SOLUTIONS FOR THE FIGHT AGAINST CANCER

CAUTION: Federal Law restricts this device to sale by or
on the order of a licensed Physician or Radiation Therapist.
INTENDED USE
The Bionix Prone Breast Treatment System (PBRT-6025-03) is
intended to be used for the positioning and re-positioning of
patients undergoing or receiving a course of external beam
radiation therapy for the treatment of cancer and other dis-
eases.
INDICATIONS FOR USE
The Bionix Prone Breast Treatment System is indicated for
use by a healthcare professional to externally support and
immobilize patients undergoing external beam radiation
therapy of the breasts.
CONTRAINDICATIONS
This device should NOT be used on patients over 350 lbs.
STORAGE
Store in a cool, dry environment.
ADVERSE REACTIONS
No adverse reactions have been identified for the use of the
Prone Breast Treatment System.
WARNINGS
• DO NOT use if the package is damaged or open.
• Inspect the Prone Breast Treatment System before each use.
• DO NOT attempt to sterilize the Prone Breast Treatment
System. Attempts to sterilize the Prone Breast Treatment
System may result in product damage and /or patient injury.

CLEANING INSTRUCTIONS
Note: It is the user’s responsibility to clean products
according to hospital protocol / local regulations.
Do not use alcohol-based cleaners on this product.
Recommended cleaning procedures include:
01. Wipe thoroughly with water-based antiseptic cleaner or
foam.
02. Allow to dry before next patient use.
01. Assemble the Bionix Prone Breast Treatment System as
shown in Figure 1. Place the Leg Cushion (A), and the
Arm Rest (B) on the couch top and lock them down on the
SecureFit bars. Bionix recommends using two SecureFit
Bars (not included with the system).
a. Lockdown bars should be approximately 98cm apart,
keeping the pad set superior to the couch top.
b. The Arm Rest (B) will attach on the SecureFit Bars at
position A1 and B1 (not shown).
c. The Leg Rest (A) will attach on the SecureFit Bars at
position A2 and B2 (not shown).
02. Place the Face Cushion Indexing Assembly (C) on the de-
vice. Loosen the knobs by turning counterclockwise and
press the button to adjust the face cushion up and down.
Secure by turning the knob clockwise and adjust to the
patients’ preference.
03. Place the Breast Bridge (D) by lifting and rotating 180 de-
grees (rotate clockwise or counterclockwise depending on
which breast is being treated), as shown in Figure 2.
a. An optional 15 degree Contralateral Breast Wedge (F)
can also be used for rotating the patient. Adjust the
wedge to treatment needs and to the comfort of the
patient.
Figure 1
F. Contralateral
Breast Wedge
E. Indexing Handles
C. Face Cushion
Indexing Assembly
A. Leg Cushion
D. Breast Bridge
(Large opening)
*sold separately*
B. Arm Rest G. Breast Bridge
(Small opening)

Figure 2
04. Have the patient engage the board from the bottom.
The patient should lie flat in the prone position with the
breast being treated, centered on the opening of the breast
bridge. Line the breast in the opening as desired, according
to individual treatment needs (See figure 2).
a. For the non-treated side, line up the patient with the
indexing markings.
b. For the treated side, line up the patient with the tattoo
marking.
Breast
Bridge
Indexing
Point
Breast
Opening
Figure 3
05. Move the adjustable head rest to the appropriate position,
favored by the patient (Figure 3). Be sure to note what
position is being used on the patient positioning checklist.
If indexing handles are used, be sure to note what position
each hand is in. If desired, position the patient as such so
that the hands are crossed and at maximum extension,
to eliminate folding in the breast.
Adjustable
Head Rest
Indexing
Point
Indexing
Marks

©2021 Bionix LLC
1670 Indian Wood Circle, Maumee, Ohio 43537
United States | Phone: [phone]
Fax: [phone] | Email: [e-mail]
bionix.com | RM95-0043A • Rev. B
ENHANCED SOLUTIONS FOR THE FIGHT AGAINST CANCER
Label Symbol Glossary (Note: not all symbols may be applicable to this product)
Symbol Title of Symbol Description of Symbol
Symbol
Designation
Number
Title of Symbol
Standard
Development
Org. Standard
Medical Device Indicates the item is a medical device. 5.7.7 ISO/DIS 15223-
1:2020(E) DRAFT
Manufacturer Indicates the medical device manufacturer, as defined in EU Direc-
tives 90/385/EEC, 93/42/EEC and 98/79/EC. 5.1.1 ISO 15223-2016
Authorized represen-
tative in the European
Community
Indicates the authorized representative in the European Community. 5.1.2 ISO 15223-2016
Date of manufacture Indicates the date when the medical device was manufactured. 5.1.3 ISO 15223-2016
Use-By Date Indicates the date after which the medical device is not to be used. 5.1.4 ISO 15223-2016
Batch Code Indicates the manufacturer’s batch code so that the batch or lot
can be identified. 5.1.5 ISO 15223-2016
Catalog Number Indicates the manufacturer’s catalog number so that the medical
device can be identified. 5.1.6 ISO 15223-2016
Serial number Indicates the manufacturer’s serial number so that a specific
medical device can be identified 5.1.7 ISO 15223-2016
Sterilized using
irradiation Indicates a medical device that has been sterilized using irradiation. 5.2.4 ISO 15223-2016
Do Not Resterilize Indicates a medical device that is not to be resterilized. 5.2.6 ISO 15223-2016
Non-sterile Indicates a medical device that has not been subjected to a steril-
ization process. 5.2.7 ISO 15223-2016
Do Not Use if Package
is Damaged
Indicates a medical device that should not be used if the package
has been damaged or opened. 5.2.8 ISO 15223-2016
Do Not Reuse
Single-Use Device
Indicates a medical device that is intended for one use, or for use on
a single patient during a single procedure. 5.4.2 ISO 15223-2016
Single patient-
multiple use
Indicates a medical device that may be used multiple times (multi-
ple procedures) on a single patient 5.4.12 ISO/DIS 15223- 1:2020(E) DRAFT
Consult Instructions
For Use Indicates the need for the user to consult the instructions for use. 5.4.3 ISO 15223-2016
Caution / Warning
Indicates the need for the user to consult the instructions for
use for important cautionary information such as warnings and
precautions that cannot, for a variety of reasons, be presented on
the medical device itself
5.4.4 ISO 15223-2016
0459 European Conformity EC Declaration of Conformity by Notified Body Annex XII MDD 93/42/EEC:2007
European Conformity EC Declaration of Conformity by Manufacturer Annex XII MDD 93/42/EEC:2007
By Prescription Only Federal (USA) law restricts this device to sale, distribution, and use
by or on the order of a physician. N/A FDA 81 Federal Regis- ter pg. 38911-38931
MR Safe Indicates an item that poses no known hazards in all MR environ-
ments.
7.4.3.1 or
7.4.4.1 F2503-13
Temperature limit Indicates the temperature limits to which the medical device can be
safely exposed 5.3.7 ISO 15223- 1:2016