Bionix SecureVac SVRT-7130 User manual

SecureVac™Cushions
INSTRUCTIONS FOR USE
ENHANCED SOLUTIONS FOR THE FIGHT AGAINST CANCER
MR Conditional up to 3T

CAUTION: Federal Law restricts this device to sale by or on the order
of a licensed Physician or Radiation Therapist.
DEVICE DESCRIPTION
Bionix SecureVac Cushions are reusable immobilization devices designed
for customizable, long-term multi-patient use. The SecureVac Cushions
maintain their shape over the course of external beam radiation therapy
for the treatment of cancer and other diseases.
INTENDED USE
The Bionix SecureVac Cushions are intended to be used for the repeatable
positioning and repositioning of patients undergoing or receiving a course
of external beam radiation therapy for the treatment of cancer and other
diseases.
INDICATIONS
The Bionix SecureVac Cushions are indicated for use by a healthcare
professional to externally support and immobilize patients that require
repeatability and reproducibility while undergoing or receiving external
beam radiation therapy.
CONTRAINDICATIONS
No contraindications have been identified for the use of SecureVac
Cushions.
STORAGE
Store in a cool, dry environment with cushions slightly evacuated.
ADVERSE REACTIONS
No adverse reactions have been identified for the use of SecureVac cushions.
WARNINGS
• SecureVac Cushions can burst if overinflated - DO NOT OVER-INFLATE.
• Do NOT use SecureVac Cushions if the package is damaged or open.
• Inspect the SecureVac Cushions before each use.
• Do NOT attempt to sterilize the SecureVac Cushion. Attempts to sterilize
the SecureVac Cushion may result in product damage and / or patient
injur y.
• Using alcohol based cleaners on this product can compromise integrity of
device.
• DO NOT lift SecureVac Cushions by hose, may cause damage to device.

Figure 1: SecureVac™ Cushion Components
B. Coupling Insert
E. Coupling Body
F. Release Button
D. SecureVac Cushion
INSTRUCTIONS FOR USE
A. Pinch Clamp
C. Grommet
B. Coupling Insert
A. Pinch Clamp
Figure 2: Connecting SecureVac™ Cushion to Pump
This manual is valid for all sizes of SecureVac Cushions
Note: When using SecureVac Cushion(s), it may be necessary to use a
lockdown adapter to prevent movement. See accessory items below.

INFLATION
01. Remove the red cap (not pictured) from the end of the Coupling Insert (B)
02. Release the Pinch Clamp (A) on the tubing leading to the Bionix SecureVac
Cushion (D).
03. Insert the Coupling Insert (B), the end of the tube protruding from the Bionix
SecureVac Cushion into the Coupling Body (E) until you hear a click, as
shown in Figure 2. Ensure for inflating, the SecureVac Cushion is connected
to the tube marked PRESSURE with the RED washer attached to the Bionix
SecureVac Pump or other approved
vacuum/pressure system.
04. To begin inflating the cushion, turn on the Bionix SecureVac Pump or other
approved vacuum/pressure system.
05. Re-secure the Pinch Clamp (A) once the SecureVac Cushion has reached the
desired amount of inflation.
06. Replace the red cap.
07. When SecureVac Cushion is not in use, hang using the S-Hooks (SVRT-7121)
and Grommet (C).
WARNING: Over inflation of the cushion can cause it to burst.
DEFLATION
01. Remove the red cap (not pictured) from the end of the Coupling Insert (B).
02. Release the Pinch Clamp (A) on the tubing leading to the Bionix SecureVac
Cushion (D).
03. Insert the Coupling Insert (B), the end of the tube protruding from the Bionix
SecureVac Cushion, into the Coupling Body (E) until you hear a click, as
show in Figure 2. Ensure for deflating, the SecureVac Cushion is connected
to the tube marked VACUUM with the BLUE washer attached to the Bionix
SecureVac Pump or other approved vacuum/pressure system.
04. To begin deflating the SecureVac Cushion, turn on the Bionix SecureVac
Pump or other approved vacuum/pressure system.
05. Once your SecureVac Cushion is deflated to the desired firmness, tighten
pinch clamp (A), and disconnect the Coupling Body (C) from the Coupling
Insert (B) by pressing the release button, as shown in Figure 2.
06. Turn off the SecureVac Pump.
a. NOTE: Be sure to turn off the pump AFTER the Pinch Clamp is tightened
and the SecureVac Cushion is disconnected from the pump. Doing so be-
forehand can allow air back into the SecureVac Cushion.
07. Replace the red cap.
08. When SecureVac Cushion is not in use, hang using the S-Hooks (SVRT-7121)
and Grommet (C).

CLEANING INSTRUCTIONS
Note: It is the user’s responsibility to clean products per 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.
DISPOSAL INSTRUCTIONS
Dispose of properly in accordance with local regulations
and standard hospital or clinic procedures
SecureVac Part Numbers and Sizes:
Description
SVRT-7130 150cm x 70cm, 55L Fill
SVRT-7380-A 150cm x 100cm, 80L Fill
SVRT-7450-A 100 x 100cm, 50L Fill
SVRT-7535-A 100 x 70cm, 35L Fill
SVRT-7600 Tri-Vac Cushion
Upper Chamber: 60 x 100cm, 28L Fill
Middle Chamber: 65 x 70cm, 20L Fill
Lower Chamber: 90 x 70cm, 35L Fill
SVRT-762 5 T-Vac C ushion
Upper Chamber: 100 x 60cm, 28L Fill
Lower Chamber: 70 x 100cm, 30L Fill
SVRT-7820-A 70 x 70cm, 20L Fill
SVRT-7915 70 x 50cm, 15L Fill
SVRT-6017 T-Form SecureVac Box Adapter
SVRT-7101 SecureVac Pump (110v)
SVRT-7103 SecureVac Pump (220v)
SVRT-7108 SecureVac Foot Switch
SVRT-7120 Rolling Storage Cart
SVRT-7121 S-Hooks

Label Symbol Glossary (Note: not all symbols may be applicable to this product)
Symbol Title of Symbol Description of Symbol
Symbol
Designa-
tion
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
Directives 90/385/EEC, 93/42/EEC and 98/79/EC. 5.1.1 ISO 15223-2016
Authorized rep-
resentative in the
European Com-
munity
Indicates the authorized representative in the European
Community. 5.1.2 ISO 15223-2016
Date of manu-
facture
Indicates the date when the medical device was manufac-
tured. 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
sterilization process. 5.2.7 ISO 15223-2016
Do Not Use if Pack-
age 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
(multiple procedures) on a single patient 5.4.12 ISO/DIS 15223- 1:2020(E) DRAFT
Consult Instruc-
tions 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 Con-
formity EC Declaration of Conformity by Notified Body Annex XII MDD 93/42/ EEC:2007
European Con-
formity 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
Register pg. 38911-
38931
MR Safe Indicates an item that poses no known hazards in all MR
environments.
7.4.3.1 or
7.4.4.1 F2503-13
MR Conditional
An item with demonstrated safety in the MR environment
within defined conditions including conditions for the static
magnetic field, the time-varying gradient magnetic fields and
the radiofrequency fields.
3.3.1.11 F2503-11
Temperature limit Indicates the temperature limits to which the medical device
can be safely exposed 5.3.7 ISO 15223- 1:2016

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Maumee, Ohio 43537 | United States
Phone: [phone] (+1 419.727.8421)
Fax: [phone] (+1 419.727.8426)
Email: [e-mail] (internat[email protected])
www.bionix.com | RM95-0039 | Rev. 02
ENHANCED SOLUTIONS FOR THE FIGHT AGAINST CANCER
MR Conditional up to 3T