Bionix SecureVac SVRT-7130 User manual

RM95-0039 Rev. A Page 1of 6
SecureVac™ Cushions Instructions for Use
Caution: Federal Law restricts this device to sale by or on the order of a licensed Physician or Radiation Therapist.
DEVICE DESCRIPTION
Bionix Radiation Therapy 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 Radiation Therapy 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 Radiation Therapy 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.
ADVERSE REACTIONS
No adverse reactions have been identified for the use of SecureVac Cushions.
WARNINGS
•SecureVac Cushions can burst if overinflated- DO NOT OVERINFLATE
•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 injury.
•Using alcohol based cleaners on this product can compromise integrity of device
•DO NOT lift SecureVac Cushions by hose, may cause damage to device
STORAGE
Store in a cool, dry environment with cushions slightly evacuated.

RM95-0039 Rev. A Page 2of 6
INSTRUCTIONS FOR USE
Figure 1: SecureVacTM Cushion Components
Figure 2: Connecting SecureVacTM 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.

RM95-0039 Rev. A Page 3of 6
INFLATION
1. Remove the red cap (not pictured) from the end of the Coupling Insert (B)
2. Release the Pinch Clamp (A) on the tubing leading to the Bionix Radiation Therapy SecureVac
Cushion (D).
3. Insert the Coupling Insert (B), the end of the tube protruding from the Bionix Radiation Therapy
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 Radiation Therapy SecureVac Pump or other approved
vacuum/pressure system.
4. To begin inflating the cushion, turn on the Bionix Radiation Therapy SecureVac Pump or other
approved vacuum/pressure system.
5. Re-secure the Pinch Clamp (A) once the SecureVac Cushion has reached the desired amount of
inflation.
6. Replace the red cap.
7. 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
1. Remove the red cap (not pictured) from the end of the Coupling Insert (B).
2. Release the Pinch Clamp (A) on the tubing leading to the Bionix Radiation Therapy SecureVac
Cushion (D).
3. Insert the Coupling Insert (B), the end of the tube protruding from the Bionix Radiation Therapy
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 Radiation Therapy SecureVac Pump or other approved
vacuum/pressure system.
4. To begin deflating the SecureVac Cushion, turn on the Bionix Radiation Therapy SecureVac Pump
or other approved vacuum/pressure system.
5. 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.
6. Turn off the SecureVac Pump.
aNOTE: Be sure to turn off the pump AFTER the Pinch Clamp is tightened and the
SecureVac Cushion is disconnected from the pump. Doing so beforehand can allow air
back into the SecureVac Cushion.
7. Replace the red cap.
8. When SecureVac Cushion is not in use, hang using the S-Hooks (SVRT-7121) and Grommet (C).

RM95-0039 Rev. A Page 4of 6
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:
1. Wipe thoroughly with water-based antiseptic cleaner or foam.
2. Allow to dry before next patient use.
DISPOSAL INSTRUCTIONS
Dispose of properly in accordance with local regulations and standard hospital or clinic procedures.
Visit www.BionixRT.com for Warranty information
Note: See the table below for additional accessories:
Description
Quantity
RM60-0021
SecureVac Replacement O-Ring Coupling Insert
1
SVRT-1101
SecureVac Hose Adapters, Bionix Pump to S&S Vac Fix Cushions
1
SVRT-1111
SecureVac Hose Adapters, Bionix Pump to Civco Vac Lok Cushions
1
SVRT-6017
SecureVac Box Adapter
1
SVRT-7101
Dual Action Vacuum Pump
1
SVRT-7103
SecureVac Dual Action Pump (220V)
1
SVRT-7105
SecureVac Hose Adapters, Civco Pump to Bionix SecureVac Cushion (6 IN)
1
SVRT-7106
SecureVac Hose Adapter, Bionix Pump to Bionix SecureVac Cushion (8 FT)
1
SVRT-7107
SecureVac Hose Adapters, Central Pump to Bionix SecureVac Cushion (8 FT
1
SVRT-7108
SecureVac Foot Switch
1
SVRT-7110
SecureVac Repair Kit
1
SVRT-7111
SecureVac Hose Adapters, Bionix Foot Switch to Civco Vac Lok Cushions
1
SVRT-7120
Rolling Storage Cart
1
SVRT-7121
SecureVac S-Hooks (5 per pack)
1
Additional SecureVac Part Numbers and Sizes:
Description
SVRT-7130
SecureVac Cushion, 150 x 70cm, 50L Fill
SVRT-7131
SecureVac Cushion, 80cm x 150cm x 35L Fill
SVRT-7132
SecureVac Cushion, 80cm x 150cm x 47L Fill
SVRT-7133
SecureVac Cushion, 80cm x 150cm x 55L Fill
SVRT-7134
SecureVac Cushion, 80cm x 150cm x 70L Fill
SVRT-7380-A
SecureVac Cushion, 100cm x 150cm x 80L Fill
SVRT-7450-A
SecureVac Cushion, 100cm x 100cm x 50L Fill

RM95-0039 Rev. A Page 5of 6
SVRT-7535-A
SecureVac Cushion, 100cm x 70cm x 35L Fill
SVRT-7600
SecureVac Cushion, Upper: 60 x 100cm, 28L Fill Middle: 65 x 70cm X 20L Fill, Lower: 90cm x 70cm x 35L Fill
SVRT-7625
SecureVac Cushion, Upper: 100cm x 60cm x 28L Fill Lower: 70cm x 100cm x 24L Fill
SVRT-7630
SecureVac Cushion, 115cm x 114cm x 25L Fill
SVRT-7635
SecureVac Cushion, 115cm x 114cm x 35L Fill
SVRT-7820-A
SecureVac Cushion, 70cm x 70cm x 20L Fill
SVRT-7915
SecureVac Cushion, 70cm x 50cm x 15L Fill

RM95-0039 Rev. A Page 6of 6
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
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 15223-2012
Authorized
representative in the
European
Community
Indicates the authorized representative in the
European Community.
5.1.2
ISO 15223-2012
Date of manufacture
Indicates the date when the medical device was
manufactured.
5.1.3
ISO 15223-2012
Use-By Date
Indicates the date after which the medical device is
not to be used.
5.1.4
ISO 15223-2012
Batch Code
Indicates the manufacturer’s batch code so that the
batch or lot can be identified.
5.1.5
ISO 15223-2012
Catalog Number
Indicates the manufacturer’s catalog number so that
the medical device can be identified.
5.1.6
ISO 15223-2012
Serial number
Indicates the manufacturer’s serial number so that a
specific medical device can be identified
5.1.7
ISO 15223-2012
Sterilized using ethylene
oxide
Indicates a medical device that has been sterilized
using ethylene oxide.
5.2.3
ISO 15223-2012
Sterilized using irradiation
Indicates a medical device that has been sterilized
using irradiation.
5.2.4
ISO 15223-2012
Do Not Resterilize
Indicates a medical device that is not to be resterilized.
5.2.6
ISO 15223-2012
Non-sterile
Indicates a medical device that has not been subjected
to a sterilization process.
5.2.7
ISO 15223-2012
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 15223-2012
Biological Risks
Indicates that there are potential biological risks
associated with the medical device.
5.4.1
ISO 15223-2012
Do Not Reuse
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 15223-2012
Consult Instructions For
Use
Indicates the need for the user to consult the
instructions for use.
5.4.3
ISO 15223-2012
Caution
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 15223-2012
European Conformity
EC Declaration of Conformity by Notified Body
Annex XII
MDD 93/42/EEC:2007
European Conformity
European Conformity
Annex XII
MDD 93/42/EEC:2007
℞Only
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
Bionix Development Corporation
5154 Enterprise Blvd.
Toledo, OH 43612
Obelis s.a
Boulevard Général Wahis 53
1030 Brussels, Belgium