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).