7625 West New York Street | ||
Indianapolis, Indiana 46214-4911 USA | ||
Telephone: (317) 273-6960 | ||
Facsimile: (317) 273-6979 | ||
Order Desk Telephone: (800) 401-1723 | ||
Order Desk Facsimile: (800) 515-9254 | ||
E-mail: info@floteco2.com | ||
TECHNICAL BULLETIN
MRI (MAGNETIC) SAFETY & COMPATIBILITY OF FLOTEC'S
Integrated Valve Regulator
FLOPAC
MRI Safe and MRI Compatible.
Magnetic attraction is a
critical factor in MRI (Magnetic Resonance Imaging) equipment. MRI medical
scanning systems utilize magnets that are so powerful they can pull steel and
other ferrous metal items across the room into the magnet. It is of the utmost
importance that the magnetic attractions of any items within the magnet’s
field of influence fall within the acceptable standard.
The use of MRI compatible
and safe portable oxygen delivery systems must ensure the safety of both patient
and caregiver as non-magnetic systems pose no physical safety concerns, as well
as offer no interference in the performance of the device nor of the MRI scanner
itself.
This can be accomplished if the pressure regulator and cylinder are constructed of non-magnetic materials such as aluminum or some aluminum alloys, brass and non-magnetic stainless steel.
Flotec manufactured oxygen
medical gas regulators (including Flopac) are constructed utilizing
materials such as these; e.g... aluminum-alloy regulator body, flow meter body,
and liter flow selector knob as examples.
Our Flopac™
integrated regulator / cylinder system’s manual pressure shut-off knob and
flange plate washer are machined using the same aluminum-alloy.
However, this regulator is
not constructed entirely of aluminum-alloy and brass. Some critical component
parts of Flotec regulators are made of “non-magnetic” stainless steel such
as the springs, shims, detent balls, roll pins, and the Flopac’s external
carry handle.
Flotec oxygen pressure
regulator, Cat. # RR810-310H1, s/n 421763, was submitted for deflection testing
to Emanuel Kanal, MD, FACR, Director, MR Services UPMS Presbyterian,
This Flotec oxygen regulator
was also tested for torque and artifact generation
potential. All testing was performed in a GE Signa® LX 3.0T MR System.
Specifications of this System are included in our Technical Bulletin “MRI
(Magnetic) Safety & Compatibility of Flotec Aluminum Regulators”
This Flotec oxygen regulator
was tested with a hand held magnet prior to flow rate accuracy measurements and
function testing being performed. No gross ferromagnetic attraction was noted
with the oxygen regulator when exposed to this relatively weak hand held magnet.
Accuracy of flow
measurements were examined on this Flotec regulator in two separate locations:
a)
Location #1 just inside the magnet
bore opening
b)
Location #2 at the entrance to the
magnet room (approximately 33 feet from the
magnet bore opening.
Measurements
were taken with a Sherwood MRI compatible Post valve attached.
Test Results:
Flotec oxygen pressure
regulator, Cat. # RR810-310H1, s/n 421763 demonstrated 21
degrees
of deflection on the deflection angle test. This was below the 45-degree
maximum threshold established for claims of MRI safety.
Further, no alteration of
flow rate / function was identified or observed for this oxygen
Regulator
These include:
-
PR-50 Stainless Steel Shims (p/n
810-6506-001, 810-6487-001)
-
Flowmeter Stainless Steel Detent
Roller Balls (p/n 553-0001-003)
-
Flowmeter Stainless Steel Detent
Springs (p/n 151-0001-001)
-
Flowmeter Stainless Steel Roll Pin
(p/n 112-2125-004)
-
Flowmeter Stainless Steel Button
Head Cap Screw (p/n 109-4008-006)
The
differences between Flopac™
Pressure Regulator FP4-XX-B05-7105T2 and the formally tested Flotec Oxygen
Pressure Regulator are as follows:
(The
formally tested Flotec RW series yoke style regulator was connected via a
standard MRI Compatible Cylinder Post valve)
b)
Flopac™
pressure regulator utilizes an InGage™ series oxygen regulator
incorporating an internal contents pressure gauge with all brass high-pressure
bourdon tube.
(The formally tested Flotec RW series yoke style regulator uses an externally threaded standard high pressure gauge and rubber boot)
c)
Flopac™
pressure regulator utilizes a special all brass high-pressure inlet
connector
module with manual cylinder pressure on /off valve and CGA 540 check valve port
for venting, vacuuming and transfilling. This module is threaded directly onto
the cylinders access orifice.
(The
formally tested Flotec RW Series yoke style regulator attaches onto a
standard CGA-870 cylinder post valve)
d)
Flopac™
pressure regulator utilizes a specially designed burst disk integrally
incorporated into the connector module.
(The formally tested Flotec RW series yoke style regulator utilized the standard cylinder post valve burst disk)
Flopac™
Oxygen Pressure Regulator was tested with a 3200 Gauss hand held magnet. No
gross ferromagnetic attraction was noted with the Flopac regulator when exposed
to this hand held magnet.
non-
magnetic.
b)
Flopac™
oxygen regulator Stainless Steel “Halo Handle” is non-
magnetic.
c)
Flopac™
oxygen regulator CGA-540 check-valve hex nut (weight: 1.39g) demonstrates
minimal magnetic characteristics easily compensated by the mass and weight of
the entire device.
d)
Flopac oxygen regulator on-off
valve lock-washer (weight: 0.3g) demonstrates minimal magnetic characteristics
easily compensated by the mass and weight of the entire device.
CONCLUSIONS:
The Flopac™ Oxygen Pressure Regulator,
Cat. # FP4-XX-B05-7105T2, exhibits equal to or less than the degree of
ferromagnetic attraction as compared with the formally tested and previously
approved Flotec aluminum RW series oxygen yoke style regulator Cat. #
RR810-310H1 s/n 421763.
As Flopac™ is only labeled as MRI Compatible and
Safe when utilized in conjunction with a corresponding Aluminum or Composite
cylinder, the cylinders’ additional weight further ensures that no
ferromagnetic potential is present.
Therefore,
Flopac™ meets the criteria for
both MRI safety and MRI compatibility.
VP
of Engineering
Flotec
Inc.
TB-MRI
Compatibility Flopac.doc(