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Electronic Signature Information

Name

DOC0899034

Revision

Type

Controlled Document

Title

Final iVent201 MRI Image Quality Waiver Form

Originator

212030967_william_r_phelan

Name

Reason For Change

File Size (Bytes)

iVent201 MRI Image Quality

Test V11 FINAL.doc

iVent201 MRI Image Quality Test doc with doc number and
page numbers added per Shlomi Deler

188928

Route

Signer

Status

R-4426975

100035647_shlomi__deler

Approve

4 Jan 2011 16:52:05 GMT

R-4426975

212064784_rebecca_n_zimmer

Approve

4 Jan 2011 20:15:04 GMT

Approved

* Printed versions are For Reference Only *

Comments

Completion Date

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DOC0899034, Rev:1

iVent201
Guidance on MRI Requirements and Image Quality Test
Table of Contents
1

Introduction ..............................................................................................................................................2

Purpose .....................................................................................................................................................2

Using iVent201 in MR Environment ...........................................................................................................2

Approved

3.1

Intended User .................................................................................................................................... 2

3.2

Intended Use of iVent201with MRI..................................................................................................... 2

3.3

MR Preparation Area.......................................................................................................................... 4

3.4

Transfer into MR Environment ........................................................................................................... 5

MR Conditional iVent201 Image Quality Test .............................................................................................5

4.1

MR Conditional Image Quality Test Protocol ...................................................................................... 5

4.2

MR Conditional Image Quality Test Results Record............................................................................. 6

MR Image Quality Validation Record and Acknowledgement .....................................................................6

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1 Introduction
The special conditions of the Magnetic Resonance (MR) Environment (as defined below) increase the
requirements both on the equipment used and on the operators. The strong magnetic field requires that only
non-magnetic devices or devices with a low content of magnetic material are allowed in this environment. The
use of Radio Frequency (RF) fields puts extreme demands on the Electromagnetic compatibility (EMC) of
devices used during the imaging sequences of the MR scanner.
The IVent201 ventilator is classified as MR Conditional. MR Conditional means that the ventilator has been
demonstrated to pose no known hazards in a specified MR Environment with specified MR conditions for use.
The conditions required for use of the iVent201 in the MR Environment are described in this iVent201
Guidance on MRI Requirements and Image Quality Test (Guidance). If these conditions are met, a successful
Image Quality Test is performed, and the MR Image Quality Validation Record attached hereto at Section 5 is
signed, the use of the iVent201 is indicated for use in the specific MR Suite where the testing occurred.

2 Purpose
This Guidance outlines the requirements necessary to use the iVent201 ventilator in the MR Environment, and
the measures that must be undertaken for the use of the iVent201 with Magnetic Resonance Imaging (MRI).
Note: MR Environment is defined as the volume within the 0.50 millitesla (mT) (5 Gauss) line of an MR system,
which includes the entire three-dimensional space surrounding the MR scanner. For cases where the 0.50 mT
line is contained within the Faraday shielded volume, the entire room shall be considered the MR
environment1.

3 Using iVent201 in MR Environment

3.1 Intended User
The Responsible Organization2 must review the applicable requirements as stated in this Guidance and
implement them in its quality system (see Section 4, Image Quality Test).

3.2 Intended Use of iVent201with MRI

The iVent201 ventilator (serial number 15,000 and higher) is classified as MR Conditional for 1.5T and 3T MR
scanners. This means that the iVent201 can be used in the MR Environment only if the operational conditions
specified in this section are met.
CAUTION:

The iVent201 ventilator cannot be subjected to field strength greater than 100 Gauss and must
be kept outside of 100 Gauss perimeter, typically about 3.0 meters from the magnets

ASTM standard F2503-5, Marking Medical Devices and other items for safety in the magnetic resonance environment ,
ASTM International, West Conshohocken PA, 2006, www.astm.org.

Approved

A Responsible Organization is an entity that is accountable for the use and maintenance of the medical equipment or
system that includes the MR Environment.

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isocenter. For maximum safety, each facility must measure the Gauss field around the imaging
device and map the field force levels to ensure that the ventilator is not placed inside the
mapped Gauss lines.
NOTE:

All staff operating the ventilator in the MR suite must be advised that the static magnetic field
is always present whether or not a scan is occurring. Passing the ventilator along the side of
the scanner, even though a scan is not taking place, will damage the ventilator or may bring it
within the field that causes physical attraction between the ventilator and the MR device. Do
not bring the ventilator within the 100 Gauss boundary at any time.

Upon completion of mapping, the 100 Gauss strength lines should be permanently marked on the floor with a
durable tape, or with GE Healthcare Gauss line warning floor label (GE P/N 350C0323-01), shown below. It is
recommended that the clinical staff put tape marks on the floor indicating where specific equipment can be
safely placed within the MR suite.
To ensure that the ventilator remains outside the 100 Gauss boundary while the patient is within the range of
the imaging magnet, a patient circuit extension may be required. In such cases, GE Healthcare offers an MRI
Patient Circuit extension (GEHC P/N M1173617).
It is very likely that the magnetic shielding of some MRI units may not be 100% effective. Therefore, the Gauss
levels at a given distance may differ in different areas within the same radius from the center of the magnet
core. For this reason, it is important to map correctly the Gauss levels for each individual MRI suite. Further,
stationary objects that are ferrous, such as steel I-beams in the building wall or floor, affect the field lines of
the magnet, and therefore the 100 Gauss line may not be symmetrical, and should be mapped out on both
sides of the MR device.

100 Gauss Line Warning Floor Label

MR CLASS

Approved

MR Conditional per ASTM 2503-05

WARNING!

Use of the ventilator other than as instructed may cause the ventilator to
malfunction, and may cause permanent damage to the ventilator.

CAUTION!

Connect the potential equalization pin on the back of the ventilator to the ground
during battery (DC power) operation.
Before using the ventilator in the MR suite, remove the green cover and the

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attached metal chain from the high-pressure oxygen fitting.

To avoid degrading image quality, do not use the static mechanics function during
MRI scanning.
Lock the ventilators roll stand wheels to prevent inadvertent movement.
The ventilator will be attracted to the magnet if it is brought within the 100 Gauss
field line of the MR magnet. If there is a risk of personnel moving the ventilator,
the ventilator should be tethered to the wall, or placed within a retaining box
affixed to the floor.
The SpO2 option is not intended for use in the MR Environment.
GEHC recommends using longer (3.8m/ 12.5 ft, GE P/N M1173406) patient circuits
when operating in the MR Environment.

NOTE

Oxygen Cylinder Holder GE P/N M1206572 in the USA, and GE P/N M1162046
outside the USA) and Roll Stand (GE P/N M1206571 in the USA, and GE P/N
M1162044 outside the USA) are the only metal GEHC accessories that are
acceptable for use within the MRI Suite.

3.3 MR Preparation Area

Remove gas cylinder (if used). Connect IVent201 to the gas supply of the MR preparation area.
Make sure the IVent201 is labeled MR Conditional and that a laminated MRI Card (GEHC P/N
M1161864) is attached to the units handle.
Transfer the IVent201 to an MR-approved mounting solution.
Make sure that the patient tubing is sufficiently long, attaching an extension if needed.

Approved

MRI Card

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Remove all MR unsafe accessories such as:

iVent201 plug-in modules apart from batteries
Active humidifier, humidifier holder and accessories
Nebulizers, nebulizer holders and accessories
Patient support arms
IV poles

3.4 Transfer into MR Environment

Check that the IVent201 is appropriately equipped for the MR Environment.

Make sure that gas cylinders have been removed.
Switch the oxygen gas supply to the MR room supply.
Ensure that the IVent201 is positioned outside of the 100 Gauss safety line at all times.
Lock both brakes of the IVent201 mobile cart MR (if used).

NOTE: Both brakes must always be on before releasing the iVent201.

4 MR Conditional iVent201 Image Quality Test

The iVent201 MR Conditional has been demonstrated to pose no known hazards in a specified MR
Environment under specified conditions of use. The ventilator must be outside the 100 Gauss line at all times
to be used safely.

4.1 MR Conditional Image Quality Test Protocol

Prior to validation of the iVent 201 as MR Conditional, a test is required to evaluate the performance of the MR
imaging engine with iVent201 in the MR suite. This test will require approximately 30 minutes of MR suite
time, as well as an MR technician who will be able to run the required scans for the tests.
Before initiating the scans below, insure that the MR technician has mapped the 100 Gauss line around the
open end of the scanner through which the patient is introduced. This line will be approximately 3 meters from
the isocenter of the scanner. Insure that the 100 Gauss line is marked on the floor with tape.
CAUTION

The ventilator must be prevented from crossing the 100 Gauss line, whether the scanner is
active or not. There is a magnetic moment to the ventilator and if it is brought closer than the
100 Gauss line, it can be pulled toward the magnet. If the ventilator is running on AC and it is
brought closer than the 100 Gauss line, the power supply will be damaged and will require
repair. It is recommended that either a physical barrier be placed on the floor, or a tethering
system be deployed to prevent the ventilator from crossing the 100 Gauss line.

Approved

Scan Sequences for Testing

1.

Execute a gradient echo scan with a small flip angle of 10 degrees with the ventilator turned off in the MRI
room using a standard phantom placed in the center of a head coil. This scan will serve as a reference
against which scans with the ventilator running shall be compared.

2.

Now using identical parameters and the identical setup, execute the same scan as in 1 above, but this
time, set the iVent201 ventilator to the 50Kg settings running with an Rp20 and attach a balloon test lung
to the patient circuit. Make sure the ventilator is oriented so that the screen is facing in the direction of

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the control room window and that the ventilator roll stand is on the far side of the 100 Gauss line from
the scanner magnet.
3.

Next, perform a scan with the ventilator running in the MR suite, but remove the head coil and set the
scan parameters for a body scan. Place a phantom target in the scanner.

4.

Lastly, the technician should perform a scan that is known to be sensitive to RF interference in order to
determine the sensitivity of the system to interference.

5.

If RF interference is noted, the hospital staff may elect to run the test again with the ventilator running
under battery power only to ascertain whether or not this reduces interference. The ventilator may be
run under battery power under the close supervision of respiratory therapy staff that are trained to
understand the battery charge status of the ventilator.

The Radiologist and MR technician must keep the scan files acquired in Scan Sequences 1-4 above and the site
Radiologist should qualify the scan results as acceptable or not. If the image quality is deemed not acceptable,
then the iVent201 is not to be used in this particular MR suite.
NOTE If the interference is deemed acceptable, the Radiologist and MR technician must be advised that any
addition of equipment, or change in MR scanner configuration (software or hardware) may result in an
increase in interference which is beyond the scope of the MR Environment Guidance.

4.2 MR Conditional Image Quality Test Results Record

Following completion of the test as specified above, please complete the form below.
1. General MR Scanner Information
Date
Name of Tester
Hospital / Department
MRI Room Number
Scanner Model / Manufacturer
Static Magnetic Field Strength
Scanner Serial Number
Scanner Software Version

2.

iVent201 after 5 Minutes of Ventilation

iVent201 serial no:__________________________________________________________________________

Position of iVent201: ________________________________________________________________________
Image quality OK:

Approved

Pre-use check after test passed:

Yes
Yes

No
No

(tick as appropriate)
(tick as appropriate)

5 MR Image Quality Validation Record and Acknowledgement

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The purpose of this Validation Record and Acknowledgement is to verify that the requirements set forth in the
foregoing Guidance document and Image Quality Test, have been implemented at the time of installation. The
Guidance discloses the limitations of use of the iVent201 in the MR Environment due to possible image
artifacts. The customer must operate the ventilator in a manner consistent with this Guidance.
By signing below, the Responsible Organization hereby confirms and acknowledges the following:
1.

Implementation of all applicable Responsible organization actions according to this Guidance. This
applies to all iVent201 units used in specific MR environments.

2.

Successful completion of the MR Image Quality Test according to Section 4 of this Guidance.

3.

Authorized representatives of the Responsible Organization have read and understood the limitations of
use of the iVent201 in the MR Environment and the possibility that an increase in image artifact may
result if the MR Environment or MR scanner configuration are changed following the completion of the
MR Image Quality Test.

4.

The Responsible Organization shall retain full responsibility for MR image quality when using the iVent201
in the MR Environment, including but not limited to an increase in image artifact due to changes in the
MR hardware, software, or MR Environment.

RESPONSIBLE ORGANIZATION:
Place and Date
Signature
Print Name
Title or
Position
WITNESSED BY [GE Healthcare representative]:
Signature
Print Name
Title or Position
A copy of this Guidance, together with copies of the completed Tables 1 and 2 of section 4.2, should be
returned to _____________________________at GE Healthcare, [add relevant address].

Approved

Fax: _______________, email: ______________

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