Invivo Magnitude 3150M User manual

Invivo Research, Inc
MagnitudeTM 3150M MRI Monitor
Omni-TrakTM 3150 MRI Monitor
Operations Manual
INVIVO
RESEARCH
INCORPORATED
12601 Research Parkway
Orlando, FL 32826
1-800-331-3220
1-407-275-3220
www.invivoresearch.com

TABLE OF CONTENTS
Paragraph Number Page Number
i
List of Figures ............................................................... iii
Equipment Classification ....................................................... iii
Precautions .................................................................. iv
User Responsibility ........................................................... xi
MRI Accessories ............................................................ xii
1. INTRODUCTION .................................................... 1-1
1.1 Features ............................................................. 1-1
1.2 Use of this Manual ..................................................... 1-2
1.3 Product Description .................................................... 1-2
1.3.1 System Parameters ............................................... 1-2
1.3.2 User Interface ................................................... 1-2
1.3.3 Versatility ...................................................... 1-2
1.4 Top Panel ............................................................ 1-2
1.4.1 Control Panel ................................................... 1-3
1.4.2 Flat Panel Display ............................................... 1-4
1.5 System Screen ........................................................ 1-6
1.6 Parameter Input Panel .................................................. 1-6
1.7 Monitoring System Location ............................................. 1-6
1.7.1 MRI Monitoring Components ...................................... 1-7
1.7.2 3150(M) MRI Monitoring Precautions ............................... 1-7
1.8 Cleaning Instructions ................................................... 1-8
1.8.1 Cleaning Accessories .............................................. 1-9
2. INSTALLATION ..................................................... 2-1
2.1 Introduction .......................................................... 2-1
2.2 Monitor Installation .................................................... 2-1
2.2.1 Monitor Location ................................................ 2-1
2.2.2 Preparing the 3150(M) MRI Monitor for Use .......................... 2-1
2.2.3 Monitor Start Up ................................................ 2-2
2.2.4 3150(M) MRI Monitor/Remote Monitor Communication ................ 2-2
3. MONITOR PREPARATION FOR USE .................................. 3-1
3.1 Introduction .......................................................... 3-1
3.2 ECG Setup ........................................................... 3-1
3.3 Pressure Zeroing ...................................................... 3-1
3.4 NIBP Setup .......................................................... 3-1
3.5 Alarm System ......................................................... 3-1
4. PATIENT PARAMETERS ............................................. 4-1
4.0 Introduction .......................................................... 4-1
4.1 ECG Monitoring ...................................................... 4-1
4.1.1 Monitoring Precautions ........................................... 4-1
4.1.2 Maintenance of Optimum ECG Waveform Integrity ..................... 4-3
4.1.3 Associated Displays .............................................. 4-4

TABLE OF CONTENTS
Paragraph Number Page Number
ii
4.1.4 ECG Control Keys ............................................... 4-4
4.1.5 Alarm Limits ................................................... 4-4
4.2 NIBP Monitoring ...................................................... 4-4
4.2.1 Simplified Theory of Operation ..................................... 4-4
4.2.2 Patient and Cuff Preparation ....................................... 4-5
4.2.3 Associated Displays .............................................. 4-6
4.2.4 Adult/Neonate Selection .......................................... 4-6
4.2.5 NIBP Control Keys .............................................. 4-6
4.2.6 Alarm Limits ................................................... 4-6
4.2.7 Blood Pressure Reading Intervals ................................... 4-7
4.2.8 NIBP Normal Operation .......................................... 4-7
4.3 Invasive Pressure Monitoring ............................................ 4-7
4.3.1 Probe Preparation ................................................ 4-7
4.3.2 Zeroing Pressure Channels ......................................... 4-8
4.3.3 Associated Displays .............................................. 4-8
4.3.4 Alarm Limits ................................................... 4-8
4.4 SpO2 Monitoring ...................................................... 4-9
4.4.1 SpO2 Monitoring Considerations ................................... 4-9
4.4.2 Patient and Probe Preparation ...................................... 4-9
4.4.3 Associated Displays .............................................. 4-9
4.4.4 Alarms ....................................................... 4-10
4.4.5 SpO2 Messages ................................................ 4-10
4.5 End Tidal CO2 Monitoring (EtCO2) ...................................... 4-10
4.5.1 Theory of Capnography .......................................... 4-11
4.5.2 Patient Circuit Preparation ........................................ 4-11
4.5.3 Associated Displays ............................................. 4-12
4.5.4 EtCO2 Alarms ................................................. 4-13
4.5.5 EtCO2 Messages ............................................... 4-13
4.6 Cardiac/Peripheral Gating Option ........................................ 4-13
5.0 BATTERY OPERATION .............................................. 5-1
5.1 Introduction .......................................................... 5-1
5.2 Battery Location and Access ............................................. 5-1
5.3 Battery Charging ...................................................... 5-1
5.4 Battery Operation Time ................................................. 5-1
5.4.1 Battery Low Indication ............................................ 5-1
5.4.2 Maintaining Battery Life .......................................... 5-1
5.5 Battery Replacement ................................................... 5-1
Appendix A: Specifications ................................................... A-1
Appendix B: Repair ..........................................................B-1
Appendix C: Warranty ........................................................C-1
Appendix D: Declaration of Conformity ......................................... D-1
Appendix E: Primer for Patient ECG Monitoring During MRI Procedures ...............E-1
Appendix F: List of Symbols ................................................... F-1

iii
LIST OF FIGURES
Figure Number Page Number
1-1 3150(M) MRI Monitor Top Panel ......................................... 1-2
1-2 Control Panel ......................................................... 1-3
1-3 The Normal Screen .................................................... 1-4
1-4 The Informational Display ............................................... 1-4
1-5 Vital Signs Trace Display ................................................ 1-5
1-6 Vital Signs Numeric Display ............................................. 1-5
1-7 Parameter Input Panel .................................................. 1-6
2-1 The Power Adapter and RF Antenna Connectors ............................. 2-2
4-1 Patient Placed in Magnet Bore Head First ................................... 4-2
4-2 Electrode Placement .................................................... 4-2
4-3 Patient Placed in Magnet Bore Feet First .................................... 4-3
4-4 The ECG Display ...................................................... 4-4
4-5 Oscillometric Measurement Method ....................................... 4-5
4-6 The NIBP Display ..................................................... 4-6
4-7 The Invasive Pressure Display ............................................ 4-8
4-8 The SpO2 Display ..................................................... 4-9
4-9 The EtCO2 Display ................................................... 4-12
EQUIPMENT CLASSIFICATION
Classification according to IEC-601-1
According to the type of protection against
electrical shock:
Class I equipment.
According to the degree of protection against
electrical shock:
Type CF (defibrillator-proof) equipment.
According to the degree of protection against
harmful ingress of water.
Ordinary equipment (enclosed equipment
without protection against ingress of water).
According to the methods of sterilization or
disinfection:
Non-sterilizable. Use of Liquid surface
disinfectants only.
According to the mode of operation: Continuous operation.
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.

iv
NOTE
This Operations Manual will describe both the MagnitudeTM 3150M and Omni-TrakTM 3150 MRI
Monitors in detail. For simplicity the manual will refer to both these systems by the name “3150(M) MRI
Monitor”except in the cases where a feature applies only to one of the two systems, in which case the
specific 3150(M) MRI system will be referenced.
PRECAUTIONS
General
Federal law in the USA or Canada restricts this device to sale by, or on , the order of a physician.
The 3150(M) MRI Patient Monitoring System is comprised of the 3150(M) MRI Monitor and a
Remote Monitor (Millennia®3155MVS or 3155A). Always operate the 3150(M) MRI Monitor with
its designated remote monitor.
The accuracy of the measurements can be affected by the position of the patient, the patient’s
physiological condition, and other factors. Always consult a physician for interpretation of
measurements made by this monitor.
To avoid remote monitor fall, secure monitor on the shelf or bracket prior to use.
An explosion hazard exists if this monitor is used in the presence of flammable anesthetics.
The operator should read and thoroughly understand this manual and the associated remote monitor
manual (Invivo Research, Inc. Part Number 9545) completely before attempting to operate the 3150(M)
MRI Monitor.
If any system failure occurs (e.g. an unexplained continuous audible alarm) remove the monitor from
use, and refer it to qualified service personnel.
When the message “SOUND OFF”is displayed on the 3150(M) MRI Monitor (an “X” is displayed on
the screen of the remote 3155 MVS or 3155A monitor), the audible alarm tone will not sound for any
reason.
Perform operational checkout before each use. If monitor fails to function properly, refer to qualified
service personnel.
For safe and accurate operation and MRI compatibility, use only recommended Invivo Research patient
electrodes, cabling, lead wires, cuffs, hoses, sensors, tubing, etc. A listing of these can be found in the
Accessory Listing within this manual, or by contacting Invivo Research directly.
For continued operation, always connect the monitor to AC Main Power through the AS153 AC Power
Adapter when a Low Battery indication occurs. Failure to do this can lead to interruption of monitoring
and/or damage to the monitor’s battery(s).
The system may not conform to all performance specifications if stored or used outside the
environmental specifications identified in Appendix A in the rear of this manual.
Do not apply any unnecessary pressure to the screen area of the monitor. Severe pressure applied to this
portion of the monitor could result in damage or failure of this screen.
All equipment not complying with IEC 601-1 should be placed outside the patient environment. Only
connect IEC 601-1 compliant equipment to this monitor. To avoid potentially hazardous leakage
currents, always check the summation of leakage currents when several items of equipment are
interconnected.
For proper equipment maintenance, perform the service procedures at the recommended intervals as
described in the monitor’s service manual.
Single use devices should never be reused.

v
PRECAUTIONS (Continued)
Electrical Safety
To avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it with liquid
cleaning agents. Always disconnect monitor from AC Main Power before performing cleaning or
maintenance.
Shock hazard exists if operated without chassis cover. Refer servicing to qualified service personnel
only.
For continued protection against fire hazard, replace fuses with same type and rating only.
Avoid use of electrical power extension cords. Electrical power extension cords may create a safety
hazard by compromising the grounding integrity of the monitor.
If the integrity of the earth conductor of the AC main power cable is in doubt, operate the monitor
on internal battery power until proper earth connection is confirmed.
If monitor becomes accidentally wet during use, discontinue operation of the monitor until all
affected components have been cleaned and permitted to dry completely. Contact your local Invivo
Research, Inc. representative if additional information is required.
This monitor and its listed accessories maybe safely powered by the voltages 110-120/220-240 VAC
having a frequency of 50 or 60 Hz.
MRI Use Precautions
Certain components of this device will be affected bythe magnetic and radio frequency fields present
in your MRI System. Confer with your MRI physicist and/or Radiology staff to identify the proper
placement and use areas for the monitor and its accessories, as defined on the monitor or accessory
labeling. Failure to properly place the monitor and its accessories in the Magnet Room will result
in monitor failure, and possible patient or user injury. Always position the 3150(M) MRI Monitor
at, or outside, the 5000 Gauss (0.5T) field line of the MRI system. A slight distortion of the MRI
magnetic field homogeneity could result or possible damage to either the monitor's NIBP or EtCO2
pump could occur.
Always verify proper communication of the 3150(M) MRI Monitor with the Remote Monitor(s)
prior to patient use.
MRI Magnet Room Placement. The 3150(M) MRI Monitor is designed to be used in conjunction
with one or two remote monitor(s). The 3150(M) MRI Monitor is specially designed not to
interfere with MRI operations and may be used inside the MRI Magnet Room in any location at or
outside the 5000 Gauss (0.5T) Field Line of the MRI System. If brought closer than the 5000 Gauss
Field Line, the NIBP monitor pump and EtCO2 pump may fail to operate.
The Remote Monitor(s) are also specificallydesigned not to interfere with MRIoperations, and may
be used in the Magnet Room at or outside the 1000 Gauss (0.1T) Field Line of the MRI System. If
brought closer than the 1000 Gauss Field Line, monitor damage (failure to operate) may result.
Risk of RF current burn. Cables which become inadvertentlylooped during MRI act as conductive
lines for RF induced currents. When lead wires or other cables form a conductive loop in contact
with the patient's tissue, minor to severe burning can result.

vi
MRI Compatibility
The Quadtrode®MRI ECG Electrode Pad, and ECG Patient Lead Wires and Cable, are
compatible with Magnetic Resonance Imaging (MRI) Systems within the following
guidelines:
!MRI systems with static magnetic field strengths up to 1.5 Tesla.
!Usable within the MRI system bore with Specific Absorption Ratios (S.A.R.'s) up
to 4.0 w/kg (peak). Use with higher S.A.R.'s greatly increases the risk of patient
burns.
!Non-Magnetic materials are used in the construction of these assemblies.
!If scanned directly across the plane of the ECG electrode element, a slight image
distortion may be seen at the skin surface where the electrode element is
positioned.
PRECAUTIONS (Continued)
MRI Use Precautions (Continued)
Perform the following to minimize risk of RF current burn:
1. Place cables and lead wires neatly in straight alignment with no looping.
2. Keep the length of lead wires and patient cable within the bore to a minimum.
3. RF burn risk increases when multiple sensors/cables are in use. Such combinations are not
recommended.
4. The high radio frequency (RF) power used in MRI scanning poses an ever-present risk of
excessive heat at the monitoring sites and, therefore, the risk of RF current burn. Should
power levels greater than S.A.R. of 4 w/kg peak (0.4 w/kg average) be used, the risk of
patient burn greatly increases. As a result, monitoring of ECG or Respiration (derived
from ECG leads) at power levels of greater than 4 w/kg peak (0.4 w/kg average) is not
recommended for the general patient population. Such monitoring should only be attempted
on conscious patients with good temperature reflex so they may warn the operator of
excessive heat at the monitoring sites.
5. High RF Power may cause patient heating or burns. For scans with average S.A.R. > 1 w/kg,
limit scan time to 5 minutes and pause at least 3 minutes between scans to allow ECG Cable
to cool.
ECG
For best ECG and Heart Rate monitoring, always select the optimum lead configuration which has
the least artifact and largest waveform(s) being detected for monitoring use.
Failure to respond to a Lead Fail alarm will cause a lapse in your patient’s monitoring. Always
respond promptly to this and any other alarms.
MRI induced radiofrequency artifact can sometimes cause inaccurate heart rates. Inspect the ECG
waveform during MRI scanning if spurious heart rates are observed.