Invivo Magnitude 3150M Operation Manual
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Invivo Magnitude 3150M Operation Manual

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  • Page 3 Invivo Research, Inc Magnitude 3150M MRI Monitor Omni-Trak 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...

  • Page 5: Table Of Contents

    TABLE OF CONTENTS Paragraph Number Page Number List of Figures ............. . . Equipment Classification .
  • Page 6 TABLE OF CONTENTS Paragraph Number Page Number 4.1.4 ECG Control Keys ..........4.1.5 Alarm Limits .

  • Page 7: List Of Figures

    LIST OF FIGURES Figure Number Page Number 3150(M) MRI Monitor Top Panel ......... Control Panel .

  • Page 8: Precautions

    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.
  • Page 9 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.
  • Page 10 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.
  • Page 11 PRECAUTIONS (Continued) ECG (Continued) (static) magnetic field artifact can present artificially-induced augmented T waves during ECG monitoring. Due to the effects of the magnetic field on the moving blood of the patient, follow the recommended ECG Electrode Placement to minimize this type of artifact. An inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm.
  • Page 12 Use only MRI compatible fiberoptic SpO2 accessories (See MRI Accessory list in this Section). Use only the Fiberoptic SpO2 sensors recommended by Invivo Research, Inc. A listing of these can be found in the Accessory List within this manual, or by contacting Invivo Research, Inc. directly.
  • Page 13 PRECAUTIONS (Continued) SpO2 (Continued) The SpO2 monitoring portion of this monitor is intended to measure arterial hemoglobin oxygen saturation of functional hemoglobin (saturation of hemoglobin functionally available for transporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, may affect the accuracy of the measurement.
  • Page 14 Room. This product, or any of its parts, should not be repaired other than in accordance with written instructions provided by Invivo Research Inc., or altered without prior written approval of Invivo Research Inc. The user of this product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Invivo Research Inc., or its authorized service personnel.

  • Page 15: User Responsibility

    Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should such repair or replacement become necessary, Invivo Research Incorporated (IRI) recommends that a telephone call or written request for service be made to the factory or nearest service center.

  • Page 16: Mri Accessories

    MRI ACCESSORIES Item Description Model Number ® Quadtrode MRI ECG Patient Cable and Lead Wire Set ......9240 ®...
  • Page 17 PULSE OXIMETRY Item Description Model Number MRI Fiberoptic Finger Sensor w/cable (16 ft. length) ....... 9367 MRI Fiberoptic Wrap Sensor w/cable (16 ft.
  • Page 18 Adapter, Luer Lock, Female/Female ..........9027 For conversion of Millennia male front panel connector for use with non-Invivo sampling lines.
  • Page 19 MRI GATING OPTIONS FOR MAGNITUDE 3150M GE Horizon/LX Magnitude Gating Option for MRI ......9278 Provides cardiac and peripheral gating.
  • Page 20 MRI GATING OPTIONS FOR 3150 Item Description Model Number GE Horizon/LX 3150 MRI Gating Option ........9244 Provides cardiac and peripheral gating.
  • Page 21 MISCELLANEOUS Item Description Model Number Magnitude 3150M and 3150/3155 Repeater Kit ....... . . 9454 Service Technician Installation fee quoted separately.

  • Page 23: Introduction

    3155A Remote Monitors, they will be referred to (in this manual) only as “Remote Monitor(s).” CAUTION For continued patient safety and image integrity, use only those Invivo Research accessories and equipment specifically designated for MRI. 1.1 Features. The 3150(M) MRI Monitor has been carefully engineered to take full advantage of the most advanced technology.

  • Page 24: Use Of This Manual

    1.2 Use of this Manual. For detailed information on any feature which the 3150(M) MRI Monitor provides, consult the Table of Contents and, after you have located the particular paragraph which you want to read, turn to the appropriate page. Every item in this document (such as pages, paragraphs, figures, tables, etc.) is numbered with the Section Number first followed with the Sequential Number of the item being numbered.

  • Page 25: Control Panel

    1.4.1 Control Panel. (See Figure 1-2) The 3150(M) MRI Monitor control panel provides secondary control over some of the features of the monitor. The following is a description of the Control Keys. ALARM. (Item 1) The ALARM Silence Control Key may be used to silence an existing alarm or, if no alarm condition exists, to place the Alarms on Hold.

  • Page 26: Flat Panel Display

    1.4.2 Flat Panel Display. The Flat Panel Display Screen displays up to four (4) Parameter Waveforms of approximately five (5) seconds of patient data. The Normal Screen (See Figure 1-3) contains three (3) different display groups: the first located along the top of the screen and is called the Information Display, the second is located in the middle of the screen is called the Vital Signs Trace Display and the third is located at the bottom of the screen and is called the Vital Signs Numeric Display.
  • Page 27 ECG Lead. ECG Lead provides a visual indication of the ECG Lead Selection. The Lead options are: I, II, III, AVR, AVL, AVF and CAL. ECG Scale. ECG Scale provides a visual indication of the ECG Scale Selection. The Size options are: 5, 10, 15, 20, 25, 30, 40 and A (Auto). Patient.

  • Page 28: System Screen

    The Invivo Research cabling from the monitors inside the Magnet Room runs through a special Filter Block mounted on the wall (penetration panel) outside the Magnet...

  • Page 29: Mri Monitoring Components

    1.7.1 MRI Monitoring Components. Complete MRI Patient Monitoring Requirements are met with the 3150(M) MRI Monitor and Remote Monitor. No other monitor or device is necessary. NOTE The 3150(M) MRI Monitor should be securely mounted (wheel locks engaged) and at least five (5) feet from the bore (outside the 5000 Gauss <0.5T> Field Line of the MRI System), never directly in line with the bore.

  • Page 30: Cleaning Instructions

    Integrity of the ECG waveforms and readouts should be maintained at their optimum. To ensure quality ECG performance: ® Use only Invivo Research Quadtrode MRI ECG Electrode Pad (IRI Part Number 9303N). Never use alcohol to prepare the skin for electrode application, as it removes electrolytes required for good electrode contact.

  • Page 31: Cleaning Accessories

    1.8.1 Cleaning Accessories. Any reusable patient accessories should be cleaned after each use. Disposable patient accessories should be discarded and replaced with new items. To clean reusable accessories, first, remove the accessory from the monitor. Remove any dirt or debris using soap and water. Avoid immersing accessory in any fluid for cleaning. Inspect the accessory for any cracks, holes, tears, cuts, etc., that could affect operation, and replace as necessary.

  • Page 33: Installation

    Save all packing materials, invoice and bill of lading as these may be required to process a claim with the carrier if damage during shipment occurred. Contact Invivo Research, Inc. Customer Service for prompt assistance in resolving shipping problems. Once satisfied that all the listed parts are present and that no damage has occurred during shipment, follow the instructions provided in the shipping carton for the required assembly procedure of this monitor.
  • Page 34 Ensure that all patient cables meet manufacturers recommended condition for patient use. Visually inspect for breaks, cracks and/or fraying. Report any problems to Invivo Research, Inc., or an authorized Invivo Research, Inc. Service Representative. Verify the accuracy and proper functioning before using the monitor on a patient.
  • Page 35 On the 3150(M) MRI Monitor, turn the Power Switch to the ON position. Once the 3150(M) MRI Monitor has come on line, turn the front panel Power Switch on the Remote Monitor to the ON position. After the Remote Monitor is on line, verify that the signal is received from the 3150(M) MRI Monitor Verify that the lower right hand box on the Display Screen is labeled REMOTE, both squares inside the box are together and the STATUS box is...
  • Page 36 interference is coming from another machine (or machines) within the immediate environment. If Remote Transmission is still not possible, contact a Qualified Service Representative for further assistance.

  • Page 37: Introduction

    SECTION 3 MONITOR PREPARATION FOR USE MONITOR PREPARATION FOR USE. Introduction. The 3150(M) MRI Monitor is fundamentally a Data Acquisition Monitor, ® that is, most of the operational parameters are set remotely at the Millennia 3155MVS or 3155A Remote Monitor. The operator is provided some limited control of the patient monitoring with Control Keys to select the ECG Lead and Waveform Size, Zero EtCO2, P1 and P2 and, for the NIBP Parameter, the ability to change the selected Patient Type, to select the Automatic Mode Cycle Time and to Start/Stop NIBP readings.

  • Page 39: Patient Parameters

    RF induced currents. When lead wires or other cables form this conductive loop in contact with the patient's tissue, minor to severe burning can result. Use only with the Invivo Research Patient Cable, #9240, which consists of both the 9240A (MRI Lead Wire Cable) and the 9240B (MRI ECG Cable) Assemblies.
  • Page 40 CAUTION High RF power may cause patient heating or burns. Invivo strongly recommends that every user become familiar with these ECG monitoring precautions. Manual pre-scanning, high TGs, large patients, body coil transmit/surface coil receive type scans and fast scan techniques are clues that should alert you to be especially cautious about potential electrode heating.

  • Page 41: 4.1.2 Maintenance Of Optimum Ecg Waveform Integrity

    Route ECG patient cable down the center of the bore, not touching the sides. To further reduce RF current pickup, keep the length of the ECG patient cable within the bore to a minimum. This can very often be accomplished and is strongly recommended for large patients of "L" spine or similar exams by placing the patient in the bore feet first and routing the patient cable directly from the electrodes over the patients shoulder and out the bore (See Figure 4-3).

  • Page 42: Associated Displays

    Figure 4-4. The ECG Display 4.1.3 Associated Displays. (See Figure 4-4) ECG information is displayed as a waveform in the Trace A location and as numerical data on the left side of the waveform trace. The following is a description of the items located within the ECG Display: Heart Rate Numeric.

  • Page 43: Patient And Cuff Preparation

    Figure 4-5. Oscillometric Measurement Method As cuff pressure is reduced to just below the systolic pressure, the force of the height of the systolic pressure wave forces the occluded artery open, blood spurts through the artery and the amplitude of the oscillations increase sharply. This is the systolic pressure.

  • Page 44: Associated Displays

    WARNING Do not attach the cuff to a limb being used for infusion. Cuff inflation can block the infusion causing possible harm to patient. Cuff Positioning. The cuff should be wrapped firmly (not snug) around the arm of the patient and positioned as close to heart level as possible. If the cuff is not at heart level, add 1.8 mmHg to the displayed readings for each inch that the center of the cuff is located above the patient's heart level;...

  • Page 45: Blood Pressure Reading Intervals

    4.2.7 Blood Pressure Reading Intervals. A blood pressure reading may be taken at automatic intervals, or the operator can take manual control of the monitor's determination cycles at any time using the NIBP START/STOP Control Key on the 3150(M) MRI Control panel.
  • Page 46 4.3.2 Zeroing Pressure Channels. The transducer must be zeroed before each use and at regular intervals during use. The transducer must be vented to atmospheric pressure before the transducer may be successfully zeroed. Upon completion of the zeroing cycle, a message appears momentarily to inform the operator if the transducer has been successfully zeroed (See Paragraph 4.3.5).
  • Page 47 SpO2 Monitoring. Select the Fiberoptic SpO2 sensor to be used and connect to the SpO2 isolated patient connector on the Parameter Input Panel. Place probe in desired location on patient. After four to six pulses, the oxygen saturation value (percent of saturation) and pulse waveform (if selected) will appear on the display.
  • Page 48 SpO2 Waveform Trace. (Item 3) The SpO2 waveform for the connected patient. 4.4.4 Alarms. Alarm Limits are set at the Remote Monitor, no adjustment of Alarm Limits is available at this monitor. 4.4.5 SpO2 Messages. The following is a list of message which may be displayed during SpO2 monitoring: Searching The monitor is searching for a good pulse.
  • Page 49 NOTE To perform Zero Calibration, the monitor pulls ambient air through the CO2 Zero Intake Port located on the top of the base directly behind the column. The Calibration system assumes that the ambient air will contain normal amounts of trace CO2. If this monitor is placed in an unventilated area that allows CO2 (from the rear panel CO2 Exhaust Port - if not connected to a Gas Scavenging System) to accumulate, the result could be inaccurate Zeroing of the EtCO2 module and resulting inaccurate patient readings.
  • Page 50 For best fit and compatibility, Invivo Research strongly recommends the use of the Invivo CO2 Sampling Kit (Part No. 9010D), which contains all the above tubing and endotracheal tube adaptor. The following sizes of sampling nasal cannulae are available: Part No.
  • Page 51 . There are two Gating options provided: Monitor Heart Rate Source and SpO2 Pulse. This option requires custom cabling specific to each MRI System. For assistance installing proper cabling to operate the Gating System, contact Invivo Research, Inc. Technical Support at (888) 221-1593. 4-13...
  • Page 53 SECTION 5 BATTERY OPERATION BATTERY OPERATION. Introduction. This monitor is equipped with four (4) Lead Acid Gel Cell Batteries which provide battery power for eight hours with fully charged batteries. The batteries are designed to be used whenever the monitor is being moved or when the monitor cannot be readily connected to an AC Power Source through the AS153 AC Power Adapter.
  • Page 55 APPENDIX A SPECIFICATIONS GENERAL PATIENT SAFETY Designed to meet the requirements of CSA, UL 2601 and IEC 601-1. Defibrillator protection up to 5 KV. POW ER REQUIREM ENTS Operating Voltages 120 VAC ±10%, 50/60 Hz 240 VAC ±10%, 50/60 Hz Power Consumption 50 Volt-Amperes nominal, 90 Volt-Amperes maximum (using AS153 Power Ad apter)
  • Page 56 GENERAL DISPLAY Type LCD: 240 x 128 pixels Screen Size 122 x 65 mm. 138 mm (5.64 in.) Sweep Speed 25 mm/S. 3.125 mm/S (Respiration Only). Waveform Display Mode Fixed trace with moving Erase Bar Waveform Display Height 25 mm (±10%) Display Bandwidth 33 Hz minimum ECG CHANNEL...
  • Page 57 ECG CHANNEL CARDIOTACH (Continued) Sensitivity -5 mV to +5 mV Display Gain Scales 5, 6, 7, 8, 9, 10, 12, 15, 18, 20, 25, 30, 35, 40 and Autoscale. (mm/mV) Bandwidth Monitor: 0.5 to 40 Hz MRI View: 0.5 to 10 Hz adaptive, 0.5 to 40 Hz for Baseline Offset: Automatically nulled.
  • Page 58 NON-INVASIVE BLOOD PRESSURE MEASUREMENT RANGE Systolic 30 to 250 mmHg. Diastolic 10 to 240 mmHg. Mean 15 to 250 mmHg. Pulse Rate 40 to 238 bpm (Measurements are possible only in pulse rate range of 40 to 238 bpm.) ACCURACY Pulse Rate 2% full scale Pressure Zero Offset...
  • Page 59 PRESSURE CHANNELS (Optional) PRESSURE SCALE RANGES 0 to +250 mmHg, 0 to +200 mmHg, (Set at Remote Monitor) 0 to +150 mmHg, 0 to +100 mmHg 0 to + 75 mmHg, -10 to + 40 mmHg TRANSDUCER ADAPTER CABLE COMPATIBILITY Invasive pressure input mates with an Amphenol connector (MS-3106A 14S-6P).
  • Page 60 Pitch of pulse tone is modulated by saturation values from 70 to 100%. Saturation Range 50 to 100% Saturation Accuracy With Invivo Research Fiberoptic Probes: at 90 to 100% 2.2% at 80 to 90% 2.5% at 70 to 80% 2.8% at 60 to 70% 3.3% at 50 to 60%...
  • Page 61 END-TIDAL CO2 (Optional) TECHNIQUE IR absorption, using a single IR source and three detector channels on a single substrate. Temperature of the IR source is feedback-controlled. Internal design and software algorithms make the sensor largely self-compensating, precluding the need for mechanical choppers or temperature compensation/control.
  • Page 62 ECG of SpO2 respectively in the ECG Heart Rate Source menu at the 3155 Remote Monitor.) NOTE Patient Gating requires use of a Gating Cable that is unique to your MRI System. Contact Invivo Research Technical Support for further information. EQUIPMENT CLASSIFICATION Classification according to IEC-601-1 According to the type of protection against Class I equipment.
  • Page 63 APPENDIX B REPAIR All repairs on products under warranty must be performed by Invivo Research Incorporated (IRI) personnel, or an authorized IRI Service and Repair Center. Unauthorized repairs will void the warranty. If a monitor fails to function properly or requires maintenance, contact IRI Technical Service at 1- 800-331-3220 during normal business hours EST or 24 hour emergency technical assistance.
  • Page 65 (30) days on expendable parts. This warranty shall become null and void if product has been repaired other than by Invivo Research, Inc. (IRI), or if the product has been subject to misuse, accident, negligence or abuse.
  • Page 67 APPENDIX D DECLARATION OF CONFORMITY...
  • Page 69 Following shaving the skin, abrade the skin using Trace Aid ECG Abrasive Skin Prepping Gel (Invivo Research part number 9009). This gel can provide a conductive paste as well as abrade the upper surface of the skin. Separate instructions are provided with this gel, and should be followed accordingly.
  • Page 70 Electrode Impedance Meter for the acceptable impedance level. ECG Patient Cable and Lead Wires - The Invivo Research 9240 ECG Patient Cable and Lead wires are specially designed for use in the MRI bore. The 9240A Lead Wires are constructed of special material to help reduce the amount of radio frequency energy which can flow through these wires.
  • Page 71 Proper Cable Placement inside the MRI Bore - (Refer to the Figures 2 and 3 illustrations on MRI Monitoring Precautions Card - Invivo Research part number L2010). The ECG Lead Wires must always be kept in a straight line inside the MRI bore. No loops of any kind (circular, “U”...
  • Page 72 ! Dry or expired electrodes - Use of dried out or expired electrodes will reduce the conductive path and possibly the contact surface area between the skin and electrode, which can reduce the effective area between the skin and electrode. Also, if the expired electrode adhesive ring does not allow the electrode to be firmly secured to the skin, any “lifting”...
  • Page 73 APPENDIX F LIST OF SYMBOLS...
  • Page 75 NOTES...

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Omni-trak 3150

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