Millenna 3155A + 3155MVS Operations Manual Release 11 Dec 2002

TABLE OF CONTENTS Paragraph Number Page Number List of Figures... iv List of Tables... v Equipment Classification ... v Precautions... vi User Responsibility ... xi Accessory List...xii 1.0 1.1

1.2

1.3

1.4 1.5 2.0 2.1 2.2

2.3

3.0 3.1 3.2

INTRODUCTION... 1-1 Product Description ... 1-1 1.1.1 System Parameters ... 1-2 1.1.2 User Interface... 1-2 1.1.3 Versatility ... 1-2 Controls... 1-2 1.2.1 Front Panel Controls ... 1-2 1.2.2 The Side Panel ... 1-7 1.2.3 Back Panel Connections and Inputs... 1-7 Display ... 1-7 1.3.1 Informational Display ... 1-8 1.3.2 Vital Signs Trace Display ... 1-9 1.3.3 NIBP, Agents and Remote Display... 1-10 Yes/No Menu ... 1-11 Cleaning ... 1-11 1.5.1 Cleaning Accessories ... 1-12 INSTALLATION... 2-1 Introduction... 2-1 Monitor Installation ... 2-1 2.2.1 Monitor Mounting... 2-1 2.2.2 Monitor Location ... 2-1 2.2.3 Preparing the 3155A/3155MVS Monitor for Use ... 2-1 2.2.4 Monitor Start Up ... 2-2 2.2.5 3150(M) and 3155A/3155MVS Remote Monitor Communication ... 2-2 Software Installation ... 2-4 2.3.1 Program Update/Upgrade ... 2-4 2.3.2 Monitor Setup Storage ... 2-5 2.3.3 Monitor Setup Recall ... 2-5 MONITOR PREPARATION FOR USE ... 3-1 Introduction... 3-1 SETUPS Menu... 3-1 3.2.1 Recall Setups... 3-1 3.2.2 Store Setups ... 3-2 3.2.3 Parameter Selection ... 3-3 3.2.4 Display Setup ... 3-4 3.2.5 Sound Adjust... 3-5 3.2.6 Patient ... 3-6 i

TABLE OF CONTENTS Paragraph Number Page Number 3.2.7 Set Time ... 3-6 3.2.8 Default Setups... 3-7 3.2.9 Sweep Speed ... 3-7 3.2.10 Respiration Speed ... 3-7 3.2.11 Service (Bio-Med) ... 3-7 3.2.12 Return... 3-10 3.3 Store/Recall Setups ... 3-10 3.4 Monitor Initialization ... 3-10 3.4.1 Default Initialization ... 3-10 3.4.2 Pre-Configured Initialization ... 3-11 4.0 4.1 4.2

4.3

4.4

4.5

4.6

PATIENT PARAMETERS... 4-1 Introduction... 4-1 ECG Monitoring ... 4-1 4.2.1 Associated Waveforms and Displays... 4-1 4.2.2 The ECG Menu ... 4-1 4.2.3 Alarm Limits... 4-4 4.2.4 Trended Data... 4-4 4.2.5 ECG Messages ... 4-4 Invasive Pressure Monitoring ... 4-5 4.3.1 Associated Waveforms and Displays... 4-5 4.3.2 The Invasive Pressure Menu... 4-5 4.3.3 Alarm Limits... 4-7 4.3.4 Trended Data... 4-7 Non-Invasive Blood Pressure (NIBP) Monitoring ... 4-7 4.4.1 Theory of Oscillometric Measurement ... 4-8 4.4.2 Associated Displays ... 4-9 4.4.3 The NIBP Menu... 4-10 4.4.4 NIBP Menu Options ... 4-10 4.4.5 Using the Automatic Interval Mode ... 4-12 4.4.6 Manually Starting/Stopping a Reading Cycle... 4-12 4.4.7 Stat Mode Operation ... 4-12 4.4.8 Alarm Limits... 4-13 4.4.9 Adult vs. Neonatal Mode Operation ... 4-13 4.4.10 Trended Data... 4-13 SpO2 Monitoring ... 4-13 4.5.1 Associated Waveforms and Displays... 4-13 4.5.2 SpO2 Menu ... 4-14 4.5.3 Alarm Limits... 4-15 4.5.4 Trended Data... 4-15 End-Tidal CO2 (ETCO2) Monitoring... 4-15 4.6.1 Patient and Tubing Preparation... 4-15 4.6.2 Associated Waveforms and Displays... 4-16 4.6.3 ETCO2 Menu... 4-17 4.6.4 Calibration of CO2/N2O Measurement System ... 4-17 4.6.5 Alarm Limits... 4-17 4.6.6 Trended Data... 4-17 ii

TABLE OF CONTENTS Paragraph Number Page Number 4.7 Anesthetic Agent/Oxygen Monitoring... 4-18 4.7.1 Patient and Tubing Preparation... 4-18 4.7.2 Associated Displays ... 4-18 4.7.3 Agent Menu ... 4-19 4.7.4 Gas Calibration ... 4-19 4.7.5 Alarm Limits... 4-20 4.7.6 Trended Data... 4-20 4.7.7 Agent/O2 Messages ... 4-20 4.7.8 Oxygen Sensor Replacement ... 4-20 5.0 5.1 5.2 5.3

5.4 5.5

6.0 6.1 6.2 6.3 6.4 6.5 6.6 6.7 7.0 7.1 7.2 7.3 7.4 7.5 7.6

PRINTING AND TRENDING ... 5-1 Introduction... 5-1 5.1.1 Record Key ... 5-1 The RECORDER Menu... 5-2 Printing Charts ... 5-3 5.3.1 Strip Chart Printouts ... 5-3 5.3.2 Tabular Chart Printouts ... 5-4 5.3.3 System Data Report ... 5-5 Loading Printer Paper ... 5-5 Trending Feature ... 5-5 5.5.1 HISTORY Menu Options ... 5-5 5.5.2 Theory of Operation... 5-6 5.5.3 Trend Options ... 5-7 ALARMS ... 6-1 Introduction... 6-1 Alarm Limits... 6-1 6.2.1 Default (Pre-Set) Alarm Limits ... 6-1 6.2.2 Range of High and Low Alarm Limits ... 6-1 Alarms Menu ... 6-2 6.3.1 Individual Parameter Alarm Limits Box ... 6-7 Turning Alarms Off on Individual Parameters ... 6-7 Alarm Violations... 6-7 Adjusting the Alarm Tone Volume ... 6-7 6.6.1 Disabling the Alarm Tone... 6-8 Standby Mode ... 6-9 BATTERY OPERATION ... 7-1 Introduction... 7-1 Battery Location and Access ... 7-1 Loading and Unloading Battery(s) ... 7-1 Battery Charging... 7-1 Battery Operation Time ... 7-1 7.5.1 Battery Low Indication ... 7-1 7.5.2 Maintaining Battery Life ... 7-1 Battery Replacement... 7-1

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TABLE OF CONTENTS Paragraph Number Page Number Appendix A. Specifications ...A-1 Appendix B. Repair ...B-1 Appendix C. Warranty...C-1 Appendix D. Declaration of Conformity...D-1 Appendix E. KpA to mmHg Conversion Chart ... E-1 Appendix F: List of Symbols ... F-1

LIST OF FIGURES Figure Number Page Number 1-1 The Front Panel... 1-2 1-2 The Direct Control Keys... 1-3 1-3 Menu-Select and Operation Keys ... 1-4 1-4 The Back Panel ... 1-7 1-5 The Normal Screen ... 1-8 1-6 The Informational Display... 1-8 1-7 The Middle Screen Vital Signs Trace Display ... 1-9 1-8 The Bottom Vital Signs Numeric Display ... 1-10 3-1 The SETUPS Menu ... 3-1 3-2 The RECALL SETUPS Menu ... 3-2 3-3 The STORE SETUPS Menu... 3-3 3-4 The PARAMETER SELECTION Menu ... 3-3 3-5 The SOUND ADJUST Menu ... 3-4 3-6 The SET TIME Menu ... 3-6 3-7 The SERVICE (BIO-MED) Menu ... 3-7 3-8 The SYSTEM CONFIG Menu ... 3-8 4-1 ECG Display ... 4-1 4-2 The ECG Menu ... 4-2 4-3 The ECG SCALE Menu ... 4-2 4-4 The HR SOURCE Menu... 4-3 4-5 Invasive Pressure Display ... 4-5 4-6 The P1 Menu (ART Selected) ... 4-6 4-7 Invasive Pressure SET LABEL Menu ... 4-6 4-8 Oscillometric Measurement Method ... 4-8 4-9 The NIBP Display... 4-9 4-10 The NIBP Menu... 4-10 4-11 The NIBP INTERVAL Menu... 4-10 4-12 The HISTORY Menu... 4-11 4-13 The SpO2 Display... 4-13 4-14 The SpO2 Menu... 4-14 4-15 Patient Sample Circuit ... 4-15 4-16 The ETCO2 Display ... 4-16 4-17 The ETCO2 Menu ... 4-17 4-18 The AGENT Display ... 4-18 4-19 Oxygen Sensor Installation Diagram ... 4-21 5-1 The RECORDER Menu... 5-1 iv

LIST OF FIGURES Figure Number Page Number 5-2 Sample Strip Chart... 5-3 5-3 Sample Tabular Chart ... 5-4 5-4 System Data Report ... 5-4 5-5 Loading the Printer Paper ... 5-5 5-6 The HISTORY Menu... 5-5 5-7 The MULTI TRENDS Menu... 5-6 5-8 The Trend SELECT Menu... 5-7 5-9 Sample Mult Trends Printout... 5-8 6-1 The ALARMS Menu ... 6-4 6-2 Anesthetic Agents Alarm Limits Menu ... 6-5

LIST OF TABLES Table Number Page Number 6-1 Alarm Limit Factory Default Settings...6-2 6-2 Range of Alarm Limits ... 6-3

EQUIPMENT CLASSIFICATION Classification according to IEC-601-1 According to the type of protection against Class I equipment. electrical shock: According to the degree of protection against Type CF (defibrillator-proof) equipment. electrical shock: According to the degree of protection against Ordinary equipment (enclosed equipment harmful ingress of water: without protection against ingress of water). According to the methods of sterilization or disinfection:

Non0sterilizable. Use disinfectants only.

According to the mode of operation:

Continuous operation.

of

Liquid

surface

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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Precautions General Federal law in the USA or Canada restricts this device to sale by, or on the order of, a physician. The Millennia® 3155A/3155MVS Monitor supplied with your Omni-TrakTM 3150/MagnitudeTM

3150M monitor is factory set to communicate only with the specific monitor it came with.

The Omni-TrakTM 3150/MagnitudeTM 3150M MRI Patient Monitoring System is comprised of the 3150(M) and a Millennia® 3155A/3155MVS Remote Monitor. Always operate the OmniTrakTM 3150/MagnitudeTM 3150M MRI Patient 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 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 completely before attempting to operate the Millennia® 3155A/3155MVS 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 an “X” appears in the Alarm Bell symbol, 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, use only recommended Invivo Research patient cable, lead wires, cuffs, hoses, sensors, tubing, etc. A listing of these can be found in the Accessory Listing within the 3150(M) manual (Part Number 9538), 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. Organic vapors (e.g. from cleaning agents) in sampling line or room air may alter anesthetic agent readings. Alcohol in patient's breath may modify the anesthetic agent readings.

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Precautions 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 DC 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. If the integrity of the earth conductor of the AC mains power cable is in doubt, operate the monitor on internal battery power until proper earth connection is confirmed. Avoid use of electrical power extension cords. Electrical power cords may create a safety hazard by compromising the grounding integrity of the monitor. 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 may be safely powered by the voltages 110-120/220-240 ~ having a frequency of 50 or 60 Hz. Occupational Safety Connect the sample gas outlet on the monitor's rear panel to scavenging system to prevent pollution of room air. Handle the Patient Sampling Line and its contents as you would any body fluid. Infectious hazard may be present. MRI Use Precautions Certain components of this device will be affected by the 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 Millennia® 3155A/3155MVS Monitor 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. Always verify proper communication of the Omni-TrakTM 3150/MagnitudeTM 3150M MRI Patient Monitor with the Millennia® 3155A/3155MVS Monitor prior to patient use. MRI Magnet Room Placement. The Omni-TrakTM 3150 MRI/MagnitudeTM 3150M MRI Patient Monitor is designed to be used in conjunction with a remotely located Millennia® 3155A/3155MVS Monitor. The Omni-TrakTM 3150/MagnitudeTM 3150M MRI Patient 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.

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Precautions ECG An inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. Heart rate values may be adversely affected by cardiac arrhythmia, or by operation of electrical stimulators. For other ECG related precautions, refer to the 3150(M) Monitor Operations Manual (IRI Part Number 9538). NIBP Always use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuff hose. For other NIBP related precautions, refer to the 3150(M) Monitor Operations Manual (IRI Part Number 9538). SpO2 The numeric measurement values are updated every 1 second on the monitor display. The pulse oximeter feature in this monitor is designed to display functional SpO2 values. The pulse oximeter pulsatile waveform is not proportional to the pulse volume, but adjusts the waveform amplitude as needed for proper viewing. All monitor alarms are categorized as medium priority, unless otherwise specified. For other SpO2 related precautions, refer to the 3150(M) Monitor Operations Manual (IRI Part Number 9538). EtCO2 Always select the appropriate EtCO2 gas sampling flow rate for the patient being monitored. Verify that the patient’s breathing efforts and timing coincide with the monitor’s waveform before completion of the patient set-up. The N2O measurements are automatically pressure compensated over an ambient pressure minimum range from 645 to 795 mmHg. The EtCO2/N2O measurement displays the sampled value within 1 second of when the gas was sampled. The alarm tone volume exceeds 60 dBA at a distance of 1 meter when the alarm tone volume adjustment is set above selection number 4. Frequently inspect the EtCO2 patient tubing for proper gas flow. Avoid kinking of the EtCO2 patient tubing that can result in leaking, reduction, or cut-off of the sample gas flow. Inaccurate gas measurements could result. EtCO2 patient tubing and its associated components are intended for single-patient use only. Avoid cleaning or disinfecting these items for reuse. Inaccurate gas measurements could result. To prevent inaccurate or missed readings, keep the EtCO2 patient tubing clear of any moving mechanisms which may kink, cut or dislodge the patient tubing. Avoid connecting the EtCO2 calibration gas canister to the monitor by any method other than with the designated calibration tubing. Connecting by any other method could invalidate the calibration, and/or damage the monitor. Respiration rate measurement errors could result during ventilation rates above 80 breaths per minute.

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Precautions Anesthetic Agents Inadequate ventilation of the monitor may cause inaccurate readings or damage to electronic components. Ensure that the exhaust gas is not removed from the monitor under too strong suction. To prevent suction, there must always be an opening to the room air. Strong suction may change the operating pressure of the monitor and cause inaccurate readings or internal damage. Inspect waste gas line for deterioration on a routine basis. Replace as needed. Remove sampling line from patient airway whenever nebulized medications are being delivered. Use only Invivo Research, Inc. sampling lines and accessories; other sampling lines may cause inaccurate readings and malfunctions. In Desflurane Gas Mixtures, the change in concentration of the other anesthetic may become clinically significant before a gas mixture alarm is given. Some Hydrocarbons (e.g. Acetone, Methane) may cause a mixed agent alarm to occur. Replace the sampling line and filter between each patient use. Routinely inspect the hose assemblies for proper attachment and orientation. Replace hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. If hose assemblies with damage which could result in leaks are used, prolonged and/or inaccurate patient readings could result. If questionable oxygen or anesthetic agent gas measurements are observed, recheck patient connections, anesthesia gas machine and/or vaporizer before re-adjusting oxygen or anesthesia delivery. Always respond to patient tubing disconnect alarms immediately to prevent lapse in patient monitoring. Routinely verify the monitor’s internal barometric pressure reading with local conditions during the initial start-up period. Gas mixtures of Desflurane and Sevoflurane will not cause a multiple agent alarm. The optical filters used to determine Desflurane and Sevoflurane are very similar, making it very difficult to determine the presence of Desflurane and Sevoflurane at the same time. The identification could be either Desflurane or Sevoflurane in concentration values (Fi and ET) greater than either of the actual concentrations of Desflurane and Sevoflurane. During the 15 minute warm-up with no sample line connected to the monitor it is possible to have a false identification and value display of Enflurane. With no gas reading (Agent Icon box with white X for agent identification and agent values of “--“) when Agent Vaporizer is first turned on, it may take 30 seconds to 1.5 minutes for agent identification and reading to be displayed. Once identification is established, changes in concentration are virtually immediate. With a 200% change in concentration, an auto Zero will occur, and full accuracy of the changed concentration will be accomplished within approximately 30 seconds. Whenever the Millennia® 3155A’s Agent sensor changes from steady state condition, the Millennia® 3155A will perform an auto zero to restabilize the sensor readings. During this time, 15 seconds to 1.5 minutes, it is possible for a false identification and concentration value to occur. Examples are as follows: a. b. c. d. e. f.

No gas, during warm-up and when sample line is disconnected. Applying sample line for the first time. When switching from one Agent to another. Applying N2O in concentrations of 70% or more. Going from N2O of greater than 50% to 0%. When going from high Agent concentrations to low or off.

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Precautions Pressures Air that may be trapped within the pressure transducer or its associated tubing should be removed by flushing the system following established hospital or catheter lab procedures. The fluid within the pressure transducer system is a conductive connection to the patient, and should not contact other conductive parts, including earth ground. Other 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. This monitor is equipped with a demonstration mode which displays simulated electronic patient data for training or demonstration purposes. Do not attach a patient to the monitor whenever this simulation is present on the monitor display (“SIMULATION” can also be seen in the screen center). Failure to properly monitor the patient could result. The patient connector inputs for all parameters are protected against the use of a defibrillator by internal circuitry, and when the recommended patient cables or accessories are used. The use of this circuitry and these recommended cables and accessories also protects against the hazards resulting from use of high frequency surgical equipment. There are no known electromagnetic or other hazardous interference between the monitor and other devices including MRI Scanners. However, care should be taken to avoid the use of cellular phones or other unintended radio-frequency transmitters in the proximity of the monitoring system. This monitor uses rechargeable batteries which contain lead, which must be recycled, or disposed of properly. For proper disposal methods, contact your local Invivo Research, Inc. representative or distributor.

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USER RESPONSIBILITY This product will perform in conformity with the description contained in this operators manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked and calibrated periodically. A malfunctioning product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary refer unit to qualified service personnel. This product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer, or altered without written approval of Invivo Research, Incorporated (IRI). The user of the 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 or Invivo Research authorized service personnel. Using this Manual. Whenever the various options are discussed, “XXX” is used to indicate a variable setting. It is required that every operator read this manual completely, including any patient information in sections about monitoring features the operators monitor does not have, before attempting to operate the Millennia® 3155A/3155MVS Monitor. Precautions (listed earlier in this section) cover of wide ranges of information crucial to the safe monitoring of patients. It is required that every operator read the PRECAUTIONS completely, including the Precautions associated with monitoring features that the operators monitor does not have, before attempting to operate the Millennia® 3155A/ 3155MVS Monitor. For further information or assitance with this product: Invivo Research, Incorporated 407-275-3220 or 800-331-3220

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Accessory List END -TIDAL CO2 Item Description Part Number ETCO2 Sampling Kit ...9010D Contains 20 foot co-extruded sampling tube polyethylene inner core with PVC jacket, Nafion® tube, elbow adapter, 0.8 micron disk filter. Nasal ETCO2 Sampling Kit...9010DA Contains 10 foot co-extruded sampling tube, polyethylene inner core with PVC jacket, Nafion® tube, elbow adapter, 0.8 micron disk filter. Nasal ETCO2 Sampling Kit Replacements Co-extruded Nasal ETCO2 Sampling Line...9028 10 foot co-extruded polyethylene inner core with PVC jacket, male/female locking luer, package of 50. Co-extruded Nasal ETCO2 Sampling Line...9041 20 foot co-extruded polyethylene inner core with PVC jacket, male/female locking luer, package of 25. Endotracheal Tube Adapter, package of 50...9025 Hydrophobic Disk Filter, 0.8 Micron, Male / Female Locking Luer, package of 50...9026 Nafion® tube, ME dryer (1 replacement) ...9010H Nasal ETCO2 Supplies ETCO2 Calibration Gas, aerosol 10% CO2, 50% N2O, Bal. N2...9010F Adult Nasal ETCO2 Sampling Cannula 7 foot line...9012 Pediatric Nasal ETCO2 Sampling Cannula 7 foot line ...9013 Infant Nasal ETCO2 Sampling Cannula 7 foot line ...9014 Intermediate Infant Nasal ETCO2 Sampling Cannula 7 foot line ...9015 Adult Bifurcated/Divided Cannula-O2 and ETCO2...9016 7 foot O2 line and 7 foot CO2 line. For simultaneous delivery of oxygen and ETCO2 sampling. Infant Bifurcated/Divided Cannula -O2 and ETCO2 ...9016A 7 foot O2 line and 7 foot CO2 line. For simultaneous delivery of oxygen and ETCO2 sampling. Intermediate Infant Bifurcated/Divided Cannula-O2 and ETCO2 ... 9016B 7 foot O2 line and 7 foot CO2 line. For simultaneous delivery of oxygen and ETCO2 sampling. Pediatric Bifurcated/Divided ETCO2 Cannula -O2 and ETCO2 ... 9016C 7 foot O2 line and 7 foot CO2 line. For simultaneous delivery of oxygen and ETCO2 sampling.

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Accessories End-Tidal CO2 (Continued) Item Description

Part Number

Nasal ETCO2 Supplies (Continued) Adapter, Luer Lock, Female/Female ...9027 For conversion of Millennia® male front panel connector for use with non-Invivo sampling lines. Package of 10. Water Trap Start Up Kit, Disposable ...9436 Includes water trap and connection tubing, Nafion® tube ME dryer, Hydrophobic disk filter 0.08 micron. Waste Gas Scavenger Line...9471 Includes 8 foot waste gas line to redirect the waste gas. Anesthetic Agent Anesthetic Oxygen Sensor Kit...9461 Includes Anesthetic Oxygen Sensor (P/N 9445) and an Anesthetic O2 Sensor Adapter. Oxygen Sensor, Galvanic...9445 Inspired 02 Sensor Kit, Disposable...9464 Contains a P/N 9445 Oxygen Sensor and allows for measurement of the O2 directly in the patient airway at the ventilator. Water Trap Kit, Disposable ...9436 Includes water trap and connection tubing, Nafion tube ME dryer, Hydrophobic disk filter 0.08 micron. Waste Gas Scavenger Line...9471 Includes 8 foot waste gas line to redirect the waste gas. Anesthetic Agent Check Gases: QC Check Gas: 7% Desflurane, 5% CO2, 60% N2O, 21% O2, Balance N2; 3.7 Liter Aerosol Container...9034A QC Check Gas: 1% Enflurane, 5% CO2, 60% N2O, 21% O2, Balance N2; 7.6 Liter Aerosol Container... 9034B QC Check Gas: 1.5% Sevoflurane, 5% CO2, 60% N2O, 21% O2, Balance N2; 3.8 Liter Aerosol Container... 9034C QC Check Gas: 1% Isoflurane, 5% CO2, 60% N2O, 21% O2, Balance N2; 11 Liter Aerosol Container...9034D QC Check Gas: 1% Halothane, 5% CO2, 60% N2O, 21% O2, Balance N2; 11 Liter Aerosol Container... 9034E QC Check Gas: 5% CO2, 45% N2O, 50% O2; 11 Liter Aerosol Container ...9034F xiii

Accessories CARTS AND MOUNTS Item Description

Part Number

GCX Wall Mount Bracket/3155 Millennia® Series...9401G Installs on any wall, polymount bracket. Permits monitor to swivel allowing viewing from any angle and smoothly tilt from 0 to 28 degrees avoiding glare on the monitor and permitting easy access to controls. Variable height adjustments permits optimal vertical positioning of the monitor includes all mounting hardware, but requires 9003E or 9003EA 3155 Millennia® Mounting Brackets. Invivo Bed Rail Mount Bracket... 9003E Invivo Bed Rail Mounting Bracket allows the 3155 Millennia® to be hung over a bed rail during transportation and works with all Invivo and GCX 3155 Millennia® Carts and Mounts. Includes all mounting hardware. Invivo Anesthesia Gas Machine Mounting Bracket... 9003EA Mounting Bracket allows the Millennia® to be Mounted to the GCX Pivot Arm Anesthesia gas Machine mount, GCX Wall Mount or Invivo Mobile Stand. (Does not have the Bed Rail Hook for space considerations.) Includes all mounting hardware. GCX 3155 Millennia® Flat Surface/Table Top Mount (Requires 9003E Mounting Bracket) ...9035 GCX manual tilt polymount bracket and stand allows for installation on a flat surface or countertop that can support the 3155 Millennia® weight (fully configures maximum of 19 lbs.). Includes mounting hardware, but requires the Invivo Bed Rail Mounting Bracket P/N 9003E). PRODUCT NOTE For Millennia® 3155A Anesthesia Gas Machine Mounting options and pricing, contact Invivo Marketing Department. MISCELLANEOUS Thermal Array Recorder Paper, 10 rolls pr box... 9180T Millennia® 3155A/3155MVS AC Power Supply, 120 VAC, 50/60Hz...AS153 Millennia® 3155A/3155MVS AC Power Supply, 100 VAC, 50/60Hz...AS153-J Millennia® 3155A/3155MVS Rechargeable Battery Pack, 12V... HB10 Millennia® 3155A/3155MVS Software Upgrade Kit ...9458 Includes both the current AM46 PCMCIA revision upgrade and a AM55 PCMCIA SRAM Data Storage card and all instructions. Millennia® 3155A/3155MVS PCMCIA Card, AM46...9465 Contains the latest software revision. Software Update. Millennia® 3155A/3155MVS PCMCIA Card, AM55...9466 SRAM Data Storage / Recall AM55 is used to Store and Recall the Millennia® 3155A/ 3155MVS system setups. This will eliminate the need to manually set up the Millennia® 3155A/3155MVS to the user preferred selections of display setup, alarm limit values, recorder functions, patient type, NIBP interval, or other initial settings after a software update is done with the PCMCIA card or to set up multiple monitors with identical settings. Millennia® 3155A/3155MVS Operations Manual ...9545 Millennia® 3155A/3155MVS Service Manual...9546 AS153 Fuse, 120 VAC, 3/4 A Slo-Blo...FU13 AS153 Fuse, 250 VAC, 2/5 A, Slo-Blo...FU25

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SECTION 1 INTRODUCTION 1.0 INTRODUCTION. 1.1 Product Description. The Millennia® 3155A/3155MVS Monitor is the Remote Control Unit in the Invivo Research, Incorporated 3150 Series MRI Monitoring System. This monitor provides Remote Control (through a cable or RF Radio Link) to a Omni-TrakTM 3150/MagnitudeTM 3150M MRI Patient Monitor (located in the MRI Magnet Room). Used with the Omni-TrakTM 3150 MRI Patient Monitor, the Millennia® 3155A/3155MVS Monitor provides four waveform traces compiling, processing, analyzing and displaying patient data from up to seven different patient parameters. The information that this Monitoring System is capable of supplying to the physician may be used as an aid in the determination of a diagnosis concerning the condition of a patient. There is no direct patient connection to the Millennia® 3155A/3155MVS Monitor (patient connection is performed in the Magnet Room with the Omni-TrakTM 3150/MagnitudeTM 3150M MRI Patient Monitor) except in the case of Agent monitoring when the Millennia® 3155A is used with the patient sample line connected directly into the front of the monitor. The Millennia® 3155A/3155MVS Monitor is compact, comes equipped with up to three batteries to supply emergency and/or transport power plus may “float” between the Magnet Room and Control Room (as determined by the needs of each unique monitoring situation). It also contains (as a optional feature) a recorder designed to provide printouts of the concise charts and trends required by today's specialists for analysis and documentation. The Millennia® 3155A/3155MVS can be used inside the MRI Magnet Room when positioned at or outside the 1000 Gauss (0.1T) Field Line. For the purposes of this manual, the OmniTrakTM 3150 and MagnitudeTM 3150M MRI Patient Monitors will be referred to as the 3150(M) and the Millennia® 3155A and 3155MVS Monitors will be referred to as the 3155A/3155MVS. During MRI procedures that require anesthetic agents monitoring, where the 3155A is used in the MRI exam room, the dual monitor system (software MDC01 and higher) allows the operator to add a 3155MVS to the MRI monitoring system. The 3155MVS and 3155A interact through the 3150(M) to allow monitoring at a remote site (such as the MRI control room). NOTE The 3150(M) ETCO2 is turned Off when the Agent/ETCO2 is turned On at the Millennia® 3155A. When the Millennia® 3155A is used to monitor Agent/ETCO2, it must be located in the Magnet Room with the gas sample line connected directly to the front of the 3155A. If operating a dual monitor system, the 3155MVS and 3155A patient monitors are interactive with one another though the 3150(M). As the “communication unit” the 3150(M) acts to keep the commands that control patient parameter function synchronized throughout the MRI monitoring system. Should the 3150(M) be turned off, it is possible to have patient parameters on the 3155A set to a particular configuration with the 3155MVS set to a different configuration; when the 3150(M) is turned on the system will synchronize and all patient configurations will reflect the 3155A configuration. The 3155A/3155MVS Monitor provides control and display of the following Vital Sign Parameters: •

ECG

•

NIBP

•

Two Invasive Blood Pressures

•

Pulse Oximetry

•

ETCO2

•

Respiration

•

N2O

•

O2

•

Identifies and measures Five (5) Major Anesthetic Agents

1-1

1.1.1 System Parameters. The 3155A/3155MVS System Parameters allow simultaneous processing and display of up to four parameter waveforms and associated numeric values from each different parameter. All the Patient Information is clearly displayed on a Flat Panel Display Screen. 1.1.2 User Interface. A simple to use interface has been developed to minimize operator learning time. A Rotary Knob, which detents from selection to selection, is used to access the parameter menu's, access the various setup features and finalize any changes to the setup of the monitor. Frequently used menus (such as: Alarms, Trends and Recorder) have a Control Key which, when pressed, will open the associated menu. 1.1.3 Versatility. With its complete offering of vital sign parameters, the 3155A/3155MVS Monitor may be configured to meet the monitoring needs of a wide spectrum of patients from Neonate to Adults. Every available parameter may be easily accessed and adjusted to the unique needs, condition and situation of each patient. 1.2 Controls. Control of the Monitoring Features is provided through the use of a Rotary Knob; as the operator turns the Rotary Knob (either clockwise or counterclockwise), with each detent the next Vital Signs Display will become highlighted (selected) and, when the appropriate display is selected, pressing the Rotary Knob will bring up the menu for the desired parameter. For adjustment of the Operational Features, the front panel provides two different sets of control keys: the menu-select keys bring up operational menus, while the direct control and operational keys provide manual control of selected patient parameters.

Figure 1-1. The Front Panel 1.2.1 Front Panel Controls. (See Figure 1-1) The 3155A/3155MVS Monitor front panel consists of one Rotary Knob, six Direct Control keys, four Menu-Select keys, five Operational keys, one Alarm Silence key and the Power On/Off switch. The 3155A also contains an ETCO2/Gas Input Port and additional graphics on the bottom of the front panel. The following is a general description of the front panel controls. a. The Rotary Knob. The Rotary Knob is located to the right of the Display Screen. The function of the Rotary Knob is menu specific. For this reason, its various functions are described throughout this document where it is used; in general, however, the Rotary Knob operates as described below: (1) As the Rotary Knob is rotated, either clockwise or counterclockwise, the monitor display “scrolls” through the various screen items (screen icons, menu options and patient parameters) which are available for selection. When the appropriate item is “highlighted,” it may be selected by pressing and releasing the Rotary Knob. All menus have a RETURN option which will return the monitor to the previous menu selection.

1-2

(2)

b.

During normal operation each active parameter has a Menu-Select icon on the screen. When the Rotary Knob is rotated, the Menu-Select icon which is being pointed at becomes “highlighted.” Rotating the Rotary Knob will cause the monitor to “scroll through” the available menu selections. Once the appropriate Menu-Select icon is highlighted, pressing the Rotary Knob completes the selection and brings up the required menu. Once the menu is selected, the Rotary Knob is used to scroll through the available choices and make adjustments to the selected parameter. The following Menu-Select Icons may be available on the Normal Screen (depending on which parameters are available, enabled and turned on): ECG, P1, P2, NIBP, ETCO2, Agents and SpO2.

Figure 1-2. The Direct Control Keys Direct Control Keys. (See Figure 1-2) There are six Direct Control keys: ZERO ALL, NIBP START/STOP, NIBP STAT, EVENT MARK, FREEZE and RECORD. These keys provide the operator with direct control of the following features: Starting/Stopping NIBP Readings, Starting/Stopping the NIBP STAT Mode, Freezing all Traces, Starting the Recorder, Adding a Marker to the Recorder and Zeroing all Invasive Pressure Channels. (1) ZERO ALL. (Item 1) The Pressure Transducer is zeroed by the 3150(M) MRI Patient Monitor in the MRI Magnet Room, therefore this key is inactive and pressing it will display a message to indicate that this function is not available in the Remote Mode of Operation. See the 3150/ 3150M MRI Patient Monitor Operation Manual (Part Number 9538) for further information. (2) NIBP START/STOP. (Item 2) This key starts a new NIBP measurement, or stops a measurement that is already in progress. (3) NIBP STAT. (Item 3) This key starts the NIBP STAT Mode measurements. This mode may be terminated by depressing the NIBP START/STOP key. The STAT Mode performs up to five (5) NIBP measurements in rapid succession (with a short pause between readings) within a maximum time frame of five (5) minutes. This feature is not available with dual monitor software (MPC01 or higher). (4) EVENT MARK. (Item 4) The EVENT MARK key prints a marker on the ECG Recorder Strip when the printer is running. If the printer is not running, pressing this key has no effect.

1-3

(5)

(6)

c.

FREEZE. (Item 5) The 3155A/3155MVS Monitor freezes the ECG waveform from Trace A for closer examination upon user demand. When the ECG trace is active, pressing the FREEZE key will freeze it into the Trace B location while Trace A remains active. When the trace is frozen, pressing the FREEZE key will release it. A “Blue Box” appears around the frozen waveform as a visual indication that the waveform is not active. While the Freeze feature is active, the monitor will not allow any changes to the Parameter Setups or Recall Setups; if the operator attempts to access the PARAMETER SELECTION or RECALL SETUP menus, a WARNING Box alerts the operator that entry to the selected menu is not allowed while FREEZE is enabled. RECORD. (Item 6) Pressing this key records the Single Trace or Dual Trace selections (as specified by operator adjustments made in the RECORDER Menu). The recorder stops automatically after approximately 30 seconds, or when the RECORD key is pressed again; in either case, the printout ends with a “Snap Shot” of the active patient parameter data.

Figure 1-3. Menu-Select and Operation Keys Menu-Select Keys. (See Figure 1-3) The Menu-Select keys allow the operator to specialize the operation of the 3155A/3155MVS Monitor to suit specific procedures and/or situations. Pressing a Menu-Select key will activate the “pop-up” menu for the selected feature which is then controlled by the Rotary Knob so that the associated parameters may be adjusted. The four Menu-Select keys are SETUP, ALARMS SCREEN, RECORDER FUNCTIONS and TRENDS. (1) SETUP. (Item 1) The SETUP key allows the operator to access the various available setup options (See Section 3). (2) ALARMS SCREEN. (Item 2) The ALARMS SCREEN key allows the operator to setup the Alarms monitoring feature (See Section 6). If operating a dual monitor system, with a 3155A and 3155MVS communicating with the 3150(M), the adjustments made here are interactive between the two 3155 monitors to ensure that the monitored parameters remain consistent between all components of the MRI monitoring system.

1-4

(3)

d.

e.

TRENDS. (Item 3) The TRENDS key allows the operator to setup the Trend monitoring feature. The exact operation of the TRENDS key is based on whether or not a feature is currently highlighted. If a feature is currently highlighted, pressing the TRENDS key will bring up a Trend which is specific to the highlighted feature; if a feature is not currently highlighted, pressing the TRENDS key will bring up the HISTORY Menu and Tabular Display (See Section 5). (4) RECORDER FUNCTIONS. (Item 4) The RECORDER FUNCTIONS key allows the operator to setup the Recorder option (See Section 5). Operational Keys. (See Figure 1-3) The are five Operational keys: HELP, STANDBY and NORMAL SCREEN. (1) HELP. (Item 5) The HELP key is for future operational enhancement. (2) STANDBY. (Item 6) Pressing the STANDBY key places the 3155A/ 3155MVS Monitor into the Standby Mode. The monitor stays in Standby Mode until the STANDBY key is pressed a second time. Except for the three (3) key features given below, the monitor operates normally by continuing to provide current patient information on the Display Screen. If operating a dual monitor system, with a 3155A and 3155MVS communicating with the 3150(M), pressing this key will place both monitors into the Standby Mode. While in Standby Mode: • All audible alarms are disabled. The disabled alarms are indicated on the screen by the “X” through the bell shaped Alarm Status Symbol. • Active NIBP automatic measurements are suspended. • No automatic printout is generated. (3) NORMAL SCREEN. (Item 7) Pressing the NORMAL SCREEN key returns the 3155A/3155MVS Monitor from any menu to the normal screen. (4) NIBP INTERVAL. Pressing the NIBP INTERVAL key brings up the NIBP INTERVAL Menu where the cycle time (time between readings) of the NIBP Automatic Reading Mode may be adjusted. (5) CLEAR TRENDS. Pressing the CLEAR TRENDS key allows the operator to clear all the stored data from memory. To prevent accidental erasure of patient data, there is a Yes/No box associated with this key that appears to ensure that the operator meant to clear the trend data. If operating a dual monitor system, with a 3155A and 3155MVS communicating with the 3150(M), pressing this key will clear the trend file of both monitors. Alarm Silence Key. Pressing the ALARM SILENCE key will silence any active alarm. The letter “S” appears in the Alarm Bell and an “Alarm Silenced” message appears in the center of the screen as visual indications that an alarm has been silenced. If operating a dual monitor system, with a 3155A and 3155MVS communicating with the 3150(M), the ALARM SILENCE key is interactive throughout the MRI monitoring system. The details of this key's function depend on the monitor's settings: (1) Unlatched Alarms. If the alarm system has been set to UNLATCHED in the ALARMS Menu and an Alarm Limit is violated, pressing the ALARM SILENCE key will silence the Alarm Tone when an active Alarm Limit has been violated. While the parameter continues to violate its limits, the numerics of the violating parameter continue to flash on the screen. If operating a dual monitor system, with a 3155A and 3155MVS communicating with the 3150(M), the adjustments made here are interactive between the two 3155 monitors to ensure that the monitored parameters remain consistent between all components of the MRI monitoring system. 1-5