Invivo 2GMOD WIRELESS MODULE FOR MR-COMPATIBLE PATIENT MONITOR User Manual S User s Manual Wireless Modules

Invivo Corporation WIRELESS MODULE FOR MR-COMPATIBLE PATIENT MONITOR S User s Manual Wireless Modules

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Invivo CorporationPRECESS MRI PATIENT MONITORING SYSTEMOPERATIONS MANUAL

NOTENotified body number 0413 is only relevant for the MDD 93/42/EEC Directive.

TABLE OF CONTENTSParagraph Number Page NumberEquipment Classification................................................................................................................. iPrecautions...................................................................................................................................... iiUser Responsibility...................................................................................................................... xviUser Responsibility Precess MRI Patient Monitoring Accessories............................................ xviiPart Number Precess MRI Patient Monitoring Accessories...................................................... xviii1.0 INTRODUCTION. ........................................................................................................ 1-11.1 Product Description ......................................................................................................... 1-11.1.1 System Parameters............................................................................................... 1-21.1.2 User Interface....................................................................................................... 1-31.1.3 Versatility............................................................................................................. 1-31.2 Wireless Processor Unit (WPU) ...................................................................................... 1-31.2.1 Operating Environment........................................................................................ 1-31.2.2 Power Supply....................................................................................................... 1-31.3 Patient Connections ......................................................................................................... 1-31.3.1 NIBP and Agent Monitoring................................................................................ 1-31.3.2 Invasive Pressure Monitoring .............................................................................. 1-31.3.3 Temperature Monitoring...................................................................................... 1-31.4 ECG Monitoring .............................................................................................................. 1-31.5 SpO2 Monitoring ............................................................................................................. 1-41.6 Display Control Unit (DCU)............................................................................................ 1-41.6.1 DCU Controls ...................................................................................................... 1-41.6.2 DCU Display...................................................................................................... 1-101.7 Cleaning. ........................................................................................................................ 1-181.7.1 Cleaning Accessories......................................................................................... 1-182.0 INSTALLATION........................................................................................................... 2-12.1 Unpacking The System.................................................................................................... 2-12.2 System Configuration. ..................................................................................................... 2-12.3 Battery Installation and Removal. ................................................................................... 2-12.3.1 Battery Locations................................................................................................. 2-12.3.2 WPU And DCU Battery Installation And Removal ............................................ 2-22.3.3 WECG And WSpO2 Battery Installation And Removal..................................... 2-32.4 Battery Charging.............................................................................................................. 2-52.4.1 WPU And DCU Battery Charging....................................................................... 2-52.4.2 WECG/WSpO2 Battery Charging ....................................................................... 2-52.5 Battery Operation........................................................................................................... 2-102.6 System Setup.................................................................................................................. 2-102.6.1 WPU and DCU .................................................................................................. 2-102.7 System Location ............................................................................................................ 2-132.8 Before Connecting To A Patient.................................................................................... 2-133.0 PATIENT PARAMETERS........................................................................................... 3-13.1 ECG Monitoring .............................................................................................................. 3-13.1.1 Wireless ECG Module and ECG Patient Lead Wires.......................................... 3-13.1.2 ECG Electrode - Use only Invivo Quadtrode MRI ECG Electrodes.................. 3-23.1.3 Associated Waveforms and Displays .................................................................. 3-43.1.4 The ECG Menu.................................................................................................... 3-4

3.1.5 ECG Alarm Limits............................................................................................... 3-83.1.6 ECG Trended Data............................................................................................... 3-83.1.7 ECG Messages..................................................................................................... 3-93.2 Non-Invasive Blood Pressure (NIBP) Monitoring .......................................................... 3-93.2.1 Theory of Oscillometric Measurement .............................................................. 3-113.2.2 NIBP Patient and Cuff Preparation.................................................................... 3-123.2.3 Associated NIBP Displays................................................................................. 3-123.2.4 The NIBP Menu................................................................................................. 3-143.2.5 NIBP Menu Options .......................................................................................... 3-143.2.6 Using the Automatic NIBP Interval Mode ........................................................ 3-173.2.7 Manually Starting/Stopping an NIBP Reading Cycle ....................................... 3-173.2.8 NIBP STAT Mode Operation ............................................................................ 3-173.2.9 NIBP Alarm Limits............................................................................................ 3-173.2.10 NIBP Adult vs. Neonatal Mode Operation........................................................ 3-173.2.11 NIBP Trended Data ........................................................................................... 3-183.2.12 NIBP Messages.................................................................................................. 3-183.3 SpO2 Monitoring ........................................................................................................... 3-193.3.1 Wireless SpO2 Module and Fiber-Optic SpO2 Sensor ..................................... 3-193.3.2 SpO2 Sensor Positioning ................................................................................... 3-193.3.3 Associated SpO2 Waveforms and Displays ...................................................... 3-203.3.4 SpO2 Menu ........................................................................................................ 3-203.3.5 SpO2 Alarm Limits............................................................................................ 3-213.3.6 SpO2 Trended Data ........................................................................................... 3-223.3.7 SpO2 Messages.................................................................................................. 3-223.4 End-tidal CO2 (ETCO2) Monitoring............................................................................. 3-233.4.1 Water Trap and Sampling Line Preparation ...................................................... 3-233.4.2 Water Trap Replacement ................................................................................... 3-253.4.3 Associated ETCO2 Waveforms and Displays ................................................... 3-253.4.4 ETCO2 Menu..................................................................................................... 3-263.4.5 Calibration of CO2 Measurement System ......................................................... 3-273.4.6 ETCO2 Alarm Limits ........................................................................................ 3-293.4.7 ETCO2 Trended Data ........................................................................................ 3-293.4.8 ETCO2 Messages .............................................................................................. 3-293.5 Anesthetic Agent/Oxygen Monitoring........................................................................... 3-293.5.1 Anesthetic Agent Patient and Tubing Preparation............................................. 3-303.5.2 Associated Anesthetic Agent Displays .............................................................. 3-303.5.3 Agent Menu ....................................................................................................... 3-323.5.4 Gas Calibration .................................................................................................. 3-333.5.5 Agent Alarm Limits ........................................................................................... 3-343.5.6 Agent Trended Data........................................................................................... 3-343.5.7 Agent/O2 Messages ........................................................................................... 3-343.5.8 Oxygen Monitoring............................................................................................ 3-353.6 Invasive Pressure Monitoring ........................................................................................ 3-363.6.1 Invasive Pressure Transducer Preparation......................................................... 3-363.6.2 Associated Invasive Pressure Waveforms and Displays ................................... 3-373.6.3 The Invasive Pressure Menu.............................................................................. 3-383.6.4 Invasive Pressure Alarm Limits......................................................................... 3-403.6.5 Invasive Pressure Trended Data ........................................................................ 3-413.6.6 Invasive Pressure Messages............................................................................... 3-41

3.7 Temperature Monitoring................................................................................................ 3-413.7.1 Associated Temperature Displays ..................................................................... 3-413.7.2 TEMP Menu ...................................................................................................... 3-423.7.3 Temperature Alarm Limits ................................................................................ 3-433.7.4 Using the Fiber-Optic Surface Temperature Sensor.......................................... 3-433.7.5 Temperature Trended Data ................................................................................ 3-443.7.6 Temperature Messages ...................................................................................... 3-443.8 Respiration Monitoring.................................................................................................. 3-453.8.1 Associated Respiration Displays ....................................................................... 3-453.8.2 Respiration Patient Preparation ......................................................................... 3-454.0 PREPARATION FOR USE.......................................................................................... 4-14.1 Introduction...................................................................................................................... 4-14.2 Setups Menu .................................................................................................................... 4-14.2.1 DCU Setups Menu. .............................................................................................. 4-14.2.2 Store/Recall Setups .............................................................................................. 4-34.3 Monitor Initialization..................................................................................................... 4-164.3.1 Default Initialization .......................................................................................... 4-164.3.2 Pre-Configured Initialization ............................................................................. 4-165.0 RECORDING AND TRENDING. ............................................................................... 5-15.1 Introduction...................................................................................................................... 5-15.1.1 Record Key .......................................................................................................... 5-15.2 The Recorder Menu ......................................................................................................... 5-15.3 Recording Charts ............................................................................................................. 5-35.3.1 Strip Chart Record ............................................................................................... 5-35.3.2 Tabular Chart Record........................................................................................... 5-45.3.3 Trend Chart .......................................................................................................... 5-45.3.4 System Data Report ............................................................................................. 5-55.4 Loading Recorder Paper .................................................................................................. 5-55.5 Trending Feature.............................................................................................................. 5-55.5.1 History Menu Options ......................................................................................... 5-56.0 ALARMS. ....................................................................................................................... 6-16.1 Introduction...................................................................................................................... 6-16.2 Alarm Limits.................................................................................................................... 6-16.2.1 Default (Pre-Set) Alarm Limits ........................................................................... 6-16.2.2 Range of High and Low Alarm Limits ................................................................ 6-36.3 Alarm Setup ..................................................................................................................... 6-46.3.1 Parameter Alarms Status Screen.......................................................................... 6-76.4 Turning Alarms OFF on Individual Parameters .............................................................. 6-76.5 Alarm Violations.............................................................................................................. 6-76.6 Adjusting the Alarm Tone Volume ................................................................................. 6-86.6.1 Disabling the Alarm Tone.................................................................................... 6-86.7 Standby Mode .................................................................................................................. 6-9specifications .............................................................................................................................. A-1repair ............................................................................................................................................B-1warranty .......................................................................................................................................C-1Declaration of conformity........................................................................................................... D-1List of symbols.............................................................................................................................E-1EMC............................................................................................................................................. F-1NOTES........................................................................................................................................ G-1

iEQUIPMENT CLASSIFICATIONClassification according to IEC-60601-1According 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 flammable anesthetic mixture with air or with oxygen or nitrous oxide.

iiiAll equipment not complying with IEC 60601-1 must be placed outside the patient environment.Only connect IEC 60601-1-compliant equipment to the Precess MRI Patient Monitoring System. Always check the summation of leakage currents when several items of equipment areinterconnected.Annual preventative maintenance is recommended unless stated otherwise in the service manual.For proper equipment maintenance, perform the service procedures at the recommended intervalsas described in the service manual, Part Number 9568.Single-use devices should be disposed of after use and must never be reused.Organic vapors (e.g. from cleaning agents) in sampling line or room air may alter anesthetic agentreadings.Alcohol in patient's breath may modify the anesthetic agent readings.Always consult a physician for interpretation of waveforms and values.All system alarms are categorized as high priority, unless otherwise specified. Warning StatementThe manufactuer is not responsible for any radio or TV interference caused by unauthorized modificationsto this equipment. Such modification could void the user's authority to operate the equipment. FCC COMPLIANCE STATEMENT This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

ivPRECAUTIONSElectrical SafetyAlways disconnect the Precess MRI Patient Monitoring System from AC Main Power beforeperforming cleaning or maintenance system. To avoid an electrical hazard, never immerse anypart of the patient monitoring system in any cleaning agent fluid or attempt to clean it with liquidcleaning agents. If the Precess MRI Patient Monitoring System becomes accidentally wet during use, discontinueoperation until all affected components have been cleaned and permitted to dry completely.Contact Invivo Service Support if additional information is required.Shock hazard exists if operated without chassis cover. Refer servicing to Invivo Service Supportpersonnel only.For continued protection against fire hazard, replace fuses with same type and rating only.Connect the Precess MRI Patient Monitoring System to a three-wire, grounded, hospital-gradereceptacle only. The three-conductor plug must be inserted into a properly wired three-wirereceptacle.Do not under any circumstances remove the grounding conductor from the power plug.Avoid use of electrical power extension cords. Electrical power extension cords will create asafety hazard by compromising the grounding integrity of the Precess MRI Patient MonitoringSystem.None of the interconnection ports on the rear of the DCU or WPU (e.g. Communication Ports,Auxiliary Input/Output port [AUX I/O], USB port, Keyboard, Gating Connection or Video Input)are intended for direct patient connection. An electric shock hazard can exist if the patient iselectrically connected to any of these connections.The Precess MRI Patient Monitoring System and its listed accessories may be safely powered bythe voltages 100-240 VAC having a frequency of 50 or 60 Hz.If the integrity of the earth ground conductor of the AC main power cable is in doubt, operate thePrecess MRI Patient Monitoring System on internal battery power until proper earth groundconnection is confirmed.

vPRECAUTIONSPatient SafetyWhenever a patient is under anesthesia or connected to a ventilator constant attention byqualified medical personnel is needed. Some equipment malfunctions may occur in spite ofequipment or monitoring alarms.Always test the sampling line adapter for a tight connection and proper operation before attachingto a patient.As with all medical equipment, carefully route patient cabling to reduce the possibility of patiententanglement or strangulation.Occupational SafetyConnect the sample gas outlet on the monitor's rear panel to a scavenging system to preventpollution of room air.Handle the Patient Sampling Line and its contents as you would any body fluid. Infectious hazardmay be present.

viPRECAUTIONSMRI Use PrecautionsCertain components of the Precess MRI Patient Monitoring System will be affected by themagnetic and radio frequency fields present in your MRI magnet room. Confer with your MRIphysicist and/or Radiology staff to identify the proper placement and use areas for the PrecessMRI Patient Monitoring System and its accessories, as defined on the system or accessorylabeling. Failure to properly place the Precess MRI Patient Monitoring System and its accessoriesin the magnet room will result in system or accessory failure, and possible patient or user injury.Possible damage to the NIBP or ETCO2 pump could occur. A dB/dT above 40T/second maysaturate the ECG amplifier of this device, leading to erratic readings. Always verify propercommunication of the Precess MRI Patient Monitoring System with the corresponding RemoteMonitor (Display Control Unit (DCU)) prior to patient use.MRI Magnet Room PlacementThe Precess MRI Patient Monitoring System is designed to be used in conjunction with a RemoteMonitor (Display Control Unit (DCU)). The Precess MRI Patient Monitoring System is specially designed not to interfere with MRIoperations. IT MAY BE USED INSIDE THE MRI MAGNET ROOM IN ALOCATION AT OR OUTSIDE THE 5,000 (5,000 OR LESS) GAUSS (0.5T)FIELD LINE OF THE MRI SYSTEM, AS MEASURED FROM THECENTER LINE OF THE MRI BORE, BUT IN NO CASE CLOSER THAN3 FEET (1 METER) FROM THE MRI SYSTEM. ALWAYS ENSURE THATTHE WHEELS ARE IN THE LOCKED POSITION WHEN THEMONITORING SYSTEM IS LEFT UNATTENDED.Field strength variations in a particular MRI magnet room (which may be due to active shieldingtechnology, manufacturer variability, future enhancements, etc) can make distinguishing the 5,000Gauss level difficult and therefore the Precess MRI Patient Monitoring System must never beplaced closer than 3 feet (1 meter) from the MRI System. This variation may require moving thePrecess MRI Patient Monitoring System away from the magnet if system abnormalities ormalfunctions are observed. Prior to clinical use, the operator must be aware of the minimumdistance from the MRI System for proper operation. If brought closer than 3 feet (1 meter) and/or the 5,000 Gauss Field Line, system failure and/orpatient or user injury may result.

vii 5,000 G/3 FT (1M), WHICHEVER IS FARTHER FROM THE MRI SYSTEMALWAYS ENSURE THAT THE WHEELS ARE IN THE LOCKED POSITION WHEN THE MONITORING SYSTEM IS LEFT UNATTENDED. The Remote Monitor (Display Control Unit (DCU)) is also specifically designed not to interferewith MRI operations. If the recorder option is present, it may be used in the magnet room at oroutside the 1,000 Gauss (0.1T) Field Line of the MRI System. Do not move the Remote Monitorcloser than the specified Gauss Field Line or damage (failure to operate) to the recorder mayresult. If the recorder option is not present, the Remote Monitor may be used at or outside the5,000 Gauss (0.5T) Field Line or no closer than 3 feet (1 meter) from the MRI System.Dislodge the Precess MRI Patient Monitoring System by gently pulling from the base of thesystem pole at its lowest point. This will prevent the base of the unit from experiencing higherMRI pull forces in the vertical direction. WARNINGIf the Precess MRI Patient Monitoring System rolls to the face of the MRIsystem due to magnetically induced pull force, DO NOT ATTEMPT TODISLODGE THE PRECESS MRI PATIENT MONITORING SYSTEM BYPULLING FROM THE DOCKED REMOTE MONITOR OR GUIDEHANDLE AT THE TOP OF THE PRECESS MRI PATIENT MONITORINGSYSTEM.

viiiPRECAUTIONSRisk of RF current burnCables which become inadvertently looped during MRI act as conductive lines for RF inducedcurrents. When lead wires or other cables form a conductive loop in contact with the patient'stissue, minor to severe burning can result.Perform the following to minimize risk of RF current burn:a. Place cables and lead wires neatly in straight alignment with no looping.b. Use only the ECG Lead Wires designated for use with this product. See AccessoryList.c. RF burn risk increases when multiple sensors/cables are in use. Such combinationsare not recommended.d. The high radio frequency (RF) power used in MRI scanning poses an ever-presentrisk of excessive heat at the monitoring sites and, therefore, the risk of RF currentburn. Power levels greater than S.A.R. of 4 w/kg increase the risk of patientburns. As a result, monitoring of ECG at power levels of greater than 4 w/kg is notrecommended for the general patient population. Such monitoring must only beattempted on conscious patients with good temperature reflex so they may warnthe operator of excessive heat at the monitoring sites.e. High RF Power may cause patient heating or burns. Use caution for scan timesgreater than 15 minutes. It is recommended that ECG electrode temperature bechecked during scans greater than 15 minutes.MRI CompatibilityThe Quadtrode MRI ECG Electrodes (Invivo Part Numbers 9303, 9371 and 9372), and ECGPatient Lead Wires (Invivo Part Numbers 9224, 9223 and 9222), are compatible with MagneticResonance Imaging (MRI) Systems within the following guidelines:• MRI systems with static magnetic field strengths up to 3.0 Tesla.• Usable within the MRI system bore with Specific Absorption Ratios (S.A.R.'s) up to 4.0 w/kg. Use with higher S.A.R.'s greatly increases the risk of patient burns. 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.

ixPRECAUTIONSECGAn inoperative ECG parameter or WECG module is indicated by absence of an ECG waveformand a simultaneous Lead Fail alarm.For best ECG, heart rate, and/or respiration monitoring, always select the optimal leadconfiguration which has the least artifact and largest waveform(s) being detected for monitoringuse.Failure to respond to a Lead Fail alarm will cause a lapse in your patient’s monitoring. Alwaysrespond promptly to this and any other alarms.Heart rate values may be adversely affected by cardiac arrhythmia, or by operation of electricalstimulators.NIBPAlways use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuffhose.When using the NIBP portion of this instrument to measure blood pressure, remember that thepatient’s blood pressure readings are not continuous, but are updated each time a blood pressuremeasurement is taken. Set a shorter interval for more frequent updating of the patient’s bloodpressure.Do not attach the cuff to a limb being used for infusion. Cuff inflation can block infusion, possiblycausing harm to the patient.Arrhythmias and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions)can result in inaccurate readings and/or prolonged measurements. If questionable readings areobtained, re-check patient’s vital signs by alternate means before administering medication.To ensure accurate and reliable measurements, use only recommended patient cuffs/hoses. Usethe appropriate cuff size for each patient as recommended by the current American HeartAssociation (AHA) guidelines for blood pressure monitoring to ensure patient safety andaccuracy.Routinely inspect the cuff and hose assemblies for proper attachment and orientation. Replacecuff and/or hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in thesystem. If cuff and/or hose assemblies with damage which could result in leaks are used,prolonged and/or inaccurate patient readings could result.Use only cuffs designated by Invivo. See Accessory List on page xv.This equipment complies in full to EN 1060-1:1996 + A1:2002, Specification for non-invasivesphygmomanometers - Part 1: General requirements.

xPRECAUTIONSSpO2Avoid placement of the SpO2 sensor on the same limb with an inflated blood pressure cuff. Cuffinflation could result in inaccurate readings and false alarm violations.SpO2 monitoring requires the detection of valid pulses to correctly determine SpO2 and HeartRate values. During conditions of gross artifact, or in the absence of valid pulses, the SpO2/ratevalues will not be correct.The SpO2 patient monitoring portion of this system is intended to measure arterial hemoglobinoxygen saturation of functional hemoglobin (saturation of hemoglobin functionally available fortransporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such ascarboxyhemoglobin or methemoglobin, will affect the accuracy of the measurement. Also,Cardiogreen and other intravascular dyes may, depending on their concentration, causeinaccuracy of the SpO2 measurement.Always shield the SpO2 sensor from extraneous incident light sources. Such extraneous light cancause SpO2 reading or pulse detection errors.Frequently inspect the SpO2 sensor site for possible pressure tissue necrosis during prolongedmonitoring. Reposition the sensor at least every four (4) hours. Special care must be exercisedwhen tape is used to secure the sensor, as the stretch memory properties of most tapes can easilyapply unintended pressure to the sensor site.The numeric measurement values are updated every one (1) second on the system display.A pulse oximeter should be considered an early warning device. As a trend towards patientdeoxygenation is indicated, blood samples must be analyzed by a laboratory co-oximeter tocompletely understand the patient’s condition.The pulse oximeter feature in this system is designed to display functional SpO2 values.The pulse oximeter pulsatile waveform is not proportional to the pulse volume, but adjusts thewaveform amplitude as needed for proper viewing.Arrhythmias and/or erratic heart beats (or severe motion artifact, such as tremors or convulsions)can result in inaccurate readings and/or prolonged measurements. If questionable readings areobtained, re-check patient’s vital signs by alternate means before administering medication.Ambient light (including photodynamic therapy), physical movement (patient and imposedmotion), diagnostic testing, low perfusion, electromagnetic interference, electrosurgical units,dysfunctional hemoglobin, presence of certain dyes and inappropriate positioning of the pulseoximeter probe can all lead to inaccuracies of the pulse oximeter equipment.

xiPRECAUTIONSInvasive PressuresFor best invasive pressure monitoring, always select the appropriate waveform scale for thewaveform being observed.For invasive pressure monitoring, routinely inspect the catheter and/or pressure line for leaks afterzeroing. Always follow the pressure transducer/catheter manufacturer’s use recommendations.Never place the pressure transducer(s) within the MRI bore. Transducer failure, inaccuratereadings or noisy MRI images can result.Invasive blood pressure transducers are sensitive to vibrations that can occur during MRIscanning, which can lead to pressure reading inaccuracies. Always mount the invasive bloodpressure transducer away from areas where vibration is likely to occur.Non-physiological pulsatile invasive pressure waveforms (e.g., such as found during intra-aorticballoon pump use) can lead to inaccurate blood pressure readings. If questionable values areobserved, re-check patient’s pressures by alternate means before administering medication ortherapy.The fluid within the pressure transducer system is a conductive connection to the patient, andmust not contact other conductive parts, including earth ground.Use only approved pressure transducers and cables, as listed in the Accessory Section.Follow the safe use instructions that are supplied with the pressure transducer.RespirationWhen setting up respiration monitoring, always observe and adjust the respiration gain of thesystem while watching the patient’s breathing efforts before completing selection of the gainsetting. Failure to do this can result in inaccurate readings, or false respiration detection.

xiiPRECAUTIONSEnd-tidal CO2 (ETCO2)Verify that the patient’s breathing efforts and timing coincide with the DCU waveform beforecompletion of the patient set-up.The ETCO2/N2O measurement displays the sampled value within 1 second of when the gas wassampled.Frequently inspect the ETCO2 patient tubing. Avoid kinking of the ETCO2 patient tubing that canresult in leaking, reduction, or cut-off of the sample gas flow. Inaccurate gas measurements couldresult.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 movingmechanisms which may kink, cut or dislodge the patient tubing.Do not allow tubing to become kinked so that the sample flow is reduced or cut off.Do not overtighten the patient gas sample line to the water trap connector. Overtightening thisconnector can cause failure of the water trap assembly and resultant inaccurate patient gasmeasurements.Leaks or internal venting of sampled gas will lead to inaccurate measurements.CO2 and Anesthetic Agent calibration cylinders and test gas mixtures must be completely drainedof pressure before disposal.Do not block the gas exhaust port on the rear of the Wireless Processing Unit (WPU).Always inspect patient tubing after attachment to the system by following the patient tubingmanufacturer's recommendations.Consult the instructions that come with the ETCO2 accessories, as they contain guidanceregarding the length of time that the components may be used.An internal leak may result in condensation within the system. If this is suspected, please contactInvivo.The Precess contains an exhaust port at the rear of the WPU that may be connected to the facility'sanesthetic gas scavenging system, using the appropriate exhaust tube accessory. Follow thefacility's guidelines for connecting to the scavenging system, including proper disposal ofsampled gas.Mainstream cyclical pressure of 10kPa can damage the equipment since this system usessidestream technology as the measurement technique.Return of the sampled gas to the PCU will cause a positive pressure that can reduce flow whichcan affect accuracy at higher breath rates. Accuracy is reduced because ETCO2 value willdecrease and inspired CO2 will, in turn, increase.TemperatureUse only MRI-compatible fiber-optic temperature sensor accessories (see MRI Accessory List inthis section).The fiber-optic temperature sensors are constructed of fiber-optic glass and must always behandled with care to prevent damage. Improper handling can result in inaccurate readings andshorten the temperature sensor's useful life.

xiiiDuring longer term monitoring sessions (4 hours or more), frequent medical attention must begiven to the sensor site for possible pressure tissue necrosis , especially on tender skin of neonatalpatients.Do not immerse complete sensor in any type of liquid.

xivPRECAUTIONSAnesthetic AgentsInadequate ventilation of the system will cause inaccurate readings or damage to electroniccomponents.Do not block the gas exhaust port on the rear of the Wireless Processing Unit (WPU).Ensure that the exhaust gas is not removed from the system under too strong a vacuum. Toprevent this condition, there must always be an opening to the room air. Too high a vacuum levelwill change the operating pressure of the system and cause inaccurate readings or internaldamage.Inspect gas exhaust/waste gas line for deterioration on a regular basis. Replace as needed.Remove sampling line from patient airway whenever nebulized medications are being delivered.Use only Invivo sampling lines and accessories; other sampling lines will cause inaccuratereadings and malfunctions.Some Hydrocarbons (e.g. Acetone, Methane) will cause a mixed agent alarm to occur.Replace the sampling line and inspect water trap between each patient use.Do not overtighten the patient gas sample line to the water trap connector on the PCU.Overtightening this connector can cause failure of the water trap assembly and result in inaccuratepatient gas measurements.Routinely inspect the hose assemblies for proper attachment and orientation. Replace hoseassemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. If hoseassemblies with damage that could result in leaks are used, prolonged and/or inaccurate patientreadings could result.If questionable anesthetic agent gas measurements are observed, recheck patient connections,anesthesia gas machine and/or vaporizer before re-adjusting anesthesia delivery.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 agentidentification and reading to be displayed. Once identification is established, changes inconcentration are virtually immediate. With a 200% change in concentration, an auto Zero willoccur, and full accuracy of the changed concentration will be accomplished within approximately30 seconds.Whenever the Precess MRI Patient Monitoring System Agent sensor changes from steady statecondition, the Precess MRI Patient Monitoring System will perform an auto zero to restabilize thesensor readings. During this time, 15 seconds to 1.5 minutes, it is possible for a falseidentification and concentration value to occur. Examples are as follows:• 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.Leaks or internal venting of sampled gas will lead to inaccurate measurements.CO2 and Anesthetic Agent calibration cylinders and test gas mixtures must be completely drainedof pressure before disposal.

xvPRECAUTIONSOtherThis product, or any of its parts, must not be repaired other than in accordance with writteninstructions provided by Invivo, or altered without prior written approval of Invivo Corporation.The user of this product shall have the sole responsibility for any malfunction which results fromimproper use, faulty maintenance, improper repair, damage, or alteration by anyone other thanInvivo, or its authorized service personnel.This patient monitoring system is equipped with a demonstration mode which displays simulatedelectronic patient data for training or demonstration purposes. Do not attach a patient to thesystem whenever this simulation is present on the DCU. (“SIMULATION” can also be seen in theDCU. Failure to properly monitor the patient could result.The patient connector inputs for all parameters are protected against the use of a defibrillator byinternal circuitry when the recommended patient cables or accessories are used. The use of thiscircuitry and these recommended cables and accessories also protects against the hazardsresulting from use of high frequency surgical equipment.Do not use two Precess MRI Patient Monitoring Systems in the same MRI room. This will leadto communication errors.A small but noticeable degradation for the ECG and SpO2 radio system will occur in the presenceof high powered radios.There are no known electromagnetic interference or other hazardous interference between thePrecess MRI Patient Monitoring System and other devices. However, care must be taken toavoid the use of cellular phones or other unintended radio-frequency transmitters in the proximityof the monitoring system.This system uses rechargeable batteries that contain hazardous material. These batteries must berecycled, or disposed of properly. For proper disposal methods, contact Invivo representative ordistributor.Avoid ammonia, phenol or acetone based cleaners for they will damage the system surfaces.Dispose of the system and parts thereof according to local regulations.The Precess MRI Patient Monitoring System has a defibrillation-proof type degree ofprotection. When using a defibrillator, make sure to follow all precautions related to both thesystem and the defibrillator equipment. During a defibrillation procedure, the ECG waveform willsaturate then recover in less than eight (8) seconds in accordance with AAMI/ANSI EC13.When using a defibrillator, do not introduce discharges of 360 joules or more, repeated five (5)times over five (5) minutes. Read safety instructions provided with the defibrillator. The Precessis designed to withstand defibrillation and will recover within five (5) seconds (per IEC 60601-1).

USER RESPONSIBILITY This product will perform in conformity with the description contained in this operators manualand accompanying labels and/or inserts, when assembled, operated, maintained and repaired inaccordance with the instructions provided. This product must be checked and calibratedperiodically. A malfunctioning product must not be used. Parts that are broken, missing, plainlyworn, distorted or contaminated must be replaced immediately. Should such repair or replacementbecome necessary refer unit to qualified service personnel. This product or any of its parts mustnot be repaired other than in accordance with written instructions provided by the manufacturer,or altered without written approval of Invivo. The user of the product shall have the soleresponsibility for any malfunction which results from improper use, faulty maintenance, improperrepair, damage or alteration by anyone other than Invivo or Invivo authorized service personnel.Using this ManualWhenever the various options are discussed, “XXX” is used to indicate a variable setting. It isrequired that every operator read this manual completely, including any patient information insections about monitoring features the operator’s system does not have, before attempting tooperate the Precess MRI Patient Monitoring System.The figures contained in this manual show a fully equipped system. Therefore, figures within thismanual may depict monitoring features that your system may not contain. For information onfeatures and enhancements that are not contained in your system, contact Invivo at (407)275-3220, or (US Toll-Free) 800-331-3220.Precautions (listed earlier in this section) cover of wide ranges of information crucial to the safemonitoring of patients. It is required that every operator read the PRECAUTIONS completely,including the precautions associated with monitoring features that the operator’s system does nothave, before attempting to operate the Precess MRI Patient Monitoring System.This device is covered under one or more of the following U.S. Patents: 5,482,036; 5,490,505;5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830;6,157,850; 6,277,081 and international equivalents. U.S.A. and international patents pending.Possession or purchase of this device does not convey any express or implied license to use thedevice with replacement parts which would, alone, or in combination with this device, fall withinthe scope of one or more of the patents relating to this device.For further information or assistance with this product:Invivo Corporation407-275-3220, or Toll-Free (US) 800-331-3220

xvii Precess MRI Patient Monitoring AccessoriesItem Description Part NumberGeneralPrecess 14.8V Battery (each).....................................................................................................9093Precess 14.4V Battery (each).....................................................................................................9064Power Supply to Precess Cable, 5 Feet (1.6 M) ................................................................. AC517APower Supply to Precess Cable, 25 Feet (7.6 M) ............................................................... AC517BPrecess Power Adapter .......................................................................................................... AS201Wireless Module Battery ChargerPrecess Wireless Module Battery Charger.................................................................................9023Power Cord 110V..................................................................................................................... AS18Power Cord 10A 220-230V Europe.......................................................................................AS18GPower Cord 220V Universal..................................................................................................AS18AECGQuadtrode MRI ECG Electrode (box 10) ...............................................................................9303AQuadtrode CV MRI ECG Electrode (box 10) ........................................................................9371ANeonatal Quadtrode MRI ECG Electrode (box 10)................................................................9372AQuadtrode MRI ECG Cable.......................................................................................................9224Quadtrode CV MRI ECG Cable ................................................................................................9223Neonatal Quadtrode MRI ECG Cable .......................................................................................9222ECG Skin Prep Gel ....................................................................................................................9009ECG Electrode Impedance Meter ..............................................................................................9392Wireless ECG Module (Note: Wireless Network must be specified)........................................9312Wireless Module Batteries .........................................................................................................9065SpO2Adult Grip Sensors (package of 3) ......................................................................................9399AAPediatric Grip Sensors (package of 3) ................................................................................. 9399APInfant Grip Sensors (package of 3) ....................................................................................... 9399AINeonatal Foot/Hand Grip Sensors (package of 3) ...............................................................9399ANSpO2 Grip Sensor ...................................................................................................................9399BWireless SpO2 Module (Note: Wireless Network must be specified).......................................9311Wireless Module Batteries .........................................................................................................9065SpO2 Clip Sensor................................................................................................................. 9399BCNIBPMRI Pediatric NIBP Cuff (9-25 cm) ...................................................................................... 9092BMRI Adult Cuff (17-45 cm)....................................................................................................9092CMRI Large Adult NIBP Cuff (39-62 cm) ...............................................................................9092DMRI Adult NIBP Hose ...........................................................................................................9092AMRI Neonatal NIBP Hose ...................................................................................................... 9092EDisposable Neonatal NIBP Cuff (6-11 cm) ............................................................................ 9092FDisposable Neonatal NIBP Cuff (8-15 cm)............................................................................9092G

xviii Precess MRI Patient Monitoring AccessoriesItem Description Part NumberETCO2ETCO2 Sample Line Kit..........................................................................................................94021ETCO2 Water Trap ..................................................................................................................94020Adult Disposable Cannula .........................................................................................................9012Pediatric Disposable Cannula ....................................................................................................9013Infant Disposable Cannula.........................................................................................................9014Small Infant Disposable Cannula ..............................................................................................9015Adult Divided Cannula ..............................................................................................................9016Pediatric Divided Cannula ......................................................................................................9016CInfant Divided Cannula...........................................................................................................9016ASmall Infant Divided Cannula ................................................................................................ 9016BAnesthetic AgentsAnesthetic Agents Sample Kit.................................................................................................94018Anesthetic Agent Water Trap...................................................................................................94012Disposable Oxygen (O2) Sensor................................................................................................9445Anesthetic Agents Airway Adapter (package of 50) .................................................................9025TemperatureFiber-Optic Temperature Sensor................................................................................................9320Temperature Sensor Applicator .................................................................................................9321Pneumatic RespirationChest Pneumograph Sensor .....................................................................................................94023Invasive PressuresEdwards Lifesciences TruWave Reusable Cable, Model PX1800.Edwards Lifesciences Pressure Monitoring Kit with TruWave Disposable Pressure Transducer,PX Series.GatingPhilips Achieva Gating Interface Cable.....................................................................................9294GE Excite Gating Interface Cable..............................................................................................9292Siemens Avanto/Espree/Trio Gating Interface Cable ................................................................9291Hitachi/Toshiba Gating Interface Cable.....................................................................................9293

1-1SECTION 1INTRODUCTION1.0 INTRODUCTION.This manual describes a fully configured Precess MRI Patient Monitoring System, and mayinclude features and/or options that are not included in your system. For additional information,contact your local sales representative or Invivo Customer Service.The Precess MRI Patient Monitoring System is intended for use by health care professionals. It isintended to monitor vital signs for patients undergoing MRI procedures and to provide gatingsignals for synchronization for the MRI scanner.Specific training is required to operate this device. For available training options, please contactInvivo Customer Service at 407-275-3220 or Toll-Free 1-888-221-1592.1.1 Product Description. The Precess MRI Patient Monitoring System is designed to assistclinicians in monitoring patient vital signs in the midst of the dynamic and evolving MagneticResonance environment. The Precess combines the latest wireless communication, radiofrequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologiesto address the challenges associated with patient monitoring in the MRI area. Built on Invivo’sstrong heritage in MRI patient vital signs monitoring, the Precess provides accurate, continuous,and reliable performance during MRI applications.The standard Precess configuration consists of wireless interfaced electrocardiogram (ECG),wireless interfaced pulse oximetry (SpO2), and non-invasive blood pressure (NIBP). Optionalparameters include end-tidal CO2 (ETCO2), anesthetic agents, invasive blood pressure (IBP) andfiber-optic temperature.The Precess system consists of the following components (See Figure 1-1):a. Wireless Processing Unit. The Wireless Processing Unit (WPU) houses thecircuitry and hardware for support of the standard and optional patient monitoringparameters. The transceivers and antennas that support wireless communicationwith the ECG and SpO2 modules as well as the Display Controller Unit are alsopart of the WPU. The unit is powered by an AC – DC power adapter or tworemovable batteries that are recharged by the same power adapter. The batteriesprovide approximately 8 hours of continuous operation when NIBP, ECG, andSPO2 parameters are runing at 5-minute intervals. Refer to section 2.5 for moreinformation.b. Patient Connection Unit. The Patient Connection Unit (PCU) contains theconnectors that support all the non-wireless parameters (i.e. NIBP, ETCO2, etc.).c. Display Controller Unit. The WPU communicates to the Display Controller Unit(DCU) via a bi-directional 2.4 GHz communication link. The large color LCDdisplay, keypad, and recorder of the DCU form an easy-to-use user interface fordisplay, control, and documentation of the system patient monitoring parameters.Indications for UseThe Precess MRI Patient Monitoring System is intended to monitor vital signs for patientsundergoing MRI procedures and to provide signals for synchronization of the MRI scanner.The Precess MRI Patient Monitoring System is intended for use by health care professionals.

1-2d. Wireless ECG Module. The Wireless ECG (WECG) module communicates twoleads of ECG simultaneously to the WPU. These two leads of ECG can bedisplayed at the DCU and are output from the WPU unit for interface to the MRIsystem cardiac gating input.e. Wireless SpO2 Module. The Wireless SpO2 (WSpO2) communicates the SpO2value and pulse waveform to the WPU. The information is available for display atthe DCU and is output from the WPU for interface to the MRI system pulseperipheral gating input.Figure 1-1. Precess Components1.1.1 System Parameters. The Precess MRI Patient Monitoring System parameters allowsimultaneous processing and display of up to eight (8) parameters, six (6) waveforms, andassociated numeric values from each different parameter. All of the patient information is clearlydisplayed on a flat panel display screen.The Precess MRI Patient Monitoring System includes the following vital sign parameters:• Dual Lead ECG • Pulse Oximetry (SpO2) • NIBP• ETCO2 • Pneumatic Respiration • Anesthetic Agents• Temperature • Invasive Pressure (IBP)Wireless ECGModuleWireless SPO2Module

1-31.1.2 User Interface. A simple-to-use interface has been developed to minimize operatorlearning time. On the Display Control Unit (DCU), there is a Rotary Knob (which detents fromselection to selection) that is used to access the parameter menus, access the various setup featuresand finalize any changes to the setup of the system. 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 diverse offering of vital sign parameters, the Precess MRI PatientMonitoring System may be configured to meet the monitoring needs of a wide spectrum ofpatients from Neonate to Adults. Every available parameter may be easily accessed and adjustedto the unique needs, condition and situation of each patient.1.2 Wireless Processor Unit (WPU). The WPU contains wireless transceivers, dataacquisition and processing circuitry that communicate with the wireless Display Control Unit(DCU), ECG (WECG) module and SpO2 (WSpO2) module.1.2.1 Operating Environment. The WPU is designed to operate at the 5,000 Gauss line in thegenerated RF field of an MRI system measured from the center line of the bore.1.2.2 Power Supply. The WPU Power Supply is designed to operate on the floor at least 10 feetfrom a 3.0 Tesla unshielded MRI system (200 Gauss). When attached, the power supply chargesthe WPU (and DCU) battery packs whether the WPU is operating or not.1.3 Patient Connections. The physical patient connections for NIBP, Invasive Pressure andthe Anesthetic Agents options are located on the Patient Connection Unit (PCU) (See Figure 1-2).ECG, SpO2 and Pneumatic Respiration all use wireless technology to deliver their measurementsto the Wireless Processor Unit (WPU).Figure 1-2. Patient Connection Unit (PCU)1.3.1 NIBP and Agent Monitoring. The PCU contains the physical connections for the Non-Invasive Blood Pressure (NIBP) and, when installed, the optional Anesthetic Agents parameters.If Anesthetic Agents is installed, the PCU also contains a water trap to prevent moisturecontamination of the agent components.1.3.2 Invasive Pressure Monitoring. The PCU contains the physical connections for twoinvasive pressure channels, P1 and P2. Use the recommended Invasive Pressure Transducers thatare listed in the Accessories Section page xvii.1.3.3 Temperature Monitoring. The PCU contains the physical connection for one temperaturechannel. This Temperature Connector is for use with the fiber optic probe or sensor listed in theAccessories Section on page xvii. Temperature values are displayed in °C or °F, as selected by theoperator. 1.4 ECG Monitoring. ECG is monitored using a Wireless ECG Module (WECG). TheWECG module converts the ECG signals into radio signals for transmission to the WirelessProcessor Unit (WPU). The module also receives information through the wireless link, convertsthe information to electrical signals and performs the commanded task (i.e. lead configurationchange, scaling, etc.).

1-4•Compatibility. The WECG module supports the Quadtrode family of MRIcompatible ECG Electrodes.•Visual Indicators. The WECG module contains one (1) bi-color LED thatindicates the status of the battery charge.•Battery Life. The WECG module will operate at least eight (8) hours on a fullycharged battery.1.5 SpO2 Monitoring. SpO2 is monitored using a Wireless SpO2 Module (WSpO2). TheWireless SpO2 Module consists of a wireless transceiver to communicate with the WirelessProcessor Unit and convert the SpO2 pulse signal into radio signals for transmission to theWireless Processor Unit (WPU).•Compatibility. The Wireless WSpO2 module utilizes a fiber optic SpO2 sensor.•Visual Indicators. The WSpO2 module contains one (1) bi-color LED thatindicates the status of the battery charge.•Battery Life. The WSpO2 module will operate at least eight (8) hours on a fullycharged battery.1.6 Display Control Unit (DCU). The DCU provides control and display of the monitoredparameters.1.6.1 DCU Controls. (See Figure 1-3) The DCU front panel contains all the controls and accessfor complete patient monitoring. Control is provided by the push button keys and Rotary Knob.The Power Indicator is a three color LED that provides a visual indication of the DCU powerstatus with monitor power being turned off and on using the Power Switch. There is also aSpeaker to provide the sounds which the monitor produces and an Antenna for transmission/reception of wireless signals. The following is a general description of the DCU.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 variousfunctions 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, theDCU 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 pressingand releasing the Rotary Knob. All menus have a RETURN option whichwill return the display to the previous menu selection.

1-5Figure 1-3. The DCU Front Panel(2) During normal operation each active parameter has a Menu-Select icon onthe DCU display. When the Rotary Knob is rotated, the Menu-Select iconwhich is being pointed at becomes “highlighted.” Rotating the RotaryKnob will cause the display to “scroll through” the available menuselections. Once the appropriate Menu-Select icon is highlighted, pressingthe Rotary Knob completes the selection and brings up the required menu.Once the menu is selected, the Rotary Knob is used to scroll through theavailable menu 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, NIBP, SpO2, ETCO2, Agents, Invasive Pressures, and Temperature.b. The Top Keypad Set. (See Figure 1-4) There are six push keys in the top keypadset. The top three (FREEZE, EVENT MARK and ZERO ALL) provide directcontrol of a system feature while the bottom three (SETUP, ALARMS SCREENand RECORDER SETUP) provide access to operational menus. The six push keysare described below.Figure 1-4. The DCU Top Keypad Set

1-6:c. The Middle Keypad Set. (See Figure 1-5)The middle keypad set contains sixpush keys. The three on the left provide control of the NIBP monitoring featurewith two of the keys (NIBP START/STOP and NIBP STAT) providing directcontrol of NIBP measurements and the third (NIBP INTERVAL) bringing up amenu that allows adjustment of the NIBP Auto Mode Interval feature. On the rightside of this set are two keys which control the Trending feature of the monitor(TRENDS and CLEAR TRENDS) while a third (RECORD) provides a hardcopyprintout of selected parameters as specified by operator adjustments in theRecorder Menu. The six push keys are described below.(1) FREEZE. The Precess MRI Patient Monitoring System freezes the ECGwaveform from Trace A for closer examination upon user demand. Whenthe ECG trace is active, pressing the FREEZE key will freeze it into theTrace B location while Trace A remains active. When the trace is frozen,pressing the FREEZE key will release it. A “Blue Box” appears around thefrozen waveform as a visual indication that the waveform is not active.While the Freeze feature is active, the monitor will not allow any changesto the Parameter Setups or Display; if the operator attempts to access theParameter Selection Menu, a WARNING Box alerts the operator that entryto the selected menu is not allowed while FREEZE is Enabled.(2) EVENT MARK. The EVENT MARK key prints a marker on the ECGRecorder Strip when the printer is running. If the printer is not running,pressing this key has no effect.(3) ZERO ALL. The ZERO ALL key initiates a zero of the pressuretransducer of all available invasive pressure channels.(4) SETUP. The SETUP key allows the operator to access the variousavailable setup options.(5) ALARMS SCREEN. The ALARMS SCREEN key is a dual function keythat allows the operator to setup the Alarms monitoring feature. When themonitor display is in the Normal Screen and the ALARMS SCREEN keyis pressed, the Main Alarm Setup Screen will appear. When the monitordisplay has any icon highlighted and the ALARMS SCREEN key ispressed, an Alarm Setup Screen for the highlighted parameter appears.(6) RECORDER SETUP. The RECORDER SETUP key allows the operatorto setup the Recorder option.

1-7Figure 1-5. The DCU Middle Keypad Set(1) NIBP START/STOP. This key starts a new NIBP measurement, or stops ameasurement that is already in progress.(2) NIBP INTERVAL. Pressing the NIBP INTERVAL key brings up the NIBPInterval Menu where the cycle time (time between readings) of the NIBPAutomatic Reading Mode may be adjusted.(3) NIBP STAT. This key starts the NIBP STAT Mode measurements. Thismode may be terminated by depressing the NIBP START/STOP key. TheSTAT Mode performs up to five (5) NIBP measurements in rapidsuccession (with a short pause between readings) within a maximum timeframe of five (5) minutes.(4) TRENDS. The TRENDS key allows the operator to setup the Trendmonitoring feature. The exact operation of the TRENDS key is based onwhether or not a feature is currently highlighted. If a feature is currentlyhighlighted, pressing the TRENDS key will bring up a Trend which isspecific to the highlighted feature; if a feature is not currently highlighted,pressing the TRENDS key will bring up the History Menu and TabularDisplay (See Section 5).(5) CLEAR TRENDS. Pressing the CLEAR TRENDS key allows the operatorto clear all the stored data from memory. To prevent accidental erasure ofpatient data, there is a YES/NO box associated with this key that appears toensure that the operator meant to clear the trend data.NOTEIn various menus, the operator may accidentally make a selection that has significantirreversible effects (e.g.: erasing patient data). To protect against such accidents a Yes/No Menu is associated with these selections. This menu has only two activeselections: YES and NO. The operator must select one of the two choices to eitherconfirm the change to take place, or to cancel it. A delay of approximately 30 secondswithout any selection is equivalent to selecting NO. The Yes/No Menu is removed uponoperator selection, at the end of the time-out feature, by pressing the NORMALSCREEN button or by pressing the STANDBY button.

1-8d. The Bottom Keypad Set. (See Figure 1-6) The bottom keypad set is not groupedlike the top and middle, but is grouped around the Rotary Knob. There are threepush keys in this set (NORMAL SCREEN, STANDBY and ALARM SILENCE)which provide direct control of operational features of the system. The three pushkeys are described below. .Figure 1-6. The DCU Bottom Keypad Set(6) RECORD. Pressing this key records the Single Trace or Dual Traceselections (as specified by operator adjustments made in the RecorderMenu).The recorder stops automatically after approximately 30 seconds, or whenthe RECORD key is pressed again; in either case, the printout ends with a“Snap Shot” of the active patient parameter data.(1) NORMAL SCREEN. Pressing the NORMAL SCREEN key returns thePrecess MRI Patient Monitoring System from any menu to the NormalScreen.(2) STANDBY. Pressing the STANDBY key places the Precess MRI PatientMonitoring System into the Standby Mode. The system stays in StandbyMode until the STANDBY key is pressed a second time. Except for thethree (3) key features given below, the system operates normally bycontinuing to provide current patient information on the display screen.While in Standby Mode:• All audible alarms are disabled. The disabled alarms are indicatedon the screen by the “X” through the bell shaped Alarm StatusSymbol.• Active NIBP automatic measurements and STAT Modemeasurements are suspended.• No automatic printout is generated.• Default NIBP inflation pressures will be used for all manual NIBPreadings.(3) Alarm Silence Key. Pressing the ALARM SILENCE key, when theaudible alarms are enabled (as denoted by the absence of the “X” throughthe bell shaped Alarm Status Symbol), will affect the system as describedbelow:

1-9(a) Alarm Silenced. Any new alarm conditions will cause the Alarm toreactivate.In addition, while alarms are silenced the following conditionsapply:•Unlatched Alarms. If the alarm system has been set toUNLATCHED in the Alarms Menu and an Alarm Limit isviolated, pressing the ALARM SILENCE key will silencethe Alarm Tone and put the letter “S” in the Alarm Bell.While the parameter continues to violate its limits, thenumerics of the violating parameter continue to flash in redon the screen. Once the parameter returns to within itsAlarm Limit, the numerics return to their designated colorand no longer flash.•Latched Alarms. If the alarm system has been set toLATCHED in the Alarms Menu and an Alarm Limit isviolated, while the parameter continues to violate its limits,pressing ALARM SILENCE key stops the Alarm Tone, butthe numerics remain red and continue to flash, even after theparameter returns to within its Alarm Limits.•ALARM HOLD. If the ALARM SILENCE key is pressedwhen the Alarm Tone is Enabled but no alarm conditioncurrently exists, a “SOUND ON HOLD” message appearsin the upper center of the display with a count down timerstarting at 120 (counting down at a 1 second rate) denotingthat the Alarm Tone is being temporarily held silent. Inaddition, an “H” will appear in the Alarm Status Symbol tofurther alert the operator that the Alarm System is on Hold.If the Alarm Tone is sounding, the first pressing of theALARM SILENCE key stops the Alarm Tone, and puts theletter “S” in the Alarm Bell, and a second press EnablesALARM HOLD.The system automatically exits ALARM HOLD after twominutes (120 seconds), and the “SOUND ON HOLD”message disappears from the display, reactivating the AlarmTone. Remember that a current alarm condition (which hasbeen silenced) will not sound again unless the conditionreturns within limits and then violates the limit again. Alsoremember that a silenced alarm may not be accompanied bythe Alarm Silence message. Pressing the ALARMSILENCE key before the two minute period is over willalso reactivate the Alarm Tone and remove the “SOUNDON HOLD” message from the display. The duration of theSound On Hold feature is not user adjustable, and has apredefined value of two minutes (120 seconds).The user is able to put Alarms on Hold (SOUND ONHOLD) only when the Alarm Tone is active (no X appearsin the bell symbol in the upper left of the display). AlarmHold is useful for temporarily disabling the Alarm Tone.This might be useful, for example, when changing ECGleads or for any user activity which might cause a “false”alarm.

1-10(b) Front Panel Communication Power Light. (See Figure 1-6.) TheFront Panel Power Light (located beneath the Rotary Knob) is athree color LED that indicates the AC/Battery Power condition ofthe monitor. The Power Light will illuminate Green, Yellow andRed as described below:•Green Light. A SOLID GREEN Light indicates that themonitor is on AC power, the power switch is ON, the unithas good communications with a WPU, and if batteries areinserted they are charging. SLOW BLINKING GREEN(1 per 2.5 seconds) indicates that the monitor is on ACpower, power switch is OFF, and if batteries are insertedthey will be charging. FAST BLINKING GREEN(1 per. 6 seconds) indicates the unit is on AC power, thepower switch is ON, there are no communications, and ifbatteries are inserted they will be charging.•Yellow Light. A SOLID YELLOW Light indicates the unitis on battery power, the power switch is ON, and the unithas good communications with a WPU. FAST BLINKINGYELLOW (1 per. 6 seconds) indicates the unit is on batterypower, the power switch is ON, and there are nocommunications.•Red Light. A RED Light indicates WARNING becauseWPU and/or DCU shutdown is soon to occur. The internalbatteries have fallen below the required operational outputand an AC Wall Outlet must be located, and the systemplugged into it through the AC Power Adapter,immediately. SOLID RED indicates the unit has a lowbattery condition, the power switch is ON, and the unit hasgood communications with the WPU. FAST BLINKINGRED (1 per. 6 seconds) indicates that the unit has a lowbattery condition, the power switch is ON, and there are nocommunications.•No Light. NO LIGHT indicates that the unit is on batterypower and the power switch is OFF.1.6.2 DCU Display. (See Figure 1-7.) The DCU Display Screen displays four groups of data:The Informational Display, Vital Signs Trace Display, Vital Signs Numeric Display, and StatusDisplay. The entire display screen with its four different display groups is called the “NormalScreen”. The four display areas are described below.WARNINGAn active silenced alarm may not be accompanied by an Alarm Silence messageor an “S” in the Alarm Bell icon if the Alarm Hold sequence has been activated,or if a subsequent additional alarm has occurred and self-corrected.

1-11Figure 1-7. The DCU Normal Screena. Informational Display. (See Figure 1-8) The Informational Display is located atthe top of the Normal Display. This display provides the operator with the currenttime, the Alarm Status Bell Symbol, a flashing Heart Rate Symbol, a flashingLung Symbol, any current user messages and the current Patient Selection.Figure 1-8. The DCU Informational Display(1) Time. The current time is displayed in a 12 or 24 hour format (hh:mm:ss).The time, date and clock mode (12 or 24 hour) is adjusted in the SET TIMEMenu.(2) Alarm Status Symbol. The Precess MRI Patient Monitoring Systemsounds an Alarm Tone when any monitored parameter violates itsprogrammed Alarm Limits. The status of the Alarm Tone is indicated bythe bell shaped Alarm Status Symbol.(a) The letter “H” appearing in the bell indicates that the alarms havebeen placed on temporary HOLD with the ALARM SILENCE key.Similarly, during power-up the “SOUND ON HOLD” messagedisplayed in the center of the screen indicates that the Alarm Toneis temporarily placed on HOLD. A 120 second countdown timer isalso displayed under the message.(b) The letter “X” appearing in the bell symbol indicates that thealarms have been turned OFF from the ALARMS Menu or thatStandby Mode has been engaged. In this case the Alarm Tone willnot sound for any reason.WARNINGWhen an “X” appears in the Alarm Status Symbol, the audible Alarm Tone will NOT sound for any reason.

1-12(c) The letter “S” appearing in the bell indicates that a current alarmhas been silenced with the ALARM SILENCE key. This featurewill disable only the alarms that were current when the ALARMSILENCE key was pressed, any new alarms will cause the AlarmTone to sound.(3) Heart Symbol. The Heart Symbol flashes on the screen each time a heartbeat is detected. A tone is sounded at the same time (unless turned off inthe ECG Menu or the SPO2 Menu).(4) Lung Symbol. The Lung Symbol flashes on the screen at the end of eachdetected breath whenever the ETCO2 monitoring feature is turned ON.(5) Messages. These messages assist the operator in various aspects of theoperation of this monitor.(6) Patient Selection. Indicates the selected patient (ADULT or NEONATAL).b. Vital Signs Trace Display. (See Figure 1-9.) The Vital Signs Trace Display islocated in the middle of the Display Screen. This display provides the operatorwith a trace of the selected parameters and also contains Numerical Vital Signindications for the selected patient parameter.Figure 1-9. The DCU Vital Signs Trace Display(1) The Vital Signs Trace Display portion of the screen is divided into sixseparate trace areas. When turned on, the traces are fixed on the screen andupdated with an Erase Bar. When a Trace has been turned OFF, that portionof the screen is blank. The numeric values for each Trace appear near theright screen boundary.(2) If the value is greater than or equal to a maximum calculable value, “OVR”(Over Range) is alternately displayed with the numeric value.(3) TRACE A, C and D are assigned according to parameter and come on/gooff as parameters are turned on or off. Trace B is the location used for the“Freezing” of a waveform and is also used for ECG 2.• TRACE 1 = ECG1• TRACE B = ECG2/Freeze ECG1• TRACE C = SpO2• TRACE D = ETCO2/Agents Waveform• TRACE E = P1• TRACE F = P2

1-13The following is a description of each Trace:(a) TRACE A. The ECG trace is displayed in this position, unlessturned Off from either the ECG Menu or the Setups Menu. Themain menu for this trace and for the Heart Rate are brought up withthe selection of the ECG Menu-Select Icon.• The Heart Rate is displayed near the right screen boundaryin the Trace A position. The numerics turn RED and flash ifa Heart Rate Alarm Limit is violated. The color of thenumerics is that of the selected HR Source.• The annotation below the Heart Rate value indicates theSource of the Heart Rate, as selected from the ECG Menu,the NIBP Menu and the SPO2 Menu. Heart Rate Sourcechoices are AUTO, ECG, SPO2, ART and NIBP.• A RED flashing numeric value on the screen indicates thatan alarm for this value has been violated. This provides avisual indication of alarm violations, even when the AlarmTone is turned OFF.• If AUTO is selected as the HR SOURCE, the highestpriority active input is utilized for displaying the Heart Rate,in the order listed above. The ECG Trace must be OFF, orLead Fail present, for the Auto Source not to be the ECGTrace.• If the system does not find a valid Heart Rate Source whenset to AUTO and NIBP is OFF, the heart rate is annotatedwith “NONE.”• The displayed Lead for the ECG 1 is indicated near the leftscreen boundary.• A Scale Indicator is displayed near the left screen boundaryin the ECG waveform area(s). It represents a 1mVamplitude in the currently selected Scale.(b) TRACE B. Trace B displays ECG 2 or a frozen waveform fordetailed analysis.(c) TRACE C. Trace C displays the SpO2 waveform (if SpO2Enabled).(d) TRACE D. Trace D displays the Respiration waveform (if ETCO2enabled).c. Vital Signs Numeric Display. (See Figure 1-10.) The Vital Signs NumericDisplay is located at the bottom and right of the display screen. This display isdivided with boxes that provide the operator with numerical indications for NIBP,Temperature, RESP, and Agents.Figure 1-10. The DCU Vital Signs Numeric DisplayThe following is a description of the NIBP, Temperature, RESP, and Agents boxes.

1-14(1) Non-Invasive Blood Pressure (NIBP). NIBP is the first parameter (fromthe left) displayed in the Vital Signs Display. The Systolic, Diastolic andMean blood pressure values are displayed along with measurementinformation such as the Elapsed Time (ET) since the last measurement andthe time until the next measurement (if in the Automatic Mode). While inthe Manual mode, MANUAL is shown in the place of the time until thenext measurement.During a reading cycle the current cuff pressure is displayed (“CUFF:XXX”).Between the measurements the elapsed time (time since the last reading) isdisplayed (ET= 00:00:00) instead of the cuff pressure.The NIBP error messages are shown in place of the “NEXT: 00:00:00.”If errors are detected by the NIBP circuitry, one of the following messagesare displayed which preclude the determination of the blood pressure:(a) OVER PRES: Cuff inflation pressure has exceeded 280 ±5 mmHg.(b) CALIB: The system detected DC offset below 1 mmHg or above11 mmHg.(c) NOT INFLATING: Cuff inflation runs longer than 30 seconds.(d) LONG PRES: Cuff pressure remains at one level for more then30 seconds.(e) CUFF LEAK: The cuff inflation pump has run for more than20 seconds. Check hose and cuff connections.(f) RESID PRES: Cuff pressure above 20 mmHg for more then180 seconds.(g) WRONG CUFF: The wrong cuff is attached for the patient setting.Select ADULT or NEO (as appropriate) in the Setups Menu.(2) Temperature. The Temperature box is the second parameter (from the left)displayed in the Vital Signs Display area. The Temperature box providesdisplay of the patient temperature. If the Temperature reading is below20.0 degrees C (69.8 degrees F), the display will show “UND”. If theTemperature reading is over 44.0 degrees C (111.2 degrees F), the displaywill show “OVR”. If the temperature sensor is not plugged into thetemperature sensor input on the PCU, the display will show “---”. (3) Pneumatic Respiration. The Pneumatic Respiration box is the fourthparameter (from the left) displayed in the Vital Signs Display area. Thisbox displays the numeric value of the patient Respiration rate measured inthe Respiration Per Minute (RPM). The Respiration rate is measured by apneumatic bellows belt that is placed around the patient’s chest. As thepatient breathes, the movement of the chest modulates the air inside thepneumatic bellows. The Respiration rate is calculated by analyzing the airsignal at the bellows. Note that a waveform of the Pneumatic Respiration isnot available.(4) Agents. The Agents box is in the middle of the Normal Screen. This boxdisplays the numerical values for N2O, anesthetic agents Sevoflurane,Isoflurane, Desflurane, Halothane, and identifies the presence of anestheticagent Enflurane. Five gases are identified and specified by name next to thenumerical value for the gas being measured. A numeric value will not bedisplayed for Enflurane.

1-15d. Wireless System Status Display. The System Status Display (Figure 1-11) islocated at the bottom of the Normal Screen Display and provides the operator withvisual indications of the operational status of the system. From left to right, thesymbols represent DCU Power Status (1), WPU Communication-Power Status (2),SPO2 Communication-Battery Status (3), ECG Communication-Battery Status(3), and the Communication Network Indication (4).Figure 1-11. Wireless System Status Display(1) DCU Power Status (1). The DCU Power Status area is donated by theDCU symbol (Figure 1-12). Below the DCU Symbol are indicators thatshow the power status for that particular DCU. When the DCU is operatingfrom line power, the AC Power Cord Icon is displayed as in Figure 1-11. Ifbatteries are not installed in the DCU, then the Battery Not Installed Icon(Figure 1-13) is displayed just to the right of the AC Power Cord Icon.When the DCU is operating from battery power, a Battery Gauge Iconindicating the amount of time remaining on the battery power is displayed(Figure 1-13). The numeric display of the amount of time remaining isformatted as “hours:minutes” and is updated in 15 minute increments.When less than thirty (30) minutes of operating time remains, the numericTime Remaining Display will disappear, the message “LOW” will appearin the Battery Gauge Icon, the Battery Icon will flash in the color RED, andan audible tone will be output.Figure 1-12. DCU Symbol.Figure 1-13. Example of Power Indicator Symbols (DCU & WPU)Battery Symbol DCU Indicator WPU IndicatorBattery life remaining in hours: minutesOn AC Power Battery Not Installed (appears only when battery not in unit)

1-16(2) WPU Communication-Power Status (2). The WPU Status area isdenoted by the WPU symbol (Figure 1-14). When this symbol is present,good communication has been established between that DCU and theWPU. When communication is lost or has not been established between theDCU and the WPU, the WPU symbol with the slashed enclosure (Figure1-15) will be displayed. Below the WPU Symbol are indicators that showthe power status for that WPU. When the WPU is operating from linepower, the AC Power Cord Icon is displayed (Figure 1-13). If batteries arenot installed in the WPU, then the Battery Not Installed Icon (Figure 1-13)is displayed just to the right of the AC Power Cord Icon. When the WPU isoperating from battery power, a Battery Gauge Icon indicating the amountof time remaining on battery power is displayed (Figure 1-13). Thenumeric display of the amount of time remaining is formatted as“hours:minutes” and is updated in 15 minute increments. When less thanthirty (30) minutes of operating time remains, the numeric TimeRemaining Display will disappear, the message “LOW” will appear in theBattery Gauge Icon, the Battery Icon will flash in the color RED, and anaudible tone will be output.Figure 1-14. WPU Display SymbolFigure 1-15. WPU No Communication Display(3) SPO2 and ECG Communication-Battery Status (3). The SPO2 andECG Communication-Battery Status areas are denoted by the SPO2symbol and ECG symbol (Figure 1-16). These symbols represent theWireless SpO2 and Wireless ECG Modules. Below the SPO2 and ECGSymbols are the SPO2 and ECG Battery Gauge Icons that indicate theamount of capacity remaining in each battery. The Wireless SpO2 andWireless ECG Modules will operate for eight (8) hours when the batterygauge shows full (100%) capacity. An indication of 75% will provideapproximately six (6) hours of operation, 50% approximately four (4)hours, 25% approximately two (2) hours, and 12% approximately one (1)hour. When less than thirty (30) minutes of operating time remains, thenumeric time remaining will disappear from the display, the message“LOW” will appear in the Battery Gauge Icon, the Battery Icon will flashin the color RED, and an audible tone will be output. When communicationis lost or has not been established between the Wireless SpO2 Module andthe WPU, the SPO2 Symbol will become large in size and will besurrounded by the slashed enclosure (Figure 1-17). Likewise, whencommunication is lost or has not been established between the WirelessECG module and the WPU, the ECG Symbol will become large and will besurrounded by the slashed enclosure (Figure 1-17).

1-17Figure 1-16. Wireless SpO2 and ECG Battery SymbolsFigure 1-17. Wireless SpO2 and ECG No Communication Display(4)Communication Network Indication (4). The Communication NetworkIndication Symbol provides the wireless communication networkdesignation for the particular Precess system. In order for the Precesssystem to properly communicate with all components (DCU, WPU,Wireless SpO2 and ECG Modules), the Network Designators (Figure 1-18)on each system component must be the same. Each Network Designator hasits own characteristic color, shape, and number in order that each designatoris easily distinguishable. In areas where multiple Precess systems are beingutilized, it is extremely important that each component within a system isset to the proper network, otherwise a component on the wrong networkwill interfere with another system or incorrect patient vital signsinformation will be obtained and displayed..Figure 1-18. Network DesignatorsNOTEIn environments where multiple Precess systems are being utilized, the operator mustbe aware of each system’s network setting. Operating on the same or wrongcommunication network will interfere with another system or incorrect patient vitalsigns information will be obtained and displayed. Figure 1-18 shows eachCommunication Network Designator.Network 1 Network 2 Network 3 Network 4 Network 5

e. Yes/No Menu. In various menus, the operator may accidentally make a selectionthat has significant irreversible effects (e.g.: erasing patient data). To protectagainst such accidents a Yes/No Menu is associated with these selections. Thismenu has only two active selections: YES and NO. The operator must select one ofthe two choices to either confirm the change to take place, or to cancel it. A delayof approximately 30 seconds without any selection is equivalent to selecting NO.The Yes/No Menu is removed upon operator selection, at the end of the time-outfeature, by pressing the NORMAL SCREEN button or by pressing the STANDBYbutton.1.7 Cleaning. The system is not sterilizable. Never immerse any part of the system in anyfluid or attempt to clean it with liquid cleaning agents. Remove dirt and dust from the DCU,WPU, and/or modules by wiping it with a soft, damp cloth.Stains can be removed from the DCU, WPU, and/or module housings by scrubbing briskly with adamp cloth. Unplug the system and remove the batteries before cleaning. Do not permit liquid tocontact the front or rear of the DCU, or permit liquid to drip into the printer or around displayscreen. If liquid entersmust any components, contact Invivo Technical Support.1.7.1 Cleaning Accessories. Any reusable patient accessories must be cleaned after each use.Disposable patient accessories mustwill be discarded and replaced with new items. To clean reusable accessories, first, remove the accessory from use. Remove any dirt or debrisusing 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, andreplace as necessary.If disinfection is required, use only the recommended liquid surface disinfectants, unlessotherwise specified in the accessories listing. Recommended surface disinfectants include dilutesolutions of either quaternary ammonium compounds, iodophors or gluteraldehydes.

2-1SECTION 2INSTALLATION2.0 INSTALLATION2.1 Unpacking The System. Remove each system component from the shipping boxes andcarefully examine all components for damage that may have occurred during shipment. Check allitems against the included packing list and purchase request. To resolve any issues or concernswith your order or product, or to report shipping damage, contact Invivo Customer Service. Saveall packing materials and related shipping documents, as these will be required to process a claimwith the carrier if damage during shipment occurred.2.2 System Configuration. Before proceeding, read the Precautions and User ResponsibilitySections (Pages v to xvi.). These sections provide important safety information. The standardPrecess MRI Patient Monitoring System consists of one (1) WPU, one (1) DCU, one (1) WECGmodule, and one (1) WSpO2 module. The DCU attaches to the WPU by sliding the DCU onto theWPU Power-Mounting Shoe. When installed in the WPU Power-Mounting Shoe, the DCUreceives power from the WPU. With the WPU connected to line power and the DCU installed inthe Power-Mounting Shoe, the DCU batteries are charged through the WPU. For added flexibility,the system can be configured with two (2) additional DCUs, for a total of three (3) DCUs. TheseDCUs can be located either inside the MRI exam room, inside the MRI control room, or in anMRI holding area.2.3 Battery Installation and Removal. All batteries can be removed and installed into theirrespective unit at any time. Note that the operation of the WECG and WSpO2 will be interruptedwhen the batteries are removed. Likewise, the operation of the WPU and DCU will be interruptedif the batteries are removed and the unit(s) is/are not powered by a power supply. The WECG andWSpO2 batteries (Part Number 9065) are completely non-magnetic and can be removed andreplaced from the wireless modules while in the MRI magnetic field; however, the batteries mustbe kept out of the Field of View, otherwise image artifact can occur.2.3.1 Battery Locations.The WPU has two batteries (Invivo Part Number 9064 or 9093) that arelocated on the bottom front of the unit (Figure 2-1). The DCU also has two batteries (Invivo PartNumber 9064 or 9093) that are located on each side of the unit (Figure 2-2). Note that the WPUand DCU batteries are interchangeable. The WSpO2 and WECG modules each have a battery(Invivo Part Number 9065) located on the back of the units (Figure 2-3 and Figure 2-4). Notethat the WECG and WSpO2 batteries are also interchangeable.NOTEThe 9065 battery and wireless module must not be placed in the Field of View tominimize the chance of image artifact.CAUTIONPrior to clinical use, the operator must be aware of the minimum distance from the MRI System for proper operation.The WPU and DCU batteries (Part Number 9064 or 9093) contain some ferrous materials that are attracted to the MRI magnetic field. DO NOT remove the batteries from the WPU or DCU when these units are closer than the 1,000 Gauss line (0.1 Tesla) as the batteries will be attracted to the magnetic field, thus causing patient or user injury.

2-22.3.2 WPU And DCU Battery Installation And Removal.The WPU and DCU batteries slideinto their respective battery compartments and automatically latch into place. When installing thebatteries, note that they must be orientated properly into the battery compartment in order thatthey will latch into place. The battery packaging is designed such that the battery fits the contourof the unit geometry. If the battery does not latch automatically into place when fully inserted intothe battery compartment, then the battery is probably not orientated properly. Orientate the batteryin the other direction and reinstall the battery into the battery compartment. Never force a batteryinto the battery compartment as it will damage the battery or the Precess MRI Patient MonitoringSystem. In order to remove a battery from the WPU or DCU, simply press the associated BatteryEject Button and that battery will partially eject for easy removal (see Figure 2-1 and Figure 2-2). Refer to the Caution below regarding battery disposal. .Figure 2-1. WPU Battery LocationFigure 2-2. DCU Battery LocationsBattery Eject Button (On Underside)Battery Eject Button (On Underside)Battery Eject ButtonBattery Eject Button

2-32.3.3 WECG And WSpO2 Battery Installation And Removal. The wireless module batterieseach slide into the battery slots on the WECG and WSpO2 modules and latch into place on eachside. To remove the batteries, use your fingers to simultaneously press the latches on both sides ofthe battery and the battery will slide out of the module (see Figure 2-3 and Figure 2-4). Refer tothe Caution below regarding battery disposal.Figure 2-3. WSPO2 Module Battery LocationFigure 2-4. WECG Module Battery LocationBattery LatchBattery LatchBatteryLatchBattery Latch

2-4 .WARNING• Stop using the battery if it exhibits abnormal heat, odor, color, deformation oris in an abnormal condition.• If punctured or liquid leaks onto your skin or clothes, wash well with freshwater immediately.• If liquid leaking from the battery gets into your eyes, do not rub your eyes.Wash them well with clean water and consult a doctor immediately.CAUTION• Never heat the battery nor throw into a fire. Keep the battery contacts away from metalobjects.• Replace batteries with only Invivo supplied batteries. Refer to the Accessories list onpage xvii.• Store battery in a dry place, 0°C to 40°C.• Dispose of battery properly*.• Do not disassemble or incinerate battery.• Charge battery before use.• Batteries have life cycles, so if the time that the battery is powering the equipmentbecomes much shorter than usual, the battery life is at an end. Replace the battery witha new one.• Remove a battery whose life cycle has expired from equipment immediately.• If the terminals of the battery become dirty, wipe them with a dry cloth before using thebattery.* Disposal in Europe: The European Community (EC) has issued two directives; 91/157/EEC and 93/86/EEC. Each member country implements these independently. Thus, ineach country the manufacturers, importers and users are responsible for the properdisposal or recycling of batteries.* Disposal in the US: Lithium batteries are neither specifically listed nor exempted fromthe Federal Environmental Protection Agency (EPA) hazardous waste regulations, asconveyed by the Resources Conservation and Recovery Act (RCRA). The only metal ofpossible concern in the cell is the lithium metal that is not listed or characterized as a toxichazardous waste. Significant amount of spent cells and batteries that are untreated andnot fully discharged are considered as reactive hazardous waste. Thus, hazardous wasteof spent cells and batteries can be disposed after they are first neutralized through anapproved secondary treatment prior to disposal (as required by U.S. Land Ban Restrictionof the Hazardous and Solid Waste Amendments of 1984). Disposal of spent batteries mustbe performed by authorized, professional disposal company, which has the knowledge inthe requirements of the Federal, the State and the Local authorities regarding hazardousmaterials, transportation and waste disposal. In any case it is recommended to contact thelocal EPA office.CAUTIONAll batteries must be removed prior to shipping the Precess MRI Patient Monitoring System.

2-6WARNING• When charging the battery, only use the Invivo Wireless Module BatteryCharger for Precess MRI Patient Monitoring System, Part Number 9023.• Do not attach the battery to power supply plug or directly to an automobilecigarette lighter.• Do not place the battery in or near fire, or in direct sunlight. Heatingthe battery will damage the safety circuitry, which can causeadditional heating, rupture, or ignition of the battery.• The battery charger is NOT MRI COMPATIBLE, and MUST belocated outside the Magnet Room.CAUTION• To reduce the risk of injury, charge only rechargeable batteries Part Number 9065.Other types of batteries will burst causing personal injury and damage.• To prevent electrical shock when cleaning the unit, always unplug the unit fromAC power.WARNINGDo not continue charging the battery if it does not recharge within thespecified charging time. Doing so will cause the battery to becomehot, explode, or ignite.The temperature range over which the battery can be charged is 0°C to45°C. Charging the battery at temperatures outside this range will cause severedamage to the battery or reduce battery life expectancy.If the power module or power cord is damaged, it must be replaced by anauthorized Invivo part.For protection against fire hazard, there are no repairable parts. If servicing isneeded, contact Invivo or an authorized Invivo Service Agent.To prevent against electrical shock, refer all servicing to an authorizedInvivo Service Agent.

2-7c. Wireless Module Battery Charger Description. The following is a description ofPrecess Part Number 9023 Battery Charger, indicators, and connections (Figure 2-6).Figure 2-6. 3.7V Battery Charger, Part Number 9023(Item 1) - Battery Charger Power Indicator. This green LED indicates thatpower is being supplied to the battery charger from either Part Number9063 Power Module or Model 9023 battery charger.(Item 2) - Battery Bay 1 Indicator. This LED indicates the charging status of thebattery inserted in Battery Bay 1.(Item 3) - Battery Bay 1. Battery Bay 1 provides for the insertion of Part Number9065 Lithium Battery for recharging purposes.(Item 4) - Battery Bay 2. Battery Bay 2 provides for the insertion of Part Number9065 Lithium Battery for recharging purposes.(Item 5) - Battery Bay 2 Indicator. This LED indicates the charging status of thebattery inserted in Battery Bay 2.(Item 6) - Reconditioning Button. The Reconditioning Button is provided toallow the user to accept reconditioning of Part Number 9065 Lithium Batterywhen there is a flashing blue LED indicator. Reconditioning will result in a longerdown time for the battery being reconditioned.(Item 7) - Battery Bay 3 Indicator. This LED indicates the charging status of thebattery inserted in Battery Bay 3.(Item 8) - Battery Bay 3. Battery Bay 3 provides for the insertion of Part Number9065 Lithium Battery for recharging and reconditioning purposes.(Item 9) - Battery Bay 4. Battery Bay 4 provides for the insertion of Part Number9065 Lithium Battery for recharging purposes.(Item 10) - Battery Bay 4 Indicator. This LED indicates the charging status of thebattery inserted in Battery Bay 4.

2-8d. Wireless Module Battery Charger Power Connection Procedure. The WirelessModule Battery Charger uses 5 Vdc from Part Number 9063 Power Module.Connection is made by plugging Part Number 9063 Power Module into an ACoutlet, then connecting the output power cable into the power connection on theback of the charger unit (Figure 2-7).Figure 2-7. Wireless Module Battery Charger Power Connectione. Charging Cycle Description. The Wireless Module Battery Charger systemconsists of four separate charger bays that are individually fused. If there is afailure in any of the four charger bays that causes the internal fuse to blow, theother bays will still operate (provided there has not been such a failure in them aswell). When a battery is inserted into the charger, the associated LED will light toindicate the status of the battery. This charge indicator will change colors as thestatus of the battery changes during the charging cycle. The battery indicator willremain lit with a solid green LED when the battery is charged to within 5% of thefull value (4.2 Vdc). See Table 2-1 for the list of LED indications.Table 2-1. LED IndicationsLED Condition LED IndicationYELLOW FLASHING Low battery charging. Battery capacity < 70%.GREEN FLASHING Medium battery charging.Battery capacity > 70%.GREEN SOLID Charge complete.Battery capacity > 95%.Input 100-240 VacOutput 5 Vdc

2-9If the indicator is showing a RED LED, remove power from the battery charger toallow it to reset and then re-apply power and use as normal. If after resetting thebattery charger the LED again shows RED, then there is a fault in the battery orbattery bay.* If the indicator is showing a SOLID RED LED, this is indicating a fault in thebattery. If the battery has been removed and re-inserted into the same battery bayor another bay, and during the charge cycle again shows SOLID RED, then thebattery needs to be replaced.** If the indicator shows a FLASHING RED LED, this is indicating that there willbe a fault in that battery bay. Remove and re-insert the battery into the battery bay.If during the charge cycle the indicator again shows FLASHING RED, then thatbattery bay is no longer usable. Try inserting the battery into another bay. If theindicator on the alternate bay shows that it is charging normally, then when theLED is SOLID GREEN, the battery is completely charged and usable.*** During the first 15 seconds of inserting the battery, if the indicator shows aBLUE FLASHING LED, the chip in the battery is requesting that the battery bereconditioned. If this is ignored, the battery will go through its normal rechargecycle, but the Precess MRI Patient Monitoring System will not give the correctindication of battery life. To recondition the battery, it must be moved to BatteryBay 3 and the RECONDITIONING button pressed. Reconditioning takes 8 hours.f. Wireless Module Battery Charging Procedure. Perform the following to chargePart Number 9065 Lithium Battery.Step 1. Insert Part Number 9065 Lithium Battery into an open battery bayuntil it is firmly seated.Step 2. Check the status indicator for that battery bay. If it is flashing blueand you want to recondition the battery, move it to Battery Bay 3. If it isavailable, then push the Reconditioning Button. Otherwise, the charger willgo into its normal charge cycle after 15 seconds.Step 3. When the indicator shows solid green, the battery is fully chargeand ready for use.RED FLASHING ** Charger malfunction.Charge control has been lost.Remove battery.RED SOLID * Battery fault.A charging parameter of current, voltage, temperature, or time has exceeded limits.BLUE FLASHING *** Battery capacity reconditioning requested.The battery Smart Chip requests a reassessment of battery capacity.BLUE SOLID Reconditioning in progress.NO Color No battery detected.Table 2-1. LED IndicationsLED Condition LED Indication

2-102.5 Battery Operation. The bottom area of the DCU display contains the System StatusArea. This area is dedicated to displaying battery and wireless communication status. Refer toSection 1.6.2, page 1-10, for a full explanation of the Battery Status Display. Maximum operationtime of the battery (Invivo Part Number 9093 or 9064) is approximately eight (8) hours whenNIBP, ECG, SpO2 parameters are running on 5-minute intervals, and anesthetic agents and EtCO2are turned off. (Battery operation time will be reduced by up to two (2) hours by performingcertain operations like anesthetic agents, printing charts and trends, or short automatic NIBP cycletimes).The minimum voltage value for normal operation for Invivo Part Number 9064 battery is 14.4V.The minimum voltage value for Invivo Part Number 9065 battery is 3.5V. The minimum voltagevalue for normal operation for Invivo Part Number 9093 is 14.8V.The Precess performs an automatic switchover to internal batteries when the line power isinterrupted and batteries in the WPU and DCU are in place. 2.6 System Setup.2.6.1 WPU and DCU.a. Install the batteries into the WPU and DCU as described above in Section 2.3.b. Locate a Precess AC to DC Power Supply (Invivo Part Number AS201) and attachthe AC Power Cord as shown in Figure 2-8. Connect the male end of the 25 ft. DCPower Cable (Invivo Part Number AC517B) to the DC OUTPUT on the PowerSupply (Figure 2-9). Locate this Power Supply in the MRI Exam Room near anapproved AC outlet at a distance of at least 10 feet (3 meters) from the MRImagnet. Plug the AC Power Cord into the AC outlet. Plug the female end of theDC Power Cable into the Power Input on the WPU (see Figure 2-10).c. Locate another Precess AC to DC Power Supply (Invivo Part Number AS201) andattach the AC Power Cord. Connect the male end of the 5 ft. DC Power Cable(Invivo Part Number AC517A) to the DC OUTPUT on the Power Supply. Locatethis Power Supply in the MRI Control Room or MRI Holding Room near anapproved AC outlet. Plug the AC Power Cord into the AC outlet. Plug the femaleend of the DC Power Cable into the Power Input on the back of the DCU(see Figure 2-11).d. Repeat Step C for each additional DCU that will be used with the system.e. When installing the system for the first time, all batteries mustwill be charged forat least twelve (12) hours with the Precess system turned off in order that thebatteries are fully charged and conditioned for operation.f. Turn on the WPU with the power switch located next to the Patient ConnectionsUnit (PCU).g. Turn on the DCU with the power switch located at the front panel.h. Verify the proper operation of each installed patient parameter. Reference Section 3in this manual.

2-11Figure 2-8. AC Power Connection To Precess AC to DCPower Supply (Part Number AS201)Figure 2-9. Precess DC Power Connection To Precessc AC To DC Power Supply (Part Number AS201)

2-12Figure 2-10. WPU Hardwire LocationFigure 2-11. DCU Power InputWPU Power DoorDCU Power Door

2-132.7 System Location. The Precess MRI Patient Monitoring System is compatible with allMRI systems between 0.15 and 3.0 Tesla. Select a location where the system is outside the 5,000Gauss (0.5T) Field Line (outside the 1,000 Gauss (0.1T) Field Line for a DCU with the RecorderOption). Also, choose a location where the system will not come in contact with liquids andwhere it will not be exposed to temperatures above 44°C (110°F). Maintain adequate air flowaround each system component in order that the normal operating temperature range is notexceeded.2.8 Before Connecting To A Patient. Perform the following steps to prepare the system foruse.Step 1. Ensure that there is no damage to any system component.Step 2. Ensure that all patient connections are properly connected.Step 3. Ensure that all patient accessories being utilized (NIBP hoses, cuffs, ECG leadwires, etc.) are listed in the Accessories section of this manual (Page xv). Visually inspectall accessories for damage. Replace any accessories that show signs of damage or abuse.Step 4. Report any problems to an authorized Invivo Service Representative.Step 5. Verify that each patient parameter is functioning properly before using the systemon a patient. Never use a system that is suspected of not operating properly or out ofcalibration.CAUTIONThe WPU and DCU batteries (Part Number 9064 or 9093) contain some ferrousmaterials that are attracted to the MRI magnetic field. DO NOT remove the batteriesfrom the WPU or DCU when these units are closer than the 1,000 Gauss line(0.1 Tesla) as the batteries will be attracted to the magnetic field, thus causing patientor user injury.WARNINGEnsure Part Number AS201 Power Supply remains 10 feet (3 meters) or morefrom the magnet.

3-1SECTION 3PATIENT PARAMETERS3.0 PATIENT PARAMETERS.3.1 ECG Monitoring. Unless it has been turned off in the ECG Menu, the selected ECG leadis displayed as TRACE A. TRACE B may also be selected. Most ECG functions are contained inthe ECG Menu. Additional features useful with ECG monitoring are found in three secondarymenus:•RECORDER Menu. Used to select all recorder functions and to set the recorderand trace speed.•ALARMS Menu. Used to Set and/or Disable the ECG alarms. The range ofAlarm Limits for the ECG Heart Rate is 30 to 249 bpm.•HEART RATE TREND Menu. Used to setup and print Trended information.•PEDIATRIC ECG Menu. This menu is used to provide specific ECG filtering forthose patients with narrow QRS complexes and higher heart rates (> 120 beats perminute) that may cause disruption of normal ECG processing. See Paragraph 4.2for further explanation.For further information on the secondary menus, see the corresponding paragraphs of thisdocument.Although it may appear that electrocardiogram (ECG) monitoring in the Magnetic ResonanceImaging (MRI) area is similar to that performed in other areas of the clinical environment, theconditions found inside the MRI area are unique and require additional precautions to be followedin order to permit the safe monitoring of the patient during MRI procedures. It is always importantto remember that the risk of radio frequency (RF) heating is ever-present when any electricalconductor, for example ECG lead wires, are placed in the MRI system bore. By following theInvivo operating precautions, warnings, and the guidelines below, these risks can be minimized.3.1.1 Wireless ECG Module and ECG Patient Lead Wires. The Invivo Wireless ECG Module(Part Number 9312, Figure 3-1) and ECG Patient Lead Wires are specially designed for use in theMRI system bore, although the module must not be placed within the MRI procedure Field-Of-View (FOV). Placing the Wireless ECG Module within the FOV may interrupt ECG monitoringduring the MRI procedure and cause artifact on the MRI image. The Invivo MRI ECG lead wires(Part Numbers 9224, 9223, and 9222) are constructed of special material to reduce the amount ofradio frequency (RF) energy that can flow through these wires. The ECG Lead Wires must alwaysbe kept in a straight line and must not touch the MRI system bore. Any loop (circular, “U” shaped,“S” shaped) in the lead wires and/or contact with the MRI system bore will cause heating of thelead wires or the patient electrodes. Never use any ECG lead wires other than the Invivo MRIECG lead wires (Invivo Part Numbers 9224, 9223, and 9222).The misuse or the use of leadwires other than the Invivo MRI ECG Lead Wires will cause excessive RF current to flow throughthe lead wires, thus causing the potential for heating at the ECG lead wires and the electrodes.Heating of the ECG lead wires and electrodes can lead to minor severe burns at the patient’s skin.

3-2The Wireless ECG Module, ECG Patient Lead Wires, and Quadtrode ECG Electrodes arecompatible with MRI systems up to 3.0 Tesla with Specific Absorption Ratios (SAR) up to 4.0 W/kg. Use at SAR levels above 4.0 W/kg increases the heating risk at ECG patient lead wiresand electrodes.Figure 3-1. WECG Module with Power/Communication LED3.1.2ECG Electrode - Use only Invivo Quadtrode MRI ECG Electrodes. These ECG electrodesare design specifically for use in the MRI environment. Use of the Invivo Quadtrode electrodes willminimize the possible risk of ECG electrode and cable heating during MRI procedures and reduce theamount of MRI generated artifact on the ECG waveform. Three different Quadtrode MRI ECGElectrodes are available for differing applications:•Invivo Quadtrode MRI ECG Electrodes (Part Number 9303A) are designedfor use during general MRI procedures on adult and pediatric patients above 10 kg(22 lbs.).•Invivo Quadtrode CV MRI ECG Electrodes (Part Number 9371A) aredesigned for use during Cardiovascular (CV) MRI procedures.•Invivo Neonatal Quadtrode MRI ECG Electrodes (Part Number 9372) aredesigned for use during general MRI procedures on neonatal or infant patientsbelow 10 kg (22 lbs.).Follow the Patient Preparation and Quadtrode Placement instructions provided on eachQuadtrode foil package.•Electrode Site Selection. Monitoring ECG in the MRI environment is particularlychallenging because of the inherent distortion of the ECG waveform by the MRImagnetic field. These blood flow induced distortions of the ECG are due to thelarge amount of blood moving through the vessels of the heart (aorta). Blood(a very good electrical conductor) moving through the large magnetic field of theMRI produces an electrical potential that adds to the ECG signal. This inducedelectrical potential is seen primarily as an augmentation of the ECG T-waveamplitude, although other non-specific waveform changes are also apparent on theECG. Since an elevated T-wave or ST segment will be associated with truephysiologic disorders, the statis magnetic field-induced ECG-distortions will beproblematic. For this reason, a baseline recording of the ECG prior to placing thepatient inside the MRI magnetic bore will be necessary. The proper placement ofthe ECG electrodes in the MRI is critical to reducing the blood flow induceddistortion of the ECG waveform. With proper strategic placement of the ECGelectrodes and minimization of the electrode lead wire length, this blood flowinduced distortion can be kept to a minimum. Following the instructions providedWARNINGBefore applying a Quadtrode® MRI ECG Electrode to a patient, always verify thatthe expiration date on the back of the Quadtrode® foil packaging is valid.Power/Communication LED

3-3on the specific Quadtrode foil packaging will minimize the blood flow induceddistortion on the ECG signal. Additional artifacts caused by the static, gradient,and RF electromagnetic fields can severely distort the ECG, making observation ofthe morphologic changes and detection of arrhythmia quite difficult. Monitoring adifferent ECG lead (I, II, III, AVL, AVR, AVF) will minimize some of theseartifacts.•Electrode Site Preparation. If necessary, shave the selected site(s) to remove anyhair from the electrode site(s). Apply ECG Skin Prep Gel (Invivo Part Number9009) to a gauze pad. Briskly rub the selected site(s) with this gauze pad. Removeexcess gel with a clean gauze. The ECG Skin Prep gel contains light abrasivepumice and saline that clean and enhance the conductive properties of the patientsskin, thus enhancing ECG performance. Isopropyl/rubbing alcohol must not beused to prep the skin as it breaks down the conductive properties of the skin, thusdegrading ECG performance. Follow the Patient Preparation and QuadtrodePlacement instructions provided on each Quadtrode foil package.•Checking Electrode Contact Quality. Electrode preparation has a direct bearingon ECG performance. The result of poor electrode preparation will be poor ECGmonitoring performance. A standard means to evaluate electrode contact is tomeasure the electrical conductance (impedance) between electrodes to verify thatthe impedance is below 8,000 ohms. Once the electrode site has been prepared andthe Quadtrode placed, the optional Electrode Impedance Meter (Invivo PartNumber 9392) can be attached to the LA, RA, and LL Quadtrode connections.Refer to the instructions on the Electrode Impedance Meter. Since only three leadwires can be connected simultaneously, the user will need to check the fourthelectrode (RL) with the LL (Red) lead wire. If electrode contact is poor (greaterthan 8,000 ohms), remove and discard the electrode, and repeat the site preparationaccording to the instructions above. Never reuse a removed electrode since itsadhesive will not securely fasten the Quadtrode electrode to the patient’s skin. Re-check the impedance electrodes and verify that acceptable impedance is achieved.•Other Electrical Conductors Inside The MRI System Bore. No other electricalconductor (e.g. wires, leads, probes, etc.) are tomust be placed inside the MRIsystem bore at the same time as the Invivo MRI ECG lead wires (Part Numbers9224, 9223, and 9222) as the risk of lead wire and electrode heating increases. It isalways important to identify if the patient has any metallic wires, conductors,implants, stents, etc. within his/her body as these items will interact, thusincreasing the risk of lead wire and electrode heating.Table 3-1. WECG Power/Communication LEDLED Indication Power Source Communication StatusSOLID YELLOW On battery power Good communications with a WPUSOLID RED Low battery condition Good communications with a WPUBLINKING YELLOW On battery power No communicationsBLINKING RED Low battery condition No communicationsNO LIGHT Dead battery N/A

3-43.1.3 Associated Waveforms and Displays. (See Figure 3-2.) ECG information is displayed asa waveform in the Trace A location and as numeric data in the Box 1 and 2 locations. Thefollowing is a description of the items contained within the ECG Display.Figure 3-2. ECG Trace and Numerical Displaysa. ECG Lead. (Item 1) Displays the ECG Lead selected for use.b. Scale Indicator. (Item 2) This indicator is provided for a reference and representsa 1 millivolt signal amplitude.c. Message Areas. (Item 3) These areas display software messages: The area on theleft displays ECG specific messages while the larger area on the right displays alltypes of system messages.d. Waveform Traces. (Item 4) Displays the ECG waveform of the patient.e. Heart Rate Numeric. (Item 5) Displays the current Heart Rate indication for thepatient.f. Alarm Limit High. (Item 6) Displays the value set for the High Limit of the ECGHeart Rate Alarm. This item is under operator control and may be turned on or offas required.g. Alarm Limit Low. (Item 7) Displays the value set for the Low Limit of the ECGHeart Rate Alarm. This item is under operator control and may be turned on or offas required.h. Heart Rate Source. (Item 8) Displays the source selected for the Heart Rate.3.1.4 The ECG Menu. (See Figure 3-3.) Selecting the ECG Menu-Select Icon brings up theECG Menu. This menu has a time-out feature. If no action is taken for approximately 60 seconds,the monitor will automatically return to the Normal Screen.Figure 3-3. The ECG Menu

3-5The following selections are available in the ECG Menu:a. TRACE A LEAD. Selecting this menu option allows the selection of theECG 1 Lead. The options are I, II (default), III AVL, AVR, AVF and OFF.b. TRACE B LEAD. Selecting this menu option allows the selection of theECG 2 Lead. The options are I, II, III AVL, AVR, AVF, and OFF.c. SCALE. Selecting this menu option allows the selection of the scale for theECG waveform(s). The options are AUTO, 1, 5, 10 (default), 15, 20, 25, 30, and40 mm/mv (See Figure 3-4). The selected scale appears on the right hand side ofthis menu option. If AUTO is selected, a scale is picked that would make thecurrent waveform(s) fill the ECG viewing area. This scale will be in effect untilanother scale is selected (AUTO or any other selection). A Scale Indicatorassociated with the Trace is displayed on the left side of the screen, and denotes a1 millivolt signal amplitude.Figure 3-4. The ECG SCALE Sub-Menu(1) If the Scale of the ECG trace is so large that the top or bottom of the ECGwaveform is distorted or flattened, the “OVERSCALE” message flashes inthe ECG waveform area. This message will override other ECG errormessages. Use the SCALE Menu Option (in the ECG Menu) to resize thewaveform until the “OVERSCALE” message stops flashing. If thiscontinues, the Auto Scale Option must be selected to prevent furtherwaveform distortion.(2) The ECG waveform may be frozen for closer examination by pressing theFREEZE Control Key. When the waveform is frozen, it is displayed belowTrace A with a “Blue Box” around it. While FREEZE is Enabled, changesto the Parameter Selections are not allowed; if the operator tries to accessthe Parameter Selection Menu, a WARNING Box appears to alert theoperator that the selected menu may not be accessed.

3-6d. GATING SOURCE. Selecting this menu option allows the selection of theSource to be used for MRI Gating. The options are ECG and PULSE. The MRIGating connector is located at the back of the WPU. This connector is denoted bythe symbol below. An optional gating interface cable is needed to connect thePrecess system to various manufacturers’ MRI systems.e. HR SOURCE. Selecting this menu option allows the selection of the Source to beused for the Heart Rate display in TRACE A area. The options are AUTO, ECG(default), ART, SPO2 and NIBP (See Figure 3-5).Figure 3-5. The ECG HR SOURCE Sub-Menu(1) The Heart Rate is displayed in the ECG parameter box. It is annotated withits Source (e.g., “60 ECG” indicates a Heart Rate of 60, derived fromECG).(2) If AUTO is chosen, the Heart Rate is selected automatically from thehighest priority active input. When set to AUTO the Precess MRI PatientMonitoring System searches for another source for rate only when LEADFAIL occurs or the ECG parameter is turned OFF. The priority, fromhighest to lowest, is ECG, SpO2, and NIBP.(3) The Precess MRI Patient Monitoring System examines the highest priorityactive input. If not found, it will go to the next highest priority parameter. Ifnone of the parameters are presenting a Heart Rate and NIBP is shut OFF,then “NONE” is displayed on the screen in the Heart Rate position.(4) HR Tone Source is only set for ECG or SpO2.(5) This menu option is identical to, and interactive with, the similarly namedmenu options under SPO2 and NIBP.f. HR TONE SOURCE. Selecting this menu option selects the Source to be used forthe Heart Rate Tone. The options are QRS, SPO2 and OFF (default). When thisParameter is set to OFF, the Heart symbol will not be displayed.

3-7(1) When the SpO2 Parameter provides the Heart Rate Tone, the Tone ismodulated by the SpO2 value.(2) If the Heart Rate Tone Source is turned OFF, the Heart Symbol is removedfrom the display.(3) This menu option is identical to, and interactive with, the HR Tone SourceOption in the Sound Adjust Menu.g. FILTER MODE. Selecting this menu option allows the user to choose the ECGFilter that provides the best ECG performance during various types of MRIsequences. The following Filter Modes are available:(1) Monitor. This Filter Mode provides ECG waveform filteringcharacteristics that meet the specification of the Association for theAdvancement of Medical Instrumentation (AAMI). Note that this Filterwill not provide optimum performance during active MRI sequences.(2) MRI 0.15 - 1.5T (A). This Filter Mode provides optimum performance on0.15 to 1.5 Tesla MRI systems during non-Cardiovascular (CV) MRIsequences. This MRI Filter utilizes an adaptive filter scheme for removalof gradient artifact generated by MRI systems.(3) MRI 0.15 - 1.5T (B). This Filter Mode provides optimum performance on0.15 to 1.5 Tesla MRI systems during Echo Train MRI sequences. ThisMRI Filter utilizes an adaptive filter scheme for removal of gradientartifact generated by MRI systems.(4) Cardiac 1.5 - 3.0T. This Filter Mode provides the optimum ECGperformance during Cardiovascular (CV) MRI procedures that involvesteady state free precession imaging with balanced gradient (True-FISP,FIESTA, or Balanced FFE) sequences on 1.5 and 3.0 Tesla MRI systems.This MRI Filter utilizes an adaptive filter scheme for removal of gradientartifact generated by MRI systems.(5) 3.0T. This Filter Mode provides optimum performance on 3.0 Tesla MRIsystems during non-Cardiovascular (CV) MRI sequences. This MRI Filterutilizes an adaptive filter scheme for removal of gradient artifact generatedby MRI systems.Due to the variety of MRI sequence characteristics, the ECG filter moderecommendations above my not provide optimum performance in all cases.Therefore, in situations where the recommended filter mode does not provideoptimum ECG performance, the selection of other ECG filter modes nay impoprveECG performance.ECG performance can be affected by ECG electrode placement as well as MRI procedure, image slice angle, and image slice thickness. In situations where ECGperformance is not optimal, select the ECG lead (I, II, III, AVL, AVR, or AVF) thatprovides optimum ECG performance

3-8Figure 3-6. Filter Mode Menuh. ECG TEST SIGNAL. Selecting this menu option opens the ECG Test SignalMenu. This menu option is identical to and interactive with the Calibrate Option inthe Recorder Menu. The following options are available in the ECG Test SignalMenu:(1) OFF. Selecting this menu option turns the CALIBRATION feature OFF.(2) RECORDER. Selecting this menu option sends a 1mV pulse calibrationwaveform to the ECG Vital Sign and will also be the ECG waveformprinted by the Recorder if so configured. The message “ECG TESTSIGNAL” is displayed over the ECG waveform on the screen.(3) ECG. Selecting this menu option sends a 1mV peak to peak calibrationsignal to the ECG vital sign and will also be the ECG waveform printed bythe Recorder if so configured. The message “ECG TEST SIGNAL” isdisplayed over the ECG waveform on the screen. It is important to note thatthis is a hardware generated calibration waveform and originates as asquare wave by the WECG module.(4) RETURN. Selecting this menu option closes the Calibrate Menu.i. RETURN. Selecting this menu option will return the DCU Display to the NormalScreen.3.1.5 ECG Alarm Limits. Alarm Limits may be set two ways. To set the Alarm Limits for everyavailable parameter, from the Normal Screen (with no icons highlighted), press the ALARMSSCREEN Menu-Select Key. To set the Alarm Limits for ECG Heart Rate only, highlight the ECGIcon and press the ALARMS SCREEN Menu-Select Key to access the individual parameterAlarm Limits Box. The range of Alarm Limits for the ECG Heart Rate is 30 to 249 bpm.3.1.6 ECG Trended Data. For complete information on the trending of patient ECG data, seeSection 5, Recording and Trending.

3-93.1.7 ECG Messages. The following is a list of messages that may be displayed during ECGmonitoring:3.2 Non-Invasive Blood Pressure (NIBP) Monitoring The NIBP feature measures anddisplays systolic, diastolic and mean arterial pressures, and pulse rate. LOW and HIGH AlarmLimits are available for all three pressures. When the Precess MRI Patient Monitoring System isconfigured to obtain the patient's heart rate from the NIBP, the Heart Rate Alarm is alsoapplicable to this parameter. The system may be set to take NIBP readings at automatic intervalsfrom 1 to 240 minutes (there is a 20 second pause between readings to allow for peripheralperfusion), or the operator can manually initiate a reading at any time.LEAD FAIL LEAD FAIL is displayed when a faulty or disconnected ECG Lead isdetected by the system.NOTEIf the RL lead and an additional lead become disconnected, the system will not detecta lead failure.OVERSCALE OVERSCALE is displayed if the scale of the ECG Trace is so largethat the tops of the ECG waveforms are being “clipped” (the tops andbottoms cut off). This message suppresses all other ECG ErrorMessages and the Alarm Tone will not sound.To reduce the scale,and remove the OVERSCALE message, access the SCALE menuoption in the ECG Menu.NOTEThe NIBP measurement range for Adult and Neonates is provided in Appendix A.An “out-of-range-signal” for NIBP is a measured pressure that is not within this range.

3-10When a successful reading is taken, the elapsed time display indicates the beginning of this cycle.The time until next measurement indicates when the next automatic measurement will be made.A manual reading does not restart this cycle time. The NIBP INTERVAL Key may be used toadjust the cycle time. The NIBP START/STOP Key may be used to manually Start/Stop ameasurement. The NIBP STAT Key allows the start of STAT Mode (which makes five (5) NIBPdeterminations in rapid succession).Figure 3-7. 3160 Keypad•Error. If an error is detected, the Alarm Tone will sound, and an error messagewill appear on the display.•Artifact. Non-Invasive blood pressure monitoring is sensitive to patient motionartifact. Such artifact can cause readings to be slow or even an incorrect pressurereading.•Standard Routine. Visual checks of the patient, other vital signs and checking thelimb to which the cuff is attached must be standard routines with NIBP use.CAUTIONSubstitution of a component different from that supplied might result in measurementerror.If a measurement is in progress and communication is lost between the DCU andWPU, the measurement is aborted.NIBP accuracy has not been verified in the presence of some common arrhythmiassuch as atrial or ventricular premature beats or atrial fibrillation.

3-11Most NIBP functions are contained in the primary NIBP Menu. However, additional featuresuseful with NIBP monitoring can be found in the three secondary menus associated with thisparameter:•RECORDER Menu. Used to select Recorder functions and to Set the RecorderTrace Speed.•ALARMS Menu. Used to Set and/or Disable the NIBP Alarms. The range ofAlarm Limits for the NIBP is 5 to 249 mmHg.•NIBP TREND Menu. Used to Setup and Print Trended information.3.2.1 Theory of Oscillometric Measurement. This system obtains blood pressure measurementsbased on the Oscillometric principle. Oscillometric Monitors use an inflatable occlusive cuffwhich can also be used in the manual auscultatory technique; however, rather than monitoringKorotkoff sounds, Oscillometric Monitors detect and measure oscillations induced in the cuff bythe movement of the arterial wall. In basic terms, oscillometric monitors utilize a pressuretransducer which is connected to the cuff via a hose. The transducer transforms the oscillationsinduced into the cuff pressure into electrical currents. Under control of a microprocessor andsoftware algorithms, the electrical current can then be measured and correlated with the cuffpressure to determine arterial blood pressure. The following describes the process ofOscillometric Measurement:Figure 3-8. Oscillometric Measurement Methoda. As the occlusive cuff is inflated to a suprasystolic pressure, the artery is occludedso that no blood passes through. At this point, even though no blood flows underthe cuff, there are small pulsations induced into the cuff pressure by the partially-occluded proximal portion of the artery lying under the cuff (See Figure 3-8).b. As cuff pressure is reduced to just below the systolic pressure, the force of theheight of the systolic pressure wave forces the occluded artery open, blood spurtsthrough the artery and the amplitude of the oscillations increase sharply. This is thesystolic pressure.NOTEBlood pressure measurements determined with this device are equivalent to thoseobtained by a trained observer using the cuff/stethoscope auscultatory method, withinthe limits prescribed by the American National Standard, Manual, electronic, orautomated sphygmomanometers.

3-12c. With further reduction in cuff pressure the artery opens for a longer time duringeach cardiac cycle, which causes increasingly larger oscillations in the cuffpressure until they reach a point of maximum oscillation amplitude. This point ofmaximum oscillations has been well demonstrated to be Mean Arterial Pressure.d. With continued cuff pressure reduction, the underlying artery is open throughoutthe cardiac cycle, and the arterial wall movement is less. The cuff pressureoscillations begin to decrease in amplitude until they become uniform. The point atwhich the amplitudes become uniform is diastolic pressure.3.2.2 NIBP Patient and Cuff Preparation. The patient must remain calm and motionless whilethe system is being used. If the patient is overactive, prolonged or inaccurate readings will result.Perform the following to prepare the patient and cuff for monitoringa. Cuff Selection. The cuff is selected and positioned as it would be for anauscultatory blood pressure determination, and the current guidelines of theAmerican Heart Association must be followed. The bladder width of the cuff mustbe 40% of the circumference of the limb. For a correct fit on adult and pediatriccuffs, the Index line on the end of the cuff must fall between the two Range linesprinted on the inside of the cuff. For correct fit on neonatal cuffs, choose the sizewith the stated circumference range that fits the circumference of the limb of theneonate.b. Cuff Positioning. The cuff must be wrapped firmly (not snug) around the arm orleg of the patient. If the cuff is not at heart or leg level, add 1.8 mmHg to thedisplayed readings for each inch (2.54 cm) that the center of the cuff is locatedabove the patient's heart level; subtract 1.8 mmHg from the displayed readings foreach inch that the cuff is located below the patient's heart level.c. Cuff Connections. Select the proper hose (twin-lumen for adults, single-lumen forneonates), and attach hose to cuff. Route the hose from the cuff to the PCU so itdoes not kink, tangle or limit access to the patient.3.2.3 Associated NIBP Displays. When NIBP is enabled, it is displayed in a box at the lowerleft of the Normal Screen. The box is a specialized display panel that includes the informationconcerning the NIBP status in one of two user selectable formats. The two available formats areSystolic/Diastolic and Mean Only (See Figure 3-9); the user selects the format using the FormatOption in the NIBP Menu (See Section 3.2.5). The two available displays are described below:NOTEThe point of maximum oscillations is coincident with mean arterial pressure regardlessof arterial elasticity so long as the ratio of air volume in the cuff to the volume of theartery under compression does not greatly exceed ten (10) to one (1). For this reason itis advisable to keep the cuff air volume to a minimum by using the smallest cuff sizepossible for each patient.WARNINGDo not attach the cuff to a limb being used for infusion. Cuff inflation can blockthe infusion causing possible harm to patient.

3-13Figure 3-9. The NIBP Displaya. The NIBP Systolic/Diastolic Display. The items contained in this user selectabledisplay are described below:(1) Icon Label. (Item 1) This label identifies the Parameter whose numericdata is being displayed within the Icon Box. Box 11 (in the lower left of theBottom Numeric Display) is dedicated to the display of NIBP information.(2) Manual. (Item 2) While in the Automatic Mode, “NEXT” is shown andthe time until the next NIBP determination is displayed here; in the ManualMode, the word “MANUAL” is displayed here.(3) Mean Numeric. (Item 3) A numeric indication of the patient's Meanpressure reading.(4) Systolic Numeric. (Item 4) A numeric indication of the patients NIBPSystolic reading.(5) Diastolic Numeric. (Item 5) A numeric indication of the patients NIBPDiastolic reading.(6) Diastolic Alarm Limits. (Item 6) A numeric indication of the settings ofthe High (to the left in the example) and Low (right in the example)Diastolic Alarm Limits.(7) Systolic Alarm Limits. (Item 7) A numeric indication of the settings ofthe High (to the left in the example) and Low (right in the example)Systolic Alarm Limits.(8) Unit of Measurement. (Item 8) Displays the Unit of Measurement beingused for presentation of the numeric data. This item may be toggledbetween mmHg and kPa using the System Configuration Menu (See Section 4.0 for further information).(9) ET. (Item 9) The Elapsed Time (ET) since the last NIBP determination isdisplayed here. During an NIBP determination, this message changes todisplay the cuff pressure.b. The NIBP Mean Display. The items contained in this user selectable display aredescribed below:(1) Icon Label. (Item 1) This label identifies the parameter whose numericdata is being displayed within the Icon Box. Box 11 (in the lower left of theBottom Numeric Display) is dedicated to the display of NIBP information.(2) Manual. (Item 2) While in the Automatic Mode, “NEXT” is shown andthe time until the next NIBP determination is displayed here; in the ManualMode, the word “MANUAL” is displayed here.(3) Systolic/Diastolic Numeric. (Item 3) A numeric indication of the patient'sSystolic/Diastolic pressure reading.(4) Mean Numeric. (Item 4) A numeric indication of the patients NIBP Meanreading.(5) Mean Alarm Limits. (Item 5) A numeric indication of the settings of theHigh (on top in the example) and Low (bottom in the example) MeanAlarm Limits.

3-14(6) Unit of Measurement. (Item 6) Displays the Unit of Measurement beingused for presentation of the numeric data. This item may be toggledbetween mmHg and kPa using the System Configuration Menu (See Section 4 for further information).(7) ET. (Item 7) The Elapsed Time (ET) since the last NIBP determination isdisplayed here. During an NIBP determination, this message changes todisplay the cuff pressure.3.2.4 The NIBP Menu. Selecting the NIBP Menu-Select Icon will bring up the NIBP Menu(Figure 3-10). This menu provides the operator with the ability to switch the Automatic ModeON and OFF, set the Automatic Reading Interval, set the Heart Rate Source and bring up aTabular Chart containing a History of the NIBP and SpO2 determinations. This menu has atime-out feature. If no action is taken for approximately 60 seconds, the display willautomatically return to the Normal Screen.Figure 3-10. The NIBP Menu3.2.5 NIBP Menu Options. The following is a description of the operation of the NIBP Menuoptions:a. INTERVAL. Selecting this menu option allows the operator to change theAutomatic Measurement Time Interval setting (Figure 3-11). The options are 1, 2,

3-152.5, 3 (default), 5, 10, 15, 20, 30 or 45 minutes, and 1, 2 or 4 hours. The IntervalMenu can also be accessed by pressing the NIBP INTERVAL Key.Figure 3-11. The NIBP Interval Menu(1) As the Rotary Knob turns clockwise, the interval selection will increase.After reaching “RETURN,” the interval selection will “roll over” to“1 MIN” and continue to increase.(2) As the Rotary Knob turns counter-clockwise, the interval selection willdecrease. After reaching “1 MIN,” the interval selection will “roll over” to“RETURN” and continue to decrease.b. AUTO MODE. Selecting this menu option allows the operator to switch the NIBPAutomatic Mode between ON and OFF (default). When switched from OFF toON, the operator must manually initiate the first reading (by pressing the NIBPSTART/STOP Control Key); subsequent readings are taken automatically at theoperator selected interval. When in Manual Mode, readings may only be initiatedfrom the NIBP START/STOP or NIBP STAT Control Keys. A reading cycle maybe stopped at any time if the NIBP START/STOP Control Key or STANDBYControl Key is pressed while it is in progress.c. HR SOURCE. Selecting this menu option allows the selection of the source to beused for the Heart Rate display in the ECG area. The options are AUTO, ECG(default), ART (arterial pressure), SPO2 and NIBP.This menu option is identical to, and interactive with, similarly named menuoptions under ECG and SPO2.d. HISTORY. Selecting this menu option brings up the History Menu (See Figure 3-12),and displays the last 48 NIBP readings together with the heart rate, SpO2, CO2 andrespiration values at the time in a tabular form (6 readings per page). The tabular data isretained in non-volatile memory when power is interrupted (i.e., if there is a loss ofpower, the data remains in the History File).NOTENIBP AUTO mode is suspended while in STANDBY mode.

3-16Figure 3-12. The HISTORY MenuThe following options are available in the History Menu:(1) PRT ALL. Selecting this menu option prints all stored Tabular Data.(2) PRT PAGE. Selecting this menu option prints the current page.(3) PREV PAGE. Selecting this menu option allows the selection of theprevious page of tabular data.(4) NEXT PAGE. Selecting this menu option allows the selection of the nextpage of the tabular data.(5) CLEAR ALL. Selecting this menu option clears the patient Trend Data.(6) MULTI TRENDS. Selecting this menu option will bring up theMultiTrends Menu where the operator may configure Multiple Trends fordisplay.(7) RETURN. Selecting this menu option will return the display to the NIBPMenu.e. FORMAT. Selecting this menu option allows the operator to change the displayformat of the Pressure numerics. If SYS/DIA is selected, the Systolic and Diastolicnumerics will be in a large font separated by a “slash” and the Mean numeric willbe in a smaller font bracketed with parenthesis. If MEAN is selected, the Meannumeric is displayed in the large font with the Systolic and Diastolic numericsseparated by a “slash” in a smaller font.f. RETURN. Selecting this menu option will return the display to the NormalScreen.NOTEHistory Data is retained when a new patient is connected to the system. Therefore, toavoid confusion, all previously acquired data must be cleared prior to connection to anew patient. This is accomplished by pressing CLEAR ALL and following allassociated commands to clear all previous patient data.

3-173.2.6 Using the Automatic NIBP Interval Mode. This system may be setup to take NIBPreadings automatically at intervals set by the operator. To set this system to make AutomaticNIBP determinations, turn the Rotary Knob until the NIBP Menu-Select Icon is highlighted andthen press the Rotary Knob to bring up the NIBP Menu. To set the Interval Time, highlight theINTERVAL Menu selection and press the Rotary Knob to access the Time Selection menu. Toturn the Automatic Mode of Operation ON or OFF, highlight the AUTO MODE Menu selection,press the Rotary Knob and select ON or OFF. Once the Automatic Mode has been turned ON,press the NIBP START/STOP Control Key to activate.3.2.7 Manually Starting/Stopping an NIBP Reading Cycle. An NIBP cycle may be started orstopped by pressing the NIBP START/STOP or STANDBY Control Key.3.2.8 NIBP STAT Mode Operation. The STAT Mode is specifically intended for clinicians whoneed to obtain successive readings for rapid assessment of the trend of a patient's pressures. Toinitiate a series of up to five STAT Readings, the operator presses the NIBP STAT Control Key.The system will perform up to five NIBP cycles in a period of five (5) minutes. At the end of thefive (5) minute period, the STAT Mode will terminate (even if a reading is in progress) regardlessof how many readings have been completed.3.2.9 NIBP Alarm Limits. Alarm Limits may be set two ways. To set the Alarm Limits forevery available parameter, from the Normal Screen (with no icons highlighted), press theALARMS SCREEN Menu-Select Key. To set the Alarm Limits for NIBP only, highlight theNIBP Icon and press the ALARMS SCREEN Menu-Select Key to access the individualParameter Alarm Limits box.3.2.10 NIBP Adult vs. Neonatal Mode Operation. This system allows the operator to determinepressures on a wide range of patients by allowing the Patient Type to be switched from ADULT toNEO (Adult Mode is used for Adult and Pediatric patients and Neonate Mode is used forNeonates only). Several operational parameters (including cuff inflation pressure) are varieddepending on the setting of the Patient Menu Option in the Setups Menu. The Adult/PediatricMode uses a higher pump volume and a much larger cuff is used on the patient; in the NeonatalMode the pump rate is lower and a much smaller cuff is used on the patient (See Accessories for“NIBP” on page xvii of this manual for cuff selection and sizes). The Alarm Limits change whenthe patient type is switched from ADULT to NEO (or NEO to ADULT).Whenever the NIBP Patient Mode is switched (either from ADULT to NEO or NEO to ADULT),for 20 seconds the Alarm Tone will sound while the informational display message area indicates“Change NIBP Cuff.” To change the patient type, press the SETUP Control Key, scroll to thePatient Menu Selection and press the Rotary Knob. The “WRONG CUFF” NIBP message willappear if a reading is initiated and the system detects that an incorrect cuff is being used for theselected patient mode (ADULT or NEO). Replace the patient cuff with the appropriate size cuffand press the NIBP START/STOP control a second time, this will re-initiate the reading.NOTENIBP AUTO mode is suspended while in STANDBY mode.WARNINGThe patient's blood pressure determinations are not continuous. The bloodpressure determinations are only updated immediately after a blood pressuremeasurement is taken. When set to the shortest of the automatic intervals, theconstant measurements can cause blood pooling in the limb. Blood pooling inthe limb will artificially increase the value of the blood pressure determinations.WARNINGThe initial cuff inflation pressure will increase to 170 mmHg when changing thepatient mode from Neonate to Adult.

3-183.2.11 NIBP Trended Data. For complete information on the trending of patient NIBP data, seeSection 5, Recording and Trending.3.2.12 NIBP Messages. The following is a list of messages that may be displayed during NIBPmonitoring:.CALIB Displayed if the system detects that the NIBP section is out ofcalibration.CHANGE NIBP CUFFDisplayed for 30 seconds whenever the Patient Mode is switchedbetween Adult and Neonate.CUFF LEAK Displayed if the system detects a leak in the cuff during the lastreading attempt. This message is also displayed, with othermessages, between reading attempts to provide a visual indicationthat a leak was detected in the cuff during the previous readingattempt.CUFF=XXX Displayed while the system is making an NIBP determination.Provides a visual indication of the actual pressure of the cuffthroughout the measurement.ET=XXX Indicates the time since the last NIBP measurement wascompleted.LONG PRESS Displayed if the system detects cuff pressure remaining the samefor more then 30 seconds or if a reading has been in progress formore than 150 seconds for adults (80 seconds for neonates).NOT INFLATING Displayed if the system detects the cuff inflation cycle runninglonger than 30 seconds for adults (6 seconds for neonates).OVER PRES Displayed if the system detects a cuff pressure of 285 mmHg(adult, 150 neonate) or higher.RESIDUAL PRES Displayed if the system detects that cuff pressure remains above20 mmHg for more then 2.5 minutes.WRONG CUFF Displayed if the system detects that an incorrect cuff is being used.Select the appropriate cuff for the patient.NOTEWhen positioning the SpO2 sensor, special care must be taken to avoid applyingexcessive pressure and the maximum application time is reduced to two (2) hours.WARNINGProbes are designed for use with specific patient monitoring systems. Theoperator is responsible for checking the compatibility of the system, probe, andcable before use. Incompatible components can result in degradedperformance.NOTERefer to the facility's biohazard procedure for disposal of SpO2 grip sensors when theybecome unusable. Usually sensors are disposed of as medical waste per hospitalprocedures as they are likely to be contaminated.

3-193.3 SpO2 Monitoring. The SPO2 Menu is brought up (if this parameter is turned on throughthe Setups Menu) with the SPO2 Menu-Select Icon.The following three secondary menus support the SpO2 monitoring feature:•RECORDER Menu. Used to select Recorder functions and to set the Recorderand Trace Speed.•ALARMS Menu. Used to Set and/or Disable the SpO2 Alarms. The range ofAlarm Limits for SpO2 is 50 to 99%, Off.•SpO2 TREND Menu. Used to setup and print Trended information.3.3.1 Wireless SpO2 Module and Fiber-Optic SpO2 Sensor. The Invivo Wireless SpO2 Module(Part Number 9311, See Figure 3-13) and Fiber-Optic SpO2 Sensor are designed for use in the MRIenvironment. The Fiber-Optic SpO2 Sensor is specifically designed for use in the MRI system boreand can be placed within the MRI procedure Field-Of-View (FOV), although the Wireless SpO2Module must be kept outside of the MRI system bore. Placing the Wireless SpO2 Module inside theMRI system bore may interrupt SpO2 monitoring during the MRI procedure.Use only the Fiber Optic SpO2 sensor (Part Number 9399B) designed for the Precess WirelessSpO2 Module. Connecting a SpO2 sensor other than Part Number 9399B into the Wireless SpO2Module will cause inaccurate SpO2 readings and may damage the Wireless SpO2 Module.Figure 3-13. Wireless SpO2 Module3.3.2 SpO2 Sensor Positioning. The monitoring site, sensor position, sensor connection and theambient environment all have possible impacts on the operation of the Precess MRI PatientMonitoring System. The following is a list of possible messages (which are indicated in the SpO2display), causes, and possible solutions:a. LOW LIGHT. The transmission of the light is partially blocked. The tissue at thesite may be too opaque and/or thick. If the sensor is positioned on the finger, checkthe fingernails for nail polish, long fingernails and artificial fingernails; removefingernail polish completely, for artificial nails: use a Multi-Site sensor at anotherlocation, and, for long fingernails: either trim the nails or use a Multi-site sensor atanother location.b. PROBE OFF. The sensor is not sensing or detecting the patient's pulse. There aretwo possible causes of this, either the sensor is not detecting the pulse or the sensoris receiving too much light to operate. Check the ambient lighting, if a light isshining directly into the sensor, reposition the sensor to a darker area or cover thesensor to cut down the light entering the sensor. Check the sensor cable connectionfor proper connection. Try a different sensor.c. SEARCHING. The system is searching for a good pulse. Give the system time tolock onto a good pulse.Power/Communication LED

3-20d. LOW QUAL. The signal correlation between the red and infrared light channels istoo low for accurate saturation calculation. Contact Invivo Technical Service forfurther assistance.3.3.3 Associated SpO2 Waveforms and Displays. (See Figure 3-14) If the SpO2 is turned onthe waveform is displayed in Trace Location C and the numerical information in Box 2. Thefollowing is a description of the items contained within the SpO2 Display:Figure 3-14. SpO2 Displaya. SpO2 Waveform. (Item 1) The SpO2 Waveform is displayed in TraceLocation C.b. Icon Label. (Item 2) This label identifies the Parameter numerics that aredisplayed within this box. SpO2 is monitored using Box 3.c. SpO2 Numeric. (Item 3) A numeric indication of the patient's SpO2 reading.d. SpO2 High and Low Alarm Limits. (Item 4) A numeric indication of the settingsof the High and Low SpO2 Alarm Limits.e. Heart Rate. (Item 5) Heart Rate Value derived from SpO2.3.3.4 SpO2 Menu. (See Figure 3-15) The menu for the SpO2 is brought up with the selectionof the SPO2 Menu-Select Icon. This menu has a time-out feature. If no action is taken forapproximately 60 seconds, the display will automatically return to the Normal Screen.Figure 3-15. The SpO2 MenuThe following is a description of the SPO2 Menu options:a. SIZE. (See Figure 3-16.) Selecting this menu option provides the operator withthe ability to change the Size of the SpO2 pulse waveform. The options are 10%,20%, 40% (default), 60%, 80% and 100%.

3-21Figure 3-16. The SpO2 SIZE Menub. GATING SOURCE. Selecting this menu option allows the selection of theSource to be used for MRI Gating. The options are ECG and PULSE. The MRIGating connector is located at the back of the WPU. This connector is denoted bythe symbol below. An optional gating interface cable is needed to connect thePrecess system to various manufacturers’ MRI systems.c. HR SOURCE. Selecting this menu option allows the selection of the Source to beused for the Heart Rate display in the ECG area. The options are AUTO, ECG(default), ART (arterial pressure), SPO2 and NIBP.This menu option is identical to, and interactive with, similarly named menuoptions under ECG and NIBP.d. HR TONE SOURCE. Selecting this menu option selects the Heart Rate ToneSource. The options are QRS, SPO2 and OFF (default). When the Source is theQRS, the Tone sounds at the detection of QRS from the ECG Parameter. When theSource is the SpO2, the Tone sounds at the detection of the pulse from the SpO2Parameter.The Pulse Tone is modulated by the SpO2 value. The pitch will be at the lowestfrequency when its value is at the low end of scale.This menu option is identical to, and interactive with, the HR Tone Source Optionin the Sound Adjust and ECG Menus.e. RETURN. Selecting this menu option will return the display to the NormalScreen.3.3.5 SpO2 Alarm Limits. Alarm Limits may be set two ways. To set the Alarm Limits forevery available Parameter, from the Normal Screen (with no icons highlighted), press theALARMS SCREEN Menu-Select Key. To set the Alarm Limits for SpO2 only, highlight theSpO2 Icon and press the ALARMS SCREEN Menu-Select Key to access the individualParameter Alarm Limits Box. The range of Alarm Limits for SpO2 is 50 to 100%.

3-223.3.6 SpO2 Trended Data. For complete information on the Trending of patient SpO2 data, SeeSection 5.0, Recording and Trending.3.3.7 SpO2 Messages. The following is a list of messages that may be displayed during SpO2monitoringNOTEThe SpO2 waveform is normalized, it is auto scaled to fit the display width. Signalinadequacy is indicated by a LOW QUAL message.BAD PROBE The Precess MRI Patient Monitoring System has sensed a shorted or open connector in the sensor. Contact Invivo Technical Service for further assistance.LOW LIGHT The transmission of the light is partially blocked. The tissue at the site may be too opaque and/or thick. If the sensor is positioned on the finger, check the fingernails for nail polish, long fingernails and artificial fingernails; remove fingernail polish completely, for artificial nails: use a Multi-Site sensor at another location, and, for long fingernails: either trim the nails or use a Multi-site sensor at another location.LOW QUAL The signal correlation between the red and infrared light channels is too low for accurate saturation calculation. Contact Invivo Technical Service for further assistance.PROBE OFF The sensor is not sensing or detecting the patient's pulse. There are two possible causes of this, either the sensor is not detecting the pulse or the sensor is receiving too much light to operate. Check the ambient lighting, if a light is shining directly into the sensor, reposition the sensor to a darker area or cover the probe to cut down the light entering the sensor. Check the sensor cable connection for proper connection. Try a different sensor.SEARCHING The system is searching for a good pulse. Give the system time to lock onto a good pulse.HW FAIL The system has detected a hardware failure. Remove the system from service immediately and refer it to Invivo qualified service personnel for repair. This system must not, for any patient that requires accurate SpO2 measurement, ever be placed back into service before the repair is performed.

3-233.4 End-tidal CO2 (ETCO2) Monitoring. The ETCO2 Menu is brought up (if thisParameter is turned on through the Setups Menu) with the ETCO2 Menu-Select Icon. The ETCO2feature provides sidestream measurement of CO2 with a continuous real-time CO2 WaveformDisplay. This feature will perform an automatic zeroing at periodic intervals while continuouslyperforming pressure corrections. ETCO2 monitoring also provides Respiration Monitoring.The following three secondary menus support the ETCO2 monitoring feature:•RECORDER Menu. Used to select Recorder functions and to set the Recorderand Trace Speed.•ALARMS Menu. Used to Set and/or Disable the ETCO2 Alarms. The range ofAlarm Limits for ETCO2 is 5 to 80 mmHg.•ETCO2 TREND Menu. Used to Setup and Print Trended information.3.4.1 Water Trap and Sampling Line Preparation. The accuracy of the data collected is greatlyinfluenced by the proper use, fitting and maintenance of the sampling tubing, water trap and nasalcannula or airway adapter.a. The patient sampling circuit (See Figure 3-17) consists of the blue (1 mm)sampling line, Part Number 94021, and either a sampling nasal cannula or a airwayadaptor connected to a patient airway. All fittings in the circuit are Luer-Lock type.All fittings must be fitted together securely to keep them from separating duringthe procedure, and to ensure proper sampling without the introduction of outsideair. Loose fitting will result in gas measurement errors.b. Nasal Cannula. The nasal cannula is of the “around-the-ear” type. Place the nasalprongs gently inside the nose, loop the excess tubing over the patient's ears andthen down under the chin. The cannula may then be fitted by sliding the plasticring up until the cannula is secure and comfortable.NOTEEnd-tidal CO2 (ETCO2) monitoring allows exhaled CO2 to be measured non-invasively. The Precess™ with ETCO2 feature is intended to monitor inspired andexpired levels of CO2 through a sampling tube.Before using the ETCO2 monitoring feature, connect the Gas Exhaust output at therear of the Precess™ WPU to the facility gas scavenging system utilizing 0.25 inch(6 mm) inside diameter tubing.Do not block the gas exhaust port on the rear of the WPU.The time from switching “ON” the ETCO2 portion of the Precess™ to obtainingspecified operating performance is 2 minutes.CAUTIONBefore using the ETCO2 analyzer, read the PRECAUTIONS and USER RESPONSIBILITIES which follow the Table of Contents(Pages v through xiii).

3-24c. Patient Airway Adaptor. When using the patient airway adaptor, attach thesample line to the airway adapter. Install the airway adapter into the patient circuittubing. Take great care not to dislodge or move the patient circuit tube whenattaching the adaptor.Figure 3-17. The Patient Sampling CircuitCAUTIONDo not allow the tubing to become kinked so that the sample flow is reduced or cut off.Be careful that the tubing remains clear of any table moving mechanisms which maykink or cut the tubing.Always discard the Water Trap when it becomes filled. Do not attempt to clean or reusethe Water Trap. Accidental water ingress into the Precess MRI Patient MonitoringSystem can affect the gas measurements.NOTEAlways inspect patient tubing after attachment to the Precess MRI Patient MonitoringSystem by following the patient tubing manufacturer's recommendations.It is recommended that the sampling line is changed after each patient use.An internal leak may result in condensation within the system. If this is suspected,please contact Invivo.An ETCO2 Low Flow Alarm indicates the following:1. A sample line is not connected to the water trap.2. The gas exhaust port is obstructed.3. Use of a sample line other than Invivo Part Number 94021.The Precess™ contains an exhaust port at the rear of the WPU that may be connectedto the facility's anesthetic gas scavenging system, using the appropriate exhaust tubeaccessory. Follow the facility's guidelines for connecting to the scavenging system,including proper disposal of sampled gas.

3-253.4.2 Water Trap Replacement. (Figure 3-18) Remove the sample line from the Water Trapport and perform the following to replace the Water Trap:Figure 3-18. Water Trap Installation Diagrama. To remove the Water Trap, simultaneously press the two release tabs (located onthe left and right side of the trap near the top) and pull the Water Trap from theenclosure.b. To install the Water Trap, line the trap up with the enclosure (the enclosure isshaped to the Water Trap) and press it into place until there is an audible “click”from both of the release tabs.c. Attach sample line to Water Trap port.3.4.3 Associated ETCO2 Waveforms and Displays. (See Figure 3-19) ETCO2 information isdisplayed as a waveform in Trace Location D and numeric data in ETCO2 box. The following is adescription of the items contained within the ETCO2 Display:NOTEThe Water Trap must be checked every eight (8) hours and replaced as necessary.Disposal of water traps must be done according to the facilities biohazard procedure.WARNINGAlways test sampling line adapter for a tight connection and proper operationbefore attaching to a patient.Overtightening the sampling line may damage the water trap. Tighten thesampling line no more than 1/2 turn.

3-26Figure 3-19. The ETCO2 DisplayFor optimum fit and compatibility, Invivo strongly recommends the use of the Invivo CO2Sampling Kit (Part Number 94021), which contains the ETCO2 sample line tubing.a. Inspired CO2 Numeric. (Item 1) A numeric indication of the patient's InspiredCO2 reading.b. Respiration Waveform. (Item 2) The ETCO2 derived Respiration Waveform isdisplayed in Trace Location D.c. Icon Label. (Item 3) This label identifies the parameter numerics that aredisplayed within this box.d. ETCO2 Numeric. (Item 4) A numeric indication of the patient's ETCO2 reading.e. ETCO2 Alarm Limits. (Item 5) A numeric indication of the settings of the High(on top in the example) and Low (bottom in the example) ETCO2 Alarm Limits.f. Unit of Measurement. (Item 6) Displays the Unit of Measurement being used forpresentation of the ETCO2 numeric data.g. Unit of Measurement. (Item 7) Displays the Unit of Measurement being used forpresentation of the ETCO2 derived Respiration numeric data.h. Respiration Alarm Limits. (Item 8) A numeric indication of the settings of theHigh (on top in the example) and Low (bottom in the example) Respiration AlarmLimits when derived from the ETCO2 module.i. Respiration Numeric. (Item 9) A numeric indication of the patient's Respirationreading derived from the ETCO2 module.3.4.4 ETCO2 Menu. (See Figure 3-20) The menu for the ETCO2 is brought up with theselection of the ETCO2 Menu-Select Icon. This menu has a time-out feature. If no action istaken for approximately 60 seconds, the display will automatically return to the Normal Screen.

3-27Figure 3-20. The ETCO2 MenuThe following is a description of the ETCO2 Menu Options:a. SIZE. Selecting this menu option brings up the SIZE Menu where the operatormay select 40, 60 or 80 mmHg for the Scale Size of the ETCO2 WaveformDisplay.b. GRIDS. Selecting this menu option brings up the GRIDS Menu where theoperator may turn the ETCO2 Grids ON or OFF.c. ZERO CAL. Selecting this menu option causes the Precess MRI PatientMonitoring System to perform the Zero Calibration routine.d. UNIT. Selecting this menu options brings up the UNIT Menu where the operatormay toggle the unit between mmHg and kPa.e. RETURN. Selecting this menu option will return the monitor to the NormalScreen.3.4.5 Calibration of CO2 Measurement System. The system will perform automatic ZeroCalibration cycles as part of its normal function. The Zero Calibration cycle is discussed below.a. Zero Calibration Cycle. A Zero Calibration cycle consists of the realignment ofthe Zero point. During this calibration, the system makes sure that a concentrationof 0% is measured when room air is flowing through its sample chamber. During aZero Calibration cycle the system performs the following steps:(1) Switches the input gas valve to the Zero Intake Port placed on the bottomof the WPU Patient Connection Module.(2) Room air is absorbed through the Zero Intake Port and flushes thepneumatic system for a few seconds.(3) Once the channel readings have stabilized, a snapshot is taken and the Zeropoint is realigned using these readings as a reference.

3-28(4) The Input Gas Valve is then switched back to the normal position and thegas being measured is given a few seconds to flush the pneumatic systemto clear out the room air.(5) After the readings stabilize, the ETCO2 system begins it’s normalfunctioning routine.b. Automatic Zero Calibration Cycles. An Automatic Zero Calibration cycle istriggered when certain time intervals have passed since the system has completedits warm-up cycle. The timetable for Automatic Zero Calibration cycles is thefollowing: Immediately after the ETCO2 parameter is activated; 30 minutes afteractivation, 90 minutes after activation, then every two hours after that.c. ETCO2 Gas Calibration Test. Perform the following to test the ETCO2 Gas Calsystem:(1) Turn on the ETCO2 icon as follows:(a) Press the SETUP Control Key.(b) Turn the Rotary Knob to highlight the PARAMETER SELECTIONOption.(c) Press the Rotary Knob to bring up the PARAMETER SELECTIONMenu.(d) Turn the Rotary Knob until the ETCO2 Menu selection ishighlighted.(e) Press the Rotary Knob to select ETCO2.(f) Turn the Rotary Knob until the ON Menu Option is highlighted.(g) Press the Rotary Knob to select ON.(h) Press the NORMAL SCREEN Control Key to display the NormalScreen.(2) Allow the ETCO2 Bench to warm up for approximately 25 minutes.(3) Perform ETCO2 Validation Calibration Test as follows:(a) Connect the aerosol QC CHECK GAS can (Invivo Part Number9034F) to the GAS (ETCO2) port on the water trap.(b) Apply the gas to the GAS port for a minimum of 30 seconds, thenverify the following upper numeric value in the ETCO2 icon:• ETCO2 = 38 (±4) mmHg.*(c) Disconnect the QC CHECK GAS can from the system.NOTETo perform Zero Calibration, the system pulls ambient air through the PatientConnection Module (PCU) CO2 Zero Intake Port. The Calibration system assumesthat the ambient air will contain normal amounts of trace CO2. If this system is placedin an unventilated area that allows CO2 (from the rear panel CO2 Exhaust Port - if notconnected to a Gas Scavenging System) to accumulate, the result could be inaccurateZeroing of the ETCO2 module and resulting inaccurate patient readings.NOTE*This CO2 reading varies according to altitude. The above reading indicates theexpected CO2 value to be observed when conducting this test on the Precess MRIPatient Monitoring System located at sea level (or 0 altitude).

3-293.4.6 ETCO2 Alarm Limits. Alarm Limits may be set two ways. To set the Alarm Limits forevery available parameter, from the Normal Screen (with no icons highlighted), press theALARMS SCREEN Menu-Select Key. To set the Alarm Limits for ETCO2 only, highlight theETCO2 Icon and press the ALARMS SCREEN Menu-Select Key to access the individualparameter Alarm Limits Box. The range of Alarm Limits for ETCO2 is 5 to 60 mmHg and OFFfor the Low Limit, and 5 to 80 mmHg and OFF for the High Limit.Inspired CO2 has a fixed high alarm limit of 25 mmHg. When this upper threshold is exceeded,the Inspired CO2 numeric flashes RED in color and the Alarm Tone sounds.3.4.7 ETCO2 Trended Data. For complete information on the trending of patient ETCO2 data,see Section 5, Recording and Trending.3.4.8 ETCO2 Messages. The following is a list of messages that may be displayed duringETCO2 monitoring:3.5 Anesthetic Agent/Oxygen Monitoring. (Optional) The Anesthesia Gas Sensor (AGS) isa non-dispersive, single path Infra-Red spectrometer based upon a high stability IR sensortechnology known as Stabilized Thermopile Bridge (STB). Utilizing the STB technology, theInvivo AGS yields high output, low noise and ultra stable gas measurements.The following two secondary menus support the Anesthetic Agent/Oxygen monitoring feature:•RECORDER Menu. Used to select Recorder functions and to set the Recorderand Trace Speed.•ALARMS Menu. Used to Set and/or Disable the Agent Alarms.NOTEPress the ALARM SILENCE Control Key to silence the fixed inspired CO2 alarm.CO2 OCCLUSION The air lines have become blocked. Check exposed hosefor kinks and blockages. If blockage appears to be internalto the unit, contact a Qualified Service Representative.ETCO2: HW FAIL The ETCO2 has failed, contact a Qualified ServiceRepresentative.ETCO2 WARMING UP The ETCO2 is warming up in preparation for use. Thewarm-up cycle is approximately two (2) minutes.READJUSTING CO2 ZEROThe ETCO2 module is performing its automatic ZeroAdjustment Routine.ETCO2: LOW FLOW The ETCO2 Low Flow Alarm indicates the one or more ofthe following: A sample line is not connected to the watertrap; the gas exhause port is obstructed; or a sample lineother than Invivo Part Number 94021 is being used.NOTEBefore using the Agents monitoring feature, connect the Gas Exhaust output at the rear of the Precess ™ WPU to the facility gas scavenging system utilizing 0.25 inch (6 mm) inside diameter tubing.

3-303.5.1 Anesthetic Agent Patient and Tubing Preparation. Use only Invivo sampling lines andaccessories (Part Number 94018); other sampling lines may cause inaccurate readings. It isrecommended that the sampling line and airway adapter are changed after each patient use.3.5.2 Associated Anesthetic Agent Displays. (See Figure 3-21) Anesthetic Agent informationis only displayed as numeric data. The Agent identification and measurement are individuallyperformed on both inspired and expired gases. With any two mixtures involving gasesSevoflurane, Isoflurane, and Desflurane, the inspired primary anesthetic agent (the gas with thehighest concentration) is displayed with its ID and concentration in the Fi location of the AgentIcon box. The expired primary anesthetic agent is displayed with its ID and concentration in theEt location of the Agent Icon box. An alarm sounds and “MULTIPLE AGENTS” is displayed anytime two or more anesthetic agents are detected. If Halothane or Enflurane are involved in anymixture of anesthetic agents, “---” may appear in the Fi and/or Et location while a pure inspired orexpired gas is displayed in its appropriate location. See Table 3 -2 and Table 3-3 for a completedescription of the Agent Display during mixed Agent conditions.Figure 3-21. Anesthetic Agents DisplayThe following is a description of the items contained within the Anesthetic Agent Display.a. Icon Label. (Item 1) This label identifies the Parameter numerics that aredisplayed within this box.b. Agent Expired Numeric. (Item 2) A numeric indication of the value of the gasbeing expired.c. Agent Inspired Numeric. (Item 3) A numeric indication of the value of the gasbeing inspired.d. Anesthetic Agent Designation. (Items 4 and 5) Displays the identification of thegas being monitored. The Agent Identifications are as follows:(1) Halothane HAL(2) Isoflurane ISO(3) Sevoflurane SEV(4) Desflurane DES(5) Enflurane ENFWARNINGAlways test sampling line adapter for a tight connection and proper operationbefore attaching to a patient.Overtightening the sampling line may damage the water trap. Tighten thesampling line no more than 1/2 turn.

$3-31e. Et. (Item 4) Indicates that the top row numeric is the End Tidal (expired) values ofthe gas being monitored (with the designation of the gas located just below Et).f. Fi. (Item 5) Indicates that the bottom row numeric is the fraction of inspired (Fi)values of the gas being monitored (with the designation of the gas located justbelow Fi).g. Unit of Measurement. (Item 6) Displays the Unit of Measurement being used forpresentation of the Anesthetic Agents and Oxygen numeric data (i.e. Percentage).h. Oxygen Numeric. (Item 7) A numeric indication of the patient’s Oxygenmeasurement.i. O2. (Item 8) Indicates that the patient’s oxygen is being monitored in this row.Table 3-2. Agent Display During Mixed Agent ConditionsNOTEThe presence of Enflurane (ENF) will be detected, but a concentration value will not be provided.Display MULTIPLE AGENTS MessagePhysical GasSevoflurane, Isoflurane, Desflurane or any mixture of two where the gas with the highest concentration is considered primary.Agent DisplayInspired(Fi)Expired(Et)Fi ID%InspiredConcentrationEt ID%ExpiredConcentrationNo Agent 1 Agent 1 Agent 1 Agent 1Yes Agent 1 Agent 2 Agent 1 Agent 2Yes Agent 2 Agent 1 Agent 2 Agent 1Yes Agent 1 - PrimaryAgent 2 - SecondaryAgent 1 - PrimaryAgent 2 - SecondaryAgent 1 Agent 1Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 1 - PrimaryAgent 2 - SecondaryAgent 2 Agent 1Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 2 - PrimaryAgent 1 - SecondaryAgent 2 Agent 2Yes Agent 1 - PrimaryAgent 2 - SecondaryAgent 1 Agent 1 Agent 1Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 1 Agent 2 Agent 1Yes Agent 1 - PrimaryAgent 2 - SecondaryAgent 2 Agent 1 Agent 2Yes Agent 2 - PrimaryAgent 1 - SecondaryAgent 2 Agent 2 Agent 2Yes Agent 1 Agent 1 - PrimaryAgent 2 - SecondaryAgent 1 Agent 1No - - --- ---Yes Agent 1 Agent 2 - PrimaryAgent 1 - SecondaryAgent 1‘ Agent 2Yes Agent 2 Agent 2 - PrimaryAgent 1 - SecondaryAgent 2 Agent 2$

Invivo 2GMOD WIRELESS MODULE FOR MR-COMPATIBLE PATIENT MONITOR User Manual S User s Manual Wireless Modules

Invivo Corporation WIRELESS MODULE FOR MR-COMPATIBLE PATIENT MONITOR S User s Manual Wireless Modules

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