Precess 3160 Series Operations Manual Edition 7

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

TABLE OF CONTENTS Paragraph Number Page Number Equipment Classification ... i Precautions... ii User Responsibility... xvi User Responsibility Precess MRI Patient Monitoring Accessories... xvii Part Number Precess MRI Patient Monitoring Accessories ... xviii 1.0 1.1

1.2 1.3

1.4 1.5 1.6 1.7 2.0 2.1 2.2 2.3

2.4 2.5 2.6 2.7 2.8 3.0 3.1

INTRODUCTION. ... 1-1 Product Description ... 1-1 1.1.1 System Parameters ... 1-2 1.1.2 User Interface... 1-3 1.1.3 Versatility... 1-3 Wireless Processor Unit (WPU) ... 1-3 1.2.1 Operating Environment... 1-3 1.2.2 Power Supply ... 1-3 Patient Connections ... 1-3 1.3.1 NIBP and Agent Monitoring... 1-3 1.3.2 Invasive Pressure Monitoring ... 1-3 1.3.3 Temperature Monitoring... 1-3 ECG Monitoring ... 1-3 SpO2 Monitoring ... 1-4 Display Control Unit (DCU)... 1-4 1.6.1 DCU Controls ... 1-4 1.6.2 DCU Display... 1-10 Cleaning. ... 1-18 1.7.1 Cleaning Accessories ... 1-18 INSTALLATION... 2-1 Unpacking The System. ... 2-1 System Configuration. ... 2-1 Battery Installation and Removal. ... 2-1 2.3.1 Battery Locations ... 2-1 2.3.2 WPU And DCU Battery Installation And Removal ... 2-2 2.3.3 WECG And WSpO2 Battery Installation And Removal... 2-3 Battery Charging... 2-5 2.4.1 WPU And DCU Battery Charging... 2-5 2.4.2 WECG/WSpO2 Battery Charging ... 2-5 Battery Operation... 2-10 System Setup... 2-10 2.6.1 WPU and DCU ... 2-10 System Location ... 2-13 Before Connecting To A Patient... 2-13 PATIENT PARAMETERS... 3-1 ECG Monitoring ... 3-1 3.1.1 Wireless ECG Module and ECG Patient Lead Wires... 3-1 3.1.2 ECG Electrode - Use only Invivo Quadtrode MRI ECG Electrodes... 3-2 3.1.3 Associated Waveforms and Displays ... 3-4 3.1.4 The ECG Menu ... 3-4

3.2

3.3

3.4

3.5

3.6

3.1.5 ECG Alarm Limits... 3-8 3.1.6 ECG Trended Data... 3-8 3.1.7 ECG Messages ... 3-9 Non-Invasive Blood Pressure (NIBP) Monitoring ... 3-9 3.2.1 Theory of Oscillometric Measurement ... 3-11 3.2.2 NIBP Patient and Cuff Preparation... 3-12 3.2.3 Associated NIBP Displays... 3-12 3.2.4 The NIBP Menu... 3-14 3.2.5 NIBP Menu Options ... 3-14 3.2.6 Using the Automatic NIBP Interval Mode ... 3-17 3.2.7 Manually Starting/Stopping an NIBP Reading Cycle ... 3-17 3.2.8 NIBP STAT Mode Operation ... 3-17 3.2.9 NIBP Alarm Limits... 3-17 3.2.10 NIBP Adult vs. Neonatal Mode Operation... 3-17 3.2.11 NIBP Trended Data ... 3-18 3.2.12 NIBP Messages... 3-18 SpO2 Monitoring ... 3-19 3.3.1 Wireless SpO2 Module and Fiber-Optic SpO2 Sensor ... 3-19 3.3.2 SpO2 Sensor Positioning ... 3-19 3.3.3 Associated SpO2 Waveforms and Displays ... 3-20 3.3.4 SpO2 Menu ... 3-20 3.3.5 SpO2 Alarm Limits... 3-21 3.3.6 SpO2 Trended Data ... 3-22 3.3.7 SpO2 Messages... 3-22 End-tidal CO2 (ETCO2) Monitoring... 3-23 3.4.1 Water Trap and Sampling Line Preparation ... 3-23 3.4.2 Water Trap Replacement ... 3-25 3.4.3 Associated ETCO2 Waveforms and Displays ... 3-25 3.4.4 ETCO2 Menu... 3-26 3.4.5 Calibration of CO2 Measurement System ... 3-27 3.4.6 ETCO2 Alarm Limits ... 3-29 3.4.7 ETCO2 Trended Data ... 3-29 3.4.8 ETCO2 Messages ... 3-29 Anesthetic Agent/Oxygen Monitoring... 3-29 3.5.1 Anesthetic Agent Patient and Tubing Preparation... 3-30 3.5.2 Associated Anesthetic Agent Displays ... 3-30 3.5.3 Agent Menu ... 3-32 3.5.4 Gas Calibration ... 3-33 3.5.5 Agent Alarm Limits ... 3-34 3.5.6 Agent Trended Data... 3-34 3.5.7 Agent/O2 Messages ... 3-34 3.5.8 Oxygen Monitoring... 3-35 Invasive Pressure Monitoring ... 3-36 3.6.1 Invasive Pressure Transducer Preparation ... 3-36 3.6.2 Associated Invasive Pressure Waveforms and Displays ... 3-37 3.6.3 The Invasive Pressure Menu... 3-38 3.6.4 Invasive Pressure Alarm Limits... 3-40 3.6.5 Invasive Pressure Trended Data ... 3-41 3.6.6 Invasive Pressure Messages... 3-41

3.7

3.8

4.0 4.1 4.2 4.3

5.0 5.1 5.2 5.3

5.4 5.5 6.0 6.1 6.2

Temperature Monitoring... 3-41 3.7.1 Associated Temperature Displays ... 3-41 3.7.2 TEMP Menu ... 3-42 3.7.3 Temperature Alarm Limits ... 3-43 3.7.4 Using the Fiber-Optic Surface Temperature Sensor... 3-43 3.7.5 Temperature Trended Data ... 3-44 3.7.6 Temperature Messages ... 3-44 Respiration Monitoring... 3-45 3.8.1 Associated Respiration Displays ... 3-45 3.8.2 Respiration Patient Preparation ... 3-45 PREPARATION FOR USE. ... 4-1 Introduction... 4-1 Setups Menu ... 4-1 4.2.1 DCU Setups Menu. ... 4-1 4.2.2 Store/Recall Setups ... 4-3 Monitor Initialization ... 4-16 4.3.1 Default Initialization ... 4-16 4.3.2 Pre-Configured Initialization ... 4-16 RECORDING AND TRENDING. ... 5-1 Introduction... 5-1 5.1.1 Record Key ... 5-1 The Recorder Menu ... 5-1 Recording Charts ... 5-3 5.3.1 Strip Chart Record ... 5-3 5.3.2 Tabular Chart Record... 5-4 5.3.3 Trend Chart ... 5-4 5.3.4 System Data Report ... 5-5 Loading Recorder Paper ... 5-5 Trending Feature... 5-5 5.5.1 History Menu Options ... 5-5

ALARMS. ... 6-1 Introduction... 6-1 Alarm Limits... 6-1 6.2.1 Default (Pre-Set) Alarm Limits ... 6-1 6.2.2 Range of High and Low Alarm Limits ... 6-3 6.3 Alarm Setup ... 6-4 6.3.1 Parameter Alarms Status Screen... 6-7 6.4 Turning Alarms OFF on Individual Parameters ... 6-7 6.5 Alarm Violations... 6-7 6.6 Adjusting the Alarm Tone Volume ... 6-8 6.6.1 Disabling the Alarm Tone... 6-8 6.7 Standby Mode ... 6-9 specifications ... A-1 repair ...B-1 warranty ...C-1 Declaration of conformity... D-1 List of symbols...E-1 EMC... F-1 GUIDELINES TO PREVENT EXCESSIVE HEATING AND BURNS ASSOCIATED WITH

MAGNETIC RESONANCE PROCEDURES ... G-1 NOTES... H-1

EQUIPMENT CLASSIFICATION Classification according to IEC-60601-1 According to the type of protection against Class I equipment. electrical shock: According to the degree of protection against Type CF (defibrillator-proof) equipment. electrical shock: According to the degree of protection against Ordinary equipment (enclosed equipment harmful ingress of water: without protection against ingress of water). According to the methods of sterilization or Non-sterilizable. Use of liquid surface disinfection: 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.

i

PRECAUTIONS General Laws in the USA, Canada and E.U. restricts this device to sale by, or on, the order of a physician. The Precess MRI Patient Monitoring System should not be used to transport a patient outside of a healthcare facility. The position of the patient and the patient’s physiological condition may affect the accuracy of the measurements. Always consult a physician for interpretation of measurements made by the Precess MRI Patient Monitoring System. Secure all components on mounting solutions recommended in the Accessory Listing section. Failure to secure all components could result in damage to the Precess MRI Patient Monitoring System. Do not use the Precess MRI Patient Monitoring System in the presence of flammable anesthetics. Using the Precess MRI Patient Monitoring System in the presence of flammable anesthetics would create an explosion hazard. The operator must read and thoroughly understand this operations manual before attempting to use the Precess MRI Patient Monitoring System. Perform operational checkout before each use. If the Precess MRI Patient Monitoring System fails to fuction accurately, remove it from use, and refer it to Invivo service personnel. When an “X” appears in the Alarm Bell symbol, the audible alarm tone will not sound for any reason. Use only recommended Invivo patient cable, lead wires, cuffs, hoses, sensors, tubing, etc. Using other brands will compromise the safety and accuracy of the Precess MRI Patient Monitoring System. A list of all Invivo brand accessories can be found in the Accessories section within this manual. For continued operation, always connect the Precess MRI Patient Monitoring System to AC Main Power when a Low Battery indication signal occurs. Failure to do this can lead to the interruption of monitoring and/or damage to the batteries. The Precess MRI Patient Monitoring System must be used and stored according to the following environmental specifications: Operating Temperature:10 to 40°C (50 to 104°F), or 15 to 35°C (59 to 95°F) when EtCO2 or anesthetic agents parameters are operating. Storage Temperature: Batteries (Invivo Part Numbers 9093 or 9064, and 9065): 0 to 40°C (32 to 104°F). Disposable Oxygen (O2) Cell (Invivo Part Number 9445): -40 to 45°C (-40 to 113°F). WPU, DCU, wireless modules, and additional accessories: -40 to +70°C (0 to 158°F). When storing the 3160 system in temperatures beyond the minimum ranges mentioned above, remove the designated component and store it appropriately. Relative Humidity: 0 to 80%, non-condensing Failure to follow these specifications may affect the accuracry of the Precess MRI Patient Monitoring System. Do not apply unnecessary pressure to the screen area of the Display Control Unit (DCU). Severe pressure applied to the screen area of the DCU could result in damage or failure of this screen. ii

All 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 are interconnected. Annual preventative maintenance is recommended unless stated otherwise in the service manual. For proper equipment maintenance, perform the service procedures at the recommended intervals as 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 agent readings. 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.

iii

PRECAUTIONS Electrical Safety Always disconnect the Precess MRI Patient Monitoring System from AC Main Power before performing cleaning or maintenance system. To avoid an electrical hazard, never immerse any part of the patient monitoring system in any cleaning agent fluid or attempt to clean it with liquid cleaning agents. If the Precess MRI Patient Monitoring System becomes accidentally wet during use, discontinue operation 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 Support personnel 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-grade receptacle only. The three-conductor plug must be inserted into a properly wired three-wire receptacle. 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 a safety hazard by compromising the grounding integrity of the Precess MRI Patient Monitoring System. 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 is electrically connected to any of these connections. The Precess MRI Patient Monitoring System and its listed accessories may be safely powered by the 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 the Precess MRI Patient Monitoring System on internal battery power until proper earth ground connection is confirmed.

iv

PRECAUTIONS Patient Safety Whenever a patient is under anesthesia or connected to a ventilator constant attention by qualified medical personnel is needed. Some equipment malfunctions may occur in spite of equipment or monitoring alarms. Always test the sampling line adapter for a tight connection and proper operation before attaching to a patient. As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

Occupational Safety Connect the sample gas outlet on the monitor's rear panel to a scavenging system to prevent pollution of room air. Handle the Patient Sampling Line and its contents as you would any body fluid. Infectious hazard may be present.

v

PRECAUTIONS MRI Use Precautions Certain components of the Precess MRI Patient Monitoring System will be affected by the magnetic and radio frequency fields present in your MR system room. Confer with your MRI physicist and/or Radiology staff to identify the proper placement and use areas for the Precess MRI Patient Monitoring System and its accessories, as defined on the system or accessory labeling. Failure to properly place the Precess MRI Patient Monitoring System and its accessories in the system 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 may saturate the ECG amplifier of this device, leading to erratic readings. Always verify proper communication of the Precess MRI Patient Monitoring System with the corresponding Remote Monitor (Display Control Unit (DCU)) prior to patient use.

MR System Room Placement The Precess MRI Patient Monitoring System is designed to be used in conjunction with a Remote Monitor (Display Control Unit (DCU)). The Precess MRI Patient Monitoring System is specially designed not to interfere with MRI operations. IT MAY BE USED INSIDE THE MR SYSTEM ROOM IN A

LOCATION AT OR OUTSIDE THE 5,000 (5,000 OR LESS) GAUSS (0.5T) FIELD LINE OF THE MR SYSTEM, AS MEASURED FROM THE CENTER LINE OF THE MR BORE, BUT IN NO CASE CLOSER THAN 3 FEET (1 METER) FROM THE MR SYSTEM. ALWAYS ENSURE THAT THE WHEELS ARE IN THE LOCKED POSITION WHEN THE MONITORING SYSTEM IS LEFT UNATTENDED. Field strength variations in a particular MR system room (which may be due to active shielding technology, manufacturer variability, future enhancements, etc) can make distinguishing the 5,000 Gauss level difficult and therefore the Precess MRI Patient Monitoring System must never be placed closer than 3 feet (1 meter) from the MR System. This variation may require moving the Precess MRI Patient Monitoring System away from the magnet if system abnormalities or malfunctions are observed. Prior to clinical use, the operator must be aware of the minimum distance from the MR System for proper operation. If brought closer than 3 feet (1 meter) and/or the 5,000 Gauss Field Line, system failure and/or patient or user injury may result.

vi

5,000 G/3 FT (1M), WHICHEVER IS FARTHER FROM THE MR SYSTEM

ALWAYS 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 interfere with MRI operations. If the recorder option is present, it may be used in the system room at or outside the 1,000 Gauss (0.1T) Field Line of the MR System. Do not move the Remote Monitor closer than the specified Gauss Field Line or damage (failure to operate) to the recorder may result. If the recorder option is not present, the Remote Monitor may be used at or outside the 5,000 Gauss (0.5T) Field Line or no closer than 3 feet (1 meter) from the MR System.

WARNING If the Precess MRI Patient Monitoring System rolls to the face of the MR system due to magnetically induced pull force, DO NOT ATTEMPT TO DISLODGE THE PRECESS MRI PATIENT MONITORING SYSTEM BY PULLING FROM THE DOCKED REMOTE MONITOR OR GUIDE HANDLE AT THE TOP OF THE PRECESS MRI PATIENT MONITORING SYSTEM. Dislodge the Precess MRI Patient Monitoring System by gently pulling from the base of the system pole at its lowest point. This will prevent the base of the unit from experiencing higher MR pull forces in the vertical direction.

vii

PRECAUTIONS Risk of RF current burn Cables which become inadvertently looped during an MRI examination may act as conductive lines for RF induced currents, resulting in excessive heating and possible burns. When lead wires or other cables form a conductive loop in contact with the patient's tissue, minor to severe burning can result. Please refer to the additional information in Appendix G to prevent excessive heating associated with MRI procedures. Perform the following to minimize risk of MRI-related heating: 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 Accessory List. c. RF burn risk increases when multiple sensors/cables are in use. Such combinations are not recommended. d. The high radio frequency (RF) power used in MRI scanning poses an ever present risk of excessive heat at the monitoring sites and, therefore, the risk of RF current burn. Should power levels greater than a whole body averaged specific absorption rate (SAR) of 4 W/kg be used, the risk of patient burn greatly increases. As a result, monitoring of ECG at power levels of greater than an MR system reported, whole body averaged SAR of 4 W/kg is not recommended for the general patient population. Such monitoring should only be attempted on conscious patients with normal thermoregulatory capabilities so they may warn the operator of possible excessive heat at the monitoring sites. e. High levels of RF energy may cause patient heating or burns. Use caution for scan times (i.e., per pulse sequence) greater than 15 minutes. For MRI scans with average SAR > 1 W/kg, limit scan time to 15 minutes and pause at least 3 minutes between scans to allow the ECG electrodes to cool.

MRI Information The Quadtrode® MRI ECG Electrodes (Invivo Part Numbers 9303, 9371 and 9372), and ECG Patient Lead Wires (Invivo Part Numbers 9224, 9223 and 9222), are acceptable for use with Magnetic Resonance (MR) Systems within the following guidelines: • •

MR systems with static magnetic field strengths of 3.0 Tesla or less Usable within the MR system bore using an MR system reported, whole body average Specific Absorption Rates (SARs)) up to 4.0 W/kg. Use with higher SARs 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 ECG electrode element is positioned.

viii

PRECAUTIONS ECG An inoperative ECG parameter or WECG module is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. For best ECG, heart rate, and/or respiration monitoring, always select the optimal lead configuration which has the least artifact and largest waveform(s) being detected for monitoring use. Failure to respond to a Lead Fail alarm will cause a lapse in your patient’s monitoring. Always respond promptly to this and any other alarms. Heart rate values may be adversely affected by cardiac arrhythmia, or by operation of electrical stimulators. Rapidly changing gradients of the MR system can cause artifact on the ECG waveform and may result in erratic readings. During the duration of erratic ECG readings, evaluate changes in other available vital signs or switch the HR SOURCE from ECG to SpO2.

NIBP Always use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuff hose. When using the NIBP portion of this instrument to measure blood pressure, remember that the patient’s blood pressure readings are not continuous, but are updated each time a blood pressure measurement is taken. Set a shorter interval for more frequent updating of the patient’s blood pressure. Do not attach the cuff to a limb being used for infusion. Cuff inflation can block infusion, possibly causing 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 are obtained, re-check patient’s vital signs by alternate means before administering medication. To ensure accurate and reliable measurements, use only recommended patient cuffs/hoses. Use the appropriate cuff size for each patient as recommended by the current American Heart Association (AHA) guidelines for blood pressure monitoring to ensure patient safety and accuracy. Routinely inspect the cuff and hose assemblies for proper attachment and orientation. Replace cuff and/or hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. 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-invasive sphygmomanometers - Part 1: General requirements.

ix

PRECAUTIONS SpO2 Avoid placement of the SpO2 sensor on the same limb with an inflated blood pressure cuff. Cuff inflation could result in inaccurate readings and false alarm violations. SpO2 monitoring requires the detection of valid pulses to correctly determine SpO2 and Heart Rate values. During conditions of gross artifact, or in the absence of valid pulses, the SpO2/rate values will not be correct. The SpO2 patient monitoring portion of this system is intended to measure arterial hemoglobin oxygen saturation of functional hemoglobin (saturation of hemoglobin functionally available for transporting oxygen in the arteries). Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, will affect the accuracy of the measurement. Also, Cardiogreen and other intravascular dyes may, depending on their concentration, cause inaccuracy of the SpO2 measurement. Always shield the SpO2 sensor from extraneous incident light sources. Such extraneous light can cause SpO2 reading or pulse detection errors. Frequently inspect the SpO2 sensor site for possible pressure tissue necrosis during prolonged monitoring. Reposition the sensor at least every four (4) hours. Special care must be exercised when tape is used to secure the sensor, as the stretch memory properties of most tapes can easily apply 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 patient deoxygenation is indicated, blood samples must be analyzed by a laboratory co-oximeter to completely 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 the waveform 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 are obtained, re-check patient’s vital signs by alternate means before administering medication. Ambient light (including photodynamic therapy), physical movement (patient and imposed motion), diagnostic testing, low perfusion, electromagnetic interference, electrosurgical units, dysfunctional hemoglobin, presence of certain dyes and inappropriate positioning of the pulse oximeter probe can all lead to inaccuracies of the pulse oximeter equipment.

x

PRECAUTIONS Invasive Pressures For best invasive pressure monitoring, always select the appropriate waveform scale for the waveform being observed. For invasive pressure monitoring, routinely inspect the catheter and/or pressure line for leaks after zeroing. Always follow the pressure transducer/catheter manufacturer’s use recommendations. Never place the pressure transducer(s) within the MR bore. Transducer failure, inaccurate readings or noisy MRI images can result. Invasive blood pressure transducers are sensitive to vibrations that can occur during MRI scanning, which can lead to pressure reading inaccuracies. Always mount the invasive blood pressure transducer away from areas where vibration is likely to occur. Non-physiological pulsatile invasive pressure waveforms (e.g., such as found during intra-aortic balloon pump use) can lead to inaccurate blood pressure readings. If questionable values are observed, re-check patient’s pressures by alternate means before administering medication or therapy. The fluid within the pressure transducer system is a conductive connection to the patient, and must 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.

Respiration When setting up respiration monitoring, always observe and adjust the respiration gain of the system while watching the patient’s breathing efforts before completing selection of the gain setting. Failure to do this can result in inaccurate readings, or false respiration detection.

xi

PRECAUTIONS End-tidal CO2 (ETCO2) Verify that the patient’s breathing efforts and timing coincide with the DCU waveform before completion of the patient set-up. The ETCO2/N2O measurement displays the sampled value within 1 second of when the gas was sampled. Frequently inspect the ETCO2 patient tubing. Avoid kinking of the ETCO2 patient tubing that can result in leaking, reduction, or cut-off of the sample gas flow. Inaccurate gas measurements could result. ETCO2 patient tubing and its associated components are intended for single-patient use only. Avoid cleaning or disinfecting these items for reuse. Inaccurate gas measurements could result. To prevent inaccurate or missed readings, keep the ETCO2 patient tubing clear of any moving mechanisms which may kink, cut or dislodge the patient tubing. 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 this connector can cause failure of the water trap assembly and resultant inaccurate patient gas measurements. 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 drained of 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 tubing manufacturer's recommendations. Consult the instructions that come with the ETCO2 accessories, as they contain guidance regarding 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 contact Invivo. The Precess contains an exhaust port at the rear of the WPU that may be connected to the facility's anesthetic gas scavenging system, using the appropriate exhaust tube accessory. Follow the facility's guidelines for connecting to the scavenging system, including proper disposal of sampled gas. Mainstream cyclical pressure of 10kPa can damage the equipment since this system uses sidestream technology as the measurement technique. Return of the sampled gas to the PCU will cause a positive pressure that can reduce flow which can affect accuracy at higher breath rates. Accuracy is reduced because ETCO2 value will decrease and inspired CO2 will, in turn, increase.

Temperature Use only MRI-compatible fiber-optic temperature sensor accessories (see MRI Accessory List in this section). The fiber-optic temperature sensors are constructed of fiber-optic glass and must always be handled with care to prevent damage. Improper handling can result in inaccurate readings and shorten the temperature sensor's useful life. xii

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

xiii

PRECAUTIONS Anesthetic Agents Inadequate ventilation of the system will cause inaccurate readings or damage to electronic components. 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. To prevent this condition, there must always be an opening to the room air. Too high a vacuum level will change the operating pressure of the system and cause inaccurate readings or internal damage. 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 inaccurate readings 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 inaccurate patient gas measurements. Routinely inspect the hose assemblies for proper attachment and orientation. Replace hose assemblies with cracks, holes, tears, cuts, etc. that could cause leaks in the system. If hose assemblies with damage that could result in leaks are used, prolonged and/or inaccurate patient readings 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 agent identification and reading to be displayed. Once identification is established, changes in concentration are virtually immediate. With a 200% change in concentration, an auto Zero will occur, and full accuracy of the changed concentration will be accomplished within approximately 30 seconds. Whenever the Precess MRI Patient Monitoring System Agent sensor changes from steady state condition, the Precess MRI Patient Monitoring System will perform an auto zero to restabilize the sensor readings. During this time, 15 seconds to 1.5 minutes, it is possible for a false identification and concentration value to occur. Examples are as follows: • 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 drained of pressure before disposal. xiv