Page 2 Invivo Corporation PRECESS MRI PATIENT MONITORING SYSTEM OPERATIONS MANUAL...
Page 3 NOTE Notified body number 0413 is only relevant for the MDD 93/42/EEC Directive.
Page 4: Table Of Contents
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...
Page 5 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....................
Page 6 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....................
Page 7: Equipment Classification
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).
Page 8: Precautions
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.
Page 9 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.
Page 10 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.
Page 11: Patient Safety
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.
Page 12 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 MRI magnet 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.
Page 13 5,000 G/3 FT (1M), WHICHEVER IS FARTHER FROM THE MRI 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.
Page 14 15 minutes. MRI Compatibility 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 compatible with Magnetic Resonance Imaging (MRI) Systems within the following guidelines: •...
Page 15 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...
Page 16 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.
Page 17 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 MRI bore.
Page 18 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.
Page 19 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...
Page 20 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.
Page 21 This product, or any of its parts, must not be repaired other than in accordance with written instructions 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 from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Invivo, or its authorized service personnel.
Page 22: User Responsibility
Invivo. The user of the product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Invivo or Invivo authorized service personnel.
Page 23 Precess MRI Patient Monitoring Accessories Item Description Part Number General Precess 14.8V Battery (each).....................9093 Precess 14.4V Battery (each).....................9064 Power Supply to Precess Cable, 5 Feet (1.6 M) ..............AC517A Power Supply to Precess Cable, 25 Feet (7.6 M) ............... AC517B Precess Power Adapter ......................
Page 24 Precess MRI Patient Monitoring Accessories Item Description Part Number ETCO2 ETCO2 Sample Line Kit......................94021 ETCO2 Water Trap ........................94020 Adult Disposable Cannula ......................9012 Pediatric Disposable Cannula ....................9013 Infant Disposable Cannula......................9014 Small Infant Disposable Cannula ....................9015 Adult Divided Cannula ......................9016 Pediatric Divided Cannula ......................9016C Infant Divided Cannula......................9016A Small Infant Divided Cannula ....................
Page 25: Introduction
Resonance environment. The Precess combines the latest wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies to address the challenges associated with patient monitoring in the MRI area. Built on Invivo’s strong heritage in MRI patient vital signs monitoring, the Precess provides accurate, continuous, and reliable performance during MRI applications.
Page 26: System Parameters
Wireless ECG Module. The Wireless ECG (WECG) module communicates two leads of ECG simultaneously to the WPU. These two leads of ECG can be displayed at the DCU and are output from the WPU unit for interface to the MRI system cardiac gating input.
Page 27: User Interface
1.1.2 User Interface. A simple-to-use interface has been developed to minimize operator learning time. On the Display Control Unit (DCU), there is a Rotary Knob (which detents from selection to selection) that is used to access the parameter menus, access the various setup features and finalize any changes to the setup of the system.
Page 28: Spo2 Monitoring
• Compatibility. The WECG module supports the Quadtrode family of MRI compatible ECG Electrodes. • Visual Indicators. The WECG module contains one (1) bi-color LED that indicates the status of the battery charge. • Battery Life. The WECG module will operate at least eight (8) hours on a fully charged battery.
Page 29 Figure 1-3. The DCU Front Panel During normal operation each active parameter has a Menu-Select icon on the DCU display. When the Rotary Knob is rotated, the Menu-Select icon which is being pointed at becomes “highlighted.” Rotating the Rotary Knob will cause the display to “scroll through” the available menu selections.
Page 30 FREEZE. The Precess MRI Patient Monitoring System freezes the ECG waveform from Trace A for closer examination upon user demand. When the ECG trace is active, pressing the FREEZE key will freeze it into the Trace B location while Trace A remains active. When the trace is frozen, pressing the FREEZE key will release it.
Page 31 Figure 1-5. The DCU Middle Keypad Set NIBP START/STOP. This key starts a new NIBP measurement, or stops a measurement that is already in progress. NIBP INTERVAL. Pressing the NIBP INTERVAL key brings up the NIBP Interval Menu where the cycle time (time between readings) of the NIBP Automatic Reading Mode may be adjusted.
Page 32 RECORD. Pressing this key records the Single Trace or Dual Trace selections (as specified by operator adjustments made in the Recorder Menu). The recorder stops automatically after approximately 30 seconds, or when the RECORD key is pressed again; in either case, the printout ends with a “Snap Shot”...
Page 33 Alarm Silenced. Any new alarm conditions will cause the Alarm to reactivate. In addition, while alarms are silenced the following conditions apply: • Unlatched Alarms. If the alarm system has been set to UNLATCHED in the Alarms Menu and an Alarm Limit is violated, pressing the ALARM SILENCE key will silence the Alarm Tone and put the letter “S”...
Page 34: Dcu Display
WARNING An active silenced alarm may not be accompanied by an Alarm Silence message or 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. (See Figure 1-6.) The Front Panel Communication Power Light.
Page 35 Figure 1-7. The DCU Normal Screen (See Figure 1-8) The Informational Display is located at Informational Display. the top of the Normal Display. This display provides the operator with the current time, the Alarm Status Bell Symbol, a flashing Heart Rate Symbol, a flashing Lung Symbol, any current user messages and the current Patient Selection.
Page 36 The letter “S” appearing in the bell indicates that a current alarm has been silenced with the ALARM SILENCE key. This feature will disable only the alarms that were current when the ALARM SILENCE key was pressed, any new alarms will cause the Alarm Tone to sound.
Page 37 The following is a description of each Trace: TRACE A. The ECG trace is displayed in this position, unless turned Off from either the ECG Menu or the Setups Menu. The main menu for this trace and for the Heart Rate are brought up with the selection of the ECG Menu-Select Icon.
Page 38 Non-Invasive Blood Pressure (NIBP). NIBP is the first parameter (from the left) displayed in the Vital Signs Display. The Systolic, Diastolic and Mean blood pressure values are displayed along with measurement information such as the Elapsed Time (ET) since the last measurement and the time until the next measurement (if in the Automatic Mode).
Page 39 Wireless System Status Display. The System Status Display (Figure 1-11) is located at the bottom of the Normal Screen Display and provides the operator with visual indications of the operational status of the system. From left to right, the symbols 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).
Page 40 WPU Communication-Power Status (2). The WPU Status area is denoted by the WPU symbol (Figure 1-14). When this symbol is present, good communication has been established between that DCU and the WPU. When communication is lost or has not been established between the DCU and the WPU, the WPU symbol with the slashed enclosure (Figure 1-15) will be displayed.
Page 41 Figure 1-16. Wireless SpO2 and ECG Battery Symbols Figure 1-17. Wireless SpO2 and ECG No Communication Display Communication Network Indication (4). The Communication Network Indication Symbol provides the wireless communication network designation for the particular Precess system. In order for the Precess system to properly communicate with all components (DCU, WPU, Wireless SpO2 and ECG Modules), the Network Designators (Figure...
Page 42: Cleaning
DCU, or permit liquid to drip into the printer or around display screen. If liquid entersmust any components, contact Invivo Technical Support. 1.7.1 Cleaning Accessories. Any reusable patient accessories must be cleaned after each use.
Page 43: Installation
To resolve any issues or concerns with your order or product, or to report shipping damage, contact Invivo Customer Service. Save all packing materials and related shipping documents, as these will be required to process a claim with the carrier if damage during shipment occurred.
Page 44: Wpu And Dcu Battery Installation And Removal
2.3.2 WPU And DCU Battery Installation And Removal.The WPU and DCU batteries slide into their respective battery compartments and automatically latch into place. When installing the batteries, note that they must be orientated properly into the battery compartment in order that they will latch into place.
Page 45: Wecg And Wspo2 Battery Installation And Removal
2.3.3 WECG And WSpO2 Battery Installation And Removal. The wireless module batteries each slide into the battery slots on the WECG and WSpO2 modules and latch into place on each side. To remove the batteries, use your fingers to simultaneously press the latches on both sides of the battery and the battery will slide out of the module (see Figure 2-3 Figure...
Page 46 • Never heat the battery nor throw into a fire. Keep the battery contacts away from metal objects. • Replace batteries with only Invivo supplied batteries. Refer to the Accessories list on page xvii. • Store battery in a dry place, 0°C to 40°C.
Page 47: Battery Charging
Battery Charging. 2.4.1 WPU And DCU Battery Charging. When the WPU and DCU batteries (Invivo Part Number 9064 or 9093) are removed from the unit, the user can determine battery capacity by simply pressing “Power Level” button on the battery. When this button is pressed, LED indicators show the battery capacity from 20 to 100% capacity in 20% increments.
Page 48 WARNING • When charging the battery, only use the Invivo Wireless Module Battery Charger for Precess MRI Patient Monitoring System, Part Number 9023. • Do not attach the battery to power supply plug or directly to an automobile cigarette lighter.
Page 49 Wireless Module Battery Charger Description. The following is a description of Precess 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 that power is being supplied to the battery charger from either Part Number 9063 Power Module or Model 9023 battery charger.
Page 50 Wireless Module Battery Charger Power Connection Procedure. The Wireless Module Battery Charger uses 5 Vdc from Part Number 9063 Power Module. Connection is made by plugging Part Number 9063 Power Module into an AC outlet, then connecting the output power cable into the power connection on the back of the charger unit (Figure 2-7).
Page 51 Table 2-1. LED Indications LED Condition LED Indication 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.
Page 52: Battery Operation
1-10, for a full explanation of the Battery Status Display. Maximum operation time of the battery (Invivo Part Number 9093 or 9064) is approximately eight (8) hours when NIBP, ECG, SpO2 parameters are running on 5-minute intervals, and anesthetic agents and EtCO2 are turned off.
Page 53 Figure 2-8. AC Power Connection To Precess AC to DC Power Supply (Part Number AS201) Figure 2-9. Precess DC Power Connection To Precessc AC To DC Power Supply (Part Number AS201) 2-11...
Page 54 WPU Power Door Figure 2-10. WPU Hardwire Location DCU Power Door Figure 2-11. DCU Power Input 2-12...
Page 55: System Location
Visually inspect all 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 system on a patient.
Page 56: Patient Parameters
View (FOV). Placing the Wireless ECG Module within the FOV may interrupt ECG monitoring during 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 of radio frequency (RF) energy that can flow through these wires.
Page 57: Ecg Electrode - Use Only Invivo Quadtrode Mri Ecg Electrodes
ECG Electrode - Use only Invivo Quadtrode MRI ECG Electrodes. These ECG electrodes are design specifically for use in the MRI environment. Use of the Invivo Quadtrode electrodes will minimize the possible risk of ECG electrode and cable heating during MRI procedures and reduce the amount of MRI generated artifact on the ECG waveform.
Page 58 (e.g. wires, leads, probes, etc.) are tomust be placed inside the MRI system bore at the same time as the Invivo MRI ECG lead wires (Part Numbers 9224, 9223, and 9222) as the risk of lead wire and electrode heating increases. It is always important to identify if the patient has any metallic wires, conductors, implants, stents, etc.
Page 59: Associated Waveforms And Displays
3.1.3 Associated Waveforms and Displays. (See Figure 3-2.) ECG information is displayed as a waveform in the Trace A location and as numeric data in the Box 1 and 2 locations. The following is a description of the items contained within the ECG Display. Figure 3-2.
Page 60 The following selections are available in the ECG Menu: TRACE A LEAD. Selecting this menu option allows the selection of the ECG 1 Lead. The options are I, II (default), III AVL, AVR, AVF and OFF. TRACE B LEAD. Selecting this menu option allows the selection of the ECG 2 Lead.
Page 61 GATING SOURCE. Selecting this menu option allows the selection of the Source to be used for MRI Gating. The options are ECG and PULSE. The MRI Gating connector is located at the back of the WPU. This connector is denoted by the symbol below.
Page 62 When the SpO2 Parameter provides the Heart Rate Tone, the Tone is modulated by the SpO2 value. If the Heart Rate Tone Source is turned OFF, the Heart Symbol is removed from the display. This menu option is identical to, and interactive with, the HR Tone Source Option in the Sound Adjust Menu.
Page 63: Ecg Alarm Limits
Figure 3-6. Filter Mode Menu ECG TEST SIGNAL. Selecting this menu option opens the ECG Test Signal Menu. This menu option is identical to and interactive with the Calibrate Option in the Recorder Menu. The following options are available in the ECG Test Signal Menu: OFF.
Page 64: Ecg Messages
3.1.7 ECG Messages. The following is a list of messages that may be displayed during ECG monitoring: LEAD FAIL is displayed when a faulty or disconnected ECG Lead is LEAD FAIL detected by the system. NOTE If the RL lead and an additional lead become disconnected, the system will not detect a lead failure.
Page 65 When 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 to adjust the cycle time.
Page 66: Theory Of Oscillometric Measurement
Most NIBP functions are contained in the primary NIBP Menu. However, additional features useful with NIBP monitoring can be found in the three secondary menus associated with this parameter: • RECORDER Menu. Used to select Recorder functions and to Set the Recorder Trace Speed.
Page 67: Nibp Patient And Cuff Preparation
With further reduction in cuff pressure the artery opens for a longer time during each cardiac cycle, which causes increasingly larger oscillations in the cuff pressure until they reach a point of maximum oscillation amplitude. This point of maximum oscillations has been well demonstrated to be Mean Arterial Pressure. NOTE The point of maximum oscillations is coincident with mean arterial pressure regardless of arterial elasticity so long as the ratio of air volume in the cuff to the volume of the...
Page 68 Figure 3-9. The NIBP Display The NIBP Systolic/Diastolic Display. The items contained in this user selectable display are described below: Icon Label. (Item 1) This label identifies the Parameter whose numeric data is being displayed within the Icon Box. Box 11 (in the lower left of the Bottom Numeric Display) is dedicated to the display of NIBP information.
Page 69: Nibp Menu Options
Unit of Measurement. (Item 6) Displays the Unit of Measurement being used for presentation of the numeric data. This item may be toggled between mmHg and kPa using the System Configuration Menu (See Section 4 for further information). ET. (Item 7) The Elapsed Time (ET) since the last NIBP determination is displayed here.
Page 70 2.5, 3 (default), 5, 10, 15, 20, 30 or 45 minutes, and 1, 2 or 4 hours. The Interval Menu can also be accessed by pressing the NIBP INTERVAL Key. Figure 3-11. The NIBP Interval Menu As the Rotary Knob turns clockwise, the interval selection will increase. After reaching “RETURN,”...
Page 71 Figure 3-12. The HISTORY Menu The following options are available in the History Menu: PRT ALL. Selecting this menu option prints all stored Tabular Data. PRT PAGE. Selecting this menu option prints the current page. PREV PAGE. Selecting this menu option allows the selection of the previous page of tabular data.
Page 72: Using The Automatic Nibp Interval Mode
3.2.6 Using the Automatic NIBP Interval Mode. This system may be setup to take NIBP readings automatically at intervals set by the operator. To set this system to make Automatic NIBP determinations, turn the Rotary Knob until the NIBP Menu-Select Icon is highlighted and then press the Rotary Knob to bring up the NIBP Menu.
Page 73: Nibp Messages
3.2.11 NIBP Trended Data. For complete information on the trending of patient NIBP data, see Section 5, Recording and Trending. 3.2.12 NIBP Messages. The following is a list of messages that may be displayed during NIBP monitoring: CALIB Displayed if the system detects that the NIBP section is out of calibration.
Page 74: Spo2 Monitoring
• 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, 3-13) and Fiber-Optic SpO2 Sensor are designed for use in the MRI See Figure environment.
Page 75: Associated Spo2 Waveforms And Displays
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. 3.3.3 Associated SpO2 Waveforms and Displays. (See Figure 3-14) If the SpO2 is turned on the waveform is displayed in Trace Location C and the numerical information in Box 2.
Page 76: Spo2 Alarm Limits
Figure 3-16. The SpO2 SIZE Menu GATING SOURCE. Selecting this menu option allows the selection of the Source to be used for MRI Gating. The options are ECG and PULSE. The MRI Gating connector is located at the back of the WPU. This connector is denoted by the symbol below.
Page 77: Spo2 Trended Data
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.
Page 78: End-Tidal Co2 (Etco2) Monitoring
The ETCO2 Menu is brought up (if this End-tidal CO2 (ETCO2) Monitoring. Parameter is turned on through the Setups Menu) with the ETCO2 Menu-Select Icon. The ETCO2 feature provides sidestream measurement of CO2 with a continuous real-time CO2 Waveform Display. This feature will perform an automatic zeroing at periodic intervals while continuously performing pressure corrections.
Page 79 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 connected to the facility's anesthetic gas scavenging system, using the appropriate exhaust tube accessory.
Page 80: Water Trap Replacement
NOTE The 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. 3.4.2 Water Trap Replacement. (Figure 3-18) Remove the sample line from the Water Trap port and perform the following to replace the Water Trap: Figure 3-18.
Page 81: Etco2 Menu
Figure 3-19. The ETCO2 Display For optimum fit and compatibility, Invivo strongly recommends the use of the Invivo CO2 Sampling Kit (Part Number 94021), which contains the ETCO2 sample line tubing. Inspired CO2 Numeric. (Item 1) A numeric indication of the patient's Inspired CO2 reading.
Page 82 Figure 3-20. The ETCO2 Menu The following is a description of the ETCO2 Menu Options: SIZE. Selecting this menu option brings up the SIZE Menu where the operator may select 40, 60 or 80 mmHg for the Scale Size of the ETCO2 Waveform Display.
Page 83 Allow the ETCO2 Bench to warm up for approximately 25 minutes. Perform ETCO2 Validation Calibration Test as follows: Connect the aerosol QC CHECK GAS can (Invivo Part Number 9034F) to the GAS (ETCO2) port on the water trap. Apply the gas to the GAS port for a minimum of 30 seconds, then verify the following upper numeric value in the ETCO2 icon: •...
Page 84: Etco2 Trended Data
Infra-Red spectrometer based upon a high stability IR sensor technology known as Stabilized Thermopile Bridge (STB). Utilizing the STB technology, the Invivo AGS yields high output, low noise and ultra stable gas measurements. The following two secondary menus support the Anesthetic Agent/Oxygen monitoring feature: •...
Page 85: Anesthetic Agent Patient And Tubing Preparation
3.5.1 Anesthetic Agent Patient and Tubing Preparation. Use only Invivo sampling lines and accessories (Part Number 94018); other sampling lines may cause inaccurate readings. It is recommended that the sampling line and airway adapter are changed after each patient use.
Page 86 Et. (Item 4) Indicates that the top row numeric is the End Tidal (expired) values of the gas being monitored (with the designation of the gas located just below Et). 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 just below Fi).
Page 87: Agent Menu
WARNING Minimum Alveolar Concentration (MAC) values are empirical and are not absolute values. Invivo's AGS MAC values correspond to those of healthy adults and cannot be applied to children. Age and other individual factors influencing the behavior of volatile agents are not taken into account.
Page 88: Gas Calibration
Attach the T-fitting on the “QC CHECK GAS” can corresponding to the agent to be verified (Table 3-4 for a list of available aerosol gas cans) to the GAS (ETCO2) port on the water trap. Table 3-4. Invivo Gas Mixture. Agent Gas Can P/N %Agent %CO2...
Page 89: Agent Alarm Limits
Apply the selected agent to the GAS port for a minimum of 30 seconds, then continue to apply gas to the system while performing the following steps. Verify the reading below applicable to the Agent currently being verified. (Readings are displayed in the AGENTS Icon.): Agent Agent ID Reading...
Page 90: Oxygen Monitoring
Message flashes red with Alarm sound. Occurs MULTIPLE AGENTS when more than one Anesthetic Agent is identified. Message flashing red. Occurs during CO2/ READJUSTING CO2 Anesthesia Gas Sensor zeroing operation. ZERO The life Oxygen Sensor has expired and must be REPLACE O2 SENSOR replaced.
Page 91: Invasive Pressure Monitoring
Oxygen Sensor Replacement. The Oxygen Sensor (Invivo Part Number 9445) is located on the rear of the WPU near the DCU mounting pole. The Oxygen Sensor has an expected life of greater than six months with expected life inversely proportional to changes in Oxygen Concentration, Temperature and Pressure. The Oxygen Sensor begins aging immediately upon the opening of the package and should, therefore, not be opened until ready for use.
Page 92: Associated Invasive Pressure Waveforms And Displays
RETRY button (on the monitor display screen) to attempt to zero the Transducer again. If the Transducer still does not zero, try another transducer and/or cable. If condition still does not clear, contact Invivo Service Department or authorized Invivo Service Personnel.
Page 93: The Invasive Pressure Menu
3.6.3 The Invasive Pressure Menu. Selecting the P1 Menu-Select Icon will bring up the P1 Menu (See Figure 3-24). The title of this menu is dependent upon the operator selected Label for P1; if “NONE” is selected the title will be P1; if any other available Label is selected the title will be the selected Label (for example, the label ART is selected in Figure 3-25 and the menu title is...
Page 94 ZERO SET. Selecting this menu option zeros the Pressure Transducer for this channel. The Transducer must be zeroed before each use and at regular intervals during use. The Transducer must be vented to atmospheric pressure before the ZERO-SET Menu Option is selected. On successful completion of zeroing, the message “DONE”...
Page 95: Invasive Pressure Alarm Limits
PRES GRID. Selecting this menu option selects the Pressure Grid. The options are ON and OFF (default). With this menu option set to ON, graticule lines appear on the screen, and numbers indicating the values of these lines appear at the left-hand side of the lines (See 3-27).
Page 96: Invasive Pressure Trended Data
3.6.5 Invasive Pressure Trended Data. For complete information on the Trending of patient Invasive Pressure data, see Section 5, Recording and Trending. 3.6.6 Invasive Pressure Messages. The following is a list of messages that may be displayed during Invasive Pressure monitoring: Displayed during ZEROING of the transducer if the offset is too ERR:LO-RANGE low to be zeroed.
Page 97: Temp Menu
Figure 3-28. The Temperature Display Icon Label. (Item 1) This label identifies the parameter whose numeric data is being displayed within the Icon Box. Temperature Numeric. (Item 2) A numeric indication of the patient's Temperature reading. Alarm Limits. (Item 3) A numeric indication of the settings of the High (on top in the example) and Low (bottom in the example) Temperature Alarm Limits.
Page 98: Temperature Alarm Limits
• Failure to properly apply sensor will cause incorrect measurements. • The Invivo Part Number 9320 sensor is designed only to measure patient surface temperature. Do not insert this sensor into any patient body orifice. • Do not alter or modify sensor in any way. Alterations or modifications will affect performance, accuracy and will void warranty.
Page 99: Temperature Trended Data
Fiber-Optic Surface Temperature Sensor to a patient: Before each use, carefully inspect the FiberTEMP reusable Fiber-optic surface temperature sensor (Invivo Part Number 9320) for damage. Use only FiberTEMP Sensor Applicators (Invivo Part Number 9321, 3-30) to apply this sensor to the patient. Applying the sensor to the Figure patient with tape will damage sensor and thus void sensor warranty.
Page 100: Respiration Monitoring
Respiration Monitoring. Respiration is monitored by detecting the patient’s abdominal or chest wall motion through a pneumatic bellows placed at the patient’s chest. There are no user adjustable options for this Parameter. 3.8.1 Associated Respiration Displays. (See Figure 3-31.) Respiration information can only be displayed as numeric data.
Page 101: Preparation For Use
SECTION 4 PREPARATION FOR USE PREPARATION FOR USE. Introduction.This system provides the operator with the ability to store and recall different system configurations, select and display the available parameters, select special system functions, set the date and time and select test menus. Access to this wide array of features is available through the Setups Menu which is accessed by pressing the SETUP Menu-Select Key.
Page 102 Figure 4-1. The DCU SETUPS Menu When the second DCU is used in the Precess MRI Monitoring System, commands which control the system patient parameters functions (i.e. ECG, NIBP, P1, P2, SpO2, ETCO2, Agent Analysis, Temperature, Respiration, and Alarms) are synchronized between the two DCUs via the WPU. Commands that do not directly control patient parameters (i.e.
Page 103: Store/Recall Setups
In a scenario where the WPU and one DCU unit is turned ON and the two units are communicating, the second DCU, when it is turned ON, will “inherit” the settings from the first DCU. In other words, the settings from the already ON DCU will be communicated (via the WPU) to the second DCU that has been turned ON.
Page 104 Figure 4-2. The DCU RECALL SETUPS Menu The following is a description of the RECALL SETUPS Menu Options: A. To select this menu option, turn the Rotary Knob until A is highlighted, then press the Rotary Knob to select. Selecting this menu option brings up a YES/NO Confirmation Menu and, upon confirmation, will Recall the Setups for the monitor from the Memory Block A.
Page 105 Figure 4-3. The DCU STORE SETUPS Menu The following is a description of the STORE SETUPS Menu options: A. Selecting this menu option will store all setups for the system in the storage Memory Block A. B. Except for using the Memory Block B, this menu option is identical in function to Menu Option A.
Page 106 Figure 4-4. The DCU PARAMETER SELECTION Menu The following is a description of the PARAMETERS SELECTION Menu Options: ECG. Selecting this menu option will turn the ECG display ON (default) or OFF. The Heart Rate will remain on the screen, allowing it to be displayed from another Source if the Heart Rate Source (the HR SOURCE selection) is set to AUTO.
Page 107 DCU Sound Adjust. Selecting this menu option will bring up the SOUND ADJUST Menu (See Figure 4-5) which allows the user to switch the Alarm Tone ON and OFF, set the Heart Rate Tone Source and set the Volume for the different sounds the Precess MRI Patient Monitoring System produces.
Page 108 ALARM VOLUME. Selecting this menu option allows the selection of volume for the Alarm Tone. The range is 1 - 10 (default is 4). The Precess MRI Patient Monitoring System generates the Alarm Tone (while in the VOLUME Menu) to provide the user with an audible indication of the current Volume Level setting.
Page 109 Pediatric ECG. Selecting this menu option provides additional ECG filtering when patients, particularly pediatric patients, present with a narrow QRS complex and/or high heart rates. This menu item will have 2 options: OFF or ON. The factory default setting will be OFF. Figure 4-6.
Page 110 The setting of the PEDIATRIC ECG item will be stored in the user settings (A through F or USER) when the user stores the system settings. The setting of this item will also be recalled from one of the stored settings when the user performs a “settings recall”...
Page 111 Default Setups. Selecting this menu option will switch the power-on Defaults between FACTORY and USER Modes. If set to FACTORY, the system will power up with the entire system reset to Factory Default values. If set to USER, the system will power up and automatically Recall the User Defaults from memory. Sweep Speed.
Page 112 Figure 4-10. The DCU SERVICE (BIO-MED) Menu The following is a description of the options available in the SERVICE (BIO-MED) Menu: S/W REV. Selecting this menu item brings up another window which contains detailed information about the operating software of the DCU. This window contains the revision level and date of build along with other technical information concerning the DCU software.
Page 113 NIBP TESTS. Pressing this menu option brings up a submenu with LEAK TEST as an option. Selecting the LEAK TEST Option will display NIBP LEAK TEST with the Peak (beginning) Pressure and Final (current) Pressure displayed, along with the number of Passes and Failures of the test to determine the leak rate of the NIBP system.
Page 114 Figure 4-11. DCU GAS CAL Menu SYSTEM CONFIG. The SYSTEM CONFIG Menu (See Figure 4-12) is brought up by selecting the SYSTEM CONFIG Menu Option. Most of the options in this menu are sensitive and are, as a result, protected by a five (5) digit password that must be entered before the option may be adjusted.
Page 115 • NIBP: Selecting this menu option will Enable/Disable the NIBP module. Not accessible at the DCU. • P1: Selecting this menu option will Enable/Disable the P1 module. Not accessible at the DCU. • P2: Selecting this menu option will Enable/Disable the P2 module. Not accessible at the DCU.
Page 116: Monitor Initialization
• MONITOR MODE: This menu item is set automatically depending on which unit is being viewed. For the DCU, this option is set to REMOTE Mode. For the WPU, this option is set to LOCAL Mode. Not accessible at the DCU. •...
Page 117: Recording And Trending
SECTION 5 RECORDING AND TRENDING RECORDING AND TRENDING. Introduction. The Precess MRI Patient Monitoring System thermal array strip recorder can record one or two waveforms (as selected from the RECORDER Menu). The Recorder prints patient parameters on the edge of the strip chart and ends with a “snapshot” patient data report. 5.1.1 Record Key.
Page 118 If a parameter is off during any portion of the data storage period, the message ‘---/---’ shall be printed in place of its value. The Data Report printout ends with a lined area for writing in the ID/CASE number, the Patient's Name and the Operator Comments. PRINT NIBP REPORT.
Page 119: Recording Charts
DISABLED. Selecting this menu option will turn the Automatic Report Feature OFF. ENABLED. Selecting this menu option will turn the Automatic Report Feature ON. RETURN. Selecting the menu option will return the display to the Recorder Menu. AUTO RUN TIME. Selecting this menu option brings up the AUTO RUN TIME Menu where the operator can select the Automatic Strip Run Time.
Page 120: Tabular Chart Record
Setting Up the Strip Chart. Perform the following procedure to configure the Strip Chart to the appropriate application: Press the RECORDER SETUP Menu-Select Key. To change Trace 1, which is defaulted to ECG1, press the Rotary Knob, highlight the desired parameter and press the Rotary Knob to accept the new selection.
Page 121: System Data Report
5.3.4 System Data Report. (See Figure 5-4.) The System Data Report provides a hardcopy printout of the numerical indications of all the active patient parameters along with the date and time of the determination. Loading Recorder Paper. Perform the procedure in to load the recorder Figure 5-5 paper.
Page 122 PREV PAGE. Selecting this menu item will change the display to the previous page of the NIBP History File. NEXT PAGE. Selecting this menu item will change the display to the next page of the NIBP History File. CLEAR ALL. Selecting this menu item will clear all the data from the NIBP History File.
Page 123: Alarms
The alarms system can be tested using a patient simulator (ECG, NIBP and SpO2) to exceed the individual parameter alarm limits as required. If a problem with the alarm tone or message system is suspected, this system must be referred to an Invivo qualified service technician for evaluation.
Page 124 Table 6-1. Alarm Limit Factory Default Settings Adult Values Neonatal Values Parameter Low Limit High Limit Low Limit High Limit Heart Rate 45 bpm/ 160 bpm/ 90 bpm/ 210 bpm/ 6.0 kPa 21.3 kPa 12.0 kPa 28.0 kPa NIBP Systolic 65 mmHg/ 190 mmHg/ 70 mmHg/...
Page 125: Range Of High And Low Alarm Limits
6.2.2 Range of High and Low Alarm Limits.Each patient parameter has a LOW and HIGH Alarm Limit value position as indicated by. numerics in the LOW and HIGH columns of Table 6-2. Alarm Limits displayed in this menu may be changed manually or automatically using the Rotary Knob after the patient parameter is selected.
Page 126: Alarm Setup
Alarm Setup. Pressing the ALARMS SCREEN Menu-Select Key while in the Normal Monitoring Mode (Normal Screen displayed) with no icons highlighted will bring up the Alarms Menu (See Figure 6-1). Figure 6-1. The ALARMS Menu This menu has the following menu options associated with it: SET INDIVIDUAL.
Page 127 LOWER WINDOW. Selecting this menu option selects the percent value that is used in calculating the LOW Alarm Limits with the Calculate All Menu Option. The menu options are 5%, 10%, 15%, 20% (default), or 30%. The system uses the current value of the Parameter and brackets it with the percentages set by this menu option and the UPPER WINDOW Menu Option.
Page 128 Figure 6-2. GAS ALARMS (Anesthetic Agents Alarm Limit) Menu This menu has the following options associated with it: SET INDIVIDUAL. Selecting this menu option allows the operator to adjust individual Anesthetic Agent Alarm Limits. Once this menu option is selected, turning the Rotary Knob will allow the operator to scroll through the individual Agent Alarm Limits for manual modification.
Page 129: Parameter Alarms Status Screen
DEFAULT LIMITS. Selecting this menu option causes the system to automatically set the LOW and HIGH Alarm Limits for all parameters at once based on the System Defaults (See Default Limits in Appendix A Table 6-1 for a listing of the System Default Values). TYPE.
Page 130: Adjusting The Alarm Tone Volume
The numerics of the violated Parameter flash on the display and the audible alarm, once silenced, will not sound again until after the alarm condition has been corrected. Only a second (different) parameter alarm will cause the alarm sound to reactivate.
Page 131: Standby Mode
ALARM SILENCE. When the system goes into Alarm, pressing the ALARM SILENCE Control Key silences the Alarm Tone for the current alarm only. While the DCU is in the Silence mode, the letter “S” is displayed within the Alarm Status Symbol (Alarm “Bell”), the Alarm Bell flashes and the text “Alarm Silenced”...
Page 132: Specifications
BATTERY Type Lithium-Ion Operation Time Invivo Part Number 9093 or 9064: As indicated by battery status display. Maximum operation time of battery is approximately eight (8) hours when NIBP, ECG, and SpO2 parameters are running on 5-minute intervals, and anesthetic agents and EtCO2 are turned off.
Page 133 Storage Temperature Batteries (Invivo Part Numbers 9093 or 9064, and 9065): 0 to 40°C (32 to 104°F). Disposable Oxygen (O ) Cell (Invivo Part Number 9445): -40 to 45°C (-40 to 113°F). WPU, DCU, wireless modules, and additional accessories: -40 to +70°C (-40 to 158°F).
Page 134 RECORDER (Thermal Array Recorder) Chart Speeds 25 or 50 mm/second. Number of Channels Paper Type and Size Non-Grid Thermal Paper, 50 mm wide. Alphanumeric annotation of date, time delay, paper speed, scales, lead configuration, patient mode, NIBP (systolic, mean, diastolic), heart rate, respiration rate, Et, FiCO2, Agents Et, Agents Fi and SpO2.
Page 135 ECG CHANNEL ECG AMPLIFIER Protected against defibrillator and electrosurgery potentials. Standard Lead Configurations I, II, III, AVR, AVL, AVF. Lead Fail Active, sensing signal imbalance. HEART RATE Range 30 to 300 bpm. Accuracy ±0.5%, ±1 bpm Resolution 1 bpm. CARDIOTACH Sensitivity Adults: >...
Page 136 NON-INVASIVE BLOOD PRESSURE GENERAL Oscillometric method (with inflatable cuff). Determines systolic, diastolic and mean arterial pressures, and pulse rate. Patient Types Adult and Neonate. PNEUMATIC SYSTEM Cuff Inflation Pressure Initially mmHg Adult/Pediatric. (120 mmHg for Neonate). Subsequent inflation pressures determined by last measured systolic pressure.
Page 137 PULSE OXIMETER Pitch of pulse tone is modulated by saturation value. Saturation Range 0 to 100%. Saturation Accuracy 70 to 100% ±3% 0 to 69% unspecified. Pulse Range 30 to 240 bpm ±3 bpm. Pulse Accuracy ±3 counts. Averaging Smart algorithm utilizes 4 to 12 seconds data stream depending on signal to noise ratio.
Page 138 Functional SpO2 and SaO2 values were compared using Bland-Altman statistical analysis to demonstrate accuracy through the production of Arms, Bias and Precision values. Clinical validation for Invivo Model 9311 Wireless Pulse Oximeter Module with Invivo Model 9399B Reusable Sensor demonstrated on accuracy value of 1.91% Arms in the range 70-100% SaO2.
Page 139 INVASIVE PRESSURE CHANNELS (Optional) PRESSURE AMPLIFIER Range -10 to +248 mmHg. Sensitivity 5 uV/V/mmHg. Gain Accuracy ±0.5%. Bandwidth 0 to 12 Hz (-3 dB). AUTO ZERO Range +300 mmHg. Zero Accuracy ±1.0 mmHg. Response Time 1 second, notifies operator when done. PRESSURE WAVE DISPLAY Number of Channels 0, 1 or 2.
Page 140 ALARM LIMITS Heart Rate Low: 30 to 249 bpm High: 60 to 249 bpm Systolic, Mean, Diastolic Systolic, Mean, Diastolic: Low: -10 to 249 bpm High: -10 to 249 bpm INVASIVE PRESSURE CHANNELS. Continued... TRANSDUCER ADAPTER CABLE COMPATIBILITY Invasive pressure input mates with an Amphenol connector (MS-3106A 14S-6P). With this con- nector and the following connection information, transducer adapter cables may be made or ordered from various transducer adapter cable manufacturers.
Page 141 Low-Flow End-Tidal CO2 [Optional] Side stream, non-dispersive infrared absorption technique. Including multiple water trapped filtration system and microprocessor logic control of sample handling and calibration. Output CO2 Waveform, ETCO2, FiCO2, Respiration Rate. Units of measurement mmHg or KPa. Measurement Range CO2: 0 to 76 mmHg.
Page 142 MEASURED INTERFERING GASES AND EFFECTS No Effect (NE) = Total Error < 10%. Minimal Effect (ME) = Total Error > 10%, but within Specification. Interferes (INT) = Total Error > 15% of Measured Value + 0.2 of the Interfering Gas Value, or False Positive ID occurs. A-11...
Page 143 ANESTHETIC AGENTS (Optional) Technique Side Stream, non-dispersive infrared (NDIR) absorption technique, including water trap filtration system and microprocessor logic control of sample handling and calibration. Measurement Range (after Halothane: 0.15 to 6.0 Vol.%. maximum warm-up period) Isoflurane: 0.15 to 6.0 Vol.%. Sevoflurane: 0.15 to 9.0 Vol.%.
Page 144 ANESTHETIC AGENTS. Continued... Maximum Warm-up Time: 20 minutes Auto ID Threshold: (refer to 0.15 ±Accuracy Vol% for all gases. paragraph 3.5.4 for warm-up information) Multiple Agents Alarm The equivalent impurity of 0.3% volume or 30% of the primary Threshold: anesthetic agent gas (whichever is greater). NOTE Except for combinations of Isoflurane and Sevoflurane, where the concentration of Sevoflurane that shall trigger...
Page 145 ANESTHETIC AGENTS. ALARM LIMITS. Continued... ET Desflurane Low: Off, 0.1 to 20 High: 0.1 to 20, Off Fi Desflurane Low: Off, 0.1 to 20 High: 0.1 to 20, Off Low: 15 to 99 High: 15 to 99 OXYGEN Range 0 - 100%. Signal Output (at constant 14 ±±4 mV.
Page 146 < 2 Vol.% @ 50 Vol.% Diethyl Ether. Trichloroethylene No Known Effects. Nitric Oxide < 2 Vol.% @ 100 PPM Nitric Oxide. Temperature (Optional) TEMPERATURE For use with Invivo Fiber-Optic Temperature Sensors which utilize Fabry-Perot Interferometer Technology. Channel One. Scales Degrees C or Degrees F. Range 20.0 to 44.0°C (68.0 to 111.2°F).
Page 147 WECG/WSPO2 3.7V Battery Charger (Part Number 9023) POWER REQUIREMENTS Input Voltage (to AC adapter) Universal AC; 85 to 265VAC @ 47 to 63Hz. Input Power 40W without power factor correction. Grounding Connection Hospital Grade (with earth ground). Protection Over/under voltage, reverse voltage, under current. DC Connector 24 Vdc power pack.
Page 148: Repair
Invivo Technical Service at 1-800-331-3220 during normal business hours EST or 24-hour emergency technical assistance. Invivo Technical Service will advise you of the corrective action required. If you are advised to return the system to Invivo for repair, please do the following: Obtain a Return Authorization Number.
Page 149 To ensure full reliability, it is recommended that all repairs be made by an Invivo Authorized Service and Repair center. For repair at your facility, a competent individual experienced in the repair of the Precess MRI Patient Monitoring Systems can repair the system only if it is authorized by Invivo Technical Service prior to the repair.
Page 150: Warranty
APPENDIX C WARRANTY Invivo warrants this product, other than its expendable parts, to be free from defects in materials and workmanship for a period of twelve (12) months from the date of original delivery to the buyer or to buyer's order, provided that same is properly operated under conditions of normal use, and that periodic maintenance and service is performed.
Page 151: Declaration Of Conformity
APPENDIX D DECLARATION OF CONFORMITY For further information, contact the Regulatory Affairs Department of Invivo Corporation at telephone number 407-275-3220.
Page 152: List Of Symbols
APPENDIX E LIST OF SYMBOLS Attention, Consult Breathing Effort Accompanying Detected Documents Non-ionizing Not MRI Compatible Radiation Symbol Percent Oxygen ON (Main Power) Pulse Saturation OFF (Main Power) Earth (Ground) “ON” (For part of the Fuse equipment)
Page 153 “OFF” (For part of the Product Part Number equipment) DANGER! Alternating Current High Voltage Class II Equipment Antenna Device conforms to the Up/Increment Medical Device Directive I (Rotate Counter- clockwise to OPEN) Down/Decrement O (Rotate Clockwise to CLOSE) Product Serial Number Locked...
Page 154 Attention! Unlocked Precautionary Alert Latex-Free Materials Date of Manufacture Are Used Equipotential Direct Current Connection Defibrillator-Proof Type CF Equipment Weight (IEC 60601-1) Protection Against Shock Potential restrictions Dangerous may apply within one or more European (EU) Voltage member states.
Page 155 Type CF Applied Part Patient Single Patient Use Only Alarms ON DO NOT REUSE Replace Fuses As Alarms Silenced Marked Attention: Electrostatic Safety Heart Beat Detected Device Observe Precautions Battery Input/Output Non-Invasive Universal Serial Bus Blood Pressure (USB)
Page 156 Oxygen Sensor Keyboard Access Here On AC Power On Battery Power Remote Display Serial Communications Low Battery Port Fiber-Optic Danger Flammable Temperature Anesthetics End-Tidal CO2 / Danger Possible O2/Anesthetic Agents Explosion Hazard Warning Shock Pneumatic Respiration Hazard...
Page 157 Do Not Adjust Radio Network Without Referring (Wireless Modules) To Service Manual Hardwire Link Network No. 1 Waste Gas Output Network No. 2 End-Tidal CO2/ O2/Anesthetic Agents Network No. 3 Input Cardiac (ECG) Network No. 4 Gating Output MR Conditional Network No.
Page 158 Radio Network Wheel Brake (Precess™ WPU Base to DCU) Federal CE and R&TTE Communications Markings Commission Intertek Classified ETL Mark DO NOT Move Precess™ Inside 5,000 Gauss Line Intertek Recognized Component ETL Mark DO NOT Move Precess™ DCU DO NOT Place SPO2 Wireless Module With Recorder Inside 1,000 Gauss Line In Bore Dispose of in accordance...
Page 160: Emc
The use of accessories, transducers and cables other than those specified in the Accessories list of this Operation Manual (with the exception of transducers and cables sold by Invivo for the equipment or system as replacement parts for internal components) will result in increased emissions or decreased immunity of the equipment or system.
Page 161 Guidance And Manufacturer’s Declaration - Electromagnetic Immunity The Precess MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Precess MRI Patient Monitoring System should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Level...
Page 162 Guidance And Manufacturer’s Declaration - Electromagnetic Immunity The Precess MRI Patient Monitoring System is intended for use in the electromagnetic environment specified below. The customer or the user of the Precess MRI Patient Monitoring System should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance...
Page 163 Recommended Separation Distances Between Portable And Mobile RF Communications Equipment And The Precess MRI Patient Monitoring System The Precess MRI Patient Monitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Precess MRI Patient Monitoring System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Precess MRI Patient Monitoring System as recommended below, according to the maximum output power of...
Page 164: Notes
APPENDIX G NOTES...

Invivo Precess 3160 series Operation Manual

1 Introduction

2 Installation

3 Patient Parameters

4 Preparation for Use

5 Recording and Trending

6 Alarms

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