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Invivo 3160 Series Operation Manual

Mri physiological monitor
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  • Page 3 Invivo Corporation 3160 MRI PHYSIOLOGICAL MONITORING SYSTEM OPERATIONS MANUAL...

  • Page 5: Table Of Contents

    TABLE OF CONTENTS Paragraph Number Page Number List of Figures ............................iv List of Tables .............................. v Equipment Classification ........................v Precautions ..............................vi User Responsibility ..........................xiv 3160 MRI Physiological Monitor Accessories .................. xv INTRODUCTION ......................1-1 Product Description ......................
  • Page 6 TABLE OF CONTENTS Paragraph Number Page Number Non-Invasive Blood Pressure (NIBP) Monitoring ............4-5 4.2.1 Theory of Oscillometric Measurement ..............4-6 4.2.2 Patient and Cuff Preparation................4-7 4.2.3 Associated Displays ..................... 4-7 4.2.4 The NIBP Menu....................4-9 4.2.5 NIBP Menu Options ....................
  • Page 7 TABLE OF CONTENTS Paragraph Number Page Number Recording Charts ......................5-3 5.3.1 Strip Chart Record ....................5-4 5.3.2 Tabular Chart Record................... 5-4 5.3.3 Trend Chart ......................5-5 5.3.4 System Data Report ..................... 5-5 Loading Recorder Paper ....................5-5 Trending Feature......................5-5 5.5.1 HISTORY Menu Options ..................

  • Page 8: List Of Figures

    LIST OF FIGURES Figure Number Page Number Patient Connection Unit (PCU) ..................1-2 The Front Panel........................ 1-3 The Top Keypad Set ......................1-4 The Middle Keypad Set ....................1-5 The Bottom Keypad Set....................1-6 The Normal Screen ......................1-8 The Informational Display....................

  • Page 9: Equipment Classification

    LIST OF FIGURES Figure Number Page Number Sample Strip Chart......................5-4 Sample Tabular Chart ...................... 5-4 System Data Report ......................5-5 Loading the Recorder Paper .................... 5-5 The HISTORY Menu....................... 5-6 The MULTI TRENDS Menu................... 5-7 The Trend SELECT Menu....................5-7 Sample Multi Trends Printout..................

  • Page 10: Precautions

    Perform operational checkout before each use. If monitor fails to function properly, refer to qualified service personnel. For safe and accurate operation, use only recommended Invivo patient cable, lead wires, cuffs, hoses, sensors, tubing, etc. A listing of these can be found in the Accessory Listing within this manual, or by contacting Invivo directly.
  • Page 11 If monitor becomes accidentally wet during use, discontinue operation of the monitor until all affected components have been cleaned and permitted to dry completely. Contact your local Invivo representative if additional information is required. Shock hazard exists if operated without chassis cover. Refer servicing to qualified service personnel only.
  • Page 12 Precautions MRI Use Precautions (Continued) Always verify proper communicationof the 3160 MRI Physiological Monitoring System with the Remote Monitor prior to patient use. MRI Magnet Room Placement. The 3160 MRI Physiological Monitoring System is designed to be used in conjunction with a remote monitor. The 3160 MRI Physiological Monitoring System is specially designed not to interfere with MRI operations and may be used inside the MRI Magnet Room in any location at or outside the 5000 Gauss (0.5T) Field Line of the MRI System.
  • Page 13 Precautions An inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. For best ECG, Heart Rate, S-T Segment, and/or Respiration monitoring, always select the optimum lead configuration which has the least artifact and largest waveform(s) being detected for monitoring use.
  • Page 14 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 15 Inspect 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 may cause inaccurate readings and malfunctions.
  • Page 16 This product, or any of its parts, should 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 17 The following is a description of the format and meaning of Notes, Cautions and Warnings: Notes. Notes are presented as shown below. Notes contain supplemental information which Invivo has deemed especially important. NOTE This is a sample note.

  • Page 18: 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 19: 3160 Mri Physiological Monitor Accessories

    3160 MRI Physiological Monitor Accessories Item Description Part Number ® Quadtrode MRI ECG Electrodes, 50/box ..................9303N MRI ECG Patient Lead Wire Set......................9218 ECG/EEG Skin Prep Gel, 1 tube 4 ounce ....................9009 Non-Invasive Blood Pressure Reusable BP Cuffs and Hoses Twin-Lumen Adult Air Hose (18 ft. length) ..................9010M Single-Lumen Neonatal NIBP Air Hose (18 ft.

  • Page 21: Introduction

    (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo’s strong heritage in MRI patient vital signs monitoring, the 3160 provides accurate, continuous, and reliable performance during all phase of MRI applications.

  • Page 22: User Interface

    The 3160 MRI Physiological Monitoring System includes the following Vital Sign Parameters: • Single Lead ECG • Pulse Oximetry • NIBP • EtCO2 • Respiration • Anesthetic Agents 1.1.3 User Interface. A simple to use interface has been developed to minimize operator learning time.

  • Page 23: Ecg Monitoring

    1.3.2 ECG Monitoring. ECG is monitored using an ECG Telemetry Transmitter (WECG). The Wireless ECG Module consists of a wireless transceiver to communicate with the WPU and convert the ECG signals into radio signals for transmission to the Wireless Processor Unit. The module also receives information through the wireless link, converts the information to electrical signals and performs the commanded task (i.e.
  • Page 24 The Rotary Knob. The Rotary Knob is located to the right of the Display Screen. The function of the Rotary Knob is menu specific. For this reason, its various functions are described throughout this document where it is used; in general, however, the Rotary Knob operates as described below: As the Rotary Knob is rotated, either clockwise or counterclockwise, the monitor display “scrolls”...
  • Page 25 ALARMS SCREEN. The ALARMS SCREEN key is a dual function key that allows the operator to setup the Alarms monitoring feature. When the monitor display is in the Normal Screen and the ALARMS SCREEN key is pressed, the Main Alarm Setup Screen will appear; when the monitor display has any icon highlighted and the ALARMS SCREEN key is pressed, an Alarm Setup Screen for the highlighted parameter appears.
  • Page 26 CLEAR TRENDS. Pressing the CLEAR TRENDS key allows the operator to clear all the stored data from memory. To prevent accidental erasure of patient data, there is a Yes/No box associated with this key that appears to ensure that the operator meant to clear the trend data. RECORD.
  • Page 27 Alarm Silence Key. Pressing the ALARM SILENCE key, when the audible alarms are enabled (as denoted by the absence of the “X” through the bell shaped Alarm Status Symbol), will affect the monitor as described below: 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.

  • Page 28: Dcu Display

    The user is able to put alarms on hold (SOUND ON HOLD) only when the Alarm Tone is active (no X appears in the bell symbol in the upper left of the screen). Alarm Hold is useful for temporarily disabling the Alarm Tone. This might be useful, for example, when changing ECG leads or for any user activity which might cause a “false”...
  • Page 29 The letter “H” appearing in the bell indicates that the alarms have been placed on temporary Hold with the ALARM SILENCE key. Similarly, during power-up the “SOUND ON HOLD” message displayed in the center of the screen indicates that the Alarm Tone is temporarily placed on hold.
  • Page 30 TRACE A, C and D are assigned according to parameter and come on/go off as parameters are turned on or off. Trace B is the location used for the “Freezing” of a waveform and is not assigned a parameter. The following is a description of each Trace: TRACE A.
  • Page 31 The following is a description of the NIBP and Agents boxes. 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 32: Cleaning

    Front Panel Power Light. (See Figure 1-5) The Front Panel Power Light (located beneath the Rotary Knob) is a three color LED that indicates the AC/Battery Power condition of the monitor. The Power Light will illuminate Green, Yellow and Red as described below: Green Light.

  • Page 33: Installation

    Check all materials against the packing list and purchase request. Save all packing materials, invoice and bill of lading as these may be required to process a claim with the carrier if damage during shipment occurred. Contact Invivo Customer Service for prompt assistance in resolving shipping problems.

  • Page 35: Preparation For Use

    SECTION 3 PREPARATION FOR USE PREPARATION FOR USE. Introduction. This monitor 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 36 The following is a description of the operation of the DCU SETUPS Menu options: Recall Setups. To select this menu option, turn the Rotary Knob until the RECALL SETUPS option is highlighted, then press the Rotary Knob to select. Selecting this menu option will bring up the RECALL SETUPS submenu and allow the operator to Recall a previously stored Monitor Setup (See Figure 3-2).
  • Page 37 PRINT SETUPS. To select this menu option, turn the Rotary Knob until PRINT SETUPS is highlighted, then press the Rotary Knob to select. Selecting this menu option brings up the PRINT SETUPS Menu, which provides a selection of system setups to print. RETURN.
  • Page 38 PRINT SETUPS. Selecting this menu option brings up the PRINT SETUPS Menu which provides a selection of system setups to print. RETURN. Selecting this menu option returns the monitor to the Normal Screen. Parameter Selection. To select this menu option, turn the Rotary Knob until the PARAMETER SELECTION option is highlighted, then press the Rotary Knob to select.
  • Page 39 RESP. This option is not available on the 3160 MRI Physiological Monitoring System. TEMP. This option is not available on the 3160 MRI Physiological Monitoring System. AUX. This option is not available on the 3160 MRI Physiological Monitoring System. AGENTS. (If option is installed) Selecting this menu option switches the Anesthetic Agent Option ON and OFF (default).
  • Page 40 HR TONE SRCE. Selecting this menu option will select the heart rate tone source. The options are OFF (default), QRS and SPO2. When source is QRS, the tone sounds at the detection of QRS from the ECG parameter. When source is SpO2, the tone sounds at the detection of the pulse from the Pulse Oximeter parameter.
  • Page 41 Figure 3-6. The SET TIME Menu The following is a description of the operation of the SET TIME Menu options: NOTE No new window is provided for the following selections. The setting to be adjusted becomes highlighted within the existing menu. FORMAT.
  • Page 42 Respiration Speed. Selecting this menu option will bring up the RESP SPEED Menu. The RESP SPEED Menu allows the operator to set the Respiration Speed at the following predetermined levels: 25 mm/s, 12.5 mm/s, 6.25 mm/s, 3.125 mm/s, 1.5625 mm/s and 0.33333 mm/s. Figure 3-7.
  • Page 43 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 inforation 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 44 • P1: This option is not available on the 3160 MRI Physiological Monitoring System. • P2: This option is not available on the 3160 MRI Physiological Monitoring System. • P3: This option is not available on the 3160 MRI Physiological Monitoring System. •...
  • Page 45 RETURN. Selecting this menu option returns the monitor to the SETUPS Menu. (12) Return. Selecting this menu option returns the monitor to the Normal Screen. Figure 3-10. WPU SETUPS Menu WPU Setups Menu. While in the WPU SETUPS Menu, the available parameters may be turned off and on, the monitor sounds may be adjusted, the patient mode may be switched between adult and neonate, and the date and time may be adjusted.
  • Page 46 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 47 Figure 3-12. The SOUND ADJUST Menu The following is a description of this menu's options: ALARMS. Selecting this menu option will turn the alarm sound ON and OFF. When turned off, an “X” appears in the bell symbol on the screen, and on the one in the menu option area, indicating that the alarm sound has been disabled.
  • Page 48 Patient. Selecting this menu option determines the Adult (default) or the Neonatal Mode for the operation of the ECG and NIBP parameters. ADULT. The initial NIBP inflation pressure is 170 mmHg. The maximum inflation pressure is 285 mmHg. Also, the adult NIBP pre-amplifier and the adult NIBP algorithm are used.
  • Page 49 Pressing ENTER after the new time and date are completely set puts the newly set time and date into effect. Otherwise, the old time is restored upon exiting the SET TIME Menu. RETURN. Selecting this menu options returns the monitor to the Normal Screen.
  • Page 50 WARNING The Simulation Mode will display real looking waveforms which are computer generated. The monitor will not monitor patients while in the Simulation Mode. Do not activate the Simulation Mode when this monitor is connected to a patient. To exit the Simulation Mode, the monitor must be powered Off.
  • Page 51 • PRINT OSC DATA. This option is for future service enhancement. • RETURN. Selecting this menu option returns the monitor to the Normal Screen. GAS CAL. Selecting this menu option will bring up the GAS CAL Menu (See Figure 3-16). Figure 3-16.
  • Page 52 • It is important to note that if the Escape option is selected, the monitor will return control of the monitor to the operator but the Calibration Screen will remain on the display; to remove the Calibration Screen turn the monitor off. Figure 3-17.
  • Page 53 Figure 3-19. System Configuration Menu SYSTEM CONFIG. The SYSTEM CONFIG Menu (See Figure 3- 19) 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 54: Store/Recall Setups

    • CO: This option is for future service enhancement. • RECORDER: Selecting this menu option will enable/ disable the RECORDER module. • CS COMM: Selecting this menu option will enable/disable CS COMM. • PARALLEL PORT: Selecting this menu option will enable/disable the Parallel/Printer Port.

  • Page 55: Monitor Initialization

    ECG. Selected lead, scale setting, trace speed, filter mode, QRS tone ON/OFF and heart rate source. RECORDER. Off or auto, trace delay, recorder speed and the selected traces. NIBP. Manual, off or auto and the automatic time interval. EtCO2. Size, grids and flow. TREND GRAPHS.

  • Page 57: Patient Parameters

    4.1.1 Patient and Lead Preparation. Acquisition of the patient's ECG signal is achieved with a Invivo approved patient cable with the appropriate lead wires and electrodes. Patient skin preparation, type of electrode used, and technique used to apply electrodes are major factors that can affect the quality of tracing displayed on the monitor.

  • Page 58: Associated Waveforms And Displays

    4.1.2 Associated Waveforms and Displays. (See Figure 4-1) 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. ECG Lead.
  • Page 59 Figure 4-3. The ECG SCALE Sub-Menu SCALE. Selecting this menu option allows the selection of the scale for the ECG waveform(s). The options are AUTO, 1, 5, 10, 15 (default), 20, 25, 30, and 40 mm/mv (See Figure 4-3). The selected scale appears on the right hand side of this menu option. If AUTO is selected, a scale is picked that would make the current waveform(s) fill the ECG viewing area.
  • Page 60 Figure 4-4. The ECG HR SOURCE Sub-Menu The heart rate is displayed in the ECG parameter box. It is annotated with its source (e.g., “60 ECG” indicates a heart rate of 60, derived from ECG). If AUTO is chosen, the heart rate is selected automatically from the highest-priority active input.

  • Page 61: Alarm Limits

    OFF. Selecting this menu option turns the Calibration feature OFF. RECORDER. Selecting this menu option sends a 1mV pulse calibration waveform to the ECG Vital Sign and will also be the ECG waveform printed by the recorder if so configured. The message CAL is displayed over the ECG waveform on the screen.

  • Page 62: Theory Of Oscillometric Measurement

    If a measurement is in progress and communication is lost between the DCU and WPU, the measurement is aborted. 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: •...

  • Page 63: Patient And Cuff Preparation

    4.2.2 Patient and Cuff Preparation. The patient should remain calm and motionless while the monitor is being used. If the patient is overactive, prolonged or inaccurate readings may result. Perform the following to prepare the patient and cuff for monitoring: Cuff Selection.

  • Page 64: The Nibp Menu

    Diastolic Numeric. (Item 5) A numeric indication of the patients NIBP Diastolic reading. Diastolic Alarm Limits. (Item 6) A numeric indication of the settings of the High (to the left in the example) and Low (right in the example) Diastolic Alarm Limits.

  • Page 65: Nibp Menu Options

    4.2.4 The NIBP Menu. Selecting the NIBP Menu-Select Icon will bring up the NIBP Menu (See Figure 4-7). This menu provides the operator with the ability to switch the Automatic Mode On and OFF, set the automatic reading interval, set the Heart Rate source and bring up a Tabular Chart containing a History of the NIBP and SpO2 determinations.

  • Page 66: The History Menu

    NOTE Invasive Pressure is not available with this system. If ART is selected as the HR SOURCE a Warning box appears that informs the operator that this option is not available. HR SOURCE. Selecting this menu option allows the selection of the source to be used for the heart-rate display in the ECG area.

  • Page 67: Using The Automatic Interval Mode

    4.2.6 Using the Automatic Interval Mode This monitor may be setup to take NIBP readings automatically at intervals set by the operator. To set this monitor 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 68: Nibp Messages

    4.2.12 NIBP Messages. The following is a list of messages that may be displayed during NIBP monitoring: CALIB Displayed if the monitor detects an out of range DC Offset. CHANGE NIBP CUFF Displayed for 30 seconds whenever the Patient Mode is switched between Adult and Neonate.

  • Page 69: Associated Waveforms And Displays

    SEARCHING. The monitor is searching for a good pulse. Give the monitor time to lock onto a good pulse. 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. Figure 4-10. SpO2 Display 4.3.2 Associated Waveforms and Displays...

  • Page 70: Alarm Limits

    BAD PROBE The monitor has sensed a shorted or open connector in the sensor. Contact Invivo Technical Service for further assistance. HIGH LIGHT There is too much light passing through the tissue at the present sensor site. Move the sensor to an area with thicker tissue.

  • Page 71: End-Tidal Co2 (Etco2) Monitoring

    Try a different sensor. Hardware Failure The monitor has detected a hardware failure. Remove the system from service immediately and refer it to Invivo qualifed service personnel for repair. This monitor should not, for any patient that requires accurate SpO2 measurement, ever be placed back into service before the repair is performed.
  • Page 72 The patient sampling circuit (See Figure 4-13) consists of the sampling line and either a sampling nasal cannula or a side stream adaptor connected to an endotracheal connector. All fittings in the circuit are Luer-Lock type. All fittings should be fitted together securely to keep them from separating during the procedure, and to ensure proper sampling without the introduction of outside air.

  • Page 73: Water Trap Replacement

    Trace Location D and as numeric data in Box 4. The following is a description of the items contained within the EtCO2 Display: For best fit and compatibility, Invivo strongly recommends the use of the Invivo CO2 Sampling Kit (Part No. 9010D), which contains all the above tubings and endotracheal tube adaptor.

  • Page 74: Etco2 Menu

    Unit of Measurement. (Item 7) Displays the Unit of Measurement being used for presentation of the EtCO2 derived Respiration numeric data. Respiration Alarm Limits. (Item 8) A numeric indication of the settings of the High (on top in the example) and Low (bottom in the example) Respiration Alarm Limits when derived from the EtCO2 module.

  • Page 75: Alarm Limits

    After the readings stabilize, the EtCO2 system begins it’s normal functioning routine. Automatic Zero Calibration Cycles. An automatic Zero Calibration cycle is triggered when certain time intervals have passed since the monitor has completed its warm-up cycle. The timetable for automatic Zero Calibration cycles is the following: 2, 4, 6, 8, 10, 20, 40 and 60 minutes.

  • Page 76: Anesthetic Agent/Oxygen Monitoring

    Anesthetic Agent/Oxygen Monitoring. (Optional) The Anesthesia Gas Sensor (AGS) is a non-dispersive, single path 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.

  • Page 77: Associated Displays

    4.5.2 Associated Displays. (See Figure 4-17) Anesthetic Agent information is only displayed as numeric data. Agent data can be displayed in Boxes 7 through 10. The Agent identification and measurement are individually performed on both inspired and expired gases. With any two mixtures involving gases Sevoflurane and Isoflurane, the inspired primary anesthetic agent (the gas with the highest concentration) is displayed with its ID and concentration in the Fi location of the Agent Icon box.
  • Page 78 Table 4-1. Agent Display During Mixed Agent Conditions Physical Gas Sevoflurane, Isoflurane or any mixture of two Agent Display Display where the gas with the highest concentration is MULTIPLE considered primary. AGENTS Fi ID Et ID Message Inspired Expired % Inspired %Expired (Fi) (Et)

  • Page 79: Agent Menu

    Sevoflurane 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 80: Alarm Limits

    On the WPU only, if the Agents option is run over a continuous 12 hour period with an O2 concentration of 22% or greater there is a Warning Box that will appear to alert the operator that a one (1) minute O2 Calibration sequence must be run. The Warning Box will offer the operator a Yes/No option of running the one (1) minute O2 Calibration sequence, if the operator selects NO, the message will reappear in 30 minutes.

  • Page 81: Oxygen Monitoring

    Zeroing Port, is 20.9% (during calibration, the patient GAS Input Port must not be connected to an oxygen source). 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.

  • Page 83: Recording And Trending

    SECTION 5 RECORDING AND TRENDING RECORDING AND TRENDING. Introduction. The 3160 MRI Physiological 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. The Recorder option provides the following features: •...
  • Page 84 Figure 5-1. The RECORDER Menu TRACE DELAY. Selecting this menu option allows the selection of the time delay for the trace data being sent to the recorder. The options are 0, 4 (default), 8 and 16 seconds. PRINT DATA REPORT. Selecting this menu option activates the recorder to print a patient data report (in tabular form) of up to 60 stored patient parameter readings stored in the time interval preselected by the DATA INTERVAL menu option in this menu.

  • Page 85: The Recorder Menu

    AUTO. If AUTO is selected, violation of an alarm limit for HR, NIBP, EtCO2 and SpO2 automatically activates the recorder trace and writes ECG Trace A. In addition to ECG Trace A, a second trace will be written below it when the parameter is in a trace location.

  • Page 86: Strip Chart Record

    Figure 5-2. Sample Strip Chart 5.3.1 Strip Chart Record. (See Figure 5-2) The Strip Chart may be configured to contain one or two parameter waveforms and also contains the numerical value of every active parameter as well as a “Parameter Snapshot” of the current values of every active parameter at the end of the printout strip. Setting Up the Strip Chart.

  • Page 87: Trend Chart

    5.3.3 Trend Chart. Trend Charts may be printed for every parameter being monitored. To print an individual trend chart, first highlight the icon of the parameter to be printed then press the Trends Menu-Select key and select the RECORD menu option. Figure 5-4.
  • Page 88 Figure 5-6. The HISTORY Menu 5.5.1 HISTORY Menu Options. The HISTORY Screen is a Tabular Listing of a patient's NIBP determinations. The menu provides the option to move from page to page and to print all or part of the History File.

  • Page 89: Alarms

    SECTION 6 ALARMS ALARMS. Introduction. The 3160 MRI Physiological Monitoring System permits user access to every parameter alarm with a single select key. Alarm Limits may be turned on, adjusted (manually or automatically) or turned off in the ALARMS Menu. Individual parameter alarms may also be turned on and/or adjusted by highlighting the parameter icon and pressing the ALARMS SCREEN Menu- Select key.
  • Page 90 This menu has the following menu options associated with it: SET INDIVIDUAL. Selecting this menu option allows the operator to adjust individual Alarm Limits. Once this menu option is selected, turning the knob will allow the operator to scroll through the individual HIGH and LOW Alarm Limits for manual modification.

  • Page 91: Gas Alarms (Anesthetic Agents Alarm Limit) Menu

    TYPE. Selecting this menu option will select whether the audio and visual alarms are latched or unlatched (see definitions below). UNLATCHED. The Alarm Tone stops if the violated parameter returns to within its limits, or the ALARM SILENCE key is pressed. LATCHED.

  • Page 92: Parameter Alarms Status Screen

    LOWER WINDOW. Selecting this menu option selects the percent value that is used in calculating the LOW Alarm Limits with the CALCULATE AGENT/O2 menu option. The menu options are 5%, 10%, 15%, 20% (default), or 30%. The monitor 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 93: Adjusting The Alarm Tone Volume

    The numerics stop flashing after the parameter returns to within its Alarm Limits. If the alarm system has been set to LATCHED, the numeric continues to flash after the parameter returns to within its Alarm Limits, until the ALARM SILENCE control key is pressed.

  • Page 94: Standby Mode

    ALARM SILENCE. When the monitor goes into Alarm, pressing the ALARM SILENCE control key silences the Alarm Tone for the current alarm only. While the monitor 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 95 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 96 Table 6-2. Range of Alarm Limits Input Adult Neonate Unit High High Heart Rate Off, 30 to 249 60 to 249, Off Off, 30 to 249 60 to 249, Off NIBP Off, 5 to 249 5 to 249, Off Off, 5 to 249 5 to 249, Off mmHg Off, 0.7 to 33.2...

  • Page 97: Battery Operation

    SECTION 7 BATTERY OPERATION BATTERY OPERATION. Introduction. The system components are equipped with Lithium Ion Batteries which provide battery power for at least eight (8) hours. Battery Location and Access. The WPU has two batteries that are located on the front of the unit;...

  • Page 99: Specifications

    APPENDIX A SPECIFICATIONS GENERAL PATIENT SAFETY Designed to meet the requirements of CSA 22.2 and UL 2601. Defibrillator protection up to 5 KV. POWER REQUIREMENTS Operating Voltages 86 to 265 VAC Frequency 47 to 65 Hz. Power Consumption, Maximum < 100 Watts. BATTERY Type Lithium Ion...
  • Page 100 RECORDER (Thermal Array Recorder) Chart Speeds 25 or 50 mm/second. 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 101 ECG CHANNEL ECG AMPLIFIER Protected against defibrillator and electrosurgery potentials. Standard Lead Configurations Lead Fail Active, sensing signal imbalance. HEART RATE Range 30 to 300 bpm. Accuracy ±0.5%, ±1 bpm Resolution 1 bpm. CARDIOTACH Sensitivity Adults: >200 uV minimum. Neonates: >100 uV minimum. Pacemaker Pulse Rejection Meets requirements of AAMI EC13-1983 standard for cardiac monitors (Pacer Reject...
  • Page 102 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 170 mmHg for Adult/Pediatric. (120 mmHg for Neonate). Subsequent inflation pressures determined by last measured systolic pressure.
  • Page 103 END-TIDAL CO2 (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 maximum warm- CO2: 0 to 76 mmHg. up period) N2O: 5 to 100 %. Accuracy (after 15 minute warm-up and CO2: ±3mmHg or 12% (whichever is greater).
  • Page 104 PULSE OXIMETER Pitch of pulse tone is modulated by saturation value. Saturation Range With Invivo Sensors: 1 to 100%. Saturation Accuracy ±3 digits at 70 to 100%. Pulse Range 20 to 300 bpm. Pulse Accuracy ±3 counts. ALARM LIMITS SpO2 Alarm Limits Minimum: 50 to 99 or Off.
  • Page 105 Anesthetic Agents (Optional) Technique Side Stream, non-dispersive infrared (NDIR) absorption technique. Measurement Range (after Halothane: 0.15 to 6.0 Vol. %. maximum warm-up Isoflurane: 0.15 to 6.0 Vol. %. period) Sevoflurane: 0.15 to 9.0 Vol. %. Carbon Dioxide: 0 to 76 mmHg. Nitrous Oxide: 5 to 100 Vol.
  • Page 106 Oxygen Monitoring Range 0 - 100 %. Signal Output (at constant temperature and 14 ± 4 mV. pressure) Maximum Response Time (10 to 90%) 10 Seconds. Accuracy, Full Scale ± 3 %. NOTE Gas measurement performance requirements are met after the maximum warm-up period. Accuracy, Full Scale, Over Operating Temperature ±...
  • Page 107 SYSTEM DEFAULTS MISCELLANEOUS Adult Neonate Heart Rate Source Patient Adult/Pediatric Pacer Pulse Reject Reject Trace Speed 25 mm/second 25 mm/second Pulse Tone Source Sound Volume Levels Alarm Tone: 4 Alarm Tone: 4 Heart Rate Tone: 4 Heart Rate Tone: 4 Key Click: 4 Key Click: 4 ECG 1...
  • Page 108 SYSTEM DEFAULTS ALARM LIMITS Adult Neonatal High High Heart Rate 45 bpm 160 bpm 90 bpm 210 bpm NIBP Systolic 65 mmHg 190 mmHg 70 mmHg 100 mmHg NIBP Mean 55 mmHg 135 mmHg 40 mmHg 90 mmHg NIBP Diastolic 40 mmHg 125 mmHg 35 mmHg 50 mmHg...
  • Page 109 SYSTEM DEFAULTS ALARM MODES Mode Unlatched Window Size RECORDER Trace 1 Assignment ECG1 Trace 2 Assignment Trace Time Delay 4 Seconds Data Acquisition Interval 4 Minutes GRIDS EtCO2 SCREEN TRACE CHARACTERISTICS Mode Fixed with moving erase bar A-11...

  • Page 111: Repair

    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 monitors can repair the monitor if it is authorized by Invivo Technical Service prior to the repair.

  • Page 113: 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 115: 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 117: Kpa To Mmhg Conversion Chart

    APPENDIX E kPa to mmHg Conversion Chart mmHg mmHg mmHg mmHg mmHg mmHg 23.3 45.8 68.3 12.1 90.8 15.1 113.3 24.0 46.5 69.0 12.2 91.5 15.2 114.0 24.8 47.3 69.8 12.3 92.3 15.3 114.8 25.5 48.0 70.5 12.4 93.0 15.4 115.5 26.3 48.8...
  • Page 118 mmHg mmHg mmHg mmHg mmHg mmHg 18.1 135.8 21.1 158.3 24.1 180.8 27.1 203.3 30.1 225.8 33.1 248.3 18.2 136.5 21.2 159.0 24.2 181.5 27.2 204.0 30.2 226.5 33.2 249.0 18.3 137.3 21.3 159.8 24.3 182.3 27.3 204.8 30.3 227.3 33.3 249.8 18.4...

  • Page 119: List Of Symbols

    APPENDIX F LIST OF SYMBOLS...
  • Page 121 NOTES...

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