Invivo Corporation 3160 MRI PHYSIOLOGICAL MONITORING SYSTEM OPERATIONS MANUAL
TABLE OF CONTENTS Paragraph Number Page Number List of Figures ........................................................................................................................................... iv List of Tables .............................................................................................................................................. v Equipment Classification ........................................................................................................................
TABLE OF CONTENTS Paragraph Number Page Number 4.2 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 .............................................................................................
TABLE OF CONTENTS Paragraph Number Page Number 5.3 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 .................................................................
LIST OF FIGURES Figure Number Page Number 1-1 Patient Connection Unit (PCU) ....................................................................................... 1-2 1-2 The Front Panel................................................................................................................ 1-3 1-3 The Top Keypad Set ........................................................................................................ 1-4 1-4 The Middle Keypad Set ..................................................
LIST OF FIGURES Figure Number Page Number 5-2 Sample Strip Chart........................................................................................................... 5-4 5-3 Sample Tabular Chart ...................................................................................................... 5-4 5-4 System Data Report ......................................................................................................... 5-5 5-5 Loading the Recorder Paper ........................................
Precautions General Federal law in the USA or Canada restricts this device to sale by, or on, the order of a physician. The accuracy of the measurements can be affected by the position of the patient, the patient’s physiological condition, and other factors. Always consult a physician for interpretation of measurements made by this monitor. To avoid monitor fall, secure monitor on the shelf or bracket prior to use. An explosion hazard exists if this monitor is used in the presence of flammable anesthetics.
Precautions Electrical Safety To avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it with liquid cleaning agents. Always disconnect monitor from AC Main Power before performing cleaning or maintenance. 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.
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.
Precautions ECG 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. 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.
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 may not be correct.
Precautions End-Tidal CO2 (Continued) 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 overtighten the patient gas sample line to the water trap connector.
Precautions Anesthetic Agents (Continued) 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.
Precautions Other (Continued) Notes, Cautions and Warnings. In the body of the manual notes, cautions and warnings are as shown below to make them stand out on the page. The following is a description of the format and meaning of Notes, Cautions and Warnings: a. Notes. Notes are presented as shown below. Notes contain supplemental information which Invivo has deemed especially important. NOTE This is a sample note. b. Cautions. Cautions are presented as shown below.
USER RESPONSIBILITY This product will perform in conformity with the description contained in this operators manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked and calibrated periodically. A malfunctioning product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately.
3160 MRI Physiological Monitor Accessories ECG 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 ............................................................................................
SECTION 1 INTRODUCTION 1.0 INTRODUCTION. This manual describes a fully configured monitor, and may include features and/or options that are not included in your monitor. For additional information, contact your local sales representative, or Invivo Customer Service. 1.1 Product Description. The Model 3160 MRI Physiological Monitoring System is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment.
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.
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. lead configuration change, scaling, etc.). a. Compatability.
a. b. The Rotary Knob. The Rotary Knob is located to the right of the Display Screen. The function of the Rotary Knob is menu specific.
(5) (6) c. 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. RECORDER SETUP. The RECORDER SETUP key allows the operator to setup the Recorder option.
(5) (6) d. 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. Pressing this key records the Single Trace or Dual Trace selections (as specified by operator adjustments made in the RECORDER Menu).
(3) 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. (a) Alarm Silenced.
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” alarm. 1.4.2 DCU Display.
(a) (3) (4) (5) (6) b. 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. A 180 second countdown timer is also displayed under the message.
(3) (4) (5) (6) (7) c. 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. 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.
The following is a description of the NIBP and Agents boxes. (1) 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). While in the Manual mode, MANUAL is shown in the place of the time until the next measurement.
e. 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: (1) Green Light. A Green Light indicates that the monitor is connected to AC Line Power and that the internal battery circuitry is operational. In normal operation, this light will be illuminated Green. (2) Yellow Light.
SECTION 2 INSTALLATION 2.0 INSTALLATION 2.1 Introduction. 2.2 Monitor Installation. Remove the monitor from the shipping carton and examine for any damage which may have occurred during shipment. 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. 2.2.
SECTION 3 PREPARATION FOR USE 3.0 PREPARATION FOR USE. 3.1 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. NOTE If a particular parameter is not installed, it can not be set to ON.
The following is a description of the operation of the DCU SETUPS Menu options: (1) 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). This menu has a time-out feature.
(h) (2) 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. (i) RETURN. Selecting this menu option returns the monitor to the Normal Screen. Store Setups. To select this menu option, turn the Rotary Knob until the STORE SETUPS option is highlighted, then press the Rotary Knob to select.
(h) (3) PRINT SETUPS. Selecting this menu option brings up the PRINT SETUPS Menu which provides a selection of system setups to print. (i) 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. Selecting this menu option will bring up the PARAMETERS SELECTION Menu (See Figure 3-4). Figure 3-4.
(i) (4) RESP. This option is not available on the 3160 MRI Physiological Monitoring System. (j) TEMP. This option is not available on the 3160 MRI Physiological Monitoring System. (k) AUX. This option is not available on the 3160 MRI Physiological Monitoring System. (l) AGENTS. (If option is installed) Selecting this menu option switches the Anesthetic Agent Option ON and OFF (default). (m) RETURN. Selecting this menu option returns the monitor to the Normal Screen. Sound Adjust.
(b) (c) 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. The pulse tone is modulated by the SpO2 value. The lower the SpO2 value the lower the pitch of the pulse tone will be.
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. (a) (7) (8) FORMAT. Selecting this menu option switches the format of the time display between 12 hour and 24 hour. (b) SECOND. Selecting this menu option allows scrolling through seconds. (c) MINUTE. Selecting this menu option allows scrolling through minutes.
(9) 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. NETWORK Menu (10) Network. Selecting this menu option brings up the NETWORK Menu. The NETWORK Menu (See Figure 3-7) allow the operator to set the network designation of the monitor.
The following is a description of the options available in the SERVICE (BIO-MED) Menu: (a) 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. To exit this window, the operator either selects the OK button on the window or the NORMAL SCREEN key on the monitor front panel.
• • • • • • • • • • • • • • • • • • • • • 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. P4: This option is not available on the 3160 MRI Physiological Monitoring System. SPO2: Selecting this menu option will enable/disable the SpO2 module.
(d) (12) b. RETURN. Selecting this menu option returns the monitor to the SETUPS Menu. 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.
The following is a description of the PARAMETERS SELECTION Menu options: (a) 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. (b) NIBP. Selecting this menu option switches the NIBP ON (default) and OFF. (c) P1. This option is not available on the 3160 MRI Physiological Monitoring System. (d) P2.
Figure 3-12. The SOUND ADJUST Menu The following is a description of this menu's options: (a) 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. This menu option is identical to, and interactive with, the SOUND menu option in the ALARMS Menu. (b) HR TONE SRCE. Selecting this menu option will select the heart rate tone source.
(3) (4) Patient. Selecting this menu option determines the Adult (default) or the Neonatal Mode for the operation of the ECG and NIBP parameters. (a) 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. ECG Heart Rate detection sensitivity is 200 µV minimum. (b) NEONATE. The initial inflation pressure is 120 mmHg. The maximum inflation pressure is 150 mmHg.
(5) (6) 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. (i) RETURN. Selecting this menu options returns the monitor to the Normal Screen. Sweep Speed. Selecting this menu option will bring up the SWEEP SPEED Menu. The SWEEP SPEED Menu allows the operator to switch the recorder and the screen trace speed between 25 and 50 mm/second.
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. (b) (c) SIMULATION MODE. This menu option allows the operator to turn the Simulation Mode ON.
• (d) 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. GAS CAL Menu (e) The following menu options are provided in this menu: • ZERO CAL. Selecting this menu option will cause the monitor to perform a Zero Cal of the Agent System. • SPAN CAL.
• 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. Monitor Calibration YES/NO Menu Figure 3-18.
Figure 3-19. System Configuration Menu (f) SYSTEM CONFIG. The SYSTEM CONFIG Menu (See Figure 319) 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. The Language and Pressure Unit options are the only options in this menu which do not require that the service code be entered.
• • 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. • ANALOG OUTPUT: Selecting this menu option will enable/disable the Analog Output Port. • NETWORK: Selecting this menu option provides a method of connecting to a specific network.
c. ECG. Selected lead, scale setting, trace speed, filter mode, QRS tone ON/OFF and heart rate source. d. RECORDER. Off or auto, trace delay, recorder speed and the selected traces. e. NIBP. Manual, off or auto and the automatic time interval. f. EtCO2. Size, grids and flow. g. TREND GRAPHS. Time bases and scales. h. SpO2. Size. Once the monitor is setup properly, the setups may be stored in one of the available memory blocks. The stored setups can be brought up via the RECALL SETUPS Menu. 3.
SECTION 4 PATIENT PARAMETERS 4.0 PATIENT PARAMETERS. 4.1 ECG Monitoring. Unless it has been turned off in the ECG Menu, the selected ECG lead is displayed as TRACE A. Most ECG functions are contained in the ECG Menu. Additional features useful with ECG monitoring are found in three secondary menus: • RECORDER Menu. Used to select all recorder functions and to set the recorder and trace speed. • ALARMS Menu. Used to set and/or disable the ECG alarms.
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. a. ECG Lead. (Item 1) Displays the ECG Lead selected for use. b. Scale Indicator. (Item 2) This indicator is provided for a reference and represents a 1 millivolt signal amplitude. c. Message Areas.
Figure 4-3. The ECG SCALE Sub-Menu c. 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. This scale will be in effect until another scale is selected (AUTO or any other selection).
Figure 4-4. The ECG HR SOURCE Sub-Menu (1) e. f. g. 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). (2) If AUTO is chosen, the heart rate is selected automatically from the highest-priority active input. When set to AUTO the 3160 Vital Signs Monitoring System searches for another source for rate only when LEAD FAIL occurs or the ECG parameter is turned OFF.
(1) (2) h. 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. (3) ECG. Selecting this menu option sends a 2mV peak to peak (1mV peak) calibration signal to the ECG vital sign and will also be the ECG waveform printed by the recorder if so configured.
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: • RECORDER Menu. Used to select recorder functions and to set the recorder trace speed. • ALARMS Menu. Used to set and/or disable the NIBP alarms. The range of Alarm Limits for the NIBP is 5 to 249 mmHg.
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: a. Cuff Selection. The cuff is selected and positioned as it would be for an auscultatory blood pressure determination, and the current guidelines of the American Heart Association should be followed.
(5) (6) (7) (8) (9) b. 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. Systolic Alarm Limits. (Item 7) A numeric indication of the settings of the High (to the left in the example) and Low (right in the example) Systolic Alarm Limits. Unit of Measurement.
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. This menu has a time-out feature. If no action is taken for approximately 60 seconds, the monitor will automatically return to the Normal Screen. 4.2.5 NIBP Menu Options.
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. c. HR SOURCE. Selecting this menu option allows the selection of the source to be used for the heart-rate display in the ECG area. The options are AUTO, ECG (default), ART (arterial pressure), SPO2 and NIBP. This menu option is identical to, and interactive with, similarly named menu options under ECG and SPO2. Figure 4-9.
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. To set the Interval Time, highlight the INTERVAL menu selection and press the Rotary Knob to access the time selection menu.
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. CUFF LEAK Displayed if the monitor detects a leak in the cuff during the last reading attempt.
b. c. d. e. PROBE OFF. The sensor is not sensing or detecting the patient's pulse. There are two possible causes of this, either the sensor is not detecting the pulse or the sensor is receiving too much light to operate. Check the ambient lighting, if a light is shining directly into the sensor, reposition the sensor to a darker area or cover the sensor to cut down the light entering the sensor. Check the sensor cable connection for proper connection. Try a different sensor. HIGH LIGHT.
The following is a description of the SPO2 Menu options: a. SIZE. (See Figure 4-12) Selecting this menu option provides the operator with the ability to change the size of the SpO2 pulse waveform. The options are 10%, 20%, 40% (default), 60%, 80% and 100%. Figure 4-12. The SpO2 SIZE 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. b. c. d. HR SOURCE.
LOW LIGHT The transmission of the light is partially blocked. The tissue at the site may be too opaque and/or thick. If the sensor is positioned on the finger, check the fingernails for nail polish, long fingernails and artificial fingernails; remove fingernail polish completely, for artificial nails: use a Multi-Site sensor at another location, and, for long fingernails: either trim the nails or use a Multi-site sensor at another location.
a. b. c. 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. Loose fitting will result in Gas measurement errors. Nasal Cannula.
CAUTION Do not allow the tubing to become kinked so that the sample flow is reduced or cut off. Be careful that the tubing remains clear of any table moving mechanisms which may kink or cut the tubing. Always discard the Water Trap when it becomes filled. Do not attempt to clean or reuse the Water Trap. Accidental water ingress into the monitor can affect the Gas measurements. Always inspect patient tubing after attachment to the monitor following the patient circuit’s manufacturer’s recommendations. 4.4.
g. h. i. j. 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. Respiration Numeric. (Item 9) A numeric indication of the patient's Respiration reading derived from the EtCO2 module. N2O Numeric.
(5) b. c. 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. After the first hour since warm-up, the monitor will perform a Zero Calibration cycle every hour.
ETCO2: HW FAIL The EtCO2 has failed, contact a Qualified Service Representative. ETCO2 WARMING UP The EtCO2 is warming up in preparation for use. The warmup cycle is approximately two (2) minutes. NO CO2 CAL: STILL WARMING CO2 Calibration cannot initialize because the EtCO2 system has not completed warming up. (For non-Agent EtCO2 only) READJUSTING CO2 ZERO The EtCO2 module is performing its automatic Zero Adjustment Routine. 4.5 Anesthetic Agent/Oxygen Monitoring.
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.
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.
Table 4-2. Agent Display During Mixed Agent Conditions Physical Gas Halothane and involved mixes. Display MULTIPLE AGENTS Message Inspired (Fi) Expired (Et) No Yes Yes Yes Yes No Yes No Yes No Agent 1 Agent 1 Agent 1 Mix Mix Agent 1 Mix - Agent 1 Agent 2 Mix Agent 2 Mix Agent 2 Mix - i. Agent Display Fi ID % Inspired Concentration Agent 1 Agent 1 Agent 1 ----Agent 1 --------- Et ID %Expired Concentration Agent 1 ----Agent 2 ------Agent 2 ----- Anesthetic Agent Designation.
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.
READJUSTING CO2 ZERO Message flashing red. Occurs during CO2/Anesthesia Gas Sensor zeroing operation. REPLACE O2 SENSOR The Oxygen Sensor is bad and must be replaced. NOTE When the Agents parameter is turned on the O2 sensor is automatically calibrated during initial warm up of the EtCO2/Agent Module. During this time the patient GAS input port must not be connected to an oxygen source as the monitor requires 20.9% Oxygen (room air) for automatic calibration. 4.5.8 Oxygen Monitoring.
SECTION 5 RECORDING AND TRENDING 5.0 RECORDING AND TRENDING. 5.1 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: • Selection of the traces to be sent to the recorder.
Figure 5-1. The RECORDER Menu c. d. e. f. g. h. 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.
(2) 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. The priority of the second trace recording is RESP(CO2). SpO2 is written as the second trace recording when its alarm limit is in violation and is the only other parameter in a trace location.
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. a. Setting Up the Strip Chart. Perform the following procedure to configure the Strip Chart to the appropriate application: (1) Press the RECORDER SETUP Menu-Select Key.
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. 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. 5.
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. The following is a description of the options available in the HISTORY Menu: a. PRT ALL. Selecting this menu item will print a complete NIBP History File. b. PRT PAGE. Selecting this menu item will print the NIBP History File page that the screen is currently at. c. PREV PAGE.
SECTION 6 ALARMS 6.0 ALARMS. 6.1 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 MenuSelect key.
This menu has the following menu options associated with it: a. 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. Once the limit to be modified is highlighted, pressing the knob selects the limit and turning the knob changes the value.
g. h. i. TYPE. Selecting this menu option will select whether the audio and visual alarms are latched or unlatched (see definitions below). (1) UNLATCHED. The Alarm Tone stops if the violated parameter returns to within its limits, or the ALARM SILENCE key is pressed. (2) LATCHED. The Alarm Tone will cease only when the ALARM SILENCE key is pressed, even if the violating parameter has returned to within its limits. LIMITS DISPLAY.
(4) (5) (6) 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. ALARM SOUND. Selecting this menu option will turn the alarm sound on/ off.
e. f. 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. The numerics of the violated parameter flash on the screen and the audible alarm, once silenced, will not sound again until after the alarm condition has been corrected.
(3) 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” is displayed in the middle of the display screen.
Table 6-1. Alarm Limit Factory Default Settings Adult Values Parameter Low Limit High Limit Heart Rate 45 bpm/ 160 bpm/ 6.0 kPa 21.3 kPa NIBP Systolic 65 mmHg/ 190 mmHg/ 8.7 kPa 25.3 kPa Mean 55 mmHg/ 135 mmHg/ 7.3 kPa 18.0 kPa Diastolic 40 mmHg/ 125 mmHg/ 5.3 kPa 16.7 kPa SpO2 85% Off EtCO2 15 mmHg/ 60 mmHg/ 2.0 kPa 8.0 kPa Respiration 4 rpm 40 rpm ET Halothane Off 1.5 Fi Halothane Off 2.2 ET Isoflurane Off 2.3 Fi Isoflurane Off 3.4 ET Sevoflurane Off 4.1 Fi Sevoflurane Off 6.
Table 6-2. Range of Alarm Limits Input Adult Low Neonate High Low Unit High Heart Rate Off, 30 to 249 60 to 249, Off Off, 30 to 249 60 to 249, Off bpm NIBP Off, 5 to 249 Off, 0.7 to 33.2 5 to 249, Off 0.7 to 33.2, Off Off, 5 to 249 Off, 0.7 to 33.2 5 to 249, Off 0.7 to 33.2, Off mmHg kPa SpO2 Off, 50 to 99 70 to 99, Off Off, 50 to 99 70 to 99, Off % Respiration Off, 4 to 40 20 to 150, Off Off, 4 to 40 20 to 150, Off rpm EtCO2 Off, 5 to 60 Off, 0.7 to 8.0 5 to 80, Off 0.
SECTION 7 BATTERY OPERATION 7.0 BATTERY OPERATION. 7.1 Introduction. The system components are equipped with Lithium Ion Batteries which provide battery power for at least eight (8) hours. 7.2 Battery Location and Access. The WPU has two batteries that are located on the front of the unit; the DCU also has two batteries and they are located on each side of the unit; the WSPO2 and WECG telemetry transmitters both have a single battery which is located on the back of the units. 7.
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 Operation Time At least eight (8) hours. DIMENSIONS Height WPU: 6.5 inches (16.5 cm) for the roll around design, 6 inches (15.2 cm) for the table mount design. PCU: 5 inches (12.7 cm). DCU: 12 inches (30.5 cm).
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. Automatic activation on alarm with alarm parameter printed at the beginning of trace. DISPLAYED PARAMETERS Time Battery-backed quartz crystal clock.
ECG CHANNEL ECG AMPLIFIER Protected against defibrillator and electrosurgery potentials. Standard Lead Configurations II. 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 mode). Bandwidth Monitor: 0.5 to 40 Hz.
NON-INVASIVE BLOOD PRESSURE GENERAL Patient Types PNEUMATIC SYSTEM Cuff Inflation Pressure Cuff Inflation Pressure Range Overpressure Protection Oscillometric method (with inflatable cuff). Determines systolic, diastolic and mean arterial pressures, and pulse rate. Adult and Neonate. Initially 170 mmHg for Adult/Pediatric. (120 mmHg for Neonate). Subsequent inflation pressures determined by last measured systolic pressure. Adult: 110 to 265 mmHg. Neonate: 80 to 135 mmHg.
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 warmup period) CO2: 0 to 76 mmHg. N2O: 5 to 100 %. Accuracy (after 15 minute warm-up and CO2: ±3mmHg or 12% (whichever is greater). mean airway O2 at 30% concentration) N2O: ±2% Vol., +8% relative (at volumes greater than 5%). Zero Drift CO2: 1 mmHg/Hr.
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. Maximum: 70 to 99 or Off. PULSE Alarm Limits (when "HR" derived Minimum: 30 to 249. from SpO2) Maximum: 60 to 249.
Anesthetic Agents (Optional) Technique Measurement Range (after maximum warm-up period) Accuracy Side Stream, non-dispersive infrared (NDIR) absorption technique. Halothane: 0.15 to 6.0 Vol. %. Isoflurane: 0.15 to 6.0 Vol. %. Sevoflurane: 0.15 to 9.0 Vol. %. Carbon Dioxide: 0 to 76 mmHg. Nitrous Oxide: 5 to 100 Vol. %. Halothane: ±0.15 Vol. % + 12% relative,. Isoflurane: ±0.15 Vol. % + 12% relative. Sevoflurane: ±0.15 Vol. % + 12% relative.
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 ± 5 %. Drift < 1 % / Month. Linearity ± 1 % of Full Scale. Temperature Compensation Yes. Operating Temperatures 0 to +40 °C.
SYSTEM DEFAULTS MISCELLANEOUS Adult Neonate Heart Rate Source ECG ECG Patient Adult/Pediatric N/A Pacer Pulse Reject Reject Trace Speed 25 mm/second 25 mm/second Pulse Tone Source QRS QRS Sound Volume Levels Alarm Tone: 4 Heart Rate Tone: 4 Key Click: 4 Alarm Tone: 4 Heart Rate Tone: 4 Key Click: 4 Status On On Scale 15 mm/mV 15 mm/mV Lead Configuration II II Frequency Response Monitor Monitor Status On On Size 40% (Relative) 40% Pulse Tone Source QRS QRS Adult Neon
SYSTEM DEFAULTS ALARM LIMITS Adult Neonatal Heart Rate Low 45 bpm High 160 bpm Low 90 bpm High 210 bpm NIBP Systolic NIBP Mean NIBP Diastolic SPO2 ET Halothane Fi Halothane ET Isoflurane 65 mmHg 55 mmHg 40 mmHg 85 % Off Off Off 190 mmHg 135 mmHg 125 mmHg Off 1.5 % 2.2 % 2.3 % 70 mmHg 40 mmHg 35 mmHg 90 % Off Off Off 100 mmHg 90 mmHg 50 mmHg 98 % 1.5 % 2.2 % 2.
SYSTEM DEFAULTS ALARM MODES Mode Unlatched Window Size 20% RECORDER Trace 1 Assignment ECG1 Trace 2 Assignment Off Trace Time Delay 4 Seconds Data Acquisition Interval 4 Minutes GRIDS EtCO2 Off SCREEN TRACE CHARACTERISTICS Mode Fixed with moving erase bar A-11
APPENDIX B REPAIR All repairs on products under warranty must be performed by Invivo personnel, or an authorized Invivo Service and Repair Center. Unauthorized repairs will void the warranty. If a monitor fails to function properly or requires maintenance, contact 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.
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. This same warranty is made for a period of thirty (30) days on expendable parts.
APPENDIX D DECLARATION OF CONFORMITY For further information, contact the Regulatory Affairs Department of Invivo Corporation at telephone number 407-275-3220.
D-2
APPENDIX E kPa to mmHg Conversion Chart kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg 0.1 0.8 3.1 23.3 6.1 45.8 9.1 68.3 12.1 90.8 15.1 113.3 0.2 1.5 3.2 24.0 6.2 46.5 9.2 69.0 12.2 91.5 15.2 114.0 0.3 2.3 3.3 24.8 6.3 47.3 9.3 69.8 12.3 92.3 15.3 114.8 0.4 3.0 4.4 25.5 6.4 48.0 9.4 70.5 12.4 93.0 15.4 115.5 0.5 3.8 3.5 26.3 6.5 48.8 9.5 71.3 12.5 93.8 15.5 116.3 0.6 4.5 3.6 27.0 6.6 49.5 9.6 72.0 12.6 94.5 15.6 117.
kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa 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 18.4 138.0 21.4 160.5 24.4 183.0 27.4 205.5 30.4 228.0 33.4 250.5 18.5 138.8 21.5 161.3 24.5 183.8 27.5 206.3 30.5 228.8 33.5 251.3 18.6 139.5 21.6 162.0 24.6 184.5 27.6 207.0 30.
APPENDIX F LIST OF SYMBOLS F-1
NOTES