Covidien INVOS 5100C Operator's Manual
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Covidien INVOS 5100C Operator's Manual

Regional saturation patient monitoring system
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Operator's Manual
INVOS™ Regional Saturation Patient Monitoring System
Model 5100C

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  • Page 1 Operator's Manual INVOS™ Regional Saturation Patient Monitoring System Model 5100C...
  • Page 2 © 2018 Covidien. All rights reserved. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trade- marks of their respective owners. Other brands are trademarks of a Covidien company.

  • Page 3: Table Of Contents

    Table of Contents Introduction Intended Audience ............1-1 Key Terms .
  • Page 4 Digital Output Port ............3-3 VGA Output Port .
  • Page 5 Table of Contents 5.1.9 RS-232 Digital Output Format Selection Screen ........5-12 5.1.10 Tabular Trends Screen .
  • Page 6 Using the Digital Output Port ..........7-7 7.4.1 Using a Philips VueLink™* Open Interface (VOI) Module .
  • Page 7 Table of Contents Maintenance Overview ..............9-1 Software Upgrades .
  • Page 8 Clinical Studies Overview ..............B-1 Hypoxia Study .
  • Page 9 List of Figures Figure 2-1.   Disposable Sensors ............... 2-2 Figure 2-2.  ...
  • Page 10 Figure 8-4.   Tabular Trends for Entering Induction Time Screen........8-7 Figure 8-5.  ...
  • Page 11 List of Tables Table 1-1.   Safety Symbol Definitions ..............1-5 Table 5-1.  ...
  • Page 12 Page Left Intentionally Blank Operator’s Manual...

  • Page 13: Introduction

    1 Introduction Intended Audience This manual provides information to health-care professionals in a hospital setting for operation and maintenance of the INVOS™ regional saturation patient monitoring system. Refer to the institution for any additional training or skill requirements beyond those identified here for operation and maintenance of the INVOS™...
  • Page 14 Introduction Blue LED—indicates AC power supply and battery charge ON Caution; consult accompanying documents Digital output Do not dispose in trash. Use special collection. Fuse Green LED—indicates power ON HOME Potential equalization Preamplifier Light source Serial number Stand-by (ON/OFF) Type BF equipment Operator's Manual...

  • Page 15: Monitor

    Labeling Symbols USB port VGA output port Monitor 1.3.2 Alarm Baseline Battery Signal strength indicator Silence alarm Other Symbols 1.3.3 Catalog number Follow instructions for use Consult instructions for use Authorized representative in the European community Operator's Manual...
  • Page 16 Introduction Do not reuse Manufacturer Type BF equipment Dangerous voltage INMETRO certification CE – Conformité Européene authorization mark 0123 – TÜV SÜD Product Service GmbH (notified body) Prescription only US federal law restricts this device to sale by or on the order of a phy- sician Operator's Manual...

  • Page 17: Warnings, Cautions, And Notes

    Warnings, Cautions, and Notes Warnings, Cautions, and Notes The INVOS™ system is easy to use; however, it is necessary to adhere to the warnings and cautions in this manual. Safety Symbols 1.4.1 Table 1-1.  Safety Symbol Definitions Symbol Definition WARNING Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment.
  • Page 18 Introduction  WARNING: Shock and patient hazard: Users may not modify any components of the INVOS™ system or its software.  WARNING: Explosion hazard: Do not use the INVOS™ system in the presence of flammable anesthetics or in other flammable environments. ...

  • Page 19: General Cautions

    Warnings, Cautions, and Notes During this period of no communication, the INVOS™ system will continue to monitor the patient and generate alarm signals. The operator of the remote display should not rely upon the remote display’s alarm system to generate alarm signals. ...
  • Page 20 Do not place the sensor over nevi, hematomas or broken skin, as this may cause readings that are not reflective of somatic tissue or no readings at all.  Caution: Use only Covidien recommended or provided accessories. Use of the INVOS™ system with any other sensor will compromise accuracy.  Caution:...

  • Page 21: General Notes

    Caution: Do not attempt to perform any service or tamper with the warranty seal unless you have been authorized in writing by Covidien. Repairs made by anyone not authorized by Covidien during the warranty period will void the product warranty.

  • Page 22: Use Of The Product

    Introduction Use of the Product Do not use this product if it is found defective in any way; contact the Covidien customer service department for repair or replacement. If the INVOS™ system is not operated, maintained, and repaired in compliance with this manual (including product inserts and warnings), it will not func- tion as described.

  • Page 23: Invos™ System Warranty

    1 year of delivery. Covidien sole and exclusive obligation (customer’s sole and exclusive remedy) with respect to this warranty shall be to repair or, at Covidien sole discretion, replace products that prove to be defec- Operator's Manual...

  • Page 24: Warranty Labor

    Disclaimer of Consequential Damages 1.8.4 Covidien’s liability of any losses, damages, or expenses of any kind that arise out of, or which are in connection with, the products covered by the warranty set forth herein or their design, manu- facture, or sale, whether the claim is in contract, tort, or otherwise, including, without limitation,...

  • Page 25: Failure Of Product

    INVOS™ system will void the product’s warranty.  Note: If the unit in question is under warranty, do not attempt to repair the unit. Instead, return it to Covidien for repair (see section 1.8.8 Who to Contact for Authorized Repair). Repairs made by anyone not authorized by Covidien during the warranty period will void the product warranty.
  • Page 26 Introduction Page Left Intentionally Blank 1-14 Operator's Manual...

  • Page 27: Product Overview

    2 Product Overview Overview This chapter provides information that the operator should know before attempting to operate the INVOS™ regional saturation patient monitoring system. Indications for Use The noninvasive INVOS™ 5100C is intended for use as an adjunct monitor of regional hemoglo- bin oxygen saturation of blood in the brain or in other tissue beneath the sensor.

  • Page 28: Invos™ Adult Regional Saturation Sensor, Pediatric Regional Saturation Sensor, And Oxyalert Nirsensor

    Product Overview INVOS™ Adult Regional Saturation Sensor, Pediatric Regional Saturation 2.4.1 Sensor, and OxyAlert NIRSensor The INVOS™ adult regional saturation sensor, pediatric regional saturation sensor, and OxyAlert NIRSensor are disposable transducers capable of producing and detecting optical data from the patient, converting that data to electrical signals, and sending them to the INVOS™...
  • Page 29 Principles of Operation Figure 2-2.  INVOS™ System (Model 5100C) Red-colored hemoglobin molecules within red blood cells have the highest light absorption of the wavelengths used. The exact shade of red of each hemoglobin molecule indicates the amount of oxygen it is carrying. The type and quantity of absorption data returned to the detectors reflects relative amounts of deoxyhemoglobin and total hemoglobin, from which a regional oxygen saturation (rSO ) value...
  • Page 30 Product Overview Page Left Intentionally Blank Operator's Manual...

  • Page 31: Installation

    3 Installation Overview This chapter provides information for unpacking and installing the INVOS™ regional saturation patient monitoring system, as well as connections and elements. Unpacking  Note: ™ Verify all the environmental requirements are met before unpacking the INVOS system (see section Specifications).

  • Page 32: Serial Numbers

    Installation Remove all tape and packing materials from the INVOS™ system and accessories. Visually inspect the INVOS™ system and accessories for signs of shipping damage. If there is damage, report it to the shipping carrier (UPS, FedEx, or other) immediately. ...

  • Page 33: Digital Output Port

    Digital Output Port This port provides real time (every 5–6 seconds) and stored (every 30 seconds) digital data com- munications with other devices such as a PC. Consult Covidien for compatibility with other com- mercial devices (see section 7.4 Using the Digital Output Port).

  • Page 34: Vga Output Port

    Installation VGA Output Port This port provides standard video signals for an external monitor (see section 7.2 Using the VGA Port). Potential Equalization Connector The potential equalization connector (grounding post) provides a redundant external connection to earth ground if necessary. Alarm Speaker The alarm speaker provides an audio output signal to alert the operator to problems and alarms that may occur while monitoring (see sections...

  • Page 35: Usb Port

    The USB port also allows for software upgrades (see section 7.3 Using the USB Port).  Note: USB flash drives not supplied by Covidien may not meet system requirements. Additional drives may be ordered from Covidien (see section 3.12 Accessories). Accessories 3.12...
  • Page 36 Must be used with the PMAC71RSC-L-CHn reusable sensor cables. Check with your sales representative on availability in your region. Accessories can be ordered by contacting the Covidien customer service department at 800 635 5267, Customer.Service-RMS@covidien.com, or via the internet at www.covidien.com.

  • Page 37: Preamplifier

    Preamplifier Figure 3-2.  Side Connections USB connector Preamplifier A, channel 1 and 2 connector Preamplifier B, channel 3 and 4 connector Preamplifier 3.13 The preamplifier provides an electrically isolated connection for the sensor. Connect the 15 foot preamplifier cable to the side panel connection on the monitor. To do this, hold the connector at the end of the preamplifier cable with the red dot facing up.

  • Page 38: Figure 3-3. Preamplifiers, Reusable Sensor Cables, And Sensor Connections

    Installation If the connector will not fully enter the side panel connection, remove it and examine for any defects in both components. If both components show no signs of damage, realign the dots and try again.  Caution: Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause inaccurate readings, erratic readings or no readings at all.

  • Page 39: Reusable Sensor Cable

    Reusable Sensor Cable Reusable Sensor Cable 3.14 The reusable sensor cables are intended for multiple use and should not be discarded. Connect the reusable sensor cables to the preamplifier (see Figure 3-3.  ).  Caution: Make certain to connect the sensor cables as follows: Cable 1 to the preamplifier connector marked 1, cable 2 to the preamplifier connector marked 2, cable 3 to the preamplifier connector marked 3, and cable 4 to the preamplifier connector marked 4.

  • Page 40: Sensor Somatic Site Selection

    Installation hematomas or other anomalies, such as arteriovenous malformations, as this may cause readings that are not reflective of brain tissue or no readings at all. Sensor Somatic Site Selection 3.15.4 Select the sensor site over the tissue area of interest (site selection will determine which body region is monitored).

  • Page 41: Sensor Placement

     Note: If space is limited, sensors may overlap, provided the three optical windows on each sensor pad remain unobstructed.  Note: For extended monitoring, Covidien recommends using a new sensor every 24 hours. Operator's Manual 3-11...

  • Page 42: Care Of And Removing The Sensor

    Installation Care of and Removing the Sensor 3.15.7 Although the sensor is a nonsterile, disposable item, it should be treated with proper care to prevent damage or data corruption. To remove any sensor from the sensor cable, grip the blue sensor and cable connectors while pulling out.

  • Page 43: Oxyalert Nirsensor Lot Number

    Infant/Neonatal OxyAlert NIRSensor Sensor Application OxyAlert NIRSensor Lot Number 3.16.2 The OxyAlert NIRSensor lot number appears on the individual sensor packaging. OxyAlert NIRSensor Cerebral Site Selection 3.16.3 Select the sensor site on the right or left side of forehead. Placement of the sensor in other cere- bral locations, or over hair, may cause inaccurate readings, erratic readings, or no readings at all.

  • Page 44: Monitoring With The Oxyalert Nirsensor

    For extended monitoring, Covidien recommends using a new sensor every 24 hours or if the adhesive is inadequate to seal the sensor to the skin.

  • Page 45: Care Of And Removing The Oxyalert Nirsensor

    When INVOS™ System is Part of a Medical Monitoring System Care of and Removing the OxyAlert NIRSensor 3.16.8 Although the OxyAlert NIRSensor is a disposable item, it should be treated with proper care to prevent damage or data corruption. To remove the sensor from the preamplifier, grip the sensor cable connectors while pulling out. Do not pull on any cables.
  • Page 46 Installation Page Left Intentionally Blank 3-16 Operator's Manual...

  • Page 47: Quick Setup

    4 Quick Setup Overview This chapter briefly describes the setup of the INVOS™ regional saturation patient monitoring system (see also Chapter Introduction, Chapter Installation, and Chapter 6 Operation for com- plete instructions). Initial Setup Plug in the INVOS™ system monitor to a power source. ...

  • Page 48: Figure 4-2. Connecting The Sensor Cable Connectors To The Preamplifier

    Different INVOS™ system sensors (adult, pediatric, and infant/neonatal) cannot be used on the same monitor. (See sensor instructions for use inside carton.) Figure 4-3.  Connecting the Sensors to the Sensor Cables Connect any optional accessories, including the Covidien USB flash drive. Operator's Manual...

  • Page 49: Figure 4-4. Connecting Optional Accessories

    As a reminder to insert the USB, the blinking message “USB flash drive not connected” will appear on the Start screen when the system is turned on. USB flash drives not supplied by Covidien may not meet system requirements. Additional drives may be ordered from Covidien (see section 3.12...
  • Page 50 Quick Setup Page Left Intentionally Blank Operator's Manual...

  • Page 51: Screens

    5 Screens Overview The INVOS™ regional saturation patient monitoring system shows the following different screens, which the operator can access using the navigation bar: Welcome • Start • Patient identifier • Main • User configuration • Event mark list • Baseline reset warning •...

  • Page 52: Welcome Screen

    Screens Welcome Screen 5.1.1 The Welcome screen is displayed, followed by a 10-second self-test after pressing the ON/OFF key. Figure 5-1.  Welcome Screen Start Screen, Navigation Bar, Key Panel and Software Version 5.1.2 The Start screen displays the software version, date, time, and operator-selectable navigation bar. For each screen, the navigation bar is displayed at the bottom of the screen and above the corre- sponding menu key.

  • Page 53: Figure 5-2. Start Screen, Navigation Bar, Key Panel And Software Version

    Overview Figure 5-2.  Start Screen, Navigation Bar, Key Panel and Software Version Software version Blue LED, AC power, and charge indi- cator Reminder to connect the USB flash drive ON/OFF (stand-by) Navigation bar (menu options) HOME Menu keys New Patient/Previous Patient Select NEW PATIENT to begin monitoring a new case. New patient data files are created. Select PREVIOUS PATIENT to continue monitoring.

  • Page 54: Patient Identifier Screen

    Screens Patient Identifier Screen 5.1.3 The Patient identifier screen allows for storing in memory the individual patient medical record number or name. The identifier allows the operator to locate the stored files when using the Case archive function or AUC and Database operational mode. Figure 5-3.  Patient Identifier Screen Main Screen 5.1.4...

  • Page 55: Figure 5-4. Main Screen Elements (Two-Channel Monitoring)

    Overview Figure 5-4.  Main Screen Elements (Two-Channel Monitoring) Date/time and operating status messages area Battery symbol Alarm messages and symbol area Navigation bar (menu options) Data channel area (data channel label, rSO , values, baseline, SSI, Trend data graph area status messages) Operator's Manual...

  • Page 56: Figure 5-5. Main Screen (Four-Channel Monitoring)

    Screens Figure 5-5.  Main Screen (Four-Channel Monitoring) Date and time Monitoring status messages Adult, pediatric, or neonatal indication for Battery power status sensor model Upper and lower alarm limits Channel indicator Alarm status message Time scale, in hours; selectable up to 24 hours Alarm symbol trend (high and low) scale Signal strength indicator...

  • Page 57: User Configuration Screen

    Overview User Configuration Screen 5.1.5 The User configuration screen consists of two pages, displaying settings for parameters that the operator can change, such as alarms and scales (see section 6.5 Run Function (Patient Monitoring) in Normal Mode). Alarm messages, channel identification, and rSO area elements will continue to be displayed.

  • Page 58: Event Mark List Screen

    Screens Event Mark List Screen 5.1.6 An event mark may be stored in memory and displayed on the screen to mark significant events. A vertical dashed line and event code will appear on the Main screen at the event time, and an event code will appear in the event mark column of the Tabular trends screen, digital output, or USB flash drive output data (see section 6.5.2 Event...

  • Page 59: Figure 5-9. Event Mark List Screen (Icu Event Mark List)

    Overview Figure 5-9.  Event Mark List Screen (ICU Event Mark List) Figure 5-10.  Event Mark List Screen (Vascular Event Mark List) Operator's Manual...

  • Page 60: Baseline Reset Screen

    Screens Figure 5-11.  Event Mark List Screen (NICU Event Mark List) Baseline Reset Screen 5.1.7 The Baseline reset screen is displayed when the operator attempts to reset a baseline after the baseline has been previously set either manually or automatically (see section 6.5.1 Baseline Set Status).

  • Page 61: Channel Inactivity Screen

    Overview Figure 5-12.  Baseline Reset Screen Channel Inactivity Screen 5.1.8 The Channel inactivity screen is displayed if all channels are inactive for 25 minutes. Figure 5-13.  Channel Inactivity Screen Operator's Manual 5-11...

  • Page 62: Digital Output Format Selection Screen

    Screens RS-232 Digital Output Format Selection Screen 5.1.9 The RS-232 digital output format selection screen is displayed to select the real-time and case history data output formats. The operator should select Output Formats 1–3 based on the person- al computer, multi- parameter monitor or data collection system interface software (see section 7.5 Data Output Formats).

  • Page 63: Tabular Trends Screen

    Overview Tabular Trends Screen 5.1.10 The Tabular trends screen displays stored data in a numerical, tabular format (see sections 6.5 Run Function (Patient Monitoring) in Normal Mode 6.6 Case Archive Function). Alarm messages, channel identification, and rSO area elements will continue to be displayed when operating in Run function.

  • Page 64: Case Archive File List Screen

    Screens Figure 5-18.  Tabular Trends Screen—Manual Set Baseline in Normal Mode When displaying the Tabular trends screen, lines of data are color coded to increase visibility of marked events and baseline status. Yellow indicates an event mark. Red indicates a baseline status desaturation ≥20% or ≤40 rSO value.

  • Page 65: Review Screen

    Overview Figure 5-19.  Case Archive File List Screen Data File Name Format Stored data files created by the INVOS™ system are automatically named by the software using the date (YYMMDD) followed by a letter indicating the type of recording (N = Normal run func- tion, C = control, I = intervention) and a file extension consisting of a sequence number.

  • Page 66: Figure 5-20. Trend Graph Screen-Case Archive Function In Normal Mode

    Screens In Real-time review—tabular trends approximately 28 hours of data will be temporarily stored until the unit is turned off. When the case memory is full, the oldest line of data will be deleted to make room for newer line of data. Figure 5-20.  Trend Graph Screen—Case Archive Function in Normal Mode Figure 5-21.  Trend Graph Screen—Run Function in Normal Mode 5-16...

  • Page 67: Operation

    6 Operation Overview This chapter provides instructions on how to change settings and operate the INVOS™ regional saturation patient monitoring system. Read this chapter completely before attempting to operate the system. Prior to initial installation in a clinical setting, have a qualified service technician verify the per- formance of the INVOS™...

  • Page 68: Date, Time, And Patient Identifier Settings

    STS adult cardiac surgery database (see Chapter Database Operational Mode and Area Under the Curve). Diagnostic mode: The Diagnostic mode is for technical service. Contact Covidien customer service for more infor- mation regarding this mode.  Note:...

  • Page 69: Time

    Date, Time, and Patient Identifier Settings Month DATE/TIME NEW PATIENT PREVIOUS PATIENT NEXT MENU DATE TIME PREVIOUS MENU MONTH YEAR PREVIOUS MENU INCREASE DECREASE MONTH = XX PREVIOUS MENU Use the INCREASE or DECREASE options to adjust and change the month as necessary. Press PREVIOUS MENU again to return to the Start screen.

  • Page 70: Patient Identifier

    Operation Minutes DATE/TIME NEW PATIENT PREVIOUS PATIENT NEXT MENU TIME DATE PREVIOUS MENU MINUTES HOURS SECONDS PREVIOUS MENU INCREASE DECREASE MINUTES = XX PREVIOUS MENU Use the INCREASE or DECREASE options to adjust and change the minutes as necessary. Press PREVIOUS MENU again to return to the Start screen.

  • Page 71: Run Function (Patient Monitoring) In Normal Mode

    Run Function (Patient Monitoring) in Normal Mode Select <–, –>, and NEXT ROW to scroll through the characters and SELECT to enter highlighted character. When entry is complete, select DONE in the Patient identifier entry screen to save the unique alphanumeric identification and display the Main screen. Up to 24 alphanumeric characters may be entered.

  • Page 72: Baseline Set And Status

    Operation Both decreases and increases from baseline may signify dysfunction and developing pathology. Changes in rSO values of ≥20% from baseline are considered clinically significant and cause for concern and possible interventions (see Appendix B Clinical Studies).  Note: At start up, when selecting new patient or previous patient, the alarms for each channel become active only after a sensor has been connected.
  • Page 73 Run Function (Patient Monitoring) in Normal Mode or baselines may be set for all channels in use at once, individually for a selected channel or chan- nels and manually to a previous rSO Set Current rSO as Baseline for All Channels To set a baseline, press the HOME key to display the Main screen, then perform the following navigation bar options:...
  • Page 74 Operation To set an individual channel baseline, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU SET BASELINES SET CHANNEL MANUAL SET PREVIOUS MENU CHANNEL 1 SET CHANNEL 2 SET CHANNEL 3 SET...

  • Page 75: Event Mark

    Run Function (Patient Monitoring) in Normal Mode Select NEXT or PREVIOUS to scroll to the desired line of rSO data, then SELECT BASELINES to manually set the baseline. On the Main screen, the manually set baselines will be displayed in the graph area for each chan- nel.

  • Page 76: Table 6-1. Event Codes And Descriptions For Operating Room

    Operation Table 6-1.  Event Codes and Descriptions for Operating Room White events reflect relatively routine occurrences during surgery. These are listed in the order they typically occur during a case. Yellow events mark events clinicians may consider “cautionary” because they could cause ischemia. These are listed alphabetically. Green events mark interven- tions taken and are listed alphabetically.

  • Page 77: Table 6-2. Event Codes And Descriptions For Intensive Care Unit

    Run Function (Patient Monitoring) in Normal Mode Table 6-2.  Event Codes and Descriptions for Intensive Care Unit White events reflect relatively routine occurrences. These are listed in the order they typically occur. Yellow events mark events clinicians may consider “cautionary” because they could cause ischemia.

  • Page 78: Table 6-3. Event Codes And Descriptions For Vascular Application

    Operation Table 6-3.  Event Codes and Descriptions for Vascular Application White events reflect relatively routine occurrences during surgery. These are listed in the order they typically occur during a case. Yellow events mark events clinicians may consider “cautionary” because they could cause ischemia. These are listed alphabetically. Green events mark interven- tions taken and are listed alphabetically.

  • Page 79: Alarm Limits

    Run Function (Patient Monitoring) in Normal Mode Table 6-4.  Event Codes and Descriptions for Neonatal Intensive Care Unit White events reflect relatively routine occurrences in the environment. These are listed in the order they typically occur. Yellow events mark events clinicians may consider “cautionary” because they could cause ischemia.
  • Page 80 Operation scale limit. When being decreased, the upper alarm limit is allowed to bump the lower alarm limit until it reaches 5 units above the lower rSO scale limit. Upper Alarm Limits To manually change the upper alarm limit settings, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE MENU...
  • Page 81 Run Function (Patient Monitoring) in Normal Mode To automatically set lower alarm limits, press the HOME key to display the Main screen, then perform the following navigation bar options: NEXT MENU BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF USER CONFIGURATION OUTPUT SELECT TIME SCALE NEXT MENU...

  • Page 82: Alarm Volume

    Operation When finished, press the HOME key to exit the User configuration menu and return to the Main screen. On the Main screen, the new alarm limit is displayed (numerical and graphical). Alarm Volume 6.5.4 To change the alarm volume, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE MENU...
  • Page 83 Run Function (Patient Monitoring) in Normal Mode Press key #3 five times. The indication changes to ALARM OFF REMINDER ON. Operator's Manual 6-17...

  • Page 84: Rso2 Scale

    Operation Press the HOME key to save changes. To turn the Alarm audio off reminder off: Navigate to page 3 of the User configuration screen. Continue pressing NEXT until ALARM OFF REMINDER ON is highlighted. Press key #3 six times. The indication changes to ALARM OFF REMINDER OFF. Press the HOME key to save changes.

  • Page 85: Time Scale In User Configuration Menu

    Run Function (Patient Monitoring) in Normal Mode Upper rSO Scale To change the upper rSO scale limit, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT USER CONFIGURATION...

  • Page 86: Usb Storage Rate

    (see section 7.3 Using the USB Port). USB flash drives not supplied by Covidien may not meet system requirements. Additional drives may be ordered from Covidien (see section 3.12 Accessories).

  • Page 87: Event Mark List

    Run Function (Patient Monitoring) in Normal Mode To adjust the USB storage rate, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT USER CONFIGURATION TIME SCALE NEXT MENU...

  • Page 88: Data Channel Labels

    Operation Data Channel Labels 6.5.9  Note: For quicker access to parameters on page 2 of the User configuration menu, select PREVIOUS to wrap around from the top to bottom of page 1, then select NEXT to access page 2. To assist in identifying sensor site locations, data channel labels are displayed in Run function.

  • Page 89: Two- Or Four-Channel Monitoring

    Run Function (Patient Monitoring) in Normal Mode In the User configuration menu, select NEXT to scroll to COLOR CODED LABELS. Select YES or When finished, press the HOME key to exit the User configuration menu and return to the Main screen. Two- or Four-Channel Monitoring 6.5.11 When using just one preamplifier, specify two-channel monitoring.

  • Page 90: Restore Defaults

    Operation Restore Defaults 6.5.12 The Restore defaults function sets many user configuration settings to their factory default values. To access the Restore defaults function: Navigate to page 3 of the User configuration screen. Continue pressing NEXT until RESTORE DEFAULTS is highlighted. Press the RESTORE key.

  • Page 91: Alarms And Status Messages

    Run Function (Patient Monitoring) in Normal Mode Restore defaults does not affect the following settings: Date • Time • Language • Number of channels (two or four) • Control mode • Intervention mode • Database features • Digital output enable •...
  • Page 92 Operation  Note: Physiological alarms and technical alarms related to the sensor (POOR SIGNAL QUALITY, EXCESSIVE LIGHT, INTERFERENCE DETECTED, SENSOR NOT CONNECTED, REPLACE SENSOR, SENSOR UNUSABLE) may be delayed by up to 5 seconds. PREAMP NOT CONNECTED, USB STORAGE FULL, USB STORAGE ERROR, COM PORT UNAVAILABLE, and PRINTER UNAVAILABLE have no inherent delay.
  • Page 93 Run Function (Patient Monitoring) in Normal Mode If the rSO should drop below the baseline threshold, the baseline and percentage change are shown in yellow, as in Figure 6-3.   Figure 6-3.  rSO Below Baseline In addition to the visual indicator, a repeated series of tones is generated (see section A.2.6 Alarm Tone Definitions).

  • Page 94: Figure 6-4. Technical Alarm Indicated

    Operation Figure 6-4.  Technical Alarm Indicated The following conditions are medium-priority technical alarms: Preamp not connected: one or both preamplifiers are disconnected • Sensor not connected: one or more sensors are disconnected, or a reusable cable is disconnected • Poor signal: signal quality is too low for a reliable measurement; check sensor placement •...
  • Page 95 Run Function (Patient Monitoring) in Normal Mode There may be a delay of up to 5 seconds between the detection of an alarm condition and its pre- sentation. Battery Capacity Alarm Notification Battery operation symbol/gauge —Appears in the lower right corner above the naviga- tion bar when the INVOS™...

  • Page 96: Table 6-5. Status Messages-Rso2 Value Displayed

    Operation Status Codes Status codes are numbers associated with specific conditions that are displayed in the Tabular trends screen as lines of data in Run function and Case archive function (see section 5.1.10 Tabular Trends Screen, Table 5-1.  , Table 6-5.  and Table 6-6.  ). The status codes help the user to identify alarm and status message conditions and troubleshoot the system setup.
  • Page 97 Run Function (Patient Monitoring) in Normal Mode Table 6-5.  Status Messages—rSO Value Displayed (Continued) Status message Status code Color, location Cause Action SYSTEM SIGNAL OK No text message dis- SSI at full strength See section 9.8.5 Trou- played on screen bleshooting Signal Strength Indicator (SSI) for SSI unstable and less than full strength.

  • Page 98: Signal Strength Indicator (Ssi)

    Operation Table 6-6.  Status Messages—rSO Value Not Displayed (Continued) Status message Status code Cause Action INTERFERENCE DETECTED Noise corrupting rSO data (for exam- Move or turn off source of inter- accompanied by alarm tone ference. Normal operation of the ple, electrocautery). INVOS™ system will resume when the excessive noise stops.

  • Page 99: Time Scale

    Run Function (Patient Monitoring) in Normal Mode Time Scale 6.5.15 The trend graph time scale may be adjusted in the Time scale menu or the User configuration menu. To change the hours viewed (x-scale) of rSO values plotted on the trend data graph, adjust the time scale.
  • Page 100 Operation BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT USER CONFIGURATION TIME SCALE NEXT MENU REVIEW PATIENT I.D. PREVIOUS MENU MAIN MENU <– TREND GRAPH TREND GRAPH –> TABULAR TRENDS MAIN MENU Select the <– TREND GRAPH or TREND GRAPH –> options to scroll across the trend lines on the screen.

  • Page 101: Case Archive Function

    Case Archive Function Case Archive Function Case archive function allows review of up to 28 separate cases of 24-hour duration and two case examples. When run-on data storage exceeds 24-hours, it will be stored as a separate case. Case history data files are selected for review in the Case archive file list. The data may be viewed in graphical or tabular format (see sections 5.1.10 Tabular Trends Screen,...

  • Page 102: Case Archive Function-Tabular Trends Screen Format

    Operation  Note: The Case archive list will display only the cases with four-channel monitoring when the configuration is for four channels, respectively, it will display only the cases with two-channel monitoring when the configuration is two channel. When reviewing in graphical format during Case archive function, a message in yellow may be displayed in the upper area of the graphs to alert for the following cases: “USB STORAGE ERROR”, “USB STORAGE FULL”, and “COM PORT UNAVAILABLE.”...

  • Page 103: Using The Monitor Ports

    Use the serial (digital) out port to perform digital data outputting (download) functions •  WARNING: Accessories not supplied by Covidien may not meet IEC 60601-1 standards. Contact the Covidien customer service department for compatible products that meet these requirements.  Note: Make sure the appropriate output device is connected and ready to accept data before selecting an output.

  • Page 104: Figure 7-1. Vga Video Connector Pin-Out

    Using the Monitor Ports Figure 7-1.  VGA Video Connector Pin-Out Digital output female connector at monitor pin-out (left) Monitor cable male connector pin-out (right) Table 7-1.  VGA Video Connector Pin-Out Descriptions Pin # Signal name Pin # Signal name No connect Green Ground Blue No connect No connect DDC DAT...

  • Page 105: Using The Usb Port

    As a reminder to insert the USB, the blinking message “USB FLASH DRIVE NOT CONNECTED” will appear on the Start screen when the system is turned on. USB flash drives not supplied by Covidien may not meet system requirements. Additional drives may be ordered from Covidien (see section 3.12...
  • Page 106 Using the Monitor Ports Downloading an Individual Case Archive To access Case archive function and download an individual case from the Case archive file list, press the ON/OFF key to display the Start screen, then perform the following navigation bar options: NEW PATIENT PREVIOUS PATIENT...
  • Page 107 Using the USB Port When downloading a case, a message in yellow may be displayed in the upper area to alert for “USB STORAGE ERROR” and “USB STORAGE FULL.”This message will appear until the error is cor- rected and the screen is refreshed. When downloading is complete, perform the following navigation bar options to return to the Start screen: PREVIOUS MENU...

  • Page 108: Usb Port Output-Run Function

    Using the Monitor Ports All files will be deleted from the USB flash drive. When deleting is complete, perform the following navigation bar options to return to the Start screen: DELETE ALL FILES DELETE ALL USB CASE ARCHIVE MENU PREVIOUS MENU DOWNLOAD FILES DELETE FILES START SCREEN...

  • Page 109: Using The Digital Output Port

    Database summary menu data. Digital output port interfacing is described in this section using a VueLink™* Open Interface module and the HyperTerminal™* program. Contact Covidien’s customer service department for compatibility with other commer- cial devices or to order a null modem cable (see sections 7.4.1 Using a Philips VueLink™* Open Inter-...

  • Page 110: Using A Philips Vuelink™* Open Interface (Voi) Module

    Using the Monitor Ports Figure 7-2.  Digital Output Connector Pin-Out Pin # Signal name Pin # Signal name Data carrier detect Data set ready Receive data Request to send Transmit data Clear to send Data terminal ready Ring indicator Ground Using a Philips VueLink™* Open Interface (VOI) Module 7.4.1 ...
  • Page 111 Using the Digital Output Port Philips VOI/RS-232 interface cable (Philips VueLink™* P/N M1032 #K6B) • VueLink™* adapter cable, DB25F to DB9F (Covidien P/N VLI) • The following hardware is needed for Philips IntelliBridge™* communication: ™* Philips IntelliBridge EC10 module (Philips P/N 865115, driver code IB-ED101-A.3) •...

  • Page 112: Select Digital Output Port Data Format

    Using the Monitor Ports Once the INVOS™ system components and the Philips components are connected, the monitor is on and in Run function. To enable transmission from the INVOS™ system, press the HOME key to display the Main screen and perform the following navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF...

  • Page 113: Using Hyperterminal™* Via Null Modem Cable To Capture And Store Data

    Using the Digital Output Port Selecting Digital Output Port Data Format—Four-Channel Monitoring Once the INVOS™ system components and the external device are connected, the INVOS™ system monitor is on and in Run function, press the HOME key to display the Main screen and perform the following navigation bar options to begin interfacing: BASELINE MENU EVENT MARK...

  • Page 114: Figure 7-3. Null Modem Cable Diagram For Connection To Digital Output Port

    Using the Monitor Ports Null Modem Cable Connect Covidien’s null modem cable to the digital output port (see Figure 7-3.  , if not using Covidien’s null modem cable). Connect the null modem to a COM port on the PC.  Note: Both configurations shown in Figure 7-3.  are acceptable.

  • Page 115: Table 7-2. Input Com Port Settings Using Hyperterminal

    Using the Digital Output Port Set the inputs for the COM port (see Table 7-2.  ). Table 7-2.  Input COM Port Settings Using HyperTerminal™* Input Setting Bits per second 9600 baud Data bits Parity None Stop bits Flow control None For additional information about using HyperTerminal™*, select the Help menu in HyperTermi- nal™*.
  • Page 116 Using the Monitor Ports Select MAIN MENU to return to the Main screen. The INVOS™ system will begin to communicate with the PC via HyperTerminal™* in real-time format. This setting will be retained until changed by selecting a different output format. In Run Function—Case History Data Output Once the INVOS™...

  • Page 117: Data Output Formats

    For two-channel software versions, format 1 and 2 include zeros for the fields that corre- spond to channels 3 and 4. The digital output data format 3 (two-channel only) outputs data for channels 1 and 2. For additional information about connectivity and data formats, contact Technical Services: 1.800.255.6774, option 1 HQTSWEB@covidien.com Operator's Manual 7-15...

  • Page 118: Graph Data Files-Rso2 Versus Time With Microsoft Excel

    Using the Monitor Ports Graph Data Files—rSO versus Time with Microsoft Excel 7.5.1 In Microsoft Excel, a macro can be written that automates graphing rSO data versus time and places event marks on a chart. Versions of Microsoft Excel may be different, but the general steps to chart without a macro include the following: Turn on the PC and open the Microsoft Excel program.

  • Page 119: Database Operational Mode And Area Under The Curve

    INVOS™ System Database Application Software 8.1.1 To inquire about the Database operational mode versions of application software and Database operational mode access, contact Covidien’s customer service department at 800 635 5267, Customer.Service-RMS@covidien.com, www.covidien.com, or via your local representative.

  • Page 120: Database Variable And Fields

    Database Operational Mode and Area Under the Curve Database Variable and Fields Field Name: Preinduction Baseline Regional Oxygen Saturation—Left 8.2.1 Format: Integer Valid Data: 1-99 Definition: Indicates the percent baseline left cerebral regional oxygen saturation (rSO ) values at the beginning of the operation, when the patient is awake and functional. Patient can be sedated or on supplemental oxygen at the time measurement is taken.

  • Page 121: Field Name: Cerebral Oximeter Provided The First Indication

    Database Operational Mode Screens Definition: Indicates the cumulative integral of time and depth of desaturation events below the threshold of 75% of the baseline rSO value (relative decline of 25% below baseline) for the right . Calculated by the cerebral oximeter by multiplying the difference between the threshold and current rSO values times the duration that rSO is below the threshold.

  • Page 122: Start Screen In Database Operational Mode

    Database Operational Mode and Area Under the Curve Database summary screen—real-time review • Database summary screen—case archive review • Start Screen in Database Operational Mode 8.3.1 The Start screen displays the software version, date, time, and operator-selectable navigation bar. The INVOS™ system software version appears where XX.XX.XX is shown in Figure 8-1.  and Figure 8- 2.  ...

  • Page 123: Figure 8-2. Four-Channel Start Screen In Database Operational Mode

    Database Operational Mode Screens Figure 8-2.  Four-Channel Start Screen in Database Operational Mode Operator's Manual...

  • Page 124: Main Screen In Database Operational Mode

    Database Operational Mode and Area Under the Curve Main Screen in Database Operational Mode 8.3.2 The Main screen is composed of several elements. These include real-time rSO values, trend data, system status, alarm limits and messages, rSO limits, date, and time. It also displays navigation bar options for the baseline parameter, event marking, audible alarm, and other default parameters.

  • Page 125: Tabular Trends For Entering Induction Time Screen

    Database Operational Mode Screens Tabular Trends for Entering Induction Time Screen 8.3.3 The Tabular trends for entering induction time screen displays stored data in a numerical, tabular format (see Figure 8-4.  , section 8.6.1 Marking the Induction Time, and Table 5-1.  ). Alarm messages, channel identification, and rSO area elements will continue to be displayed.

  • Page 126: Database Summary Screen

    Database Operational Mode and Area Under the Curve Figure 8-5.  Tabular Trends for Entering Skin Closure Time Screen Database Summary Screen 8.3.5 The Database summary screen displays the database metrics in a summary menu format (see Fig- ure 8-6.  , Figure 8-7.  , Figure 8-8.  , Figure 8-9.  , and section 8.6 Collecting Metrics in Database Opera- tional Mode).

  • Page 127: Figure 8-7. Database Summary Screen-Real-Time Review Before Skin Closure

    Database Operational Mode Screens Figure 8-7.  Database Summary Screen—Real-Time Review Before Skin Closure Figure 8-8.  Database Summary Screen—Real-Time Review After Skin Closure Operator's Manual...

  • Page 128: Features

    Database Operational Mode and Area Under the Curve Figure 8-9.  Database Summary Screen—Case Archive Review Features Database operational mode is for patient monitoring, and collecting and downloading cerebral oximetry metrics for the STS adult cardiac surgery database. This mode is similar to the Normal mode and, in addition, permits the calculation and display of area under the curve.

  • Page 129: Operating In The Database Operational Mode

    Operating in the Database Operational Mode When the INVOS™ system is in Database operational mode, the system will indicate that on the Start screen (see Figure 8-1.  and Figure 8-2.  ). Contact your representative or Covidien’s customer service department for database activation instructions. ...

  • Page 130: Baseline Set And Status Database Operational Mode

    Database Operational Mode and Area Under the Curve Baseline Set and Status Database Operational Mode 8.5.1  WARNING: For area under the curve (AUC) to calculate you must set left and right baselines prior to induction in real-time or accept the auto-baseline value when prompted by the device (approximately 5 minutes after first rSO data is received).

  • Page 131: Patient Identifier In Database Operational Mode

    Operating in the Database Operational Mode When finished, press the HOME key to exit the Baseline menu and return to the Main screen. Set Individual Channels to Current rSO Baseline in Four-Channel Monitoring To set an individual channel baseline, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE + EVENTS...

  • Page 132: Collecting Metrics In Database Operational Mode

    Database Operational Mode and Area Under the Curve Entering or Editing Patient Identifier through Main Screen To enter or edit a Patient identifier, press the HOME key to display the Main screen, then perform the following navigation bar options: NEXT MENU BASELINE + EVENTS DATABASE SUMMARY ALARM AUDIO ON/OFF...

  • Page 133: Marking The Induction Time

    Collecting Metrics in Database Operational Mode  WARNING: For area under the curve (AUC) to calculate you must set left and right baselines prior to induction in real-time or accept the auto-baseline value when prompted by the device (approximately 5 minutes after first valid rSO data is received).

  • Page 134: Marking The Skin Closure Time

    Database Operational Mode and Area Under the Curve Figure 8-10.  Events Marked on Main Screen During Database Operational Mode Marking the Current Time as Induction Time in the OR Event List To mark the induction event, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE + EVENTS DATABASE SUMMARY...

  • Page 135: Capturing The First Alert Metric

    Collecting Metrics in Database Operational Mode Marking the Skin Closure Time in the Database Summary Menu Using Tabular Data To mark the skin closure event, press the HOME key to display the Main screen, perform the following navigation bar options: BASELINE + EVENTS DATABASE SUMMARY ALARM AUDIO ON/OFF...

  • Page 136: Marking Metrics At The End Of A Case

    Database Operational Mode and Area Under the Curve To capture first alert data, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE + EVENTS DATABASE SUMMARY ALARM AUDIO ON/OFF NEXT MENU INDUCTION TIME SKIN CLOSURE TIME FIRST ALERT DOWNLOAD MENU...

  • Page 137: Reviewing The Case In Database Operational Mode

    Reviewing the Case in Database Operational Mode The monitor will prompt to use the auto-set baselines. An alert will display with the message “AUTO BASELINE(S) SET—PLEASE ACCEPT AUTO BASELINE(S) OR SET NEW BASELINE(S) WITH CURRENT VALUES” in yellow (see Figure 8-6.  ). Perform the following navigation bar menu option: ACCEPT AUTO BL NEW BASELINES PREVIOUS MENU...
  • Page 138 Database Operational Mode and Area Under the Curve To use real-time review in graphical format, press the HOME key to display the Main screen, then perform the following navigation bar options: BASELINE + EVENTS DATABASE SUMMARY ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT USER CONFIGURATION TIME SCALE...

  • Page 139: Case Archive Function In Database Operational Mode

    Reviewing the Case in Database Operational Mode Press the HOME key to exit real-time review and return to the Main screen. Case Archive Function in Database Operational Mode 8.7.2  Note: Database software is not compatible with cases collected using previous software versions. Therefore, previous cases stored on the INVOS™...

  • Page 140: Outputting The Metrics In Database Operational Mode

    8.8.1 Prior to Next Patient  Note: USB flash drives not supplied by Covidien may not meet system requirements. Additional drives may be ordered from Covidien (see section 3.12 Accessories). To capture the Database summary screen as an output to the USB flash drive, make certain the INVOS™...

  • Page 141: Outputting Database Summary To Usb Flash Drive In Case Archive Function

    Outputting Database Summary to USB Flash Drive in Case Archive Function 8.8.2  Note: USB flash drives not supplied by Covidien may not meet system requirements. Additional drives may be ordered from Covidien (see section 3.12 Accessories). To capture the Database summary screen as an output to the USB flash drive, make certain the INVOS™...
  • Page 142 Database Operational Mode and Area Under the Curve Page Left Intentionally Blank 8-24 Operator's Manual...

  • Page 143: Overview

    Additional calibration is not required. Software Upgrades Software upgrades are performed using a USB flash drive supplied by Covidien. To inquire about software upgrades contact Covidien’s customer service department. USB flash drives supplied by Covidien are accompanied by software upgrade instructions for use Repair Policy Have all repairs performed by Covidien’s authorized repair representative (see section...

  • Page 144: Battery Recharge

    Maintenance  Caution: Do not autoclave the INVOS™ system.  Caution: Do not gas sterilize the INVOS™ system. Disconnect the AC power from the INVOS™ monitor. Turn the system off by selecting the green ON/ key. Clean the outside surface of the enclosure with a cloth dampened with Isopropyl alcohol–70% or a mild soap and water solution.

  • Page 145: Check Battery Status

    Battery Recharge Check Battery Status 9.5.1 Place the monitor on a sturdy, flat surface and plug it in to a power source (mains) by attaching the power cord to the inlet (see Figure 3-1.  ).  Note: Use only hospital-grade AC mains outlets. Turn the mains power switch on.

  • Page 146: Maintenance Schedule

    Replace the lithium battery on the CPU. (The lithium battery is not user replaceable. See section 1.8.8 Who to Contact for Authorized Repair.) After 10 years Replace the disk on the chip module. This replacement is only available at Covidien authorized repair facilities. (See section 1.8.8 Who to Contact for Authorized Repair.)

  • Page 147: Electrical Inspection Points

    7.4 Using the Digital Output Port. Verify that the data is correctly transmitted. USB port Connect a Covidien USB flash drive to the USB port. Follow the procedure described in section 7.3 Using the USB Port. Verify that the monitor can write data on the USB flash drive.

  • Page 148: Functional Test With Optional Field Test Device

     Note: Only a Covidien-supplied field test device should be used with the INVOS™ system. No other field test devices should be connected to the system. For additional information on acquiring and using a field test device, contact Covidien’s customer service department.

  • Page 149: Who To Contact For Technical Service

    Caution: Do not attempt to perform any service or tamper with the warranty seal unless you have been authorized in writing by Covidien. Repairs made by anyone not authorized by Covidien during the warranty period will void the product warranty.

  • Page 150: Troubleshooting Chart

    Maintenance Troubleshooting Chart 9.8.3 Table 9-3.  provides problems that may be encountered while using the INVOS™ system and a list of the possible causes for each problem. Table 9-3.  INVOS™ System Troubleshooting Chart Indication Possible cause Action Does not turn on No AC power or battery power Plug the INVOS™...

  • Page 151: Troubleshooting The Digital Output

    Defective monitor Service the INVOS™ system. Defective inverter board Service the INVOS™ system. For additional troubleshooting assistance, contact Covidien’s customer service department at 800 635 5267, Customer.Service-RMS@Covidien.com, www.covidien.com, or via an authorized repair representative. Troubleshooting the Digital Output 9.8.4 Table 9-4.  provides problems that may be encountered while outputting data and a list of the possible causes and action to correct for each problem (see section 7.4 Using the Digital Output...

  • Page 152: Table 9-5. Signal Strength Indicator Troubleshooting Chart

    Maintenance and an alarm message and help notes are displayed (see section 6.5.13 Alarms and Status Messag- es). Table 9-5.  provides SSI ranges and a list of the possible causes and action to correct for each, if necessary. Table 9-5.  Signal Strength Indicator Troubleshooting Chart SSI indication Description/cause Action...

  • Page 153: Specifications

    A Specifications Overview This chapter provides product specifications for the INVOS™ regional saturation patient moni- toring system. Specifications Physical A.2.1 Table A-1.  Physical Specifications Oximeter Preamplifier Dimensions Height 24 cm (9.5 in.) 24 cm (9.5 in.) Width 29 cm (11.25 in.) 8 cm (3.13 in.) Depth 19 cm (7.5 in.) 4.5 cm (1.75 in.)

  • Page 154: Electrical

    Specifications Table A-2.  Operational Specifications (Continued) Diagnostics Automatic self-test Continuous operation Safety class Type BF Class I Power External AC mains or backup battery Signal strength indicator 0–5 bars (5 being the highest signal strength) See sections 6.5.14 Signal Strength Indicator (SSI) 9.8.5 Troubleshooting Signal Strength Indi- cator (SSI) Electrical...

  • Page 155: Alarm Conditions

    Specifications Alarm Conditions A.2.5 Table A-5.  Alarm Conditions Priority Rate Color Type Messages Medium Sounds every 8 seconds Yellow Physiological High rSO while the alarm condi- Steady message, slow Low rSO tion persists flashing label Technical Sensor not connected Excessive light Poor signal quality Preamp not connected Replace sensor Interference detected...

  • Page 156: Alarm Tone Definitions

    Specifications Alarm Tone Definitions A.2.6 Table A-6.  Alarm Tone Definitions Tone category Description Medium priority alarm tone Volume level High, medium, and low Sound pressure 57 dB (high volume), 49 dB (medium volume), 40 dB (low volume) Pitch (±5 Hz) 720 Hz Pulse width (±20 msec) 146 msec Number of pulses in burst...

  • Page 157: Additional

    UL 60601-1 CSA C22.2.601.1 EN 60601-1 Essential performance The INVOS™ system has no essential performance characteristics. Corporate information Covidien’s quality system is registered to the ISO 13485 standard.  Note: Specifications subject to change without notice to user. Operator's Manual...
  • Page 158 Specifications Guidance and Manufacturer’s Declaration—Electromagnet- ic Compatibility (EMC)  WARNING: The INVOS™ system is intended for use by healthcare professionals only. The INVOS™ system may cause radio interference or may disrupt the operation of nearby equipment, regardless of whether it is CISPR compliant or not. It may be necessary to take mitigation measures, such as reorienting or relocating the INVOS™...

  • Page 159: Guidance And Manufacturer's Declaration-Electromagnetic

    Guidance and Manufacturer’s Declaration—Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration—Electromagnetic Emissions A.3.1 The INVOS™ system is intended for use in the electromagnetic environment specified below. The customer or user of the INVOS™ system should ensure that it is used in such an environment. Table A-8.  Electromagnetic Emissions Emissions test Compliance...

  • Page 160: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Invos™ System

    Specifications Table A-9.  Electromagnetic Immunity (Continued) Immunity test IEC/EN 60601-1-2 test Compliance level Electromagnetic environment level guidance Voltage dips, short interrup- <5% U <5% U Mains power quality should be that tions, and voltage variations of a typical commercial or hospital (>95% dip in U ) for 0.5 (>95% dip in U ) for 0.5...
  • Page 161 Guidance and Manufacturer’s Declaration—Electromagnetic Compatibility (EMC) Table A-10.  Electromagnetic Immunity—Conducted and Radiated RF Immunity test IEC/EN 60601-1-2 test Compliance level Electromagnetic environment guid- level ance Frequency of transmitter Equation for separation distance (d) Conducted RF 3 Vrms 3 Vrms 1.2 P IEC/EN 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz 150 kHz to 80 MHz...

  • Page 162: System Diagram

    Specifications System Diagram Figure A-1.  shows a diagram of the INVOS™ system. This diagram can also be used when trouble- shooting (see section 9.8 Troubleshooting Techniques). Figure A-1.  Diagram of INVOS™ System (Model 5100C) Monitor Main power supply Human interface Preamplifier A Keypad Preamplifier B (optional) A-10 Operator's Manual...
  • Page 163 System Diagram Liquid crystal display (LCD) Reusable sensor cable (RSC) 1 blue “1” Digital interface board (DIB) Sensor 1 LCD inverter RSC2 taupe “2” Computer processing unit (CPU) Sensor 2 Data memory RSC3 orange “3” Program memory Sensor 3 Data processing module RSC4 green “4”...
  • Page 164 Specifications Page Left Intentionally Blank A-12 Operator's Manual...

  • Page 165: B Clinical Studies

    This chapter provides information on two clinical studies using the INVOS™ regional saturation patient monitoring system. A reference bibliography containing additional clinical studies is available on Covidien’s website (www.covidien.com) or by contacting Covidien’s customer service department. An adult volunteer study was performed comparing the regional oxygen saturation (rSO ) from the INVOS™...
  • Page 166 Clinical Studies Results: Figure B-1.  rSO and fSO , 20 Subjects Transitions 96 and 97 data; last 20 subjects; 179 data points. y=0.9133x–0.1755; =0.9575; bias=0.26; standard deviation=2.9. Table B-1.  Bias, Error, and Correlation for rSO and fSO Individual subjects (N=20) Range Pooled (N=180) transi- mean tions 2.49...

  • Page 167: Pediatric Clinical Study

    Pediatric Clinical Study Pediatric Clinical Study A prospective clinical study was performed to validate the performance of the INVOS™ system in the pediatric cath lab. The study compared the regional oxygen saturation index (rSO ) from the INVOS™ system to estimates of actual cerebral oxygen saturation derived from blood sample anal- ysis in 22 patients.

  • Page 168: Interventional Studies

    Clinical Studies Figure B-2.  Trend Data, 22 Subjects, 90 Points 22 patients, 90 points. y=1.0372x–0.0062, R =0.9609, bias=–0.02, standard devi- ation=1.63. Interventional Studies In controlled studies of carotid endarterectomy (references 1-3), changes in the rSO2 of 12-20 points (absolute) or 20% to 30% (relative) correlated with changes in the patient’s neurological status.

  • Page 169: Validation Studies

    Validation Studies Edmonds HL Jr, Ganzel BL, Austin EH 3rd. Cerebral oximetry for cardiac and vascular surgery. Semin Car- diothorac Vasc Anesth. 2004;8:147-66. Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surgery Forum 2004;7(5):#2004-1062.
  • Page 170 Clinical Studies Page Left Intentionally Blank Operator's Manual...
  • Page 171 Values are accumu- lated throughout the operation. Units are minute-percent. Authorized repair representative Those trained individuals authorized by Covidien to service the INVOS™ system. Battery operation The battery has an approximate 20-30 minutes of operation capacity. Recharge time from 50% discharge to full charge is approximately 20 hours and 100% discharge to full charge is approx- imately 24 hours.

  • Page 172: Glossary

    Glossary Case history Refers to data relating to oxygen saturation levels and status that can be downloaded at the end of a case. Connection port Any of the various inputs or outputs on or relating to the sensor and the INVOS™ system monitor. CPU board Central processing unit board.
  • Page 173 Light waves just beyond the red end of the visible spectrum. INVOS™ In vivo optical spectroscopy (INVOS™) is the name of the patented technology that a Covidien company uses in the operation of the INVOS™ system. The noninvasive INVOS™ system is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor.
  • Page 174 Glossary Optical spectroscopy Study of the spectra (series of colors). Relates to the theories behind the INVOS™ system and the interactions between matter and light. Power supply board Board that accepts incoming AC power from 100-240 volts and converts it to correct DC levels. Preamplifier and external preamplifier cable Preamplifier provides connection of sensor cable and initial amplification of patient signal.
  • Page 175 Status codes Condition or state as relating to operations of the INVOS™ system monitor. Status codes are numbers displayed on the Tabular trends screen and outputted in lines of INVOS™ system data notifying the operator of status messages (for example, REPLACE SENSOR, SSI at full strength). Status messages Condition or state as relating to operations of the INVOS™...
  • Page 176 Glossary Page Left Intentionally Blank Operator's Manual...
  • Page 178 Part No. PT00055043 Rev C 2018-11 COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company.

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