INVOS PM7100 Operators Manual Rev B

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Table of Contents 1

Introduction

1.1 1.2 1.3

1.5

Overview... 1-1 Intended Audience... 1-1 Safety Information... 1-2 Safety Symbols... 1-2 Explosion, Shock, and Toxicity Hazards... 1-2 Patient Monitoring and Safety... 1-3 Operation... 1-4 Sensors, Cables, and Other Accessories... 1-5 Electromagnetic Interference... 1-5 Cleaning... 1-7 Obtaining Technical Assistance... 1-7 Technical Services... 1-7 Related Documents... 1-8 Warranty Information... 1-9

2

Product Overview

2.1 2.2 2.3 2.4

2.5

Overview... 2-1 Product Description... 2-1 Indications for Use... 2-2 Product Views... 2-3 Full System... 2-3 Monitor Components... 2-4 Product and Carton Label Symbols... 2-13

3

Installation

3.1 3.2 3.3 3.4

Overview... 3-1 Safety Reminders... 3-1 Unpacking and Inspection... 3-2 Power Options... 3-3 AC Power... 3-3 Battery Power... 3-5 Setup... 3-7 Install the Battery... 3-7 Insert the Monitor into the Docking Station... 3-9 Connect the Preamplifier(s)...3-11 Connect the Reusable Sensor Cables (RSCs)...3-12 Apply Power...3-13 Set Institutional Defaults...3-16 Power Off the Monitoring System...3-17 Position the Monitoring System in the Clinical Setting...3-17

1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.7 1.4 1.4.1 1.4.2

2.4.1 2.4.2

3.4.1 3.4.2 3.5 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6 3.5.7 3.5.8

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Table of Contents 4

Operation

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8

Overview... 4-1 Safety Reminders... 4-2 Quick Start... 4-5 Operational Defaults... 4-7 Menu Structure... 4-9 Monitoring System Memory... 4-9 Set Up for Patient Monitoring... 4-11 Optional Set-Up Tasks... 4-16 Changing the Sensor Placement Sequence...4-16 Repositioning On-Screen Sensors...4-17 Assigning or Modifying the Patient ID...4-19 Changing the On-Screen Sensor Labels...4-21 Changing the Screen Brightness...4-23 Baselines... 4-24 Trend View Management... 4-27 About the Trend View...4-28 Changing the Trend View - Two Graphs or One Graph...4-29 Turning Trend Line Averaging On/Off...4-30 Zooming the Trend View...4-32 Reviewing Data that has Scrolled Off the Trend View...4-32 Viewing Previous rSO2 Values on the Trend Graph...4-33 Alarm Management... 4-35 Alarm Indicators...4-35 Setting Alarm Limits...4-38 Changing the Alarm Volume...4-40 Silencing or Pausing Alarms...4-41 Dismissing an Alarm...4-43 Event Marks... 4-44 About Event Marks...4-44 Marking Events...4-45 Viewing an Event Mark Label...4-45 Renaming an Event...4-46 Changing the Event List...4-47 Area Under the Curve (AUC)... 4-49 About Area Under the Curve (AUC)...4-49 Changing the AUC Threshold...4-50 Resetting AUC Collection...4-51 Finish Monitoring... 4-51 Case Histories... 4-52 About Case Histories...4-52 Viewing Case Histories...4-52 Exporting Case Histories...4-55

4.8.1 4.8.2 4.8.3 4.8.4 4.8.5 4.9 4.10 4.10.1 4.10.2 4.10.3 4.10.4 4.10.5 4.10.6 4.11 4.11.1 4.11.2 4.11.3 4.11.4 4.11.5 4.12 4.12.1 4.12.2 4.12.3 4.12.4 4.12.5 4.13 4.13.1 4.13.2 4.13.3 4.14 4.15 4.15.1 4.15.2 4.15.3

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Operator’s Manual

Table of Contents 5

Data Management

5.1 5.2 5.3 5.4 5.5

Overview... 5-1 Safety Reminders... 5-1 Displaying Monitoring System Screens on an External Monitor... 5-2 Downloading Case Histories to a USB Drive... 5-2 Transmitting Monitoring System Data to External Devices via the Serial Port... 5-3 Serial Port Specifications... 5-3 Transmitting Real-Time Data to a Philips IntelliBridge™* and VueLink™* Open Interface (IVOI) Module... 5-5 Transmitting Case Data to a Computer... 5-6 Data Formats... 5-8 Case Histories Downloaded via USB... 5-8 Case Data Downloaded via Serial Port...5-10 Event Codes for Data Downloads...5-13 Status Codes for Data Downloads...5-17

5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 5.6.4 6

Performance Considerations

6.1 6.2 6.3 6.4 6.5

Overview... 6-1 Safety Reminders... 6-1 Patient Conditions... 6-2 Sensor Use Considerations... 6-2 EMI (Electromagnetic Interference)... 6-2

7

Product Maintenance

7.1 7.2 7.3

7.4 7.5 7.6 7.7 7.8

Overview... 7-1 Safety Reminders... 7-1 Cleaning the Monitoring System... 7-2 Materials... 7-2 Procedure... 7-3 Maintenance Schedule... 7-3 Service and Calibration... 7-4 Service Life... 7-4 Software and Firmware Updates... 7-4 Recycling and Disposal... 7-5

8

Alarms and Troubleshooting

8.1 8.2 8.3 8.4

Overview... 8-1 Alarm Messages... 8-2 Error Conditions... 8-7 Product Return... 8-11

7.3.1 7.3.2

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Table of Contents

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9

Accessories

9.1 9.2 9.3

Overview... 9-1 Safety Reminder... 9-1 Accessories/Parts List... 9-2

10

Theory of Operations

10.1 10.2

Overview... 10-1 Theoretical Principles... 10-1

11

Product Specifications

11.1 11.2 11.3 11.4 11.5 11.6 11.6.1 11.6.2 11.6.3 11.7 11.8 11.9 11.10 11.10.1 11.11

Overview... 11-1 Physical Characteristics... 11-2 Electrical... 11-3 Battery... 11-3 Environmental Conditions... 11-4 Alarm Audio and Visual Characteristics... 11-4 Alarm Audio Characteristics...11-5 Alarm Visual Characteristics...11-5 POST Pass Tone...11-6 Sensor Operating Range... 11-6 Equipment Classifications... 11-6 Biocompatibility Testing... 11-7 Manufacturer’s Declaration... 11-7 Electromagnetic Compatibility (EMC)...11-9 Essential Performance... 11-14

A

Clinical Studies

A.1 A.2 A.3 A.4

Overview... A-1 Hypoxia Study... A-1 Interventional Studies... A-3 Validation Studies... A-4

Operator’s Manual

List of Tables Table 1-1. Table 2-1. Table 3-1. Table 3-2. Table 3-3. Table 3-4. Table 4-1. Table 4-2. Table 4-3. Table 4-4. Table 4-5. Table 4-6. Table 4-7. Table 5-1. Table 5-2. Table 5-3. Table 5-4. Table 5-5. Table 5-6. Table 5-7. Table 5-8. Table 5-9. Table 7-1. Table 8-1. Table 8-2. Table 9-1. Table 11-1. Table 11-2. Table 11-3. Table 11-4. Table 11-5. Table 11-6. Table 11-7. Table 11-8. Table 11-9. Table 11-10. Table 11-11. Table A-1. Table A-2.

Operator’s Manual

Safety Symbol Definitions... 1-2 Label Symbol Descriptions... 2-13 Monitoring System - Standard Shipped Items... 3-2 AC Power Indicators... 3-5 Battery Status Indicators - Monitoring System Operating on Battery Power... 3-6 Institutional Settings... 3-16 Quick Start Steps... 4-5 Operational Defaults... 4-7 Menu Structure... 4-9 System Memory - Common Situations and Recommended Actions... 4-10 Alarm Audio Button States... 4-36 Audible and Visual Alarm Indicators... 4-37 Alarm Limits Settings... 4-38 Serial Port Pin-Out Descriptions... 5-4 Hardware Requirements for Philips VueLink™* and IntelliBridge™* Communication . . . 5-5 Case History Downloads - Data Fields... 5-10 Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields... 5-12 Data Downloads - Event Codes 1 to 40... 5-13 Data Downloads - Event Codes 41 to 80... 5-14 Data Downloads - Event Codes 81 to 120... 5-15 Data Downloads - Event Codes 121 to 254... 5-16 Data Downloads - Status Codes... 5-17 Maintenance Schedule... 7-3 Alarm Conditions... 8-2 Error Conditions and Resolutions... 8-7 Monitoring System Accessory Part Numbers... 9-2 Transport, Storage, and Operating Condition Ranges... 11-4 Alarm Audio Characteristics... 11-5 Average Alarm Sound Pressure Levels... 11-5 Alarm Visual Characteristics... 11-5 POST Pass Tone Characteristics... 11-6 INVOS™ Adult rSO2 Sensor Operating Range... 11-6 Electromagnetic Emissions Guidelines and Compliance... 11-9 Electromagnetic Immunity Guidelines and Compliance...11-10 Recommended Separation Distance Calculations...11-11 Test Specifications for Enclosure Port Immunity to RF Wireless Communications Equipment...11-13 Recommended Separation Distances...11-14 Performance Characteristics: Accuracy Bias, Error (SD), RMSD, and Correlation (R2) for rSO2 and fSO2, 20 Subjects... A-2 Trend Bias, Error (SD), and Correlation (R2) for ΔrSO2 and ΔfSO2, 20 subjects... A-3

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List of Figures Figure 1-1. Figure 2-1. Figure 2-2. Figure 2-3. Figure 2-4. Figure 2-5. Figure 2-6. Figure 2-7. Figure 2-8. Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 3-8. Figure 3-9. Figure 3-10. Figure 3-11. Figure 3-12. Figure 3-13. Figure 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7. Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11. Figure 4-12. Figure 4-13. Figure 4-14. Figure 4-15. Figure 4-16. Figure 4-17. Figure 4-18. Figure 4-19. Figure 4-20. Figure 4-21.

Operator’s Manual

Start-up Screen Showing Code Version... 1-8 INVOS™ Patient Monitor Components... 2-3 Monitor - Front... 2-4 Monitor - Left Side... 2-5 Monitor - Right Side... 2-6 Monitor - Back... 2-7 Docking Station - Bottom View... 2-8 Docking Station - Connector for Monitor... 2-9 Sample Monitoring Screen Elements... 2-10 Power Input Connection at Bottom of Docking Station... 3-3 Docking Station Power Indicator... 3-4 Battery Location at Back of Monitor... 3-6 Battery Slot and Latch at Back of Monitor... 3-8 Battery Installed in Monitor... 3-9 Monitor Mounted in Docking Station... 3-10 Connecting the Preamplifier Cable... 3-11 Connecting the RSC to the Preamplifier... 3-12 Power Input Connection at Bottom of Docking Station... 3-13 Power Button on Top of Monitor... 3-14 Set-Up Screen - Preamplifier(s) Connected... 3-15 Set-Up Screen - No Preamplifier(s) Connected... 3-15 Monitoring System on Stand with Preamplifier Hung on Rail... 3-17 Set-Up Screen - Prompt for Sensor Connection... 4-12 Monitoring Screen - New Case - No Baselines Set... 4-14 Default Sensor Placement Sequence... 4-16 Optional Sensor Placement Sequences... 4-17 Highlighting an On-Screen Sensor... 4-18 Sensor Icons Next to CURRENT Values (Press to Locate Sensor on Patient)... 4-18 Patient Icon... 4-19 Entering a Patient ID Before Monitoring... 4-20 Patient Icon... 4-20 Entering a Patient ID During Monitoring... 4-21 Sensor Label Menu... 4-22 SETTINGS - GENERAL - SCREEN BRIGHTNESS... 4-23 Monitoring Screen - New Data Set - No Baselines Set... 4-25 SET BASELINES - No Baselines Previously Set... 4-25 SET BASELINES - Baselines Previously Set... 4-26 Monitoring Screen with Baselines Set... 4-27 Trend View... 4-28 Trend View - One Graph (Left, Default) and Two Graphs (Right)... 4-29 SETTINGS - TRENDS - TWO AXIS VIEW vs. ONE AXIS VIEW... 4-30 Trend Line Averaging... 4-31 SETTINGS - TRENDS - TREND LINE AVERAGING... 4-31

ix

List of Figures Figure 4-22. Figure 4-23. Figure 4-24. Figure 4-25. Figure 4-26. Figure 4-27. Figure 4-28. Figure 4-29. Figure 4-30. Figure 4-31. Figure 4-32. Figure 4-33. Figure 4-34. Figure 4-35. Figure 4-36. Figure 4-37. Figure 5-1. Figure 5-2. Figure 5-3. Figure 5-4. Figure A-1. Figure A-2.

x

Trend View Review Mode... 4-33 Trend Graph Pop-Up... 4-34 Monitoring Screen - Trend Graph Pop-Up... 4-34 Visual Alarm Indicators... 4-36 SET ALARM LIMITS - Default Settings... 4-39 SET ALARM LIMITS - Upper Limits On... 4-39 SETTINGS - ALARMS - ALARM VOLUME... 4-41 Dismissible Alarm... 4-43 Events Marked in Trend View... 4-44 ADD EVENT Menu... 4-45 Event Mark Label... 4-46 EDIT EVENT Menu... 4-47 SETTINGS - EVENTS (Screen 1)... 4-48 AUC SUMMARY Screen... 4-49 CASE HISTORY List... 4-53 Case History Example... 4-54 VGA Port on Docking Station... 5-2 Serial Port on Docking Station... 5-3 Serial Port Pin-Outs... 5-4 Null Modem Cable Diagram for Connection to Serial Port (Two Options)... 5-7 Accuracy rSO2 and fSO2, 20 Subjects... A-2 Trend rSO2 and fSO2, 20 Subjects... A-3

Operator’s Manual

1 Introduction

1.1

Overview This manual contains information for operating the INVOS™ patient monitor (the “monitoring system”). This manual applies to the following product: PM7100

1.2

•

Intended Audience, page 1-1

•

Safety Information, page 1-2

•

Obtaining Technical Assistance, page 1-7

•

Warranty Information, page 1-9

Intended Audience This manual provides information to health-care professionals in a hospital setting for operation and maintenance of the monitoring system. Refer to the institution for any additional training or skill requirements beyond those identified here for operation and maintenance of the monitoring system. Before operating the monitoring system, carefully read this manual, the Instructions for Use for the accessories, and all precautionary information and specifications.

1-1

Introduction

1.3

Safety Information This section contains important safety information for use of the monitoring system.

1.3.1 Safety Symbols

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. Caution Cautions alert users to exercise appropriate care for safe and effective use of the product. Note Notes provide additional guidelines or information.

1.3.2 Explosion, Shock, and Toxicity Hazards

   

1-2

WARNING: Explosion hazard - Do not use the monitoring system in the presence of flammable anesthetics. WARNING: Explosion hazard - When replacing the battery, do not use the incorrect type. Use only the battery available from Medtronic. See Accessories/Parts List, page 9-2. WARNING: Shock hazard - Ensure the monitoring system is properly grounded when operating on AC power. WARNING: Shock hazard - When connecting the monitoring system to any instrument, verify proper operation before clinical use. Any equipment connected to the data interface must be certified according to the latest IEC/EN 60950-1 standard for data-

Operator’s Manual

Safety Information

processing equipment, the latest IEC/EN 60601-1 standard for electromedical equipment, or the latest IEC/EN safety standards relevant to that equipment. All combinations of equipment must be in compliance with Requirements for Medical Electrical Systems within IEC/EN Standard 60601-1. Anyone who connects equipment to the data interface is configuring a medical system and, therefore, is responsible for ensuring the system complies with the Requirements for Medical Electrical Systems IEC/EN Standard 60601-1 and the electromagnetic compatibility IEC/EN Standard 60601-1-2. Performance may degrade if it is connected to secondary I/O devices when the equipment is not connected to earth reference.



WARNING: Toxicity hazard - The LCD panel (screen) contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances.

1.3.3 Patient Monitoring and Safety

     Operator’s Manual

WARNING: The monitoring system should not be used as the sole basis for diagnosis or therapy. It is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: Always disconnect and remove the monitoring system and sensors during magnetic resonance imaging (MRI) scanning. Attempting to use the monitoring system during an MRI procedure could cause burns or adversely affect the MRI image or the monitoring system's performance. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Do not set alarm limits to extreme values that render the monitoring system ineffective. Ensure alarm limits are appropriate for each patient. WARNING: Do not silence, pause, or decrease the volume of audible alarms if patient safety could be compromised.

1-3

Introduction

  

WARNING: An external multi-parameter system will not generate an alarm or error message if remote communication between the multi-parameter system and the monitoring system has been broken. During this period of no remote communication, the monitoring system will continue to monitor, generate alarms, and display status messages. The multi-parameter system operator should not rely on the multiparameter system for generating alarms. WARNING: Choking hazard - The reusable sensor cables (RSCs) include a strain-relief clip that, if detached, may pose a choking hazard. Caution: If two sensors are placed in close proximity to each other on a patient, the same preamplifier should be connected to both sensors to avoid poor performance.

1.3.4 Operation

     1-4

WARNING: Inspect the monitoring system and all accessories before use to ensure there are no signs of physical damage or improper function. Do not use if damaged. WARNING: If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact Medtronic or a local Medtronic representative. WARNING: Monitoring system readings can be affected by certain patient conditions. Refer to Patient Conditions, page 6-2. WARNING: Explosion hazard - When replacing the battery, do not use the incorrect type. Use only the battery available from Medtronic. See Accessories/Parts List, page 9-2. WARNING: To ensure proper performance, avoid shock, and prevent device damage or failure, do not expose the monitoring system to extreme moisture, such as direct exposure

Operator’s Manual

Safety Information

to rain. Do not immerse in water, solvents, or cleaning solutions, since the monitoring system and connectors are not waterproof.



Caution: Dispose of the battery in accordance with local guidelines and regulations.

1.3.5 Sensors, Cables, and Other Accessories

  

WARNING: The use of accessories, sensors, and cables other than those specified may result in poor performance of the monitoring system and increased electromagnetic emissions or decreased electromagnetic immunity of the monitoring system. WARNING: Failure to cover the sensor site with opaque material when operating under high ambient light conditions may result in poor performance. Caution: Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.

1.3.6 Electromagnetic Interference

  

Operator’s Manual

WARNING: Electromagnetic emissions from the monitoring system may interfere with other critical devices. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the monitoring system, including cables. Otherwise, degradation of monitoring system performance may result. WARNING: The use of accessories, sensors, and cables other than those specified may result in poor performance of the monitoring system and increased electromagnetic emissions or decreased electromagnetic immunity of the monitoring system.

1-5

Introduction

      

1-6

WARNING: The monitoring system is intended for use by healthcare professionals only. It may cause radio interference or may disrupt the operation of nearby equipment. Mitigation for such disruption may require re-orienting or relocating the monitoring system or shielding the location. WARNING: Any radio frequency transmitting equipment or other nearby sources of electrical noise may result in disruption of the monitoring system. WARNING: The monitoring system is designed for use in environments in which the signal can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the monitoring system may not seem to operate correctly. WARNING: EMI disruption can cause cessation of operation or other incorrect functioning. WARNING: The monitoring system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the monitoring system to verify normal operation in the desired configuration. Technical alarms may indicate that the configuration is not appropriate for the monitoring system. Caution: This device has been tested and found to comply with the limits for medical devices related to IEC 60601-1-2: 2007 and IEC 60601-1-2:2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. Caution: When operating medical electrical equipment, special precautions related to electromagnetic compatibility (EMC) are required. Install the monitoring system according to the EMC information included in this manual.

Operator’s Manual

Obtaining Technical Assistance

 

Caution: The monitoring system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. If interference is suspected, move monitoring system cables away from the susceptible device. Caution: The use of an electrosurgical or electrocautery instrument in the vicinity of the monitoring system may interfere with the signal and cause poor performance or no readings at all.

1.3.7 Cleaning

  1.4

Caution: Do not autoclave or gas sterilize any components of the monitoring system. Caution: To prevent device damage or failure, do not expose the monitor to isopropyl alcohol.

Obtaining Technical Assistance

1.4.1 Technical Services

For technical information and assistance, contact Medtronic or a local Medtronic representative. Medtronic Technical Services 5870 Stoneridge Drive, Suite 6 Pleasanton, CA 94588 USA 1.800.635.5267 or 1.925.463.4635 or contact a local Medtronic representative www.medtronic.com

When calling Medtronic or a local Medtronic representative, have the monitoring system serial numbers and software versions available. Serial numbers are located

Operator’s Manual

1-7

Introduction

on the back of the monitor and the preamplifiers. The software version for the monitoring system is displayed on the start-up screen at power-on. Figure 1-1. Start-up Screen Showing Code Version



Note: An authorized technician can view serial numbers and software versions through the monitoring system’s service mode. Refer to the monitoring system’s service manual.

1.4.2 Related Documents

1-8

•

INVOS™ Adult rSO2 Sensor Instructions for Use - Provides important information about sensor selection and use.

•

INVOS™ Preamplifier Instructions for Use - Provides instructions for connecting the monitoring system’s preamplifiers.

•

INVOS™ Patient Monitor Service Manual - Provides information to authorized technicians for use when servicing the monitoring system.

Operator’s Manual

Warranty Information

1.5

Warranty Information To obtain product warranty information, contact Medtronic or a local Medtronic representative. See Technical Services, page 1-7. The information contained in this document is subject to change without notice. Medtronic makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Medtronic shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

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Operator’s Manual