INVOS PM7100 Operators Manual Rev A

Medtronic and Medtronic logo are trademarks of Medtronic. ™* brands are trademarks of their respective owner. Other brands are trademarks of a Medtronic company.

Symbols Reference code (part number) Serial number Lot number European Community (EC) authorized representative Prescription only. US federal law restricts this device to sale by or on the order of a physician. Protection against fluid ingress: Protected against vertically falling water drops when tilted to 15º Manufacturer Date of manufacture Fragile Keep dry Must consult instructions for use Consult instructions for use kPa

Atmospheric pressure limits (see Environmental Conditions, page 112)

kPa

°F °C

Temperature limits (see Environmental Conditions, page 112)

°F °C

Humidity limits (see Environmental Conditions, page 112) Proper waste disposal for electrical and electronic equipment MR unsafe - Do not use during magnetic resonance imaging Defibrillation-proof type BF applied part CSA – Canadian Standards Association certification mark CE – Conformité Européene authorization mark. 0123 – TÜV SÜD Product Service GmbH (notified body). 0123

Not made with natural rubber latex Electromagnetic interference may occur in the vicinity of equipment marked with this symbol

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Quantity included in package (example: 20)

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Do not immerse

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Table of Contents 1 Introduction... 7 Overview... 7 Intended Audience... 7 Safety Information... 7 Obtaining Technical Assistance... 10 Warranty Information... 11 2 Product Overview... 13 Overview... 13 Product Description... 13 Indications for Use... 14 Product Views... 14 3 Installation... 23 Overview... 23 Safety Reminders... 23 Unpacking and Inspection... 23 Power Options... 24 Setup... 27 4 Operation... 37 Overview... 37 Safety Reminders... 37 Quick Start... 39 Operational Defaults... 40 Menu Structure... 41 Monitoring System Memory... 42 Set Up for Patient Monitoring... 42 Optional Set-Up Tasks... 46 Baselines... 52 Trend View Management... 55 Alarm Management... 60 Event Marks... 66 Area Under the Curve (AUC)... 70 Finish Monitoring... 72 Case Histories... 73 5 Data Management... 77 Overview... 77 Safety Reminders... 77 Displaying Monitoring System Screens on an External Monitor... 77 Downloading Case Histories to a USB Drive... 78 Transmitting Monitoring System Data to External Devices via the Serial Port... 78 Data Formats... 82 6 Performance Considerations... 91 Overview... 91 Safety Reminders... 91 Patient Conditions... 91 Sensor Use Considerations... 91 Operator's Manual

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EMI (Electromagnetic Interference)... 92 7 Product Maintenance... 95 Overview... 95 Safety Reminders... 95 Cleaning the Monitoring System... 95 Maintenance Schedule... 96 Service and Calibration... 97 Service Life... 97 Software and Firmware Updates... 97 Recycling and Disposal... 97 8 Alarms and Troubleshooting... 99 Overview... 99 Alarm Messages... 99 Error Conditions... 102 Product Return... 105 9 Accessories... 107 Overview... 107 Safety Reminder... 107 Accessories/Parts List... 107 10 Theory of Operations... 109 Overview... 109 Theoretical Principles... 109 11 Product Specifications... 111 Overview... 111 Physical Characteristics... 111 Electrical... 112 Battery... 112 Environmental Conditions... 112 Alarm Audio and Visual Characteristics... 113 Sensor Operating Range... 114 Equipment Classifications... 114 Biocompatibility Testing... 114 Manufacturer’s Declaration... 114 Essential Performance... 119 Appendix A. Clinical Studies... 121 Overview... 121 Hypoxia Study... 121 Interventional Studies... 123 Validation Studies... 124

Figures Figure 1. Start-up Screen Showing Code Version... 10 Figure 2. INVOS™ Patient Monitor Components... 14 Figure 3. Monitor - Front... 15 2 Operator's Manual

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Figure 4. Monitor - Left Side... Figure 5. Monitor - Right Side... Figure 6. Monitor - Back... Figure 7. Docking Station - Bottom View... Figure 8. Docking Station - Connector for Monitor... Figure 9. Sample Monitoring Screen Elements... Figure 10. Power Input Connection at Bottom of Docking Station... Figure 11. Docking Station Power Indicator... Figure 12. Battery Location at Back of Monitor... Figure 13. Battery Slot and Latch at Back of Monitor... Figure 14. Battery Installed in Monitor... Figure 15. Monitor Mounted in Docking Station... Figure 16. Connecting the Preamplifier Cable... Figure 17. Connecting the RSC to the Preamplifier... Figure 18. Power Input Connection at Bottom of Docking Station... Figure 19. Power Button on Top of Monitor... Figure 20. Set-Up Screen - Preamplifier(s) Connected... Figure 21. Set-Up Screen - No Preamplifier(s) Connected... Figure 22. Monitoring System on Stand with Preamplifier Hung on Rail... Figure 23. Set-Up Screen - Prompt for Sensor Connection... Figure 24. Monitoring Screen - New Case - No Baselines Set... Figure 26. Default Sensor Placement Sequence... Figure 27. Optional Sensor Placement Sequences... Figure 28. Highlighting an On-Screen Sensor... Figure 29. Sensor Icons Next to CURRENT Values (Press to Locate Sensor on Patient) . Figure 30. Patient Icon... Figure 31. Entering a Patient ID Before Monitoring... Figure 32. Patient Icon... Figure 33. Entering a Patient ID During Monitoring... Figure 34. Sensor Label Menu... Figure 35. SETTINGS - GENERAL - SCREEN BRIGHTNESS... Figure 36. Monitoring Screen - New Data Set - No Baselines Set... Figure 37. SET BASELINES - No Baselines Previously Set... Figure 38. SET BASELINES - Baselines Previously Set... Figure 39. Monitoring Screen with Baselines Set... Figure 40. Trend View... Figure 41. Trend View - One Graph (Top, Default) and Two Graphs (Bottom)... Figure 43. SETTINGS - TRENDS - TWO AXIS VIEW vs. ONE AXIS VIEW... Figure 44. Trend Line Averaging... Figure 45. SETTINGS - TRENDS - TREND LINE AVERAGING... Figure 46. Trend View Review Mode... Figure 47. Trend Graph Pop-Up... Figure 48. Monitoring Screen - Trend Graph Pop-Up... Figure 49. Visual Alarm Indicators... Figure 50. SET ALARM LIMITS - Default Settings... Figure 51. SET ALARM LIMITS - Upper Limits On... Figure 52. SETTINGS - ALARMS - ALARM VOLUME... Figure 56. Dismissible Alarm... Operator's Manual

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Figure 58. Events Marked in Trend View... 67 Figure 59. ADD EVENT Menu... 67 Figure 60. Event Mark Label... 68 Figure 61. EDIT EVENT Menu... 69 Figure 62. SETTINGS - EVENTS (Screen 1)... 70 Figure 63. AUC SUMMARY Screen... 71 Figure 64. CASE HISTORY List... 73 Figure 65. Case History Example... 74 Figure 66. VGA Port on Docking Station... 78 Figure 67. Serial Port on Docking Station... 79 Figure 68. Serial Port Pin-Outs... 79 Figure 69. Null Modem Cable Diagram for Connection to Serial Port (Two Options) . . 81 Figure 70. Accuracy rSO2 and fSO2, 20 Subjects... 122 Figure 71. Trend rSO2 and fSO2, 20 Subjects... 123

Tables Table 1. Monitoring System - Standard Shipped Items... 23 Table 2. AC Power Indicators... 25 Table 3. Battery Status Indicators - Monitoring System Operating on Battery Power . . 26 Table 4. Institutional Settings... 34 Table 5. Quick Start Steps... 39 Table 6. Operational Defaults... 40 Table 7. Menu Structure... 41 Table 8. System Memory - Common Situations and Recommended Actions... 42 Table 9. Alarm Audio Button States... 61 Table 10. Audible and Visual Alarm Indicators... 62 Table 11. Alarm Limits Settings... 62 Table 12. Serial Port Pin-Out Descriptions... 79 Table 13. Hardware Requirements for Philips VueLink™* and IntelliBridge™* Communication... 80 Table 14. Case History Downloads - Data Fields... 83 Table 15. Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields... 85 Table 16. Data Downloads - Event Codes 1 to 40... 86 Table 17. Data Downloads - Event Codes 41 to 80... 86 Table 18. Data Downloads - Event Codes 81 to 120... 87 Table 19. Data Downloads - Event Codes 121 to 254... 87 Table 20. Data Downloads - Status Codes... 88 Table 21. Maintenance Schedule... 96 Table 22. Alarm Conditions... 99 Table 23. Error Conditions and Resolutions... 103 Table 24. Monitoring System Accessory Part Numbers... 107 Table 25. Transport, Storage, and Operating Condition Ranges... 113 Table 26. Alarm Audio Characteristics... 113 Table 27. Average Alarm Sound Pressure Levels... 113 Table 28. Alarm Visual Characteristics... 114 Table 29. POST Pass Tone Characteristics... 114 4 Operator's Manual

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Table 30. INVOS™ Adult rSO2 Sensor Operating Range... 114 Table 31. Electromagnetic Emissions Guidelines and Compliance... 116 Table 32. Electromagnetic Immunity Guidelines and Compliance... 116 Table 33. Recommended Separation Distance Calculations... 117 Table 34. Test Specifications for Enclosure Port Immunity to RF Wireless Communications Equipment... 118 Table 35. Recommended Separation Distances... 119 Table 36. Performance Characteristics: Accuracy Bias, Error (SD), RMSD, and Correlation (R2) for rSO2 and fSO2, 20 Subjects... 122 Table 37. Trend Bias, Error (SD), and Correlation (R2) for ΔrSO2 and ΔfSO2, 20 subjects 123

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1. Introduction 1.1. Overview

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

Intended Audience, page 7

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Safety Information, page 7

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Obtaining Technical Assistance, page 10

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Warranty Information, page 11

1.2. 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.

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

Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment.

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Cautions alert users to exercise appropriate care for safe and effective use of the product.

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Notes provide additional guidelines or information.

1.3.1. Explosion, Shock, and Toxicity Hazards 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 107. 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-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 Operator's Manual

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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.

1.3.2. Patient Monitoring and Safety 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. 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 multiparameter system operator should not rely on the multi-parameter 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.

1.3.3. Operation 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 91. 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 107.

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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 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.

1.3.4. 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.

1.3.5. Electromagnetic Interference 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. 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

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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.

1.3.6. Cleaning 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.

1.4. 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 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. Start-up Screen Showing Code Version

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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 •

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

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

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

1.5. Warranty Information To obtain product warranty information, contact Medtronic or a local Medtronic representative. See Technical Services, page 10. 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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2. Product Overview 2.1. Overview This chapter contains basic information about the INVOS™ patient monitor (the “monitoring system”). •

Product Description, page 13

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Indications for Use, page 14

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Product Views, page 14

2.2. Product Description

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The monitoring system provides continuous, noninvasive indications of changes in regional oxygen saturation of blood (rSO2) in cerebral and somatic tissues. The monitoring system consists of: •

A tablet-style monitor that can be operated on AC or battery power

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A VESA™* docking station for the monitor, with USB, Serial (RS-232), and VGA ports

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An AC power supply and cord that attaches to the docking station

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Up to two preamplifiers to accommodate up to four sensors (two per preamplifier)

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Up to four reusable sensor cables (RSCs) to attach sensors to the preamplifiers

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INVOS™ rSO2 sensors

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Additional accessories as described in Chapter 9, Accessories, page 107

Monitoring system features include: •

User configurable rSO2 baselines (page 52), alarm limits (page 62), and AUC thresholds (page 70)

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Physiological and technical alarm reporting (page 99)

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User configurable data display (rSO2, change from baseline, sensor labels, and trend data) (Figure 9, page 20)

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Alarm silencing (page 64)

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Event marking (page 66)

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Visual representations of sensor locations (page 47)

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Sensor functional state (page 99):

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Sensor off

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Sensor disconnect

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Sensor fault

Case history storage and export (page 73)

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Real-time data output to external devices such as a Philips multi-parameter system or PC (page 78)

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VGA, Serial (RS-232), and USB interfaces (Figure 4, page 16 and Figure 7, page 19)

2.3. Indications for Use The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals greater than 40 kg at risk for reduced-flow or no-flow ischemic states.

2.4. Product Views 2.4.1. Full System 2.4.1.1. System Component Overview Figure 2. INVOS™ Patient Monitor Components

1. Sensors 2. Preamplifier 3. Docking station

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4. Monitor 5. Reusable sensor cable (RSC)

2.4.2. Monitor Components 2.4.2.1. Monitor - Front Figure 3. Monitor - Front

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1. VESA™*-compliant stand accessory 2. Power cord (connected to bottom of docking station) 3. Docking station

4. Monitor indicators (power/battery, hard disk activity, wireless) 5. Monitor 6. Docking station power indicator (illuminates blue when the docking station is receiving AC power)

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2.4.2.2. Monitor - Left Side Figure 4. Monitor - Left Side

1. Lever for adjusting monitor angle 2. I/O port cover with latch (slide to access ports inside) 3. USB 3.0 port

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4. USB 2.0 port 5. Docking station