INVOS 5100C Operations Manual Rev D

INVOS 5100C System Operations Manual

Description of Symbols OXIMETER ENCLOSURE

DISPLAY

Alternating Current

Alarm

Backup Battery

Baseline

Blue LED – indicating AC Power Supply and Battery Charge ON

Battery

Caution; consult accompanying documents

Signal Strength Indicator

Digital Output

Silence Alarm

Do not dispose in trash. Use special collection. Fuse Green LED – indicating power ON

OTHER LABELS

HOME Potential Equalization

Catalog number

Preamplifier

Follow instructions for use

Light Source

Consult instructions for use

Serial Number

Authorized representative in the European Community

Stand-by (ON/OFF)

Do not reuse

Type BF Equipment

Manufacturer

USB Port

Type BF Equipment

VGA Output Port

Dangerous voltage

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INVOS 5100C System Operations Manual

Table of Contents Description of Symbols... iii

4.5.7 AUC Summary Screen (Normal Mode)...26 4.5.8 Baseline Reset Screen...27 4.5.9 Channel Inactivity Screen...28 4.5.10 RS-232 Digital Output Format Selection Screen ...28 4.5.11 Tabular Trends Screen...29 4.5.12 Case Archive File List Screen...31 4.5.13 Case Review Screen...32

Chapter 1 Warnings/Cautions... 1 1.0 Key Terms... 1 1.1 Warnings... 1 1.2 Precautions... 2 1.3 Indications For Use... 3 1.4 Contraindications... 3

Chapter 5 Installation ... 35 5.0 Chapter Overview...35 5.1 Unpacking...35 5.2 Serial Numbers ...35 5.4 Digital Output Port ...37 5.5 VGA Output Port ...37 5.6 Potential Equalization Connector ...37 5.7 Alarm Speaker...37 5.8 Cooling Fan ...37 5.9 AC Input and Fuse ...37 5.10 USB Port ...37 5.11 Accessories...38 5.12 Preamplifier ...39 5.13 Reusable Sensor Cable...40 5.14 Adult and Pediatric SomaSensor Application .40 5.14.1 SomaSensor Lot Number...40 5.15 Infant/Neonatal OxyAlert NIRSensor Application ...41 5.15.1 OxyAlert NIRSensor Lot Number...41 5.16 When INVOS System is Part of a Medical Monitoring System...41

Chapter 2 Before You Begin... 5 2.0 Chapter Overview... 5 2.1 How to Use this Manual... 5 2.2 Application of the INVOS System... 5 2.3 SomaSensor® and OxyAlert® NIRSensor... 5 2.4 Use of Product... 6 2.5 Customer Inquiries... 6 2.5.1 Service and Repair... 6 Chapter 3 Quick Setup ... 7 3.0 Chapter Overview... 7 3.1 Initial Setup, Adult Sensors... 7 Chapter 4 INVOS 5100C Description... 9 4.0 Chapter Overview... 9 4.1 Principle of Operation... 9 4.2 Specifications... 9 4.2.1 Physical... 9 4.2.2 Operational...10 4.2.3 Electrical...10 4.2.4 Environmental Requirements...10 4.2.5 Alarm Conditions...11 4.2.6 Alarm Tone Definitions...11 4.2.8 Factory Default Settings...12 4.2.9 Additional...13 4.3 Guidance and Manufacturer’s Declaration Electromagnetic Compatibility (EMC)...14 4.3.2 Guidance and Manufacturer’s Declaration Electromagnetic Immunity...15 4.4 System Diagram...17 4.5 Display Screens...18 4.5.1 Welcome Screen ...18 4.5.2 Start Screen, Navigation Bar, Key Panel and Software Version...19 4.5.3 Patient Identifier Screen...20 4.5.4 Main Screen...21 4.5.5 User Configuration Screen ...24 4.5.6 Event Mark List Screen...25

Chapter 6 Operating the INVOS System... 43 6.0 Chapter Overview...43 6.1 INVOS System Pre-use Check...43 6.2 Operational Modes...43 6.3 Language, Date, Time, and Patient Identifier Settings ...44 6.3.1 Language...44 6.3.2 Date ...44 6.3.3 Time ...45 6.3.4 Patient Identifier...45 6.4 Run Function (Patient Monitoring) in Normal Mode ...46 6.4.1 Baseline Set and Status ...47 6.4.2 Event Mark...49 6.4.3 Alarm Limits...54 6.4.4 Alarm Volume...55 6.4.5 rSO2 Scale...56 6.4.6 Time Scale in User Configuration Menu...56

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Table of Contents

6.4.7 USB Storage Rate...57 6.4.8 Event Mark List...58 6.4.9 Data Channel Labels...58 6.4.10 Color Code Data Channel Labels...58 6.4.11 Cumulative Saturation Below Threshold (AUC) in Normal Mode...59 6.4.12 Trend Line Averaging...60 6.4.13 2- or 4-Channel Monitoring...60 6.4.14 Set All Defaults...61 6.4.15 Alarms and Status Messages...62 6.4.16 Signal Strength Indicator (SSI) ...65 6.4.17 Time Scale ...65 6.4.18 Real-Time Review ...65 6.5 Case Archive Function...66 6.5.1 Case Archive Function – Graphical Format ...67 6.5.2 Case Archive Function – Tabular Trends Screen Format...67

8.1.1 Field Name: Pre-Induction Baseline Regional Oxygen Saturation - Left...85 8.1.2 Field Name: Pre-Induction Baseline Regional Oxygen Saturation - Right...85 8.1.3 Field Name: Cumulative Saturation Below Threshold - Left...85 8.1.4 Field Name: Cumulative Saturation Below Threshold - Right...86 8.1.5 Field Name: Cerebral Oximeter Provided The First Indication...86 8.1.6 Field Name: Skin Closure Regional Oxygen Saturation - Left...86 8.1.7 Field Name: Skin Closure Regional Oxygen Saturation - Right...86 8.2 Database Operational Mode Display Screens..86 8.2.1 Start Screen in Database Operational Mode ...87 8.2.2 Database Case Type Selection Screen...88 8.2.3 Database Configuration Confirmation Screen ...88 8.2.4 Main Screen in Database Operational Mode ...89 8.2.5 Tabular Trends for Entering Induction Time Screen ...90 8.2.6 Tabular Trends for Entering Skin Closure Time Screen ...90 8.2.7 Adult Database Summary Screen...91 8.3 Features ...93 8.4 Operating in the Database Operational Mode ...94 8.4.1 Baseline Set and Status Database Operational Mode ...94 8.4.2 Patient Identifier in Database Operational Mode ...95 8.5 Collecting Adult Cardiac Surgery Database Metrics in Database Operational Mode...96 8.5.1 Marking the Induction Time...96 8.5.2 Marking the Skin Closure Time...98 8.5.3 Capturing the First Alert Metric...98 8.5.4 Marking Metrics at the End of a Case...99 8.6 Reviewing the Case in Database Operational Mode ...99 8.6.1 Real-Time Review of Database Information ...99 8.6.2 Case Archive Function in Database Operational Mode... 100 8.7 Outputting the Metrics in Database Operational Mode... 101 8.7.1 Outputting Database Summary Screen to USB Flash Drive During a Case or Prior to Next Patient ... 101 8.7.2 Outputting Database Summary to USB Flash Drive in Case Archive Function... 102 8.7.3 Printing Database Summary to Smart

Chapter 7 Using the Monitor Ports: Video Out, USB, Serial (Digital) Out ... 69 7.0 Chapter Overview...69 7.1 Using the VGA Port...69 7.2 Using the USB Port ...70 7.2.1 USB Port Output - Case Archive Function...70 7.2.2 USB Port Output - Run Function...72 7.3 Using the Digital Output Port ...72 7.3.1 Using a Philips IntelliBridge and VueLink Open Interface (IVOI) Module ...73 7.3.2 Select Digital Output Port Data Format ...75 7.3.3 Using HyperTerminal via Null Modem Cable to Capture and Store Data ...76 7.3.4 Connecting a Smart Label Printer for Printing Database Operational Mode Summary ...79 7.4 Data Output Formats...80 7.4.1 Real-Time Data Format – USB ...80 7.4.2 Case History Data Format - USB ...81 7.4.3 Real-Time Data Format – Digital Output Format 1 ...81 7.4.4 Case History Data Format – Digital Output Format 1 ...82 7.4.5 Real-Time Data Format – Digital Output Format 2 ...82 7.4.6 Case History Data Format – Digital Output Format 2 ...82 Chapter 8 Database Operational Mode Adult Cardiac Surgery Database... 85 8.0 Chapter Overview...85 8.0.1 INVOS System Database Application Software ...85 8.1 Database Variable and Fields...85

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INVOS 5100C System Operations Manual

Appendix A Clinical Studies... 127 A.0 Chapter Overview... 127 A.1 Hypoxia Study... 127 A.2 Pediatric Clinical Study... 128 A.3 Interventional Studies... 129 A.4 Validation Studies... 130

Label Printer During a Case or Prior to Next Patient ... 102 8.7.4 Printing Database Summary to Smart Label Printer in Case Archive Function... 103 Chapter 9 Congenital Heart Surgery Database... 105 9.0 Chapter Overview... 105 9.0.1 INVOS System Database Application Software ... 105 9.1 Collecting Congenital Heart Surgery Database Metrics... 105 9.1.1 Intraoperative Near Infrared Spectroscopy (NIRS) Metrics (Cerebral and Somatic)... 106 9.1.2 Postoperative Near Infrared Spectroscopy (NIRS) Metrics (Cerebral and Somatic)... 111

Glossary ...131

Chapter 10 INVOS System Warranty... 115 10.0 Chapter Overview... 115 10.1 Key Points... 115 10.2 Limited Warranty and Disclaimer... 115 10.3 Warranty Labor... 116 10.4 Disclaimer of Consequential Damages... 116 10.5 Failure of Product... 116 10.6 Purpose of Product... 116 10.7 Returning an INVOS System for Service... 116 10.8 Warnings about Unauthorized Repair... 117 10.9 Who to Contact for Authorized Repair... 117 Chapter 11 Maintenance ... 119 11.0 Chapter Overview... 119 11.1 Software Upgrades... 119 11.2 Repair Policy... 119 11.3 Cleaning the INVOS System... 119 11.4 Battery Recharge... 120 11.4.1 Check Battery Status... 120 11.4.2 Re-Charge Battery... 120 11.5 Maintenance Schedule... 120 11.6 Annual Inspection Procedure... 121 11.6.1 Mechanical Inspection Points... 121 11.6.2 Electrical Inspection Points... 121 11.6.3 Functional Test with Optional Field Test Device ... 122 11.7 Troubleshooting Techniques... 123 11.7.1 Who to Contact for Technical Service... 123 11.7.2 Check Fuses... 123 11.7.3 Troubleshooting Chart... 124 11.7.4 Troubleshooting the Digital Output... 125 11.7.5 Troubleshooting Signal Strength Indicator (SSI)... 125

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INVOS 5100C System Operations Manual

Chapter 1 Warnings/Cautions NOTE: US FEDERAL REGULATIONS RESTRICT THE SALE OF THIS DEVICE TO, OR ON THE ORDER OF, LICENSED MEDICAL PRACTITIONERS.

1.0

Key Terms

rSO2:

Regional Oxygen Saturation

INVOS®:

In Vivo Optical Spectroscopy. Used in reference to the INVOS Cerebral/ Somatic Oximeter

Cerebral (application for INVOS):

Brain area of measurement

Pediatric (application for INVOS):

Disposable Pediatric SomaSensor has been designed for use with pediatric patients weighing less than 40 kilograms

Infant/Neonatal (application for INVOS): Disposable Infant/Neonatal OxyAlert NIRSensor has a small adhesive pad and a gentle hydrocolloid adhesive for use with infant or neonatal patients. Suitable for patients weighing less than 40 kilograms Somatic (application for INVOS):

Tissue area of measurement other than cerebral

SomaSensor®:

Trademark name for disposable sensor for use with the INVOS Cerebral/ Somatic Oximeter

OxyAlert® NIRSensor:

Trademark name for disposable sensor for use with the INVOS Cerebral/ Somatic Oximeter

Sensor:

Used in this manual to represent the SomaSensor and OxyAlert NIRSensor patient applied transducer

1.1 •

Warnings Shock hazard: º

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.

º

Backup battery is not user replaceable.

º

Do not immerse the INVOS System in any liquids as they may cause electric shock hazard or damage the device.

º

If the integrity of the external protective earth ground is in doubt, the INVOS System should be operated from the internal backup battery power source.

º

Only make external connections to the types of equipment specified in the interfacing chapter of this manual (See Chapter 7 Using the Monitor Ports). Connecting any other types of equipment may result in damage to the INVOS System or compromise its safety. When a Personal Computer (PC) or specified printer is used for data downloading and collection, the device should be in compliance with IEC 60601 “Medical Electrical Equipment” Standard or IEC: “Non-medical equipment in compliance with relevant IEC safety standards.” It is recommended that the PC be placed outside of the “Patient Environment.” If this condition cannot be met and the PC is also placed inside the “Patient Environment,” then additional protective earth or leakage current reduction measures, such as a power supply separation device shall be used (See IEC 60601-1-1, subclause 19.201 and table BBB. 201). Follow all warnings and precautions provided with device.

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Chapter 1 - Warnings/Cautions

•

Explosion hazard: Do not use the INVOS System in the presence of flammable anesthetics or in other flammable environments.

•

Cross-contamination hazard: The SomaSensor and OxyAlert NIRSensor are designed for single use only and may not be reused. Reuse may cause inaccurate readings, erratic readings, or no readings at all. Also, reuse may cause an increased risk of cross-contamination among patients. Do not autoclave or gas sterilize the INVOS System or sensors.

•

Patient hazard: º

The SomaSensor and OxyAlert NIRSensor are designed for external use only as described in the instructions. Do not use the sensors internally for any reason.

º

Ensure alarm limits are appropriate for the patient being monitored with each use of the INVOS system.

º

Do not preset different or inappropriate alarm limits for the same or similar equipment in any single area, since this may compromise patient safety.

•

Fire hazard: Do not block airflow to the back of the INVOS Monitor.

•

The clinical value of trend data has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

1.2

Precautions

•

INVOS readings represent a small volume of tissue beneath the sensor and may not reflect oxygenation disturbances that occur elsewhere.

•

Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause inaccurate readings, erratic readings or no readings at all.

•

Use care when placing or removing sensor. Do not place on broken or undeveloped skin.

•

For cerebral site selection, do not place the sensor over nevi, sinus cavities, the superior sagittal sinus, subdural or epidural 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.

•

For somatic site selection, avoid placing the sensor over thick fatty deposits, hair or bony protuberances. 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.

•

Use only Covidien recommended or provided accessories. Use of the INVOS System with any other sensor will compromise accuracy.

•

If present, the following may cause inaccurate readings: o

“Cardiogreen,” “Indigo Carmine,” “Methylene Blue” or other intravascular dyes

o

Carboxyhemoglobin or other dyshemoglobins

o

Hemoglobinopathies

o

Conjugated hyperbilirubinemia (direct)

o

Myoglobin (Mb) in muscle tissues

•

Do not place the sensor on regions with severe tissue edema to reduce the possibility of skin lesions.

•

Use of an electrosurgical/electrocautery instrument in the vicinity of the INVOS System may interfere with the signal and result in no readings and the status message “INTERFERENCE DETECTED.”

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INVOS 5100C System Operations Manual

•

Environments with excessive ambient light such as bright sunlight or strong operating room lighting may require loosely covering the area of the sensor with an opaque drape.

•

In order to maintain full backup battery charge, the INVOS System must be plugged into AC mains power with the back panel AC mains power switch turned on. The blue LED on the key panel illuminates to indicate the power is connected and the battery is charging. Periodically disconnect the INVOS monitor from the AC power source and briefly operate the monitor to check the charge condition of the backup battery.

•

Adult, pediatric and infant/neonatal sensors cannot be mixed/used simultaneously on the same monitor or a “REPLACE SENSOR” status message will appear. Cerebral sensors can be used with somatic sensors of the same type on the same monitor.

•

To avoid pressure sores do not apply external pressure (e.g. headbands, wraps, tape) to sensor.

•

Sensors do not need to be removed for X-ray or CT Scan. However, sensors will appear on image. Sensors must be removed for MRI.

•

Do not set alarm limits to extreme values that render the alarm system useless. Ensure alarm limits are appropriate for each patient.

1.3

Indications For Use

The noninvasive INVOS 5100C is 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 in individuals greater than 2.5 kg at risk for reduced-flow or no-flow ischemic states. It is also 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 in any individual.

1.4

Contraindications

None.

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Chapter 1 - Warnings/Cautions

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INVOS 5100C System Operations Manual

Chapter 2 Before You Begin 2.0

Chapter Overview

This chapter provides information that the operator should know before attempting to operate the INVOS System.

2.1

How to Use this Manual

Please comply with the warnings listed in Chapter 1, and consult this manual for operation and maintenance instructions. Read the manual completely before using the INVOS System to ensure proper, safe operation. Do not attempt to repair the INVOS System during the warranty period. Only Covidien or its Authorized Repair Representative should make repairs during the warranty period.

2.2

Application of the INVOS System

The INVOS System provides noninvasive and continuous information of changes in regional oxygen saturation of blood. The measurement takes place in real time, providing an immediate indication of a change in the critical balance of regional oxygen delivery and oxygen consumption. The INVOS System consists of: •

Monitor and Power Cord

•

One or two Preamplifiers with cables, locking mechanism and hooks

•

Reusable Sensor Cables for use with SomaSensor Models SAFB-SM (Adult) and SPFB (Pediatric)

•

Disposable Sensors (one through four - See Figure 2-1 Disposable Sensors)

•

Accessories (See Section 5.11 Accessories)

2.3

SomaSensor® and OxyAlert® NIRSensor

The SomaSensor 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 System. They are applied to the forehead or somatic region via self-contained, medical-grade patient adhesive. Electrical signals from the detectors are sent through the shielded cable to the INVOS System for processing. The sensors are designed for single use only and may not be reused. Reuse of the sensors may cause inaccurate readings, erratic readings, or no readings at all. Reuse will also cause an increased risk of cross-contamination (See Section 5.14 Adult and Pediatric Sensor Application, Section 5.15 Infant/Neonatal OxyAlert NIRSensor Application and Instructions For Use inside carton). Light Emitting Diode (LED) Detectors

Figure 2-1 Disposable Sensors

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Chapter 2 - Before You Begin

2.4

Use of Product

Do not use this product if it is found defective in any way; contact Covidien’s 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 function as described. The user is responsible for operating and maintaining the INVOS System according to instructions outlined in this manual. The manufacturer (Covidien) is not responsible for injury or losses if the INVOS System is not used in compliance with instructions.

2.5

Customer Inquiries

For any questions regarding INVOS System safety and effectiveness or any other information, please contact Covidien’s Customer Service Department.

2.5.1

Service and Repair

If the INVOS System fails to operate as stated, it should be taken out of service immediately (See Section 11.7 Troubleshooting Techniques). WARNING: 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. For troubleshooting assistance, contact Covidien’s Customer Service Department at 800-635-5267, Customer. [email protected] or www.covidien.com or an Authorized Repair Representative. If the problem cannot be solved via phone or online, follow the steps below to return the unit for service: 1.

To obtain a Return Material Authorization (RMA) number, contact a Covidien’s Customer Service Representative at: Covidien llc 15 Hampshire Street Mansfield, MA 02048 USA Ph: 800-635-5267 Web: www.covidien.com Email: [email protected]

2.

When returning an INVOS System, ship it prepaid, in the original container as received. It is important to use the original container and packing material to prevent damage to the INVOS System in shipping. Covidien will not assume responsibility for damage caused in shipment if the customer does not use original shipping materials. Shipping materials can be obtained by contacting Covidien’s Customer Service Department. Also include:

•

Detailed description of the problem or need.

•

RMA number and serial number of the INVOS Monitor.

•

Name and phone number of the person to contact within your facility.

•

Information regarding where and to whom to return the INVOS System.

•

All accessories that came with the product: Preamplifier, AC Line Cord, and any other optional attachments.

NOTE: FOR ADDITIONAL WARRANTY AND REPAIR INFORMATION SEE CHAPTER 9 INVOS SYSTEM WARRANTY.

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INVOS 5100C System Operations Manual

Chapter 3 Quick Setup 3.0

Chapter Overview

This chapter briefly describes the setup of the INVOS System (See also Chapter 1 Warnings/Cautions, Chapter 5 Installation and Chapter 6 Operating the INVOS System for complete instructions).

3.1 1.

Initial Setup, Adult Sensors Plug in INVOS Monitor to power source.

NOTE: THE BLUE LED ILLUMINATES TO INDICATE THE POWER IS CONNECTED AND THE BATTERY IS CHARGING. IF BLUE LIGHT IS NOT ON, TURN BACK PANEL MASTER (MAINS) POWER SWITCH ON. 2.

Connect Preamplifier(s) to INVOS Monitor. Align red dot on the Preamplifier cable silver connector with red dot on side panel input connection. Insert cable connector into side panel connection while keeping the dots aligned. Be sure to fully insert the connector until it locks.

3.

Connect the Reusable Sensor Cable Connectors to Preamplifier(s). Use color-coding. Close preamp locking mechanism down over cables once inserted. Blue clip can join together two cables.

NOTE: OXYALERT NIRSENSORS CONNECT DIRECTLY TO THE PREAMPLIFIER AND DO NOT USE THE REUSABLE SENSOR CABLE (APPLIES TO STEPS 3 AND 4).

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Chapter 3 - Quick Setup

4.

Attach Sensors to Reusable Sensor Cables. Hold connectors. (Sensor cable can be connected to sensors before or after placement). Different INVOS System sensors (adult, pediatric and infant/neonatal) cannot be used on the same monitor. (See sensor Instructions For Use inside carton.)

5.

Connect any optional accessories, including the Covidien USB Flash Drive.

NOTE: THE USB FLASH DRIVE SHOULD BE INSERTED WHEN THE CASE BEGINS TO CAPTURE REAL-TIME DATA TO THE USB. KEEP THE USB FLASH DRIVE INSERTED FOR THE FULL DURATION OF THE CASE. IF REMOVED, THERE WILL BE GAPS IN THE CASE DATA COLLECTED. REGARDLESS OF USB FLASH DRIVE USAGE, THE INVOS SYSTEM WILL MONITOR AND STORE DATA TO ITS INTERNAL MEMORY, SO ENTIRE CASES CAN BE DOWNLOADED IN THE “CASE HISTORY” FORMAT (SEE 7.2 USING THE USB PORT). AS A REMINDER TO INSERT THE USB, A BLINKING MESSAGE “USB FLASH DRIVE NOT CONNECTED” WILL APPEAR ON THE “START SCREEN” WHEN THE SYSTEM IS POWERED ON. USB FLASH DRIVES NOT SUPPLIED BY COVIDIEN MAY NOT MEET SYSTEM REQUIREMENTS. ADDITIONAL DRIVES MAY BE ORDERED FROM COVIDIEN (SEE SECTION 5.11 ACCESSORIES). key.

6.

Turn power ON by selecting the green ON/OFF

7.

After displaying the Welcome Screen, the INVOS System performs a 10-second self-test, stopping at the Start Screen, a display of the software version, date and time.

8.

If necessary, set the DATE/TIME by following the options menus. The date and time may only be changed from the Start Screen.

9.

Press NEW PATIENT. Monitoring begins.

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INVOS 5100C System Operations Manual

Chapter 4 INVOS 5100C Description 4.0

Chapter Overview

This chapter provides product principles of operation and specifications for the INVOS® 5100C System.

4.1

Principle of Operation The INVOS System “reflects the color of life®.” The harmless, near-infrared wavelengths generated by the INVOS System’s light-emitting diodes (LEDs) easily pass through scalp and bone tissue beneath the sensor. Once in vivo they are either absorbed or scattered back up to the sensor’s shallow and deep detectors. Red-colored hemoglobin molecules within red blood cells have the highest light absorption of the wavelengths used, and 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 de-oxyhemoglobin and total hemoglobin, from which a regional oxygen saturation (rSO2) value unique to the specific area under the sensor is calculated. Values are measured continuously, with display screen updates provided to clinicians every five seconds.

Since brain cells and organ tissues die within minutes without proper oxygenation, measurement of this color provides potentially life-saving or life-changing information. When rSO2 values show an oxygen deficit or change, the care team can intervene to potentially lessen or prevent adverse events.

4.2

Specifications

4.2.1

Physical

Dimensions

OXIMETER

PREAMPLIFIER

Height

9.5” (24 cm)

9.5” (24 cm)

Width

11.25” (29 cm)

3.13” (8 cm)

Depth

7.5” (19 cm)

1.75” (4.5 cm)

10.9 lbs. (4.95 kg)

1.2 lbs. (.52 kg)

Weight Preamplifier Cable Length

15 feet (4.5 m)

Reusable Sensor Cable Length (SomaSensor)

5 feet (1.5 m)

OxyAlert NIRSensor Cable Length

5 feet (1.5 m)

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Chapter 4 - INVOS 5100C Description

4.2.2

Operational

Range of rSO2

15 – 95 (updated every 5 – 6 seconds)

Repeatability

Hardware (including sensor) repeatability is within 1 rSO2 point from unit to unit (measured in vitro).

Alarm Limit Range

High: 20 – 95; Low: 15 – 90 High and low limits cannot cross

Trend Memory

24 hours at 2 samples per minute

Diagnostics

Automatic self-test

Safety Class

Continuous Operation 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 6.4.14 Signal Strength Indicator and 11.7.5 Troubleshooting Signal Strength Indicator

4.2.3

Electrical

Input Voltage

100 – 240VAC

Frequency

50/60 Hz

Current

1.0A – 0.5A (maximum at 100 and 240 volts respectively)

Fuse

F2.5A 250V

Backup Battery

12VDC; approximately 20 minutes

Digital Output

RS-232 communications

USB Port

USB 2.0 Flash Memory (does not support other USB devices)

4.2.4

Environmental Requirements

Operating Temperature

+60°F to +90°F (+16°C to +32°C)

Storage Temperature

-4°F to 110°F (-20°C to +45°C)

Humidity

20% - 80%, non-condensing

Altitude

To 10,000 feet (3,048 m)

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INVOS 5100C System Operations Manual

4.2.5

Alarm Conditions

PRIORITY Medium

RATE

COLOR

TYPE

Sounds every 8 seconds while the alarm condition persists

Yellow Steady message, Slow flashing label

Physiological

MESSAGES High rSO2 Low rSO2

Technical

Sensor not connected Excessive Light Poor signal quality Preamp not connected Replace sensor Interference detected Sensor unusable

Low

Sounds every 16 seconds while the alarm condition persists

Steady yellow

Technical

Battery low COM Port unavailable Printer unavailable USB storage full USB storage error Auto baseline set

Note: During multiple-alarm conditions, alarms are presented as follows: •

If Two medium-priority alarms occur simultaneously, the alarm status message toggles between the two.

•

If a medium-priority and low-priority alarm occur simultaneously, Only the mediumpriority alarm is displayed AND ONLY THE MEDIUM-PRIORITY TONE IS SOUNDED.

•

A medium-priority physiological alarm overrides a low-priority alarm.

4.2.6

Alarm Tone Definitions

TONE CATEGORY

DESCRIPTION Medium Priority Alarm Tone

Volume level

High, Medium, and Low

Sound pressure

60 dB (High volume), 52 dB (Medium volume), 44 dB (Low volume)

Pitch (± 5Hz)

770 Hz

Pulse width (± 20 msec)

200 msec

Number of pulses in burst

3

Repetitions

Continually

Interburst interval

Approximately 9 sec Low Priority Alarm Tone

Volume level

High, Medium, and Low

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Chapter 4 - INVOS 5100C Description

TONE CATEGORY

DESCRIPTION

Sound pressure

60 dB (High volume), 52 dB (Medium volume), 44 dB (Low volume)

Pitch (± 5Hz)

770 Hz

Pulse width (± 20 msec)

200 msec

Number of pulses

1 pulse

Repetitions

Continually every 16 seconds while visual alarm is presented Alarm Reminder Tone

Volume level

High, Medium, and Low

Pitch (± 20Hz)

770 Hz

Pulse width (± 20 msec)

900 msec

Number of pulses

1 pulse

Repetitions

Continually every 3 minutes

4.2.7

Display Colors During Alarm Condition

Alarm Priority

Display Message/Value

Behavior

Medium

rSO2

Color Change to Yellow

Status Message

Message is displayed in Yellow

Label

Flashes between Yellow and White with 0.5 Hz frequency and 50% duty cycle

Status Message

Message is displayed in Yellow

FACTORY DEFAULT

RANGE

High Alarm Limit

OFF

20-95

Low Alarm Limit

40

15-90

Alarm Volume

Medium

Low, Medium, High

High rSO2 Scale Limit

100

60-100 in increments of 10; 5 above High Alarm Limit

Low rSO2 Scale Limit

30

0-30 in increments of 10; 5 below Low Alarm Limit

Time (Trend) Scale

1 hour

1, 2, 4, 8, 12, 24 hours

USB Storage Rate

5 seconds

5, 30, and 60 seconds

Event Mark List

OR

OR, ICU, Vascular, NICU

Low

4.2.8

Factory Default Settings

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INVOS 5100C System Operations Manual

FACTORY DEFAULT

RANGE

Channel Labels

L, R, S1, S2

A – Z, S1 – S4

Color Coded Labels

No

Yes, No

Output Format (Digital Output)

1

1 - 3 (See Section 7.4 Data Output Formats)

Alarm Audio Off Reminder

OFF

OFF, ON

4.2.9

Additional

Software

Software version is displayed on the Start Screen.

End-of-life Management and Recycling

Lifetime is indefinite when used under specified operating conditions and preventive maintenance is performed, subject to component availability. This product is designed to comply with the Waste Electrical and Electronic Equipment (WEEE) Directive, 2002/96/EC. For end-of-life product return and recycling, contact your Authorized Representative or Covidien’s Customer Service Department at 800-635-5267, [email protected] or via the internet at www.covidien.com.

Certification and Compliance

The INVOS System complies with the following U.S. and International regulatory standards for medical equipment: 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.

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Chapter 4 - INVOS 5100C Description

4.3 Guidance and Manufacturer’s Declaration - Electromagnetic Compatibility (EMC) WARNING: The INVOS® Cerebral/Somatic Oximeter, Model 5100C is intended for use by healthcare professionals only. This monitoring 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® Cerebral/Somatic Oximeter, Model 5100C or shielding the location. WARNING: The INVOS® Cerebral/Somatic Oximeter, Model 5100C should not be used adjacent to or stacked with other equipment, except as may be specified elsewhere in this manual. If adjacent or stacked use is necessary, the INVOS® Cerebral/Somatic Oximeter, Model 5100C should be observed to verify normal operation in the configurations in which it will be used. WARNING: The use of accessories, sensors, and cables other than those specified may result in inaccurate readings of the INVOS® Cerebral/Somatic Oximeter, Model 5100C and increased EMI emissions of the INVOS® Cerebral/Somatic Oximeter, Model 5100C. Caution: The INVOS® Cerebral/Somatic Oximeter, Model 5100C is not intended for use in residential environments and may not provide adequate protection to radio communication services in such environments. The INVOS® Cerebral/Somatic Oximeter, Model 5100C is suitable for prescription use only in the specified electromagnetic environments, in accordance with the IEC 60601-1-2:2007 standard. The INVOS® Cerebral/ Somatic Oximeter, Model 5100C requires special precautions during installation and operation for electromagnetic compatibility. In particular, the use of nearby mobile or portable communications equipment may influence INVOS® Cerebral/Somatic Oximeter, Model 5100C performance.

4.3.1

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The INVOS® Cerebral/Somatic Oximeter, Model 5100C is intended for use in the electromagnetic environment specified below. The customer or user of the INVOS® Cerebral/Somatic Oximeter, Model 5100C should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment Guidance

RF emission CISPR 11

Group 1

The INVOS® Cerebral/Somatic Oximeter, Model 5100C uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission CISPR 11

Class A

Harmonic emissions IEC/EN 61000-3-2

N/A

Voltage fluctuation/ flicker emissions

N/A

The INVOS® Cerebral/Somatic Oximeter, Model 5100C is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power network that supplies buildings used for domestic purposes.

IEC/EN 61000-3-3

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