Infinity Gamma Series Instructions for Use Sw VF4

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 USA Authorized EC representative: Dräger Medical AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck Germany Infinity Gamma Series User’s Guide Software Version VF4 This product is covered by one or more of the following patents: 5,224,484; 5,224,740; 5,240,008; 5,285,791; 5,355,890; 5,337,751; 5,375,604. This device bears the ! label in accordance with the provisions of the Directive 93/42/EEC of June 14, 1993 concerning medical devices.

!"0123  Dräger Medical AG & Co. KGaA, 2003. All rights reserved. Printed in the United States of America. Dräger reserves the right to modify the design and specifications contained herein without prior notice. Please contact your local Dräger Sales Representative for the most current information. Reproduction in any manner, in whole or in part, in English or in any other languages, except for brief excerpts in reviews and scientific papers, is prohibited without prior written permission of Dräger Medical AG & Co. KGaA. All Dräger devices are intended for use by qualified medical personnel only. CAUTION: Federal Law in the United States restricts these devices to sale by, or on order of a physician.

Before using all Dräger devices, read all the manuals that are provided with your device carefully. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

What’s New The functionality of the Infinity Gamma Series patient monitor has been improved and expanded to include the following new features in software version VF4: !

Support of gas monitoring functions in anesthesia and operating room environments. The Gamma XL can now display concentrations of CO2, N2O, O2 and of the anesthetic agents halothane, isoflurane, enflurane, sevoflurane, and desflurane. The Gamma XL receives these gas values from a Dräger Scio multigas module. Note: This functionality is only available for the Gamma XL (and not the Gamma). For information about multigas monitoring, see Chapter 14, Multigas.

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Support of network laser printers. Recording requests can be sent from the Infinity Gamma Series monitor via the Infinity network to a network laser printer. For information about recording functions, see Chapter 7, Recordings.

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Improved SpO2 performance during motion artifact. For information about pulse oximetry, see Chapter 12, Pulse Oximetry. NOTES:

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The Gamma XL monitor with Anesthetic Gas Monitoring requires FDA 510(k) review.

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The Gamma XL monitor with Anesthetic Gas Monitoring is not yet licensed in accordance with the Canadian Medical Devices Regulations.

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Infinity Gamma Series Software Release Notes Software Version VF4 !

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Wireless network operation requires special configurations of the monitoring network and the MULTIVIEW WORKSTATION (a service function). If you experience problems with wireless network operations, contact your Service personnel. When moving and assigning a wireless monitor to a different central station, the original central station may emit a brief network error tone and display an Offline message instead of the message Bed Disconnected. However, there is no disruption of network monitoring and the Offline message clears as soon as you assign a new bed to the central viewport. When you change the units of measure at the bedside and the central station is showing the monitor’s bed view, you must first exit the central bed view, before the change of units appears at the central station. For network and card data transfer: - Occasionally, after a data transfer from an Infinity Delta Series monitor, you may see three or four ST trends instead of the two ST leads monitored by the Infinity Gamma Series monitor. For network data transfer only: - If ST is enabled, the ST data transferred from an Infinity Delta Series monitor (VE0) or from a MULTIVIEW Telemetry System (VE0) is ST lead I and II, regardless of the ST leads selected on the Infinity Gamma Series monitor. Note: Other ST data will be permanently lost. - After a network transfer of telemetry data to an Infinity Gamma Series monitor, ST trend points may appear two minutes apart. - The IBP data transferred from an Infinity Delta Series monitor (VE0) to an Infinity Gamma Series monitor is labelled GP1 and GP2. NBP parameter values transferred from an Infinity Gamma Series monitor to an Infinity Delta Series monitor will be displayed in the trend graphs rather than in the trend tables of the destination monitor.

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On rare occasions, a docked monitor may reset when entering the Transfer Menu under certain network conditions. The monitor returns to the state prior to the reset within 30 seconds.

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When power-cycling the monitor or admitting a new patient, saved monitoring settings may occasionally return to default settings. Check monitoring settings after these events. If the Scio module is unable to measure the concentration of N2O, the monitor may enter the error code *A* (artifact) instead of *F* (failure) into the trend storage.

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Occasionally, the ECG waveform is not displayed in the second waveform channel, when you assign SpO2 to the first waveform channel. In this case, click on the second waveform channel and select the desired ECG lead again. When admitting a patient at the MULTIVIEW WORKSTATION, the monitor does not store the admit date, if it is the current date. In this case, you must enter the admit date via the monitor’s Patient Admit menu.

When the values of an anesthetic agent exceed the measuring range, the monitor displays +++ in the agent parameter box and cycles two out-ofrange error messages, one correctly identifying the agent with out-ofrange values, the other showing a previously monitored agent.

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Documentation Features Notes, Cautions, Warnings NOTE: A note presents information that helps you operate the equipment or connected devices. CAUTION: A caution provides information or instructions that must be followed to ensure proper operation and performance of the equipment. WA RN I N G : A warning contains important information regarding possible danger to you or the patient that is present during normal operation of the equipment.

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Chapter Overview Chapters Overview... 1 Monitor Setup ... 2 Network Applications... 3 Admission, Discharge, Transfer... 4 Alarms and Messages... 5 Trends... 6 Recordings... 7 ECG and Heart Rate ... 8 Arrhythmia ... 9 ST-Segment Analysis ... 10 Respiration... 11 Pulse Oximetry ... 12 End-Tidal CO2... 13 Multigas ... 14 Non-Invasive Blood Pressure... 15 Invasive Blood Pressure... 16 Temperature ... 17

Appendices Options and Accessories ... A Cleaning, Disinfecting, Sterilizing... B Default Settings and Biomedical Support... C Technical Data ... D Glossary Index

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Table of Contents Overview Important General Safety Considerations ...1-2 Electromagnetic Compatibility ...1-2 Reducing EMI ...1-3 Site of Operation ...1-3 Electrical Safety ...1-4 Connections to Peripheral Devices...1-4 Safety, Inspection, and Maintenance ...1-5 Electrosurgery and Defibrillation Safety ...1-6 Pacemaker Safety ...1-6 Device Markings...1-7 General Description...1-8 Front Panel ...1-10 Back Panel...1-11 Left Side Panel ...1-12 Right Side Panel...1-13 Interface Plate (optional) ...1-14 Infinity Gamma Display ...1-15 Alarm Colors ...1-15 Display Colors...1-16 Rotary Knob ...1-17 Fixed Keys ...1-18 Menus...1-19 Power Sources ...1-20 MultiMed/NeoMed Pod...1-21 etCO2 Pod and Multigas Module ...1-22 Recorder ...1-22 Remote Displays ...1-23

Monitor Setup Getting Started ...2-2 Using the AC Adapter...2-2 Using the Battery ...2-4 Assembling MultiMed and NeoMed Pods ...2-9

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Starting the Monitor ...2-10 Main Screen Configuration ...2-11 Waveform Selection...2-11 Bottom Channel Display...2-12 OR Mode ...2-15 Show Respiration or etCO2 Parameters ...2-16 Setting Date and Time ...2-17 Setting the Master Speaker Volume...2-18 Turning External Alarm Lights ON/OFF ...2-19 Standby...2-20 Saving Setups ...2-21

Network Applications Overview ...3-2 Network Configurations ...3-3 Basic Network Components ...3-4 Basic Bedside Setups...3-5 Network Operation...3-6 Docking Station...3-7 Docking and Undocking ...3-9 Wireless Network Configuration...3-11 Wireless Network Operation ...3-13 Network Safety Considerations...3-16 Alarm and Status Messages ...3-17

Admission/Discharge/Transfer Overview ...4-2 Patient Admission...4-3 Admit Menu...4-4 Patient Category...4-5 Name and ID ...4-6 Admit Date ...4-8 Patient Discharge...4-9 Data Transfer...4-10 Transfer Across the Network ...4-11 Transfer with a Data Memory PC Card...4-13

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Alarms and Messages Alarm Grades ...5-2 Life-Threatening Alarms...5-2 Serious Alarms...5-3 Advisory Alarms ...5-4 Alarm Settings...5-5 Setting Alarm Limits ...5-6 Turning Parameter Alarms On/Off...5-8 Turning Alarm Recordings On/Off ...5-9 External Alarm Lights...5-9 Alarm Validation...5-10 Silencing Alarms...5-11 Alarm Silence Key...5-11 All Alarms OFF Key ...5-12 Assigning Alarm Groups...5-13 Central Alarms ...5-14 Alarms in OR Mode...5-15 Messages...5-16

Trends Overview ...6-2 Trend Setup ...6-3 Trend Graphs ...6-4 Trend Table...6-6 Special Conditions and Codes ...6-8

Recordings Overview ...7-2 Recorder Preparation ...7-3 Assigning Network Recorders...7-6 Recording Waveforms...7-7 Timed Recordings...7-7 Continuous Recordings ...7-8 Recording Formats ...7-9 Recording Trends ...7-11

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Recording Alarms ...7-13 Stored Recordings...7-14 Event Recall...7-14 Saving, Printing, Deleting Stored Recordings ...7-16 Recording Status Messages ...7-17

ECG and Heart Rate Overview ...8-2 Patient Preparation ...8-3 Selecting and Preparing the Electrodes ...8-3 Preparing the Patient’s Skin ...8-3 Positioning the Electrodes...8-5 ECG Monitoring Settings ...8-8 Cable Type ...8-8 Lead Selection and Display Amplitude ...8-9 Cascade Display...8-10 One- or Two-Channel Signal Processing...8-11 Pulse Tone Source...8-12 Pulse Tone Volume ...8-13 Pacer Detection ...8-14 Displaying Sync Marks ...8-15 ECG and HR Safety Considerations...8-16 HR Alarm Settings...8-16 Neonatal ECG Monitoring...8-16 ECG 50/60 Hz Notch Filter Setting...8-16 Muscle Stimulators ...8-16 Electrosurgery (ESU) ...8-17 Infusion pumps ...8-19 Defibrillators and Cardioversion ...8-19 High P-Waves and T-Waves ...8-19 Pacemakers ...8-20 AV Sequential or DDD Pacemakers...8-21 Pacemakers with Impedance-Derived Rate Response...8-21 Large Amplitude Pacer Pulses ...8-22 Transcutaneous Electrical Nerve Stimulators (TENS)...8-22

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Arrhythmia Overview ...9-2 Turning Arrhythmia Monitoring ON ...9-4 Arrhythmia Setup...9-5 Rate and Count ...9-6 Arrhythmia Alarms...9-6 Arrhythmia Alarm Recordings...9-7 Relearning a Patient’s ECG...9-7

ST Segment Analysis Overview ...10-2 ST Monitoring Display ...10-3 ST Setup ...10-4 Isoelectric and ST Measuring Points ...10-5 ST Reference Complex...10-7 ST Alarms ...10-8

Respiration Overview ...11-2 Patient Preparation ...11-3 Selecting and Preparing the Electrodes ...11-3 Preparing the Patient’s Skin ...11-3 Electrode Placement for Respiration Monitoring ...11-3 Respiration Monitoring Display...11-5 Displaying Respiration Data ...11-6 Rsp Display Channel ...11-7 Resp Display Amplitude...11-8 Respiration Monitoring Settings ...11-9 Rsp Mode...11-9 Resp Markers ...11-10 Apnea Time...11-11 Coincidence Alarm ...11-12 Relearning a Patient’s Respiration Pattern ...11-13 Rsp Safety Considerations ...11-14 OxyCRG Monitoring (Neonatal Option) ...11-15 Displaying OCRG Waveforms...11-15 OCRG Recordings ...11-17 Page xii

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Pulse Oximetry Overview ...12-2 Sensor Application ...12-2 SpO2 Safety Considerations...12-4 SpO2 Monitoring Display ...12-5 SpO2 Display Channel...12-5 SpO2 Display Amplitude ...12-6 Cascade Display...12-7 SpO2 Monitoring Settings ...12-8 Pulse Tone Source...12-8 Pulse Tone Volume ...12-9 Signal Strength Bar Graph ...12-10 Averaging Mode ...12-11

End-Tidal CO2 Overview ...13-2 etCO2 Source ...13-3 etCO2 Display...13-4 Monitoring Preparations ...13-6 Connecting Sensor and etCO2 Pod ...13-6 Attaching the Capnostat and Airway Adapter...13-6 Calibrating the Sensor and Adapter...13-10 etCO2 Monitoring Settings...13-12 Averaging Mode ...13-12 RRc Apnea Time...13-13 Balance ...13-14 Measuring Mode...13-15 Anesthetic Agent Compensation...13-15 Atmospheric Pressure Compensation...13-17 etCO2 Alarms ...13-19

Multigas Overview ...14-2 Connections ...14-3 Gamma XL with Scio...14-3 The Scio Module ...14-4 Warm-Up ...14-6 VF4

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Site of Operation ...14-6 Installing/Removing the Water Trap...14-7 Connecting Sampling Lines and Power Cord ...14-7 OR Mode ...14-9 CO2 Display and Setup ...14-11 Multigas Display and Setup ...14-12

Non-Invasive Blood Pressure Overview ...15-2 Cuff Selection and Placement ...15-4 NBP Safety Considerations ...15-5 NBP Measurements ...15-6 Single Measurements ...15-6 Interval Mode...15-6 Inflation Mode...15-8 Measurement Tone ...15-10 NBP Measurements in OR Mode ...15-11 NPB Alarms ...15-12

Invasive Blood Pressure Overview ...16-2 Invasive Pressure Labels ...16-3 IBP Display ...16-4 Display Channel and Waveform Amplitude...16-4 Selecting and Preparing the Transducer...16-6 Zeroing and Calibration Check...16-7 Zero and Calibration Check Troubleshooting ...16-9 Calibrating Reusable Transducers...16-10

Temperature Overview ...17-2 Temperature Probes ...17-3 Placing the Probe...17-3

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Options and Accessories Options ... A-2 MultiMed/NeoMed Pods... A-2 ECG ... A-3 Pulse Oximetry (SpO2) ... A-4 End Tidal CO2 (etCO2) ... A-6 Multigas ... A-7 Temperature ... A-8 Invasive Blood Pressure (IBP)... A-8 Non-invasive Blood Pressure (NBP) ... A-10 Power Sources ... A-10 Displays and Display Components ... A-12 Recorder ... A-13 Mounting Devices ... A-13 Miscellaneous ... A-14

Cleaning, Disinfecting, Sterilizing Cleaning, Disinfecting and Sterilizing... B-2 Monitor ... B-2 Patient Cables ... B-3 Reusable ECG Electrodes ... B-3 Reusable SpO2 Sensor... B-4 NBP Cuff ... B-4 Temperature probes and cables... B-4 Reusable Pressure Transducers and Cables ... B-5 Cleaning etCO2 Pod and Accessories... B-7 Capnostat Sensor ... B-7 Reusable Airway Adapters... B-7 Nasal Sampling Cannulas and Tubing... B-7 Sidestream Sampling Pump... B-7 Scio Module and Accessories ... B-11 Emptying the Water Trap... B-11 Cleaning/Replacing the Fan Filter ... B-12

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Default Settings and Biomedical Support Default Settings... C-2 Biomedical Support ... C-12 Startup Tests ... C-13 Checking the NBP Calibration ... C-14 Biomed Menu ... C-15 Saving a Patient Setup ... C-16 Locked Options and Demo Mode ... C-17 Diagnostic Logs ... C-18 Changing Units of Measure ... C-19

Technical Data Overview ... D-2 Regulatory Compliance... D-2 Basic System Components... D-3 Monitoring Accessories ... D-9 Monitoring Specifications ... D-12

Glossary Index

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1 Overview Important General Safety Considerations... 1-2 Electromagnetic Compatibility ... 1-2 Reducing EMI ... 1-3 Site of Operation ... 1-3 Electrical Safety ... 1-4 Connections to Peripheral Devices... 1-4 Safety, Inspection, and Maintenance ... 1-5 Electrosurgery and Defibrillation Safety... 1-6 Pacemaker Safety ... 1-6 Device Markings... 1-7 General Description ... 1-8 Front Panel... 1-10 Back Panel ... 1-11 Left Side Panel... 1-12 Right Side Panel ... 1-13 Interface Plate (optional)... 1-14 Gamma Display... 1-15 Alarm Colors... 1-15 Display Colors ... 1-16 Rotary Knob ... 1-17 Fixed Keys... 1-18 Menus ... 1-19 Power Sources... 1-20 MultiMed/NeoMed Pod ...1-21 etCO2 Pod and Multigas Module... 1-22 Recorder... 1-22 Remote Displays... 1-23

Important General Safety Considerations CAUTION: Read all operating instructions carefully before using the monitor. Specific warnings and cautions are found throughout the User’s Manual where they apply. CAUTION: These devices are not intended for use in the same room as magnetic resonance equipment. WA RN I N G : Monitor operation is currently not supported in the following environments: magnetic resonance imaging (MRI), aircraft, ambulance, home or hyperbaric chamber environments. CAUTION: Use only batteries that are approved by Dräger (contact your local representative). The use of non-approved batteries may damage the device. NOTE: Dräger recommends replacing any lead-acid battery after 12 months of continued use. For safe disposal of lead-acid and lithium ion batteries, follow your local regulations. To prevent risk of fire or explosion, never dispose of the battery in fire.

Dräger is liable for the safety, reliability and performance of its equipment only if (a) maintenance, repairs, and modifications are carried out by authorized personnel, (b) if components are replaced with Dräger approved spare parts and (c) if the devices are used in accordance with Dräger Operating Instructions. A full technical description is available upon request from your local Dräger representative.

Electromagnetic Compatibility The monitor has been designed and tested for compliance with current regulatory standards as to its capacity to limit electromagnetic emissions (EMI), and also as to its ability to block the effects of EMI from external sources. The monitor complies with the following standards pertaining to EMI emissions and susceptibility: EN55011 and EN60601-1-2.

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Overview Reducing EMI To reduce possible problems caused by electromagnetic interference, we recommend the following: !

Use only Dräger-approved accessories.

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Ensure that other products used in areas where patient monitoring and/or life-support is used comply to accepted emissions standards (EN55011).

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Try to maximize the distance between electromedical devices.

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Strictly limit exposure and access to portable radio-frequency sources (e.g., cellular phones and radio transmitters). Be aware that portable phones may periodically transmit even when in standby mode.

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Maintain good cable management. Do not route cables over electrical equipment. Do not intertwine cables.

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Ensure all electrical maintenance is performed by qualified personnel.

Site of Operation CAUTION: The site of operation for the monitor must meet temperature, humidity, and air pressure requirements. For details, see the product description in Appendix A. WA RN I N G : Do not operate the monitor in presence of flammable anesthetic mixtures with air, oxygen, or nitrous oxide. Do not use the monitor near devices with microwave or other high frequency emissions that may interfere with the monitor’s operation. WA RN I N G : If fluids are accidentally spilled on the monitor, it should be removed from service immediately and thoroughly inspected by your Biomed to ensure that there is no compromise in electrical safety. CAUTION: Place the monitor on a flat and stable surface to prevent it from falling. Do not place the monitor into a cabinet, wall recess or similar enclosure during operation. These units are convection cooled (no fan) and need adequate airflow to dissipate heat.

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Electrical Safety CAUTION: Operate the monitor and any connected devices only in a clinical environment where the electrical installation is in accordance with local electric codes. The universal AC adapter, CPS, or IDS should be connected to a fully tested, hospital-grade outlet with proper grounding. WA RN I N G : Dräger devices are not intended for use in areas where there is a danger of explosion. If the devices are used where flammable anesthetic substances are used, the possibility of an explosion cannot be excluded.

If the AC adapter, CPS, or IDS is disconnected, the monitor “Battery charger” light turns off and the unit switches immediately to battery power.

Connections to Peripheral Devices All peripheral devices and connections to the monitor (except the Infinity network) must comply with IEC 60601-1 requirements. CAUTION: In the interest of patient safety and equipment performance, Dräger does not authorize the connection of other manufacturers’ equipment not approved by Dräger. It is the user's responsibility to contact Dräger to determine compatibility and warranty status if connections to other manufacturers' equipment are desired. CAUTION: When connecting peripheral devices to the monitor, make sure that the entire system complies with the following requirement: IEC 60601-1-1: Safety requirements for medical electrical systems.

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