LIFEGARD I. Patient Monitor OPERATOR S MANUAL

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1 LIFEGARD I Patient Monitor OPERATOR S MANUAL

2 Preface LIFEGARD I Patient Monitor Operator s Manual Model: AN4800 Analogic Corporation Life Care Systems Division 8 Centennial Drive Peabody, Ma (978) or (978) CE Marking Europe The following product and accessories from Analogic Corporation carry the mark to Council Directive 93/42/EEC WEEE Directive 2002/96/EC CE Product: AN4800 Accessories from other companies other than Analogic Corporation carry CE markings appropriate to the accessory. Authorized EU-representative: Villy Braender Mileparken Herlev Denmark Tel: Fax: United States Caution: United States Federal Law restricts this device to sale by or on the order of a physician. Nellcor, C-Lock, Oxisensor II, Durasensor, Dura-Y, and Oxicliq, are trademarks of Tyco Healthcare and its wholly-owned subsidiary, Nellcor Puritan Bennett Inc. SureTemp is a trademark of Welch Allyn Medical Products. All other product and company names mentioned may be the trademarks of their respective owners. The LIFEGARD I s embedded software and Oridion s Microstream software is protected by United States copyright laws and international treaty provisions. Except as otherwise expressly permitted hereby, you may not reverse engineer, decompile, or disassemble the software. Made in U.S.A. Analogic Part Number: Rev. 00 i

3 LIFEGARD I Operator s Manual This product is covered by one or more of the following U.S.A. patents and their foreign equivalents: 4,621,643; 4,653,498; 4,700,708; 4,770,179; 4,869,254; 4,911,167; 4,928,692; 4,934,372; 5,078,136; 5,368,224. PROPRIETARY MATERIAL Information and descriptions contained in this manual are the property of Analogic Corporation and may not be copied, reproduced, disseminated, or distributed without express written permission from Analogic Corporation. Information furnished by Analogic Corporation is believed to be accurate and reliable. however, no responsibility is assumed by Analogic for its use, or any infringements of patents or other rights of third parties that may result from its use. No license is granted by implication or otherwise under any patent or patent rights of Analogic. NOTE: The information contained in this manual is valid only for Monitor Software Version 1.xx. This Manual contains all of the information the operator needs to operate the LIFEGARD I monitor, recorder and software. If the software version of your product is not in the range from 1.00 to 1.99, please contact your sales representative to obtain addendum pages or a replacement manual that describes the operation of your version of the product. The monitor s software revision number can be located during the boot up sequence in the lower center of the screen. ii

4 Preface TABLE OF CONTENTS 1.0 Introduction General Intended Use Parameters and Features RS-232 Interface Setup and Use Checking the Shipment Disposing of the Monitor Proper Use of the LIFEGARD I Patient Monitor Safety Warnings, Cautions, and Notes Warnings ECG Safety Information NIBP Safety Information SpO 2 Safety Information Cautions Monitor Setup Connectors Internal Battery Optional Recorder Mounting Power On Default Settings Standby Mode Power Source Indicator Quick Start Using the LIFEGARD I Monitor General Display Overview LIFEGARD I Display Changing Settings Example of a Change Operation Initial Setup Setting the Date and Time Setup Menu Patient Monitoring Connectors Switch Panel iii

5 LIFEGARD I Operator s Manual 5.0 Alarms and Limits General Safety Information LIFEGARD I Patient Monitor Alarms Visual and Audio Alarm Indicators Patient Alarm Messages High Priority Physiological Alarm Messages Technical Alarm Messages (INOPs) Loss of Monitoring Alarms Viewing and Changing Alarm Limits Configuring the Alarm/Limits Screen Auto-Set Alarm Limits Alarm Limits and Factory-Set Default Values Audio Pause and Silencing Alarms Audio Off ECG Monitoring General ECG Safety Information ECG Leads ECG Lead Color Coding Connecting the Leads Placing the Leads Standard ECG Lead Placement Modified Chest Placement (MCL1) Controlling ECG Functions Using the Numeric Frame Heart Rate Source Heart Rate Tone Controlling ECG Functions Using the Graphic Frame Extended Low Frequency Range Pacer Detect ECG Leads Off NIBP Monitoring General Calculating Mean Arterial Pressure NIBP Safety Information Selecting a Cuff NIBP Measurement Modes To Initiate a Single Blood Pressure Measurement To Make NIBP Measurements Automatically To Initiate STAT Mode of NIBP Operation To Stop Blood Pressure Measurements Cuff Inflation Pressures Troubleshooting Low Priority NIBP Alarms Controlling NIBP Functions via Numeric Frame iv

6 Preface 8.0 SpO 2 Monitoring General Self Calibration and Noise Measurement C-Lock ECG Synchronization Measuring Functional Saturation SpO 2 Safety Information Applying the Sensor Selecting a Sensor Controlling SpO 2 Functions Using the Numeric Frame SpO 2 Response Modes Using C-Lock Pulse Amplitude Indicator Gauge Controlling SpO 2 Waveform Using the Graphic Frame Temperature Monitoring General Safety Information Setup Connection Loading a Probe Cover Taking Oral Temperatures (Using Blue-Capped Probe, Normal Mode) Taking Axillary Temperatures, Patients Under 4 Years (Using Blue-Capped Probe, Normal Mode) Taking Rectal Temperaturs (Using Red-Capped Probe, Normal Mode) Removing a Probe Cover Operating Modes Temperature Alarms Controlling Temperature Measurements Trends General Displaying Trend Data Scrolling Trend Data Transferring Trends Using RS-232 Interface SpotCheck Monitoring Terminology Overview Selecting SpotCheck Mode SpotCheck Mode Menu Accessing SpotCheck Mode Menu Selecting Next Patient Record Number Accepting the Default Record Number Changing the Default Record Number Storing Measurements Viewing Measurements Clearing All Data v

7 LIFEGARD I Operator s Manual Adding Patient Measurements Printing SpotCheck Measurements Printing All Records Printing Selected Records Printing A Single Patient Record Recording and Printing Printouts Second Snapshot Print Continuous Print What is on the Real-Time Printout Trend Print Tabular Trend Print Print-on-Alarm Recorder Paper Replacement Maintenance and Troubleshooting Error Messages Maintenance Schedule Inspecting the Monitor Inspecting the Cables and Cords Cleaning Battery Maintenance Obtaining Technical Assistance Returning System Components Specifications General General Specifications Safety Standards Electrical Environmental Measuring Parameters NIBP (Non-Invasive Blood Pressure) Measurement Display Temperature Measurement/Display SpO 2 Measurement/Display Trends Recorder vi

8 Preface Appendix A RS-232 Interface A-1 A.1 RS-232 Interface A-1 A.2 Cable Connections A-1 A.3 Nurse Call A-2 A.4 Exporting Trend Data A-2 A.4.1 Procedure A-2 A.4.2 Command Response A-2 Appendix B Features, Accessories, and Ordering Information B-1 B.1 Measurement Parameters and Features B-1 B.2 Standard Accessories B-1 B.3 Optional Accessories B-2 B.4 Exporting Trend Data B-2 Appendix C Using Color C-1 C.1 General C-1 C.2 Overview C-1 C.3 Color Configuration C-1 C.4 Color Screen Display C-2 Appendix D Electromagnetic Compatibility D-1 D.1 General D-1 D.2 Instructions for Use D-1 D.3 Reducing Electromagnetic Interference D-2 D.4 Restrictions for Use D-2 D.5 Emissions and Immunity D-2 D.6 Guidance and Manufacturer s Declaration D-2 D.7 Recommended Separation Distances D-5 vii

9 Introduction 1 Introduction 1.1 General A description of the LIFEGARD I patient monitor, along with its features is contained in this chapter. 1.2 Intended Use To ensure optimal battery performance, the monitor must be connected to AC power prior to first use of battery power. It takes 8 hours to fully charge the monitor in Standby mode, 14 hours to fully charge the monitor when it is operating. The monitor can be used during the charging time because the battery is still being charged even if the monitor is turned on. The LIFEGARD I is a multi-parameter patient monitor that monitors ECG waveforms, heart rate, non-invasive blood pressure (systolic, diastolic), functional arterial oxygen saturation, and temperature for adult and pediatric patients in all hospital environments and healthcare facilities. The LIFEGARD I can also be used to spot check heart rate, non-invasive blood pressure (systolic, diastolic), functional arterial oxygen saturation and temperature for adult and pediatric patients in an environment where an attendant is always present. Do not use the monitor to monitor neonates. The monitor is not intended for use on more than one patient at a time. 1-1

10 LIFEGARD I Operator s Manual 1.3 Parameters and Features All the parameters of the LIFEGARD I patient monitor are described in this manual. The monitor you are using may not have all the parameters and features described. This table lists each model with its corresponding features. Measurement Parameters and Features Model NIBP SpO 2 Temp ECG AN4830 Yes Yes No Yes AN4840 Yes Yes Yes Yes Optional External Recorder 1.4 RS-232 Interface 1.5 Setup and Use The monitor has an RS-232 interface which allows the user to: Export trend data to an external PC Send a nurse call signal Print to a recorder Appendix A covers the RS-232 interface in detail. Read this entire manual before operating the LIFEGARD I. Chapter 2 which contains the warnings and cautions should be read very carefully and prior to using the monitor. This check list should be used for correct setup. Tasks See Page Done Read manual 1. Check shipment Setup monitor Connect recorder (if present) Set the date and time Configure the monitor at the setup menu Fix mounting plate (if present) 3-3 Start Monitoring 1.6 Checking the Shipment Examine the carton and look for any evidence of mishandling in the shipment. Follow institutional procedures for reporting such evidence. Remove the contents from the shipping carton and compare the shipped items with the packing slip and your order. Check the monitor and the accessories to be sure there is no damage. If the optional recorder was ordered, check that it is also not damaged. It is recommended that the packing carton and packing material be kept in the event the product has to be returned. 1-2 If any problems exist, please contact a Service Coordinator at: Phone: Fax: lcssupport@analogic.com

11 The Service Coordinator must be provided with the quantity of items, the bill to address for invoice purposes, the ship to address, a purchase order number and details of the problem. You will be given a Return Material Authorization (RMA) number. All material must be shipped prepaid and the RMA number must be referenced on the purchase order and the shipping paperwork. Ship to: Analogic Corporation Life Care Systems 8 Centennial Drive Peabody, MA Attn: Receiving Dock B RMA# Introduction NOTE If it s determined that the monitor is damaged or not in proper working condition, it is not necessary to return sensors, patient cables, NIBP tubing and cuff or the power cord. 1.7 Disposing of the Monitor To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country s law for equipment containing electrical and electronic parts. Do not dispose of this device or its components in a landfill. For disposal of parts and accessories, such as ECG and SpO 2, where not otherwise specified, follow local regulations regarding disposal of hospital waste. For disposal of the lead-acid battery, follow local regulations for safe disposal of lead. 1.8 Proper Use of the LIFEGARD I Patient Monitor Before clinical use, it should be ascertained that the monitor is working properly. If unsure about the accuracy of any measurements, check the patient s vital signs using another method in order to compare with the monitor s readings. While a patient is undergoing defibrillation, the monitor can be used but inaccurate readings may result for a short while. When connecting the LIFEGARD I patient monitor to another instrument, ensure that the equipment is operating properly. Be sure to read the instrument s manual for complete instructions. Do not connect accessory equipment to the monitor s data interface if it is not certified according to the IEC Standard for data processing equipment or IEC Standard for electromedical equipment. NOTE The monitor and its accessories must be tested by qualified service personnel at regular intervals to verify proper operation, according to the procedures of the user s institution. Other important safety information is located in this manual where appropriate. 1-3

12 Safety 2 Safety 2.1 Warnings, Cautions, and Notes 2.2 Warnings The precautions are grouped into two (2) main categories, S and Cautions. In addition, the manual highlights NOTES of significant information relevant to the monitor display, operator instruction, or operator action being described in the text. S advise against certain actions or situations that could result in personal injury or death. Cautions advise against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTES provide useful information regarding a function or procedure. To ensure optimal battery performance, the monitor must be connected to AC power prior to first use of battery power. It takes 8 hours to fully charge the monitor in Standby mode, 14 hours to fully charge the monitor when it is operating. The monitor can be used during the charging time because the battery is still being charged even if the monitor is turned on. Do not use the monitor if the monitor or the accessories are damaged. Do not use the monitor with high frequency electrosurgical devices. Explosion Hazard. Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air, or with oxygen or nitrous oxide. Electric Shock Hazard. Covers should be removed by qualified service personnel only. There are no user-serviceable parts inside. Electric Shock Hazard. Keep external power supply away from water or other liquid. Do not open the monitor or attempt to change the battery. If you suspect a problem with parts within the monitor, contact the Life Care Systems Support Group or your local Analogic representative. Do not connect accessory equipment to the monitor s data interface if it is not certified according to the IEC Standard for data processing equipment or IEC Standard for electromedical equipment. 2-1

13 LIFEGARD I Operator s Manual Route patient cabling to reduce the possibility of patient entanglement or strangulation. Do not use the monitor to monitor neonates. Do not place the monitor in any position that might cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient connections because disconnection could then result in the monitor dropping on the patient. To ensure patient electrical isolation, connect only to other equipment that provides patient electrical isolation. Do not use extension cords to connect the monitor to electrical outlets. Do not use the monitor during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The monitor may affect the MRI image, and the MRI unit may affect the accuracy of the monitor s measurements. Do not use the monitor on more than one patient at a time. Do not connect this monitor to any other equipment or device other than those specified in this manual. Sterilization is not recommended for this monitor, related products, accessories or supplies unless otherwise indicated in the instructions that accompany the accessories and supplies. Electromagnetic interference may cause disruption of performance. Protect the monitor from sources of intense electromagnetic radiation. This device has been designed to provide resistance to electromagnetic interference. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the healthcare and home environments (such as cellular phones, mobile two-way radios, electrical appliances) it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device. Disruption may be evidenced by erratic readings, cessation of operation or other incorrect functioning. If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source. If assistance is required, contact the Life Care Systems Support Group or your local Analogic representative. If the battery is defective, the Loss-of-Monitoring alarm will fail to sound. Connect the monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a properly installed three-wire receptacle. If a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. 2-2

14 Safety Neither the Print-on-Alarm nor the Nurse Call initiates when the monitor detects a Loss-of-Monitoring state. If an alarm condition (except those leading to a Loss-of-Monitoring alarm) occurs while the monitor is in the Audio Off state, the only alarm indications are visual displays related to the alarm conditions. Use of accessories, transducers, and cables other than those specified may result in increased emissions and/or decreased immunity of the LIFEGARD I patient monitor. The LIFEGARD I patient monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the LIFEGARD I should be observed to verify normal operation in the configuration in which it is used. Incorrect insertion of the rectal probe can cause bowel perforation. The LIFEGARD I monitor, while on a patient and in SpotCheck mode, must never be left unattended. All audible alarms are permanently disabled and the attendant must always check the visual alarm indicators. With each new patient, all probes and sensors must be cleaned in accordance with the instructions of Paragraph 13.5, and Temperature Probe Covers must be changed. Temperature Probe Covers are NOT reusable and must be changed with each new patient. 2.3 ECG Safety Information Use only Analogic ECG electrodes and leads with the LIFEGARD I monitor. Other ECG cables and leads may cause improper performance and/or provide inadequate protection during defibrillation. When connecting the electrodes or the patient cable, ensure that the connectors never come into contact with other conductive parts, or with earth. In particular, ensure that all of the ECG electrodes are attached to the patient to prevent them from contacting conductive parts or earth. For pacemaker patients, the monitor may continue to count pacemaker rate during cardiac arrest or some arrhythmias. Do not rely entirely upon the monitor s alarm. Keep pacemaker patients under close surveillance. 2-3

15 LIFEGARD I Operator s Manual Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable placement, as specified in this manual and the electrodes directions for use. ECG cables may be damaged when connected to a patient during defibrillation. Check cables that have been connected to a patient during defibrillation for functionality before using them again. DO NOT: Use ECG leads that appear frayed, cracked, or damaged in any way. Immerse ECG leads completely in water, solvents, or cleaning solutions because the connectors are not waterproof. Electrodes are single use only. Disposal of electrodes must be in compliance with local and facility regulations. Monitoring with the Pacer Detect feature enabled does not normally affect the monitoring of non-pacemaker patients. However, in some instances, if the patient does not have a pacemaker, it may be desirable to turn the detection function Off so that artifacts in the waveform as not mistaken for a pacemaker signal. Interference from instruments near the patient and electrosurgical unit interference can cause problems with the ECG wave. See the monitor specifications for more information. 2.4 NIBP Safety Information Use only Analogic recommended blood pressure tubing and cuffs. Using other cuffs or tubing may result in inaccuracies. Do not use the monitor on patients who are linked to heart/lung machines. The monitor may not operate effectively on patients who are experiencing convulsions or tremors. Inaccurate measurements can be caused by: Incorrect cuff application or use, such as placing the cuff too loosely on the patient, using the incorrect cuff size, or not placing the cuff at the same level as the heart. Leaky cuff or tubing. Excessive patient motion. 2-4

16 Safety The monitor displays results of the last blood pressure measurement until another measurement is completed. If a patient s condition changes during the time interval between measurements, the monitor will not detect the change or indicate an alarm condition. Occasionally, electrical signals at the heart do not produce a peripheral pulse. If a patient s beat-to-beat pulse amplitude varies significantly (for example, pulsus alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and pulse rate readings can be erratic and an alternate measuring method should be used for confirmation. A patient s vital signs may vary dramatically during administration of agents affecting the cardiovascular system, such as those used to raise or lower blood pressure or raise or lower heart rate. As with all automatically inflatable blood pressure devices, continual cuff measurements can cause injury to the patient being monitored. Weigh the advantages of frequent measurement and/or use of STAT mode against the risk of injury. In some case, prolonged cycling of an oscillometric, noninvasive blood pressure monitor cuff has been associated with any or all of the following: ischemia, purpura, or neuropathy. Apply the oscillometric cuff appropriately, according to instructions, and check the cuff site and cuffed extremity regularly when blood pressure is measured at frequent intervals or over extended periods of time. Check the patient s limb on which the cuff is applied to assure that circulation is not constricted. Constriction of circulation is indicated by discoloration of the extremity. This check should be performed at the clinician s discretion at regular intervals based on the circumstances of the specific situation. Do not place the cuff on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised. Do not apply the blood pressure cuff to the same extremity as the one to which an SpO 2 sensor is attached, since cuff inflation will disrupt SpO 2 monitoring and lead to nuisance alarms. Ensure that, during use on patients, heavy objects are not placed on the tubing. Avoid crimping or undue bending, twisting, or entanglement or the tubing. Do not use STAT mode when using the thigh cuff to monitor NIBP. A Loss-of- Monitoring alarm with shutdown of all monitor functions may occur. 2-5

17 LIFEGARD I Operator s Manual 2.5 SpO 2 Safety Information Use only Analogic or Nellcor recommended SpO 2 sensors. Other sensors may cause inaccurate readings. Incorrect application or use of an SpO 2 sensor may cause tissue damage, for example, if the sensor is wrapped too tightly or if supplemental tape is applied. Inspect the sensor site as directed in the sensor s directions for use to ensure skin integrity and correct positioning and adhesion of the sensor. DO NOT: Use sensors that appear frayed, cracked, or damaged in any way. Use a sensor with exposed optical components. Immerse sensor completely in water, solvents, or cleaning solutions because the sensor and connectors are not waterproof. Sterilize sensors by irradiation, steam, or ethylene oxide. Refer to the cleaning instructions in the directions for use for reusable sensors. Inaccurate measurements can be caused by: Incorrect sensor application or use. Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin). Intravascular dyes such as indocyanine green or methylene blue. Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight. Excessive patient movement. High-frequency electrosurgical interference and defibrillators. Venous pulsations. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. There is arterial occlusion proximal to the sensor. The patient is in cardiac arrest or is in shock. Loss of pulse signal can occur in any of the following situations: The sensor is too tight. There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight. The blood pressure cuff is inflated on the same extremity as the one to which an SpO 2 sensor is attached. 2-6

18 Safety 2.6 Cautions Disposal of sensors must be in compliance with local and facility regulations. Loose sensor: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: never apply an SpO 2 sensor at ambient temperatures from above 98.6 F (37 C) because this can cause severe burns after prolonged application. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, or intravascular venous infusion line. Caution Caution U. S. Federal law restricts this device to sale or use by or on the order of a physician. The following ports on the LIFEGARD I monitor are sensitive to electrostatic discharge during patient monitoring: SpO 2 ECG Temperature probe RS-232 Follow these guidelines to reduce electrostatic discharge: Do not touch the connector pins of the port. When connecting and disconnecting cables to the ports, use ESD precautionary measures. Precautionary measures may include the following: - Make sure you are grounded prior to connection. Touch grounded metal. - Wear an ESD grounding strap and an ESD protective garment. - Provide ESD training to all users. Users should understand what electrostatic discharge is, how damage can occur, and how to prevent ESD. Caution Use only the supplied AC power cord. If in doubt regarding the integrity of the grounding of the AC power source, you should only operate the monitor from its battery. 2-7

19 LIFEGARD I Operator s Manual Caution Caution Caution Caution Caution Caution Caution Caution Caution Caution Use only the approved accessories for the LIFEGARD I patient monitor. Other leads, sensors, cuffs, or tubing will not work. Any time you press the Audio Alarm Control button, you should check the resulting state of the audio alarms indicated by the icons in the parameter frames, to ensure that the alarm system is in the expected mode. Do not sterilize any Analogic or Nellcor sensor by irradiation, steam or ethylene oxide. Do not use Oxicliq disposable sensors in a high humidity environment, such as in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors on patients who have a known allergic reaction to the adhesive. The monitor can only store a total of 99 vital sign measurements. This includes patient records and entries within patient records. If you exceed this limit, the monitor overwrites the oldest record or entry, regardless of the record number. Use only Analogic supplied paper. Using incorrect paper can result in damage to the recorder. Do not immerse the monitor or the optional recorder in liquid or use caustic or abrasive cleaners. Do not spray or pour any liquid on the monitor, the optional recorder, or its accessories. Do not allow any liquid to penetrate connectors or openings in the monitor s or optional recorder s chassis. A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or monitor. 2-8

20 Safety Figure 2-1. Explanation of Symbols Symbol REF Description Reference Number SN Serial Number CE MDD Marking On/Standby switch AC ON LED Power Save LED Initiate NIBP switch Volume Control Contrast Control Defibrillator-proof type CF equipment 5% 95% RH Humidity -20 C -4 F +60 C +140 F Temperature Limits Keep Out of Sun Keep Dry Fragile Keep Upright T M ECG Temperature Temperature Monitor Mode Enabled SpO 2 SpO 2 NIBP Alarm Audio Alarm Control 2-9

21 LIFEGARD I Operator s Manual Figure 2-1. Explanation of Symbols (continued) Symbol Description Alarm Limits Menu Audio Off NIBP Automatic Interval Mode Clock This device restricted to sale by or on the order of a physician ICES-001 Canadian ISM Requirement Battery Status Snapshot Recording Continuous Recording Heart Rate Powering Down ICG Signal Quality Indicator Heart Rate SpO 2 Entering Stand-by. Please wait. NIBP STAT Mode Audio Pause Class II Equipment Setup Menu [ Toggle Display ECG Size Bar RF Interference Caution, consult accompanying documents. Alternating Current 2-10

22 Safety Figure 2-1. Explanation of Symbols (continued) Symbol Description Date of Manufacture (Y = year, X = month) YYYY-XX IPX1 Drip Proof ETL Mark RS-232 RS-232 I/O 21V 1A External Power Supply WEEE Directive 2002/96/EC. Recorder Communication LED 21 VDC 1A 15 VAC 1A Recorder Power Supply Paper Load Direction Battery Charging LED for Recorder + Battery Compartment Electrostatic Sensitive Device Handling Pulse Amplitude Indicator Gauge Direct Current F Degree Fahrenheit C Degree Celsius Oral Axil Rectal Taken through the mouth Pertaining to the cavity beneath the junction of the arm and the body, better known as the armpit. Taken by putting the probe gently in the rectum 2-11

23 LIFEGARD I Operator s Manual LIFEGARD I Patient Monitor Shipping Label 2-12

24 Monitor Setup 3 Monitor Setup 3.1 Connectors To ensure optimal battery performance, the monitor must be connected to AC power prior to first use of battery power. It takes 8 hours to fully charge the monitor in Standby mode, 14 hours to fully charge the monitor when it is operating. The monitor can be used during the charging time because the battery is still being charged even if the monitor is turned on. There are two connectors on the LIFEGARD I s rear panel, one for the RS-232 interface and one for an external power supply. Connector Connector Type Icon RS-232 I/O DB-9 (male) RS-232 External Power Supply Circular 4-pin connector 21V 1A Power Supply Connector RS-232 Interface Port NOTE Use only the Universal Power Converter (UPC) and DC power cable that is shipped with your unit. 3-1

25 LIFEGARD I Operator s Manual The UPC operates on VAC, Hz and provides DC output voltages from 5 to 59 volts. Combined with the DC power cable, the UPC provides the 21 VDC required for the LIFEGARD I monitor. The following symbols appear on the power supply labeling. Icon O/P: 5-59 VDC 35W@35 C 25W@55 C V~ Hz 1.5A Description Identifies the output power specifications Identifies the input power specifications Caution Use only the supplied AC power cord. If in doubt regarding the integrity of the grounding of the hospital AC power source, only operate the monitor from its battery. 3.2 Internal Battery Connect the DC power cable to the receptacle on the monitor s rear panel identified by the input power icon. Take care to align the pins of the cable with the receptacle. Do not force the cable. Connect the supplied AC power cord to the UPC and to an AC power source. Ensure that the AC outlet is properly grounded and supplies the specified voltage and frequency ( VAC, Hz). An internal battery powers the monitor. This internal battery is charged through its connection to an external power source via the external power supply. The battery is continuously recharged when an external source is connected. The battery may be discharged when initially setting up the monitor. In order to recharge the battery, it should be connected to the correct external AC power source. It takes 8 hours to fully charge the monitor in Standby mode It takes 14 hours to fully charge the monitor when it is operating Once fully charged, the internal battery can power the monitor for 2.5 hours of monitoring (all modes active, one NIBP measurement every 15 minutes). When the AC power source is connected and the battery is charging, the green external power indicator LED on the front panel illuminates. The battery charge condition is indicated by a battery gauge icon, showing the amount of charge available, when operating on batteries with no external power connection When the battery charge can support only 15 minutes more of normal monitoring, a warning message appears on the screen and an audible alarm sounds. At that time, the monitor should be connected to the correct power source immediately to avoid loss of patient monitoring. NOTE Connecting and disconnecting external power sources does not interrupt monitoring. 3-2

26 3.3 Optional Recorder The optional recorder used with the LIFEGARD I monitor has an internal battery that operates the recorder for 3 hours (typical performance from a fully charged battery at 25 C and 15, 20-second printouts per hour). To use the recorder: Monitor Setup 21 VDC 1A 15 VAC 1A Step 1. Connect the DC power cable to the connector labeled on the rear panel of the recorder. Then connect the supplied AC power cord to the recorder and to a hospital AC power source. The recorder s front panel charging LED is illuminated when the recorder s external power supply is connected. RS Mounting 3.5 Power On Step 2. Connect the serial cable that was shipped with the recorder between the connectors labeled RS-232 on the rear panels of the monitor and the recorder. When the RS-232 communication link is completed the recorder s front panel communication LED is illuminated. Step 3. Select Printer from the Communication Selection option on the monitor. This option is located in the Setup menu described in Chapter 4. If the recorder becomes disconnected, a low priority alarm sounds and the message Printer Not Available appears on the screen of the monitor. The LIFEGARD I monitor can be mounted on an Analogic-specified roll stand. For information on mounting the monitor, see the operator s manual shipped with the roll stand. For information on ordering the roll stand, contact your Analogic representative. The monitor displays a startup screen and conducts a set of self-diagnostic test routines when the On/Standby button is pressed. On/Standby Button 3-3

27 LIFEGARD I Operator s Manual Default Settings The values for alarm limits, ECG lead selection, types of waveforms and/or trends that the monitor uses when switched on are factory set. Factory default values and alarm limits are listed in Alarm Limits and Factory Set Default Values in Chapter 5. See Viewing and Changing Alarm Limits in that chapter for information on changing alarm limits Standby Mode When the On/Standby button is pressed when monitoring: the display blanks trend data taken during monitoring remain in memory no further monitoring occurs battery charging continues if the monitor is connected to a hospital power source NOTE In standby mode, the monitor is not disconnected from the hospital power source. To fully disconnect the power source, the power cord must be disconnected from the rear panel of the monitor Power Source Indicator The monitor s front panel indicates the status of the external power source. External Power Connections AC source No power source connected Indicators AC icon illuminated Battery status appears in display. No LED illuminated icon. 3.6 Quick Start Steps for monitor use follows. It is recommended you become familiar with the monitor, its accessories and safety information before initial use. 1. Connect the patient cables to the monitor. 2. Attach the cuff, sensor, electrodes, and probe to the patient. 3. Press the On/Standby switch to turn on the monitor. Observe the battery status icon to see that at least 3 bars are filled. If not, plug in battery eliminator. The monitor performs a self-test and then displays the main monitoring screen. 4. Check the alarm limits and adjust if necessary. Rotate the wheel to highlight the alarm/limits icon, then press the wheel to view all alarm limits. To change a limit, rotate the wheel until the desired limit is highlighted, then press the wheel. Rotate the wheel again until the desired value is obtained. Repeat as necessary. When completed, rotate the wheel to highlight Return, then press the wheel to exit to the monitoring screen. 5. Press the contrast button to switch to a different color scheme. 6. Press the volume button to adjust the volume of the heart rate tone. Rotate the wheel to the desired volume. 3-4

28 7. Press the initiate blood pressure measurement button. Press and hold for two seconds to initiate STAT mode. Press at any time during an NIBP measurement to end the measurement and deflate the cuff. 8. Press the audio alarm button to temporarily silence audible alarms. 9. To produce a 20 second recording (if a recorder is connected), press the snapshot button to switch on the recorder. 10. Press the continuous print button to prduce a continuous printout. 11. Press On/Standby to end monitoring. Monitor Setup 3-5

29 Using the LIFEGARD I Monitor 4 Using the LIFEGARD I Monitor 4.1 General Display Shows measurement results and monitoring status 2 Patient Monitoring Connections for cables and leads Connectors 3 Switch Panel Contains single action buttons and status indicators 4 Navigation Wheel Controls measurement and display menus 5 Handle Integrated carrying handle 4-1

30 LIFEGARD I Operator s Manual 4.2 Display Overview The display screen is divided in frames as follows: Numeric Frames that show icons and numeric values of real-time physiological parameters A Graphic Frame that shows real-time physiological waveforms or tabular trend data A Message Frame that describes alarm conditions A Menu Frame that shows icons of menu choices or condition status Current Date and Time Frames Numeric Frames Numeric Frames Graphic Frame [ Message Frame Menu Frame Menu Frame Date Frame Alarm Limits Icon Toggle Display Icon Setup Icon Adult/Pediatric Select Battery Status 4.3 LIFEGARD I Display Shown is a typical monitoring condition with one waveform. The monitor has one frame to display waveforms, graphical trend or tabular trend data. Each frame is described in more detail in the table that follows [

31 Using the LIFEGARD I Monitor Call Out Icon/Measurement 1 Graphics Frame The graphics frame can display ECG, SpO 2, tabular trend data, or Spotcheck data (if enabled), but only one at a time. 2 Alarm/Message Area A message remains displayed until the problem is resolved, or until it is cleared by pressing the Audio Alarm Control button. If there is more than one message, each, in turn, is displayed for one second. 3 Alarm Limits When this is selected, a menu appears from which you can view and modify the current alarm limit settings. 4 Toggle Display Use this to cycle through the available selection of waveform(s) or display trend data or Spotcheck data. Power-up default is tabular trend. 5 Setup Displays a menu of general purpose parameters. From this menu you can turn the display backlighting On or Off, and activate the Nurse Call signal, if connected. Also in this menu is an item used by qualified service personnel to change the power-up default settings of the monitor. This function is passcode protected. 6 Monitoring Mode Display Displays current monitoring mode and determines preset alarm defaults for NIBP initial cuff inflation pressure and alarms limits. These differ between adult and pediatric modes. Toggles between adult and pediatric mode. 7 The Battery Status icon appears whenever the monitor is operating on battery power alone, providing a graphic indication of remaining battery power. The icon flashes when battery power is low. 8 Date (mm/dd/yy or dd/mm/yy) 9 Time (hour:minutes:seconds) 10 SpO 2 numeric (in % saturation) 11 Heart Rate numeric (in beats/minute) 12 NIBP Systolic/Diastolic (Mean) Arterial Pressure in mmhg numeric 13 Temperature numeric (in C or F) 4.4 Changing Settings Navigating through the settings, and making changes to screen elements is done by rotating and then pressing the navigation wheel. To highlight frames of the screen, rotate the wheel. A heavy border is drawn around a frame when it is selectable. Press the wheel to select the frame. The monitor s response may be immediate or it may display a Level 2 menu that pops up on the screen without removing the Level 1 menu. 4-3

32 LIFEGARD I Operator s Manual Example of a Change Operation To change the sweep speed of the ECG waveform: Step 1. Rotate the wheel to highlight the ECG graphics frame. A heavy border appears around that frame. Step 2. Press the wheel. The Level 1 menu appears. Step 3. Rotate the wheel to highlight Sweep Speed (25.0 mm/s). It appears in reverse video. Step 4. Press the wheel. A Level 2 menu appears and the current value (25.0 mm/s) is highlighted in reverse video. Step 5. Rotate the wheel to highlight the value 50.0 mm/s in the list. 4.5 Initial Setup Step 6. Press the wheel. The waveform speed is changed to 50 mm/s. Step 7. Rotate the wheel to highlight Return. Step 8. Press the wheel to return to the normal monitoring screen. Several tasks must be performed including setting the date and time, and setting basic features in the Setup menu before using the LIFEGARD I patient monitor. NOTE If you want to change the date format (dd/mm/yy or mm/yy/dd), do this before setting the new date. Always change the date after each daylight savings time change Setting the Date and Time To set the date and time: Step 1. Rotate the navigation wheel to highlight the Date/Time graphics frame. A heavy border appears around that frame. Step 2. Press the wheel. The Date/Time Menu appears. 4-4

33 Step 3. Rotate the wheel to select Set Date. The current date appears with the first two digits (dd or mm) in reverse video. Step 4. Rotate the wheel until the current day (or month) appears. Step 5. Press the wheel and the selected day (or month) is set. Step 6. Repeat Steps 4 and 5 to set the remainder of the date. Step 7. Rotate the wheel to select Return and press it to return to the Date/Time Menu. Step 8. Repeat Steps 3 to 7 to set the current Time Setup Menu Using the LIFEGARD I Monitor The Setup menu allows the user to set basic features that will not change during individual monitoring sessions. They are described in the following table. Selection Nurse Call Signal Power Save Mode Communication Selection Power Up Defaults Menu Description Use this to Enable (or Disable) transmission of the nurse call signal. Power save choices are Inactive, 2, 5 or 15 minutes. The screen blanks after the specified time has passed. Interaction with the monitor (for example, moving the wheel) reactivates the display. Set this to Printer (to print to an external recorder) or Trend Xfer (to transfer trends to an external computer). Access by passcode only. Allows code holder to change factory default settings. Set the desired basic features using the navigation wheel as follows: Step 1. Rotate and press the navigation wheel to highlight the Setup icon. The Setup menu appears. Step 2. Set the desired basic features using the navigation wheel. 4.6 Patient Monitoring Connectors All the patient connectors on the LIFEGARD I monitor are classified as type CF, which specifies their degree of protection against electrical shock. All are rated as defibrillatorproof. Each connector is marked with the heart symbol. Each connection is identified by a unique icon describing the parameter that is monitored through that connector. 4-5

34 LIFEGARD I Operator s Manual Caution Use only the approved accessories for the LIFEGARD I patient monitor. Other leads, sensors, cuffs, or tubing will not work. Icon Monitored Parameter Connector Type SpO 2 T ECG SpO 2 NIBP Temperature Use with Analogic LIFEGARD I ECG Lead Cable. Use with Analogic recommended sensors and sensor extension cables. Compatible with recommended Analogic blood pressure tubing and cuffs for the LIFEGARD I. Compatible with Welch Allyn Sure Temp temperature probes. 4.7 Switch Panel The following symbols identify the switches and LED (light emitting diode) indicators on the Switch Panel. Icon Switch/LED Description Operation On/Standby Switch Toggles monitor from On to Standby. AC Source LED Indicator NIBP Start/Stop Switch NIBP STAT Icon Audio Alarm Control Heart Rate Tone Volume Switch Contrast Switch When lit, indicates an AC source is connected and charging the battery. Toggles between starting and stopping NIBP measurement. Indicates STAT mode, which is initiated by pressing and holding the NIBP switch for 2 seconds. Temporarily silences the audible alarm sound for a pre-set interval. Enables the wheel to adjust the volume of the audible tone Switches to the alternate color scheme. Power Save LED blinks to indicate that the Power Save mode is active. Monitoring continues, but the display backlight is off. 4-6

35 Alarms and Limits 5 Alarms and Limits The various alarms and alarm indicators in the LIFEGARD I monitor are explained in this chapter. These alarms are comparable in all models of the LIFEGARD I. 5.1 General Safety Information If the battery is defective, the loss of monitoring alarm will fail to sound. Neither the Print-On-Alarm nor the Nurse Call signal initiate when the monitor detects a Loss-of-Monitoring state. If an alarm condition (except those leading to a Loss-of-Monitoring alarm) occurs while the monitor is in the Audio Off state, the only alarm indications are visual displays related to the alarm conditions. Caution NOTE NOTE Any time you press the Audio Alarm Control button, you should check the resulting state of the audio alarms indicated by the icons in the parameter frames, to ensure that the alarm system is in the expected mode. When the Alarm/Limits Menu displays, normal monitoring continues. Before you apply the Auto-Set limits, a valid signal must be available for a parameter. If a valid signal is not available, those limits do not change. 5.2 LIFEGARD I Patient Monitor Alarms The purpose of the alarms is to alert the user to situations requiring attention. The monitor s visual and audible response is prescribed by the priority of the alarm: high, medium (physiological), or low (INOPs). Low priority alarms, referred to as INOP, implies a situation that needs correction. The monitor has: Visual alarm indicators Audible alarm indicators Print-on-alarm (if recorder is present) Identification of out-of-limit vital signs in trend data Nurse call signal (if connected and enabled) NOTE Physiological limit alarms do not occur until alarm limits are exceeded. For example, if the alarm limit for SpO 2 is 85%, an alarm occurs only if SpO 2 measures 84% or lower. 5-1

36 LIFEGARD I Operator s Manual 5.3 Visual and Audio Alarm Indicators Visual alarms cannot be removed or suspended. The volume and pause of audible alarms can be changed. An audible alarm should not be paused or its volume decreased if it could compromise patient safety. Below are the various alarm states. Icon Alarm Description Audio Alarm Control switch Audio Pause Audio Off Audio alarms for a specific parameter are silenced, but when a new physiological alarm condition occurs, other audible alarms sound. Audio alarms are paused for a configured period of time. All audio alarms are disabled completely. The audible beep rate is governed by the priority of the alarm. An explanation of the attributes and circumstances for each priority alarm is detailed in the Patient Alarm Messages section. 5.4 Patient Alarm Messages The different alarms are listed in the following pages. They are listed alphabetically in the table (irrespective of their priority). Technical alarms are listed in the section, Technical Alarm Messages (INOPs) in this chapter High Priority The asystole alarm is the only high priority alarm in the LIFEGARD I monitor. If an asystole occurs, the word Asystole displays in the Message frame. This message overrides all other messages present in the Message frame. No message sequencing occurs. High priority audio alarms cannot be turned off using the HR Audio Alarms Off setting. Listed below are the visible and audible characteristics that accompany an asystole alarm. Alarm Message Parameter Condition Visual Indication Audible Indication Asystole ECG The interval between HR numeric blinks High-pitched tone two QRS complexes 100 times per minute repeating 3 tones is >4 seconds. per second. Red flashing background Physiological Alarm Messages The following table lists all physiological alarms. Physiological alarms are medium priority alarms. If the alarm has a status message, the message displays in the Message frame. Alarms that indicate that a parameter has exceeded its high/low limit are not accompanied by a status message. If an alarm is activated because a parameter is outside its alarm limits, the out-of-limit numeric value and the alarm icon in the corresponding numeric frame flash. 5-2

37 Alarms and Limits Physiological Alarms Alarm Message Parameter Condition Visual Indication Audible Indication High Heart Rate ECG The heart rate has HR numeric blinks 33 times Medium-pitched limit violated exceeded the high per minute. tones repeating 1.5 alarm limit. Yellow flashing background. tones per second. Low Heart Rate ECG The heart rate has HR numeric blinks 33 times Medium-pitched limit violated dropped below the per minute. tones repeating 1.5 low alarm limit. Yellow flashing background. tones per second. High SpO 2 limit SpO 2 The SpO 2 value has SpO 2 numeric blinks 33 times Medium-pitched violated exceeded the high per minute. tones repeating 1.5 alarm limit. Yellow flashing background. tones per second. Low SpO 2 limit SpO 2 The SpO 2 value has SpO 2 numeric blinks 33 times Medium-pitched violated dropped below the per minute. tones repeating 1.5 low alarm limit. Yellow flashing background. tones per second. High Systolic/ NIBP The NIBP value has NIBP numeric blinks 33 times Medium-pitched Diastolic/Mean exceeded the high per minute. tones repeating 1.5 blood pressure alarm limit. Yellow flashing background. tones per second. limit violated Low Systolic/ NIBP The NIBP value has NIBP numeric blinks 33 times Medium-pitched Diastolic/Mean dropped below the per minute. tones repeating 1.5 blood pressure low alarm limit. Yellow flashing background. tones per second. limit violated Technical Alarm Messages (INOPs) The following table lists all INOPs. If the alarm has a status message, the message displays in the Message frame. Those messages that appear in the Message frame appear in quotation marks in the following table. The values that are affected are displayed with -?-. If more than one INOP is present, the alarm messages rotate in the Message frame. Technical Alarm Messages (INOPs) INOP Message Parameter What To Do Visual Indication Audible Indication ECG Leads Off ECG Make sure that the patient Message displays in 1 beep every cable is connected, these Message frame. 4 seconds. leads are connected to Cyan background in the electrodes, and the parameter frame. electrodes are attached. Loss of Pulse SpO 2 Check that the SpO 2 Message display in 1 beep every from SpO 2 patient cable is connected Message frame. 4 seconds. and the sensor is Cyan background in correctly attached to the parameter frame. patient. Low Battery Change the battery. Battery Symbol flashes. 1 beep every Alarm commences when Message displays in 4 seconds. the monitor has a Message frame. minimum of 15 minutes operating time remaining. NIBP - Artifact NIBP Measurement subject Message displays in 1 beep every to artifacts. Message frame. 4 seconds Cyan background in parameter frame. NIBP - Blocked NIBP NIBP tubing blocked - Message displays in 1 beep every Hose measurement not possible. Message frame. 4 seconds Cyan background in parameter frame. 5-3

38 LIFEGARD I Operator s Manual Technical Alarm Messages (INOPs) (continued) INOP Message Parameter What To Do Visual Indication Audible Indication NIBP - No Cuff NIBP Monitor unable to detect Message displays in 1 beep every NIBP cuff. Message frame. 4 seconds. Cyan background in parameter frame. NIBP NIBP Remove the cuff from the Message displays in 1 beep every Overpressure patient. Make sure the Message frame. 4 seconds. rubber tube to the NIBP Cyan background in cuff is not kinked. This parameter frame. INOP arises when the NIBP cuff pressure increased above overpressure safety limits. NIBP - Time-Out NIBP NIBP measurement took Message displays in 1 beep every too long to complete. Message frame. 4 seconds. Cyan background in parameter frame. Printer Out of New paper needed. Message displays in 1 beep every Paper Message frame. 4 seconds. Printer Not Check that the recorder Message displays in 1 beep every Available cable is connected. Message frame. 4 seconds. SpO 2 Cable/ SpO 2 Check that the SpO 2 Message displays in 1 beep every Sensor patient cable is connected Message frame. 4 seconds. Disconnect and the sensor is Cyan background in properly attached to the parameter frame. patient. SpO 2 Pulse SpO 2 Make sure the SpO 2 Message displays in 1 beep every Search transducer is properly Message frame. 4 seconds. placed. If this does not Cyan background in solve the problem, make parameter frame. sure the transducer is working. Temperature Temp Check that the Message displays in 1 beep every Probe Disconnect temperature probe is Message frame. 4 seconds. properly connected to Cyan background in the monitor. parameter frame. Temperature Temp Probe failed to self-heat Message displays in 1 beep every Probe Fault to correct temperature or Message frame. 4 seconds. may be faulty. Reinsert Cyan background in probe in storage well and parameter frame. retry. Wait for the beep tone before positioning the probe for patient measurement. Temperature Temp Probe may not be in Message displays in 1 beep every Probe Position contact with patient tissue. Message frame. 4 seconds. Try repositioning probe. Cyan background in If the Temperature frame parameter frame. shows a numeric value, it may be inaccurate. 5-4

39 5.5 Loss of Monitoring Alarms When the monitor cannot continue monitoring due to a hardware error condition, or shuts down because of a low battery or loss of power, a continuous loss-of-monitoring alarm occurs. If the battery is defective, the Loss-of-Monitoring alarm will fail to sound. Alarms and Limits The monitor attempts to display an error identification number if there is a hardware error. In all other situations, the monitor shuts off and no visual indicator displays. Neither the Print-on-Alarm nor the Nurse Call initiates when the monitor detects a Loss-of-Monitoring state. 5.6 Viewing and Changing Alarm Limits When the monitor is turned on, it uses the alarm limits that were factory set or saved by authorized personnel. The user can configure alarm limits for a current monitoring session. This configuration remains in effect until it is modified or the monitor is turned off. Each time the monitor is used, the user should check the power-up default alarm limits to confirm that they are suitable for the patient being monitored. The following section explains how to configure alarm limits. 5.7 Configuring the Alarm/Limits Screen The Alarm/Limits Menu displays all of the monitor s current alarm settings. Use this screen to: View the current limit settings. After 20 seconds with no button or wheel activity, the display returns to the main monitoring screen. Change a parameter s alarm limit. When a limit is specified, it becomes effective immediately. Enable or disable audible alarms for specific parameters. Set limits to automatically calculated values using the Auto-Set Limits menu item. Enable or disable the Print-on-Alarm feature. Change the Alarm Volume setting. The user can also set alarm limits and enable or disable an audible alarm for a specific parameter through its numeric frame menu. This is described in the individual monitoring chapters that follow. NOTE When the Alarm/Limits Menu displays, normal monitoring continues. 5-5

40 LIFEGARD I Operator s Manual To access the Alarm Limits screen and change a limit: Step Action 1 Rotate the navigation wheel until the Alarm/Limits icon is highlighted. 2 Press the wheel to select the icon and enter the Alarm/Limits Menu. All current alarm limits for all monitored parameters displays. 3 Rotate the wheel until the desired limit is highlighted. Press the wheel to highlight the numeric value of that limit. The selected limit displays in reverse video. 4 Rotate the wheel to change the limit s numeric value. 5 After you select the desired limit, press the wheel to accept that value. The limit selection becomes effective immediately. 6 Repeat steps 3-5 to change other limits. To return to the previous monitoring screen, rotate the wheel until Return is highlighted, then press the wheel. The display also returns to the main monitoring screen after 20 seconds with no wheel activity. There are many other features that are accessible through the Alarm/Limits Menu. The following table summarizes these features. Default values appear in bold. Item Return Print-on-Alarm Level 2 Screen Menu, or Monitor Response When Selected Exits Level 1 menu immediately, and returns to main monitoring screen. Enabled/Disabled Automatically initiates a snapshot printout when a high or medium priority out-of-limits alarm event occurs. Auto-Set Limits Select from two options: 1. Make No Changes to Limits - limits remain for all displayed parameters. 2. Auto-Set Now - new limits are calculated according to formulas described in the Auto-Set Alarm Limits in this chapter, and replace those on the screen. HR Upper/Lower Limits Variable Select by rotating the wheel to highlight the desired limit. Press and then rotate the wheel to cycle through possible limit values that display. Pressing the wheel activates the displayed selection. HR Audible Alarm Select the bell icon to enable or disable audible alarms for HR alarm limit violations. An X appears across the bell icon when the audible alarm has been disabled. SpO 2 Upper/Lower Limits Variable Select by rotating the wheel to highlight the desired limit. Press and then rotate the wheel to cycle through possible limit values that display. Pressing the wheel activates the displayed selection. 5-6

41 Alarms and Limits Item SpO 2 Upper/Lower Limits Level 2 Screen Menu, or Monitor Response When Selected Variable Select by rotating the wheel to highlight the desired limit. Press and then rotate the wheel to cycle through possible limit values that display. Pressing the wheel activates the displayed selection. SpO 2 Audible Alarm Select the bell icon to enable or disable audible alarms for SpO 2 alarm limit violations. An X appears across the bell icon when the audible alarm has been disabled. SYS Upper/Lower Limits Variable Select by rotating the wheel to highlight the desired limit. Press and then rotate the wheel to cycle through possible limit values that display. Pressing the wheel activates the displayed selection. MAP Upper/Lower Limits Variable Select by rotating the wheel to highlight the desired limit. Press and then rotate the wheel to cycle through possible limit values that display. Pressing the wheel activates the displayed selection. DIA Upper/Lower Limits Variable Select by rotating the wheel to highlight the desired limit. Press and then rotate the wheel to cycle through possible limit values that display. Pressing the wheel activates the displayed selection. NIBP Audible Alarm Select the bell icon to enable or disable audible alarms for NIBP alarm limit violations. Alarm Volume 1, 2, 3, 4, 5, 6, 7, 8, 9 An X appears across the bell icon when the audible alarm has been disabled. Volume increases in increments of 5 dba. The lowest value is 45 dba (1) and the highest is 85 dba (9). An arrowhead points to the currently selected volume number. Press the speaker volume button on the front panel and the audible alarm sounds at the selected volume number. To change the audible alarm volume, rotate the navigation wheel until the arrowhead points to the desired volume number. The alarm continues to sound until you press the speaker button again. Audio Pause The Audio Pause field displays the current Audio Pause Period setting. This setting can only be changed in the password-protected Power-Up Defaults menu. Possible values are: 30 s, 60 s, 90 s, 120 s, 180 s When you initiate an audio pause condition, the Audio Pause icon displays. See Audio Pause and Silencing Alarms in this chapter for additional information. 5-7

42 LIFEGARD I Operator s Manual 5.8 Auto-Set Alarm Limits The Auto-Set Limits feature allows the user to set alarm limits quickly based on the patient s current vital sign values. When the Auto-Set Limits option is selected from the Alarm Limits Menu, a pop-up menu displays. Select Auto-Set Now from this menu. A calculated offset is applied to each measured vital sign to produce new upper and lower alarm limits. NOTE Before you apply the Auto-Set limits, a valid signal must be available for a parameter. If a valid signal is not available, those limits do not change. The formulas used for calculating the Auto-Set Limits are shown below. Calculated lower/upper limits must never exceed the low/high values listed below. Parameter Lower Limit Upper Limit Heart Rate HR x 0.75 or 30/min HR x 1.5 or 250/min (whichever is greater) (whichever is smaller) NIBP Systolic Systolic x Systolic x NIBP Diastolic Diastolic x Diastolic x NIBP Mean Mean x Mean x SpO 2 Resets to power-up default values Resets to power-up default values 5.9 Alarm Limits and Factory-Set Default Values The following table describes the range and increment values that are used to change alarm limits. The default values set in the factory for each parameter are also listed. Be sure that when a limit is selected, it is the same measurement unit that displays in the Numeric frames. Factory Default Alarm Settings Parameter High/Low Upper Limit Ranges Lower Limit Ranges Heart Rate (5 BPM increments) SpO 2 (1% increments) NIBP SYS (5 mmhg increments) NIBP DIA (5 mmhg increments) NIBP MAP (5 mmhg increments) Adult - 170/40 BPM Adult - 35 to 250 BPM Adult - 30 to 245 BPM Pediatric - 210/70 BPM Pediatric - 35 to 250 BPM Pediatric - 30 to 245 BPM Adult - 100/85% Adult - 90 to 100% Adult - 50 to 99% Pediatric - 100/85% Pediatric - 90 to 100% Pediatric - 50 to 99% Adult - 200/70 mmhg Adult to 240 mmhg Adult - 60 to 150 mmhg Pediatric - 150/50 mmhg Pediatric to 240 mmhg Pediatric - 50 to 150 mmhg Adult - 160/50 mmhg Adult - 80 to 180 mmhg Adult - 20 to 120 mmhg Pediatric - 100/20 mmhg Pediatric - 80 to 180 mmhg Pediatric - 20 to 120 mmhg Adult - 180/60 mmhg Adult - 90 to 200 mmhg Adult - 30 to 130 mmhg Pediatric - 130/30 mmhg Pediatric - 90 to 200 mmhg Pediatric - 30 to 130 mmhg 5-8

43 Alarms and Limits 5.10 Audio Pause and Silencing Alarms The Audio Alarm Control button s operation is described in the table below. Medium or High Only Low No Alarms Priority Alarms Priority Alarms During Audio Audio Off Action Sounding Sounding Sounding Pause Period Mode Active Single Press Starts Audio Starts Audio Silences any Terminates Audio Terminates Pause period Pause period low-priority and Pause period Audio Off mode resets alarm system to allow new alarms to be sounded Two No change to Silences all active Silences any low- Restarts Audio Terminates Audio consecutive alarm mode alarms and resets priority alarms and Pause period Off mode and presses alarm system to starts Audio Pause starts Audio within allow new alarms period Pause period 10 seconds to be sounded Press and for 2 seconds Invokes global Audio Off mode, no alarms will be sounded until the Audio Alarm Control button is pressed again. No menus are accessible, screen displays large Audio Off icon. When a Medium or High Priority alarm is silenced and reset by two consecutive presses within 10 seconds, and the alarm condition remains active, the parameter frame continues to flash but no audio tone is sounding. New alarms for that parameter will be sounded as they occur. This situation is indicated by replacing the flashing bell icon with a flashing crossed bell icon in the parameter frame. The Audio Pause period is a temporary state which pauses all audible alarms for a configured period of time. The factory default pause period is 120 seconds. When an Audio Pause condition is initiated, the Audio Pause icon (reverse video crossed bell) displays in each parameter display frame. The following conditions apply when the Audio Alarm Control button is pressed: If a new alarm occurs during an Audio Pause period, the audible alarm does NOT sound. If an alarm occurs after an Audio Pause period expires, the audible alarm sounds. If the Audio Alarm Control button is pressed when no alarms are active, the Audio Pause period still initiates. If the Audio Alarm Control button is pressed during an Audio Pause period, the Audio Pause period terminates and the Audio Pause icons are removed from the parameter s frame. If the Audio Pause period has been active more than 10 seconds, any alarms that are active at this time will sound immediately. Press the Audio Alarm Control button twice within 10 seconds of the first press to silence actively-sounding medium or high priority alarms, but allow immediate audio indication of new alarms. The first press initiates the Audio Pause period, and the second press terminates it, resetting the alarm monitoring system to sound new alarms as they occur. In this state, the silenced alarms remain flashing and a new Silence/Reset icon appears in the parameter frame. If one of the alarms silenced in the previous case reoccurs, it will not sound until 10 seconds after the second press of the button. This prevents excessive audio alarms due to signal artifact. Whenever the above two-press Silence/Reset operation is invoked, a reminder timer is started with the duration set to the same duration as the Audio Pause period. 5-9

44 LIFEGARD I Operator s Manual 5.11 Audio Off When this timer expires, any active alarm that is not in the Audio Off mode will resume sounding as a reminder that the condition is still true. If a low priority alarm occurs, pressing the Audio Alarm Control button silences the audible alarm and removes corresponding warning messages from the screen until the next alarm condition. If the Audio Alarm Control button is pressed and only low priority alarms are active, the Audio Pause period does not initiate. If multiple low priority alarms are active, pressing the Audio Alarm Control button clears all low priority audible alarms. If low and medium or high priority alarms are active, pressing the Audio Alarm Control button clears low priority alarms and silences medium and high priority audible alarms. If the Audio Alarm Control button is pressed because and NIBP value is above or below its limit, the NIBP alarm condition clears and the Audio Pause period begins. If a Loss-of-Monitoring alarm occurs during an Audio Pause period, a Loss-of- Monitoring alarm sounds. Press the Audio Alarm Control button to silence the audible alarm. All audible alarms and the record and print-on-alarm functions are disabled if the Audio Alarm Control button is held for 2 seconds. Trend memory, monitoring parameters, all function buttons, visual alarms, nurse call signal, and identification of out-of-limits vital signs continue to operate. Audio can be turned off during an audio pause period even if no alarms are active. If audio is turned off, a crossed bell symbol appears in the screen, identifying that the monitor is in Audio Off mode (see illustration below). Pressing the Audio Alarm Control button briefly a second time terminates the Audio Off Condition. If an alarm condition (except those leading to a Loss-of-Monitoring alarm) occurs while the monitor is in the Audio Off state, the only alarm indication are visual displays related to the alarm conditions. 5-10

45 ECG Monitoring 6 ECG Monitoring 6.1 General As the heart undergoes depolarization and repolarization, the electrical currents that are generated spread not only within the heart, but also throughout the body. This electrical activity generated by the heart can be measured by an array of electrodes placed on the body surface. Typically, these electrodes are attached to the patient s right arm, left arm, and left leg. The monitor processes and amplifies these signals and presents the ECG waveform on the screen. In addition to acquiring the QRS complex, the monitor also Computes and displays the heart rate in beats per minute. Detects a lead off condition if one of the electrode connections is disrupted. Detects the presence of pacemaker signals within the waveform complex of the ECG. Allows the selection of an extended low frequency range of signal detection and processing. 6.2 ECG Safety Information Use only Analogic ECG electrodes and leads with the LIFEGARD I monitor. Other ECG cables and leads may cause improper performance and/or provide inadequate protection during defibrillation. When connecting the electrodes or the patient cable, ensure that the connectors never come into contact with other conductive parts, or with earth. In particular, ensure that all of the ECG electrodes are attached to the patient to prevent them from contacting conductive parts or earth. For pacemaker patients, the monitor may continue to count pacemaker rate during cardiac arrest or some arrhythmias. Do not rely entirely upon the monitor s alarm. Keep pacemaker patients under close surveillance. Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable placement, as specified in this manual and the electrodes directions for use. ECG cables may be damaged when connected to a patient during defibrillation. Check cables that have been connected to a patient during defibrillation for functionality before using them again. 6-1

46 LIFEGARD I Operator s Manual 6.3 ECG Leads DO NOT: Use ECG leads that appear frayed, cracked, or damaged in any way. Immerse ECG leads completely in water, solvents, or cleaning solutions because the connectors are not waterproof. Sterilization is not recommended for this monitor, related products, accessories or supplies unless otherwise indicated in the instructions that accompany the accessories and supplies. Electrodes are single use only. Disposal of electrodes must be in compliance with local and facility regulations. Monitoring with the Pacer Detect feature enabled does not normally affect the monitoring of non-pacemaker patients. However, in some instances, if the patient does not have a pacemaker, it can be desirable to turn the detection function Off so that artifacts in the waveform are not mistaken for a pacemaker signal. Interference from instruments near the patient and Electro-Surgical Unit interference can cause problems with the ECG wave. See the monitor specifications for more information. Electromagnetic interference may cause disruption of performance. Protect the monitor from sources of intense electromagnetic radiation. This device has been designed to provide resistance to electromagnetic interference. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the healthcare and home environments (such as cellular phones, mobile two-way radios, electrical appliances) it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device. Disruption may be evidenced by erratic readings, cessation of operation or other incorrect functioning. If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source. If assistance is required, contact the Life Care Systems Support Group or your local Analogic representative ECG Lead Color Coding Lead AAMI IEC Right arm (RA) White Red Left arm (LA) Black Yellow Left leg (LL) Red Green 6-2

47 6.3.2 Connecting the Leads Use only Analogic ECG electrodes and leads with the LIFEGARD I monitor. Other ECG cables and leads may cause improper performance and/or provide inadequate protection during defibrillation. 6.4 Placing the Leads Step 1. Connect the ECG cable to the ECG input connector on the side panel. Step 2. Connect the ECG leads to the ECG cable. Step 3. Select the electrodes to be used. Use only one type of electrode on the patient to avoid variations in electrical resistance. For ECG monitoring, use of silver/silver chloride electrodes is strongly recommended. Using dissimilar metals for different electrodes may subject the electrodes to large offset potentials due to polarization. This can be severe enough to prevent obtaining an ECG trace. Using dissimilar metals may also increase recovery time after defibrillation. Step 4. Prepare the electrode sites according to the electrode manufacturer s instructions. Refer to Placing the Leads for electrode placement configurations. Step 5. Attach the lead wires to the electrodes. Step 6. Apply the electrodes to the patient as shown. If Standard ECG Lead Placement is used, verify that the desired Lead Selection is active in the ECG waveform frame. Lead II is best suited for most monitoring situations. If Modified Chest Lead Placement is used, verify that Lead II is active in the ECG waveform frame Standard ECG Lead Placement ECG Monitoring RA LA LL ECG Lead Pairs for Standard Lead Placement Lead-Select Option I II III Electrode Differential RA( ) LA( + ) LL = G RA( ) LL( + ) LA + G LA( ) LL( + ) RA + G 6-3

48 LIFEGARD I Operator s Manual Modified Chest Lead Placement (MCL1) (G) = LA ( ) = LL ( + ) = LL 6.5 Controlling ECG Functions Using the Numeric Frame HR Icon HR Source Icon [ Units of Measure HR Value The Heart Rate menu contains the following choices. Default values appear in parentheses. Heart Rate Menu (Numeric Frame) Level 1 Menu Heart Rate Tone Source Heart Rate Limits HR audio alarm off icon Return Level 2 Menus or Response (SpO2), ECG Variable On/Off (On) Exits Level 1 menu immediately, returns to Monitoring Screen 6-4

49 6.5.1 Heart Rate Source Whether the heart rate is derived from ECG, SpO 2, or NIBP is indicated by the heart rate source icon. If a valid ECG signal is present, the monitor automatically acquires the heart rate from it. If ECG is not present, but SpO 2 is being monitored, the heart rate value is obtained from the SpO 2 signal. If neither ECG nor SpO 2 is available, heart rate obtained from NIBP will be displayed. If HR is obtained from NIBP, the monitor displays that value for three minutes, then removes the value from the display Heart Rate Tone A short pulse tone sounds, synchronous with each heart beat. This heart rate tone is obtained from either SpO 2 or ECG. The pitch varies proportionally with changes in oxygen saturation when SpO 2 is the source, rising as SpO 2 increases toward 100%, and falling as it decreases. The heart rate tone does not change pitch if the source is ECG. Pressing the front panel volume button and then turning the wheel adjusts the heart rate tone s volume. 6.6 Controlling ECG Functions Using the Graphic Frame ECG waveforms are displayed in the graphic frame. ECG Monitoring [ Lead Pair in Use Scale Bar 1 cm Size Scale [ The ECG Waveform menu contains the following choices. Default values appear in parentheses. ECG Waveform Menu (Graphic Frame) Level 1 Menu Lead Select Sweep Speed Size Pacer Detect Extended Low Frequency Range Return Level 2 Menus or Response I, II, III 12.5 mm/s, (25) mm/s, 50 mm/s 0.5 mv/cm, (1 mv/cm), 2 mv/cm, 4 mv/cm (On), Off On, (Off) Exits Level 1 menu, returns to Monitoring Screen 6-5

50 LIFEGARD I Operator s Manual Extended Low Frequency Range The monitor displays frequencies down to 0.05 Hz when Extended Low Frequency Range is On, which provides better ST segment resolution. The ST segment represents the period from the end of ventricular depolarization to the beginning of ventricular repolarization. It is clinically important if elevated or depressed as it can be a sign of ischemia and hyperkalemia. However, the increased bandwidth may result in low-frequency wander of the ECG baseline. It is recommended that this feature is turned On only when better ST segment resolution is needed Pacer Detect The monitor detects and filters pacemaker-generated signals when Pacer Detect is On so that they will not be measured in determining a patient s heart rate. A positive-going spike on the ECG waveform (screen and printout) represents pacemaker signals. Monitoring with the Pacer Detect feature enabled does not normally affect monitoring of non-pacemaker patient. However, in some instances, if the patient does not have a pacemaker, it may be desirable to turn the detection function Off so that artifacts in the waveform are not mistaken for a pacemaker signal ECG Leads Off When all three ECG leads are properly attached to the patient, it is discerned by the monitor. After the monitor has established that all three leads are attached, if one or more of the leads comes off (or loses good electrical contact), a low-priority ECG Leads Off alarm is issued. Electromagnetic noise may cause the ECG circuit to electrically saturate, occasionally. The monitor issues an ECG Leads Off alarm if this condition occurs. Duration should be short and occurrence is rare. The ECG Leads Off alarm clears automatically as soon as the condition terminates. 6-6

51 NIBP Monitoring 7 NIBP Monitoring 7.1 General Blood pressure is measured non-invasively (NIBP) by the oscillometric method. The cuff is inflated initially, by a motorized pump, to approximately 160 mmhg (21 kpa) for adult patients, or until the pressure effectively blocks the flow of blood in the extremity. Then the pressure in the cuff is gradually reduced, while a pressure transducer detects air pressure and transmits a signal to the NIBP circuitry. Blood flows in the previously blocked artery as the cuff pressure reduces, and changes the measured pressure values sensed by the transducer. Systolic pressure is the maximum pressure in an artery at the moment when the heart is beating and pumping blood through the body. As the cuff continues to deflate, oscillation amplitude increases to a maximum, and then decreases. The peak oscillation amplitude is defined as the mean arterial pressure. The diastolic pressure is the lowest pressure in an artery in the moments between beats when the heart is resting. 7.2 Calculating Mean Arterial Pressure The monitor calculates MAP (Mean Arterial Pressure), which is the Diastolic Pressure times 2 plus the Systolic Pressure divided by three. MAP = Diastolic Pressure x 2 + Systolic Pressure NIBP Safety Information Use only recommended Analogic blood pressure tubing and cuffs. Using other cuffs or tubing may result in inaccuracies. Do not use the monitor on patients who are linked to heart/lung machines. The monitor may not operate effectively on patients who are experiencing convulsions or tremors. Inaccurate measurements can be caused by: Incorrect cuff application or use, such as placing the cuff too loosely on the patient, using the incorrect cuff size, or not placing the cuff at the same level as the heart Leaky cuff or tubing Excessive patient motion 7-1

52 LIFEGARD I Operator s Manual The monitor displays results of the last blood pressure measurement until another measurement is completed. If a patient s condition changes during the time interval between measurements, the monitor will not detect the change or indicate an alarm condition. Occasionally, electrical signals at the heart do not produce a peripheral pulse. If a patient s beat-to-beat pulse amplitude varies significantly (for example, pulsus alternans, atrial fibrillation, rapid-cycling artificial ventilator), blood pressure and pulse rate readings can be erratic and an alternate measuring method should be used for confirmation. A patient s vital signs may vary dramatically during administration of agents affecting the cardiovascular system, such as those used to raise or lower blood pressure or raise or lower heart rate. As with all automatically inflatable blood pressure devices, continual cuff measurements can cause injury to the patient being monitored. Weigh the advantages of frequent measurement and/or use of STAT mode against the risk of injury. In some case, rapid, prolonged cycling of an oscillometric, noninvasive blood pressure monitor cuff has been associated with any of all of the following: ischemia, purpura, or neuropathy. Apply the oscillometric cuff appropriately, according to instructions, and check the cuff site and cuffed extremity regularly when blood pressure is measured at frequent intervals or over extended periods of time. Check the patient s limb on which the cuff is applied to assure that circulation is not constricted. Constriction of circulation is indicated by discoloration of the extremity. This check should be performed at the clinician s discretion at regular intervals based on the circumstances of the specific situation. Do not place the cuff on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised. Do not apply the blood pressure cuff to the same extremity as the one to which an SpO 2 sensor is attached, since cuff inflation will disrupt SpO 2 monitoring and lead to nuisance alarms. Ensure that, during use on patient, heavy objects are not placed on the tubing. Avoid crimping or undue bending, twisting, or entanglement of the tubing. Do not use STAT mode when using the thigh cuff to monitor NIBP. A Loss-of- Monitoring alarm with shutdown of all monitor functions may occur. 7-2

53 NIBP Monitoring 7.4 Selecting a Cuff Use only recommended Analogic blood pressure tubing and cuffs. Using other cuffs or tubing may result in inaccuracies. Measure the patient s limb and select the proper size cuff. As a general rule, cuff width should span approximately two-thirds of the distance between the patient s elbow and shoulder. Follow the manufacturer s directions for use when applying the cuff to the arm or thigh. Connect the tubing to the NIBP connector of the monitor. 7.5 NIBP Measurement Modes Blood pressure measurements can be made in three modes: Single Automatic STAT One measurement of blood pressure (Systolic/Diastolic/Mean) is made and displayed once in the numeric frame. Measurements are made at preset intervals. As many measurements as possible are made within a 5-minute period To Initiate a Single Blood Pressure Measurement Step 1. Press (~2 seconds) the front panel NIBP button. When a measurement is begun, the monitor shows the current, variable value of the cuff pressure. After the measurement is completed, systolic, diastolic and mean values will be displayed. The monitor also displays a clock icon and a numeric value that indicates the elapsed time in minutes since last taking a measurement. The monitor erases measurements from the numeric frame after 60 minutes, or sooner if a new measurement begins. The numeric values are replaced by a -?- to indicate the absence of valid measurement values because of a low-priority alarm condition To Make NIBP Measurements Automatically Step 1. Access the NIBP numeric frame. Step 2. Select the automatic measurement interval from the menu. This activates automatic mode. Step 3. Select a time interval. The monitor makes the initial measurement xx minutes later (where xx is the chosen interval). The NIBP numeric frame displays the AUTO mode icon and the number of minutes selected for the interval between measurements.this icon and its numeric value are in addition to the clock icon and elapsed time since last measurement. NOTE If an immediate NIBP measurement is desired, press the front panel NIBP button. If an interval setting for NIBP is configured prior to accepting power-up default settings (located in the Setup menu), the configured interval mode is enabled the next time you power up. To automatically start interval mode, press the NIBP button (located on the front panel). To stop interval mode, select the NIBP menu and turn automatic interval mode Off. 7-3

54 LIFEGARD I Operator s Manual To Initiate STAT Mode of NIBP Operation Step 1. Press and hold the front panel NIBP button for at least 2 seconds. While STAT mode is active (5 minutes), the STAT icon appears in the numeric frame; the clock icon and minutes displays are removed. Upon completion of STAT mode, the monitor displays the last measurement made in that mode. Both the clock icon and elapsed time numeric return to the display. 60 minutes after completion of the STAT measurements, the displayed NIBP measurement and the clock icon are removed To Stop Blood Pressure Measurements To stop a measurement in process: Step 1. Press the front panel NIBP button. The cuff deflates automatically. If an automatic measurement was underway, the interval time is reset Cuff Inflation Pressures A field of the NIBP numeric frame displays cuff pressure. Until a measurement is made, the monitor displays the inflation pressure to which the cuff will inflate when the next measurement begins. During measurements, the sensed cuff pressure values are displayed in the frame. Initial cuff pressures are set using the NIBP numeric frame. Factory-set default values are: Adult: 160 mmhg Pediatric: 120 mmhg Troubleshooting Low Priority NIBP Alarms Several conditions may occur during an NIBP measurement that prevent successful completion of the measurement. Low Priority Alarm Message NIBP No Cuff NIBP Blocked Tubing NIBP Artifact NIBP Time-Out Recommended Action Check to see that cuff is present. Check cuff and tube connections for leaks. Take measurement again. Check to see that the tube is not obstructed or pinched. Take measurement again. Measurement could not be completed, probably due to patient motion or physiology. Check patient. Check cuff application and orientation. Take measurement again. Measurement could not be completed within the normal amount of time. Check patient. Check cuff application and orientation. Take measurement again. 7-4

55 NIBP Monitoring 7.6 Controlling NIBP Functions via Numeric Frame Units of Measure NIBP Icon [ Timer Icon and Minutes Elapsed Systolic/Diastolic Values Automatic Mode Icon and Interval in Minutes Mean Arterial Pressure Initial Inflation Pressure The following selections are contained in the NIBP menu. Default values appear in parentheses. NIBP Menu (Numeric Frame) Level 1 Menu Automatic Mode Interval Initial Inflation Pressure SYS/DIA/MAP limits NIBP Audio Alarm Off Return Level 2 Menus or Response Off, 1 min., 3 min., 5 min., 10 min., 15 min., 30 min., 60 min., 90 min , incremented in steps of 20 (160 Adult) (120 Pediatric) Variable (On)/Off (audible on) Exits Level 1 menu immediately, returns to Monitoring Screen 7-5

56 SpO 2 Monitoring 8 SpO 2 Monitoring 8.1 General Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and a photodetector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO Self Calibration and Noise Measurement Periodic SpO 2 module self calibration and noise measurements are designed to enhance the performance of the monitor. In self calibration, the gain of the receiver circuit and the frequency of the LED drive changes, searching for optimal performance. During the 2 to 4 second period of self calibration, LEDs are switched off and the heart rate tone is silent. SpO 2 and pulse rate measurements are not affected by this 2 to 4 second period. A noise measurement occurs on a periodic basis, which compensates for a noisy environment. A noise measurement occurs when the monitor has completed initialization, when a new sensor is plugged in, approximately every 15 minutes, or when oximetry processing might be affected by movement or a noisy environment. 8.3 C-Lock ECG Synchronization The LIFEGARD I utilizes C-Lock ECG synchronization to enhance signal processing during patient movement or poor perfusion. C-Lock processing uses the QRS signal as a reference point for identifying the oximetry pulse, thus enhancing good pulses and reducing the effect of random artifacts associated with motion and low perfusion. 8.4 Measuring Functional Saturation The measured SpO 2 value from an oximeter may differ from the saturation value that is calculated from a blood gas partial pressure of oxygen (PO 2 ). This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO 2 and saturation: ph, temperature, partial pressure of carbon dioxide (PCO 2 ), 2,3-DPG, and fetal hemoglobin. This monitor measures functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters such as the IL482 report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobins. To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted as follows: fractional saturation functional saturation = x (% carboxyhemoglobin + % methemoglobin 8-1

57 LIFEGARD I Operator s Manual 8.5 SpO 2 Safety Information Use only Analogic or Nellcor recommended SpO 2 sensors. Other sensors may cause inaccurate readings. Incorrect application or use of an SpO 2 sensor may cause tissue damage, for example if the sensor is wrapped too tightly or if supplemental tape is applied. Inspect the sensor site as directed in the sensor s directions for use to ensure skin integrity and correct positioning and adhesion of the sensor. DO NOT: Use sensors that appear frayed, cracked, or damaged in any way. Use a sensor with exposed optical components. Immerse sensor completely in water, solvents, or cleaning solutions because the sensor and connectors are not waterproof. Sterilize sensors by irradiation, steam, or ethylene oxide. Refer to the cleaning instructions in the directions for use for reusable sensors. Inaccurate measurements can be caused by: Incorrect sensor application or use. Significant levels of dysfunctional hemoglobins (such as carboxyhemoglobin or methemoglobin). Intravascular dyes such as indocyanine green or methylene blue. Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight. Excessive patient movement. High-frequency electrosurgical interference and defibrillators. Venous pulsations. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia. There is arterial occlusion proximal to the sensor. The patient is in cardiac arrest or is in shock. 8-2

58 SpO 2 Monitoring 8.6 Applying the Sensor Loss of pulse signal can occur in any of the following situations: The sensor is too tight. There is excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight. The blood pressure cuff is inflated on the same extremity as the one to which an SpO 2 sensor is attached. Disposal of sensors must be in compliance with local and facility regulations. NOTE Prior to applying the sensor, be sure to remove colored nail polish from the application site. Loose sensor: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: Never apply an SpO 2 sensor at ambient temperatures from above 98.6 F (37 C) because this can cause severe burns after prolonged application. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, or intravascular venous infusion line. Caution Do not sterilize any Analogic or Nellcor sensor by irradiation, steam or ethylene oxide. Do not use OxiCliq disposable sensors in a high humidity environment, such as in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors on patients who have a known allergic reaction to the adhesive. 8.7 Selecting a Sensor NOTE Use only Analogic and Nellcor recommended sensor extension cables and SpO 2 sensors with the monitor. 8-3

59 LIFEGARD I Operator s Manual When selecting a sensor, consider the patient s weight and activity, adequacy of perfusion, availability of sensor sites, need for sterility, and anticipated duration of monitoring. For more information, see the following table or contact your local Analogic representative. Oxygen Transducer Nellcor Model Analogic Model Patient Weight Oxisensor II N-25* see note <3 or >40 kg (sterile, single use) I-20 " 3 to 20 kg D-20 " 10 to 50 kg D-25 (L) " >30 kg R-15 " >50 kg Oxicliq A see note >30 kg (sterile, single use) P " 10 to 50 kg N* " <3 or >40 kg I " 3 to 20 kg Dura-y (nonsterile, D-YS* see note >1 kg reusable) D-YSE " >30 kg Nellcor reflectance sensor RS-10 see note >40 kg (nonsterile, limited reuse) Nellcor Durasensor (reusable DS100A AN4K-AC001 digit sensor) (nonsterile, limited reuse) Note: Nellcor Durasensor, DS100A, Analogic part number AN4K-AC001 is available through Analogic authorized distributors. All other transducers and adapter cables must be purchased directly from Nellcor Puritan Bennett, Inc., Tyco Healthcare or an authorized distributor. *Although these sensors are specified for use on very small patients, as well as pediatric and adult patients, the Analogic LIFEGARD monitor shall NOT be used to monitor neonates. Analogic and Nellcor oxygen transducers (sensors) can be categorized as surface devices contacting skin for a limited duration of time. Biocompatibility testing has been conducted on the sensors in compliance with ISO , which requires cytotoxicity testing, sensitization and irritation or intracutaneous reactivity testing on all devices that fall into this category. The sensors have passed the mandated biocompatibility testing and are therefore in compliance with ISO Observe all warnings and cautions in the directions for use supplied with these sensors. Carefully apply the sensor to the patient, as described in the directions. The sensor can be connected directly to the monitor s connector (identified by the SpO 2 icon) on the side panel. Typically, however, it is more convenient to connect the sensor to the monitor by using a Nellcor SpO 2 extension cable (Nellcor OxiMax - DOC10). Periodically check that the sensor remains properly positioned on the patient and that skin integrity is acceptable (see sensor directions for use). High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of an SpO 2 sensor. To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material. NOTE Failure to take this action in high ambient light conditions may result in inaccurate measurements. Disposable sensors must not be reused on different patients. They can be reused or relocated on the same patient. Reusable sensors can be reused on different patients. 8-4

60 If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor to a less active site; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh adhesive backing. For reusable sensors, follow the sensor s directions for use for cleaning and reuse. For single patient use sensors, use a new sensor for each patient. 8.8 Controlling SpO 2 Functions Using the Numeric Frame SpO 2 Monitoring SpO 2 Icon [ Pulse Amplitude Indicator Gauge Units of Measure Measured Value The SpO 2 menu contains the following selections. Default values appear in parentheses. SpO 2 Menu (Numeric Frame) Level 1 Menu SpO 2 Response C-Lock SpO 2 Limits SpO 2 Audio Alarm Off Return Level 2 Menus or Response Slow, Normal, Fast (On)/Off Variable (On)/Off (audible on) Exits Level 1 menu immediately, returns to Monitoring Screen SpO 2 Response Modes Normal (Mode 1) Recommended for most clinical situations in conjunction with C-Lock to reduce the effect of patient motion. Fast (Mode 2) Useful for special applications such as sleep studies in which the user desires fast response. Most affected by patient motion. 8-5

61 LIFEGARD I Operator s Manual Slow (Mode 3) Least affected by patient motion. Should be used only if Normal mode with C-Lock does not perform acceptably. User must be aware that changes in SpO 2 are reported more slowly relative to other modes. Heart rate from SpO 2 is not displayed when slow response mode is enabled Using C-Lock When C-Lock is turned On in the SpO 2 menu, C-Lock automatically becomes operational any time a valid ECG signal is detected by the monitor. It is not necessary to turn C-Lock Off if an ECG signal is not available; the monitor handles this function automatically. If the ECG signal is noisy, or of poor quality, SpO 2 performance may be improved by turning C-Lock Off Pulse Amplitude Indicator Gauge The pulse amplitude indicator is a segmented display within the SpO 2 numeric frame which shows the relative strength of the detected pulse. With each pulse, contiguous segments are briefly filled; the stronger the pulse, the greater the number of filled segments. 8.9 Controlling SpO 2 Waveform Using the Graphic Frame The SpO 2 Waveform menu contains the following selections. SpO 2 Waveform Menu (Graphic Frame) Level 1 Menu Sweep Speed Return Level 2 Menus or Response 12.5 mm/s, 25 mm/s, 50 mm/s Exits Level 1 menu immediately, returns to Monitoring Screen 8-6

62 Temperature Monitoring 9 Temperature Monitoring 9.1 General Welch Allyn SureTemp temperature technology is employed to measure patient temperature. The measurement is accomplished by processing the signal from a probe containing a resistance element (thermistor) whose impedance is temperature dependent. The signal from the probe is conditioned by the monitor input circuitry, processed, and the measured values are shown in the numeric frame. 9.2 Safety Information 9.3 Setup Connection The LIFEGARD I monitor uses Welch Allyn SureTemp temperature probes. Use only the specified probes for your monitor. Use disposable probe covers to limit patient cross-contamination. Probe covers are for single use only. Use only oral probes (blue cap) for taking oral and axillary temperatures. Use only rectal probes (red cap) for taking rectal temperatures. Do not use the thermometer if you see any signs of damage to the probe. Disposal of probe covers must be in compliance with local and facility regulations. Connect the temperature probe to the connector labeled T. The monitor, when set to normal temperature mode, will warm the oral/axillary probe tip in order to obtain temperature measurements very quickly (within a few seconds). The monitor will sound a tone to indicate that the warm-up is complete. The monitor will not pre-warm the rectal probe. Any time the probe is removed from the holder, the monitor checks probe functionality. If the probe is found to have a problem, a low-priority audible alarm is activated, dashes replace the numerals in the display and the message Temperature Probe Fault appears in the message frame Loading a Probe Cover Hold the probe handle with thumb and forefinger as shown above. Be careful not to hold or press the colored cap that is also the cover ejector button. Press the probe down firmly into the cover. 9-1

63 LIFEGARD I Operator s Manual Taking Oral Temperatures (Using Blue-Capped Probe, Normal Mode) 1. Check to see that ORAL is identified in the temperature frame. If not, use the wheel to select Oral in the menu for the temperature frame. Sublingual Pockets 2. Gently insert the probe tip into the patient s slightly opened mouth. Quickly slide the probe under the tongue on either side of the mouth to reach the sublingual pockets. Have the patient close his/her lips around the probe. 3. Hold the probe in place, keeping the tip in contact with tissue during the measurement. Holding the probe ensures a fast and accurate measurement. 4. When the final temperature has been reached, a tone will sound and the patient s temperature will be displayed Taking Axillary Temperatures, Patients Under 4 Years (Using Blue-Capped Probe, Normal Mode) NOTE Axillary mode is for use on patients 3 years old and younger. Will not produce accurate readings on older patients. If an axillary reading is desired for older patients, the oral probe must be used in Monitor mode. 1. Check to see that AXIL is displayed in the temperature frame. If not, use the wheel to select Axillary in the temperature menu. 2. Lift the patient s arm so that the entire axilla is easily visualized. 3. Place the probe as high as possible in the axilla. Do not allow the probe tip to come into contact with the patient until it is deliberately placed in the measurement site. Any tissue contact before this time will activate the probe position error message and may cause inaccurate temperature readings. 9-2

64 Temperature Monitoring 4. Be sure that the probe tip will be completely surrounded by axillary tissue. Clothing or any other material touching the probe tip may cause inaccurate readings. 5. Place the arm snugly at the patient s side. Hold the arm in this position without movement of the arm or probe during the measurement cycle. Movement of the arm or probe during this time will activate the probe position error message and may cause inaccurate readings. 6. An audible tone and display of a temperature reading indicates the final temperature has been reached Taking Rectal Temperatures (Using Red-Capped Probe, Normal Mode) 1. Connect the red-capped probe to the monitor. Check to see that RECTAL is displayed in the temperature frame. Incorrect insertion of the rectal probe can cause bowel perforation. 2. Separate buttocks with one hand. With the other hand, gently insert the probe only 1.5 cm (5/8 inch) inside the rectal sphincter (less for infants and children). Use of a lubricant is optional. Tilt the probe so the tip is touching tissue. Keep hand separating buttocks in place. Hold the probe in place during the entire temperature measurement process. 3. When the final temperature is reached, a tone will sound and the temperature will be displayed Removing a Probe Cover 9.4 Operating Modes After each measurement is complete, remove probe from the patient. Eject the probe cover by firmly pressing the ejection button (blue or red cap). Temperature measurements are made in either of two modes, as selected by the clinician: Normal or Monitor. Normal mode is desirable for most applications because it will complete measurements more quickly: an axillary measurement on patients under the age of 4 in about 10 seconds, an oral temperature measurement in about 4 seconds, and a rectal measurement in about 15 seconds. 9-3

65 LIFEGARD I Operator s Manual When in Normal mode, upon removing the probe from its holder on the rear of the monitor: a non-flashing asterisk group appears as the value in the frame, the monitor displays the message ORAL, AXIL, or RECTAL, indicating which probe is in use and, if the blue-capped probe is in use, what site has been selected. After the probe has warmed up, an audible signal informs the clinician that a measurement can be made. When tissue contact is sensed by the monitor, the asterisks flash. When a Normal mode measurement is completed, a valid temperature value replaces the displayed asterisks, and the message ORAL, AXIL, or RECTAL is removed. The temperature value is displayed for 30 minutes, and a clock icon in the temperature frame indicates the elapsed time since the measurement was made. Monitor mode is generally used for long term (continuous) temperature monitoring, taking axillary temperatures for patients 4 years and older, or when difficult situations prevent accurate temperatures from being taken in Normal mode. When using Monitor mode, allow the temperature readout to stabilize for 3 minutes for oral and rectal temperatures and 5 minutes for axillary temperatures. If a temperature measurement cannot be made in the Normal mode, the monitor switches automatically to the temperature Monitor mode. When in temperature Monitor mode: an M icon appears in the temperature frame temperature is measured and displayed continuously temperature values are not stored in trend memory 9.5 Temperature Alarms There are no alarm-activating limits for the temperature measurement. Any time after the temperature cable is connected to the side panel and is then disconnected, a low-priority audible alarm is activated, dashes replace the numerals in the display, and the message Temperature Probe Disconnect appears in the message frame. While in Normal mode, the monitor is able to determine when the probe has broken contact with the tissue. When this event occurs, the measurement process pauses; a lowpriority audible alarm is activated; and the message Temperature Probe Position appears. Once proper contact has been re-established, the message and tone are terminated, and the measurement proceeds. If the measurement quality is good, the measurement goes to completion. The value is displayed, and there is no alarm. If the measurement quality is marginal, but the system is able to complete a measurement, the temperature value is displayed, but the low-priority Temperature Probe Position alarm occurs. Pressing the Alarm Silence button clears the alarm, the temperature value remains, but will not be stored in trend memory. 9-4

66 If the monitor determines that the measurement quality remains poor, and is not able to complete a Normal mode measurement, the monitor reverts to temperature Monitor mode. If the measured temperature value is outside of the specified measuring range, the numeric field will display either the high end or low end (as appropriate) of the measuring range, and flash the numeric value. 9.6 Controlling Temperature Measurements Temperature Monitoring Units of Measure Temperature Icon [ Temperature Monitor Mode Field (Displayed in Monitor Mode only) Probe Site (Displayed in Normal Mode only) Measured Value Minutes since last reading Temperature (Numeric Frame) Level 1 Menu Level 2 Menus or Response Units (C ) F Operating Mode Blue Probe Site Return (Normal) Monitor (Oral) Axillary Exits Level 1 menu immediately, returns to Monitoring Screen 9-5

67 Trends 10 Trends 10.1 General Trend Data Storage A stored trend data point for heart rate and SpO 2 is calculated as the average of the values sampled over a 20-second interval. For NIBP and for Normal Mode temperature measurements, the stored points are the measured values. Twelve hours of trend data are stored in non-volatile memory, and remain in storage even if the monitor is disconnected from the mains power. Trend memory records an indication of an out-of-limits alarm event, although the average over the 20 second interval may remain within alarm limits. A new record of trend data for all measured parameters is started each time the monitor is turned on. Once trend memory has stored 12 hours of data, the oldest trend data will be overwritten by new data. Trend data in tabular format may be presented on the screen, and printed if a recorder is connected. A date/time annotation is included at the start of each new record so that you can identify the record with the patient whose signs you are monitoring Displaying Trend Data Tabular trend data are derived from the stored 20 second samples. By using the wheel to highlight and select the Toggle Display icon, the user can toggle trend data, waveforms, or spot check mode in the graphic area display. (Trend data is the factory-set default.) The following is a typical trend data display. Out-of-limits Value in Reverse Video SpO 2 not being measured Updated trend information is inserted as a top line; the others move down; the bottom line is removed from the screen. Use the Scroll/Print Trend mode to scroll through a trend record, or to view other records. 10-1

68 LIFEGARD I Operator s Manual The Trend Frame Control menu contains the following choices. Trend Frame Control Functions Level 1 Menu Scroll/Print Trend Show Trend Data Level 2 Menus or Response No level 2 menu. Wheel is activated for scrolling (Reduced), All If All is selected, a row of data is displayed for each 20 second interval. a -. Return If Reduced (default setting) is used, a row of data is displayed for each NIBP and temperature measurement, or at least one every 15 minute interval, or for every high or medium priority alarm. Exits Level 1 menu. Immediately returns to Monitoring Screen Scrolling Trend Data To select the scrolling action: Step 1. Rotate the wheel to select (highlight) the trend graphic area. Step 2. Press the wheel. The display presents a change screen and Level 1 menu, in which the top option is Scroll/Print Trend. When that option is selected (rotate and press the wheel), the Level 1 menu is removed, and scrolling action by wheel rotation is immediately enabled. The change screen appears as shown below. Rotate the wheel counterclockwise (with a click audible feedback) to move the table up one row at a time. The top row (most recent entry) is removed from the screen. After the earliest entry for this record appears in the top row, continuing to rotate moves the next oldest record into the frame. Its record number and data are changed accordingly. 10-2

69 Trends Rotate the wheel clockwise to move the table down one row at a time. The bottom row is removed from the screen. Continuing to rotate the wheel after the latest entry of this record appears in the bottom row causes the next newest record to move into the frame. When the user scrolls to the end of stored memory, the earliest (or last) trend line scrolls off the screen. The record number and total number indicates the status. Continued wheel rotation produces an audible feedback that there is no later (or earlier) record in memory Transferring Trends Using RS-232 Interface Tabular trend data can be printed on an Analogic recorder. Refer to Chapter 12, Recording and Printing. The entire trend memory can be transferred to an external computer via the RS-232 interface. See Appendix A for details. 10-3

70 SpotCheck Monitoring 11 SpotCheck Monitoring 11.1 Terminology It is important to note the distinction between the following terms; Record all vital sign measurements stored for a single patient; Entry a single set of vital sign measurements recorded at one time Overview The LIFEGARD I monitor, while on a patient and in SpotCheck mode, must never be left unattended. All audible alarms are permanently disabled and the attendant must always check the visual alarm indicators. SpotCheck is a standard LIFEGARD I monitor feature that allows the user to take a single set of vital signs measurements, heart rate, non-invasive blood pressure (systolic, diastolic), functional arterial oxygen saturation and temperature, from a patient without prolonged or continuous monitoring. Patient probes and sensors can be removed from one patient and placed onto another without sounding alarms. With each new patient, all probes and sensors must be cleaned in accordance with the instructions of Paragraph 13.5, and Temperature Probe Covers must be changed. In SpotCheck mode, all audible alarms are permanently disabled. However, visual alarms remain active. Pressing the Audio Alarm Control key causes an invalid key tone. Attempting to change a Permanent-Alarm-Silence bell icon setting from the Alarm Limits, Heart Rate, SpO 2, or NIBP menus also causes an invalid key tone. Alarm limits set through the Numeric Frames are visual only. See Viewing and Changing Alarm Limits in Chapter 5 for additional information on visual alarm indicators. NOTE Although the monitor is equipped with SpotCheck, access to operate in this mode may not be enabled. By default, SpotCheck is not enabled. It can be enabled through the password-protected Power-Up Defaults Menu. For more information on configuring SpotCheck, consult with qualified service personnel Selecting SpotCheck Mode Select this icon to change the monitor s operating mode. There are four available operating modes. To select this icon: Step 1. Rotate the navigation wheel until the icon is highlighted. Step 2. Press the navigation wheel to display one of the following operating modes: ECG waveform (only available with certain models) SpO 2 waveform Tabular Data SpotCheck mode 11-1

71 LIFEGARD I Operator s Manual When operating in SpotCheck mode, the screen displays as illustrated below. The Graphics Frame displays the SPOTCHECK MODE - AUDIO OFF header followed by tabular data. The data shows the record number followed by the time of the readings, and data values of the last two entries SpotCheck Mode Menu The SpotCheck menu enables the user to select a new patient record number, take and store vital sign measurements, display stored vital sign measurements, and delete all previous measurements taken in SpotCheck mode Accessing SpotCheck Mode Menu Step 1. Rotate the navigation wheel until the Graphics Frame is highlighted. Step 2. Press the navigation wheel to display the SpotCheck Mode Menu. To select an item within the above menu: Step 1. Rotate the navigation wheel until the desired menu item is highlighted. Choose from the following menu options: Next Patient (N) 11-2

72 SpotCheck Monitoring Store Measurement View Measurements Clear All Data Return Step 2. Press the navigation wheel and the selected item s submenu displays Selecting Next Patient Record Number Next Patient must be selected before taking a new patient s vital sign measurements. To do so, ensure that Next Patient is highlighted, then press the navigation wheel to select it. All vital sign measurements in progress are cancelled and the Record Number submenu displays. Record Number (N) Return From here, select a new record number and begin taking a new patient s vital sign measurements. Either the next available record number in the sequence, or a particular record number can be chosen. See the following two sections for additional information. The monitor stores up to 99 record numbers Accepting the Default Record Number When the Record Number submenu displays, (N) is highlighted. This number is the next available record number in the sequence. The monitor automatically defaults to this number. For example, if you are currently viewing record 1 and you select this submenu item, the next record number that displays is 2. If the current record number is 99, the next record number will be 1. To accept the current default number: Step 1. Check that Return is highlighted. Step 2. Press the wheel to exit the Record Number submenu and return to the SpotCheck Mode Menu. Step 3. Begin taking vital sign measurements. Store Measurement automatically becomes the next highlighted menu option Changing the Default Record Number When the Record Number submenu displays, (N) is highlighted. This number is the next available record number in the sequence. The monitor automatically defaults to this number. To change the default record number: Step 1. Rotate the wheel so (N) is highlighted. Step 2. Press the navigation wheel to highlight the existing number. Step 3. Rotate the wheel to the desired number. Valid range is 1 to 99. Step 4. Press the wheel to accept the changed number. Return is automatically highlighted. 11-3

73 LIFEGARD I Operator s Manual Step 5. Press the wheel to select Return, exit the Record Number submenu, and return to the SpotCheck Mode Menu. Step 6. Begin taking vital sign measurements. Store Measurement automatically becomes the next highlighted menu option. NOTE If you select a number that is out of sequence, the next time you select Next Patient, the default record number is the number following the one you selected. For example, if the default was 2 and you changed it to 20, the next time you select Next Patient, the default record number is 21, not Storing Measurements After a record number is selected, Store Measurement is automatically highlighted on the SpotCheck Mode Menu. Up to 99 entries can be stored in SpotCheck memory. If all 99 storage locations are used, the new entry overwrites the oldest entry. To store an entry, press the navigation wheel to store the vital sign measurements located in the Numeric Frames. Results are stored under the selected record number. After vital sign measurements are stored, Return automatically becomes the next highlighted menu option. To store multiple entries for the same patient: Step 1. Take new vital sign measurements. Step 2. Rotate the navigation wheel until Store Measurement is highlighted. Step 3. Press the navigation wheel to store additional vital sign measurements. The monitor can store multiple entries for a single patient under the same record number Viewing Measurements Select View Measurements from the SpotCheck Mode Menu to view stored SpotCheck measurements in tabular format. From this screen, only vital sign measurements taken in SpotCheck mode can be viewed. When this option is selected, the following screen displays: Date of most recently stored entry Number of records/ Number of entries 11-4

74 11.9 Clearing All Data Six entries are displayed on the monitor s screen. To scroll through all records, rotate the navigation wheel. The first record displayed is the most recent record number. Multiple entries from the same patient display the same record number. (See figure previous page.) To exit View Measurements and return to the SpotCheck Mode Menu, press the navigation wheel. Select Clear All Data from the SpotCheck Mode Menu to erase all SpotCheck data stored in the monitor. To clear data: Step 1. Rotate the navigation wheel until Clear All Data is highlighted. Step 2. Press the wheel to clear data. A pop-up verification box appears. Step 3. Select Yes to delete all data, or Select No to cancel deletion and return to the SpotCheck Mode Menu Adding Patient Measurements In SpotCheck mode, new vital sign measurements can be added to an existing patient s record after you have moved on to other patient records. The new measurements are stored in addition to previous measurements. The monitor can store up to 99 entries per patient record. SpotCheck Monitoring Caution The monitor can only store a total of 99 vital sign measurements. This includes patient records and entries within patient records. If the limit is exceeded, the monitor overwrites the oldest record or entry, regardless of record number. To add new measurements: Step 1. From the SpotCheck Mode Menu, check that Next Patient is highlighted. Press the navigation wheel. Step 2. From the Record Number submenu, press the navigation wheel to highlight the existing number. Step 3. Rotate the wheel until you reach the desired record number. Step 4. Press the wheel to accept the record number. Return is automatically highlighted. Step 5. Begin taking vital sign measurements. Store Measurement is automatically highlighted. Step 6. Press the wheel to store vital sign measurements. Step 7. Rotate the wheel until View Measurements is highlighted. Press the wheel to select this option. 11-5

75 LIFEGARD I Operator s Manual Added Entry Printing SpotCheck Measurements This section pertains to printing in SpotCheck mode only. Refer to Chapter 12, Recording and Printing, for general print information. The LIFEGARD I monitor uses an external standalone recorder to print measurements. The monitor must be in View Measurements mode (selected from the SpotCheck Mode Menu) to print SpotCheck data. SpotCheck data can be printed for all patients, some patients, or a single patient Printing All Records Press the bottom printer button on the recorder. The recorder prints the vital signs for all patients as shown below. 11-6

76 Printing Selected Records Press the top printer button located on the recorder. The recorder prints the vital signs for the six patient records that are currently displayed on the monitor s screen as shown below. SpotCheck Monitoring Different patient records can be printed by using the navigation wheel to scroll through patient records. When the desired patients are found, press the top printer button Printing a Single Patient Record To print a single patient record, exit View Measurements mode and the SpotCheck Mode Menu. Return to SpotCheck s main screen. Press the top printer button. The recorder prints the vital signs currently displayed on the screen as shown below. 11-7

77 Recording and Printing 12 Recording and Printing 12.1 Printouts The LIFEGARD I monitor has an optional, external standalone recorder that can print two types of real-time records Second Snapshot Print 12.3 Continuous Print Press the Snapshot button to obtain a 20 second recording of real-time graphical and numerical information. The recording begins with the values 10 seconds before the print initiation and ends 10 seconds after that event. Press the Continuous button to obtain a recording of real-time, graphical and numerical information. The recording begins 10 seconds before initiating the action and continues until printing is stopped. Printing can be stopped in any mode by pressing either of the two recorder buttons What is on the Real-Time Printout The following information is printed in both continuous and snapshot mode: Current numeric values (as appropriate for your monitor configuration): heat rate (HR), oxygen saturation (SpO 2 ), blood pressures (Sys/Dia/MAP), and temperature (T) are printed along the top of the paper. Time is printed along the bottom of the paper. Real-time waveforms of either ECG or SpO 2. The ECG waveform printout includes sweep speed, amplitude scaling (size), and the lead configuration (I, II, or III) used for the measurements. If Extended Low Frequency range was active, ELF will appear on the printout. Date Waveform Descriptors Current Vital Signs Values (out-of-limits values and time of occurrence in parentheses) Repeated every 10 seconds Space for annotations Time 12-1

78 LIFEGARD I Operator s Manual 12.5 Trend Print To print trend data: Step 1. Enter Scroll/Print Trend mode. Step 2. Scroll to the tabular trend data you wish to print. Step 3. Press the Snapshot button on the recorder to print the tabular trend data on the screen, or the Continuous button to print the full stored record. Only one trend record can be printed at one time Tabular Trend Print Date Date of newest trend Newest Data Time of information capture Space for Annotations Monitored Parameters Measurement Units Oldest Data 12.7 Print-on-Alarm The tabular trend printout begins with the standard header followed by a column of information. The date of the newest trend data is at the top of the list, followed by labels and units for each of the monitored parameters. Next is a series of columns of tabular trend data, each headed by the time the data in that column was captured. Newer data appear to the left of older data. Out-of-limits values are enclosed in brackets. In the Alarm/Limits menu, a snapshot print can be automatically initiated when an alarm event occurs. Out-of-limits vital signs values are enclosed in brackets. Instructions for setting this mode are detailed in Configuring the Alarm/Limits Screen in Chapter

79 Recording and Printing 12.8 Recorder Paper Replacement Caution Use only Analogic supplied paper. Using incorrect paper can result in damage to the printer. Load thermal paper as described in the following procedure: Paper Eject Button Step 1. Open the door at the front of the recorder by pressing the Paper Eject button. The door should tilt open. If the recorder s door does not open completely, pull it towards you until it is completely open. Step 2. Reach in and remove the empty paper core by pulling it towards you gently. Step 3. Place a new paper roll between the two round tabs of the paper holder. Orient the paper roll as shown in the picture above. The paper roll is easier to load if it is held vertically with the thumb of your right hand at the front holding the loose paper in place, and your forefinger (and/or index finger) at the back of the roll. Step 4. Pull the paper towards you until approximately 4 in. (10 cm) of paper have been unrolled. Step 5. Align the paper with the pinch roller attached to the recorder door. Step 6. Holding the paper against the roller, close the recorder door. Step 7. To ensure that the paper is aligned in the slot and has not been pinched in the door, pull the loose edge until a few in. (cm) of paper is showing. If the paper will not move, open the door and return to the alignment step. The recorder is ready for operation. 12-3

80 Maintenance and Troubleshooting 13 Maintenance and Troubleshooting 13.1 Error Messages If the monitor detects a malfunction that prevents use of the monitor until the malfunction is corrected, an Error message will appear. An Error screen, containing an error code, indicates that the monitor is unable to perform its monitoring functions because of the loss of software control or because of a detected hardware malfunction. If this is accompanied by a loss-of-monitoring alarm, press the Audio Alarm Control button to silence the tone. When an Error screen appears, record the error code number. Before calling the local Analogic representative, make sure that the battery is charged, and that all power connections are correctly made. If the monitor continues to present the Error screen, call your Analogic technical representative and report the error code number. You will be advised of the remedial action to be taken Maintenance Schedule The following table is the recommended maintenance schedule for the LIFEGARD I monitor. Maintenance Frequency Procedure Inspect the monitor, Daily See Inspecting the Monitor and cables and cords Inspecting the Cables and Cords in this Chapter. Cleaning As needed See Cleaning in this Chapter. Safety checks At least once every 2 years, See your biomed for additional according to after any repairs, if the monitor information. IEC has been dropped or as needed. Functional testing When functional defects in the See your biomed for additional procedures measurements are suspected. information. Performance At least once every year, or as See your biomed for additional Assurance needed (if you suspect defects information. in the measurements). Replace backlight 20,000 hours (about 4 years) of See your biomed for additional continuous usage, or as needed. information. NIBP maintenance Every year, or as needed, if the See your biomed for additional monitor has been opened, or information. you suspect defects in the measurement. Battery maintenance Every two years. See Battery Maintenance in this Chapter. Caution A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or monitor. 13-1

81 LIFEGARD I Operator s Manual 13.3 Inspecting the Monitor If a problem is encountered while inspecting the monitor, contact your biomedical department or the Life Care Systems Support Group. With the monitor turned off: Step Action 1 Examine the exterior of the monitor for cleanliness and general physical condition. Verify that the housing is not cracked or broken, that everything is present, that there are no spilled liquids, and that there are no signs of abuse. 2 Inspect all accessories (cables and sensors) external to the monitor, referring to the documentation for the accessories. 3 Switch the monitor on and verify that the backlight is bright enough. Check that the monitoring screen is clear and the display is at its full brightness. If the brightness is not adequate, contact your biomedical department. Analogic Corporation recommends replacing the backlight every 20,000 hours of use (about 4 years). 4 If the monitor is being operated from the battery, verify that the battery is adequately charged before beginning use Inspecting the Cables and Cords If a problem is encountered while inspecting the cables and cords, replace the cable, or contact your biomedical department. Step Action 1 Examine the power plug and cord for damage. Make sure that the prongs of the plug do not move in the casing. If damaged, replace the entire cord with the appropriate Analogic power cord. 2 Inspect the patient cables and leads and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain. 3 With the sensor or electrodes applied to the patient, and the monitor turned on, flex the patient cables near each end to make sure that there are no intermittent faults Cleaning Caution Caution Caution Do not immerse the monitor in liquid or use caustic or abrasive cleaners. Do not spray or pour any liquid on the monitor or its accessories. Do not allow any liquid to penetrate connectors or openings in the monitor s chassis. 13-2

82 Maintenance and Troubleshooting To clean the monitor, dampen a cloth with a commercial, nonabrasive cleaner, such as a 70% isopropyl alcohol solution, and wipe the top, bottom, and front surfaces lightly. Cables and cuffs are all intended for reuse and may be cleaned by wiping with a cleaning agent such as 70% isopropyl alcohol. To clean or disinfect the SpO 2 sensor: 1. Saturate a clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the sensor and cable with this gauze pad. 2. Saturate another clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the sensor and cable with this gauze pad. 3. Dry the sensor and cable by wiping all surfaces with a clean, dry gauze pad. Temperature Probe Covers are NOT reusable and must be changed with each new patient. If liquid is accidentally spilled on the monitor, clean and dry it thoroughly before reuse. If in doubt about monitor safety, refer the unit to qualified service personnel Battery Maintenance If the monitor has not been used for a long period of time, the battery will need charging. To charge the battery, connect the monitor to an appropriate power supply. Storing the monitor for a long period without charging the battery may degrade the battery s capacity. A complete battery recharge requires 8 hours in standby mode or 14 hours in operational mode. We recommend replacing the monitor s sealed, lead-acid battery at 2-year intervals. Battery replacement and general service to the monitor should be performed by qualified service personnel. Follow local governing ordinances and recycling plans regarding disposal or recycling of batteries and other device components Obtaining Technical Assistance For technical information and assistance call the Life Care Systems Support Group or your local Analogic representative Returning System Components If it is necessary to return the monitor for service, call the Life Care Systems Support Group or your local representative for shipping instructions. Have all equipment serial numbers available when calling. It is recommended that the packing carton and packing material be kept in the event the product has to be returned. To pack the monitor for return, disconnect all cables. It is not necessary to return sensors, patient cables, NIBP tubing and cuff or power cord. Pack monitor to be returned in its original shipping carton. If, for some reason, the original shipping carton and packing material is not obtainable, extreme care must be taken in packaging the monitor. A suitable carton must be used along with packing material to ensure the monitor does not incur damage in being returned to the factory. 13-3

83 Specifications 14 Specifications 14.1 General This chapter includes all hardware, regulatory, and measuring specifications for the monitor General Specifications Parameter Specification Size (excluding handle) Width Height Depth Weight (excluding accessories, options, cables) 10.5" (26.67 cm) 6.3" (16 cm) 4" (10.16 cm) without temperature option 5" (12.7 cm) with temperature option 4.6 lb (2.1 kg) Display (cold cathode fluorescent backlight) Screen Type Active Screen Size Resolution TFT (color) 3.99" x 2.94" (101.3 mm x 74.7 mm) 320 x 240 pixels 14.3 Compliance Parameter Specification IEC/EN , IEC/EN , UL , CAN/CSA C22 No M90, IEC/EN , IEC/EN , ISO9919, IEC/EN , Electromagnetic Compatibility: IEC/EN :2001 and CISPR 11 Class B* Protection Class Class I, internally and externally powered equipment, per IEC , clause Degree of Protection Type CF defibrillator-proof: per IEC , clause Mode of Operation Electromagnetic Compatibility Continuous Radiated and conducted electromagnetic energy per CISPR II, Class B * * Devices are suitable for connection to public low-voltage distribution systems. 14-1

84 LIFEGARD I Operator s Manual 14.4 Electrical Parameter Specification Power Sources Internal Battery Battery Operating Time External Power Supply 6V, 4 ampere hours, sealed, lead-acid 2.5 hours, typical, fully charged battery at 25 C, one NIBP measurement per 15 minutes 100 to 240 VAC, Hz, 1.5A, Class I 14.5 Environmental Parameter Specification Mechanical Shock IEC ; 50g, 11 ms, 3 axes, 18 total shocks, non-operating Mechanical Vibration IEC ; Sinusoidal; Hz, 0.15 mm displacement; Hz, 2g acceleration; 4 min/sweep; 20 sweeps/axis, log sweep Hz at 1 Octave/min, nonoperating Thermal Operating Temperature Storage Temperature 0 to 50 C (32 to 122 F) -20 to 60 C (-4 to 140 F) Humidity Operating Storage Water Resistance 5 to 90% RH, non-condensing 5 to 95% RH, non-condensing IEC Classification IPX1 (Protected against vertically dripping water)* * Monitor only, not the external power supply. 14-2

85 Specifications 14.6 Measuring Parameters ECG Parameter Heart Rate Range Heart Rate Accuracy Bandwidth: Normal Monitoring Bandwidth: Extended Low Frequency Range (user selectable) Leads Display Sweep Speeds Pacemaker Detection ECG size (sensitivity) Lead-off Detection Input Impedance CMRR (Common Mode Rejection Ratio) Input Dynamic Range Specification BPM ±1 BPM 0.5 Hz - 40 Hz 0.05 Hz - 40 Hz 3 lead, user selectable 12.5, 25, and 50 mm/s Indicator on waveform display, user selectable 0.5, 1, 2, 4 mv/cm detected and displayed >5 MΩ >90 db at 50 or 60 Hz ±5 mv AC, ±300 mv DC Defibrillator Discharge <5s per IEC Recovery Standards <8s per AAMI EC Meets the performance standards of ANSI/AAMI EC Instead of a 1 mv standardizing voltage (section ), a fixed, 1 cm reference bar is always present in the ECG display, along with the ECG size setting expressed in mv/cm. 14-3

86 LIFEGARD I Operator s Manual 14.7 NIBP (Non-Invasive Blood Pressure) Measurement Display Parameter Technique Specification Oscillometric Measurement Modes Auto Manual STAT Cuff pressure display Automatic measurements at intervals of 1, 3, 5, 10, 15, 30, 60 and 90 minutes Single measurement initiated by Start/Stop button Series of consecutive measurements for 5 minutes -10 to 330 mmhg while measurement is in progress Blood Pressure Measurement Display Range Systolic Mean Arterial Pressure Diastolic Pulse Rate Range Blood Pressure Accuracy 40 to 250 mmhg 27 to 220 mmhg 20 to 200 mmhg 40 to 200 BPM Mean error and standard deviation per ANSI/AAMI SP Pulse Rate Accuracy Greater of ±2 bpm or ±2% Initial cuff inflation Subsequent cuff inflation Standards 120 to 260 mmhg Default 160 mmhg, adult Default 120 mmhg, pediatric Prev SYS +30 mmhg (rounded to nearest 5 mmhg) Meets performance standards of ANSI/AAMI SP Systolic and Diastolic blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method Temperature Measurement/Display Parameter Technique Range Calibration Accuracy Clinical Accuracy Specification Thermistor Probe (Welch Allyn SureTemp ) 84 C to 108 F (29 C to 42 C) ±0.2 F (±0.1 C) Maximum of ±0.4 F 14-4

87 Specifications 14.9 SpO 2 Measurement/Display Parameter Specification % Saturation 0 to 100% % Pulse rate 20 to 250 SpO 2 Accuracy 1 Pulse rate Display Update Period 0 to 69% ± not specified 70 to 100% ±3 counts ±3 BPM 1 second OxiMax Sensors Wavelength Energy 660 nm and 890 nm Not exceeding 15 mw 1. SpO 2 accuracies are expressed as plus or minus X digits (saturation percentage points) between saturations of %. This variation equals ±one standard deviation (1SD), which encompasses 68% of the population. All accuracy specifications are based on testing the subject monitor on healthy adult volunteers in induced hypoxia studies across the specified range Trends Parameter Type Memory Storage Data interval Specification Tabular 12 hours, nonvolatile 20 seconds (stored data point is the average over 20 second interval) Recorder Parameter Type Specification Thermal Size 6.7" x 3.8" x 5.0" (17.0 cm x 9.7 cm x 12.7 cm) Weight Paper width Speed 3.8 lb (1.5 kg) 50 mm 25 mm/s Internal Battery Type Battery Operating Time (fully charged) Sealed, lead acid, 12V, 1.2 amp/hr 3 hours, typical at 25 C (fifteen 20 second printouts per hour) External Power Supply Analogic P/N VAC, Hz, 1.5A 14-5

88 RS-232 Interface Appendix A RS-232 Interface A.1 RS-232 Interface The RS-232 interface enables the user to: send a nurse call signal export trend data to an external PC print to an accessory recorder A.2 Cable Connections A 9-pin connector mounted on the rear panel provides an access port for a serial (RS- 232) interface as shown in the following figure. Power Supply Connector RS-232 Interface Port Pin connections for the 9-pin connector are as follows. Table A.1 RS-232 Serial Interface Connections Pin # Signal Direction 1 not used 2 Rx data input 3 Tx data output 4 DTR output 5 Signal Ground input/output 6 DSR input 7 RTS output 8 CTS input 9 Alarm Out output A-1

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