9200 Advisor Vital Signs Monitor Operation Manual Ver 11 Sept 2003

Table of Contents

Chapter 1: Introduction

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Proprietary Notice ... 1-1 WARRANTY ... 1-1 Limited Warranty ... 1-1 Disclaimer of Warranties ... 1-1 Conditions of Warranty... 1-1 Limitation of Remedies... 1-2 Warranty Procedure ... 1-2 CE Notice... 1-2 About This Manual ... 1-3 Conventions ... 1-3 Using the Manual ... 1-3 Definition of Symbols... 1-4 2 Warnings, Cautions & Notes ... 1-5 General Warnings, Cautions and Notes ... 1-5

Chapter 2: General Description

2-1

Intended Use ... 2-1 Features ... 2-1 Measurement Capabilities ... 2-2

Chapter 3: Setting Up the Monitor

3-1

Connect the AC Power Cord... 3-1 Selecting Patient Mode ... 3-1 Suspend Mode... 3-1 Setup ... 3-2 Using the Internal Battery ... 3-3 Starting ... 3-3 High, Medium, and Low Priority Alarm Tones ... 3-4 Time and Date... 3-5 New Patient... 3-5

Chapter 4: Description of Controls and Features

4-1

Front Panel ... 4-1 Indicators... 4-2 Patient Connectors ... 4-2 Printer... 4-3 Display ... 4-4 Parameter Colors... 4-7 Keys ... 4-8 Rear Panel ... 4-9

Chapter 5: High, Medium, and Low Priority Alarms

5-1

Alarms... 5-1 Momentary Sounds ... 5-2 Alarm Volume Adjust ... 5-2 Setting Alarm Limits... 5-3 QUICKSET Alarms ... 5-5 Alarm Tones... 5-7

Chapter 6: Pulse/Heart Rate Detection

6-1

Determining Measurement for Rate... 6-1 Rate Source ... 6-1

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Chapter 7: ECG

7-1

ECG Warnings, Cautions, and Notes...7-1 Theory of Operation ...7-1 Using the ECG Parameter...7-2 Setting Up ECG Monitoring ...7-2 Attaching the Patient...7-2 ECG Display...7-5 ECG Parameter Menu...7-7 HR ALARMS ...7-7 WAVEFORM DISPLAY ...7-7 SPEED ...7-8 RATE SRC (source) ...7-8 PULSE VOL ...7-8 ECG MONITOR...7-8 PRINT ALL LEADS SNAPSHOT (Available for 5 lead ECG only)...7-8 ECG Waveform Menu ...7-9 ECG Alarms ...7-11 ECG Messages...7-12 Correcting Lead Fail or Lead Overload Alarms ...7-13 ECG Calibration Verification ...7-13 Using the 1606 Simulator to Verify Calibration ...7-13 ECG Technical Data ...7-13

Chapter 8: Impedance Respiration

8-1

Respiration Warnings, Cautions, and Notes ...8-1 Theory of Operation ...8-1 Using the Impedance Respiration Parameter (RSP) ...8-1 Setting Up Respiration Monitoring...8-2 Attaching the Patient...8-2 Respiration Display ...8-4 Impedance Respiration Parameter Menu ...8-6 ALARM LIMITS...8-6 Impedance Respiration Alarms...8-8 Impedance Respiration Messages ...8-8

Chapter 9: Oximeter

9-1

Oximetry Warnings, Cautions, and Notes...9-1 Theory of Operation ...9-2 Using the Oximeter Parameter...9-2 Setting Up Oximeter Monitoring ...9-3 Attaching the Sensor to the Patient...9-4 Choosing the Sensor ...9-4 Checking the Sensor and Patient Cable ...9-5 Cleaning or Disinfecting the Sensor ...9-6 Oximeter Display...9-7 Oximeter Alarms ...9-8 Oximeter Messages...9-8

Chapter 10: NIBP

10-1

Non-invasive Blood Pressure Warnings, Cautions and Notes ...10-1 Theory of Operation ...10-1 Using the NIBP Parameter...10-2 Setting Up NIBP Measurement ...10-2 Connecting the Cuff and Hose...10-3 Selecting the Proper NIBP Cuff...10-4

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Connecting the Cuff and Hose ...10-4 Adult application...10-4 NIBP Display ...10-5 NIBP Measurement Modes ...10-6 NIBP Parameter Menu ...10-6 MEASUREMENT MODE...10-7 Taking NIBP Measurements ...10-8 NIBP Alarms...10-10 NIBP Messages...10-11 Application Note: NIBP Cuff Inflation Method...10-12 Non-Invasive Blood Pressure Calibration Verification...10-12

Chapter 11: Invasive Pressure

11-1

Invasive BP Warnings, Cautions and Notes...11-1 General Description ...11-1 Invasive Pressure Transducers and Interface Cables...11-1 Medical Supplies Vendors (U.S.A.)...11-3 Using the Invasive Pressure Parameter ...11-4 Setting Up Invasive Pressure Monitoring ...11-4 Setting Up the Invasive Pressure Transducer...11-5 Invasive Pressure Display ...11-6 Invasive Pressure Parameter and Waveform Menus ...11-8 Invasive Pressure Alarms...11-11 Invasive Pressure Messages ...11-12 Calibrating (Zeroing) the Invasive Pressure Transducers ...11-13

Chapter 12: Capnography

12-1

CO2 Warnings, Cautions, and Notes ...12-1 Theory of Operation...12-1 Measuring CO2 ...12-1 Measuring Respiration Rate ...12-2 N2O Compensation...12-2 Using the Capnograph Parameter ...12-3 Connecting a Non-Recirculating Scavenging System...12-4 Checking for Leaks ...12-4 Calibrating the Capnograph ...12-4 Low Calibration ...12-5 Auto-Zero Calibration...12-5 Low/High Calibration ...12-6 Attaching the Patient...12-7 Capnograph Display...12-10 Capnograph Parameter and Waveform Menus ...12-11 Parameter Menu ...12-11 Capnograph Alarms ...12-12 Capnograph Messages...12-13

Chapter 13: Temperature

13-1

Temperature Warnings, Cautions and Notes...13-1 Description...13-1 Temperature Sensors and Interface cables ...13-1 Using the Temperature Parameter...13-1 Setting Up Temperature Monitoring ...13-1 Setting Up the Temperature Sensor ...13-2 Temperature Display...13-3 Temperature Parameter Menu...13-4 Temperature Alarms, and Messages ...13-5 Advisor® Operations Manual

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Temperature Messages ...13-5

Chapter 14: Trends

14-1

Description...14-1 Displaying and Printing Trends ...14-1

Chapter 15: Printer

15-1

Features...15-1 Sample Printouts...15-4 Snapshot...15-4 Strip Chart...15-5 NIBP History Print Window...15-6 NIBP History Print All...15-7 Tabular Trend PRINT ALL ...15-8 Choosing the Printer Options...15-9 Replacing the Printer Paper ...15-11

Chapter 16: Serial Data I/O

16-1

Description...16-1 Serial Data I/O Connector Signal Description ...16-4

Chapter 17: Analog Output

17-1

Description...17-1 Connector Pinout ...17-1 End Equipment Connection ...17-2 Central Station Connection...17-3

Chapter 18: Operator’s Maintenance

18-1

Cleaning the Monitor’s Surfaces ...18-2 Long Term Storage ...18-2

Chapter 19: Operator’s Troubleshooting Chart

19-1

Troubleshooting the Occlusion Low Priority Alarm/Alert ...19-2

Chapter 20: Optional Supplies and Accessories

20-1

Ordering Information...20-2

Chapter 21: Specifications

21-1

Capnograph...21-1 Respiration Rate (CO2)...21-2 Equipment Classification ...21-6

APPENDIX A: SERVICE MENU

Appendix-1

Accessing the Service Menu... Appendix-1 PARAMETER DEFAULTS... Appendix-1 DEFAULT PARAMETER ALARM LIMITS... Appendix-1 CHANGE PASSWORD ... Appendix-3 SYSTEM LOG ... Appendix-4 PURCHASED OPTIONS... Appendix-4

APPENDIX B: ECG TECHNICAL REFERENCE

Appendix-5

ECG Technical Reference ... Appendix-5

APPENDIX C: ALARM LIMIT DEFAULTS

Appendix-8

Heart Rate ... Appendix-8

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Impedance Respiration...Appendix-8 Oximetry ...Appendix-8 NIBP ...Appendix-8 Invasive Pressure...Appendix-9 Temperature T1/T2 ...Appendix-9 Capnography (CO2) ...Appendix-10

APPENDIX D: IEC 60601-1-2 REQUIREMENTS

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Appendix-11

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Chapter 1: Introduction

Chapter 1: Introduction Proprietary Notice Information contained in this document is copyrighted by BCI, Inc. and may not be duplicated in full or part by any person without prior written approval of BCI, Inc. Its purpose is to provide the user with adequately detailed documentation to efficiently install, operate, maintain and order spare parts for the device supplied. Every effort has been made to keep the information contained in this document current and accurate as of the date of publication or revision. However, no guarantee is given or implied that the document is error free or that it is accurate regarding any specification.

WARRANTY Limited Warranty Seller warrants to the original purchaser that the Product, not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with its labeling for one year from the date of shipment to the original purchaser. Seller warrants to the original purchaser that the reusable oximeter sensors supplied as accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with its labeling for one year from the date of shipment to the original purchaser (USA ).

Disclaimer of Warranties THE FOREGOING EXPRESS WARRANTY, AS CONDITIONED AND LIMITED, IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Seller disclaims responsibility for the suitability of the Product for any particular medical treatment or for any medical complications resulting from the use of the Product. This disclaimer is dictated by the many elements which are beyond Seller’s control, such as diagnosis of patient, conditions under which the Product may be used, handling of the Product after it leaves Seller’s possession, execution of recommended instructions for use and others.

Conditions of Warranty This warranty is void if the Product has been altered, misused, damaged by neglect or accident, not properly maintained or recharged, or repaired by persons not authorized by Seller. Misuse includes, but is not limited to, use not in compliance with the labeling or use with accessories not manufactured by Seller. This warranty does not cover normal wear and tear and maintenance items.

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Limitation of Remedies The original purchaser’s exclusive remedy shall be, at Seller’s sole option, the repair or replacement of the Product. THIS IS THE EXCLUSIVE REMEDY. In no event will Seller’s liability arising out of any cause whatsoever (whether such cause is based in contract, negligence, strict liability, tort or otherwise) exceed the price of the Product and in no event shall Seller be responsible for consequential, incidental or special damages of any kind or nature whatsoever, including but not limited to, lost business, revenues and profits.

Warranty Procedure To obtain warranty service in the USA, you must request a Customer Service Report (CSR) number from Technical Service. Reference the CSR number when returning your Product, freight and insurance prepaid, to: BCI, Inc., N7 W22025 Johnson Road, Waukesha, WI 53186-1856. Telephone: 1-800-558-2345. Facsimile: 262-542-3325. Seller will not be responsible for unauthorized returns or for loss or damage to the Product during the return shipment. The repaired or replaced Product will be shipped, freight prepaid, to Purchaser. To obtain warranty information outside of the USA, contact your local distributor. Keep all original packing material, including foam inserts. If you need to ship the device, use only the original packaging material, including inserts. Box and inserts should be in original condition. If original shipping material in good condition is not available, it should be purchased from BCI, Inc. Damages occurred in transit in other than original shipping containers, are the responsibility of the shipper. All costs incurred returning devices for repair are the responsibility of the shipper.

CE Notice Marking by the symbol Directive 93/42/EEC.

m

indicates compliance of this device to the Medical Device

Authorized Representative (as defined by the Medical Device Directive): Graseby Medical Ltd. Colonial Way, Watford, Herts, UK, WD2 4LG

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Phone: (44) 1923 246434 Fax: (44) 1923 240273

Advisor® Operation Manual

Chapter 1: Introduction

About This Manual This manual provides installation, operation, and maintenance instructions for the equipment supplied. This manual is intended for health-care professionals trained in monitoring respiratory and cardiovascular activity.

Conventions This manual uses visual clues to help convey messages. The following examples show the conventions used throughout the manual. Words that are defined in context, or defined in the next sentence, are shown in italics, like this. References to other sections in the manual are shown in italics, like this: See Alarms in Chapter 5: High, Medium, and Low Priority Alarms for a description of alarms. When menus are shown, the monitor’s default settings are shown.

2 WARNINGS! Are shown like this. CAUTIONS! Are shown like this. NOTES! Are shown like this.

Using the Manual The monitor allows you to choose the measurement capabilities you need. A measurement refers to a derived or calculated value; a parameter refers to one or more specific measurements. For example, the pulse rate value and the %SpO2 value are measurements; the Oximeter parameter consists of both these measurements. Operation of the monitor is the same regardless of the number of parameters utilized. If the monitor just arrived, or if you’re not familiar with the operation of this monitor, then follow each chapter in the manual in order. Each chapter builds on the information from the previous chapter. If the monitor is already set up, or you are familiar with its operation, then turn to the chapter that describes the features you will use.

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Chapter 1: Introduction

Definition of Symbols Figure 1.1: Definition of Symbols

SYMBOL

1-4

DEFINITION

q s 2 1 7 9 0 w x →O ← h F y B

Defibrillator-proof type CF equipment.

REF

Catalog Number

SN

Serial Number

IPX1

Drip Proof

1 X M

Non AP Device

Defibrillator-proof type BF equipment. Attention, consult accompanying documents Dangerous voltage Refer servicing to qualified service personnel Output Loudspeaker Fuse On/Off BP Zero All NIBP Start/Stop Print Start/Stop Date of Manufacture Alarm Silence

AC Power LED Low Battery LED

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Chapter 1: Introduction

2 Warnings, Cautions & Notes Figure 1.2: Definition of Hazard Keywords

KEYWORD

DEFINITION

WARNING

Tells you about something that could hurt the patient or hurt the operator.

CAUTION

Tells you about something that could damage the monitor.

NOTE

Tells you other important information.

General Warnings, Cautions and Notes WARNING! Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician. WARNING! Do not use this device in the presence of flammable anesthetics. WARNING! ELECTRICAL SHOCK HAZARD when covers are removed. Do not remove covers. Refer servicing to qualified personnel. WARNING! Do not plug the monitor into an outlet controlled by a wall switch. WARNING! Do not use this device in the presence of magnetic resonance imaging (MR or MRI) equipment. WARNING! This device must be used in conjunction with clinical signs and symptoms. This device is only intended to be an adjunct in patient assessment. WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the monitor and other accessories in liquid. Evidence that liquid has been allowed to enter the monitor voids the warranty. WARNING! In the event that earth ground integrity is lost, the performance of this device and/or other devices nearby may be affected due to excessive RF emissions. WARNING! Where HF (diathermy) is used there is no danger of burning to the patient provided recommended components are used. Rate meters may be temporarily affected. The 9210 electrocautery filter is necessary for proper monitoring during electrocautery. WARNING! Equipment is protected against defibrillator discharge. Rate meters and displays may be temporarily affected during defibrillation, but will rapidly recover. WARNING: The vital signs monitor is suitable for use within the patient environment. IEC 60950 approved equipment must by placed outside of the patient environment. The patient environment is defined as any volume in which intentional or unintentional contact can occur between the patient and parts of the system or between the patient and other persons touching parts of the system.

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Chapter 1: Introduction EXAMPLE OF THE PATIENT ENVIRONMENT. THE DIMENSIONS ARE NOT PRESCRIPTIVE.

.9

5m

R

ft)

(4

1.

WARNING! When connecting this monitor to any instrument, verify proper operation before clinical use. Use only equipment meeting specifications given in this manual. Refer to the instrument’s user manual for full instructions. Accessory equipment connected to the monitor’s data interface must be certified according to the respective IEC standards, i.e., IEC 60950 for data-processing equipment or IEC 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC 60601-1-1 systems requirements. Anyone connecting additional equipment to the signal input port or signal output port configures a medical system, and, therefore, is responsible that the system complies with the requirements of the system standard IEC 60601-1-1. WARNING! Any monitor that has been dropped or damaged should be checked by qualified service personnel to insure proper operation prior to use. WARNING! Use only original manufacturer or recommended patient cables. Use of accessories other than those specified may result in increased electro-magnetic (EM) emissions or decreased EM immunity of the device. To avoid potential electro-static discharge interference, do not use cables which incorporate metal or metal coated connectors. WARNING! Medical electrical equipment, including this device, needs special precautions regarding electro-magnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual. WARNING! There is no defibrillator synchronization output on the monitor. Make no connections between the monitor and a defibrillator. WARNING! This monitor will not operate effectively on patients who are experiencing convulsions or tremors. WARNING! This monitor is not for home use.

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WARNING! The monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor should be observed to verify normal operation in the configuration in which it will be used. WARNING! This monitor is not for apnea detection. The monitor has not been tested or validated for use in apnea detection. WARNING! Verify proper operating mode before attaching patient. Refer to Chapter 3: Selecting Patient Mode. WARNING! Default parameters are provided for convenience. Verify that alarm limits are appropriate for given patient and condition, and adjust according to institutional policy. WARNING! When the monitor is connected to the Central Station, alarm limits must be set at both the Central Station and the bedside. WARNING! Each patient parameter being monitored should be tested after connection of the monitor to the Central Station to ensure proper setup. Do not connect patients or rely upon remotely displayed patient data until all testing has been performed and the system shown to be functioning properly. CAUTION! Do not allow water or any other liquid to be spilled onto the monitor. Unplug the AC power cord from the monitor before cleaning or disinfecting the monitor. CAUTION! Ensure the monitor’s AC rating is correct for the AC voltage at your installation site before using the monitor. The monitor’s AC rating is shown on the rear panel rating plate. If the rating is not correct, do not use the monitor. CAUTION! Device batteries are not user replaceable. This unit may contain a lithium, NiCad, and/or a nickel-metal-hydride battery. Disposal of such batteries should be conducted in accordance to local or federal guidelines. BCI, Inc. cannot dispose of these batteries. CAUTION! This device is intended for use by trained health care professionals. The operator must be thoroughly familiar with the information in this manual before using the device. CAUTION! Pressing front panel keys with sharp or pointed instruments may permanently damage the keypad. Press front panel keys only with your finger. CAUTION! Blocking the ventilation holes on the monitor’s rear panel can prevent air circulation inside the monitor, possibly resulting in damage to the monitor. Leave an air gap behind the monitor to allow air to circulate through the ventilation holes. CAUTION! Should the device become wet, wipe off all moisture and allow sufficient time for drying before operating. CAUTION! Do not disassemble the unit. The unit is not user serviceable. Refer to qualified service personnel. CAUTION! It is the operator’s responsibility to set alarm limits appropriately for each individual patient. CAUTION! If the accuracy of any measurement is in question, check the patient’s vital sign(s) by an alternative method and then check the monitor for proper functioning.

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Chapter 1: Introduction

CAUTION! The monitor should be operated from its internal power source (if fitted) if the integrity of the protective earth conductor is in doubt. CAUTION! Follow local governing ordinances and recycling instructions regarding disposal and recycling of device components and packaging. NOTE! Operation of this device may be affected in the presence of strong portable and mobile communications equipment. NOTE! Operation of this device may be adversely affected in the presence of computed tomograph (CT) equipment. NOTE! All user and patient accessible materials are non-toxic. NOTE! Hazards arising from software errors have been minimized. Hazard analysis was performed to meet EN1441: 1997, and EN60601-1-4: 2000. NOTE! Each input and output connection of the monitor is electrically isolated. Connection of this monitor to other equipment will not increase leakage current.

ECG Warnings, Cautions, and Notes WARNING! PACEMAKER PATIENTS. Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument. WARNING! PACEMAKER PATIENTS: If PACE DETECT is not turned on when monitoring pacemaker patients the heart rate readouts derived from the ECG patient connections are likely to display erroneous high or erratic rates. Keep pacemaker patients under close surveillance. For pacemaker patients it may be advisable to select the SpO2 parameter as the primary heart rate source. WARNING! Connect only three-lead or five-lead ECG lead wires from the patient to the ECG patient cable. Do not connect any other signal source to the ECG patient cable. WARNING! False low heart rate indicators or false Asystole calls may result with certain pacemakers because of electrical overshoots. WARNING! Reliable monitoring of pacemaker patients can only occur with PACE DETECT on. WARNING! The pacemaker pulse marker shape and size is not to be diagnostically interpreted. WARNING! Keep pacemaker patients under close observation. Rate detection in the software may continue to count the pacemaker rate during cardiac arrest and/or arrhythmia conditions. Therefore, do not rely solely on rate detection alarms. NOTE! Follow institutional standards when applying ECG electrodes. Silver/Silver Chloride disposable electrodes are strongly recommended to avoid polarization effects that result in large input offset potentials. Use of “squeeze bulb” type electrodes is not recommended. NOTE! Use only standard AAMI three-lead or five lead ECG cables.

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NOTE! Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms.

Impedance Respiration Warnings, Cautions, and Notes WARNING! This monitor is not for apnea detection. The monitor has not been tested or validated for use in apnea detection. WARNING! Electrodes of dissimilar metals should not be used. WARNING! The monitor may not detect all episodes of inadequate breathing. CAUTION! Ensure conductive parts including electrodes of the patient cable do not come into contact with any conductive surfaces or earth parts. CAUTION! The respiration parameter is disabled when the monitor is in the neonate operating mode. NOTE! Follow institutional standards when applying ECG electrodes. NOTE! The ECG/Respiration cable uses a standard AAMI three-lead or five-lead ECG/Respiration connector. Use only standard AAMI three-lead or five-lead ECG wires. NOTE! The ECG/Respiration patient circuit is electrically isolated. NOTE! The monitor is protected against damage from defibrillator, diathermy, and electrocautery discharge.

Oximetry Warnings, Cautions, and Notes WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours. WARNING! When attaching sensors with Microfoam®1 tape, do not stretch the tape or attach the tape too tightly. Tape applied too tightly may cause inaccurate readings and blisters on the patient’s skin (lack of skin respiration, not heat, causes the blisters). WARNING! Using a damaged sensor may cause inaccurate readings, possibly resulting in patient injury or death. Inspect each sensor. If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair center for help. WARNING! Using a damaged patient cable may cause inaccurate readings, possibly resulting in patient injury or death. Inspect the patient cable. If the patient cable appears damaged, do not use it. Contact your authorized repair center for help. WARNING! If any of the integrity checks fail, do not attempt to monitor the patient. Use another sensor or patient cable, or contact the equipment dealer for help if necessary. WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid. Evidence that liquid has been allowed to enter the monitor voids the warranty. WARNING! Use only SpO2 sensors supplied with, or specifically intended for use with, 1 Microfoam is a registered trademark of the 3M Company. Advisor® Operation Manual

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Chapter 1: Introduction

this device. CAUTION! Unplug the sensor from the monitor before cleaning or disinfecting. NOTE! Obstructions or dirt on the sensor’s red light or detector may cause a sensor failure. Make sure there are no obstructions and the sensor is clean. NOTE! If the oximeter parameter is being monitored, the pitch of the pulse beep is determined by the SpO2 value. The higher the SpO2 value, the higher the pulse beep pitch, and vice versa. NOTE! SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a surgical towel, for example) if necessary. NOTE! Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, patent blue (PBV), and fluorescein may adversely affect the accuracy of the SpO2 reading. NOTE! Any condition that restricts blood flow, such as use of a blood pressure cuff or extremes in systemic vascular resistance, may cause an inability to determine accurate SpO2 and pulse rate readings. NOTE! The low SpO2 alarm limit minimum test value is 80. If an operator changes the low SpO2 alarm limit to a value less than 80, and a power down - power up sequence takes place, a minimum value of 85 takes the place of the operator entered value. NOTE! Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

Non-invasive Blood Pressure Warnings, Cautions and Notes WARNING! Blood pressure measurements may be inaccurate if cuffs and/or hoses, other than those specified by BCI, are used. WARNING! Repeated use of STAT mode for periods longer than 15 minutes should be avoided to reduce the patient’s risk for soft tissue or nerve damage. When using the monitor for long periods of time, select the longest clinically appropriate measurement interval and periodically examine the patient for signs of injury and ensure proper cuff placement. WARNING! Make sure that hoses are not kinked, compressed, or restricted. WARNING! Check that operation of the equipment does not impair the circulation of the monitored patient. WARNING! Blood pressure measurements may not be accurate for patients experiencing arrhythmias. WARNING! Do not verify the Non-Invasive Blood Pressure calibration while the cuff is attached to a patient. CAUTION! To ensure that the unit remains in calibration, perform a calibration verification on a yearly basis. CAUTION! Verify the proper cuff size before each measurement.

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Chapter 1: Introduction

CAUTION! Extremity and cuff motion should be minimized during blood pressure determinations. CAUTION! Proper blood pressure cuff size and placement are essential to the accuracy of the blood pressure determination. CAUTION! Any blood pressure recording can be affected by the position of the patient, his or her physiologic condition, and other factors. CAUTION! Blood pressure measurements should be interpreted by a physician. NOTE! There are no user-serviceable adjustments for the Non-Invasive Blood Pressure calibration verification. If the monitor appears to be out of calibration, contact your authorized repair center for help. NOTE! Systolic and Diastolic blood pressure measurements determined with this device are equivalent to those obtained by the trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers. AAMI SP10-1992. NOTE! Mean Arterial blood pressure measurements determined with this device are equivalent to those obtained by an intra-arterial blood pressure measurement device as determined by BCI, Inc. NOTE! Clinical validation studies are available upon request.

Invasive BP Warnings, Cautions and Notes WARNING! Avoid conductive connection with any metal parts. NOTE! The IBP ZERO NEEDED message is displayed when the monitor is turned on or when the transducer is connected to the monitor (even if the same transducer is disconnected then reconnected to the monitor). NOTE! Use only invasive pressure transducers and interface cables specifically intended for use with this device and it’s side panel connectors. NOTE! The BP1 and BP2 waveforms must be visible and adjacent in order to be overlaid. NOTE! When BP1 and BP2 are overlaid, the scale settings for BP1 and BP2 are changed to the higher of the two scales. NOTE! Dual channel simulators may affect verification of IP operation. Use only single channel simulators.

Temperature Warnings, Cautions and Notes NOTE! Use only temperature sensors and interface cables specifically intended for use with this device.

Capnograph Warnings, Cautions and Notes WARNING: The capnograph contains no compensation for barometric pressure,

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Chapter 1: Introduction

therefore readings in mmHg and kPa are correct only under the pressure at which the capnograph is calibrated. Manual compensation can be made by performing a low cal. CAUTION: Pump motors in the capnograph may adversely affect other medical equipment, e.g. ECG tracings. CAUTION: Use of monitor during continuous nebulized medication delivery, will result in damage to the monitor (not covered by factory warranty). Disconnect the ETCO2 sample line from the patient circuit or power off during medication delivery. NOTE: All user and patient accessible materials are non-toxic. NOTE: During the auto zero calibration (autocal) sampling, the CO2 waveform and digits will disappear for 1-5 seconds. After this, breath detection restarts. This should happen only during extreme temperature changes, and not during normal patient monitoring, or during changes of ambient pressure. NOTE: The auto-zero cal is the similar to a low cal, excluding ambient pressure, so as not to stop the pump.

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Chapter 2: General Description

Chapter 2: General Description Intended Use The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). A capnography (CO2, ETCO2, INCO2, RR) module, two inch internal, graphical/alphanumeric printer, and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adult when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available only in the adult and pediatric modes and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. This monitor is not for apnea detection. The monitor has not been tested 2 WARNING! or validated for use in apnea detection.

2 WARNING! This monitor is not for home use. Verify proper operating mode before attaching patient. Refer to Chapter 2 WARNING! 3: Selecting Patient Mode.

Features Monitoring Capability is provided for patient monitoring in typical health care environments such as: Intensive Care, Cardiac Care, Emergency Department, Operating Room, Post Anesthesia Recovery, special procedure labs or labor and delivery rooms. Parameters The monitor offers ECG, Respiration, Capnography, Pulse Oximetry, NIBP, Invasive Pressure and Temperature as monitoring parameters. Display The monitor has a large, high-resolution, high-contrast, color LCD display. This provides a continuous, real-time display of up to four waveforms, measured values, chronological data, measurement trends, and alarm limits. Printer An optional built-in printer, provides waveform snapshots, waveform strips, and tabular parameter data. Annotation lines are printed every 200 mm (8 inches). The printer has three paper speeds (four if capnography is installed), a dedicated print key, and an easy to use drop-in paper replacement compartment.

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Chapter 2: General Description

Keys Dedicated keys provide quick and easy access to important functions: NIBP measurement, invasive pressure zeroing, alarms silence, and print functions. Rotary Knob The rotary knob works by rotating in either direction, moving the cursor on the display and highlighting parameter labels and menu options. Pushing the knob selects the highlighted item allowing you to further interact with the menus. Serial Output An RS-232C compatible serial output channel is standard. Analog Output The monitor provides three optional, electrically isolated, analog output channels with a 7pin connector. Power An AC voltage switch, located above the AC receptacle, switches the monitor between 110V and 220V AC line voltage sources. An optional internal rechargeable battery ensures consistent monitor operation during AC line interruption.

Measurement Capabilities Measurement capabilities: • Heart/Pulse Rate: Displays continuous heart/pulse rate value from the best source depending on quality of available data and selected source priority. • ECG: Continuous three-lead or five-lead ECG monitoring, with standard lead selections, filtering from defibrillator and electrocautery discharge (option). Displays lead selection, and alarm limits. Provides pacemaker mode with display of detected pacer marker in waveform. • Impedance Respiration: (if no CO2 monitoring) Displays respiration waveform, respiration rate, and alarm limits. This parameter is NOT available in Neonate mode. • Capnography: Continuous non-invasive monitoring of sidestream end-tidal CO2, inspired CO2, and respiration rate. Displays CO2 waveform, ETCO2, INCO2, and RR measurements with alarm limits. Nitrous oxide compensation is selectable. This parameter is NOT available in Neonate mode. • Oximeter: Continuous non-invasive monitoring of %SpO2 and pulse rate. Displays plethysmogram, pulse strength bargraph, %SpO2 measurements, and alarm limits. A variety of disposable and reusable sensors are available for monitoring patients. • NIBP: Non-invasive measurement of systolic, diastolic and mean blood pressure values. Displays NIBP chronology, cuff pressure, mode setting, measured values, and alarm limits. NIBP measurements can be made in automatic, manual or STAT modes. • Invasive Pressure: Two independent channels of invasive pressure monitoring are available to measure systolic, diastolic and mean values for each invasive pressure. Displays measured values, alarm limits, site labels and waveforms. • Temperature: Two independent channels of temperature monitoring, compatible with YSI 400- or 700-series reusable or 4400- or 4700-series disposable temperature sensors. Displays measured values and alarm limits for each channel.

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Advisor® Operation Manual