Table of Contents Chapter 1: Introduction 1-1 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 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 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......................................................................................................................................................5-6 Chapter 6: Pulse/Heart Rate Detection 6-1 Determining Measurement for Rate..................................................................................................................6-1 Rate Source.......................................................................................................................................................6-1 Chapter 7: ECG 7-1 ECG Warnings, Cautions, and Notes.............................................................................................................7-1 i Table of Contents 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............................................................................................................................................................7-7 RATE SRC (source).......................................................................................................................................7-7 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 Technical Data........................................................................................................................................7-13 Chapter 8: Oximeter 8-1 Oximetry Warnings, Cautions, and Notes.......................................................................................................8-1 Theory of Operation..........................................................................................................................................8-2 Using the Oximeter Parameter...........................................................................................................................8-2 Setting Up Oximeter Monitoring.......................................................................................................................8-3 Attaching the Sensor to the Patient....................................................................................................................8-4 Choosing the Sensor.......................................................................................................................................8-4 Checking the Sensor and Patient Cable..........................................................................................................8-5 Application Guide...........................................................................................................................................8-6 Mini Clip.........................................................................................................................................................8-7 Universal C-sensor..........................................................................................................................................8-7 Reflectance (Rectal) Sensor............................................................................................................................8-8 Cleaning or Disinfecting the Sensor...............................................................................................................8-9 Oximeter Display.............................................................................................................................................8-10 Oximeter Alarms.............................................................................................................................................8-11 Oximeter Messages..........................................................................................................................................8-11 Chapter 9: NIBP 9-1 Non-Invasive Blood Pressure Warnings, Cautions and Notes........................................................................9-1 Theory of Operation..........................................................................................................................................9-1 Using the NIBP Parameter.................................................................................................................................9-2 Setting Up NIBP Measurement.........................................................................................................................9-2 Connecting the Cuff and Hose...........................................................................................................................9-3 NIBP Display.....................................................................................................................................................9-4 NIBP Measurement Modes.............................................................................................................................9-5 NIBP Parameter Menu.......................................................................................................................................9-5 MEASUREMENT MODE.............................................................................................................................9-6 Taking NIBP Measurements..............................................................................................................................9-7 NIBP Alarms.....................................................................................................................................................9-9 NIBP Messages................................................................................................................................................9-10 Application Note: NIBP Cuff Inflation Method..............................................................................................9-11 Non-Invasive Blood Pressure Calibration Verification...................................................................................9-11 Chapter 10: Invasive Pressure 10-1 Invasive BP Warnings, Cautions and Notes....................................................................................................10-1 General Description.........................................................................................................................................10-1 Invasive Pressure Transducers and Interface Cables....................................................................................10-1 ii Table of Contents Medical Supplies Vendors (U.S.A.)..............................................................................................................10-3 Using the Invasive Pressure Parameter............................................................................................................10-4 Setting Up Invasive Pressure Monitoring........................................................................................................10-4 Setting Up the Invasive Pressure Transducer...................................................................................................10-5 Invasive Pressure Display................................................................................................................................10-6 Invasive Pressure Parameter and Waveform Menus........................................................................................10-8 Invasive Pressure Alarms...............................................................................................................................10-11 Invasive Pressure Messages...........................................................................................................................10-12 Calibrating (Zeroing) the Invasive Pressure Transducers..............................................................................10-13 Chapter 11: Capnography 11-1 CO2 Warnings, Cautions, and Notes...............................................................................................................11-1 Theory of Operation.........................................................................................................................................11-1 Measuring CO ..............................................................................................................................................11-1 2 Measuring Respiration Rate..........................................................................................................................11-2 N O Compensation........................................................................................................................................11-2 2 Using the CapnographParameter.....................................................................................................................11-3 Connecting a Non-Recirculating Scavenging System......................................................................................11-4 Checking for Leaks..........................................................................................................................................11-4 Calibrating the Capnograph.............................................................................................................................11-4 Low Calibration............................................................................................................................................11-5 Auto-Zero Calibration......................................................................................................................................11-5 Low/High Calibration...................................................................................................................................11-6 Attaching the Patient........................................................................................................................................11-7 Capnograph Display.........................................................................................................................................11-8 Capnograph Parameter and Waveform Menus................................................................................................11-9 Parameter Menu............................................................................................................................................11-9 Capnograph Alarms.......................................................................................................................................11-10 Capnograph Messages....................................................................................................................................11-11 Chapter 12: Temperature 12-1 Temperature Warnings, Cautions and Notes.................................................................................................12-1 Description.......................................................................................................................................................12-1 Temperature Sensors and Interface Cables...................................................................................................12-1 Using the Temperature Parameter....................................................................................................................12-1 Setting Up Temperature Monitoring................................................................................................................12-1 Setting Up the Temperature Sensor.................................................................................................................12-2 Temperature Display........................................................................................................................................12-3 Temperature Parameter Menu..........................................................................................................................12-4 Temperature Alarms, and Messages................................................................................................................12-5 Temperature Messages.....................................................................................................................................12-5 Chapter 13: Trends 13-1 Description.......................................................................................................................................................13-1 Displaying and Printing Trends.......................................................................................................................13-1 Chapter 14: Printer 14-1 Features............................................................................................................................................................14-1 Sample Printouts..............................................................................................................................................14-4 Snapshot........................................................................................................................................................14-4 Strip Chart.....................................................................................................................................................14-5 NIBP History Print Window.........................................................................................................................14-6 NIBP History Print All..................................................................................................................................14-7 Tabular Trend PRINT ALL...........................................................................................................................14-8 Choosing the Printer Options...........................................................................................................................14-9 Replacing the Printer Paper............................................................................................................................14-11 iii Table of Contents Chapter 15: Serial Data I/O 15-1 Description.......................................................................................................................................................15-1 Serial Data I/O Connector Signal Description..............................................................................................15-4 Chapter 16: Operator’s Maintenance 16-1 Cleaning the Monitor’s Surfaces.....................................................................................................................16-2 Long Term Storage..........................................................................................................................................16-2 Chapter 17: Operator’s Troubleshooting Chart 17-1 Troubleshooting the Occlusion Low Priority Alarm/Alert...........................................................................17-2 Chapter 18: Optional Supplies and Accessories 18-1 Ordering Information.......................................................................................................................................18-2 Chapter 19: Specifications 19-1 Capnograph...................................................................................................................................................19-1 Respiration Rate (CO2).................................................................................................................................19-2 Equipment Classification..............................................................................................................................19-6 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: ALARM LIMIT DEFAULTS Appendix-5 Heart Rate.........................................................................................................................................Appendix-5 Oximetry...........................................................................................................................................Appendix-5 NIBP.................................................................................................................................................Appendix-5 Invasive Pressure..............................................................................................................................Appendix-6 Temperature T1/T2...........................................................................................................................Appendix-6 Capnography (CO2)..........................................................................................................................Appendix-7 APPENDIX C: IEC 60601-1-2 REQUIREMENTS Appendix-8 iv Chapter 1: Introduction Chapter 1: Introduction Proprietary Notice Information contained in this document is copyrighted by SurgiVet and may not be duplicated in full or part by any person without prior written approval of SurgiVet. 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. 1-1 Chapter 1: Introduction 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. 1-2 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 %SpO value are measurements; the 2 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. 1-3 Chapter 1: Introduction Definition of Symbols Figure 1.1: Definition of Symbols SYMBOL DEFINITION q Defibrillator-proof type CF equipment s Defibrillator-proof type BF equipment 2 Attention, consult accompanying documents 1 Dangerous voltage 7 Refer servicing to qualified service personnel 9 Output 0 Loudspeaker w Fuse x On/Off →O← BP Zero All h NIBP Start/Stop F Print Start/Stop y Date of Manufacture B Alarm Silence REF Catalog Number SN Serial Number IPX1 Drip Proof 1 Non AP Device X AC Power LED M Low Battery LED 1-4 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. 1-5 Chapter 1: Introduction EXAMPLE OF THE PATIENT ENVIRONMENT. THE DIMENSIONS ARE NOT PRESCRIPTIVE. 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. 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: 1-6
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