Spectrum Operating Instructions Rev L Oct 2010

Operating Instructions

Abbott® is a U.S. registered trademark of Abbott Laboratories. CapnoLine™ is a trademark of Oridion Medical Ltd. DRYLINE™ is a trademark of Artema Medical AB Durasensor® is a U.S. registered trademark of Nellcor Puritan Bennett Inc. Edwards® is a U.S. registered trademark of Edwards Lifesciences Corporation. FilterLine® is a U.S. registered trademark of Oridion Medical Ltd. LNCS® is a U.S. registered trademark of Masimo Corp. LNOP® is a U.S. registered trademark of Masimo Corp. Masimo SET® is a U.S. registered trademark of Masimo Corp. Max-Fast® is a U.S. registered trademark of Nellcor Puritan Bennett Inc. MediCO2® is a registered trademark of Oridion Medical Ltd. Microstream® is a U.S. registered trademark of Oridion Medical Ltd. Navigator™ is a U.S. trademark of Mindray DS USA Nellcor® is U.S. registered trademark of Nellcor Puritan Bennett Inc. NIV Line™ is a trademark of Oridion Medical Ltd. Oxiband® is a U.S. registered trademark of Nellcor Puritan Bennett Inc. OxiMax® is a US registered trademark of Nellcor Puritan Bennett Inc. Oxisensor® is a U.S. registered trademark of Nellcor Puritan Bennett Inc. Oxismart® is a U.S. registered trademark of Nellcor Puritan Bennett Inc. Panorama™ is a U.S. trademark of Mindray DS USA PatientNet® is a U.S. registered trademark of GE Medical Systems Information Technologies. Spectrum® is a U.S. registered trademark of Mindray DS USA Velcro® is a registered trademark of Velcro Industries B.V. View 12™ is a U.S. trademark of Mindray DS USA Vigilance® is a US registered trademark of Edwards Lifesciences Corporation.

Copyright © Mindray DS USA, 2003. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA.

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Spectrum® Operating Instructions

Table of Contents

Foreword ... v Warnings, Precautions and Notes... v Warnings ... vi Precautions ... x Notes ... xiv Indication For Use ... xiv Unpacking ... xv Symbols and Descriptions ... xvi

General Product Description... 1 - 1 General Product Description...1 - 2 Key Features ...1 - 3 Keys and Front Panel...1 - 4 Display ...1 - 9 Rear View ...1 - 11 Left Side Panel ...1 - 12 Right Side Panel ...1 - 14 Gas Module (Optional) ...1 - 16 Front Panel ...1 - 16 Rear Panel ...1 - 17 Comm-Ports ...1 - 18 External Parameter Modules (Optional)...1 - 20 External Parameter Module Top View...1 - 21 External Parameter Module Front View ...1 - 22 Left Side View with External Parameter Module ...1 - 23 Rear View with External Parameter Module...1 - 25

Operations ... 2 - 1 Getting Started ...2 - 1 Installation Mode ...2 - 3 Installation Menu ...2 - 3 System Information Menu...2 - 6 Main Menus...2 - 8 Patient Menu...2 - 8 Monitor Setup Menu ...2 - 10 Print Setup Menu ...2 - 13 Parameters Menu...2 - 14 Functions Menu ...2 - 15 Remote View ...2 - 16 Parameter Menus and Monitoring ...2 - 22 ECG Monitoring ...2 - 22 ECG Menu ...2 - 22 Skin Preparation ...2 - 25 Electrode Patch Location ...2 - 25 Lead Placement ...2 - 27 Arrhythmia Algorithm ...2 - 34 Arrhythmia Alarms ...2 - 36 Arrhythmia Analysis (Optional) ...2 - 40 ST Analysis (Optional) ...2 - 42 Relearning ST or Arrhythmia Analysis ...2 - 44 12-lead ECG (Optional) ...2 - 45 ECG Troubleshooting ...2 - 46 Non-Invasive Blood Pressure Measurements (NIBP) ...2 - 48 Manual NIBP Measurements ...2 - 48

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Table of Contents

Automatic Interval NIBP Measurements ...2 - 50 NIBP Troubleshooting ...2 - 53 SpO2 Pulse Oximetry ...2 - 55

Masimo SET® SpO2 ...2 - 57

Nellcor® SpO2 ...2 - 57

SpO2 Troubleshooting and SpO2 Menu Performance Considerations ...2 - 58 Temperature Menu...2 - 60 Temperature Troubleshooting ...2 - 61 Respiration Menu ...2 - 61 Thoracic Impedance ...2 - 61 Microstream® CO2 Monitoring (Optional) ...2 - 62

Microstream® CO2 Menu ...2 - 63 Respiration and CO2 Troubleshooting ...2 - 64

Gas Monitoring with Gas Module ...2 - 66 Gas Module 3 Pre-use Test ...2 - 68 Gas Monitor Calibration ...2 - 69 Gas Module Troubleshooting ...2 - 72 IBP - Invasive Blood Pressure Menu (Optional) ...2 - 75 Measuring IBP ...2 - 76 IBP Troubleshooting ...2 - 77 Pulmonary Artery Wedge Pressure (PAWP)...2 - 78 Measuring PAWP ...2 - 78 PAWP Troubleshooting ...2 - 79 Cardiac Output (CO) (Optional)...2 - 80 External Parameter Module (EPM) ...2 - 80 Edwards Vigilance® Monitor (Vigilance) ...2 - 86 CO from both Vigilance and EPM ...2 - 89 Calculations ...2 - 90 Drug Calculations ...2 - 90 Hemodynamic Calculations ...2 - 95 Alarms...2 - 96 Adjusting Alarms ...2 - 96 Alarm Limits ...2 - 97 Alarm Troubleshooting ...2 - 101 Trends ...2 - 102 List Trends...2 - 102 Graph Trends...2 - 105 OxyCRG Trends ...2 - 107 Trends Troubleshooting...2 - 108 Printing (Optional) ...2 - 109 Internal Recorder (Optional)...2 - 109 Printing 12-lead to the Laser Printer ...2 - 116 Printer / Recorder Troubleshooting ...2 - 116 Connection to PatientNet® Central Station ...2 - 117 Connection to Panorama™ Central Station ...2 - 118 Connection to Panorama™ Gateway ...2 - 119 Monitor/Display Troubleshooting...2 - 120

User Maintenance ... 3 - 1 Introduction ...3 - 1 Care and Cleaning of Monitor ...3 - 1 Decontamination of Monitor ...3 - 2 Care and Cleaning of SpO2 Sensors...3 - 2

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Spectrum® Operating Instructions

Table of Contents

Sterilization and Cleaning of Reusable Bladderless Cuffs ...3 - 3 Battery Replacement and Maintenance ...3 - 3 Battery Replacement ...3 - 3 Battery Maintenance ...3 - 3 Recorder Paper Replacement...3 - 4 Care and Storage of Thermal Chart Paper ...3 - 4 Care and Cleaning of Gas Module ...3 - 5 Gas Module II and Gas Module SE ...3 - 5 Gas Module 3 ...3 - 6 Care and Cleaning of 3 and 5-lead ECG Cables and Leadwires ...3 - 7 Care and Cleaning of View 12™ ECG Analysis Module...3 - 7

Accessories ... 4 - 1 Optional Accessories ...4 - 1 NIBP Accessories...4 - 1 Oximetry Sensors and Accessories...4 - 2 Pulse Oximetry-Masimo SET® LNOP® SpO2 ...4 - 2

Pulse Oximetry-Masimo Set® LNCS® SpO2 ...4 - 3

Pulse Oximetry-Nellcor® OxiMax® SpO2* ...4 - 4

Oridion CO2 Accessories ...4 - 4 Gas Module Accessories ...4 - 5 Gas Module II and Gas Module SE ...4 - 5 Gas Module 3 ...4 - 5 Reusable Temperature Probes...4 - 6 Disposable Temperature Probes...4 - 6 ECG Accessories ...4 - 7 ECG Cables ...4 - 7 ECG Leadwires ...4 - 7 12 Lead ECG Accessories ...4 - 8 Electrodes ...4 - 9 IBP Accessories ...4 - 9 Comm-Port Accessories ...4 - 9 Base Station Accessories ...4 - 10 Miscellaneous Accessories...4 - 11 Mounting Kits and Accessories ...4 - 11 Upgrade Kits...4 - 12 Central Station Accessories...4 - 13 External Parameter Module Accessories ...4 - 13

Appendix ... 5 - 1 Safety Designations...5 - 1 Safety designations per IEC 60601-1 Standard...5 - 1 Patient Parameter Specifications ...5 - 3 ECG ...5 - 3 ECG Respiration Performance Requirements...5 - 7 NIBP Performance and Functional Characteristics ...5 - 7 IBP Performance Characteristics...5 - 10 Temperature Parameter Performance Characteristics ...5 - 12 SpO2 Performance Requirements...5 - 13 Masimo SET SpO2 Performance Requirements ...5 - 13 Nellcor SpO2 Performance Requirements ...5 - 15 CO2 Performance Characteristics ...5 - 15 MediCO2 Microstream® (Only in monitors with serial numbers below MS05000.) ...5 - 15

MiniMediCO2 Microstream® (Only in monitors with serial number MS05000 and higher.) ...5 - 17

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Table of Contents

Cardiac Output ...5 - 19 Special Functions ...5 - 20 ST Segment Analysis Performance Requirements ...5 - 20 Arrhythmia Analysis ...5 - 21 ECG Interpretation...5 - 22 Calculations...5 - 22 Hemodynamic Calculations ...5 - 22 Information Display and Control ...5 - 25 Input/Output Communications ...5 - 27 Communication Protocols...5 - 28 Power Supply ...5 - 30 Battery Power...5 - 30 Sealed Lead Acid (P/N0146-00-0043) ...5 - 30 Lithium-Ion Battery (P/N 0146-00-0069) ...5 - 31 Data Storage...5 - 32 Printing...5 - 33 Monitor Physical Characteristics ...5 - 34 Comm-Port Physical Characteristics ...5 - 36 External Parameter Module Physical Characteristics ...5 - 37 Environmental and Safety Characteristics ...5 - 38 Spectrum ...5 - 38 Gas Module 3 ...5 - 39 Agency Compliance...5 - 40 Spectrum ...5 - 40 Gas Module II and Gas Module SE ...5 - 40 Gas Module 3 ...5 - 41 Electromagnetic Capability ...5 - 41 Spectrum ...5 - 41 Gas Module SE and Gas Module 3 ...5 - 45 Warranty Statements ...5 - 49 Phone Numbers and How To Get Assistance...5 - 51 Mindray’s Responsibility ...5 - 51

Glossary... 6 - 1 Glossary of Terms ...6 - 1

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Spectrum® Operating Instructions

Foreword

Introduction

Foreword The Spectrum Operating Instructions are intended to provide information for proper operation. General knowledge of monitoring and an understanding of the features and functions of the Mindray Spectrum Monitor are prerequisites for its proper use. NOTE:

Do not operate this monitor before reading these instructions.

Information for servicing this instrument is contained in the Spectrum Monitor Service Manual, part number 0070-00-0556-02. For additional information or assistance, please contact an authorized Mindray representative in your area. CAUTION:

U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device.

NOTE:

Figures in this manual are provided for reference purposes only. Screens will likely differ based on the monitoring device configuration, licenses available, parameters selected and patient configuration of the Spectrum Monitor.

Patents: This device is covered under one or more of the following U.S. Patents 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, 5,482,036, 5,490,505, 5,632,272, 5,685,299, 5,758,644, 5,769,785, 6,002,952, 6,036,642, 6,067,462, 6,157,850, 6,206,830, 6,247,674, 6,377,845, 4,802,486, 4,960,126, 5,485,847, 5,743,263, 5,865,736, 6,035,223, 6,298,252, 6,463,310, 6,591,123, 6,675,031, 6,708,049, 6,801,797, 6,589,028, 6,896,713, Re.35,122 and foreign equivalents. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

Warnings, Precautions and Notes Please read and adhere to all warnings, precautions and notes listed here and in the appropriate areas throughout this manual. A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user. A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects. A NOTE is provided when additional general information is applicable.

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Introduction

Warnings

Warnings WARNING: Internal Electrical Shock Hazard - This unit does not contain any user-serviceable parts. Do not remove instrument covers. Refer Servicing to qualified personnel. WARNING: Trace Gas Hazard - When using the optional Gas Module, a health hazard exists when trace amounts of vaporized anesthetic agents are chronically inspired by operating room personnel. See Appendix A in NFPA 56A on Inhalation Anesthetics. During any procedure where such agents are employed, the Gas Module exhaust output should be connected to a medical gas-scavenging system. WARNING: Do not use this monitor during MRI (Magnetic Resonance Imaging) scanning. Induced current could potentially cause burns. Accuracy of measurements on this unit and the MRI unit may also be affected. WARNING: For continued protection against a fire hazard, replace all fuses with the specified type and rating. WARNING: This unit uses a common isolation path for the ECG leads and the Invasive Pressure Channels. Ensure that conductive parts of the ECG electrodes do not contact other conductive parts including earth ground. Do not connect any nonisolated accessories to the Spectrum or to the ECG or invasive pressure channel inputs when connected to a patient. Insure that the total chassis leakage currents of all connected units does not exceed 300µA. Use an IEC 60601-1 approved isolation / separation transformer if required. Do not simultaneously touch the patient and any piece of electrical equipment if any cover has been removed from the equipment. WARNING: The AC line cord and interface cables (i.e. non-patient cables) may utilize the same ground. Therefore, removal of the AC line cord does not necessarily isolate the Spectrum, if non-patient interface cables are attached. WARNING: Observe extreme caution when a defibrillator is used on a patient. Do not touch any part of patient, table, or monitor when a defibrillator is in use. WARNING: Do not incinerate battery, possible explosion may occur. WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e. Multiple outlet extension cords) used with the Spectrum or its accessories on the floor. Connect only Spectrum accessories to the same MPSO as the Spectrum. Do not overload the MPSO. WARNING: Do not connect other equipment to the same MPSO with the Spectrum, as it may increase system leakage current. WARNING: Reliably attach Potential Equalization connector to the safety ground when interconnecting Spectrum with other medical or non-medical electrical equipment to minimize the risk of excessive leakage current and/or shock hazard. WARNING: Do not reuse disposable devices.

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Warnings

Introduction

WARNING: Compressed gasses are considered Dangerous Goods/ Hazardous Materials per I.A.T.A. And D.O.T. regulations. It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled and documented according to D.O.T. and I.A.T.A. regulations. Please refer to the applicable I.A.T.A. Dangerous Goods Regulations and/or the Code of Federal Regulations 49 (Transportation, Parts 171-180) for further information. WARNING: Route cables neatly. Ensure cables, hoses and wires are kept away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce risk to hospital personnel, patients and visitors. WARNING: Do not use a damaged or broken unit or accessory. WARNING: Inaccurate Cardiac Output measurements may be caused by: •

Incorrect placement or position of the catheter

•

Excessive variation in pulmonary artery blood temperature

•

Clot formation on the thermistor

•

Anatomical abnormalities, (for example, cardiac shunts)

•

Excessive patient movement

•

Repeated intermittent flushes of cold fluid through the fluid lumens of the catheter

•

Use of a manual pump such as the Abbott® Blood Set with Pump and CAIR clamp

•

Electrocautery or electrosurgical unit interference

•

Rapid changes in cardiac output

•

Using an incorrect computation constant

WARNING: Ensure that the conductive parts of ECG electrodes do not contact other conductive parts, including earth ground. 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 the Appendix section of this manual for disclosure of the pacemaker pulse rejection capability of this instrument. WARNING: Due to physiologic differences in the patient population, the Spectrum may occasionally not alarm or may sound a false alarm for some arrhythmia patterns. The arrhythmia analysis feature is intended to detect ventricular rhythms only. High-risk patients should be kept under close surveillance. WARNING: The View 12™ ECG Analysis Module is not intended for use during electrosurgery. If the electrosurgical ground connection is not satisfactory, there exists a possibility of patient burns at the ECG electrode sites. WARNING: Computerized ECG Analysis should be reviewed by qualified medical personnel. It should not be used exclusively for treatment or non-treatment of patients.

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Introduction

Warnings

WARNING: ST segment measurements may be affected by one or more of the following ECG rhythm morphologies: wide complex QRS such as bundle branch blocks, ventricular pacemaker rhythm, left ventricular hypertrophy or Wolff-ParkinsonWhite Syndrome. Consult with qualified medical personnel prior to treatment or non-treatment. WARNING: When monitoring CO2 with a Spectrum, the maximum sampling rate at the nasal cannula is 58 ml/min. This device should not be used on patients whose breathing could be impaired by this vacuum flow rate. WARNING: When monitoring CO2, connection from the exhaust port of the Spectrum to the hospital’s waste gas scavenging system is recommended to prevent exposure of hospital personnel to the patient’s respiratory sample. WARNING: When using the Gas Module, the maximum sampling rate at the nasal cannula is 200 ml/min (120 ml/min for Gas Module 3 with a neonatal water trap). This device should not be used on patients whose breathing could be impaired by this vacuum flow rate. WARNING: Connection of the Gas Module exhaust port to the hospital’s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the patient’s respiratory sample. Vacuum (negative pressure) should not exceed 1 mmHg at the Gas Module Pump Exhaust fitting. Excessive scavenge vacuum may result in damage to the Gas Modules internal pump. WARNING: Do not clean the monitor while it is on and/or plugged in. WARNING: Operation of the Spectrum below the minimum amplitude or value of PATIENT physiological signal may cause inaccurate results. WARNING: Use of ACCESSORIES, transducers and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Spectrum. It can also cause delayed recovery after the discharge of a cardiac defibrillator. WARNING: The use of gas sampling accessories in Gas Module 3 other than specified by Mindray may cause significant measurement errors and patient risk. WARNING: Use of accessories, transducers and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Gas Module 3. WARNING: With the exception of stacking on a Gas Module with the appropriate mounting brackets, the Spectrum should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Spectrum should be observed to verify normal operation in the configuration in which it will be used.

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Warnings

Introduction

WARNING: With the exception of stacking under a Spectrum with the appropriate mounting brackets, the Gas Module 3 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Gas Module 3 should be observed to verify normal operation in the configuration in which it will be used. WARNING: The arrhythmia analysis feature is intended to detect ventricular rhythms, however, due to physiologic differences in patient populations, the Spectrum may occasionally sound a false alarm or may not recognize some arrhythmia patterns. WARNING: Ensure that the ECG lead wires are neatly secured in a manner that will prevent them from encircling the patient’s neck, creating a strangulation hazard. WARNING: Perform the decontamination process with the unit powered down and power cord removed. WARNING: If the water trap breaks or becomes damaged during operation, there is a risk that bacteria and/or mucus may contaminate the Gas Module. WARNING: Do not use Adult/Pediatric type water traps and/or sampling lines with neonates to avoid high sampling flow. WARNING: The Gas Module must not be used with flammable anesthetic agents. WARNING: The Gas Module water trap, sampling line and airway adapter should be disposed of in accordance with local regulations for contaminated and biologically hazardous items. WARNING: Do not clean the Gas Module while it is on and/or plugged in. WARNING: Connect only DRYLINE™ gas sampling lines to the water trap. Note that there may be other compatible tubes present that must not be used, e.g. IV lines. WARNING: Do not use DRYLINE™ Neonatal sampling lines (blue Luer lock nuts) with DRYLINE™ Adult/Pediatric water traps as this could result in incorrect measurement data. WARNING: Do not use DRYLINE™ Adult/Pediatric sampling lines (colorless Luer lock nuts) with DRYLINE™ Neonatal water traps as this could result in incorrect measurement data. WARNING: The contents of the water trap should be handled as a potential infection hazard. WARNING: Do not use other cleaning methods for the DRYLINE™ water traps. Do not clean or wash the filter housing of the water trap. Never allow alcohol to enter the filter housing. Never force air through the water trap.

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Introduction

Precautions

Precautions

x

CAUTION:

Always place the monitor on a rigid, flat surface or on approved mounts. Do not block ventilation or speaker vents.

CAUTION:

Never place fluids on top of this monitor. In case of accidental spillage, wipe clean immediately and have the monitor serviced to ensure no hazard exists.

CAUTION:

This unit must only be operated with Mindray approved software.

CAUTION:

To avoid possible damage to the Spectrum, use only ECG cables and accessories available from Mindray.

CAUTION:

Operation of the Spectrum below the minimum amplitude or value of patient physiological signal may cause inaccurate results.

CAUTION:

Use of accessories, transducers and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Spectrum. It can also cause delayed recovery after the discharge of a cardiac defibrillator.

CAUTION:

Dispose of single use items in accordance with hospital policy.

CAUTION:

To prevent condensation, allow the Spectrum to warm up and dry if it is moved from a cold area to a warm one.

CAUTION:

The Spectrum may not meet its performance specifications if stored or operated outside of specified temperature and humidity ranges.

CAUTION:

Prior to use, be sure the rail supporting the bed rail mounting hook can support the weight of the monitor. Consult the bed manufacturer’s specifications if necessary. Mindray cannot be responsible for injury or damage resulting from improper or inadequate support of the monitor.

CAUTION:

Use recommended Mindray supplied power cords. If a substitute is necessary use only hospital grade power cords.

CAUTION:

Sudden changes in PA blood temperature such as those caused by patient movement or bolus drug administration may cause a CO or CI value to be computed. To avoid falsely triggered curves, you should inject as soon as possible after the INJECT message appears.

CAUTION:

Line Isolation Monitor transients may resemble actual cardiac waveforms, thus inhibiting heart rate alarms. Check lead wires for damage and ensure good skin contact prior to and during use. Always use fresh electrodes and follow proper skin preparation techniques.

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Spectrum® Operating Instructions

Precautions

Introduction

CAUTION:

To assure successful triggering of a Mindray Intra-Aortic balloon pump from the Spectrum monitor, set the “ECG Filter” to “Extended” and set “Pacer Enhancement” to “On”. Both of these settings are located in the ECG setup menu of the Spectrum.

CAUTION:

The Analog Output on the Spectrum supports triggering the Intra-Aortic Balloon Pump (IABP) for 3 Lead and 5 Lead ECG cable monitoring only. Invasive Blood Pressure triggering is not supported. ECG analog output is disabled when 12 Lead ECG analysis is enabled.

CAUTION:

Removal of the View 12™ ECG Analysis Module without first disabling the 12-lead ECG card may cause a temporary disruption in patient monitoring.

CAUTION:

Cuffs must be used with the correct Mindray hoses.

CAUTION:

Please consult a physician for interpretation of blood pressure measurements.

CAUTION:

A blood pressure measurement can be affected by the position of the patient, and his / her physiological condition as well as other factors, such as patient movement.

CAUTION:

Observe caution on all patients (Neonates, Pediatrics, and Adults) when NIBP is set to the Continuous Mode and the 1 minute interval. When the NIBP continuous interval is selected, the Spectrum will continually take back to back blood pressure readings. As a safety precaution, a limit is placed on continuous and 1 minute interval measurements. In continuous mode, after 5 minutes, the NIBP interval will automatically switch to one measurement taken every 5 minutes. In 1 minute mode, after 10 minutes the NIBP interval automatically switches to measurements taken once every 10 minutes. Reports have been made of nerve injury occurring during use of automatically cycled blood pressure cuffs.

CAUTION:

Tissue damage or inaccurate measurements may be caused by incorrect sensor application or use, such as wrapping too tightly, applying supplemental tape, failing to inspect the sensor site periodically, or failing to position appropriately. Carefully read the sensor directions for use, the Spectrum Operating Instructions, and all precautionary information before use.

CAUTION:

Inaccurate SpO2 measurements may be caused by:

Spectrum® Operating Instructions

•

Incorrect sensor application or use

•

Significant levels of dysfunctional hemoglobins, (e.g., carboxyhemoglobin or methemoglobin)

•

Intra-vascular 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 excessive ambient light. In such cases, cover the sensor site with opaque material.

•

Excessive patient movement

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Introduction

xii

Precautions

•

Venous pulsations

•

Electro-surgical interference

•

Placement of a sensor on an extremity that has a blood pressure cuff, arterial catheter, or intra-vascular line.

•

Nail polish or fungus

CAUTION:

In certain situations in which perfusion and signal strength are low, such as in patients with thick or pigmented skin, inaccurately low SpO2 readings will result. Verification of oxygenation should be made, especially in preterm infants and patients with chronic lung disease, before instituting any therapy or intervention.

CAUTION:

Many patients suffer from poor peripheral perfusion due to hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings.

CAUTION:

The SpO2 sensor site should be checked at least every eight (8) hours (every four (4) hours with the Adult re-usable finger sensor). Ensure proper adhesion, skin integrity, and proper alignment. Exercise extreme caution with poorly perfused patients. Skin erosion and pressure necrosis can be caused when sensors are not frequently monitored. Assess the site every two (2) hours with poorly perfused patients and neonates.

CAUTION:

When equipped with Masimo SET® SpO2, use only Masimo SET Oxygen Transducers including Masimo SET LNOP® and LNCS™ Patient Dedicated Adhesive, Sensors and Masimo SET PC Series Patient Cables. Use of other oxygen transducers may cause improper oximeter performance.

CAUTION:

When equipped with Nellcor® SpO2, use only Nellcor oxygen transducers including Nellcor Oxisensor® and OxiMax® patient dedicated adhesive sensors. Use of other oxygen transducers may cause improper oximeter performance.

CAUTION:

Vacuum (negative pressure) should not exceed 1 mmHg at the Spectrum Pump Exhaust fitting. Excessive scavenge vacuum may result in an Occlusion message or damage to the Spectrum’s internal pump. The scavenging system must be on during calibration.

CAUTION:

Microstream® CO2 waste and CO2 FilterLine® should be treated as biohazardous waste.

CAUTION:

When cleaning sensors, do not use excessive amounts of liquid. Wipe the sensor surface with a soft cloth, dampened with cleaning solution. Do not attempt to sterilize.

CAUTION:

The internal sampling system of the Gas Module does not need to be cleaned or sterilized. There is no reverse flow back to the patient. If the internal sampling system is suspected to be clogged or dirty, the module should be serviced by an authorized service person only.

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Spectrum® Operating Instructions

Precautions

Introduction

CAUTION:

If the dust filter for the fan cannot be cleaned or is damaged, replace it with part number 0378-00-0040. Use of another type of filter may decrease the cooling effectivity and cause damage to the Gas Module.

CAUTION:

To avoid permanent damage, do not expose metal components (pins, sockets, snaps) to disinfectants, soaps or chemicals.

CAUTION:

Only connect NIBP Luer fittings to Blood Pressure Cuff or Monitor.

CAUTION:

Sudden changes in blood temperature such as those caused by bolus drug administration may cause a CO or CI value to be computed. To avoid falsely triggered curves, inject as soon as possible after the “Inject when Ready” message is displayed.

CAUTION:

Some pacemakers may contain a respiratory sensor that may produce artifact on an ECG waveform.

CAUTION:

During the decontamination process, do not get the LpH SE Germicidal detergent into any vent openings.

CAUTION:

The monitor display provides data and waveform information over its entire area. Do not cover any part of the monitor display with tape or labels.

CAUTION:

The 2.4 GHz radio optionally used in this device must be at least 20 cm away from the user and/or patient during normal operating conditions.

CAUTION:

Replace sealed lead acid batteries with Mindray P/N 014600-0043 ONLY. Replace lithium-ion batteries with Mindray P/N 0146-00-0069 ONLY.

CAUTION:

Gas Module 3 must be moisture protected whenever transported. This can be done with a protective plastic bag in which water-absorbing materials (e.g. silica gel) have been included.

CAUTION:

Contamination with CO2, N2O or Anesthetic Agent in the air surrounding the Gas Module 3 may cause significant measurement errors.

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Introduction

Notes

Notes NOTE:

This unit is not designed to be used with a peripheral pulse sensor. SpO2 is a standard function in this monitor, and may be used to obtain a plethysmograph waveform and heart rate.

NOTE:

The comparison testing conducted via the auscultatory method used both Phase 4 and Phase 5 Korotkoff sounds. Reports of study findings for both the auscultatory method as well as the intra-arterial methods are available by contacting Mindray Technical Support (800) 288-2121, ext. 8116 or (201) 995-8237.

NOTE:

Potential hazards due to errors in software or hardware have been minimized by actions taken in accordance with IEC 60601-1-4.

Indication For Use The Spectrum Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum Monitor include the monitoring of the following human physiological parameters: • ECG waveform derived from 3, 5 or 12 lead measurements • Heart Rate derived from selected sources (ECG, SpO2, IBP, NIBP) • Pulse Oximetry (SpO2) • ST Segment Analysis derived from 3, 5 or12 ECG lead measurements • Arrhythmia Detection derived from 3, 5 or 12 ECG lead measurements • Interpretation of Resting 12 lead ECG • Non Invasive Blood Pressure (NIBP) • Invasive Blood Pressure (IBP) - up to four (4) channels • Cardiac Output • Respiration Rate/waveform derived from ECG or CO2 • CO2, inspired and end tidal microstream/waveform • Temperature - up to two (2) channels • Hemodynamic Calculations • IV Drug Calculations The target populations are adult, pediatric and neonate with the exception of: • Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, and Pulmonary Artery Wedge Pressure measurements for which the target populations are adult and pediatric only, and • Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only. The Spectrum Monitor has the capability of interfacing with Mindray's Intra Aortic Balloon Pumps, Central Stations, and Gas Module products.

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Unpacking

Introduction

Unpacking Remove the instrument from the shipping carton and examine it for signs of shipping damage. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact the Mindray Service Department at (800) 288-2121 or (201) 995-8237 for prompt assistance in resolving shipping problems.

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Introduction

Symbols and Descriptions

Symbols and Descriptions SYMBOL DESCRIPTION

xvi

SYMBOL

DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Type B Equipment

Dangerous Voltage

Type BF Equipment

Equipotentiality

Defibrillator Proof Type BF Equipment

Alternating Current (AC)

Defibrillator Proof Type CF Equipment

Direct Current (DC)

Alarm Off Icon

On (only for a part of the equipment)

Alarm Mute Icon

OFF (only for a part of the equipment)

Earth (Ground)

Data Input

Protective Earth (Ground)

Data Output

Battery Charging

Data Input / Output

Full Battery

Gas Port Input

Low Battery

Gas Port Output

No Battery Present

NIBP Connection

IABP

Analog ECG and IBP output for communication to an Intra-Aortic Balloon Pump

Latex-free product

DEFIB

Analog ECG out and Sync Pulse for connection to a Defibrillator

Crossed out wheelie bin indicates separate treatment from general waste at end of life

Interference may occur in the vicinity of equipment marked with this symbol

For single-patient use only, do not reuse.

Manufacturer’s reference/catalogue number

0070-10-0648-02

Spectrum® Operating Instructions

Symbols and Descriptions

Spectrum® Operating Instructions

Introduction

For Neonatal use

Manufacturer’s batch number

Not for Neonatal use

Serial number

Conformité Européenne (CE) Marking of Conformity to European Medical Device Directive. CEXXXX represents the Notified Body number

Software Version

0070-10-0648-02

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