Spectrum OR Patient Monitor Operating Instructions Rev J Aug 2010

Table of Contents

Foreword ... v Warnings, Precautions and Notes... v Warnings ... vi Precautions ... xi Notes ... xv Intended Use ... xv Unpacking ... xvi Symbols and Descriptions ... xvii

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 - 11 Print Setup Menu ...2 - 14 Parameters Menu...2 - 15 Functions Menu ...2 - 16 Remote View ...2 - 17 Parameter Menus and Monitoring ...2 - 23 ECG Monitoring ...2 - 23 ECG Menu ...2 - 23 Skin Preparation ...2 - 27 Electrode Patch Location ...2 - 27 Lead Placement ...2 - 29 Arrhythmia Algorithm ...2 - 35 Arrhythmia Alarms ...2 - 37 Arrhythmia Analysis (Optional) ...2 - 41 ST Analysis (Optional) ...2 - 43 Relearning ST or Arrhythmia Analysis ...2 - 45 ECG Troubleshooting ...2 - 45 Non-Invasive Blood Pressure Measurements (NIBP) ...2 - 48 Manual NIBP Measurements ...2 - 48 Automatic Interval NIBP Measurements ...2 - 50

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Table of Contents

NIBP List Tile ...2 - 54 NIBP Troubleshooting ...2 - 54 SpO2 Pulse Oximetry ...2 - 56

Masimo SET® SpO2 ...2 - 58

Nellcor® SpO2 ...2 - 58

SpO2 Troubleshooting and SpO2 Menu Performance Considerations ...2 - 59 Temperature Menu...2 - 61 Temperature Troubleshooting ...2 - 62 Respiration Menu ...2 - 62 Thoracic Impedance ...2 - 62 Microstream® CO2 Monitoring (Optional) ...2 - 63

Microstream® CO2 Menu ...2 - 64 Respiration and CO2 Troubleshooting ...2 - 65

Gas Monitoring with Gas Module ...2 - 67 Gas Menu ...2 - 68 Gas Module 3 Pre-use Test ...2 - 72 Gas Monitor Calibration ...2 - 72 Gas Module Troubleshooting ...2 - 76 Spirometry (Optional)...2 - 79 Spirometry Setup ...2 - 79 Spirometry Monitoring ...2 - 82 Review Loops Menu ...2 - 84 Spirometry Setup Menu ...2 - 86 Paw Menu ...2 - 89 Flow Menu ...2 - 90 Spirometry Troubleshooting...2 - 91 IBP - Invasive Blood Pressure Menu (Optional) ...2 - 93 Measuring IBP ...2 - 94 IBP Troubleshooting ...2 - 95 Pulmonary Artery Wedge Pressure (PAWP)...2 - 96 Measuring PAWP ...2 - 96 PAWP Troubleshooting ...2 - 97 Cardiac Output (CO) (Optional)...2 - 98 External Parameter Module (EPM) (Optional) ...2 - 98 Edwards Vigilance® Monitor (Vigilance) (Optional) ...2 - 104 CO from both Vigilance and EPM ...2 - 107 Bispectral Index (BIS) ...2 - 108 BIS Setup ...2 - 110 BIS Measurement ...2 - 115 BIS Trend Setup Menu ...2 - 117 BIS Troubleshooting ...2 - 118 Time ...2 - 120 Calculations ...2 - 121 Drug Calculations ...2 - 121 Hemodynamic Calculations ...2 - 126 Alarms...2 - 127 Adjusting Alarms ...2 - 127 Alarm Limits ...2 - 128 Alarm Troubleshooting ...2 - 133 Trends ...2 - 134 Quick Trends ...2 - 134 List Trends...2 - 135

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Graph Trends...2 - 138 Trends Troubleshooting...2 - 140 Printing (Optional) ...2 - 141 Internal Recorder (Optional)...2 - 141 Printer / Recorder Troubleshooting ...2 - 145 Connection to Panorama® Central Station ...2 - 146 Connection to Viewstation OR™ Independent Display ...2 - 146 Connection to Panorama® Gateway ...2 - 147 Monitor/Display Troubleshooting...2 - 148

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 Sterilization and Cleaning of Reusable Cuffs ...3 - 3 Reusable Cuffs with Bladders ...3 - 3 Reusable Bladderless Cuffs ...3 - 4 Battery Replacement and Maintenance ...3 - 5 Recorder Paper Replacement...3 - 6 Care and Storage of Thermal Chart Paper ...3 - 6 Care and Cleaning of Gas Module ...3 - 7 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry ...3 - 7 Gas Module 3 ...3 - 8 Care and Cleaning of 3 and 5-lead ECG Cables and Leadwires ...3 - 9

Accessories ... 4 - 1 Optional Accessories ...4 - 1 NIBP Accessories...4 - 1 Oximetry Sensors and Accessories...4 - 3 Pulse Oximetry-Masimo SET® LNOP® SpO2 ...4 - 3

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

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

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

Appendix ... 5 - 1 Safety Designations...5 - 1 Safety designations per IEC 60601-1 Standard...5 - 1

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Table of Contents

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

Cardiac Output ...5 - 19 Special Functions ...5 - 20 ST Segment Analysis Performance Requirements ...5 - 20 Arrhythmia Analysis ...5 - 21 Calculations...5 - 21 Hemodynamic Calculations ...5 - 22 BIS Parameters ...5 - 24 Information Display and Control ...5 - 25 Input/Output Communications ...5 - 27 Communication Protocols...5 - 28 Power Supply ...5 - 29 Battery Power...5 - 29 Sealed Lead Acid (P/N 0146-00-0043) ...5 - 29 Lithium-Ion Battery (P/N 0146-00-0069) ...5 - 30 Data Storage...5 - 31 Printing...5 - 32 Monitor Physical Characteristics ...5 - 33 Comm-Port Physical Characteristics ...5 - 35 External Parameter Module Physical Characteristics ...5 - 36 Environmental and Safety Characteristics ...5 - 37 Spectrum OR ...5 - 37 Gas Module 3 ...5 - 38 Agency Compliance...5 - 39 Spectrum OR ...5 - 39 Gas Module II, Gas Module SE and Gas Module SE with Spirometry ...5 - 39 Gas Module 3 ...5 - 40 Electromagnetic Capability ...5 - 40 Spectrum OR ...5 - 40 Gas Module SE, Gas Module SE with Spirometry, and Gas Module 3 ...5 - 44 Warranty Statements ...5 - 49 Phone Numbers and How To Get Assistance...5 - 51 Manufacturer’s Responsibility ...5 - 51

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

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Spectrum OR™ Operating Instructions

Foreword

Introduction

Foreword The Spectrum OR Operating Instructions are intended to provide information for proper operation. General knowledge of monitoring and an understanding of the features and functions of the Spectrum OR 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 service 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 OR 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, 4,907,597, 5,010,891, 5,320,109, 5,368,041, 5,381,804, 5,458,117, 5,792,069, 6,298,255, 6,985,837, 6,882,166, 5,813,404, 6,032,072, 6,236,874, 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.

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Introduction

Warnings

A NOTE is provided when additional general information is applicable.

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 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 OR, 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: To ensure that alarms can sound if the Gas Module/ Spectrum OR lose power, charged batteries must be installed in the Spectrum OR at all times. WARNING: Do not put MPSO (Multiple Portable Socket Outlets i.e. Multiple outlet extension cords) used with the Spectrum OR or its accessories on the floor. Connect only Spectrum OR accessories to the same MPSO as the Spectrum OR. Do not overload the MPSO. WARNING: Do not connect other equipment to the same MPSO with the Spectrum OR, as it may increase system leakage current.

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Warnings

Introduction

WARNING: Reliably attach Potential Equalization connector to the safety ground when interconnecting Spectrum OR 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. 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 OR 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.

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Introduction

Warnings

WARNING: When monitoring CO2 with a Spectrum OR, 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 OR 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 OR 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 OR. 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 those specified 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 OR should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Spectrum OR should be observed to verify normal operation in the configuration in which it will be used. WARNING: With the exception of stacking under a Spectrum OR 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.

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Warnings

Introduction

WARNING: The arrhythmia analysis feature is intended to detect ventricular rhythms, however, due to physiologic differences in patient populations, the Spectrum OR 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: The conductive parts of BIS electrodes or sensor and connectors, including the neutral electrode, should not contact other conductive parts, including earth. WARNING: To reduce the hazard of burns in the high-frequency surgical neutral electrode connection, the BIS sensor or electrodes should not be located between the surgical site and the electro-surgical unit return electrode. WARNING: The BIS sensor must not be located between defibrillator pads when a defibrillator is used on a patient connected to the BISx module. WARNING: To minimize the risk of patient strangulation, the BIS Patient Interface Cable (PIC) must be carefully placed and secured. WARNING: Ensure against prolonged contact between the patient’s skin and the BISx Module. The heat that may be generated could cause discomfort. 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.

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Introduction

Warnings

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. WARNING: This Spectrum OR monitor uses a component modular device in deriving the Bispectral Index (BIS) purchased from Aspect Medical Systems, Inc. It is important to recognize that this index is derived using solely that company's proprietary technology. It is recommended that clinicians have reviewed applicable information on its utility and/or risks in published articles and literature/web site information from Aspect Medical Systems, Inc. or contact that company itself if they have clinical-based BIS questions relating to this module portion of the Spectrum OR monitor. Failure to do so could potentially result in the incorrect administration of anesthetic agents and/or other potential complications of anesthesia or sedation. We recommend that clinicians also review the following practice advisory (that includes a section on BIS monitoring): The American Society of Anesthesiologists, Practice Advisory for Intra-operative Awareness and Brain Function Monitoring (Anesthesiology 2006;104:847-64). Clinicians are also recommended to maintain current knowledge of FDA or other federal-based regulatory, practice or research information on BIS and related topics.

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Precautions

Introduction

Precautions 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 approved software.

CAUTION:

To avoid possible damage to the Spectrum OR, use only approved ECG cables and approved accessories.

CAUTION:

Operation of the Spectrum OR 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 OR. 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 OR to warm up and dry if it is moved from a cold area to a warm one.

CAUTION:

The Spectrum OR 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. The Company is not responsible for injury or damage resulting from improper or inadequate support of the monitor.

CAUTION:

Use the power cord provided with the product. 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.

CAUTION:

Follow the balloon pump manufacturer’s recommendations when connecting the unit to an intra-aortic balloon pump.

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Introduction

Precautions

CAUTION:

Cuffs must be used with the manufacturer’s correct and approved 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 OR 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 OR Operating Instructions, and all precautionary information before use.

CAUTION:

Inaccurate SpO2 measurements may be caused by:

CAUTION:

xii

•

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

•

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

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.

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Precautions

Introduction

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:

Prolonged and continuous monitoring may increase the risk of skin erosion and pressure necrosis at the site of the sensor. Check the SpO2 sensor site frequently to ensure proper positioning, alignment and skin integrity at least every eight (8) hours; with the Adult and Pediatric re-usable finger sensor, check every four (4) hours; for neonates and patients of poor perfusion or with skin sensitive to light, check every 2 - 3 hours; more frequent examinations may be required for different patients. Change the sensor site if signs of circulatory compromise occur.

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 OR Pump Exhaust fitting. Excessive scavenge vacuum may result in an Occlusion message or damage to the Spectrum OR’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:

Some disinfectants may cause skin irritation. Please rinse cuff thoroughly with water to remove any residual disinfectants.

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.

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.

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Precautions

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 BISx Module has been designed to operate with a BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Aspect's patented Zipprep technology and uses a proprietary connector. Use of other electrodes is not recommended.

CAUTION:

Do not open the BISx Module for any reason. The seal to prevent liquids from entering the module may be damaged if opened. Service or repairs must be performed by qualified biomedical technicians only.

CAUTION:

Operation of the BISx module may interfere with other equipment such as Evoked Potential Monitors, Cerebral Oximeters, and Trans-Cranial Dopplers.

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:

A functional tester cannot be used to assess the accuracy of the pulse oximeter probe or a pulse oximeter monitor.

CAUTION:

Replace sealed lead acid batteries with P/N 0146-00-0043 ONLY. Replace lithium-ion batteries with 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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Spectrum OR™ Operating Instructions

Notes

Introduction

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 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.

Intended Use The Spectrum OR Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum OR Monitor include the monitoring of the following human physiological parameters: • ECG waveform derived from 3 or 5 lead measurements • Heart Rate derived from selected sources (ECG, SpO2, IBP, NIBP) • Pulse Oximetry (SpO2) • ST Segment Analysis derived from 3 or 5 ECG lead measurements • Arrhythmia Detection derived from 3 or 5 ECG lead measurements • 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 • Bispectral Index (BIS) The target populations are adult, pediatric and neonate with the exception of: • Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, Pulmonary Artery Wedge Pressure measurements, and • IV Drug Calculations, for which the target population is adult only.

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Introduction

Unpacking

• Bispectral Index. The BISx is intended for use under direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. NOTE: The clinical utility, risk/benefit, and application of the device have not undergone full evaluation in the pediatric population. The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. The Spectrum OR Monitor has the capability of interfacing with the Company’s Panorama Central Stations and Gas Module products. For interfacing with Intra Aortic Balloon Pumps, contact the manufacturer for compatability requirements.

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 Service Department at (800) 288-2121 or (201) 995-8237 (U.S.A and Canada), or (201) 265-8800 (outside U.S.A. and Canada) for prompt assistance in resolving shipping problems.

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Spectrum OR™ Operating Instructions

Symbols and Descriptions

Introduction

Symbols and Descriptions SYMBOL DESCRIPTION

IABP

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

Latex-free product

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

DEFIB

Analog ECG out and Sync Pulse for connection to a Defibrillator

Caution: Hot Surface

Manufacturer

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

Spectrum OR™ Operating Instructions

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Introduction

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Symbols and Descriptions

For single-patient use only, do not reuse.

Manufacturer’s reference/catalogue number

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

0070-10-0670-02

Spectrum OR™ Operating Instructions

1.0

General Product Description

FIGURE 1-1 The Spectrum OR Patient Monitor

Spectrum OR™ Operating Instructions

0070-10-0670-02

1-1