Operators Manual
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Operator’s Manual
774612C © 2002 SensorMedics® Corporation Printed in the United States of America
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Operator's Manual Vmax
Copyright and Trademark Notices © 2002 SensorMedics Corporation This document is protected under Title 17 of the US Code and is the sole property of SensorMedics Corporation. No part of this document may be reproduced or stored in any electronic information retrieval system without the prior written consent of SensorMedics Corporation, except as specifically permitted under copyright laws of the United States. SensorMedics, the SensorMedics logo, Autobox, Vmax, Oxyshuttle, and MicroGard are registered trademarks of SensorMedics Corporation. FreeFlow is a trademark of SensorMedics Corporation. Microsoft, Windows, and MS-DOS are trademarks of Microsoft Corporation. Intel and Pentium are trademarks of Intel Corporation. Other brands and their products are trademarks of their respective holders and should be noted as such.
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Company Information Manufacturers USA Distribution (Vmax, 2130, V6200, and V62J) SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887–4645 Telephone: (1) (800) 231 2466 (1) (714) 283 2228 Fax: (1) (714) 283 8439 European Distribution (Vmax, V6200) SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887–4645 Telephone: (1) (800) 231 2466 (1) (714) 283 2228 Fax: (1) (714) 283 8439 European Distribution (V62J) Erich Jaeger GmbH Leibnizstrasse 7 D-97204 Hoechberg Germany Telephone: (49) (0) 931 4972-0 Fax: (49) (0) 931 4972-46 Authorized European Representative SensorMedics BV Rembrandtlaan 1b 3723 BG Bilthoven The Netherlands Telephone: (31) (0) 2289711 Fax: (31) (0) 32286244 www.sensormedics.com
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Declaration of Conformity
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Precautions • • •
Caution: Federal law restricts this device to sale by, or on the order of, a physician. Caution: This device is not suitable for use in the presence of flammable anesthetics. Service of this device is restricted to factory-trained personnel only.
Equipment Classification Classification of equipment described in this manual: • Class I • Type BF Defibrillator Proof (ECG Module) • Type B (Vmax®, V6200, and V62J) • Mode of Operation: Continuous
The Vmax and V6200 comply with the Medical Device Directives, MDD 93/42/EEC, and are approved to carry the CE Mark shown below.
The V62J complies with the Medical Device Directives, MDD 93/42/EEC, and is approved to carry the CE Mark shown below.
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Contents Copyright and Trademark Notices ... ii Company Information... iii Declaration of Conformity... iv Precautions ...v Equipment Classification...v Figures ... viii Chapter 1 • Introduction ...1 Vmax Spectra Intended Use...2 Caution and Warning Statements...3 Specifications ...8 Test Gases ...12 Explanation of Symbols ...14 Chapter 2 • Autobox™ Installation ...15 Inspect for Damage ...15 Unpacking and Setup ...15 Operator Training ...15 Required Environmental and Operational Conditions...15 Floor Space and Loading Capacity ...18 Cable and Tubing Connections ...22 Pre-use Cleaning and Disinfection ...27 Chapter 3 • Getting Started...29 Daily Startup...29 Daily Shutdown ...31 Using the Vmax Program Manager ...32 Patient File Options ...33 Patient Demographics ...35 Online Help...36 Tutorial Program...38 Chapter 4 • Flow Volume Calibration ...39 Calibration Procedure...39 Verification Procedure ...42 Plethysmograph Pressure Calibration Procedure...44 Plethysmograph Pressure Verification Procedure ...47 Chapter 5 • Pulmonary Function Testing ...49 Pulmonary Function Menu...49 Flow Volume Loops ...50 Enhanced Spirometry ...53 Maximum Voluntary Ventilation ...59 Gas Dilution Lung Volumes ...62 Single Breath Diffusing Capacity ...71 774612C
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Vmax Intrabreath Diffusing Capacity ... 76 Single Breath Oxygen Test ... 81 Chapter 6 • Plethysmography... 85 Plethysmography Test Screen... 85 Test Procedure ... 86 Loop Review Boxes ... 89 Plethysmograph Quality Assurance Messages ... 91 Chapter 7 • Respiratory Mechanics... 95 Maximal Respiratory Pressures ... 95 Compliance... 99 P.100 and Analysis of Natural Breathing ... 106 Chapter 8 • Exercise/Indirect Calorimetry Testing... 115 Entering the Program... 115 Analyzer Calibration Screen ... 116 Exercise/Indirect Calorimetry Test Screen... 120 Test Procedure ... 121 Chapter 9 • Reports... 127 Printing a Report... 127 Viewing a Report ... 128 Chapter 10 • File Manager ... 129 File Manager Screen ... 129 Archiving Patient Files ... 130 Retrieving Patient Files... 131 Deleting Patient Files... 132 Chapter 11 • Maintenance and Troubleshooting ... 133 Cleaning and Disinfecting ... 133 Routine Maintenance... 138 Other Maintenance ... 145 Troubleshooting ... 147 Parts Replacement Procedures ... 152 Index ... 155
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Figures Figure 2-1 – Vmax 22 Pulmonary Function Laboratory (with Cart) ... 18 Figure 2-2 – Vmax 22 Pulmonary Function Laboratory (with System Table) ... 19 Figure 2-3 – Vmax 229 Pulmonary Function/Cardiopulmonary Exercise Testing Instrument (with Console, Treadmill, Ergometer, and ECG Instrument) ... 19 Figure 2-4 – V6200 (with Table)... 20 Figure 2-5 – Rear Panel Connectors-Vmax Analyzer and Pneumatics Modules... 22 Figure 2-6 – Rear Panel Cables and Tubing-Vmax Analyzer and Pneumatics Modules ... 23 Figure 2-7 – Vmax Breathing Valve and Autobox Breathing Valve with Mass Flow Sensor Connections... 24 Figure 2-8 – Autobox to Vmax Connections... 25 Figure 3-1 – Enter Network Password Dialog Box ... 29 Figure 3-2 – Shut Down Windows Dialog Box ... 31 Figure 3-3 – Vmax Program Manager... 32 Figure 3-4 – Vmax Demographic Input Dialog Box ... 35 Figure 3-5 – Online Help Introduction Screen ... 37 Figure 3-6 – Example Tutorial Box... 38 Figure 4-1 – Pressure Calibration Screen ... 44 Figure 5-1 – Pulmonary Function Menu ... 49 Figure 5-2 – Flow Volume Loop Test Screen... 50 Figure 5-3 – Enhanced Spirometry Test Screen ... 54 Figure 5-4 – Maximum Voluntary Ventilation Test Screen ... 59 Figure 5-5 – Lung Volumes Test Screen ... 62 Figure 5-6 – Single Breath DLCO Test Screen ... 71 Figure 5-7 – Intra Breath DLCO Test Screen... 76 Figure 5-8 – Single Breath Oxygen Test Screen... 81 Figure 6-1 – Plethysmography Test Screen... 85 Figure 6-2 – VTG Loop Review Box ... 89 Figure 6-3 – RAW Loop Review Box ... 90 Figure 7-1 – Maximal Respiratory Pressures Test Screen... 95 Figure 7-2 – Compliance Test Screen ... 99 Figure 7-3 – Static Compliance Review Screen... 103 Figure 7-4 – Dynamic Compliance Review Box ... 104 Figure 7-5 – P.100 Test Screen ... 106 Figure 8-1 – Exercise/Metabolic Study Screen ... 115 Figure 8-2 – Analyzer Calibration Screen ... 116 Figure 8-3 – Exercise/Indirect Calorimetry Test Screen... 120 Figure 9-1 – Reports Screen... 127 Figure 10-1 – File Manager Screen ... 129
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Vmax Figure 11-1 – Cover Retaining Screw ... 140 Figure 11-2 – Removing the Cover ... 140 Figure 11-3 – Sensor Retaining Strap ... 141 Figure 11-4 – Ribbon Cable Connection ... 141 Figure 11-5 – Disconnecting the In-line Luer Fitting ... 142 Figure 11-6 – Disconnecting the Luer Fitting... 142 Figure 11-7 – Connector Locking Ears... 143 Figure 11-8 – Reconnecting the Luer Fitting ... 143 Figure 11-9 – Reconnecting the In-line Luer Fitting... 144 Figure 11-10 – Replacing the Cover... 144
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CHAPTER 1 • INTRODUCTION The Vmax Spectra respiratory analysis system incorporates the latest technology for performing highly accurate lung-function and metabolic analyses. Providing accuracy and stability over a wide range of uses, the Vmax Spectra makes available several significant feature enhancements, including the ability to operate on networks and enhancements to the DLCO application. The Vmax Spectra can be used as a stand-alone system, or it can be connected to a network and linked to other Vmax systems or to mainframe computers. In conjunction with the NetLink/IS2000 and the NetLink/ISADT options, the Vmax Spectra system is capable of communicating with hospital information systems (HIS) and with admission, discharge, and transfer systems (ADT). Enhancements to the DLCO application were developed in conjunction with a newly engineered, commercially available DLCO calibrator. This calibrator, developed by Hans Rudolph, is intended to be the Gold Standard Referee System to validate DLCO system performance. The instructions provided in this manual are intended for persons responsible for performing lung-function analyses (pulmonary function and respiratory mechanics tests) and metabolic analyses (cardiopulmonary exercise tests and nutritional assessments). Read this manual thoroughly and make sure that you fully understand the procedures before using the system. Procedures are provided in this manual for performing tests with the following instruments: • Vmax Spectra 20 Pulmonary Spirometry Instrument • Vmax Spectra 20c Pulmonary Spirometry Instrument • Vmax Spectra 22 Pulmonary Function Analysis Instrument • Vmax Spectra 22d Pulmonary Function Analysis Instrument • Vmax Spectra 22lv Pulmonary Function Analysis Instrument • Vmax Spectra 29 Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 29c Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 29n Nutritional Assessment Instrument • Vmax Spectra 29s Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 229 Pulmonary Function/Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 229c Pulmonary Function/Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 229d Pulmonary Function/Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 229lv Pulmonary Function/Cardiopulmonary Exercise Testing Instrument • Vmax Spectra 229n Pulmonary Function/Nutritional Assessment Instrument • 2130 Series Spirometer • Autobox Body Plethysmograph • Autobox DL Body Plethysmograph (with diffusion)
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VMAX SPECTRA INTENDED USE The Vmax Series has been designed and labeled as having the same indications for use as one or more of the predicate products of SensorMedics. This involves performing physicianprescribed pulmonary function and metabolic testing. More specific, intended uses are listed below. •
Differential diagnosis (Heart/Lungs)
•
Disability assessment
•
Rehabilitation evaluation
•
Exercise prescription
•
Sports medicine/research
•
Energy assessment, substrate utilization
•
Assessment of supplemental O2 requirement
•
Evaluation of medication effects
•
Pulmonary Function testing for adults and children
•
Document effectiveness of broncho-dilator therapy
•
Pulmonary disability evaluation
•
Industrial surveillance
•
Broncho-challenge testing
•
Exercise induced broncho-spasm
•
Pre-surgical risk evaluation
•
Bedside lung function
The European version of the Vmax Spectra is also intended to be combined with a Jaeger V62J body box.
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The following table identifies the chapters applicable to each instrument: Instrument Chapter
20
22
29
229 2130
Autobox
Introduction
9
9 9 9 9
9
Flow Volume Calibration
9 9 9 9 9
9
Pulmonary Function Testing
9 9 OP
9 9
9
Plethysmography
NA
NA
NA
NA
NA
9
Respiratory Mechanics
NA
OP
NA
OP
NA
OP
Exercise/Indirect Calorimetry Testing
NA
OP
9 9 NA
NA
Reports
9 9 9 9 9
9
File Manager
9 9 9 9 9
9
Maintenance and Troubleshooting
9 9 9 9 9
9
9 The chapter or section applies to this instrument. OP The chapter or section applies if the corresponding option has been added to the base instrument. NA The chapter or section does not apply to this instrument.
CAUTION AND WARNING STATEMENTS The caution and warning statements included in this manual alert the operator to potentially hazardous situations. “Caution” statements alert the operator to potential problems that could result from misuse of the equipment-problems such as device malfunction, device failure, and damage to the equipment or to other property. “Warning” statements, on the other hand, alert the operator to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the equipment. General cautions and warnings that must be read and understood before operating the equipment are provided below; specific cautions and warnings that are related to particular situations are provided in the relevant sections of this manual. Read and make sure that you understand all cautions and warnings prior to operating the equipment described in this manual and before performing the related procedure or operation.
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General Cautions The following general cautions pertain to potential problems that could result from misuse of the equipment and that could cause device malfunction, device failure, and damage to the equipment or other property. Read and make sure that you understand these cautions before using the equipment. • Use calibration gases that meet the specifications required by SensorMedics. If calibration gases do not meet these specifications, or they are incorrectly labeled, instrument malfunction and erroneous test results could result (refer to “Test Gases” on page 12). • The Vmax and Autobox instruments specified in this manual have been tested and confirmed to comply with EN60601-1 (Electrical Safety) and EN60601-1-2 (EMC) and are labeled with the CE Mark to identify this compliance. These limits are designed to provide reasonable protection in a typical medical environment; however, there is no guarantee that interference will not occur in a particular installation. The instruments generate, use, and can radiate radio frequency energy and–particularly if not installed and used in accordance with the normal operating instructions–may cause interference with other devices in the vicinity. If a SensorMedics instrument causes interference to other devices (which can be determined by turning the instrument on and off), or if other devices cause interference with the SensorMedics instrument, try to correct the interference with the following measures: • Re-orient or relocate one or both of the devices. • Increase the separation between the devices. • Connect one of the devices to an electrical outlet on a separate circuit. If the above measures do not solve the problem, contact SensorMedics for technical support (refer to “Company Information” on page iii).
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General Warnings The following general warnings are to alert the operator to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the equipment. Read and make sure that you understand these cautions before using the equipment. • The ECG Module is protected against the effects of a cardiac defibrillator discharge to ensure instrument recovery as required by test standards. If possible, remove the leads from the patient before using a cardiac defibrillator for maximum protection to the ECG Module electronics. • Properly secure large gas cylinders. Cylinders for all the necessary gases (except oxygen) are included with the instrument. You can use larger cylinders and regulators (purchased from SensorMedics or elsewhere) if the instrument is not intended to be mobile. Large gas cylinders must be secured with cylinder safety chains or safety stands (not included). • Keep all sources of ignition away from the equipment. The use of oxygen in testing requires that special care be taken to prevent fire. Any materials that will burn in air, and some that will not, ignite easily and burn rapidly in high concentrations of oxygen. Accordingly, keep all sources of ignition away from the equipment, such as an incubator, and preferably out of the room in which the equipment is being used. “No Smoking” signs should be prominently displayed. • Keep oil, grease, or greasy substances away from the oxygen regulators, cylinder valves, tubing, connections, and all other oxygen equipment. A spontaneous and violent ignition could occur if oil, grease, or greasy substances are exposed to oxygen under pressure. • On high-pressure oxygen cylinders, only use approved reducing or regulating valves marked for oxygen service. Do not use these valves for air or gases, other than oxygen, because they may be hazardous when returned to oxygen service. Such equipment must be operated strictly in accordance with the manufacturer’s directions.
•
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In view of the above considerations (and to avoid handling heavy cylinders in the nursery), keep high-pressure oxygen equipment outside the nursery. In any event, cylinders in use should be fixed into place to prevent them from being knocked over and should be located as far away as possible from the incubator. Mixtures of oxygen and flammable vapors such as alcohol, ether, ethylene, and cyclopropane could explode if ignited. Such mixtures could be ignited by electrical static spark discharges, high temperature surfaces, or all other more common sources of ignition. Only equipment designed for use in hazardous locations should be used in operating and delivery rooms. Refer to Article 517 of the ANSI/NFPA 70, National Electrical Code, for the use of flammable anesthetics.
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•
•
•
•
Only use three-prong, hospital-grade power plugs and properly grounded receptacles. In the United States and Canada, the instruments are factory-equipped with three-prong, hospital-grade power plugs. Grounding reliability and leakage current suppression can only be assured when the instruments are connected to a three-wire receptacle with the green (or yellow-green) return wire connected to earth ground. To prevent serious damage to the device and to the interconnected equipment and to prevent injuries to patients and to others associated with the device, do not use a receptacle that does not meet this specification. In addition, do not use devices to defeat the proper ground connection (such as a two-prong adapter plug). Any accessory equipment connected by the user to the analog/digital interfaces must be certified according to the applicable electrical safety standard. Applicable standards include UL-2601-1 for U.S. installations, IEC 950 for data processing equipment, and IEC 601-1 for medical equipment for the European Community. Furthermore, all configurations of accessory equipment with SensorMedics instruments must comply with the system standard IEC 601-1-1 (UL2601). Consult the accessory equipment documentation to verify compliance with these standards. Anyone connecting additional equipment to the signal input or signal output is configuring a medical system and is, therefore, responsible to assure that the system complies with the requirements of the applicable system standard. If you have any doubt about connecting additional equipment, contact SensorMedics for technical support (refer to “Company Information” on page iii). Do not attempt the insertion or maintenance of the esophageal balloon catheter unless you are thoroughly familiar with patient preparation, testing procedures, indications, and complications. Compliance testing can be considered an invasive medical procedure requiring qualified medical supervision. To ensure the safety of the patient, only use parts and accessories manufactured by SensorMedics Corporation. The ECG system has been tested for electrical safety using the components supplied by SensorMedics. The part numbers of these components are listed in the reference manual. Check every ECG electrode for wear or damage before application of the electrodes on a patient. Discard electrodes that have exposed wiring, damaged insulation, or broken components. The conductive parts of the electrodes and the associated connectors, including the neutral electrode, must not contact other conductive parts of the instrument, including the earth ground.
•
Do not use the ECG Module the presence of cardiac pacemakers or other electrical stimulators. Remove the dilution mask or the canopy from the patient before troubleshooting. During dilution testing, a battery-powered alarm will sound if the on/off switch of the
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• •
•
•
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pump is in the “on” position and there is a power loss to the Pneumatics Module. The dilution mask or canopy must be removed form the patient before troubleshooting. Stop dilution testing and remove the dilution mask or canopy from the patient before troubleshooting if any of the dilution alarm warning messages is given. When using specialized, indirect calorimetry-ventilator breathing circuits, closely monitor the patient and test the patient in a manner that does not increase work of breathing or introduce other additional risks. Follow all the cleaning procedures carefully, and thoroughly inspect the components after they are cleaned and before each patient is tested. Cleaning residue, particulate matter, and other contaminates (including pieces of torn or broken components) in the breathing circuit create a safety risk to the patient during testing procedures. Aspiration of contaminates can be potentially life threatening. Follow all the cleaning procedures carefully, and thoroughly inspect the components after they are cleaned and before each patient is tested. Certain regulatory approvals require the use of a disposable MicroGard™ filter during pulmonary function testing and the use of a sputum trap during exercise testing to achieve the required level of safety. Absence of the MicroGard™ filter or the sputum trap will degrade the safety of the equipment.
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SPECIFICATIONS Note Features and specifications are subject to change without notice. Flow/Volume/Gas Measurements Flow/Volume Type Range Resolution Flow accuracy Volume accuracy Resistance
Mass Flow Sensor 0 – 16 LPS 0.003 LPS from 0.20 – 16 LPS ±3% of reading or 0.25 LPS, whichever is greater, across the range of 0.2 to 14 LPS ±3% of reading or 0.050 L, whichever is greater <1.5 cmH2O/LPS @ 12 LPS
O2 Analyzer Type Range Resolution Accuracy
Electrochemical fuel cell 0 – 100% 0.01% ±0.02%
CO2 Analyzer Type Range Resolution Accuracy
Non-disperse infrared, thermopile 0 – 16% 0.01% ±0.02% CO2 across range of 0-10%. There is no accuracy specification above 10% CO2.
Flash Multi-Gas1 Type Non-disperse infrared, thermopile Range 0 – 0.33% CO 0 – 0.33% CH4 0 – 0.33% C2H2 Resolution 0.0005% CO 1
The Multi-Gas Analyzer is only included with diffusing capacity testing applications.
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0.0005% CH4 0.0005% C2H2 Accuracy ±0.003% CO ±0.003% CH4 ±0.003% C2H2 Transducers Flow Direction (DIR) Range: ±2 cmH2O Mouth Pressure (PM) Range ±300 cmH2O Accuracy ±1% Barometric/Sample Pressure (BP) Range 300 – 800 mm Hg Accuracy ±3 mm Hg Temperature (TEMP) Range 0 – 40ºC Accuracy ±1°C Dilution Flow Blower 0 – 80 LPM Manual ON/OFF switch Hi/Low O2/CO2 Flow Alarms
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Environmental Requirements Modules
Autobox
Operating Temperature Humidity Storage Temperature Humidity Temperature Humidity Warm up
5 – 40ºC 15 – 95%, non-condensing -20 to 50ºC 0 – 100%, non condensing 5 – 40ºC 15 – 95%, non-condensing 30 minutes
Internal Quality Assurance Gas Infusion Calibrator VE range for constant VO2/VCO2 stability: 10 - >100 LPM Temporal Alignment Verification System Integrity This feature is included with the cardiopulmonary exercise testing application. Electrical Requirements Voltage Frequency Phase Current Leakage current
100 V AC to 240 V AC 50/60 Hz Single Console: Max. 12 A at 115 V AC <100 microamperes
Computer Requirements Processor Intel® Pentium® III, 600 MHz. 866 MHz (PC) and 750 MHz (notebook) are recommended. RAM 128 MB Operating system Microsoft® Windows® 98 HDD 6 GB or greater All the supplied Spectra software has been validated using office-based Dell® computers. The Spectra software has not been validated with other computer brands. Using computers other than the computers used for validation can create malfunctions. For additional information about computer specifications, contact SensorMedics for technical support (refer to “Company Information” on page iii).
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Dimensions and Weights Modules (each) 9.5 cm high x 33 cm wide x 36 cm deep (3.75 in x 13 in. x 14 in) 5.79 kg avg. (13 lb) Console 96.5 cm high x 57.2 cm wide x 78.7 cm deep (38 in x 22.5 in x 31 in) 65.25 kg (145 lb) (39.3 in x 23 in x 37 in) 56.81 kg (125 lb) Table 76 cm high x 122 cm wide x 76 cm deep (30 in x 48 in x 30 in) 68.2 kg (150 lb) V62J Cabin 185 cm high x 87 cm wide x 80 cm deep (72.8 in x 42 in wide x 31.5 in deep) 119 kg (265 lb) V62H Cabin 185 cm high x 203 cm wide x 100 cm deep (72.8 in x 79.9 in wide x 39.4 in deep) 146 kg; 154 kg with ramp (325 lb; 343 lb with ramp) V6200 Cabin 167 cm high x 132.1 cm wide x 81.3 cm deep (66 in x 52 in wide x 32 in deep) 227 kg (500 lb) Approx. Standards Quality system registration FDA MDD 93/42/EEC Electrical safety EMC
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ISO 9001/EN 46001 510(k) market clearance CE marked EN 60601-1 EN 60601-1-2