Breeze Suite Operator Manual An Introduction to Spirometry and Gas Exchange Testing Rev A

The MedGraphics Breeze Suite Operator Manual is Part No. 142133-001 Rev. A. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician if it is to be used for diagnosis and/or prescribing of therapy. MedGraphics is a registered trademark of Medical Graphics Corporation. Medical Graphics Corporation makes no claim for use of the product other than for those uses specified herein and disclaims any liability resulting from other uses. Observe all warnings and cautions. Copyright Medical Graphics Corporation 2001. All rights reserved. Unauthorized use, copying, or distribution is prohibited. Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, MN 55127 (651) 484-4874 (800) 950-5597 (651) 484-8941 (Fax) www.medgraphics.com

Table of Contents Introduction ...1 Introducing Breeze Suite 4.0 ...1 Recommended Computer ...2 MedGraphics Compatible System Specifications ...2 Cautions, Warnings and Compliance Statements...7 Declaration of Conformity...7 Hardware Equipment Classifications ...7 System Warning and Caution Statements ...8 General Specifications and Operational Requirements, 9 Maintaining Device: EMI/RFI Immunity...9 Choosing Accessory Equipment to Maintain Product Safety ...10 Environmental Concerns ...10 SpiroCard Specific Information...10 Getting Started ... 13 Setting Up Equipment ...13 Managing Site Information...19 Selecting Predicteds ...20 Opening a Patient File and Starting a Visit ...21 Setting up Gas Exchange Software ... 25 About GX Scripts ...25 About the Settings Tab ...26 Creating and Editing Exercise Protocols ...26 Creating and Editing Alarms ...30 Creating and Editing Breath Thresholds...31 Choosing a Borg Scale ...32 Specifying Blood Pressure Check Reminders ...32 Specifying External Dead Space ...32 Data Averaging ...32 Configuring the Screen ...33 Gas Exchange Testing... 35 Test Pad Controls ...35 VO2 Test Procedure ...35 Viewing Flow Volume Loops (Optional Software)...37 Resting and Metabolic Tests ...37

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PWave ...39 Manual Data and Event Entry ...40 Curve Fitting...40 Using the Window Tab ...42 Reviewing and Adjusting the Anaerobic Threshold ...44 Modify Graphs...45 Setting up Spirometry Software... 47 Working with Test Configurations ...47 General Test Options ...48 FVC General Test Options ...48 SVC General Test Options ...49 MVV General Test Options...49 Units Test Options...50 Setting up the Data Grid...50 Graph Options...51 Working with Protocol Logs ...51 Spirometry Testing... 53 Spirometry Technique...53 FVC Test Procedure ...55 SVC Testing...58 MVV Testing ...60 Manual Data and Event Entry ...62 Exercise Prescription Option ... 63 Report Functions... 65 BRP Trend Plots ...65 Trend Plots ...66 Post Test Comments ...66 Pulmonary Consult ...66 Reports ...67 Maintenance Procedures ... 69 Inspecting Pneumotach ...69 Cleaning Pneumotach ...69 Quality Control ...70 Shape Table Generation...71 Replacing Pink Sample Line...72 Replacing Gas Tanks ...73 Replacing the Drying Line and Cartridge...74

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Syringe Leak Test ...75 Refreshing O2 Cell...75 Replacing O2 Cell ...76 Cleaning CO2 Analyzer ...77 Replacing Fuses ...79 Cleaning the SpiroCard...81 Appendix ... 83 Breeze Suite CPX EXPRESS Download Instructions...83

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Introduction Introducing Breeze Suite 4.0 Breeze Suite is a true multi-tasking software package that allows simultaneous display of gas exchange graphics, tabular data, and full, 12-lead ECG information.

Breeze Suite includes the following programs: Program Breeze

Purpose Open patient files and create visits. Perform gas exchange and spirometry maneuvers. View and manipulate results in a variety of user-defined windows. Locate the subject’s anaerobic threshold and adjust it if necessary.

Access

Report Designer

Build test and graphic reports.

Breeze Predicteds

Choose predicted equations and adjust age ranges. With the optional User Defined Predicteds program, create or modify predicted equations for both gas exchange and pulmonary testing. Complete the Interpretation while viewing the configurable graphics and tabular displays.

Select Start/Programs/ Medgraphics/Report Designer. Select Start/Programs/ Medgraphics/ Predicteds.

Physicians Review Station

Manage the Breeze test database.

DBTools

Click the icon or select Start/Programs/ Medgraphics/Breeze.

Select Start/Programs/ Medgraphics/ Physicians Review Station. Select Start/Programs/ Medgraphics/DBTools.

Breeze Suite Options • Spirometry (Pre, Post, & Challenge) • Pulmonary Consult • Spirometry Interpretation • Exercise Consult • Rule-Based Exercise Interpretation • ExerScript (Exercise Prescription) • Nutrition (Indirect Calorimetry) • ExFVL (Exercise Flow Volume Loops) • User Defined Predicteds ™

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Recommended Computer • • • •

Pentium III 500 MHz 128 MB RAM, 4 GIG Hard Disk Windows 98 Microsoft Office 2000 Professional

MedGraphics Compatible System Specifications CPX/D The MedGraphics CPX/D System transcends conventional stress testing by adding gas exchange for the direct measurement of V02. This gives you objective, reproducible data on your patients’ functional capacity and a method of determining the primary cause of exercise intolerance or dyspnea. Both are essential: neither stress testing nor resting pulmonary function tests measure the complete cardiorespiratory unit during exercise. Flow Device • Bi-directional differential pressure • PreVent™ pneumotach • Range: ± 18 L/sec • Accuracy: ± 3% or 50 ml, whichever is greater (meets or exceeds ATS/ERS clinical performance standards) • Resolution: 8.64 ml/sec • Deadspace: 39 ml O2 Analysis • Type: Zirconia • Range: 0 - 100% • Response: <80 msec • Accuracy: ± 0.03% 02 CO2 Analysis • Type: NDIR • Range: 0 - 10% • Response: <130 msec • Accuracy: ± 0.05% CO2 Gas Sample • Patented gas drying sample circuit • Side stream sampling flow rate: 80-100ml./min • Warm-up Time: 30 minutes from cold start

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CCM/D The MedGraphics CCM/D System provides ventilatory and metabolic data to assist the clinician in optimizing nutritional support for both spontaneous breathing and mechanically ventilated patients. Additional ventilatory and hemodynamic evaluations can be performed from the direct measurement of VE, VO and VCO. 2

Flow Device • Bi-directional differential pressure • preVent™ pneumotach • Range: ± 18 L/sec • Accuracy: ± 3% or 50 ml, whichever is greater (meets or exceeds ATS/ERS clinical performance standards) • Resolution: 8.64 ml/sec • Deadspace: 39 ml O2 Analysis • Type: Zirconia • Range: 0 - 100% • Response: <80 msec • Accuracy: ± 0.03% 02 CO2 Analysis • Type: NDIR • Range: 0 - 10% • Response: <130 msec • Accuracy: ± 0.05% CO2

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CPFS/D The CPFS/D is a full function spirometry system meeting the current ATS/ERS recommendations for accuracy and performance as well as all applicable safety standards. The system consists of a flow module containing the transducers and electronics to produce a bi-directional flow signal with the MedGraphics preVent pneumotach. Flow Range ± 18 L/second (± 1080 L/min) Resolution 8.64 ml/sec Accuracy Independently validated and shown to meet ATS recommendations for accuracy

against the 24 standard waveforms of Hankinson and Graner, for FVC, FEV1, FEF 25-75%. ± 3% or 50 ml, whichever is greater Deadspace 39 ml Resistance <1.20 cmH20/L/sec @ 12 L/sec (exceeds ATS/ERS specifications

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SpiroCard The MedGraphics SpiroCard is the first and only spirometer to use PC Card technology. It meets all current ATS/ERS recommendations for accuracy and performance as well as all applicable safety standards. Measurement Method FLOW: Pneumotach (US Patent #4,905,709), VOLUME: flow integration. Measurement Range FLOW: ±14 liters/second, VOLUME: 0-8 liters BTPS. Accuracy Complies with American Thoracic Society (ATS) Standards for Spirometry, 1994 Update. Flow: ± 5% of indication or 200 ml/sec, whichever is greater for FEF 25-75, and ± 10% or 400ml/sec whichever is greater for PEF. Volume: ± 3% of indication or 50 ml, whichever is greater for FVC and FEV1.

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CPX Express CPX Express is a compact yet fully featured metabolic measurement system. The CPX Express is completely self-contained with integrated instrumentation, touch pad, and display for conducting accurate and reproducible assessment of functional capacity over the entire physiological range. Using a cable provided by Medical Graphics Corporation, you can download information collected with CPX Express to Breeze Suite to take advantage of the program’s advanced data manipulation and display features. Refer to the Appendix for more information. Flow Device • • • • •

Bi-directional differential pressure preVent pneumotach Range: ±18 L/sec Accuracy: ±3% or 50 ml, whichever is greater (meets or exceeds ATS/ERS clinical performance standards) Resolution: 8.64 ml/sec Deadspace: 39 ml ™

O2 Analysis • • • •

Type: Zirconium Oxide Range: 0-100% Response: <90 msec Accuracy: ±0.1% O2 absolute

CO2 Analysis • • • •

Type: NDIR Range: 0-10% Response: <130 msec Accuracy: ±0.1% CO2 absolute

Gas Sample • • • •

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Medical Graphics Patent: #5,042,500 Patented gas drying sample circuit. Side stream sampling flow rate: 80-100ml/min Warm-up Time: 30 minutes from cold start.

Breeze Suite Operator Manual

Cautions, Warnings and Compliance Statements Declaration of Conformity A copy of the Declaration of Conformity statement is available from your authorized sales representative or Medical Graphics Corporation’s web site (www.medgraphics.com).

Hardware Equipment Classifications Attention: Consult accompanying documents. Read this user manual in its entirety before operating this equipment. Equipment is suitable for continuous operation. Class I Equipment/Internally Powered Class I refers to "grounded equipment" or equipment that uses low voltage for operation. The connection to the system's A/C power supply protective earth ground ensures that no accessible metal parts become live during a failure in the system's basic insulation. Note: To ensure grounding reliability, this equipment must be plugged in to a power outlet identified as "Hospital Grade" or "Hospital Use." Note: If your device is not supplied with the proper AC/DC power (line) cord, consult your authorized distributor/representative. They will provide the proper power cord for the device.

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Type BF Equipment Type BF Equipment with applied part defines the specific degree of protection against electric shock, particularly regarding allowable leakage currents. The applied patient circuit (pneumotach) is electrically isolated from all other parts of the equipment. Ordinary Equipment The design of the equipment enclosure provides no protection against the ingress or seepage of liquids.

52FM

Underwriters Laboratories: Canadian and United States Gas Exchange Medical Equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL2601-1 and CAN/CSA C22.2 No. 601.1.

System Warning and Caution Statements Danger indicates an imminently hazardous situation, which, if not avoided, will result in death or serious injury. Warning indicates a potentially hazardous situation, which, if not avoided, could result in death or serious injury. Caution Indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. The following section explains system warning and caution statements with respect to the system itself. Warning: To reduce the risk of electric shock, NEVER remove any protective covers. Refer servicing to qualified service personnel. Dangerous voltages may exist within the equipment case. Refer all service to trained, authorized service representatives. If power must be applied to perform maintenance, follow proper safety procedures while working on an ENERGIZED system. Warning: Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. Caution: When connecting external devices to the system, verify that the item being connected to the system is compatible. Incompatible connections may damage the components. Caution: Ensure that the gas supply pressures are at or within the range(s) specified on the device labeling near the gas supply inlet.

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Caution: Use adequate electrostatic discharge (ESD) precautions when connecting cables to the devices. Before connecting any cable to the system, touch one of the metal screw heads located on the system. This will help neutralize static build-up that may have accumulated on your body.

General Specifications and Operational Requirements, Power Requirements A/C Input Flow Module: 0.45 – 0.35 Amps @100 - 240V, 50/60Hz, 1 Phase Gas Module: 0.85 – 0.55 Amps @100 - 240V, 50/60Hz, 1 Phase Bio Burden (Cleaning) Refer to the product bulletin provided with the patient contact device (i.e. facemask, pneumotach). This will provide the recommended cleaning procedure to assure proper cleaning and disinfection. Environmental Conditions (Operating) Ambient Temp: 15 to 35 °C (60 to 95 °F). Rel. Humidity: ≤90% (w/o condensing). Atmospheric Pressure: 700 hPa to 1060 hPa . Environmental Conditions (Shipping and Storage) Ambient Temp: -40 to 70°C (-40 to 158 °F). Rel. Humidity: 10-100% (inc. condensing). Atmospheric Pressure: 500 hPa to 1060 hPa.

Maintaining Device: EMI/RFI Immunity The system components have been tested for Electro-Magnetic Interference (EMI)/Radio-Frequency Interference (RFI) compliance. Caution: Using accessory equipment that does not comply with the equivalent EMI/RFI immunity and emission requirements of this equipment may lead to a reduced level of EMI/RFI immunity or emissions of the resulting system configurations. When choosing accessory equipment, ensure the EMC certification on the accessory has been performed in accordance with the appropriate standards (i.e. European Norm (EN)). Note: System and subsystem components have been engineered and third party tested for EMI/RFI compliance to EN60601-1-2. Refer servicing to qualified personnel to maintain system safety and EMI/RFI integrity. To maintain EMI/RFI system integrity: •

All interfacing cables must be constructed so as to provide adequate EMI/RFI shielding.

•

Cable connector ends should be securely attached to its matting plug/receptacle on the device.

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Choosing Accessory Equipment to Maintain Product Safety Warning: Other accessory devices, such as computers, may be interfaced to this device. Using accessory equipment that does not comply with the equivalent safety requirements of this equipment may lead to a reduced level of safety in the resulting system. Medical Graphics Corporation recommends that the user/customer employ the use of a line isolation transformer with all such accessory devices. Line isolation transformers are available from Medical Graphics Corporation. When choosing accessory equipment, consider: •

Use of the accessory in the patient vicinity.

•

Evidence that accessory safety certification has been performed in accordance with the appropriate EN 60601-1 and/or EN 60601-1-1 harmonized European standard.

•

System components requiring third party testing have been engineered and third-party tested according to UL 2601-1 and CSA C22.2 No. 60601-1-M90, both based on the European EN 60601-1 safety standard.

This device is not intended for service by an untrained user. Return the defective unit to the manufacturer for servicing. Contact your authorized representative. Device service manual and schematics are available from Medical Graphics Corporation.

Environmental Concerns This device may contain hazardous waste as defined by your local hazardous waste/environmental laws and regulations. “End of Life” devices may be returned to Medical Graphics Corporation for proper disposal. Contact your authorized Medical Graphics Corporation service representative.

SpiroCard Specific Information Contraindications Do not operate in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field (i.e. electric motor) as to interfere in any manner with the operation of the SpiroCard. Warnings • When performing patient testing, ensure that the computer and printer are operating from internal battery power and the A/C power supply is disconnected from the A/C wall outlet. Perform computer and printer battery charging using A/C power supply after patient testing. This will reduce the risk of injury. If it is desired to administer tests while operating the computer and printer from A/C line power, you are advised to use the A/C isolation transformer that is available from Medical Graphics. This will reduce the risk of injury to the operator or patient. Use of the power supply provided by the computer manufacturer is not in accordance with UL 2601-1 requirements.

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•

Do not reuse. Pneumotachs are single patient use only and MUST be replaced for each patient.

•

Pneumotach should not be used on a patient with an injured mouth.

•

The opening at the end of the pneumotach must not be obstructed. Make sure the patient does not obstruct it with his/her fingers. This will result in erroneously high volume and flow results.

•

FVC and MVV testing can cause fatigue and may be dangerous for some patients. Some patients may be at risk for vertigo, arrhythmia or syncope.

Handling Do not insert a "dirty" SpiroCard into a PC Card slot. Contamination of connections and slot interior could occur causing poor operation or device failure. Avoid contaminating the luer and connectors of the SpiroCard. Storage Store the SpiroCard in a dry place. Moisture in the SpiroCard can adversely affect measurements. The card can accept a wide temperature range, but avoid sudden changes in temperature that can cause condensation inside the unit. Physical Shock Avoid physical shock to the SpiroCard. A card that has been dropped should have the calibration verified before use on a patient. EMI The SpiroCard is not to be used in the proximity of any piece of equipment that has the potential to generate a significantly large electromagnetic field (see definitions) as to interfere in any manner with the operation of the SpiroCard. Battery Refer to the HPC User's Manual for instructions on using the PC equipment and for complete battery information including type, replacement, recharging, loading, proper disposal, etc. Power Cord/AC Adapter As with all electrical devices there is a risk of electric shock, use in dry location only.

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Getting Started Setting Up Equipment CPXD Start Up, Shut Down, and Calibration CPXD System Start Up 1.

Ensure power cord is connected to system and plugged into grounded wall outlet before turning on power.

2.

Push the Main Power rocker switch on the power strip at the rear of the cart to on.

3.

Push computer power switch to on.

4.

Turn on monitor power.

5.

Push on side of rocker switch on front right panel of gas module to turn vacuum pump to on.

6.

If using a drying cartridge, check to see if the blue drying crystals are still evident before calibrating or testing.

7.

Wait for system to warm up and stabilize: 30 minutes for gas analyzers and flow module, 10 minutes for vacuum pump (concurrent with analyzers). Note: If system power is turned off for a short duration (less than 15 minutes), analyzer warm-up time is double the power-down time.

8.

Turn printer and other external devices installed with system to on.

9.

Ensure all connections and lines are snug and attached to appropriate port for calibration.

10. Ensure gas tanks are open (turn gas cylinder pressure valve to left) and

set pressure at 15 psi using pressure regulator knob. 11. Calibrate pneumotach and gas analyzers. 12. Calibrate gas analyzers before each test using auto calibration.

CPXD Shut Down After Analyzer Calibration

Close the gas tanks (turn gas cylinder pressure valve to right) on each cylinder after completing gas analyzer calibration process. The system uses these gasses only for gas analyzer calibration, not for calibrating the pneumotach or for testing.

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At end of test

Allow the system to remain turned on between tests throughout the day to avoid the 30-minute gas analyzer warm-up and stabilization. To prolong the life of the vacuum pump and analyzers, turn the pump OFF whenever possible (press down OFF side of rocker switch labeled VACUUM PUMP on right side of gas module). The system requires a 10-minute stabilization time when the pump is turned to ON again. At end of day

The system "Main Power" switch may remain turned ON overnight. To prolong the life of the vacuum pump and analyzers, turn the pump OFF whenever possible (press down OFF side of rocker switch labeled VACUUM PUMP on right side of gas module). Close gas cylinders by turning valve on top of tank clockwise until tight. Before a weekend or longer period when no testing will take place, also turn the system Main Power switch and external devices (bike, treadmill, etc.) power to OFF (press 0 portion or the I/O switch on the power strip in the rear of the cart). Pneumotach Calibration Pneumotach calibration is a two-step procedure: 1.

Set a zero reference to ensure that the system is reading zero flow when no flow is being introduced. The pneumotach must be zeroed before each test. It is also zeroed as part of the automatic gas analyzer calibration.

2.

Perform a volume calibration to match the volume being introduced with an actual syringe volume. Volume calibration of the pneumotach is required only once per day. It does not need to be performed on each new pneumotach after the initial daily calibration. The calibration routine consists of introducing a known calibration volume into the pneumotach several times at different flow rates from slow to fast. You should perform five injections and withdrawals. These signals are measured by the pneumotach system (pneumotach and transducer) and sent to the waveform analyzer. The waveform analyzer converts the analog signal to correlate with flow. Integration of flow relative to time is volume. This volume is then compared to the actual volume to calculate a calibration factor.

Before Pneumotach Calibration 1. Allow the system to warm-up and stabilize:

• 30 minutes for flow module (CP-S and CPXD systems) and gas analyzers (CPXD system) • If using a CPXD, allow 10 minutes for vacuum pump (concurrent with analyzers) 2.

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Install the pneumotach into the clip and connect it to the gray coupler (screen toward coupler).

Breeze Suite Operator Manual

3.

Connect the gray coupler/pneumotach assembly to the calibration syringe.

4.

Click Calibrate to begin calibration. Tip: Set the syringe on a solid surface during calibration to ensure accurate results.

5.

Enter the appropriate syringe size in liters.

6.

Enter the current Temperature, PBar and Humidity at the bottom of the screen.

Pneumotach Zero Calibration

Note: When adjusting for zero flow, it is important that no flow is introduced inadvertently. Due to the extreme sensitivity of the flow transducer, breathing near the pneumotach or other air movement, such as from an overhead fan or vent, may introduce flow. Eliminate these effects by connecting the pneumotach to the calibrating syringe before zeroing. It is important that the pneumotach is stationary during zero adjustments. Click Zero Flow to zero the pneumotach. A prompt reminds you to ensure that there is no flow through the pneumotach. If the calibration is unsuccessful, a message appears stating that Flow Offset is Out of Range. If this happens, repeat the procedure. If the zero continues to fail, try a different pneumotach and verify that the umbilical tubing is not occluded. After successfully zeroing the pneumotach, you can begin calibration of the pneumotach volume. Pneumotach Volume Calibration 1. Click Start or press the spacebar to begin volume calibration. 2.

A message appears prompting you to withdraw, or pull back, on the syringe plunger. Pull back smoothly on the plunger, being certain to withdraw the complete volume of the syringe. During the withdrawal, the flow should trace downward. If it does not trace downward, the pneumotach or pneumotach umbilical are connected incorrectly. Note: On the Volume-Time graph, the rate of flow is shown by the slope of the injection line: the faster the flow, the steeper the line. On the FlowVolume Loop graph, the rate of flow is indicated by the depth of the tracing.

3.

A message appears prompting you to inject, or push forward, on the syringe plunger. Push in smoothly and evenly on the plunger, being certain to inject the complete volume of the syringe.

4.

Repeat steps 2 and 3 until five injections and withdrawals are recorded or until you are satisfied that the pneumotach is performing adequately. The injections should be performed at different flows, from slow to fast, to demonstrate the linearity of the flow device.

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