Breeze Suite ULTIMA PFX Service Manual Rev A

The MedGraphics BREEZESUITE Service Manual Part No. 142154-001 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. copying, or distribution is prohibited.

All rights reserved.

Unauthorized use,

Medical Graphics Corporation 350 Oak Grove Parkway St. Paul, Minnesota 55127 (651) 484-4874 (800) 950-5597 (651) 484-8941 (Fax) www.medgraphics.com European Union (EU) Regulatory Representative Medical Product Service GmbH Borngasse 20 35619 Braunfels 49-6442-962073 49-6442-32578 (Fax)

0086

European Medical Device Directive

Devices are compliant with the European Medical Device Directive (93/42/EEC) regarding safety and EMC.

TABLE OF CONTENTS TABLE OF CONTENTS

3

1 INTRODUCTION

10

The Ultima PFXTM

10

BREEZESUITE Software

10

2 System Specifications Innovative Technology Flow Device Gas Sample O2 Analysis CO2 Analysis Size Power Requirements Consolidated Pulmonary Function Metabolic Gas Exchange External Device Interface (standard configuration) Identification Applicable Documents Clinical Applications ATS Minimal Recommendations for Single Breath Carbon Monoxide Diffusion Performance Specifications Mechanical Requirements Computer Requirements Gas Requirements Functional Characteristics Physical Requirements Ultima PFX Labeling and Package Requirements

11 11 11 11 11 11 11 11 12 12 12 12 12 13 13 14 14 14 15 15 16 16

3 System Configurations

18

3-1 System Components Flow Measurement Stand-Alone or Multi-User Networks Gases and Required Concentrations

18 18 18 18

3-2 System Connections Computer Connection Electrical Connection Gas Line Connections

19 19 19 19

3-3 Powering Up

19

Gases System Power Computer and BREEZESUITE™ Software Printer Vacuum Pump Helium Gas Flow

19 20 20 20 20 20

4 SAMPLING Line Connections

21

4-1 Sample Line Connection

21

4-2 Drying Sample Line Installation

22

4-3 Drying Cartridge Assembly & Drying Sample Line Installation Assembling the Patient Circuit Installing the Patient Circuit Connecting the Pneumotach Assembly to the Patient Circuit Discarding Cleaning Disinfecting Inspecting

23 24 24 24 25 25 25 25

5 System Calibration

27

5-1 Environmental Settings Environmental Changes

27 27

5-2 Pneumotach Calibration Rejecting Incorrect Volumes Results

28 31 31

5-3 Gas Analyzer Calibration Auto Calibration Manual Calibration

32 32 34

5-4 Calibration of External Devices Device Calibration

40 41

5-5 N2 Analyzer (Ultima PF and PFX) Nitrogen Calibration

46 46

5-6 MIP/MEP Transducer MIP/MEP Calibration

47 47

5-7 Printing the Calibration Report.

48

6 Component Identification 7 System Maintenance

50 54

7-1 After Each Patient

54

7-2 Maintaining the Computer

55

Cleaning the Computer and Keyboard Cleaning the Video Monitor Printer Maintenance Caring for Disk Drives Media Care

55 55 55 55 55

7-3 Cleaning System Surfaces Cleaning Exterior Painted Surfaces

57 57

7-4 Gas Chromatograph Column Maintenance Gas Chromatograph Column Deterioration Adjusting the Helium Pressure Adjusting Gain Control Interpreting DLCO Analysis Tracings Replacing the Gas Chromatograph Column

58 58 58 58 59 62

8 O / CO ANALYZERs 2

63

2

8-1 O2 Analyzer

63

8-2 CO2 Analyzer IR Source Gas Chambers Preamp Board Measuring Electronics Board

63 63 64 64 64

8-3 Vacuum Sampling System

64

9 Diagnostic / Repair Procedures

66

9-1 Sample Line Maintenance Storing the Sample Line/Umbilical Clearing the Sample Path

67 67 67

9-2 Adjusting the Vacuum

70

9-3 Refreshing the O2 Cell

72

9-4 Replacing O2 Cell

72

9-5 Cleaning CO2 Analyzer

76

9-6 CO2 Noise Check

78

9-7 Thermocouple Temperature Check

81

9-8 O2 Heater Adjustment

82

9-9 CO2 Coarse Zero and Gain Adjustments

83

9-10 O2 Linearity

83

9-11 CO2 Linearization Procedure 90% Response Times

85 85

9-12 Flow Zero Adjustments

87

9-13 Flow PCB Replacement

89

9-14 Syringe Leak Test

91

9-15 O2 Manifold Replacement

92

9-16 Gas Chromatograph Board Replacement

96

9-17 Mip/MEP PCB Replacement

98

9-18 PF Module Power Supply Replacement

99

9-19 PF Module GC Vacuum Pump Replacement

101

9-20 PF Module MUX Valve Replacement

102

9-21 DLCO Chamber/Patient Circuit Platform Verification and Replacement 104 Verification 104 Replacement 104 9-22 Water Manometer Setup

105

9-23 DLCO Circuit Leak Test

106

9-24 DLCO/N2 Reference Chamber Leak Test

106

9-25 Demand Valve Leak Test

108

9-26 Scissors Valve Test

109

9-27 Demand Valve Replacement

110

9-28 Right Angle Fitting

112

9-29 Replacement Instructions for Head Solenoid Replacements: Tools and Supplies Needed: Procedure:

115 115 115

9-30 Umbilical Leak Test

118

9-31 Fuses Replacing Fuses Adjusting Power Module Settings

119 119 119

9-32 Shape Table Generation Loading a shapetable Generating a Shapetable

122 122 123

9-33 Spirometry Checkout

126

10 System Theories

128

10-1 WFA Tester / Diagnostics

128

10-2 Flow/Volume Circuit Theory Spirometry Tests Components Pneumotach

129 129 129 129

10-3 DLco Circuit Theory Gas Chromatograph Theory Gas Chromatograph Column

129 130 130

10-4 Nitrogen Washout/O2 Wash-In Circuit Theory

132

10-5 MIP/MEP Transducer Circuit Theory

132

11 Quality Control

133

11-1 Quality Control Procedures Preparations: Spirometry QC Procedure: N2 FRC QC Procedure Nitrogen Washout FRC Shapetable Program

134 134 134 137 138

11-2 Quality Control Troubleshooting Tips Pneumotach/Flow Quality Control DLCO Quality Control N2 Quality Control

141 141 141 143

11-3 Quality Control Specifications Calibration Ultima System PFX Syringe Control (Ultima PFX System) Syringe Study Diffusion Syringe Study Nitrogen Washout

147 147 147 147 147

12 Troubleshooting

148

12-1 Gas Calibration

148

12-2 Flow Calibration

152

12-3 External Analog Devices

154

12-4 DLCO system trouble shooting. Helium Flow Diagrams

154 158

12-5 N2 Washout Troubleshooting

164

12-6 Mips/meps troubleshooting

164

13 SYSTEM SCHEMATICS 14 Flow Chart Diagrams/ PCB Component Layout 15 Bill of Materials and Drawings Table 0 Table 1 Table 2 Table 3 Table 4

700013-001 Ultima PF Module 700936-001 Arm Assembly Ultima PF 701063-003 Assy CPX Ultima 701064-001 Assembly Flow Boards 701066-006 Assembly Umbilical Ultima

166 190 200 200 207 215 226 227

Table 5 Table 6 Table 7 Table 8 Table 9 Table 10 Table 11 Table 12 Table 13 Table 14 Table 15 Table 16 Table 17 Table 18 Table 19 Table 20 Table 21 Table 22 Table 22 Table 23 Table 24 Table 25 Table 26 Table 27 Table 28 Table 29 Table 30 Table 31 Table 32 Table 33

703029-301 Assembly O2 Cell Heater 229 706046-002 Assembly Flow DWFA CPX Ultima 231 754539-003 Cable Assembly CPX Ultima Low Pressure Transducer 233 754549-001 Cable Assembly CPX Ultima 234 754550-001 Cable Assembly CPX2 Ultima 235 754551-002 Cable CPX Ultima O2/CO2 236 754552-001 Cable Assm CPX Ultima Pump and O2 Zero Control 237 754533-001 Cable Ass CPX Ultima Stab Led Solenoid Control 238 759008-002 Assembly Vacuum Pump CPX Ultima 239 760006-002 Assembly Power Suply 240 754531-001 Cable Assembly Flow DWFA Power 241 754532-001 Cable Assembly Flow DWFA Power 242 761010-005 Transformer CPX Ultima 243 762040-002 Power Entry Assembly CPX Ultima 244 762041-001 Assembly O2/CO2 Sensor Ultima 245 753015-003 Assembly PCB O2 Heater 247 754148-002 Cable Assembly O2/CO2 Heater 249 754149-002 Cable Assembly O2/CO2 Cell 250 754540-002 Cable Assy CPX Ultima High Pressure Transducer 251 750006-001 Oxygen Sensor (Modified) 252 750020-002 Assembly Drying Sample Line 253 753010-001 PCB DTD CO2/O2 Assembly Datex 254 753010-002 Assembly PCB CO2/O2 W/O Latch 256 753011-003 PCB CO2/O2 Motherboard 257 753117-002 PCB Data Acquisition Conn 259 754142-002 Cable Assembly Control Cable 261 754526-002 Cable Assembly 50 pin IDC 9in 262 754534-002 Cable Assembly CPX Ultima MPU PCB Conn. 263 754572-001 Cable Assembly Low Flow Transducer Pot 264 754572-002 Cable Assembly High Flow Transducer Pot 265

TM

1 INTRODUCTION

The Ultima PFX

The Ultima PFX TM transcends conventional ECG stress testing by introducing all digital data acquisition to MedGraphics' patented breath-bybreath gas exchange system. By adding gas exchange for the direct measurement of VO2, the Ultima PFX provides objective, reproducible data on functional capacity, along with a method for determining the primary cause of exercise intolerance or dyspnea. Standard stress and resting pulmonary function tests cannot measure the complete cardio-respiratory system. The Ultima PFX makes these measurements and more, with unparalleled accuracy. With digital data acquisition and precise breath-bybreath analysis, the Ultima PFX sets the benchmark for gas exchange systems in the world today. Combined with the patented MedGraphics preVentTM Pneumotach, testing will be free of cumbersome hoses and headgear. The preVentTM Pneumotach can be changed in a matter of seconds, providing instant solution for infection control. Options to measure carbon monoxide diffusion capacity, nitrogen washout and single breath nitrogen testing are also available. Muscular Inspiratory Pressure and Expiratory Pressure (MIP/MEP) measurements can also be collected.

BREEZESUITE Software BREEZESUITE combines easy to use, powerful data collection with data review on a single screen. The software offers integrated features to enable custom configurations, future expandability, and an open architecture database to provide instant data access. Helpful coaching features provide the user with simple steps for system calibration and patient testing. BREEZESUITE allows design of custom reports and configurations, using Report and Script Designer features. Physician Review Station trending of all variables for enhanced patient management. BREEZESUITE is compatible with Windows 2000TM and XP ProfessionalTM.

Innovative Technology -

2 SYSTEM SPECIFICATIONS

Patented breath-by-breath analysis and rapid response O2 and CO2 analyzers. Patented, lightweight (26 gm/<1oz) preVent Pneumotach exceeds ATS/ERS performance standards. Eliminates the need for bulky headgear and cumbersome connections. Automated detection of anaerobic threshold, respiratory compensation and VO2max. Five additional inputs for monitoring pulse-oximetry, heart rate, blood pressure, and outputs from treadmills and cycles.

Flow Device -

Bi-directional differential pressure preVent™ Pneumotach U.S. Patent Numbers 5038773 & 5119825 Range: ± 18 L/sec Accuracy: ± 3% or 50 ml (meets or exceeds ATS/ERS clinical performance standards) Resolution: 8.64 ml/sec Deadspace: 39 ml

Gas Sample -

O2 Analysis

-

CO2 Analysis

-

U.S. Patent Number 5042500 Patented gas drying sample circuit. Side stream sampling flow rate: 80-100ml/min Warm-up Time: 30 minutes from cold start.

U.S. Patent Number 4995256 Type: Zirconia Range: 0 - 100% Response: < 80 msec. Accuracy: ± 0.03% 02

-

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

-

Height: 36 cm (14”) Width: 36 cm (14”) Depth: 36 cm (14”) Weight: 12 kgs (26.5 lbs)

Size

Power Requirements -

100-240V/50-60Hz

Consolidated Pulmonary Function -

Forced Vital Capacity Slow Vital Capacity Maximal Voluntary Ventilation Lung Volumes using N2 washout technique Lung Diffusing Capacity using the single breath carbon monoxide diffusing capacity method Single Breath Nitrogen Washout Maximal Inspiratory and Expiratory Pressures

Metabolic Gas Exchange -

Oxygen consumption breathing room air Carbon Dioxide production breathing room air Measurement of fraction inspired oxygen Measurement of fraction inspired carbon dioxide Detection of end tidal oxygen and carbon dioxide levels Tidal Volume Respiratory Rate (breathing frequency) Breath expiratory time Breath total time Estimation of venous CO2 using exponential CO2 rebreathing technique Estimation of venous CO2 using equilibrium CO2 rebreathing technique

External Device Interface (standard configuration) -

Heart Rate using TTL pulse signal or analog heart rate signal Bicycle ergometer Watts as an analog signal or treadmill speed as an analog signal Bicycle ergometer RPM as an analog signal or treadmill elevation as an analog signal Arterial oxygen saturation from a pulse oximeter as an analog signal

Identification -

Proprietary Name: MedGraphics Ultima PFX Common Name: Pulmonary Function & Gas Exchange Testing System

Applicable Documents -

Standardization of Spirometry – 1994 Update, American Journal Respiratory Critical Care Medicine, 1995, Vol. 152, pp. 1107-1136.

-

UL 60601-1 and CSA C22.2 No. 601.1 Product Safety Standards.

-

IEC 601-1 International Standard- Medical Electrical Equipment, International Electro-Technical Commission. International Electrotechnical Commission.

-

Compliant with the European Unions (EU) MDD 93/42/EEC, per the relevant sections of the following EU standards or other normative

documents: EN 50081-1, EN 50082-1, EN 60601-1, & 60601-1-2. These

units have the “CE” Mark (label) placed on the chassis of the unit. -

Single Breath Carbon Monoxide Diffusing Capacity, American Review of Respiratory Disease, 1987 Vol. 136: 1299-1307.

Clinical Applications ATS Minimal Recommendations for Spirometry Systems Slow Vital Capacity (SVC) -

Volume Range: 0 – 8.0 liters Accuracy: ± 3% or 50 ml (whichever is greater) Flow Range: 0 - 14.0 l/sec Test Signal: 3 liter Calibration Syringe

Forced Vital Capacity (FVC) -

Volume Range: 0 - 8.0 liters Accuracy: ± 3% or 50 ml (whichever is greater) Flow Range: 0 - 14.0 l/sec Test Signal: 24 Standard Waveforms

Timed Forced Expiratory Volume (FEV1) -

FEF25-75%

-

Volume Range: 0 - 8.0 liters Accuracy: ± 3% or 50 ml (whichever is greater) Flow Range: 0 - 14.0 l/sec Resistance: < 1.5 cmH2O/l/sec from 0 to 12 l/sec Test Signal: 24 Standard Waveforms

-

Volume Range: 0 - 7.0 liters Accuracy: ± 5% of reading or 0.200 l/sec (whichever is greater) Flow Range: 0 – 14 l/sec Resistance: < 1.5 cmH2O/l/sec from 0-12 l/sec Test Signal: 24 Standard Waveforms

-

Range: ± 14.0 l/sec Accuracy: ± 5% of reading or ± 0.200 l/sec (whichever is greater) Resistance: < 1.5 cmH2O/l/sec from 0-12 l/sec

Flow

-

Maximal Voluntary Volume (MVV) -

Flow Range: 0 - 14.0 l/sec (± 5%)

ATS Minimal Recommendations for Single Breath Carbon Monoxide Diffusion

Inspired Volume -

-

Range: 0 -8.0 liters Accuracy: ± 3% of reading Inspiratory/Expiratory Resistance: < 1.5 cm H2O/l/sec at 6 l/sec

Gas Chromatograph Linearity -

Check gas chromatograph operation with gas of known concentration. Linearity: ± 1% (ATS reference)

Medical Graphics gas exchange specifications: Physiologic, volume collection. -

VE ± 5% VO2 ± 8% VCO2 ± 8%

Medical Graphics gas exchange specifications: Gas Exchange System Validator. -

VE ± 3% VO2 ± 5% VCO2 ± 5%

Performance Specifications Electrical Requirements -

-

Voltage: 100V, 120V(790705-002), 230V(790705-202), or 240V(790705-302) Current: .85A max @ 240VAC 1.5A max @ 120VAC Frequency: 50/60 Hz Power cord grounding resistance: <0.1 ohm Chassis Leakage Current: < 100 microamperes System Warm-up time: 30 Minutes

Mechanical Requirements Arm mobility -

Vertical Extension: 17 inches Horizontal extension: 12 inches Radius of Extension: 180 degrees

Sample Line/Umbilical Reach: 7 Feet

Computer Requirements Hardware-

Determined by Software

-

Windows OS 2000 or Higher Breeze Suite Software

Software-

Gas Requirements Two Calibration Gasses are required. These gasses must bracket the range of expected use. Recommended gasses are 0%CO2 /21%O2 /Bal N2 and 5%CO2 /12%O2 /Bal N2. -

Helium: 10 - 30 psi (99.95% He) Oxygen: 135 ± 5 psi minimum (USP Grade, 99.95% O2) DLCO mix: 135 ± 5 psi minimum (Neon-0.5%, CO-0.3%, O221%, N2-Bal)

Functional Characteristics Flow/Volume (Disposable Pneumotach) -

-

Flow Range: + 18 l/sec Integrated Volume Accuracy: + 50ml or 3% of measured volume Resolution: + 10 ml/sec Dead Space: < 39 ml Sample Rate: 100 s/sec minimum Resistance: <1.20 cm H2O/L/sec at 12 L/sec

Pressure Transducer - operating range -

MIP/MEP: ± 3 psi (reference: ± 5 psi)

DLco Gas Analysis Method: Thermal Conductivity Gas Chromatography -

Sample size: 3 ml Analysis time: 60 - 120 sec Warm-up time: 12 minutes Range: Neon: 0 - 0.5%, CO: 0 - 0.3% (Ref. ± 0.5%) Accuracy: ± 0.03 units full scale Circuit Dead Space: 145 ml (including pneumotach & mouthpiece)

Gas Analyzers -

Sample rate: 80 - 100 ml/mn

Oxygen analyzer Type: Zirconia -

Range: 0-100% Response: (10-90%) < 80ms Accuracy: ± 0.03% O2 Warm-up time: 30 minutes

Carbon Dioxide Analyzer Type: Infrared Absorption -

Range: 0-10% Response: (10-90%) < 130 ms Accuracy: ± 0.05% CO2 Warm-up time: 30 minutes

Physical Requirements Size and Weight: Ultima PFX Main Unit: -

14”L X 13”WX14”H

- 26 Pounds Ultima Arm: -

16 in x 32 in x 8 in (h x w x d in un-extended position) 10 in x 42 in x 8 in (extended position) 19Pounds

Ultima Module: -

13 in x 12.5 in x 5.9 in (w x d x h in) 20.4Pounds

Materials: -

Polyurethane instant set polymer painted on the exterior with an internal coating of Spraylat Series 599-Y1399 Copper Conductive Coating

Bio-burden: The preVentTM pneumotach, BreathPath™ patient circuit and the molded rubber mouthpiece received Bio-burden testing on March 26, 1998. The cleaning and disinfecting method for reuse and reprocessing in health care facilities evaluated was per Medical Graphics Product Bulletin #174 (140085-001) Product Bulletin #213 (140212-001) and Product Bulletin #188 (140149-001). An independent laboratory conducted the evaluation. The process was assessed as effective and safe.

Biocompatibility:

The preVentTM pneumotach, BreathPath™ patient circuit and the molded rubber mouthpiece received biocompatibility testing following ISO 10993-XX Biocompatibility standards. An independent laboratory conducted testing. Test results are as follows:

In Vitro Cytotoxicity -

preVent pneumotach: Non-Toxic Adult mouthpiece: Non-Toxic BreathPath patient circuit: Non-Toxic

Oral Irritation Evaluation -

preVent pneumotach: Acceptable Adult mouthpiece: Acceptable BreathPath patient circuit: Acceptable

-

preVent pneumotach: Grade I - Weak Sensitizer Adult mouthpiece: Grade I - Weak Sensitizer BreathPath patient circuit: Grade I - Weak Sensitizer

-

Sensitization

Ultima PFX Labeling and Package Requirements Labeling -

Systems shall be labeled with the product serial number.

-

Systems shall be labeled with the appropriate MGC label and/or logo. All systems shall be shipped with user manuals on a CD. All systems shall have the appropriate warning labels. All systems have Reference Pressure label.

Packaging -

Packaging shall be such that the system will not be damaged during shipment.

All specifications subject to change without notice. Products may vary from those illustrated. Please contact your Medical Graphics representative for latest information, pricing and product availability. ©Copyright, Medical Graphics Corporation, 2004. MedGraphics, CPX Ultima and preVent are registered trademarks of Medical Graphics Corporation. Part #060002-001 RevA

3 SYSTEM CONFIGURATIONS 3-1 System Components

BREEZESUITE systems are equipped with some of the following hardware components, depending on the specific configuration of each system. Options to measure carbon monoxide diffusion capacity (Ultima PFX), nitrogen washout and single breath nitrogen testing are also available. Muscular Inspiratory Pressure and Expiratory Pressure (MIP/MEP) measurements can also be collected.

Flow Measurement The patient arm of the Ultima PFX contains the BreathPath TM patient circuit and the preVent TM pneumotach. Flow is measured by a pneumotach connected to a pair of differential pressure transducers, generating an electrical signal that translates into flow and volume calculations.

Mouth Pressure The measurement of mouth pressure is similar to the measurement of box pressure. The preVent TM pneumotach is connected to a pressure transducer that measures the pressure at the patient's mouth.

Other Testing Components There are a number of other tests that can be performed on this Medical Graphics system that will be looked at more closely in this manual. DLCO, Nitrogen Washout, MIP/MEP testing will all be discussed in this manual.

Computer and Printer The computer workstation includes a video display monitor, a keyboard, mouse and the microcomputer (CPU). The color monitor is on a tilt-and-swivel base and provides SVGA compatibility. Diskette, hard disk and CD/RW drives are standard with the system. One 3.5" diskette contains 1.44 megabytes of data; the hard drive capacity is more than sufficient in size to properly run the system. The user may use a floppy diskette, CD-R or CR-RW to transfer programs and data to and from the hard disk (or network), or to save patient and test data for archiving. Software upgrades are provided on CD-ROM for user installation. All programs are stored on the hard drive (or on a network) for accelerated program loading and data transfer, expanded data storage and improved reliability. NOTE: CD-R and CD-RW are the most effective media type, as they store the greatest amount of information on one disc. Storing data to a 3.5” floppy, although possible, can be very time consuming. Many floppy disks are required to store the average size database; the transfer time to store data on each floppy can be significantly longer.

Stand-Alone or Multi-User Networks At installation, BREEZESUITE software will be configured to store patient information and test data either on the system hard disk (stand-alone) or a computer network (multi-user).

Gases and Required Concentrations

Compressed gases are used in the Ultima PFX systems during testing and calibration. The gases needed are: Oxygen 100% (135 psi) Diffusion Gas Mixture (135 psi): 0.5 ± 0.05% Ne 0.3 ± 0.015% CO 21 ± 0.15% O2 Remaining balance N2 Helium 100% (10 - 30 psi): 99.95% He <50 ppm CO2 <50 ppm CO <15 ppm H2O

Two Calibration Gasses are required for Gas Exchange Testing. These gasses must bracket the range of expected use. Recommended gasses are: Reference Gas: 0%CO2 /21%O2 /Bal. N2 Calibration Gas: 5%CO2 /12%O2 /Bal. N2

3-2 System Connections

Before using the Ultima PFX, first make all necessary connections to the computer, suitable electrical outlet, and to all gas supply lines. (See figures 1.3, 1.4)

Computer Connection Connect the communications cable (USB) from the computers USB Port to the Computer Interface port on the Ultima. The Computer Interface connection is located on the back of the Ultima PFX system.

Electrical Connection Plug the electrical cord on the Ultima PFX system into a power outlet marked “Hospital Grade” or “Hospital Use.”

Gas Line Connections Connect all gas supply lines to the ports located on the Ultima PFX system. Make sure all connections are secure before turning on the gases. If it becomes necessary to disconnect the gas supply lines from the system, bleed all high-pressure lines. WARNING: Failure to bleed all high-pressure lines prior to disconnecting them from the Ultima PFX systems could result in injury.

3-3 Powering Up

Before applying power to the BREEZESUITE system, check the following: 1. All cables must be connected. 2. Power cords must be plugged into the appropriate electrical outlets. 3. All gas connections must be complete and secure.

Gases Turn on all gases slowly to prevent a sudden increase in pressure to the system. Once the gases are turned on, the computer controls the flow of each gas. Check all gas regulators for proper

pressure settings. See page 13 for gas pressure and mix specifications.

System Power Turn on the System Power switch, located as follows: ULTIMA Series: located on the back of the Ultima, next to the power cord connection. PF, and PFX Series: located on the backside of the unit next to the power cord connection.

Computer and BREEZESUITE™ Software Turn on the power to the computer and monitor. If the video display remains dark, check the brightness adjustment control on the monitor (see the monitor operator manual). After the computer is turned to ON, double-click the BREEZE icon. The BREEZESUITE splash screen briefly displays, followed by the Patient Information screen.

Printer Turn the printer power switch to ON. The “Power” and/or indicator lights should illuminate. If the indicator is not lit, press the power switch again.

Vacuum Pump The Ultima PFX systems have a vacuum pump that must be turned on 10 minutes prior to performing nitrogen washout studies. Turn the vacuum pump on from any of the tabbed BREEZESUITE screens by clicking the GX Vac On/Off button at the top of the screen. The button name will change to N2 On, and the timer window next to the button will indicate how long the pump has been running. After the 10-minute warm-up period, “READY” will appear in this window, and testing can then be performed.

Helium Gas Flow Use the He On/Off button to turn the helium gas flow on and off from any of the tabbed BREEZESUITE screens. Turn the helium gas flow to ON at least 12 minutes prior to performing a DLCO diffusion study. When turned on, the timer window next to the button will indicate how long the helium gas has been on. After the 12 minute warm-up period, “READY” will appear in the window. When not in use, turn the helium gas to “Off” to prolong the supply of helium gas, as well as the life of the gas chromatograph column.

4 SAMPLING LINE CONNECTIONS 4-1 Sample Line Connection

The connection between the drying line and the pink sample line is a luer fitting. The sample line filter is located inside the luer fitting on the pink sample line. Inspect the filter every 5 to 7 hours of use, when experiencing calibration failures, or if you suspect debris may have contaminated the filter. The filter should be changed if there is any sign of discoloration.

Picture illustrates the umbilical cover pulled back. Pink line is in the luer fitting.