K4 b User Manual IX Edition Sept 2003

Table of contents Getting started

13

Important notices... 14

Intended use ... 14 Warnings ... 14 Contraindication ... 16

Contraindications for the Spirometer tests ... 16 Absolute contraindications... 16 Relative contraindications... 16 Contraindications for Bronchial provocation tests... 16 Absolute contraindications... 16 Relative contraindications... 16 Contraindications for Exercise testing ... 16 Environmental condition of use ... 17 Safety and conformity ... 18

Safety ... 18 EMC... 18 Telemetry... 18 Quality Assurance... 18 Medical Device Directive (CE mark) ... 18 Keynotes ... 19

Typographic keynotes ... 19 Graphic keynotes... 19 System overview ... 20

Portable Unit (PU)... 20 Telemetry Data Transmission, Receiver Unit (RU)... 20 Battery Charger Unit (CU)... 20 Flowmeter ... 21 Gas analysers... 21 PC Software ... 21 Before starting ... 22

Checking the packing contents... 22 K4 b2 standard packaging ... 22 Warranty registration ... 23

Register the product via software ... 23 How to contact COSMED ... 23 Complain, feedback and suggestions... 23 Options/Accessories... 24

Accessories... 24 Options ... 24 Telemetry data transmission ... 24 Spirometry Kit ... 24 PC configuration required ... 25 2

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Technical features ...26

Portable Unit... 26 Receiver Unit... 26 Battery charger Unit ... 26 Flowmeter... 26 Oxygen Sensor (O2)... 26 Carbon Dioxide Sensor (CO2)... 26 Humidity absorber ... 26 Power Supply... 26 Environmental Sensors ... 26

Measurements

27

Pulmonary function tests and measured parameters ...28

Breath by Breath exercise testing... 28 Indirect Calorimetry... 28 Lactate Threshold (V-Slope)... 28 O2 Kinetics ... 29 Spirometry Tests (option) ... 29 FVC - Forced Vital Capacity... 29 VC/IVC - Slow Vital Capacity and Ventilatory pattern 29 MVV - Maximum Voluntary Ventilation... 30 Bronchoprovocation Response ... 30

Installation

31 Installation sequence ...32

Battery Charger Unit... 32 Check voltage ... 32 Turn the Unit on ... 32 Charge the batteries ... 32 Battery low ... 33 Portable Unit ... 33 Warm up ... 34 Warming-up the unit by main power... 34 Turning on/off the portable unit ... 34 Connect the rechargeable battery... 34 Receiver Unit ... 35 Turning on/off the receiver unit... 35 Receiver unit power supply ... 35 Calibration Gas Cylinder ... 35 Connecting the K4 b2 to the patient ...36

Assemble the mask and the flowmeter ... 36 Using the "Ultimate Seal" ... 36 Apply the seal to the mask... 37 To remove seal on mask ... 37 Assembling the flowmeter for spirometry tests ... 37 Fixing the K4 b2 to the patient ... 38 Index - 3

Connecting the K4 b2 to the PC ... 39

Connect the Portable Unit to the PC ... 39 Connect the Receiver Unit to the PC ... 39 Software installation... 40

Installing the software ... 40 Run the software ... 40 PC port configuration... 40 Software main features ... 41

Display ... 41 Tool bar ... 41 Show/hide the toolbar ... 41 Dialog windows ... 41 Use of the keyboard ... 41 Use of the mouse... 41 Scroll bars ... 41 On line help... 41 Software version... 41

Calibration

43 Gas calibration procedures ... 44

Running the Calibration program... 44 Log file... 44 Setting reference values ... 44 Set the reference values using the PC software ... 44 Set the reference values using the Portable Unit... 45 Room air calibration... 45 Room air calibration using the PC software ... 45 Room air calibration using the Portable Unit... 45 Reference gas calibration ... 45 The calibration unit... 46 Reference gas calibration using the PC software... 46 Reference gas calibration using the Portable Unit ... 46 Gas delay calibration... 47 Delay calibration using the PC software... 47 Delay calibration using the Portable Unit ... 47 Print the calibration report ... 48 Edit the calibration factors ... 48 Turbine calibration ... 49

Assembling the flowmeter for calibration ... 49 Calibrating the turbine... 49 Turbine calibration using the PC software... 49 Turbine calibration using the Portable Unit... 50 Checking the system signals... 51

The control panel... 51 Using the control panel ... 51

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Operating modes

53 2

K4 b Operating modes ...54

Holter Data Recorder ... 54 Telemetry Data Transmission (option) ... 54 Serial (Laboratory) Station... 54 Portable Unit User Interface diagram ...55 Holter Data Recorder Mode ...56

Operating sequence... 56 Warming-up the system... 56 Enter new patient ... 56 Calibrate and start the test... 56 Stop the test ... 57 Transferring test to PC... 57 Telemetry Data Transmission Mode...58

Operating sequence... 58 Warming-up the system... 58 Connect the receiver unit to the PC ... 58 Enable transmission... 58 Enter new patient ... 58 Enable reception on PC ... 59 Calibrate and start the test... 59 Stop the test ... 60 Transferring test to PC... 60 Serial Mode ...61

Operating sequence... 61 Warming-up the system... 61 Connect the Portable unit to the PC... 61 Calibrate the system... 61 Enter patient data ... 61 Start the test ... 62 Stop the test ... 62

Database Management

63

Exercise testing patient's database...64

Enter a new patient... 64 Find a patient... 64 Edit patient data ... 64 Delete a patient ... 64 Uploading tests from the Portable Unit ...65 Archive maintenance ...66

Reorganise the archive ... 66 Delete the archive ... 66 Delete a test... 66 Backup and restore... 66 Backup ... 66 Restore ... 66 Index - 5

Spirometry patient's database... 67

Patient Card... 67 Visit Card... 67 Test Card... 68 Import/export a Tests card ... 68 Diagnosis Database ... 68 Spirometry program settings... 69

Graphs... 69 Serial port... 69 Units of measurements... 69 Using extra fields ... 69 Customise the fields... 69

Exercise testing

71

Recommendations for the exercise testing... 72

The evaluation of the cardiorespiratory function ... 72 Precautions ... 72 Laboratory... 72 Ending the test ... 72 Preparing the patient ... 72 Before testing... 72 Patient assent... 73 Ending the test ... 73 Real time test ... 74

Start a test... 74 Abort the test without saving data ... 74 End the test saving data ... 74 View data in real-time... 74 View graphs in real-time... 74 Parameters to view ... 74 Manual protocol ... 75 Enter Load and Phase ... 75 Set the markers... 75 Automatic protocol... 75 Modify the load during the test... 75 Set the BPM alarm ... 75 Enter the BPM ... 75 Data management... 76

Viewing data ... 76 View data in table form ... 76 Creating graphs ... 76 View data in graph form ... 76 Customise the graphs ... 77 Switch from graph to data and vice versa... 77 Viewing predicted values... 78 View predicted values... 78 2

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Anaerobic (Lactate) Threshold detection... 78 View the Lactate Threshold... 78 Detect the Lactate Threshold ... 78 Customise graphs for the LT viewing... 78 Fittings ... 79 Fit a graph with a linear regression... 79 Fit a graph with a Mono-exponential regression ... 79 Calculate the "Mean Value" ... 80 Oxygen Kinetic ... 80 Run the O2 Kinetic function... 80 Information about the Test... 81 View the Information... 81 Modify the information... 81 Summary ... 81 View the summary... 81 Print the data ... 81 Print the current window ... 82 Print the report ... 82 View the report ... 82 Data Editing ...83

Editing values and input numerical values ... 83 Data filtering... 83 Using the User fields ... 84 Deleting steps ... 84 Advanced Editing ... 84 Restore the original test ... 85 Overwrite the original test ... 85 Customise the desktop ... 85 Customise the display colours ... 85 Smart edit ... 85 Apply the graphical noise suppression ... 85 Apply the threshold noise suppression ... 85 Customise the parameters ... 86 Create a new parameter ... 86 Create a new predicted parameter... 86 Exporting data... 87 Export a test ... 87 DDE with Excel... 87 Creating Test Protocols...88

Create a new protocol ... 88 Software configuration...89

Data viewing ... 89 Select the parameters to view ... 89 Select the parameters to view during the test ... 89 Sort the parameters ... 89 Steady State... 89 Index - 7

Customise the Steady State detection criteria... 89 Printout reports... 90

Set up the printout... 90 Select parameters to be printed ... 90 Customise the printout header ... 90 Electronic reports (*.pdf) ... 91 Print the current window... 91 Print the customised report... 91 Events management during exercise testing ... 92

Flow Volume loops ... 92 Flow Volume loop during the test ... 92 O2, CO2 vs Time ... 92 O2, CO2 vs Time during the test ... 92 O2 Saturation (optional)... 93 O2 Saturation during the test ... 93 Spirogram... 93 Spirogram during the test... 93 View the events after the test ... 93 Raw data... 93 Save Raw data... 94

Resting Metabolic Rate Test

95

Metabolism ... 96

Total Metabolic Rate... 96 Resting Metabolic Rate (RMR)... 96 Importance to measure RMR ... 96 Measure of the rest metabolic rate with indirect calorimetry... 96 How to perform a RMR test... 96 Recommendations ... 97 Performing a test ... 98

Calibrations ... 98 How to prepare a patient ... 98 Start the test... 98 Viewing the test... 99 How to modify the average interval... 100 Print... 100

Sub-maximal Exercise Testing

103

Introduction ... 104

Pre-test screening ... 104 Sub-maximal exercise testing... 105

Considerations with sub-maximal exercise testing ... 105 Staffing... 106 Test termination ... 106 Considerations for accuracy... 107 Performing the test ... 108

An example of testing protocol ... 108 2

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Spirometry

109 Setting spirometry options ...110

Spirometry... 110 Automatic Interpretation... 110 Quality control... 110 Parameters manager ... 111 Predicted values manager... 111 Predicteds set ... 111 Set the current predicted ... 112 Formula definition ... 112 Page set-up ... 113 Spirometry tests...114 Forced Vital Capacity (pre)...115

Recommendations... 115 Perform a FVC (pre) test... 115 Test encouragement ... 115 Perform the FVC test with the encouragement... 116 Slow Vital Capacity ...117

Perform a SVC test ... 117 Maximum Voluntary Ventilation ...118

Perform a MVV test... 118 Bronchial Provocation Test...119

Bronchodilator test... 119 Methacholine and Histamine Bronchial provocation Tests ... 119 Perform the test ... 120 Bronchial Provocation protocols Database ... 120 Enter a new Bronchial provocation protocol in the archive ... 120 Viewing results ...121

Tests of the current patient ... 121 Delete a test ... 121 Printing results ...122

Printing Reports ... 122 Printing the active window ... 122 To print the active window ... 122 Printing a series of reports ... 122 Electronic reports (*.pdf) ... 122 Export data ... 123 Export a test ... 123

External devices

125

GPS ...126

GPS initialisation ... 126 Initialize the GPS... 126 Fixing the antenna to the subject ... 126 Operating sequence... 127 Run a test with GPS... 127 Index - 9

Monitoring GPS parameters in real time ... 128 Pulse Oximeter (option) ... 129

Operating Sequence ... 129

System maintenance

131

System maintenance... 132

Cleaning and disinfection... 132 Cleaning the turbine flowmeter ... 132 Precautions during the cleaning of the turbine... 133 Suggested disinfection solutions... 133 Masks cleaning and disinfection ... 133 Disassembling the different parts of the mask ... 133 Cleaning the mask... 133 Disinfecting the mask ... 133 Permapure maintenance ... 134 Inspections ... 134 Replace the fuses... 134

Appendix

137 Service - Warranty ... 138

Warranty and limitation of liability... 138 Return goods policy for warranty or non warranty repair... 138 Repair Service Policy... 139 Privacy Information ... 140

Personal data treatment and purposes ... 140 How your personal data are treated... 140 The consent is optional, but… ... 140 Holder of the treatment ... 140 Customer rights ... 140 Converting factors configuration ... 141 Calculations references... 142

VO2 and VCO2... 142 Anaerobic threshold (modified V-Slope)... 142 O2 kinetics ... 142 ATS 94 recommendations ... 143

ATS recommendations... 143 Predicted values ... 144

ERS93 ... 144 Reference Adult: ... 144 Reference Paediatric: ... 144 KNUDSON 83 ... 144 Reference Adult/ Paediatric: ... 144 ITS (White race)... 144 Reference Adult/ Paediatric: ... 144 ITS (Black race) ... 144 Reference Adult/ Paediatric: ... 144 2

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LAM... 144 Reference Adult/ Paediatric:... 144 Multicéntrico de Barcelona... 144 Reference Adult/ Paediatric:... 144 NHANES III ... 144 Reference Adult/ Paediatric:... 144 Automatic diagnosis (algorithm) ... 145 Quality Control Messages... 145 References ...146

Gas Exchange References... 146 Indirect calorimetry ... 146 Spirometry ... 146 Sub-maximal testing ... 146

Index - 11

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Important notices Intended use The measurement of oxygen uptake during sport or real life activities is of great interest for the development of training programs and the study of their effects on elite athletes or for assessing the efficacy of a rehabilitation therapy. A common method for assessing the effects of endurance training is the monitoring of various respiratory parameters during submaximal exercise. One difficulty to achieve this goal during sport that cannot be simulated in the laboratory is to use a reliable and valid portable system to measure VO2 and VCO2 in a field setting. Such a portable apparatus may also be useful to determine the energy cost of many sport and real life activities. K4 b2 is an electrical medical device designed to perform pulmonary function tests. It is to be used by physicians or by trained personnel on a physician responsibility. Caution: Federal law restricts this device to sale by or on the order of a physician. This equipment has been conceived with the aim of providing an auxiliary instrument allowing: •

the formulation of lung pathology diagnosis;

•

important studies concerning human physiology;

• the collection of important information in sport medicine. No responsibility attaches COSMED Srl for any accident happened after a wrong use of the device, such as: •

use by non qualified people;

•

non respect of the device intended use;

•

non respect of the hereunder reported precautions and instructions.

Warnings The device, the programme algorithms and the presentation of measured data have been developed according to the specifications of ATS (American Thoracic Society) and ERS (European Respiratory Society). Other international references have been followed when these were not available. All bibliography references are reported in Appendix. The present handbook has been developed with respect of the European Medical Device Directive requirements which sort K4 b2 within Class II a. It is recommended to read carefully the following precautions before putting the device into operation. The precautions reported below are of fundamental importance to assure the safety of all COSMED equipment users. 1. This user manual is to be considered as a part of the medical device and should always be kept on hand. 2. Safety, measure accuracy and precision can be assured only: • using the accessories described in the manual or given with the device. Actually non recommended accessories can affect safety unfavourable. Before using non recommended accessories it is necessary to get in touch with the manufacturer; • ordinary equipment maintenance, inspections, disinfection and cleaning are performed in the way and with the frequency described; • any modification or fixing is carried out by qualified personnel; • the environmental conditions and the electrical plants where the device operates are in compliance with the specifications of the manual and the present regulations concerning electrical plants. In particular grounding reliability and leakage current suppression can only be assured when the device three – wire receptacle is connected to a yellow - green return connected to earth ground. Attempting to defeat the proper connection of the ground wire is dangerous for users and equipment. 2

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3.

Before powering the system, check the power cables and the plugs. Damaged electrical parts must be replaced immediately by authorised personnel. 4. Large gas cylinders, which may be given by the manufacturer or purchased by the customer, should be secured with cylinder safety chains or safety stands. 5. When removing the protective cap, inspect the cylinder valve for damaged threads, dirt, oil or grease. Remove any dust or dirt with a clean cloth. If oil or grease is present on the valve of a cylinder which contains oxygen, do not attempt to use. Such combustible substances in contact with oxygen are explosive. 6. Be certain that the materials of the pressure regulators are chemically compatible with the intended gas service before installation. Inspect the regulator for the proper connection and note the ranges of the pressure gauges. Also examine the physical condition of the regulator including threads and fittings. Remove any dust or dirt from the regulator or cylinder valve with a clean cloth. Do not install a regulator on a cylinder valve containing oxygen if grease or oil is present on either. Such substances in contact with oxygen are explosive. 7. Cleaning residue, particulates, and other contaminates (including pieces of torn or broken components) in the breathing circuit pose a safety risk to the patient during testing procedures. Aspiration of contaminates can potentially be life-threatening. You must follow all the cleaning procedures in System Maintenance, and you must thoroughly inspect the components after cleaning and before each patient test. 8. This device is not suitable for use in presence of flammable anaesthetics. It is not an AP nor an APG device (according to the EN 60 601-1 definitions). 9. Keep the device away from heat and flame source, flammable or inflammable liquids or gases and explosive atmospheres. 10. In accordance with their intended use K4 b2 is not to be handled together with other medical devices unless it is clearly declared by the manufacturer itself. 11. It is recommended to use a computer with electromagnetic compatibility CE marking and with low radiation emission displays. 12. It is necessary to make the PC, connected to the K4 b2, compliant with EN 60601-1 by means of an isolation transformer. 13. Graphical symbols used in accordance to present specifications are described here below: Equipment type B (EN60601-1) Danger: high temperature OFF ON Protective earth ground Alternating current

Chapter 1 - Getting started - 15

Contraindication The physical strain to execute the respiratory manoeuvre is contraindicated in case of some symptoms or pathology. The following list is not complete and must be considered as a piece of mere information.

Contraindications for the Spirometer tests Absolute contraindications

For FVC, VC and MVV tests: • Post-operating state from thoracic surgery For FVC tests: •

Severe instability of the airways (such as a destructive bronchial emphysema)

•

Bronchial non-specific marked hypersensitivity

•

Serious problems for the gas exchange (total or partial respiratory insufficiency)

Relative contraindications

For FVC tests: •

spontaneous post-pneumothorax state

•

arterial-venous aneurysm

•

strong arterial hypertension

• pregnancy with complications at the 3rd month. For MVV test: •

hyperventilation syndrome

Contraindications for Bronchial provocation tests The bronchial provocation tests must be executed according to the doctor’s discretion. There are not data that reveal specific contraindication for the bronchial provocation test through inhalation. The modern standard processes have been revealing secure in several clinical studies. However it is recommendable to respect the following contraindications: Absolute contraindications

•

Serious bronchial obstruction (FEV1 in adults)

•

Recent myocardium infarct

•

Recent vascular-cerebral accident

•

Known arterial aneurysm

•

Incapacity for understanding the provocation test procedures and its implications.

Relative contraindications

•

Bronchial obstruction caused by the respiratory manoeuvre.

•

Moderate or serious bronchial obstruction. For ex. Predicted value FEV1 less than 1.51 in men and predicted value FEV1 in women less than 1.21.

•

Recent infection in the superior air tracts

•

During the asthmatic re-acuting

•

Hypertension

•

Pregnancy

•

A pharmacology treatment epilepsy

Contraindications for Exercise testing Read carefully the exercise testing chapter.

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Environmental condition of use COSMED units have been conceived for operating in medically utilised rooms without potential explosion hazards. The units should not be installed in vicinity of x-ray equipment, motors or transformers with high installed power rating since electric or magnetic interferences may falsify the result of measurements or make them impossible. Due to this the vicinity of power lines is to be avoided as well. Cosmed equipment are not AP not APG devices (according to EN 60601-1): they are not suitable for use in presence of flammable anaesthetic mixtures with air, oxygen or nitrogen protoxide. If not otherwise stated in the shipping documents, Cosmed equipment have been conceived for operating under normal environmental temperatures and conditions [IEC 601-1(1988)/EN 60 601-1 (1990)]. •

Temperature range 10°C (50°F) and 40°C (104°F).

•

Relative humidity range 20% to 80%

•

Atmospheric Pressure range 700 to 1060 mBar

•

Avoid to use it in presence of noxious fumes or dusty environment and near heat sources.

•

Do not place near heat sources.

•

Cardiopulmonary resuscitation emergency equipment accessible.

•

Adequate floor space to assure access to the patient during exercise testing.

•

Adequate ventilation in the room.

Chapter 1 - Getting started - 17

Safety and conformity Safety

IEC 601-1 (1988) /EN 60 601-1 (1990); Find reported below the complete classification of the device: •

Class I type B device

•

Protection against water penetration: IP00, ordinary equipment unprotected against water penetration

•

Non sterile device

•

Device not suitable in the presence of flammable anaesthetics;

•

Continuous functioning equipment;

EMC

The system meets the EMC Directive 89/336 EN 60601-1-2 EN 55011 Class B (emission), IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4 Telemetry

I-ETS 300 220, CEPT T/R 01-04 pr ETS RES 0908 (CE type conformity) Transmission frequency and output power can be changed upon request according to the destination country requirements. Quality Assurance

UNI ISO 9001 (Registration n° 387 Cermet) Medical Device Directive (CE mark)

MDD 93/42/EEC (Notified Body 0476). Class IIa

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Keynotes Here are the keynotes used to make the manual easier to read.

Typographic keynotes These are the typographic keynotes used in the manual. Style

Description

Bold “Italic”

indicates a control or a key to be pressed. indicates a messages shown by the firmware.

Graphic keynotes These are the graphic keynotes used in the manual. Illustration

Description

shows the button to click in the software to activate the related feature.

Chapter 1 - Getting started - 19

System overview Portable Unit (PU) It is fixed to the patient during the test by an anatomic harness. The PU contains the O2 and CO2 analyzers, sampling pump, UHF transmitter, barometric sensors and electronics. It is powered by the rechargeable battery fixed to the back side of the harness. K4 b² is also provided with a small display, the PU shows in real time the following parameters: VT, VE, VO2, VCO2, R, HR, Rf Marker, battery charge level, temperature and barometric pressure. Besides data processing and presentation, the Portable Unit has the following functions: •

Patient data input

•

Environment data input (humidity)

•

Gas and turbine calibration (automatic)

•

Memory functions

•

Tests data management

•

Data loading to a PC (via RS232)

Telemetry Data Transmission, Receiver Unit (RU)

The RU consists of a small unit connected to a PC through the RS 232 serial port. The transmission is achieved by a miniaturized transmitter module located inside the Portable Unit.

Battery Charger Unit (CU)

The CU allows the simultaneously charge of the 3 Ni-Cd batteries and to supply the PU during the warm up time.

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Flowmeter The system uses a bi-directional digital turbine. It opposes a very low resistance to flow (<0,7 cmH2O/l/s to 12 l/s). The air passing through the helical conveyors, takes a spiral motion which causes the rotation of the turbine rotor. The rolling blade interrupts the infrared light beamed by the three diodes of the optoelectronic reader. Every interruption represents 1/6 turn of the rotor, this allows to measure the number of turn in the time.

Gas analysers The O2 and CO2 analysers are temperature-controlled and the internal pressure and expired flow are monitored for an higher reliability if the measurements. The K4 b² uses Nafion Permapure ® which is a semipermeable capillary tube capable of removing the humidity in excess without altering the gas concentrations.. The analysers calibration is automatic and shows both graphically and numerically the flow and concentration signals and the accuracy of the baseline/gain.

PC Software The PC software, running on Windows™, allows the user to manage data stored in the Portable Unit or transmitted to PC. Here following a list of the main features available: •

Test data management.

•

Viewing data in table and graphic form

•

Automatic and manual detection of anaerobic threshold (modified V-slope method).

•

On-line data presentation during tests.

•

Advanced data elaboration (filtering, smoothing, built in spread-sheet features).

•

O2 Kinetics (O2 deficit, O2 debt and time constant in both rising and falling edge of a constant load exercise test).

•

Flow-Volume loops during the test and overlapped on the rest FVC.

•

Real time display of the O2 and CO2 waveforms during the test.

•

Control of any ergometer provided with a RS232 interface.

•

Custom fittings (linear and exponential).

•

Spirometry (FVC, VC, IVC, MVV).

•

File exporting in three different formats (Lotus 123™, Excel™, ASCII).

•

Automatic detection of the "Steady State".

•

Adding parameters and predicted equations trough the "Formula Editor" tool-kit.

•

DDE with Microsoft Excel.

•

Customizing software environments (colours, printed parameters...).

•

Help on line.

Chapter 1 - Getting started - 21