Attachment 3 Revised Operation Manual

Transcription

1 Attachment 3 Revised Operation Manual

2 CardioTech GT-105 Spirometry System Operation Manual REV. 1.4

3 Warning Information WARNING The user should read and understand all product literature, labeling and warnings prior to operation GT-105 spirometry system Throughout this manual, the following indicators are used as follows; WARNING Warning alerts the user to potential serious outcomes (including injury or adverse events) to the patient or user. It also alerts the user to potential serious damages to the stored data or the unit. NOTE Important information for the safe, effective, and convenient use of GT-105 spirometer. -1- Rev.1.4

4 Table of Contents 1. Precautions Introduction Spirometry / Intended use 3. Configuration Standard accessories / Parts description 4. System Preparation Hardware attachment 5. Basic Operation Operational procedure 6. Pre-measurement Settings General settings / Factory defaults setting 7. Calibration Patient ID Input Spirometry Tests SVC / FVC / MVV / MV 10. BD [Bronchodilator] Test. 49 FVC 11. Challenge Test Interpretation 59 Spirometry / COPD / QC check 13. Patient Database Database / Data batch processing -2- Rev.1.4

5 14. Description of the Measured Parameters SVC / FVC/ MVV/ MV 15. Print-out Predicted Formula Knudson / Morris / Polgar / ITS / ECCS / Crapo-Hsu / ASIA / Predicted Curve 17. Maintenance.. 84 Cleaning / 18. Troubleshooting Guide Glossary of Spirometry Terms Technical References 92 Product specifications 21. Environment Protection Accessories. 94 Accessories / Spirobank software 23. Limited Warranty Contact Information. 97 EC representative / Manufacturer / Your local dealer -3- Rev.1.4

6 1. Precautions WARNING Please read this operation manual carefully, and operate GT-105 spirometry system properly and safely. 1. Precautions 1.1 Contraindication and prohibition Precautions for use Prepare the device for operation according to instructions in this operation manual. Check to be sure that all the cords are connected correctly and firmly. When the device is used with other equipment, check to be sure that they can be used safely without causing mutual interference. Observe the patient closely. If any abnormality is observed, proper action, which may include stopping the test, should be taken immediately. Do not allow the patient to touch the device directly. When disconnecting the cords, do not apply excessive force. Clean the accessories, cords, and flow sensor after use. Keep them in a clean environment. A bacterial filter must be used to reduce the risk of patient cross contamination. If any abnormality is found in the device, Turn off the power and plug off the Flow sensor cord. In case of malfunction, mark the device with the notice, "FAILURE" or "DON'T USE". And contact our sales office, our authorized representative, or medical dealer in your area as quickly as possible. GT-105 should be used by trained healthcare professionals and is not intended for patient operation. Equipments connected to Signal I/O ports, such as RS-232C and USB have to comply with IEC If not, IEC In order to connect other equipments, use a separation transformer for the power supply, or connect it by means of a separation device Precautions for handling Strong electromagnetic waves in the surrounding may cause noise in the curve or malfunction. If any unexpected malfunction occurs during operation, check the electromagnetic environment and take appropriate measures. Examples: 1) Use of a cellular phone The electromagnetic wave may cause unexpected malfunction. Turn off the power source of cellular phones and radio equipment in the room or building where electrical equipment for medical equipment is installed. 2) When high-frequency noise generated by other equipment enters through the socket for power source Identify the source of noise, and take countermeasures such as installing a noise limiter in the circuit. If possible, stop the operation of the equipment that generates the noise. Connect the power cord to another power supply socket. 3) Electrostatic effect (caused by electrical discharge in the device or in the surrounding) Completely remove the electrostatic charge from the operator and patient. Humidify the room. 4) Effect of thunderbolt An excessive voltage may be induced in the device when a thunderbolt occurs in the neighborhood. In such a case, operate the device using an uninterrupted power supply. -4- Rev.1.4

7 5) Noise generation If noise is caused to a receiver of radio or television by the device, move the receiver to a distant place from the device Precautions for installation Avoid placing the device in the following places. 1) A place likely to be splashed with water. 2) A place with the direct sun light, high temperature, high humidity, dust, and air containing salt or sulfur. 3) A place with inclination, vibration, or shock (same during transportation.) 4) A place where chemical substances are stored or gasses are generated Precautions for maintenance and inspection Do not make any modifications to the devices; any modifications made will void the warranty. Do not disassemble the device, anytime. Perform routine maintenance and inspection on the device. 1.2 Standards and Compliance Electrical Safety Standards IEC : IEC (Electrical Safety), IEC : 2000 (EMC) EMC COMPLIANCE Guidance and manufacturer's declaration - electromagnetic emissions GT-105 is intended for use in the electromagnetic environment specified below. The customer or the user of the GT-105 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR11 CISPR11 CISPR11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Class B Complies GT-105 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. GT-105 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and manufacturer's declaration - electromagnetic immunity The GT-105 is intended for use in the electromagnetic environment specified below. The customer or the user of the GT-105 should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC ±6kV Contact ±8kV air ±6kV Contact ±8kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst ±2kV for power supply lines ±2kV for power supply lines Main power quality should be that of a typical commercial or hospital environment. IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply input lines ±1kV mode differential ±2kV common mode <5% UT (>95% dip in UT ) for 0.5 cycle <40% UT (>60% dip in UT) for 5 cycle ±1kV mode differential ±2kV common mode <5% UT (>95% dip in UT ) for 0.5 cycle <40% UT (>60% dip in UT) for 5 cycle Main power quality should be that of a typical commercial or hospital environment. Main power quality should be that of a typical commercial or hospital environment. If the user of GT-105 requires continued operation during power mains interruptions, it is recommended that GT-105 be powered from an uninterruptible power supply or a battery. -5- Rev.1.4

8 IEC Power frequency (50/60Hz) magnetic field IEC <70% UT (>30% dip in UT) for 25 cycle" <70% UT (>30% dip in UT) for 25 cycle" 3 A/m 3 A/m If image distortion occurs, it may be necessary to position GT-105 further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low. Guidance and manufacturer's declaration - electromagnetic immunity The GT-105 is intended for use in the electromagnetic environment specified below. The customer or the user of the GT-105 should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Conducted RF IEC Vrms 150kHz to 80MHz 3 Vrms [V1] Portable and mobile RF communications equipment should be used no closer to any part of GT-105, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d=[3.5/v1] P 150kHz to 80MHz Radiated RF IEC V/m 80MHz to 2.5GHz 3 V/m [V1] d=[3.5/e1] P 80MHz to 800MHz d=[7/e1] P 800MHz to 2.5GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range interference may occur in the vicinity of equipment marked with the following symbol: Guidance and manufacturer's declaration - electromagnetic immunity GT-105 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the GT-105 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and GT-105 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150kHz to 80MHz d=[3.5/v1] P 80MHz to 800MHz d=[3.5/e1] P MHz to 2.5GHz d=[7/e1] P Name of cable Manufacturer Length Shielding Ferrite Core AC power cable for Kawasaki Electric Wire 3.0m None Provided 220V AC power cable for Kawasaki Electric Wire 3.0m None Provided 100V The EMC of GT-105 had been tested based on the criteria described above. -6- Rev.1.4

9 2. Introduction Thank you for purchasing the CardioTech, GT-105. GT-105 provides you SVC, FVC, MVV, MV, and bronchodilator inhalation & broncho-constrictor challenge tests. Patient data can be saved in the internal memory, also be downloaded to a computer for database creation and A4 printing with optional Spirobank software. It also provides the useful information to help physicians to diagnose patients lung function as well as COPD. GT-105 features the large full color LCD, high-speed in-line thermal printer, highly accurate pneumotacho flow sensor, and RS-232C/USB interfaces for data transfer. GT-105 is suitable in early detection of respiratory impairments such as Asthma and COPD. We trust our product will enable you to use office-based Spirometry tests to diagnose and enhance your patient s pulmonary health. Caution: Federal (U.S.A.) restricts this device to sale by or on the order of a physician. Spirometry testing Spirometry is used to measure the rate at which the lung changes volume during forced breathing maneuvers. The most commonly performed test procedure uses the forced expiratory vital capacity (FVC) maneuver, in which the subject inhales maximally and then exhales as rapidly and completely as possible. The FVC test is the most important. Generally, it provides most of the information that is to be obtained from pulmonary function testing. ( Interpretation of Pulmonary Function Tests by Robert Hyatt et al) The FVC test shows how fast he can blow (flow) and how much he can blow (volume). These parameters are compared to normal values derived from Predicted formula based upon the patient s age, height and sex. Depending on the results, it is decided whether the patient is normal, or has an obstructive or a restrictive lung disease. Scope of this manual This manual will show you how to use the CardioTech, GT-105 Spirometry system. Read and understand the entire manual before trying to use this device. Intended use CardioTech, GT-105 Spirometry system 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 s responsibility. It is intended for use with pediatric and adult patients in hospitals, physicians offices, and occupational health testing environments. Indications for use The CardioTech Spirometry System, Model GT-105 is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient s lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician s offices, laboratories, and occupational health environments. -7- Rev.1.4

10 3. Configuration Standard Accessories When you get your CardioTech GT-105, carefully open the box and unpack the system. Make sure that you have all the parts listed below and that nothing looks damaged. Included with this system are the following: # Description Q ty 1. Cardboard mouthpiece (50pcs/box) * 1 box 2. Nose clip (Plastic) 1 pcs 3. Printer paper (112mm width, thermal) 1 roll 4. Flow sensor head 2 pcs 5. Flow sensor body 1 pc 6. Power cord & AC adapter 1 pc 7. Operation manual 1 copy A bacterial filter*, purchased separately, must be used with the CardioTech GT-105 Spirometer. * single patient use (1) (2) (3) (4) (5) (6) (7) -8- Rev.1.4

11 <OVERVIEW> Front View of GT-105 Part Name Note (1) Flow Sensor Holder Use this holder as a grip when you carry the unit (2) Printer Cover Opened by the one-touch lever (3) Printer (under the cover) 112mm width inline printer (4) LCD Color 8 inch LCD (5) One-touch Lever To open Printer cover (6) Operation Panel *See next page for details Rear View of GT-105 Part Name Note (1) Mouse Connection Port PS2 Mouse Only (2) Power Supply inlet For connecting the power cord Side View of GT Rev.1.4

12 Part Name Note (1) Power Switch Power ON and OFF (2) LCD Brightness adjuster Change the brightness of LCD (3) USB Connection Port For Data transfer (4) RS-232C Comm. Port For Data transfer (5) Flow Sensor Spiral Tube Connect Tube A to A and Tube B to B Connection Ports (6) Upper case (7) Lower case Operation Panel (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14) (15) (16) (17) (18) Part Name Note (1) ID key For Entering Patient information (2) Data Save Key For Saving Measurement data (CF memory) (3) Data Transfer Key For Transferring the data to PC (4) Interpretation Key For Viewing the diagnostic interpretation (5) BD Test Key For Bronchodilator test (6) Menu Key For Main Menu screen (7) Clear Key For Correcting or canceling the data (8) Start Key For Starting the measurement (9) Stop Key For Stopping the measurement (10) Print Key For Printing (11) Arrow Keys For Moving cursor (12) Numeric Keys For Entering numbers (13) Return Key For Confirming the data (14) SVC Key For SVC measurement (15) FVC Key For FVC measurement (16) MVV/MV Key For Selecting MVV or MV measurement (17) MTC key For Methacholine Challenge Test (18) Pilot lamp Green: Operating by AC Power Orange: DC is being charged Off: Operation by DC power -10- Rev.1.4

13 4. System Preparation Make sure that the power switch of GT-105 is OFF before attaching the power cord, flow sensor, and other optional device, such as mouse, RS-232C, and USB cables.. WARNING Be sure to connect the power cord to the right voltage power outlet. 1. Connecting the Power cord 1) Connect the attached power cord to the power supply inlet located in the rear of the body. 2) Connect the other end of the cord to V or VAC, 50/60Hz power supply. 2. Connecting the Flow sensor spiral tube 1) Attach the coupler of the sensor tube A to the sensor tube connection port A on the unit. 2) Attach the coupler of the sensor tube B to the sensor tube connection port B on the unit. Sensor tube Coupler Sensor tube connection port 3) Turn and secure the couplers as drawn Rev.1.4

14 4) Make sure that the couplers are fixed tightly. 5) To detach the sensor tubes, turn the coupler counterclockwise. 3. Preparing the Flow sensor Bacterial filter Mouthpiece Flow Sensor Head 1) Insert the Flow sensor head into a Flow sensor body. * Adjust the marks of the Flow sensor head and the Flow sensor body. * marks are shown only on one side. 2) Insert them completely. * Make sure it is secured. 3) Connect the Bacterial filter to the mouthpiece connecting port of the flow sensor head. * Connect the Mouthpiece to the bacterial filter. * Please clean or replace the flow sensor head if necessary in order to prevent infection. * Bacterial filter prevents infection and contamination inside the flow sensor head. Using the bacterial filter is required. * Please prepare new mouthpieces and bacterial filters before starting measurements. CAUTIONS Do not disassemble the flow sensor body. If you do, it may affect measurement accuracy and hampers measurement. After cleaning the flow sensor head, make sure that it is completely dry before using it. Do not insert the finger or a stick inside the flow sensor head. It may stain or damage the film. Do not use the flow sensor heads with the film inside is contorted or bent. Please replace with new one. Do not use the flow sensor head that was dropped or collided. Please replace with new one Rev.1.4

15 4. Placing the Printer paper 1) Pull the printer lever in the arrow direction and open the printer cover as shown in the figure. 2) Place the printer paper roll into the unit. 3) Pull out some paper for extra and close the printer cover completely with click. 5. Connecting other devices (Option) A) Mouse Connect the PS/2 mouse firmly to the mouse port on the back of GT-105. * A mouse with USB/PS2 adapter can not be worked basically. (Some mouse withusb/ps2 adapter is worked, but we can not guarantee.) * A wheel of the mouse is not worked on GT-105. * In order to use a mouse, settings on the Menu are needed. (See Pre-measurement setting for details). Wheel B) PC connection using Spirobank Spirobank database software is an easy to use PC based Windows application that interfaces to GT-105 via USB or RS-232C ports. The patient data as well as the test results can be saved on the PC almost unlimitedly. The results and graphs are displayed directly on the PC screen, and printed on A4 or letter sized paper. * Spirobank database software for Windows is optionally available. * In order to transfer the data, some settings on the Menu are required. (See Pre-measurement setting for details) Rev.1.4

16 5. Basic Operation The basic procedure from switching ON the power supply to finishing measurement is as follows -14- Rev.1.4

17 1) Confirm all connections are done properly. 2) Turn on the Power 3) <Main Menu> screen is displayed. 4) Press the [ID Input] key 5) Input the patient information 6) Press [COPD] key for COPD diagnosis (if needed) 7) Input present respiratory conditions 8) Pres [ID input screen] key to go back ID screen 9) Press measurement mode key, such as [SVC] or [FVC] -15- Rev.1.4

18 10) Prepare the Flow sensor 11) Press [Start] key 12) After the flow zero adjustment, perform the measurement 13) Press [Stop] key after the measurement 14) Confirm the test result 15) Press [Data Save] key (if needed) 16) Press [Print] key (if needed) 17) Turn off the Power -16- Rev.1.4

19 6. Pre-Measurement Settings CardioTech, GT-105 can be configured to meet your individual needs. You can change the default settings, as you like. Press [Configuration] key on the <Main Menu> screen. [Configuration] screen will be displayed. Move cursor to each tab to [General] to [Program update] and press [Return] key to select. [General] Basic settings in hardware/software + Clock/Calendar Environment Data select Waveform scale Beep sound Data backup Choose the best data selection method from Manual, Auto, or ATS protocol. When Auto is chosen, all parameters are taken from the one largest SVC, FVC+FEV1, MVV, and MV tests. When ATS is chosen, the largest FVC and FEV1 are taken among the tests, even if they do not come from the same curve. All other measuring items of FVC are taken from the largest sum of FVC+FEV1 test. When Auto is chosen, the graph scale is changed automatically to show whole waveform accordingly. When Yes is chosen, the beep sounds by pressing keys. When Yes is chosen, the last test data before the power OFF is stored in memory automatically. And it appears on ID screen and the each measurement mode at the power ON. When No is chosen, no data is left on ID screen as well as on the each measurement mode at the power ON. Mouse operation When Yes is chosen, the mouse can be used to move cursor. Calendar Date format Time format Current date Current time Choose one from Y/M/D, M/D/Y, and D/M/Y as a date format. Sets the time format for 24 or 12 hour (Am/Pm). Enter the correct local date. Enter the correct local time. Press [Configuration] key to go back to the <Configuration> screen -17- Rev.1.4

20 [ID Input] Choose the items to input as patient s information Input Items Meas. units Name Birthdate Race Room Temp. Humidity Atm.Pr. Predicted Height Weight Room temp. Atm. Pr. When Yes is chosen, a patient name can be input on the <ID input> screen. (In order to input a patient name, a Mouse is needed.) When Yes is chosen, a patient s birthdate can be input on the <ID input> screen. (When the birthdate is input, the patient s age is calculated automatically.) When Yes is chosen, a patient s ethnic group can be input on the <ID input> screen. When Yes is chosen, room temperature can be input on the <ID input> screen. When No is chosen, the last input temperature is always used. The default setting is 37 degree in Celsius. Input the correct room temperature before No is chosen. When Yes is chosen, humidity can be input on the <ID input> screen. When No is chosen, the last input Humidity is always used. The default setting is 50.0%. Input the correct humidity before No is chosen. When Yes is chosen, atmospheric pressure can be input on the <ID input> screen. When No is chosen, the last input atmospheric pressure is always used. The default setting is hpa. Input the correct atmospheric pressure before No is chosen. When Yes is chosen, the selected predicted formula is appeared on the <ID input> screen. Choose preferred unit for a patient s height. Choose preferred unit for a patient s weight. Choose preferred unit for a room temperature. Choose preferred unit for a atmospheric pressure. Press [Configuration] key to go back to the <Configuration> screen [Keyboard] Choose the preferred keyboard layout Keyboard display Choose preferred Keyboard type on the <ID input> screen. QWERTY (see below) is the standard type, while AZERTY is normally used in France. Choose OFF if not needed. <ID input> screen with QWERTY virtual keyboard Press [Configuration] key to go back to the < Configuration> screen -18- Rev.1.4

21 [Evaluation] Upon completion of SVC and/or FVC tests, GT-105 will generate an interpretation of the test data. The interpretation criteria are those suggested by the ATS (American Thoracic Society) statement. ( Lung function testing AM Rev Respir. Dis., Selection of Reference Values and Interpretative Strategies, 144: , 1991) Normal limits Obstruction Restriction Input any percentage as LLN (Lower Limit of Normal Range) in both %SVC and FEV1%. Input any percentage for the each stage of Obstructive pulmonary disease. Input any percentage for the each stage of Restrictive pulmonary disease. WARNING We recommend not changing the default setting of ATS interpretation criteria as it is internationally well accepted. LLN in default setting NOTE Because data from poor patient efforts may result in false interpretations, careful analysis of the data is needed, especially when No are shown in the test quality check. Press [Configuration] key to go back to the <Configuration> screen -19- Rev.1.4

22 [Test QC] The quality of each patient effort in FVC test is checked based upon the ATS acceptability and reproducibility criteria. When Yes is chosen, OK or NO message is displayed at the end of the FVC test. Acceptability Reproducibility Ex. Start (Extrap V) Ex. Effort 1 (PEF Time) Ex. Effort 2 (FET) Ex. Duration Ex. Effort (FVC) Ex. Flow (FEV1.0) When Yes is chosen, the test maneuver of the right start is checked. When Yes is chosen, the test maneuver of forcefulness of exhalation is checked. When Yes is chosen, the test maneuver of exhalation time length is checked. When Yes is chosen, the test maneuver of completion of exhalation is checked. When Yes is chosen, the test reproducibility of exhalation volume is checked. When Yes is chosen, the test reproducibility of exhalation flow is checked. NOTE The acceptability checks are only recommendations and not requirements. Please use your own judgment when deciding to accept or reject a test. Press [Configuration] key to go back to the <Configuration> screen [Print] Choose preferred data transaction when [Print] key is pressed Print only When it is chosen, the test data is only printed by pressing [Print] key. Key function Print + Save Print + Send When it is chosen, the test data is printed and saved by pressing [Print] key. When it is chosen, the test data is printed and sent to the PC by pressing [Print] key. Print + Save + Sand When it is chosen, the test data is printed, saved, and sent to the PC by pressing [Print] key Rev.1.4

23 Print style #1 Without BD test Printed in order of [MEAS], [PRED], [%PRED] With BD test Printed in order of [MEAS], [PRED], [%PRED], [BD], [%CHANGE] (in 1 line) #2 Without BD test Printed in order of [MEAS], [PRED], [%PRED] With BD test #3 Without or with BD test Printed in order of [MEAS], [PRED], [%PRED] in the 1 st line; and [MEAS], [BD], [%CHANGE] in the 2 nd line. Printed in order of [MEAS], [PRED], [%PRED], [BD], [%CHANGE] (in one line) #4 Without BD test Printed in order of [MEAS], [PRED], [%PRED] With BD test Printed in order of [MEAS], [BD], [%CHANGE] (in 1 line) Print style #1 without BD Print style #1 with BD -21- Rev.1.4

24 Items to print Format 1 Format 2 All items Move cursor to the items to print and press [0] key to choose [PRINT] or [NOT PRINT] respectively. Press [Setup completed] key to save the setting as Format 1. Move cursor to the items to print and press [0] key to choose [PRINT] or [NOT PRINT] respectively. Press [Setup completed] key to save the setting as Format 2. All available printing items are printed. They are Header: (Print title) ID information: (Name, ID No & Date, Sex, Age, Height, Weight, BSA, Date, Race, Birthdate, Room temp., Humidity, Atm.Pr., Pred.Formula, Cal.Date, Physician, Comment) Graphs and Charts: (Diag.Commnet, Diag.Graph, QC Check, Cal.Report, Pentagon Graph, COPD Class., SVC curve, FVC curve (F/V), FVC curve (V/T) 1, FVC curve (V/T) 2, Pred. curve, MVV curve, MV curve) Items to print FVC curve (V/T) 1 FVC curve (V/T) 12 Measuring items: (SVC, IC, TV, ERV, IRV, SVC/HT, FVC, FEV0.5, FEV1, FEV3, FEV6, FEV0.5%, FEV1/FVC, FEV1/SVC, FEV3%, FEV6%, FVC/HT, FEV1/HT, FEV1/SVCpr, MMEF, PEF, FEF25, FEF50, FEF75, FEF90, FEF50/FEF75, PEF/HT, FEF25/HT, FEF50/HT, FEF75/HT, FEF75-85, FEF , MTC75-50, MTC50-25, MTC25-RV, MTCR, OI, ATI, PEF TIME, FET, ExtrapV, ExtrapV%, FIVC, FIV0.5, FIV1, FIV1/FVC, FIV1/FIVC, PIF, FIF50, FEF50/FIF50, FIF50/FEF50, CVI, MVV43, FVC+FEV1, MMEF/FVC, MVV, TV, RR, MVV/BSA, AVI, MV, TV, RR, BR, VR) Challenge Test: PC20, PD20, Threshold, FEV1.0, MCT Curve # to print (Int) Number of copies to print by the Internal printer. (1-9 copies) Print title edit Header of the print-out can be changed as you like. Type any words using a mouse Rev.1.4

25 Header (Default: Spirometry Test Report) Example) International Univ. Hosp. Press [Configuration] key to go back to the <Configuration> screen [Predicted formula] Patient s measured values are compared to normal values derived from Predicted formula based upon the patient s age, height and sex. Depending on the results, it is decided whether the patient is normal, or has an obstructive or a restrictive lung disease. Diagnosis Race adjust. Pred. formula Caucasian Black Asian Other Choose one predicted formula from KNUDSON, MORRIS, POLGAR, ITS, ECCS, CRAPO-Hsu, or ASIA 1-6. *Knudson is the most popular predicted formula in the North America and its influence area. *ECCS is the most popular predicted formula in Europe and its influence area. *For Asian people, either ASIA1 or ASIA3 are recommended. ASIA1 is Japan s traditional predicted formula with 30yrs or more history. ASIA 3 is the most updated one by the Japanese Respiratory Society (compilation). If desired, apply an adjustment factor by race to which the predicted value and LLN calculations will be multiplied. If not sure, we strongly recommend not to change the default values. NOTE No Predicted formula covers all spirometry measuring items, (such as FEV1, PEF, MMEF, etc) for all age, height, and sex groups of patients. For your convenience, the secondary Predicted formula may be used to complete it. For example, Knudson does not have predicted equation for FEF In order to complete it ITS predicted equation for FEF75-85 is taken. ECCS does not have the predicted equations for 17 or younger people. For the age group, Quanjer & Tammeling Comparisons Predicted formula is taken. Please refer the Predicted formula table at the end of this manual for details Rev.1.4

26 NOTE The patient s height, age, and sex must be entered or no predicted values are available. Press [Configuration] key to go back to the <Configuration> screen [Spirometry] Basic settings in the Spirometry test. SVC FVC MVV Rest ventilation Graph baseline SVC<FVC select Meas. mode Predicted curve F(Vol) mode Start MVV/MV Choose the number of rest ventilation before SVC test is started. (One from 3, 5 or 7 times of TV) Choose the position of the SVC waveform in the graph, either RV level or FRC level. (See below) SVC: Always his best SVC value is taken as his SVC. FVC: FVC value is taken as his SVC value when his FVC value is bigger than his SVC value. Choose the test mode of FVC test, which appears initially on the screen. (One from Flow/Volume, Volume/Time, or Cartoon. See the next page.) With or Without Predicted curve in the FVC graph. (See the next page.) Ex only: Only Exhalation curve is displayed Ex + In: Both Ex. and Inhalation curve are displayed. (See the next page.) Single: MVV test is started by pressing [Start] key once. Double: MVV test is started by pressing [Start] key twice MVV: Only [MVV] test mode key is displayed when [MVV/MV] key is pressed. MV: Only [MV] test mode key is displayed when [MVV/MV] key is pressed. Both: Both [MVV] and [MV] test mode keys are displayed when [MVV/MV] key is pressed. RV level FRC level -24- Rev.1.4

27 Flow/Volume graph Volume/Time graph Cartoon Predicted curve Actual patient s FVC curve Exhalation only Exhalation + Inhalation Press [Configuration] key to go back to the <Configuration> screen [Communication] Data transmission conditions have to be set in order to transfer the data measured by GT-105 to the PC. Correctly input the conditions to be corresponded with the computer conditions. Interface Port USB or RS-232C RS-232C Data to transmit Baud rate 2400, 4800, 9600, 19200, or Parity Naught, Even, or Odd Data lenght 8 or 7 Stop bit 1, 1.5, or 2 Spiro. Data Spiro. Waveform When Yes is chosen, the numerical data in Spirometry test are transmitted. When YES is chosen, the waveform data in Spirometry test are transmitted Rev.1.4

28 MCT. data When Yes is chosen, the numerical data in Methacholine challenge test are transmitted. MCT Waveform When YES is chosen, the waveform data in Methacholine Challenge test are transmitted. NOTE In order to transact the data on PC, The Spirobank software is needed (Option). Press [Configuration] key to go back to the <Configuration> screen [Items to display] Choose preferred items to display after the test. Items to print Move cursor to the items to display and press [0] key to choose [DISPLAY] or [NOT DISPLAY] respectively. Also choose the items to show in the Pentagon Graph (see next page). Press [Configuration] key to save the setting. Items to display -26- Rev.1.4

29 Pentagon Graph Pentagon Graph Items to display Choose any Five items %VC, %FEV0.5, %FEV1, %FEV3, %FEV0.5%, %FEV1/FVC, %FEV1/SVC, %FEV3%, %VC/HT, FEV1/HT, %MMEF, %PEF, %FEF25, %FEF50, %FEF75,%PEF/HT, %FEF50/HT, %FEF75/HT, %FEF75-85, %FEF , %FIVC, %MVV43 Choose any items. Available items to display are SVC: SVC, SVCpr, %SVC, IC, TV, IRV, ERV, SVC/HT, SVC/HTpr, %SVC/HT MVV: MVV, MVVpr, %MVV, TV, RR, MVV/BSA, AVI, MV: MV, TV, RR, BR, VR FVC: FVC, FVCpr, %FVC, FEV0.5, FEV0.5pr, %FEV0.5, %FEV0.5, FEV1, FEV1pr, %FEV1, FEV3, FEV3pr, %FEV3, FEV6, FEV0.5%, FEV0.5%pr, %FEV0.5%, FEV1/FVC, %FEV1/FVCpr, FEV1/SVC, FEV1/SVCpr, %FEV1/SVC, FEV3%, FEV3%pr, %FEV3%, FEV6%, FVC/HT, FVC/HTpr, %FVC/HT, FEV1/HT, FEV1/HTpr, %FEV1/HT, FEV1/SVCpr, MMEF, MMEFpr, %MMEF, PEF, PEFpr, %PEF, FEF25, FEF25pr, %FEF25, FEF50, FEF50pr, %FEF50, FEF75, FEF75pr, %FEF75, FEF90, FEF50/FEF75, PEF/HT, PEFHTpr, %PEF/HT, FEF25/HT, FEF50/HT, FEF50/HTpr, %FEF50/HT, FEF75/HT, FEF75/HTpr, %FEF75/HT, FEF75-85, FEF75-85pr, %FEF75-85, FEF , FEF pr, %FEF , MTC75-50, MTC50-25, MTC25-RV, MTCR, OI, ATI, PEF TIME, FET, ExtrapV, ExtrapV%, FIVC, FIVCpr, %FIVC, FIV0.5, FIV1, FIV1/FVC, FIV1/FIVC, PIF, FIF50, FEF50/FIF50, FIF50/FEF50, CVI, MVV43, MVV43pr, %MVV43, FVC+FEV1, MMEF/FVC Challenge Test: PC20, PD20, Threshold, FEV1.0 Press [Configuration] key to go back to the <Configuration> screen -27- Rev.1.4

30 7. Calibration In order to keep high degree in accuracy, it is recommended to calibrate the flow sensor periodically. GT-105 automates this process quickly and easily NOTE The American Thoracic Society (ATS) recommends a daily calibration of any Spirometer by 3L syringe. 1) Press [-] key or click [Calibration] button on the <Main menu> screen. 2) Press key or click the [SNSR#] button on the <Calibration> screen. 3) Enter the Flow sensor head number (1-10) to be calibrated and Syringe capacity (1L to 6L) to be used Rev.1.4

31 NOTE The calibration factor for each flow sensor head can be stored in memory. If you calibrate multiple flow sensor heads at a time before the test, the flow sensor head can be changed anytime during the test without calibration. (Press [ SNSR#] key on <ID input> screen to change the flow sensor head.) It would be useful to mark on each flow sensor head to distinguish one from another. The extra flow sensor heads can be purchased optionally. 4) Connect the flow sensor and the syringe with the silicone adapter. 5) Press [Start] key to start calibration. The following messages will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, do not move the syringe plunger. Hold the flow sensor without moving. 6) After the Flow Zero message, move the syringe plunger back and forth repeatedly. Keep moving the syringe plunger until it is automatically stopped Rev.1.4

32 NOTE Move the calibration syringe plunger to reach the upper and lower blue lines on the graph. 7) Be sure that OK signs are appeared both in Ex (Expiration) and In (Inspiration) at the Judgment of <Result>. (If NG is appeared, press [Start] key to repeat the calibration procedure. Usually OK signs are appeared in one or two trials of calibration.) OK or NG sign appears OK or NG sign appears NOTE Technically and physically, it is not necessary to perform calibration so frequently as long as it is well maintained. However, in order to secure the high accuracy, we also recommend doing it once a day of use as the ATS recommend. NOTE Allow more than 10 minute heat run to stabilize the electrical system before calibration. Press any of [SVC], [FVC], [MVV/MV], [ID], or [Menu] key after the calibration Rev.1.4

33 8. Patient ID Input 1) Press the [ID] key on the <Main menu > screen. * Items to input on ID screen should be selected in [ID Input] on [Configuration] screen. 2) Input the test date. 3) Input the ID number. (When it is changed, choose either New Patient or ID# Re-enter. When New Patient is chosen, all ID data and test data are cleared. When ID# Re-enter is chosen, his ID data and the last test data remain.) 4) Input the Patient s name. (Press the virtual keys by clicking a mouse.) 5) Input the Patient s gender. (*Sex information is needed to obtain his predicted value.) 6) Input the Patient s birthdate. 7) Input the Patient s age (If the birthdate is correctly input, his age is appeared automatically. *Age information is needed to obtain his predicted value.) 8) Input the Patient s height. (*Height information is needed to obtain his predicted value.) 9) Input the Patient s weight 10) Input the temperature of the test room. 11) Input the humidity of the test room. 12) Input the atmospheric pressure of the test room. NOTE Since air volumes vary with temperature and pressure (Boyle s law), Input correct values in both Temperature and Air Pressure as accurate as possible. (Standard Air Pressure (Atm) : hpa or 760mmHg at sea level.) 13) If COPD diagnosis by GOLD is needed, press key or click [COPD] button, and enter the patient s respiratory conditions Rev.1.4

34 Questionnaire screen for <COPD diagnosis by Gold> Press [ID input screen] key to go back to the <ID Input> screen 14) If needed, press key, and select the flow sensor head # to be used. NOTE The calibration factor for each flow sensor head can be stored in memory. If you calibrate multiple flow sensor heads at a time before the test, the flow sensor head can be changed anytime during the test without calibration. The extra flow sensor heads can be purchased optionally. Press [ID input screen] key to go back to the <ID Input> screen Press any of [SVC], [FVC], [MVV/MV], or [Menu] key Rev.1.4

35 9. Spirometry Tests Preparation for the measurement (*Excerpt from NIOSH SPIROMETRY TRAINING GUIDE ) 1) Attach the mouthpiece* and bacterial filter* to the flow sensor, and apply the nose clip to the patient as he may blow out or inhale through the nose during the test. *single patient use Mouthpiece* Bacterial filter* Flow Sensor Head 2) Prepare the patient. Explain the purpose of spirometry: I want to learn how hard and fast you can breathe. Note the previous position used (sitting or standing) in past Spirometric tests and use the same position if possible. Record the position to be used in the chart. Instruct the patient to loosen tight clothing, elevate the chin, and extend the neck slightly. Show the patient how to apply a nose clip and check to see that it is on properly. 3) Perform the test Explain how to position the mouthpiece (in mouth without obstruction from teeth or tongue, with a tight lip seal). Explain and demonstrate how to perform the forced expiratory maneuver. (e.g., FVC test): When you are ready, take the deepest possible breath, place your mouth firmly around the mouthpiece, and without further hesitation, blow into the spirometer as hard, fast and completely as possible, without stopping until I tell you. Actively and forcefully coach the patient as he/she performs the maneuver! (Now BLAST it out hard and fast! All you can. More! More! More! Keep on going! Blow, blow, blow!) Keep coaching until a plateau is reached.: ATS 1994 (Less than 25ml volume change in 0.5 seconds.) 4) Check the acceptability of each tracing before continuing the test Acceptable spirograms are free from: 1. Hesitation or false starts 2. Cough -33- Rev.1.4

36 3. Variable effort 4. Glottis closure 5. Early termination, before a plateau is reached 6. Leaks 7. Baseline error Review causes of errors with the patient if needed. Continue testing until three acceptable tracings have been obtained, allowing the patient to recover between tests, up to a maximum of eight trials. 5) After confirming the test result, save the data by pressing key, and/or print by pressing [Print] key. Data save Print WARNING Occasionally, a patient may become lightheaded or dizzy. Such patients should be asked to rest or lie down, and should not be tested until after the symptoms subside. In rare cases, the patient may experience pneumothorax, intracranial hypertension, chest pain, or uncontrolled coughing. In such cases, additional care directed by a physician may be required Rev.1.4

37 SVC (Slow Vital Capacity) measurement The patient should breathe normally a few times and then inhale maximally to total lung capacity and then exhale maximally. <SVC measurement> screen -35- Rev.1.4

38 1) Press the [SVC] key to display <SVC measurement> screen. 2) Attach the mouthpiece and bacterial filter to the flow sensor, and apply the nose clip to the patient. 3) Have the patient hold the flow sensor still. 4) Press the [Start] key. The following message will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, the flow sensor must be held quite still and no air should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed, and the measurement can not be started. 5) After the message, instruct the patient to place the lips and teeth around the mouthpiece, sealing lips around it firmly so that there are no air leaks. Take care not to block its opening with teeth or tongue or bite it excessively. 6) Then, ask the patient to; A) Breath normally a few times. ( Breathe normally. ) B) Then, inhale as much as possible. ( Now, deep breath. Pull it all in! ) C) Then, exhale slowly and completely. ( Now, exhale completely. Squeeze it out! ) D) Breath normally again. ( OK. Breathe normally again. ) 7) Press the [Stop] key to finish the measurement. 8) Review the test result. If it is not acceptable, repeat the test until it is correctly performed. (The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Press the [Start] key to repeat the test. Up to 3 measurements can be saved. (No.3 measurement data is pushed out after 4th measurement. In order to keep No.3 data, take the following steps shown below.) 9) In order to view the waveform data in the different tests in the same graph to compare, press [0] key. 10) In order to keep the best data manually, choose the best data by pressing either [1], [2], or [3] key. The selected data moves to No.1 position. Only one best data at No.1 is printed. (The selected data can also be deleted by pressing [CLR] key.) -36- Rev.1.4

39 11) Press [-] key to review the data of all available measuring items. 12) After all measurements are done, press the key and/or [Print] key if necessary. Data Save Print -37- Rev.1.4

40 FVC (Forced Vital Capacity) measurement The patient should breathe normally a few times and then inhale maximally to total lung capacity and then exhale as quickly and as much as possible. Then, inhale again as quickly as possible. <FVC measurement> screen in Flow/Volume graph -38- Rev.1.4

41 The Flow/Volume graph screen, Volume/Time graph screen, or Cartoon screen for kids can be chosen by pressing the [FVC] key. Each time it is pressed, screen mode is changed. Flow/Volume graph Volume/Time graph Cartoon 1) Press the [FVC] key to display <FVC measurement> screen. 2) Attach the mouthpiece and bacterial filter to the flow sensor, and apply the nose clip to the patient. 3) Have the patient hold the flow sensor still. 4) Press the [Start] key. The following message will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, the flow sensor must be held quite still and no air should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed, and the measurement can not be started. 5) After the message, instruct the patient to place the lips and teeth around the mouthpiece, sealing lips around it firmly so that there are no air leaks. Take care not to block its opening with teeth or tongue or bite it excessively. 6) Then, ask the patient to; A) Breath normally a few times. ( Breathe normally. ) B) Then, inhale as much as possible. ( Now, deep breath. Pull it all in! ) C) Then, exhale as quickly as possible without hesitation, and continue exhaling until all the air has been out. ( Now, blow out quickly, harder! Keep blowing completely ) D) Then, inhale as much and as quickly as possible. (OK now, deep breath quickly! Quickly!) E) Breath normally again. ( OK. Breathe normally again. ) 7) Press the [Stop] key to finish the measurement Rev.1.4

42 When the EOT indicator, which is displayed at the upper right corner of the graph, turns blue, it means no change in volume for more than 1 sec. And it indicates the time to press STOP. NOTE End of test criteria by ATS are as follows; 1) The subject cannot or should not continue further exhalation. The technician should terminate the test if a patient is becoming uncomfortable. 2) The Volume/Time curve shows no change in volume (<0.025L) for 1 second or more, and the subject has tried to exhale for 3 sec(or more) in children aged < 10 yrs and 6 sec or more in subjects aged > 10 yrs. Please remember that it is only recommendations and not requirements. Please use your own judgment when deciding to accept or reject a test. See page 64 for more details of test Quality checks. EOT (End of Test) indicator 8) Review the test result. If it is not acceptable, repeat the test until it is correctly performed. (The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Press the [Start] key to repeat the test. Up to 3 measurements can be saved. (No.3 measurement data is pushed out after 4th measurement. In order to keep No.3 data, take the following steps shown below.) 9) In order to view the waveform data in the different tests in the same graph to compare, press [0] key. 10) In order to keep the best data manually, choose the best data by pressing either [1], [2], or [3] key. The selected data moves to No.1 position. Only one best data at No.1 is printed. (The selected data can also be deleted by pressing [CLR] key.) -40- Rev.1.4

43 11) Press [-] key to review the data of all available measuring items. 12) After all measurements are done, press the key and/or [Print] key if necessary. Data Save Print -41- Rev.1.4

44 MVV (Maximal Voluntary Ventilation) measurement The patient should breathe as deeply and as quickly as possible over a period of 12 seconds. <MVV measurement> screen -42- Rev.1.4

45 WARNING Occasionally, a patient may become lightheaded or dizzy. Such patients should be asked to rest or lie down, and should not be tested until after the symptoms subside. In rare cases, the patient may experience pneumothorax, intracranial hypertension, chest pain, or uncontrolled coughing. In such cases, additional care directed by a physician may be required. 1) Press the [MVV/MV] key to display <MVV/MV> measurement selection screen. 2) Move cursor to the [MVV measurement] and press [Return] key. 3) Attach the mouthpiece and bacterial filter to the flow sensor, and apply the nose clip to the patient. 4) Have the patient hold the flow sensor still. 5) Press the [Start] key. The following message will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, the flow sensor must be held quite still and no air should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed, and the measurement can not be started. 6) After the message, instruct the patient to place the lips and teeth around the mouthpiece, sealing lips around it firmly so that there are no air leaks. Take care not to block its opening with teeth or tongue or bite it excessively. 7) Then, ask the patient to start breathing as deeply and as quickly as possible, and try to reach the upper and lower yellow lines on the graph. ( Breathe out and in deeply and quickly! ) 8) As soon as his breathing becomes stable, press the [Start] key again. (If Single start is chosen on [Spirometry] on <Configuration> screen, no 2 nd start is necessary.) -43- Rev.1.4

46 9) Then, ask the patient to keep breathing as deeply and as quickly as possible for 12 Seconds, and try to reach the upper and lower yellow lines on the graph. ( Breathe out and in deeply and quickly. Keep going! ) 10) After 12 seconds, it automatically stopped. 11) Review the test result. If it is not acceptable, repeat the test until it is correctly performed. (The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Press the [Start] key to repeat the test. Up to 3 measurements can be saved. (No.3 measurement data is pushed out after 4th measurement. In order to keep No.3 data, take the following steps shown below.) 12) In order to view the waveform data in the different tests in the same graph to compare, press [0] key. 13) In order to keep the best data manually, choose the best data by pressing either [1], [2], or [3] key. The selected data moves to No.1 position. Only one best data at No.1 is printed. (The selected data can also be deleted by pressing [CLR] key.) 14) Press [-] key to review the data of all available measuring items Rev.1.4

47 15) After all measurements are done, press the key and/or [Print] key if necessary. Data Save Print -45- Rev.1.4

48 MV (Minute Volume) measurement The patient should keep breathing normally for up to 60 seconds. <MV measurement> screen -46- Rev.1.4

49 1) Press the [MVV/MV] key to display <MVV/MV> measurement selection screen. 2) Move cursor to the [MV measurement] and press [Return] key. 3) Attach the mouthpiece and bacterial filter to the flow sensor, and apply the nose clip to the patient. 4) Have the patient hold the flow sensor still. 5) Press the [Start] key. The following message will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, the flow sensor must be held quite still and no air should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed, and the measurement can not be started. 6) After the message, instruct the patient to place the lips and teeth around the mouthpiece, sealing lips around it firmly so that there are no air leaks. Take care not to block its opening with teeth or tongue or bite it excessively. 7) Then, ask the patient to start breathing as normally as possible. ( Keep breathing normally. ) 8) When his breathing becomes stable, press the [Start] key again. (Double start, the 2 nd Start has to be pressed in 60 second after the 1 st Start.). 9) Then, ask the patient to keep breathing as normally as possible for 60 seconds. ( Keep breathing normally and stably. ) 10) After 60 seconds, it automatically stopped. 11) Review the test result. If it is not acceptable, repeat the test until it is correctly performed. (The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Press the [Start] key to repeat the test. Up to 3 measurements can be saved Rev.1.4

50 (No.3 measurement data is pushed out after 4th measurement. In order to keep No.3 data, take the following steps shown below.) 12) In order to view the waveform data in the different tests in the same graph to compare, press [0] key. 13) In order to keep the best data manually, choose the best data by pressing either [1], [2], or [3] key. The selected data moves to No.1 position. Only one best data at No.1 is printed. (The selected data can also be deleted by pressing [CLR] key.) 15) Press [-] key to review the data of all available measuring items. 15) After all measurements are done, press the key and/or [Print] key if necessary. Data Save Print -48- Rev.1.4

51 10. BD (Bronchodilator) Test The BD test is performed when an obstruction is identified by the initial spirometry tests. The goal of this test is to identify how much if any of a patient s obstructive disease can be reversed by a bronchodilator. This information is used both to clarifying diagnosis and to help decide on medication for treatment. The BD test is done by treating the patient with a bronchodilator after the initial spirometry tests (Pre-BD). Approximately 10 to 20 minutes after the medication (when bronchodilator shows effect) Post-BD test is performed. Increase of 10 to 15% in FEV1 or FVC values are considered significant and indicate some degree of reversibility. ( Interpretation of Pulmonary Function Test by R.E.Hyatt, P.D.Scanlon, M.Nakamura) The test maneuver is identical to the regular SVC, FVC, MVV, and MV tests, respectively. * BD test is normally done in FVC test. <BD measurement> screen -49- Rev.1.4

52 Before BD test, perform the pre-medication spirometry tests (SVC, FVC, MVV, and/or MV). Test procedure of BD test on FVC measurement. 1) Press the [FVC] key to display <FVC measurement> screen. 2) Confirm the pre-medication test data is displayed. 3) Press the key to display the BD <FVC measurement> screen. 4) Attach the mouthpiece and bacterial filter to the flow sensor, and apply the nose clip to the patient. 5) Have the patient hold the flow sensor still. 6) Press the [Start] key. The following message will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, the flow sensor must be held quite still and no air should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed, and the measurement can not be started Rev.1.4

53 7) After the message, instruct the patient to place the lips and teeth around the mouthpiece, sealing lips around it firmly so that there are no air leaks. Take care not to block its opening with teeth or tongue or bite it excessively. 8) Then, ask the patient to; A) Breath normally a few times. ( Breathe normally. ) B) Then, inhale as much as possible. ( Now, deep breath. Pull it all in! ) C) Then, exhale as quickly as possible without hesitation, and continue exhaling until all the air has been out. ( Now, blow out quickly, harder! Keep blowing completely ) D) Then, inhale as much and as quickly as possible. (OK now, deep breath quickly! Quickly!) E) Breath normally again. ( OK. Breathe normally again. ) 9) Press the [Stop] key to finish the measurement. 10) Review the test result. If it is not acceptable, repeat the test until it is correctly performed. (The ATS recommends perform minimum of 3 trials, but not more than 8 trials.) Press the [Start] key to repeat the test. Up to 3 measurements can be saved. (No.3 measurement data is pushed out after 4th measurement. In order to keep No.3 data, take the following steps shown below.) 11) In order to view the waveform data in the different tests in the same graph to compare, press [0] key. 12) In order to keep the best data manually, choose the best data by pressing either [1], [2], or [3] key. The selected data moves to No.1 position. Only one best data at No.1 is printed. (The selected data can also be deleted by pressing [CLR] key.) 13) In order to view the pre and post BD waveforms in the same graph to compare, press [9] key. *Numeric data of Pre and post BD and % change are also shown. 14) Press [-] key to review the data of all available measuring items Rev.1.4

54 15) After all measurements are done, press the key and/or [Print] key if necessary. Data Save Print -52- Rev.1.4

55 11. Challenge Test The Challenge test is one method of assessing airway responsiveness. In this test, the patient inhales an aerosol of one or more concentrations of bronchoconstrictor. FVC test performed before and after the inhalations are used to quantitate response. Results of the test are expressed by an index of responsiveness, the provocating dose (PD20) or concentration (PC20) producing a 20% fall of FEV1. WARNING The challenge tests should be performed under the direction of a physician trained in pulmonary function testing and experienced in bronchial provocation. WARNING The challenge test is designed to provoke a mild asthma attack in patients who have airways hyperreactivity. It is not prudent to perform the test in patients in whom the diagnosis of asthma or airways hyperreactivity has already been established. WARNING During the test procedure, a physician knowledgeable in challenge testing procedure and trained must be close enough to the patient to treat acute bronchospasm and use resuscitation equipment in an emergency. WARNING Follow the operational instruction of the bronchoconstrictor inhalation equipment to be used, such as a nebulizer correctly Rev.1.4

56 1) Press the [MTC] key to display <Challenge Test> screen. 2) If necessary, press the [7] key to set up the test protocol or to confirm the dilution schemes. 3) Choose either protocol for Adult or Child, and if necessary, change the name of bronchoconstrictor, and the concentration schedule Rev.1.4

57 <Protocol Setting> screen * For your reference American Thoracic Society guidelines recommend two different methods of methacholine challenge testing: the 2-min tidal breathing method with twofold increases in concentration, and the five-breath dosimeter method with fourfold increases. Guidelines for Methacholine and Exercise challenge testing by American Thoracic Society. Here are Dilution Schemes for the two recommended methacholine dosing schedule by ATS. For further information, please refer Guidelines for Methacholine and Exercise challenge testing by American Thoracic Society Rev.1.4

58 4) After confirming all setting, press [MCT] key. <Challenge test> screen 5) The test is started with C (Control) to assess the patient for non-specific responses to the Diluents, or Saline. If the measurement with Saline is not needed, you may skip it. You can choose the test # 1 or any test # manually. 6) Administer the prescribed protocol of saline or bronchoconstrictor solutions to the patient to inhale. 7) Attach the mouthpiece and bacterial filter to the flow sensor, and apply the nose clip to the patient. 8) Have the patient hold the flow sensor still. 9) Click the [Start] button. The following message will be displayed. Flow zero adjustment Hold the sensor still As long as the above message is displayed, the flow sensor must be held quite still and no air should be breathed into the flow sensor. Otherwise, the zero adjustment can not be completed, and the measurement can not be started. 10) After the message, instruct the patient to place the lips and teeth around the mouthpiece, sealing lips around it firmly so that there are no air leaks. Take care not to block its opening with teeth or tongue or bite it excessively. 11) Then, ask the patient to; A) Breath normally a few times. ( Breathe normally. ) B) Then, inhale as much as possible. ( Now, deep breath. Pull it all in! ) C) Then, exhale as quickly as possible without hesitation, and continue exhaling until all the air has been out. ( Now, blow out quickly, harder! Keep blowing completely ) D) Then, inhale as much and as quickly as possible. (OK now, deep breath quickly! Quickly!) E) Breath normally again. ( OK. Breathe normally again. ) 12) Click the [Stop] button to finish the measurement. 13) Repeat the above procedure 9) to 12). The test # is automatically counted up every time [Start] button is switched. 14) Discontinue the Challenge Test when a positive response (PC20 and/or PD20) is observed Rev.1.4

59 PC20 (PD20) Threshold 15) Review the test result. If it is not acceptable, you may repeat the test until it is correctly performed with close attention. Regarding the Frequency, following guideline is released from AARC (American Association for Respiratory Care), Methacholine Challenge Testing: 2001 Revision & Update : To ensure that a previous methacholine challenge test does not affect a later test, 230 minutes should be allowed to elapse before the test is repeated. Tolerance of methacholine may occur in patients who are not asthmatic when tests are repeated at less than 24-hour intervals. When a test is to be repeated, medications, exposures, time of day, and nebulizer employed should be held constant, if possible. 16) Press [-] key to review the data of all available measuring items. 15) After the all measurements, click the [Data Save] and/or [Print out] buttons if necessary. 16) After all measurements are done, press the key and/or [Print] key if necessary. Data Save Print -57- Rev.1.4

60 NOTE Following official statements may be useful for the Challenge test. ATS: Guidelines for Methacholine and Exercise Challenge Testing-1999 (Am J Respir Crit Care Med Vol161. pp , 2000) AARC Methacholine Challenge Testing: 2001 Revision & Update (Respiratory Care May 2001, Vol46 No.5) -58- Rev.1.4

61 12. Interpretation Interpretation of the test results are displayed upon completion of (SVC and) FVC measurement(s). Measurements are compared to the Lower Limit of Normal (LLN). COPD Classification of Severity and QC Check for test maneuver are also displayed. Spirometry Interpretation On any Measurement mode, press [INTPR.] key to display <Interpretation> screen. Spirometry Evaluation is determined by the combination of %SVC and FEV1%. (LLN Default Setting: 80% predicted for %SVC, 70% predicted for FEV1%) %SVC FEV1% Judgment 80% or more and 70% or more Normal 80% or more and Less than 70% Obstructive pulmonary disease Less than 80% and 70% or more Restrictive pulmonary disease Less than 80% and Less than 70% Mixed pulmonary disease -59- Rev.1.4

62 On <Interpretation> screen, press [Arrow] key to display, the Pentagon graph. Pentagon graph (Spirometry test result at a glance) COPD Classification of Severity On <Pentagon> screen, press [Arrow] key to display, the <COPD classification> screen. COPD (Chronic Obstructive Pulmonary Disease) is a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. Chronic cough and sputum production often precede the development of airflow limitation by many years, although not all individuals with cough and sputum production go on to develop COPD. ( Global Initiative for Chronic Obstructive Lung Disease by National Institute of Health and National Heart, lung, and Blood Institute, July 2003) -60- Rev.1.4

63 Classification Severity Characteristics Normal Stage 0: At Risk Stage I: Mild COPD Stage II: Moderate COPD Stage III: Severe COPD Stage IV: Very Severe COPD Chronic cough and sputum production; lung function is still normal. Mild airflow limitation and usually, but not always, chronic cough and sputum production. *At this stage, the individual may not be aware that his or her lung function is abnormal. Worsening airflow limitation, and usually the progression of symptoms, with shortness of breath typically developing on exertion. Further worsening of airflow limitation, increased shortness of breath, and repeated exacerbations which have an impact on patients quality of life. *Exacerbations of symptoms, which have an impact on a patient s quality of life and prognosis, are especially seen in patients with FEV1<50% predicted. Severe airflow limitation or the presence of chronic respiratory failure. Patients may have very severe (Stage IV) COPD even if the FEV1 is >30% predicted, whenever these complications are present. *At this stage, quality of life is very appreciably impaired and exacerbations may be life-threatening. Normal Spirometry No chronic symptoms. Normal Spirometry. Chronic symptoms. Exposure to risk factors. FEV1/FVC < 70% FEV1 > or = 80% predicted, With or without symptoms. FEV1/FVC < 70% 50% < or = FEV1 < 80% predicted, With or without symptoms. FEV1/FVC < 70% 30% < or = FEV1 < 50% predicted, With or without symptoms. FEV1/FVC < 70% FEV1 < 30% predicted or FEV1 < 50% predicted plus chronic respiratory failure NHLB/WHO workshop report by US department of Health and Human Services, Public Health Service, National Institute of Health, and National Heart, Lung, and Blood Institute. Classification is based on Post-Bronchodilator FEV1. For more details of COPD, visit official GOLD site at COPD Classification of Severity is provided based upon Global Initiative for Chronic Obstructive Lung Disease ( GOLD, updated December 2006) by NHLB/WHO workshop report Rev.1.4

64 QC Check (Test quality check) On <FVC measurement> screen, press [. ] key to display <QC check> screen. QC-Recommendations Quality check Check points Judge Acceptability Check Reproducibility Check Ex. Start (ExtrapV) Ex. Effort (PEF TIME) Ex. EFFORT (FET) Ex. Duration Ex. Effort (FVC) Ex. Flow (FEV1.0) OK OK OK NO OK OK FVC Test maneuver Acceptability and Reproducibility (QC) checks are displayed based upon the following criteria. Acceptability Criteria Description Suggestion as to NO Criterion ExtrapV Start faster back-extrapolated volume > 5% of FVC and > 150 ml PEF Time Blast out harder time to peak expiratory flow > 85 ms FET Blow out longer forced expiratory time < 6 s Ex. Duration Blow out more air flow > 0.2 L/s within 20 ml of FVC end point Reproducibility Criteria Description Suggestion as to NO Criterion FVC Take a deeper breath FVC > 200 ml and > 5% best FVC FEV1.0 Blow out faster FEV1 > 100 ml and > 5% best FEV1 Spirometry in the Lung Health Study. 1. Methods and quality control. by Enright PL, Johnson LR, Connett JE, Voelker H, Buist AS. Am Rev Respir Dis 1991; 143: NOTE The acceptability checks are only recommendations and not requirements. Please use your own judgment when deciding to accept or reject a test. NOTE Not every patient can exhale to comply with the criteria. Suboptimal efforts may be adequate to assist clinical decisions, where it can be judged what the recorded values underestimate true lung function Rev.1.4

65 13. Patient Database Patient test results are effectively managed with the database. You can view a list of patients previously tested or previously entered into the database. Select a patient from the list to access that patient s records and data from previous tests. Patient database 1) Press key or click the [Database] button on <Main Menu> screen to display <Database> screen. <Database> screen 2) Move cursor to the [Patient Data Search] and press [Return] key. <Patient Data Search> screen 3) You may easily find the patient on the list by search filter. Move cursor to either [Date] or [ID number] and enter the Test date (or period) or ID number. And Click the [Search] button. Then, <Search result> screen will be appeared Rev.1.4

66 indicates that the patient had the test. t indicates that the patient had the BD test, too. <Search result> screen 5) Move cursor to the patient on the list to access his previous tests and data. Then, press [Return] key. The selected patient data is displayed. Data batch processing Number of selected data can be printed, transferred, or deleted all at once. 1) Move cursor to the [Batch process], and press [Return] key Rev.1.4

67 <Patient Data Search> screen 2) You may easily find the patient on the list by search filter. Move cursor to either [Date] or [ID number] and enter the Test date (or period) or ID number. And Click the [Search] button. Then, <Batch process> screen will be appeared. 3) Move cursor to the patient on the list for batch processing. And press [0] key to select the data or [9] key to select all data on the list. * You may cancel the check by pressing [0] key again. 4) Press [Print] key to print all the data to be selected. Press key to transfer all the data to be selected. Press [CLR] key to delete all the data to be selected Rev.1.4

68 14. Description of the Measured Parameters SVC Analysis Item Description Unit Remarks SVC (VC) Difference between peak inhalation and peak L (Slow) vital capacity expiration IC IRV + TV L Inspiratory capacity TV Average ventilation at rest before VC L Tidal volume measurement ERV Max. volume of expiration beyond expiration at L Expiratory reserve volume rest IRV Max. volume of inhalation beyond inhalation at L Inspiratory reserve volume rest VC/HT VC/Height L/m -66- Rev.1.4

69 FVC Analysis Item Description Unit Remarks FVC Vital capacity with forced expiratory effort L Forced vital capacity FEV0.5 Volume of air exhaled in first 0.5 second of forced expiration L Forced expiratory volume in 0.5 second FEV1.0 FEV3.0 Volume of air exhaled in first 1 second of forced expiration Volume of air exhaled in first 3 second of forced expiration L L Forced expiratory volume in 1 second Forced expiratory volume in 3 second FEV0.5% (FEV0.5/FVC) 100 % FEV1.0%(G) (FEV1.0/FVC) 100 % (Geansler) FEV1.0%(T) (FEV1.0/SVC) 100 % (Tiffeneau) FEV3.0% (FEV3.0/FVC) 100 % FVC/HT FVC/Height L/m FEV1/HT FEV1.0/Height L/m FEV1/VCpr (FEV1.0/(Predicted VC)) 100 % MMF (FEF25-75) Mid forced expiratory flow from the point at which 25% to 75% of the FVC. L/s Maximal mid-expiratory flow PEF Peak expiratory flow L/s Peak expiratory flow FEF25 Flow speed of expired air by 25% of the FVC L/s FEF50 Flow speed of expired air by 50% of the FVC L/s FEF75 Flow speed of expired air by 75% of the FVC L/s FEF90 Flow speed of expired air by 90% of the FVC L/s FEF50/FEF75 FEF50/FEF75 Expiratory flow ratio PEF/HT PEF/Height L/s/m FEF25/HT FEF25/height L/s/m FEF50/HT FEF50/height L/s/m -67- Rev.1.4

70 FFEF75/HT FEF75/height L/s/m FEF75-85 Mean flow from 75% and 85% of FVC L/s FEF Mean flow from 200 and 1,200cc after exhaling L/s MTC75-50 Gradient between FEF25 (V75) and FEF50 L/s Mean time constant (V50) on flow-volume curve MTC50-25 Gradient between FEF50 (V50) and FEF75 L/s Mean time constant (V25) on flow-volume curve MTC25-RV Gradient between FEF75 (V25) and RV (V0) on L/s Mean time constant flow-volume curve MTCR MTC75-50/MTC25-RV Mean time constant ratio OI FVC/V 0.5PF This value will increase with stronger obstruction. L/s Obstructive index ATI {(VC - FVC)/VC} 100 % Air trapping index PEF TIME Time required from zero to peak expiratory flow sec FET Exhaling time sec Extrap V Extrap V/FVC 100 % FIVC Forced inspiratory vital capacity L FIV0.5 FIV1.0 Volume of air inhaled in first 0.5 second of forced inspiration after forced expiration Volume of air inhaled in first 1 second of forced inspiration after forced expiration L L Forced inspiratory volume in 0.5 second Forced inspiratory volume in 1 second FIV1/FVC (FIV1.0/FVC) 100 % FIV1/FIVC (FIV1.0/FIVC) 100 % PIF Peak inspiratory flow L/s FIF50 Forced inspiratory flow at 50% of FIVC L/s FEF50/FIF50 FEF50/FIF50 FIF50/FEF50 FIF50/FEF50 CVI FEV0.5/FIV0.5 Check valve index FVC (Volume/Time) 1 FVC (Volume/Time) Rev.1.4

71 MVV Analysis Item MVV Description Unit Remarks Volume of air expired in one minute during repetitive maximal respiratory effort L/min Maximum voluntary ventilation RR Respiratory frequency in one minute C/min Respiration rate TV Mean value of several quiet breathing L Tidal volume MVV/BSA MVV/BSA L/min/m 2 AVI %MVV/%VC Air velocity index -69- Rev.1.4

72 MV Analysis item Description Unit Remarks MV Volume of air ventilated in 1 minute L/min Minute ventilation TV Mean value of the volume of one respiration during the measurement L Tidal volume RR Number of respiration in 1 minute C/min Respiratory frequency BR MVV-MV L Breathing reserve VR (MVV-MV) MVV 100 % Ventilation reserve rate -70- Rev.1.4

73 Challenge test (MCT) Analysis item Description Unit Remarks PC20 PD20 The solution density that FEV1 value inhaled when 20% fell than a FEV1 standard value The accumulation density that it seems decreases 20% than a FEV1 standard value Threshold The solution density that it seems decreases 20% than a FEV1 standard value ΔFEV1 Degree of leaning of FEV1 decrease rate 12% - 20% mg/ml mg/ml mg/ml % Provocation Concentration producing a 20% fall in FEV1 Provocation Dose producing a 20% fall in FEV1-71- Rev.1.4

74 15. Print-out GT-105 All items print-out sample (1/2) (2/2) -72- Rev.1.4

75 16. Predicted Formula Crapo Hsu Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Range Sex Prediction equations Unit Ref. SVC(VC) Same as the prediction equation for FVC L FVC Male 3.58 x 10-7 x Ht or younger [10] Female 2.57 x 10-6 x Ht 2.78 L Male x Ht x A or older [16] Female x Ht x A FEV or older Male x Ht x A Female x Ht x A L [16] FEV1 Male 7.74 x 10-7 x Ht or younger [10] Female 3.79 x 10-6 x Ht 2.78 L Male x Ht x A or older [16] Female x Ht x A FEV3 15 or older Male x Ht x A Female x Ht x A L [16] Male (7.98 x 10-4 x Ht 2.46 ) / or younger [10] FEF25-75 Female (3.79 x 10-3 x Ht 2.16 ) / 60 L/s (MMF) Male x Ht x A [16] 15 or older Female x Ht x A PEF 14 or younger Male (3.35 x 10-4 x Ht 2.79 ) / 60 Female (2.57 x 10-3 x Ht 2.37 ) / 60 L/s [10] MVV 15 or older Male x (Ht / 2.54) x A Female x (Ht / 2.54) x A L/min BSA Adult Both x (Wt / ) x (Ht / 2.54) m2 [6] -73- Rev.1.4

76 ECCS (European Community of Coal and Steel) Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. SVC(VC) FVC 6 to to 70 6 to to 70 Male 1.00 x (Ht x 0.01) 2.7 Female 0.95 x (Ht x 0.01) 2.7 L [20] Male x Ht x A Female x Ht x A L [17] Male Same as the prediction equation for SVC Female Same as the prediction equation for SVC L [20] Male x Ht x A Female x Ht x A L [17] FEV1 FEV1/VC FEF25-75 (MMF) PEF 6 to to 70 6 to to 70 6 to to 70 6 to to 70 FEF25% 25 to 70 FEF50% 6 to to 70 FEF75% 25 to 70 BSA Adult Both Male 0.84 x (Ht x 0.01) 2.7 Female 0.81 x (Ht x 0.01) 2.7 L [20] Male x Ht x A Female x Ht x A L [17] Male 0.84 x 100 Female 0.84 x 100 Male x A % Female x A Male 8.2 x (Ht x 0.01) Female 6.6 x (Ht x 0.01) L/s [20] Male x Ht x A Female x Ht x A L/s [17] Male 8.2 x (Ht x 0.01) Female 6.6 x (Ht x 0.01) L/s [20] Male x Ht x A Female x Ht x A L/s [17] Male x Ht x A Female x Ht x A L/s [17] Male 5.6 x (Ht x 0.01) Female 4.6 x (Ht x 0.01) L/s [17] Male x Ht x A Female x Ht x A L/s [17] Male x Ht x A L/s [17] Female x Ht x A x (Wt / ) x (Ht / 2.54) M2 [6] * The values (except BSA) for 25 years are also applied to 18 to 24 years Rev.1.4

77 ITS (Intermountain Thoracic Society) Analyzed items Ht (height): cm, Wt (weight): kg, A (age):years Age Sex Prediction equations Unit Ref. SVC(VC) 15 or older Same as the prediction equation for FVC L FVC 15 or older Male x Ht x A Female x Ht x A L [15] FEV or older Male x Ht x A Female x Ht x A L [15] FEV1 15 or older Male x Ht x A Female x Ht x A L [15] FEV1/FVC 15 or older Male x Ht x A Female x Ht x A % [15] FEV3 15 or older Male x Ht x A Female x Ht x A L [15] FEV3/FVC 15 or older Male x Ht x A Female x Ht x A % [15] FEF or older Male x Ht x A Female x Ht x A L/s [15] MVV 15 or older Male x (Ht / 2.54) x A Female x (Ht / 2.54) x A L/min BSA Adult Both x (Wt / ) x (Ht / 2.54) m 2 [6] -75- Rev.1.4

78 Knudson Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. SVC(VC) Same as the prediction equation for FVC L 11 or younger x Ht or younger Male x Ht x A 25 or older x Ht x A FVC 10 or younger x Ht L [7] 19 or younger x Ht x A 69 or younger Female x Ht x A FEV0.5 FEV1 FEV1/ FVC FEV or older x Ht x A 25 or younger x (Ht / 2.54) x A Male 26 or older x (Ht / 2.54) x A or younger x (Ht / 2.54) x A Female 21 or older x (Ht / 2.54) x A or younger x Ht or younger Male x Ht x A 25 or older x Ht x A 10 or younger x Ht or younger x Ht x A 69 or younger Female x Ht x A 70 or older x Ht x A 25 or older Male ( x (Ht / 2.54) x A ) x or older Female ( x (Ht / 2.54) x A ) x or younger x (Ht / 2.54) x A Male 26 or older x (Ht / 2.54) x A or younger x (Ht / 2.54) x A Female 21 or older x (Ht / 2.54) x A L [8] L [7] % [8] L [8] -76- Rev.1.4

79 Morris Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. SVC(VC) Same as the prediction equation for FVC L FVC 18 or younger x (Ht / 2.54) [13] Male 19 or older x (Ht / 2.54) x A [9] L 18 or younger x (Ht / 2.54) [13] Female 19 or older x (Ht / 2.54) x A [9] FEV0.5 Adult Male 0.05 x (Ht / 2.54) x A [11] L Female x (Ht / 2.54) x A [14] FEV0.5/FVC Adult Both 0.68 x 100 % 18 or younger Both x (Ht / 2.54) [13] FEV1 Male x (Ht / 2.54) x A L 19 or older Female x (Ht / 2.54) x A [9] FEV1/ Male ( x (Ht / 2.54) x A ) x 100 Adult FVC Female ( x (Ht / 2.54) x A ) x 100 % [9] FEV3/FVC Adult Both 0.97 x 100 % 18 or younger Both x (Ht / 2.54) [10] FEF25-75 Male x (Ht / 2.54) x A L/s (MMF) 19 or older [9] Female 0.06 x (Ht / 2.54) x A PEF 25 or younger x (Ht / 2.54) x A Male 26 or older x (Ht / 2.54) x A or younger x (Ht / 2.54) x A Female 21 or older x (Ht / 2.54) x A L/s [8] 11 or younger x Ht or younger Male x Ht x A 25 or older x Ht x A FEF50 10 or younger x A L/s [7] 19 or younger x Ht x A Female 69 or younger x Ht x A 70 or older x Ht x A 11 or younger x Ht or younger Male x Ht x A 25 or older x Ht x A FEF75 10 or younger x Ht L/s [7] 19 or younger x Ht x A x A 2 Female 69 or younger x Ht x A 70 or older x A FEF75-85 Adult Male x (Ht / 2.54) x A Female x (Ht / 2.54) x A L/s [9] FEF200- Male x (Ht / 2.54) x A or older 1200 Female x (Ht / 2.54) x A L/s [9] 18 or younger Both x (Ht / 2.54) [10] MVV male 3.39 x (Ht / 2.54) x A L/min [11] 19 or older Female x A [12] BSA Adult Both x (Wt / ) x (Ht / 2.54) m 2 [6] -77- Rev.1.4

80 Polgar Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. SVC(VC) Same as the prediction equation for FVC L FVC 18 or younger x (Ht / 2.54) [13] Male 19 or older x (Ht / 2.54) x A [11] L 18 or younger x (Ht / 2.54) [13] Female 19 or older x (Ht / 2.54) x A [14] FEV0.5 Male 0.05 x (Ht / 2.54) x A [11] L Female x (Ht / 2.54) x A [14] 18 or younger x (Ht / 2.54) [13] FEV1 Male x (Ht / 2.54) x A L [11] 19 or older Female x (Ht / 2.54) x A [14] FEV1/FVC 18 or younger Both 0.86 x 100 % FEV3/FVC Adult Both 0.97 x 100 % 18 or younger x (Ht / 2.54) [10] FEF25-75 Male x (Ht / 2.54) x A L/s [15] (MMF) 19 or older Female 0.06 x (Ht / 2.54) x A [15] PEF 25 or younger x (Ht / 2.54) x A Male 26 or older x (Ht / 2.54) x A or younger x (Ht / 2.54) x A Female 21 or older x (Ht / 2.54) x A L/s [8] 11 or younger x Ht or younger Male x Ht x A 25 or older x Ht x A FEF50 10 or younger x A L/s [7] 19 or younger x Ht x A Female 69 or younger x Ht x A 70 or older x Ht x A 11 or younger x Ht or younger Male x Ht x A 25 or older x Ht x A FEF75 10 or younger x Ht L/s [7] 19 or younger x Ht x A x A 2 Female 69 or younger x Ht x A 70 or older x A FEF or older Male x (Ht / 2.54) x A Female x (Ht / 2.54) x A L/s [15] FEF200- Male x (Ht / 2.54) x A or older 1200 Female x (Ht / 2.54) x A L/s [15] 18 or younger Both x (Ht / 2.54) [10] MVV male 3.39 x (Ht / 2.54) x A L/min [11] 19 or older Female x A [12] BSA Adult Both x (Wt/0.4536) x (Ht/2.54) m 2 [6] -78- Rev.1.4

81 ASIA-1 (Adult) Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. 12 or younger Male 34.0 x Ht 2487 Female 34.3 x Ht 2609 [1] SVC(VC) 13 Male (1.40 x Age 1.20) x Ht Female (1.70 x Age 6.70) x Ht 14 to 17 Male (0.48 x Age ) x Ht Female (Age ) x Ht ml [2] 18 or older Male ( x Age) x Ht Female ( x Age) x Ht [3] FVC Same as SVC predicted value ml FVC1.0 Adult Male 34.4 x Ht 33 x Age 1000 Adult Female 26.7 x Ht 27 x Age 540 ml [25] FVC1% Adult Male x Age Adult Female x Age % [25] MMF 18 or younger Male 94 x (Ht/2.54) 2614 Female 87 x (Ht/2.54) 2389 L/s [4] 19 or older Male 51 x (Ht/2.54) x Age Female 43 x (Ht/2.54) x Age L/s [5] PEF Adult Male x Ht x Age Adult Female x Ht x Age L/s [26] FEF25 Adult Male x Ht x Age Adult Female x Ht x Age L/s [26] FEF50 Adult Male x Ht x Age Adult Female x Ht x Age L/s [26] FEF75 Adult Male x Ht x Age Adult Female x Ht x Age L/s [26] FEF75/ Adult Male ( x Age) HT Adult Female ( x Age) L/s/m [23] MVV Adult Male {86.5 (0.522 x A)} x BSA Adult Female {71.3 (0.474 x A)} x BSA L/min [3] BSA Adult Both Wt x Ht x M2 [6] -79- Rev.1.4

82 ASIA-2 (Adult + Child) Analyzed items Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. SVC(VC) Same as FVC predicted value ml FVC Male 48.1 x Ht to 17 [19] Female 41.0 x Ht 3480 ml Male ( x Age) x Ht 18 or older [3] Female ( x Age) x Ht FVC1.0 Male 41.7 x Ht to 17 [19] Female 36.2 x Ht 3080 ml Male 34.4 x Ht 33 x Age or older [25] Female 26.7 x Ht 27 x Age 540 FVC1% Adult Male x Age Female x Age % [25] MMF Male 94 x (Ht/2.54) or younger [4] Female 87 x (Ht/2.54) 2389 ml Male 51 x (Ht/2.54) x Age 19 or older [5] Female 43 x (Ht/2.54) x Age 6 to 17 Male (0.081 x Ht 7.01) Female (0.076 x Ht 6.91) [19] PEF logpef = (0.544logAge Age Male L/s 74.7/Ht )/60 18 or older logpef = (0.376logAge Age Female 58.8/Ht )/60 [27] FEF25 Adult Male x Ht x Age Female x Ht x Age L/s [26] FEF50 Male x Ht to 17 [19] Female x Ht 4.61 L/s Male x Ht x Age or older [26] Female x Ht x Age FEF75 Male x Ht to 17 [19] Female x Ht 1.54 L/s Male x Ht x Age or older [26] Female x Ht x Age FEF75/ Male ( x Age) Adult HT Female ( x Age) L/s/m [23] MVV Adult Male {86.5 (0.522 x A)} x BSA Female {71.3 (0.474 x A)} x BSA L/min [3] BSA Adult both Wt x Ht x M2 [6] -80- Rev.1.4

83 ASIA-6 (JRS: The Japanese Respiratory Society, 2001) Analyzed items SVC(VC) 18 to 95 FVC 18 to 95 FVC to 95 FEV1/ SVC FEV1/ FVC Ht (height): cm, Wt (weight): kg, A (age): years Age Sex Prediction equations Unit Ref. 18 to to 95 FEF50 18 to 95 FEF75 18 to 95 Male Female Male Female Male Female Male Female Male Female Male Female Male Female 0.045*Ht-0.023*A *Ht-0.018*A *Ht-0.024*A (0.031*Ht)-(0.019*A) *Ht-0.028*A *Ht-0.022*A *A *Ht-0.283*A *Ht-0.190*A *Ht-0.249*A *Ht-0.046*A *Ht-0.038*A *Ht-0.031*A *Ht-0.025*A L [21] L [21] L [21] % [21] % [21] L/s [21] L/s [21] -81- Rev.1.4

84 References Ref.# Freferences [1] Naoyuki, Ishida, Respiratory and Circulation Vol.14 No.9, [2] Toshiaki Ebina et al, Respiratory and Circulation Vol. 6 No. 13, , Dec 1958 [3] Baldwin, E. de F., Cournand, A., and Richards, D.W., Jr.: Pulmonary Insufficiency. I. Physiological Classification, Clinical Methods of Analysis, Standard Values in Normal Subjects. Medicine, 27: p , [4] Marion L.Dickman et.al. Spirometric Standards for Normal Children And Adolescents ( Ages 5 Years through 18 Years ) Am. Rev. Resp. Dis. Vol.104, [5] C.DuWayne Schmidt et.al. Spirometric Standards for Healthy Elderly Man and Women Am. Rev. Resp. Dis. Vol.108, [6] Dubois D, Dubois E.F. - Clinical Calorimetry : Tenth paper : A Formula to Estimate the Approximate Surface Area if Height and Weight are known. Arch.Intern.Med.,1916, 17, [7] Knudson R.J.,Lebowits M.D., Holberg C.J.,and Burrows, B.: Change in the Normal Maximal Expiratory Flow - Volume Curve with Growth and Aging., Am.Rev.Resp.Dis.,Vol.127,p , 1982 [8] Knudson R.J., Slatin, R.C., Lebowits M.D., and Burrows, B. The maximal Expiratory Flow Volume Curve. Am.Rev.Resp.Dis.,vol.113.p , 1976 [9] Morris, J.F., Koski A, Johnson LC.: Spirometric standards for healthy nonsmoking adults. Am.rev.Resp.Dis., ,57-67 [10] G.Polgar and V.Promadhat: Pulmonary Function Testing in Children. Techniques and Standards, 1971, W.B.Saunders Company. table 44, P.254 Summary Equations [11] R.C.Kory, R.Callahan, H.G.Boren, and J.C.Syner: The Veterans Administration - Army Cooperative Study of Pulmonary Function. 1. Clinical Spirometry in Normal Men Amer.J.Med. vol.30, pp , 1961 [12] G.Grimby and B.Soderholm: Spirometric studies in Normal Subjects. III. Static Lung Volumes and maximum Voluntary Ventilation in Adults with a Note on Physical Fitness, Acta Med.Scand., vol.173,p , 1963 [13] G.Polgar and V.Promadhat: Pulmonary Function Testing in Children. Techniques and Standards, 1971, W.B.Saunders Company. Equations obtained from referenced graphs by linear approximation. [14] Hollis.G.Boren, M.D., Ross C.Kory, M.D., and Lt. Col.James C.Syner, MC The Veterans Administration - Army Cooporative Study of Pulmonary Function. II. The Lung Volume and Its Subdivision in Normal Men Amer.J.Med. vol.41,pp96-114, 1966 [15] Morris, J.F. Spirometry in the Evaluation of Pulmonary Function, Medical Progress, West J.Med. 125 : Aug [16] Robert O.Crapo, Alan H.Morris, and Reed M.Gardner: Reference Spirometric Values Using Techniques and Equipment that Meet ATS Recommendations, Am.Rev.Respir.Dis ; 123: [17] Ph.H Quanjer et.al. LUNG VOLUMES AND FORCED VENTILATORY FLOWS Report Working Party Standardization of Lung Function Tests European Community for Steel and Coal Official Statement of The European Respiratory Society Eur Respir J, 1993,6,Suppl. 16,5-40 [19] Nishima, The Japanese Journal of Clinical and Experimental Medicine Vol. 54 No. 2 [20] Quanjer & Tammeling Comparisons [21] The Japanese Respiratory Society, April, 2001 [23] Tetsuro Yokoyama, M. D., F.C.C.P., and Makoto Mitsufuji, M. D.; Statistical Representation of the Ventilatory Capacity of 2,247 Healthy Japanese Adults; CHEST, VOL.61, NO.7, JUNE 1,P [25] E. Berglund, G. Birath, J. Bjure, G. Grimby, I. Kjellmer, L. Sandqvist and B. Söderholm; Spirometric Studies in Normal Subjects I. Forced Expirograms in Subjects Between 7 and 70 Years of Age; Acta Medica Scandinavica. Vol. 173, fasc. 2, [26] R. M. Cherniack, M. B. Raber; Normal standards for ventilatory function using an automated Wedge Spirometer; Am.Rev.Respir.Dis.1972 ; Vol.106:p [27] A. J. Nunn, I. Gregg; New regression equations for predicting peak expiratory flow in adults; Br. Med. J. Vol. 298, p , 22 April Rev.1.4

85 Predicted Curve PEFpr FEF25pr FEF50pr Predicted Curve FEF75pr FVCpr Description PEF Sex Position on Y axis (L/S) Position on X axis (L) Male : FVCpr x PEF prediction Female : FVCpr x FEF25 Male & Female FEF25 prediction : FVCpr x 0.25 FEF50 Male & Female FEF50 prediction : FVCpr x 0.50 FEF75 Male & Female FEF75 prediction : FVCpr x Rev.1.4

86 17. Maintenance Cleaning the Flow Sensor Please clean the sensor at the end of the day. Please follow the below steps to clean the sensor. The flow sensor head is semi-disposable type. Please replace it to new one after cleaning 15 times. Follow the below steps to clean it. 1. Detach the flow sensor head from the flow sensor body. 2. Immerse the flow sensor head in the Sterilizing solution. Flow sensor head Sterilizing solution Density Immersing time Glutaral 2.25W/V% More than 1 hour Chlorhexidine gluconate 0.5% More than 30 min Benzalkonium chloride 0.1% More than 30 min Sodium hypochlorite 0.1% More than 1 hour * Before using the sterilizing solution, please read the instruction carefully. 3. After the cleaning, take out the flow sensor head and rinse it fully with water. 4. After rinsing, shake water off and let it dry naturally and completely. 5. When the water drops are observed in the Pressure output ports, Connect the syringe to pressure output port and push out the water left inside Rev.1.4

87 6. Make sure that the flow sensor head is completely dried before use. * Make sure not to mix the cleaned flow sensor heads and others. NOTE After sterilizing / cleaning the sensor parts, be sure to perform the calibration before use. NOTE Do not immerse the sensor body for sterilization. Cleaning other items 1. Main unit If the exterior of the main unit and the flow sensor body are soiled, dust off the exterior and wipe with dry soft cloth. If it is soiled badly, wipe it with wet cloth that is wrung dry. Neither wet the main unit and flow sensor body with water nor use volatile substance (benzine, thinner). 2. LCD display Since dust collects soon on the surface of the liquid crystal display, wipe the surface occasionally with soft cloth. Since the surface can be flawed easily, neither rub it with hard substance nor hit it Rev.1.4

88 18. Troubleshooting Guide Before calling your local dear for repair and service, please check the following items. Trouble? Check Point Power cannot be turned ON Power cord is connected securely? Make sure if it is enough charged. The display is hard to read Did you store the unit in a cold place? Leave the unit for a while after turning on the power then you will get a clear display Adjust the brightness of the LCD. Measurement cannot be performed Flow sensor spiral tube is connected securely to the connection ports? Flow sensor body and flow sensor head are connected securely? Is the flow sensor damaged? No predicted values are available for specific measurement items or all items. The author of the prediction may not provide the predicted formula for the measurement item(s). Check the table of predicted formula of the author. Predicted formula has age (or height) range. If it is out of range, no predicted values are available. ZERO Adjustment cannot be done Did you blow into the flow sensor or move the flow sensor while the ZERO Adjustment? Hold the sensor still in the up-right position during zero adjustment. Printer does not work Printer paper is set in printer? Printer paper is set correctly? Is the printer cover closed securely? Make sure if it is adequately charged. Have you checked paper for correct face when setting paper in printer? The data can not be transmitted Do you have the dedicated software to transact the data? (The Spirobank software is optionally available.) Do you use the Windows OS for the Spirobank software? Does the dongle (Copy guard, or HASP) for the Spirobank software is connected to the right place? (either Parallel port or USB port). Is the 9-pin STRAIGHT serial cable used? (If a CROSSED cable is used, the data can not be downloaded.) Is USB cable is firmly connected? -86- Rev.1.4

89 Are the data transmission settings (such as Baud rate, Parity bit, Stop bit, and Waveform) on your PC (Click "Utility" and choose "Data transmission setting") exactly correspondent with your GT-105 transmission settings (Refer to Communication on "Configuration") No inspiratory measurement items, such as FIVC, FIV1, PIF are printed but marked *. Abnormal measurement data (too large or too small) is observed Predicted values seem to be strange (for example; FEV1pr is larger than FVCpr. FVCpr for 17 year old girl is larger than 18 year old girl.) Calibration error continuously shows more than +/-3% BD measurement cannot be performed Inspiratory measurement items are NOT analyzed when FIVC (Forced Inspiratory Vital Capacity) is smaller than 90% of FVC. Theoretically, Patient s FIVC must be as much as FVC. If his FIVC is much smaller than his FVC, it means he did not do their best during inhalation. Without patient s full effort, the measurement values do not have any meaning. In this case * mark is appeared on the print-out. ATS recommend not to show the inspiratory data when FIVC is smaller than 90% of FVC as the FIVC value is considered as faulty value. Do you calibrate the flow sensor recently? Do you input the temperature and PB correctly? Normal PB values are around 1013hPa or 760mmHg. (approx. 10hPa goes down every 100m altitude change. For example, in Johannesburg, South Africa, whose altitude is1800m, it is approx.830hpa) Do you keep using the damaged or not-cleaned flow sensor head? If so, replace the flow sensor head. Too much humidity contained in the flow sensor head? If so, replace the flow sensor head and/or let it dry. Did the patient start breathing while Flow zero adjustment? Do you use the nose clip? Patients may breathe through the nose. One predicted formula never cover all the age, sex, height, and race of people for all spirometry parameters. For the sake of convenience, other predicted formulas by different authors are mixed to make it complete. At the boundary between two, some contradictions may occur. (For example, ECCS predicted formula doesn t have predicted formula for 17 or younger people. Then, Quanjer & Tammeling predicted formula for 17 or younger people is used to complete ECCS predicted formula.) Did you input the temperature and PB correctly? Did you start calibration while Flow zero adjustment? Perform the calibration repeatedly (at least a few times). Pre-medicine-inhalation measurements (SVC, FVC, MVV) were performed beforehand? -87- Rev.1.4

90 19. Glossary of Spirometry Terms AARC ATS Back Extrapolation BD Test BTPS Calibration Challenge test The American Association for Respiratory Care is the professional society for respiratory therapists in hospitals and with home care companies, managers of respiratory and cardiopulmonary services, and educators who provide respiratory care training. The useful information, guideline, recommendations for Respiratory Care may be available at their web-site at The American Thoracic Society is the scientific branch of the American Lung Association. They promote the improvement of Spirometry through the use of their recommendations. Visit their web-site at for more information. The method for determining zero time from a spirogram, particularly important when the exact starting point of a forced expiatory maneuver is not obvious. Since the FEV1 is affected by the point on the graph that is selected as the start, a uniform way to determine this must be used. Bronchodilator. Administration of a bronchodilator is indicated if baseline Spirometry shows airway obstruction or asthma is suspected ( Office Spirometry ). The BD test is performed to determine the response on bronchodilator by performing FVC test before (Pre) and after (Post) medication. When bronchodilator shows effect a second FVC is performed. Also known as Bronchodilator test, Post Bronchodilator test, etc. Body Temperature and Pressure Saturated with water vapor. A volume of gas will shrink when cooled. The volume of air exhaled into a spirometer from the lungs will contract because the lungs are warmer than the spirometer. Therefore, it is necessary to adjust the recorded values with a BTPS conversion factor to determine the actual volume of air exhaled before it contracted. This corrects the volume of air saturated with water vapor to body temperature for various spirometer temperature. Periodic determination of a spirometer s ability to make accurate measurements of volume and time. Challenge test is one method of assessing airway responsiveness to diagnose asthma patients. Challenge test is performed to determine the airway hyperresponsiveness on bronchoconstrictor by performing FEV1 test before (Pre) and after (Post) medication. Also known as Methacholine challenge test, Bronchial challenge test, Bronchial provocation test, Provocation test, BC test, Broncho-provocation test, Inhalation challenge, Broncho-constrictor test etc Rev.1.4

91 COPD ERS ERV Expiratory time Expiratory volume FEF25% FEF50% FEF75% FEF25-75% FEF25-75/FVC FEF FEV1 Chronic Obstructive Pulmonary Disease is a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. Chronic cough and sputum production often precede the development of airflow limitation by many years, although not all individuals with cough and sputum production go on. COPD is a major cause of chronic morbidity and mortality throughout the world. COPD is currently the fourth leading cause of death in the world (WHO, 2000). The European Respiratory Society (ERS) with members in over 100 countries aims to alleviate suffering from respiratory disease and to promote lung health through research, knowledge sharing, medical and public education. Visit their web-site at for more information. Expiratory Reserved Volume. The maximal amount of air forcefully exhaled after a normal inspiration and expiration. The time required for the subject to reach his largest volume (FVC). For quality control process, total expiratory time is the time from the beginning of exhalation to the end of the subject s expiratory maneuver. As a rule of thumb, total expiratory time should be greater than 6 seconds. The volume that was determined by a perpendicular line drawn from the point where time equals zero to where it intersects the FVC curve. The extrapolated volume must be les than 150ml (for FVCs less than 3L) or less than 5% (for FVCs greater than 3L) for the tracing to be acceptable. A high extrapolated volume is due to a slow start or hesitation in the start of the maneuver. Flow speed of the expired air by 25% of the FVC. Also known as MEF75% or V75. Flow speed of the expired air by 50% of the FVC. Also known as MEF50% or V50. Flow speed of the expired air by 75% of the FVC. Also known as MEF25% or V25. It is mid forced expiratory flow measured from the point at which 25% of the FVC to the 75% point (during the middle half of the FVC). Also called Maximum Mid-Expiratory Flow and abbreviated MMEF, MMFR, or MMF. FEF25-75/FVC is recently considered as a surrogate measure of airway size relative to lung size, which is significantly associated with airway responsiveness. Equivalent to FEF x, but computed for 200cc and 1200cc rather than at 25% and 75%, infrequently used. Also written as FEF Forced Expiratory Volume in 1 second. The volume of air exhaled during the first second of a forced expiratory maneuver. It may also be considered the average flow during the first second of the FVC maneuver Rev.1.4

92 FEV6 FEV1/FVC FEV1/VC FIVC Flow/Volume graph FVC Forced Expiratory Volume in 6 seconds. According to some theses, it can be an acceptable alternative to forced vital capacity (FVC) for diagnosing airway obstruction in adults. The ratio of the FEV1 to the FVC expressed as a percentage. Also written as FEV1% or FEV1% (G), or FEV1/FVC ratio. The ratio of the FEV1 to the SVC expressed as a percentage. Also written as FEV1% or FEV1% (T), or FEV1/SVC ratio. Forced Inspiratory Vital Capacity. The maximum volume of air inspired with a maximally forced effort from a position of maximum expiration. GT-105 does not calculate FIVC when it is smaller than 90% of FVC as it is considered that the patient does not do his very best in inhalation. A tracing of flow rate (on the Y or vertical axis) against volume (on the X or horizontal axis) for a forced expiratory maneuver followed by a maximal inhalation. Also known as Flow/Volume curve, Flow/Volume loop. Forced Vital Capacity. The maximal volume of air which can be exhaled forcefully after maximal inspiration. NOTE: the Vital Capacity is the amount of air that can be exhaled by an individual after taking the deepest breath possible, whether or not the air is exhaled forcefully (FVC) or slowly (VC) GOLD IRV JRS Global initiative for chronic Obstructive Lung Disease program was conducted in 2001 in collaboration with the US National Heart, Lung, and Blood Institute and the World Health Organization to increase awareness of COPD among health professionals, public health authorities, and the general public, and to improve prevention and management through a concerted worldwide effort. Publications are available on the Internet at Inspiratory Reserve Volume. The maximal amount of air forcefully inhaled after a normal inhalation. The Japanese Respiratory Society promotes the study of respiratory diseases by disseminating information and promoting academic achievements in this field. LLN Lower Limit of Normal. The point which is considered to be the lower limit of the normal patient for a given parameter. This point is defined differently in the various referenced studies. MMEF See FEF25-75% MMFR See FEF25-75% MMF See FEF25-75% MVV Maximum Voluntary Ventilation. The volume of air expired in 1 minute during repetitive maximum respiratory efforts at maximum repetition rate. (Usually measured for 15 sec and multiplied by 4, or 12 sec and multiplied by 5.) NIOSH The National Institute for Occupational Safety and Health, a US government agency. Obstructive lung disease Diseases that reduce flow from the lungs. These diseases include asthma, chronic bronchitis, and emphysema Rev.1.4

93 PC 20 (Challenge test) PD 20 (Challenge test) PEF Pneumotacho Flow sensor Predicted value Reproducibility Restrictive lung disease RR TV VC Volume/Time graph Zero time point The concentration of the agonist in the inhaled aerosol leading to a fall in FEV1 of 20% The administered dose of a substance in the inhaled aerosol which causes the FEV1 to fall by 20% Peak Expiratory Flow. Maximum expiratory flow recorded during a forced expiratory maneuver. Also known as PEFR or PF. GT-105 uses a pneumotacho meter to sense airflow. A pneumotacho meter, a differential pressure transducer measures the pressure difference across a flow resistor as the air stream passes through it. The resulting pressure change is converted to a signal proportional to the airflow rate. Expected values for various lung volumes and flow rates, derived from healthy non-smoking populations. The values are adjusted for sex, age, height, and race. Also known as Reference values, or Normal values. The ability of a test to obtain the same result from an individual when it is repeated several times. Reproducibility is determined by checking for excess variability between the two largest values for FVC and FEV1 obtained from three acceptable spirograms. Diseases that reduce the ability of the lungs to expand fully but do not necessarily affect air flow. Asbestosis and silicosis, two of the most common of the occupationally caused restrictive diseases, are caused by the development of fibrotic tissue in the lungs. Respiration Rate. Breath per minute. Tidal Volume. The volume of air inhaled and exhaled during quiet, normal breathing. Vital Capacity. The maximum amount of air that can be exhaled after the fullest inhalation possible. The sum of tidal volume, expiratory reserve volume, and inspiratory reserve volume. May be measured either during inhalation or exhalation. Also known as SVC. A tracing of volume rate (on the Y or vertical axis) against time (on the X or horizontal axis) for a maximal (or forced) expiratory maneuver followed by a maximal inhalation. In the measurement of the FEV1, the point selected as the start of the test, obtained using back extrapolation Rev.1.4

94 20. Technical References Specifications Flow Detection method Variable-type pneumotacho sensor Detection range Resolution Resistance +/-14.0 L/S 0.01L/S Less than 1.5 cm H2O/L/s up to 14L/s Volume Detection method Flow integration type LCD Built-in Printer Detection range +/-10.0 L Resolution 0.01L Accuracy +/-3% or +/-0.05 L, whichever is greater 8 inch TFT color LCD (640x480dots) 112mm width, Thermal dot printer Data storage Storage capacity More than 300 data (HD) Data transfer Interface USB and RS-232C Measurement items SVC, FVC, MVV, MV + BD +Challenge Dimension & Weight H/W/D (mm), kg 310(W) x 330(D) x 95(H) mm, 2.2kg Power supply Protection against electric shock Environmental Conditions for use Type of protection Degree of protection / VAC, 50/60Hz Class II Type B Temperature 15 to +40 Humidity 10% to 85%, non-condensing Atmospheric pressure 700 to 1060 hpa Environmental Temperature 0 to +60 Conditions Humidity 10% to 85%, non-condensing for storage Atmospheric pressure 700 to 1060 hpa * The performance and specifications may change for improvement without prior notification. Flow sensing method Pneumotacho sensor is used for GT-105 to sense airflow. A differential pressure transducer measures the pressure difference across a resistive element (transparent chasmal film) as the air-stream passes through it. The resulting pressure change is converted to a signal proportional to the airflow rate Rev.1.4

95 21. Environment Protection (Advice on disposal of device, accessories, and consumables) To discard the device, accessories, consumables, etc., follow the instructions described below to protect the environment. Printer paper Cardboard mouthpiece Flow Sensor Bacterial filter Sensor head Main unit (except batteries) Lithium batteries. Process it in the same manner as other paper. Process it in the same manner as combustible medical wastes. Disinfect to prevent infectious diseases and discard as industrial wastes. Remove the lithium batteries from the main board. Discard as industrial waste. Dispose the battery after isolating positive (+) and negative (-) terminals of the battery to avoid those terminals touch each other. Keep away from metal or other conductive materials. Jumbling the batteries of direct contact with positive (+) and negative (-) terminals and metal or other conductive materials may cause short-circuit. AC adapter Nose clip Dispose the battery in accordance with applicable local regulations. They must be disposed as industrial wastes. WARNING Do not heat or dispose batteries in fire or water. It may damage the insulator, and may cause, heating, leakage or explosion. Do not disassemble batteries. Disassembling of a battery may result in such risks as injury of the fingers, damage of eye and skin due to scattered chemicals inside the battery Rev.1.4

96 22. Accessories Accessories # Description Part Number Unit 1. Cardboard mouthpiece (100pcs/box) boxes 2. Silicon mouthpiece (Re-usable, for adult) pc 3. Silicon mouthpiece (Re-usable, for child) pc 4. Nose clip (Metal) pc 5. Nose clip (Plastic, 10pcs/pack) pack 6. Flow sensor head (10pcs/box) box 7. Printer paper for GT-105 (10rolls/box) box 8. 1L Calibration syringe + Silicon adapter pc 9. 3L Calibration syringe + Silicon adapter pc 10. Spirobank software (Database software for Windows PC) pc (1) (2)/(3) (4)/(5) (6) (7) (8)/(9) (10) -94- Rev.1.4

97 Spirobank software (Database software, OPTION) Patient data measured by GT-105 can be stored and managed on your PC with the optional database software, Spirobank. Patient data can be stored almost unlimitedly. A4 or letter sized printing by your printer is available. <Patient ID screen > <Patient database table> <FVC screen> <Interpretation screen> Print-out Sample Contact your local dear for more information of Spirobank database software -95- Rev.1.4

98 23. Limited Warranty Each new GT-105 is warranted to be free from defects in material or workmanship for a period of twelve (12) months from the initial date of purchase. For the purpose of this Limited Warranty, the initial date of purchase shall be the date of shipment from the manufacturer to the initial owner of record. Should the Unit be defective in material or workmanship during the term of this Limited Warranty, an official local dealer, at its option, repair or replace the defective system or component part. Replacement Units and/or parts do not carry a new warranty and shall only be warranted for the unexpired portion of the original Limited Warranty or six (6) months, whichever is longer. The manufacturer will not assume any responsibility for damages; 1) If GT-105 is not installed and connected in accordance with the instructions furnished by the manufacturer. 2) If the serial number or any component part thereof has been altered, defaced or removed, or if purchaser cannot produce a bill of sale or other evidence to verify the initial purchase of the Unit. 3) If the defects arising from misuse, abuse, negligence or accident or from repair, maintenance, adjustment, modification or replacement made by anyone other than authorized personnel. The manufacturer s and local dealers responsibilities hereunder are limited to repair and replacement only. To obtain service under this warranty, the owner of the GT-105 must promptly notify a local dealer of any defect in material or workmanship, and the serial number as well as the date of purchase Rev.1.4

99 24. Contact Information Medical Device Safety Service GmbH Schiffgraben 41 D Hannover, Germany CHEST M.I., Inc Hongo, Bunkyo-ku, Tokyo, , Japan Tel: (M-F 9 to 5 in Japan time, in Japanese language only) Fax: (24hrs. English, Chinese, and Japanese are acceptable) NOTE When contacting your local dealer for service & maintenance, prepare the Software version of your GT-105 as well as the serial number to report. Software version Serial Number <Configuration> screen * Serial number is shown on the back of the unit Rev.1.4