Attachment 3
Revised “Operation Manual”
Page 1: ...Attachment 3 Revised Operation Manual...
Page 2: ...C Ca ar rd di io oT Te ec ch h GT 105 Spirometry System O Op pe er ra at ti io on n M Ma an nu ua al l REV 1 4...
Page 3: ...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 ale...
Page 4: ...Hardware attachment 5 Basic Operation 14 Operational procedure 6 Pre measurement Settings 17 General settings Factory defaults setting 7 Calibration 28 8 Patient ID Input 31 9 Spirometry Tests 33 SVC...
Page 5: ...apo Hsu ASIA Predicted Curve 17 Maintenance 84 Cleaning 18 Troubleshooting Guide 86 19 Glossary of Spirometry Terms 88 20 Technical References 92 Product specifications 21 Environment Protection 93 22...
Page 6: ...ntended for patient operation Equipments connected to Signal I O ports such as RS 232C and USB have to comply with IEC60601 1 If not IEC60950 In order to connect other equipments use a separation tran...
Page 7: ...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 Harmonic emis...
Page 8: ...o 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 fro...
Page 9: ...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...
Page 10: ...amaged 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...
Page 11: ...ver 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 V...
Page 12: ...r 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...
Page 13: ...ord 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 100 120V or 220 240VAC 50 60Hz power supply 2 Connecting the Flow...
Page 14: ...he 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 n...
Page 15: ...n 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 Spiro...
Page 16: ...14 Rev 1 4 5 Basic Operation The basic procedure from switching ON the power supply to finishing measurement is as follows...
Page 17: ...er 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...
Page 18: ...ensor 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 ke...
Page 19: ...All other measuring items of FVC are taken from the largest sum of FVC FEV1 test Waveform scale When Auto is chosen the graph scale is changed automatically to show whole waveform accordingly Beep sou...
Page 20: ...e default setting is 50 0 Input the correct humidity before No is chosen Atm Pr When Yes is chosen atmospheric pressure can be input on the ID input screen When No is chosen the last input atmospheric...
Page 21: ...Normal Range in both SVC and FEV1 Obstruction Input any percentage for the each stage of Obstructive pulmonary disease Restriction Input any percentage for the each stage of Restrictive pulmonary dis...
Page 22: ...When Yes is chosen the test reproducibility of exhalation volume is checked Ex Flow FEV1 0 When Yes is chosen the test reproducibility of exhalation flow is checked NOTE The acceptability checks are...
Page 23: ...d in order of MEAS PRED PRED With BD test Printed in order of MEAS PRED PRED in the 1st line and MEAS BD CHANGE in the 2nd line 3 Without or with BD test Printed in order of MEAS PRED PRED BD CHANGE i...
Page 24: ...ph 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 FVC curve V T 1 FVC curve V T 12 Measuring items SVC IC TV ERV IR...
Page 25: ...SIA1 is Japan s traditional predicted formula with 30yrs or more history ASIA 3 is the most updated one by the Japanese Respiratory Society compilation Race adjust Caucasian Black Asian Other If desir...
Page 26: ...his FVC value is bigger than his SVC value FVC Meas mode 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 Predicted...
Page 27: ...der 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 Baud rate 2400 4800 9600 1920...
Page 28: ...ct 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 prin...
Page 29: ...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 F...
Page 30: ...cess 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 ke...
Page 31: ...ensor 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 calibr...
Page 32: ...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...
Page 33: ...t 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...
Page 34: ...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...
Page 35: ...ient 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...
Page 36: ...aximum 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 dizz...
Page 37: ...35 Rev 1 4 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...
Page 38: ...atient 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 Bre...
Page 39: ...37 Rev 1 4 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...
Page 40: ...surement 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 FV...
Page 41: ...e 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 th...
Page 42: ...s 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 r...
Page 43: ...41 Rev 1 4 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...
Page 44: ...42 Rev 1 4 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...
Page 45: ...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...
Page 46: ...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 ste...
Page 47: ...45 Rev 1 4 15 After all measurements are done press the key and or Print key if necessary Data Save Print...
Page 48: ...46 Rev 1 4 MV Minute Volume measurement The patient should keep breathing normally for up to 60 seconds MV measurement screen...
Page 49: ...ruct 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 exces...
Page 50: ...o 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...
Page 51: ...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 B...
Page 52: ...ment 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 mes...
Page 53: ...ent 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 r...
Page 54: ...52 Rev 1 4 15 After all measurements are done press the key and or Print key if necessary Data Save Print...
Page 55: ...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 hyperreact...
Page 56: ...allenge 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 bronch...
Page 57: ...old increases in concentration and the five breath dosimeter method with fourfold increases Guidelines for Methacholine and Exercise challenge testing 1999 by American Thoracic Society Here are Diluti...
Page 58: ...ise 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 f...
Page 59: ...ffect 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 hou...
Page 60: ...may be useful for the Challenge test ATS Guidelines for Methacholine and Exercise Challenge Testing 1999 Am J Respir Crit Care Med Vol161 pp309 329 2000 AARC Methacholine Challenge Testing 2001 Revisi...
Page 61: ...layed 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 p...
Page 62: ...irflow 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 Chron...
Page 63: ...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 FEV1 FVC 70 30 or FEV1 50 predicted With or without...
Page 64: ...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...
Page 65: ...ata 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 Retu...
Page 66: ...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...
Page 67: ...e 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...
Page 68: ...tion and peak expiration L Slow vital capacity IC IRV TV L Inspiratory capacity TV Average ventilation at rest before VC measurement L Tidal volume ERV Max volume of expiration beyond expiration at re...
Page 69: ...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 expir...
Page 70: ...ction 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 vi...
Page 71: ...pired 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 breath...
Page 72: ...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...
Page 73: ...ndard value mg ml Provocation Concentration producing a 20 fall in FEV1 PD20 The accumulation density that it seems decreases 20 than a FEV1 standard value mg ml Provocation Dose producing a 20 fall i...
Page 74: ...72 Rev 1 4 15 Print out GT 105 All items print out sample 1 2 2 2...
Page 75: ...Male 7 74 x 10 7 x Ht 3 18 L 10 Female 3 79 x 10 6 x Ht 2 78 15 or older Male 0 0414 x Ht 0 0244 x A 2 190 16 Female 0 0342 x Ht 0 0255 x A 1 578 FEV3 15 or older Male 0 0535 x Ht 0 0271 x A 3 512 L...
Page 76: ...e 0 84 x 100 Female 0 84 x 100 25 to 70 Male 87 21 0 18 x A Female 89 10 0 19 x A FEF25 75 MMF 6 to 17 Male 8 2 x Ht x 0 01 6 8 L s 20 Female 6 6 x Ht x 0 01 5 3 25 to 70 Male 0 0194 x Ht 0 043 x A 2...
Page 77: ...0414 x Ht 0 0244 x A 2 190 L 15 Female 0 0342 x Ht 0 0255 x A 1 578 FEV1 FVC 15 or older Male 0 1300 x Ht 0 152 x A 110 49 15 Female 0 2020 x Ht 0 250 x A 126 58 FEV3 15 or older Male 0 0535 x Ht 0 0...
Page 78: ...17 x A 2 746 20 or younger Female 0 048 x Ht 2 54 0 061 x A 1 738 21 or older 0 048 x Ht 2 54 0 014 x A 0 406 FEV1 11 or younger Male 0 0348 x Ht 2 8142 L 7 24 or younger 0 0519 x Ht 6 1181 0 0636 x A...
Page 79: ...x A 8 06 L s 8 26 or older 0 2387 x Ht 2 54 0 035 x A 5 993 20 or younger Female 0 1244 x Ht 2 54 0 157 x A 3 916 21 or older 0 1244 x Ht 2 54 0 025 x A 0 735 FEF50 11 or younger Male 0 0378 x Ht 2 54...
Page 80: ...younger Female 0 1244 x Ht 2 54 0 157 x A 3 916 21 or older 0 1244 x Ht 2 54 0 025 x A 0 735 FEF50 11 or younger Male 0 0378 x Ht 2 5454 L s 7 24 or younger 0 0543 x Ht 6 3851 0 1150 x A 25 or older...
Page 81: ...nger Male 94 x Ht 2 54 2614 L s 4 Female 87 x Ht 2 54 2389 19 or older Male 51 x Ht 2 54 2954 46 x Age L s 5 Female 43 x Ht 2 54 2243 37 x Age PEF Adult Male 0 05666 x Ht 0 02403 x Age 0 22544 L s 26...
Page 82: ...2 54 2243 37 x Age PEF 6 to 17 Male 0 081 x Ht 7 01 L s 19 Female 0 076 x Ht 6 91 18 or older Male logPEF 0 544logAge 0 0151Age 74 7 Ht 5 48 60 27 Female logPEF 0 376logAge 0 0120Age 58 8 Ht 5 63 60...
Page 83: ...042 Ht 0 024 A 1 785 L 21 Female 0 031 Ht 0 019 A 1 105 FVC1 0 18 to 95 Male 0 036 Ht 0 028 A 1 178 L 21 Female 0 022 Ht 0 022 A 0 005 FEV1 SVC 18 to 95 Male 0 215 A 93 216 21 Female 0 063 Ht 0 283 A...
Page 84: ...y Ventilation in Adults with a Note on Physical Fitness Acta Med Scand vol 173 p 199 206 1963 13 G Polgar and V Promadhat Pulmonary Function Testing in Children Techniques and Standards 1971 W B Saund...
Page 85: ...tion on X axis L PEF Male PEF prediction FVCpr x 0 052 Female FVCpr x 0 061 FEF25 Male Female FEF25 prediction FVCpr x 0 25 FEF50 Male Female FEF50 prediction FVCpr x 0 50 FEF75 Male Female FEF75 pred...
Page 86: ...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...
Page 87: ...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 Neit...
Page 88: ...able 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 sens...
Page 89: ...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...
Page 90: ...irometry 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 Als...
Page 91: ...uver As a rule of thumb total expiratory time should be greater than 6 seconds Expiratory volume The volume that was determined by a perpendicular line drawn from the point where time equals zero to w...
Page 92: ...ully FVC or slowly VC GOLD 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 Healt...
Page 93: ...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 Restrictive...
Page 94: ...mm 2 2kg Power supply 100 120 220 240VAC 50 60Hz Protection against electric shock Type of protection Class II Degree of protection Type B Environmental Conditions for use Temperature 15 to 40 Humidi...
Page 95: ...Lithium batteries 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 Jumbli...
Page 96: ...11 020401 1 pc 4 Nose clip Metal 03 4511 010101 1 pc 5 Nose clip Plastic 10pcs pack 04 4511 020101 1 pack 6 Flow sensor head 10pcs box 03 2421 010103 1 box 7 Printer paper for GT 105 10rolls box 03 12...
Page 97: ...r 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 s...
Page 98: ...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 manufactur...
Page 99: ...3 5804 5031 M F 9 to 5 in Japan time in Japanese language only Fax 81 3 3812 7220 24hrs English Chinese and Japanese are acceptable NOTE When contacting your local dealer for service maintenance prepa...
Page 100: ...98 Rev 1 4 NOTE To place an order for consumables for repair or for general inquiries please contact your local dealer Your Local Dealer REV 1 4 March 1 2008...
