background image

 

53 

T

ECHNICAL 

S

PECIFICATIONS

 

 

Flow detection principle  Fleisch type pneumotachometer 
Back pressure 

Better than 0.1kPa/L/second, ATS standard. 
Highest back pressure occurs at 16L/sec. 

Volume measurement  

Flow integration 

Maximum recorded 
flow rate 

±

16L/s 

Maximum recorded 
volume 

9.9 L 

Measuring accuracy 

Better than 

±

3% or 

±

0.05L volume, whichever 

is  greater,  and 

±

5%  flow  (inspiratory: 

±

5% 

vol., 

±

8% flow) 

Operating temperature 

10–40ºC 

Safety standards 

Conforms to EN60601-1, EN60601-1-2 

Certified Spirometry 
standards 

ATS and ERS 

Size 

343 mm x 244 mm x 116 mm  

Weight 

2,250 g 

Storage Temperature 

0–50ºC 

Storage Relative 
Humidity 

10%–95% 

 

Note:  All  values  displayed  by  the  COMPACT  are  expressed  as  BTPS 
values. 

CE N

OTICE

 

Marking  by  the  symbol 

indicates  compliance  of  the  Vitalograph 

COMPACT  to  the  Medical  Devices  Directive  of  the  European 
Community. Such marking is indicative that the Vitalograph COMPACT 
meets or exceeds the following technical standards: 

• 

EN60601-1 - “General requirements for safety” 

• 

EN55011 - “Radiated and mains conducted emissions for industrial, 
scientific and medical (ISM) radio-frequency equipment” 

 

FDA N

OTICE

 

Caution: Federal Law restricts this device to sale by, or on the order of 
a physician. 

Summary of Contents for COMPACT 6600

Page 1: ...Vitalograph Compact User Manual 07330 Issue 1 Copyright Vitalograph 2004 Vitalograph Vitalograph Vitalograph Vitalograph COMPACT MODEL 6600 User Manual l...

Page 2: ...Phone 040 54 73 91 0 Fax 040 547 391 40 e mail info vitalograph de Vitalograph Inc 8347 Quivira Road Lenexa Kansas 66215 U S A Phone 913 888 4221 Fax 913 888 4259 e mail vitcs vitalograph com Vitalogr...

Page 3: ...Make before Performing a Test Session 8 Performing an FVC Test 8 Performing a Single Breath Test Continued 11 Using the Incentive Device 12 PERFORMING CLOSED CIRCUIT SPIROMETRY 15 PERFORMING A POST T...

Page 4: ...APH COMPACT 44 DISASSEMBLING THE VITALOGRAPH COMPACT 47 REASSEMBLING THE FLEISCH FLOWHEAD 48 FAULT FINDING GUIDE 49 CUSTOMER SERVICE 51 CONSUMABLES AND ACCESSORIES 51 EXPLANATION OF SYMBOLS 52 OTHER L...

Page 5: ...Vitalograph Compact User Manual 07330 Issue 1 Copyright Vitalograph 2004 B C A D...

Page 6: ...nformation about the software can be obtained from the About box This information can be used if any queries are made to Vitalograph or a service agent To access the About box 1 Press the More button...

Page 7: ...the warranty The output from the power supply is 10 volts DC 4 Connect the jackplug from the power supply into the socket on the rear of the Vitalograph COMPACT The IEC connector on the mains lead pl...

Page 8: ...ng either the Home or Return buttons or b Do not save the changes and return to the login screen by pressing the Back button Entering or Selecting Subject Information In order to save test sessions to...

Page 9: ...screen keyboard Last Name 2 Enter First Name using the on screen keyboard First Name 3 Enter Date of Birth using the on screen keyboard Date of Birth 4 Enter Male Female by selecting the relevant opti...

Page 10: ...on screen keyboard 5 There are now two options available a Return to the New Subject screen by pressing the Back button b To modify the smoking information press the Forward button This will allow yo...

Page 11: ...een keyboard First Name d Enter the population group from a drop down list Population Group e Enter date of birth using the on screen keyboard Date of Birth f Enter gender by selecting the relevant op...

Page 12: ...ect for a Non advanced User for entering information here Selecting a Subject from the Database If a subject has previously been created the details will be stored in the database Follow these steps t...

Page 13: ...ore starting a test session there are a number of checks which should be made 1 Ensure that the accuracy of the COMPACT unit was checked recently Refer to section on Checking Accuracy 2 Check that the...

Page 14: ...ll automatically create a subject ID before displaying the testing screen Depending on the Test Configuration settings you may be presented with a testing screen to either perform a VC or an IVC test...

Page 15: ...n This will finish the test session b Return to the Subject Select screen by pressing the Back button This will end the test session c Perform a Single Breath Test by pressing the FVC button d Perform...

Page 16: ...isplayed 4 Repeat to perform another IVC test if required Note A maximum of 12 IVC tests can be performed in one session 5 After performing the IVC tests you can do one of four things 1 Return to the...

Page 17: ...ng for at least 6 seconds vi If inspiratory indices are selected then inhale as quickly as possible 2 If you are prompted to accept the test press the Cancel button to reject the test or the Enter key...

Page 18: ...by default when you select the Trend tab This is a seventy year trend of the best FEV1 value A predicted line is shown from the 25 70th year if the subject s demographic information is entered a In o...

Page 19: ...to view the COPD score The COPD number is the measured FEV1 as a percent of the value compared with a reference population of people without lung disease This is used as a method of categorising the s...

Page 20: ...Note If no subject has been selected from the database then you will be presented with a list of all subjects There are two options here You can a Select the subject required Press the Enter key and t...

Page 21: ...est by pressing the Return button 4 After pressing the Enter key in FRC RV TLC value entry screen you will be brought into the Closed Circuit Test screen 5 Wait for the Exhale to Begin icon to appear...

Page 22: ...test you can view the flow data in Volume Time or Flow Volume format To switch between the different formats a Select the relevant tab Volume Time Flow Time b Press the Results tab to view the results...

Page 23: ...rsus pre delivery To perform a Post test 1 Press the More button on the Home screen 2 Press the Post Test button 3 If there is no current subject selected then you will be presented with the list of s...

Page 24: ...an external USB printer Note The internal thermal printout will fade over time when exposed to light or heat If a permanent record is required photocopy the thermal printout or print to the external U...

Page 25: ...ession will be recalled from the database 2 Review the graphs by selecting the Graphs tab a For a single breath FVC test press the Graphs tab This will show the Flow Volume and Volume Time curves for...

Page 26: ...session by pressing the Print button d Perform a Post test by selecting the Post button Note Refer to the section on Performing a Post Test Session for information on performing a Post test Modifying...

Page 27: ...e on screen keyboard Date of birth c Gender by selecting the relevant option Male Female d Height using the on screen keyboard Height Note The Subject ID cannot be altered Subject ID 2 To modify addit...

Page 28: ...n check uncheck the COPD check box e Modify subject comments using the on screen keyboard 3 Return to the New Subject screen by pressing the Back button twice x2 When you have made all the changes req...

Page 29: ...o modify a The first name using the on screen keyboard first name b The population group from a drop down list Population Group c The date of birth using the on screen keyboard Date of birth d Gender...

Page 30: ...ference between the volume measured by the spirometer and the volume pumped into the spirometer from a syringe is within 3 Follow these steps to check the accuracy of the unit 1 Attach the flowhead to...

Page 31: ...a Date of accuracy check b Time of accuracy check c Syringe serial number d Volume of syringe e Volume recorded by COMPACT The following will appear beside the log if the calibration was updated on t...

Page 32: ...ation 3 All tests for a specific subject and his or her subject information 4 All tests for a specific subject but no subject information Follow these steps to access information for deletion 1 Press...

Page 33: ...information i Do not select the Select all subjects check box ii Select the Delete Subject option iii Select a subject iv Press the Delete button A confirmation message will appear v To continue with...

Page 34: ...considerable variation in the predicted figures and most researchers have an individual preference for a particular normal set It is possible to create custom population groups with associated normal...

Page 35: ...roup name using the on screen keyboard 3 Return from screen by pressing the Back button 4 Enter the correction factor using the on screen keyboard Valid values are between 50 150 5 Select a normal set...

Page 36: ...l button TEST CONFIGURATION There are two basic test types that the COMPACT can record Closed Circuit Spirometry Single Breath Test These can be selected in the Test Configuration screen It is also po...

Page 37: ...pe can be selected as either Closed Circuit Spirometry or Single Breath Test 6 The COMPACT will by default accept all tests performed during a session and save the tests to the database at the end of...

Page 38: ...tory volume after 3 seconds L FEV3 VC FEV3 Percentage FEV3 of VC FEV 3 FVC FEV3 F Percentage FEV3 of FVC FEV6 Forced expiratory volume after 6 seconds L PEF L s Peak expiratory flow L sec PEF L min Pe...

Page 39: ...rectly calculated from the FEV L min FMFT Forced mid expiratory flow time sec FET Forced expiratory time sec Vext Extrapolated volume ml Vext FVC Vext F Percentage extrapolated volume of FVC FRC Funct...

Page 40: ...ied using the on screen keyboard The value entered must be between 100 150 The of Best Test value for the other tests can be modified using the on screen keyboard The value entered must be between 100...

Page 41: ...n 1 Press the Options button on the Home screen 2 Press the Configuration button on the Options screen 3 To access the touch screen calibration press the Touch Screen Calibration button Calibration is...

Page 42: ...n be modified by selecting one of the alternative options The date format can be either a DD MM YYYY b MM DD YYYY c YYYY MM DD 7 The time format used can be modified by selecting the alternative optio...

Page 43: ...k box Refer to the section on Getting the Vitalograph COMPACT Ready For Use for running the demonstration 15 The sound is configured on by default It can be switched off by deselecting the check box 1...

Page 44: ...changes and return to the Home screen by pressing the Home button b Do not save the changes and return to the previous screen by pressing the Back button c Save the changes and return to the previous...

Page 45: ...ault b Name The subject s name is printed by default c Weight The subject s weight is printed by default d Comments This refers to the session comments which are printed by default e Use SDS In the se...

Page 46: ...n the report by default l Lung Age The subject s lung age is printed by default m Interpretation The interpretation of the session results is printed by default n Smoking Details Information on the su...

Page 47: ...door using the finger catch on the right side of the door This will expose the head of the printer and the paper roller mechanism 2 Take out the empty roll by unclipping the roll support rod from the...

Page 48: ...OMPACT can have different users The unit can be configured so that it requires the users to login during start up Refer to the section on Logging In Users can be either non advanced or advanced they c...

Page 49: ...k box The logged on user ID will appear in the Current User dialog box 7 The COMPACT can force users to login during start up To do this check the Require User Login check box 8 When you have modified...

Page 50: ...ned or disinfected as described in the accompanying table The flowhead conditioning meshes should also be replaced in the event of damage or if visibly contaminated The frequency of cleaning and disin...

Page 51: ...Treatment Clean No Lightly wipe the surface with cotton pad or other soft material NOTE DO NOT use chemicals such as acetone toluene ethanol or isopropyl alcohol DO NOT wipe in a circular motion Strok...

Page 52: ...e end cap and discard them 3 To remove the flowhead body from the fleisch element place the fleisch element on a hard flat surface with the largest diameter at the top Push down on the flowhead body w...

Page 53: ...ch element to ensure that no liquid or particles remain in the holes grooves or pressure tappings 2 Check the O rings for damage and ensure that they are correctly positioned within the grooves 3 Appl...

Page 54: ...the flowhead fleisch element assembly Flowhead cone fleisch element filter mesh missing or blocked Flowhead body pressure port holes blocked Flowhead fleisch element assembly sealing O rings damaged...

Page 55: ...e connector on the COMPACT device and the blue tapping on the flowhead connector Ensure that the flowhead connecting tube is not pinched or trapped Problem Fault Symptoms Cannot print to internal prin...

Page 56: ...een Touch screen failure contact support Main PCB failure contact support CUSTOMER SERVICE Service and repairs should be carried out only by the manufacturer the approved importer or by Service Agents...

Page 57: ...Pin Mains Power Cable International 67127 Replacement Stylus Pen 61030 Flowhead Complete 42029SPR Flowhead ConnectionTube 67353 CD with User Manual EXPLANATION OF SYMBOLS k Type BF equipment j Class I...

Page 58: ...ards ATS and ERS Size 343 mm x 244 mm x 116 mm Weight 2 250 g Storage Temperature 0 50 C Storage Relative Humidity 10 95 Note All values displayed by the COMPACT are expressed as BTPS values CE NOTICE...

Page 59: ...Vitalograph design and manufacture in accordance with the following standards European Medical Devices Directive 93 42 EEC L169 Vol 36 BS EN ISO 9001 1994 Quality Systems Model for Quality Assurance...

Page 60: ...ilure can be recreated and the software has been installed and used in accordance with the user manual Notwithstanding this clause the software is not warranted to be free of errors 4 This Guarantee d...

Page 61: ...nter the details of a new subject Perform a test session Print a test session calibration log or report Access additional COMPACT functions Scroll through screens Access the configuration options Retu...

Page 62: ...test configuration screen Access the unit configuration screen Access the print configuration screen Access the user configuration screen Perform a Single Breath Test Perform a CCS Test View the sugge...

Page 63: ...te a new population group in the database Select test indices to be reported Incentive device used in the Single Breath Test of children Adjust the screen contrast Configure the sounds used Play the s...

Page 64: ...bject I D Population group Date of birth Note Also in format Male Female Height Weight Non smoker Smoker Ex smoker Cigs per day Year started smoking Year quit smoking Graph tab when performing Single...

Page 65: ...60 Test session information tab User I D Syringe volume Syringe serial number...

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