Vitalograph In2itive Instructions For Use Manual
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Vitalograph In2itive Instructions For Use Manual

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In2itive
MODEL 2120
Instructions for Use
© Copyright Vitalograph 2024 Current Edition (Issue 3, 10-Jan-2024) Cat. No. 09160

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Summary of Contents for Vitalograph In2itive

  • Page 1 In2itive MODEL 2120 Instructions for Use © Copyright Vitalograph 2024 Current Edition (Issue 3, 10-Jan-2024) Cat. No. 09160...
  • Page 2 Tel: +49 40 547391-0 Fax: +49 40 547391-40 E-mail: info@vitalograph.de www.vitalograph.com Technical Support Telefon: +49 40 547391-14 E-mail: technical.support@vitalograph.de © Copyright Vitalograph 2024 Current Edition (Issue 3, 10-Jan-2024) Cat. No. 09160 Vitalograph is a registered trademark. Page 2 of 56...

  • Page 3: Table Of Contents

    Contents Indications for Use ..............4 Contraindications, Warnings, Precautions and Adverse Reactions ..............4 Main Components of the Vitalograph In2itive ....8 3.1. Features of the Vitalograph In2itive ......9 Setting Up the Vitalograph In2itive ........9 Operating Instructions ............11 5.1. Entering Subject Data ..........12 5.2.

  • Page 4: Indications For Use

    A Global Leader in Respiratory Solutions 1. Indications for Use The Vitalograph In2itive is a portable device which measures subject respiratory parameters and is capable of centralising data from external cardio-pulmonary related testing devices. It is intended for use by trained healthcare professionals in a variety of professional healthcare environments, e.g.
  • Page 5 A BVF is for single use only. 4. Spirometry may support or exclude diagnosis, but it cannot make one (ATS/ERS 2019 5. The In2itive is marked as ‘Rx Only’ and as such is restricted to sale by, or on the order of a physician. 6. When using the remote flowhead on the device, ensure that...
  • Page 6 5V Power Supply do not position the Power Supply where it is difficult to unplug from the socket. 22. Use of accessories and cables other than those specified or provided by Vitalograph for this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of the device and result in improper operation. ...
  • Page 7 EMI that exceeds the test levels in immunity test tables below will result in a failed calibration verification. Reference section 5.4 of this document for details on completing a calibration verification on the In2itive. If interference is suspected or possible, move the In2itive to a new location and repeat the calibration verification. 27. The applied part is the flowhead and device body or just the flowhead when using the remote flowhead adaptor. These along with the BVF, are the contact points for the subject during a spirometry session.

  • Page 8: Main Components Of The Vitalograph In2Itive

    A Global Leader in Respiratory Solutions 3. Main Components of the Vitalograph In2itive The main components are: Figure 1: Device Components Software application running on PC/laptop (optional) Power (On/Off) Button Mini USB Port Plinth Flowhead Flowhead Cone LCD/Touch Panel Display The software applications available for the device are optional and are not required for the device to function.

  • Page 9: Features Of The Vitalograph In2Itive

    In2itive - Instructions for Use 09160 Issue 3 3.1. Features of the Vitalograph In2itive The features include: • ATS/ERS 2019 compliant • Colour touchscreen display • Wireless EMR connectivity • Portable • Fleisch type Pneumotachograph 4. Setting Up the Vitalograph In2itive Check that the contents of the packaging match the contents label inside the carton.
  • Page 10 A Global Leader in Respiratory Solutions Note: Ensure both the device cap and flowhead adaptor clicks into place 8. Unwrap flowhead connection tubing (5) and connect one end to the device cap (1). The tubing is keyed as shown in Figure 2, match this to the key on the device cap connector to ensure the tubing is in the correct orientation.

  • Page 11: Operating Instructions

    In2itive - Instructions for Use 09160 Issue 3 If the device has just been unpacked or transported, ensure that it is left sitting, fully powered and is at room temperature prior to testing. Ensure a calibration verification is completed at least once daily, prior to using the device (see Section 5.4 Calibration Verification). 5. Operating Instructions On all screens:...

  • Page 12: Entering Subject Data

    A Global Leader in Respiratory Solutions Reports will always be blank for the Quick Test as there is no subject selected. Spirometry option includes VC, FVC and Post (see Sections 5.2 Conducting a Test). 6. Configuration allows the user to: •...
  • Page 13 4. Fit a disposable BVF to the flowhead. The use of a disposable nose clip is recommended. 5. Instruct and demonstrate the test. Note: Vitalograph intends that a new Bacterial Viral Filter (BVF) be used for every subject to prevent cross contamination. 5.2.1. Testing 1. Select ‘VC Test’ or ‘FVC Test’ from ‘Spirometry’ in the Main Menu.
  • Page 14 A Global Leader in Respiratory Solutions relaxed manner with no hesitation until no more air can be expelled. d. It is vital that the operator encourages the subject to keep exhaling to ensure all air is expelled (when a plateau has been reached or expiration time reaches 15 seconds).
  • Page 15 In2itive - Instructions for Use 09160 Issue 3 reappear. The device is now ready for the next blow. g. Repeat for a minimum of three manoeuvres, up to a maximum of eight. h. Check FEV1 and FVC repeatability and perform more manoeuvres as necessary.
  • Page 16 A Global Leader in Respiratory Solutions Artifact Description Start of Test The extrapolated volume must be less than 5% of the FVC or less than 0.100L, whichever is greater. If not, the test is deemed a slow start of test. For a child aged ≥5yr and ≤6yr years old, extrapolated volume must be less than 12.5% of the FVC or 0.08L, whichever is greater. If not, the test is deemed a slow start of test and the subject should be encouraged to blast the air out of their lungs without hesitation.
  • Page 17 In2itive - Instructions for Use 09160 Issue 3 5.2.2. Post Testing Post testing can be performed on any pre-test session performed. 1. Select ‘Spirometry’ from the Menu, then select ‘Post’. 2. Select the relevant pre-test from the list and perform the test as outlined in section 5.2.1 Testing.
  • Page 18 A Global Leader in Respiratory Solutions 5.2.4. Viewing VC Test Results VC test results may be viewed as either a Volume/time (V/t) or Volume Bar graph by scrolling across the screens. First screen is the bar graph, second is the V/t graph, third is the Results screen. 5.2.5.
  • Page 19 In2itive - Instructions for Use 09160 Issue 3 Expiratory reserve volume. The volume that can be maximally expired from the level of the functional residual capacity. Inspiratory capacity. The maximal volume that can be inspired from functional residual capacity. Table 3: VC Parameters...
  • Page 20 A Global Leader in Respiratory Solutions FEV1 The expiratory volume achieved after one second. It takes the Time Zero parameter (TExt) into consideration. Therefore, it is the volume achieved after Time Zero plus one second. FEV1R ratio FEV1 divided by the largest VC from either the VC or FVC manoeuvre and is expressed as a ratio.
  • Page 21 In2itive - Instructions for Use 09160 Issue 3 FEV6 The expiratory volume achieved after six seconds. It takes the Time Zero parameter (TExt) into consideration. Therefore, it is the volume achieved after Time Zero plus six seconds. PEF is the peak expiratory flow and is the maximum/highest flow achieved over the expiratory cycle.
  • Page 22 A Global Leader in Respiratory Solutions FIV1/FIVC ratio FIV1 divided by the FIVC and is expressed as a ratio. PIF is the peak inspiratory flow and is the maximum/highest flow achieved over the inspiratory cycle. PIF is the peak inspiratory flow and is the maximum/highest flow achieved over the inspiratory cycle. is the forced inspiratory flow at 25% of FVC or FIVC (whichever is greater). is the forced inspiratory flow at 50% of FVC or FIVC (whichever is greater). is the forced inspiratory flow at 75% of FVC or FIVC (whichever is greater).
  • Page 23 In2itive - Instructions for Use 09160 Issue 3 Tidal volume. The volume of gas, which is inspired or expired during a respiratory cycle. The average volume of the last three expired tidal breaths is used. Residual Volume (RV): The volume of gas remaining in the lung at the end of a full expiration.
  • Page 24 A Global Leader in Respiratory Solutions Volume expired before the start of the forced manoeuvre. BEV/FVC ratio BEV divided by FVC and is expressed as a ratio. EOTV End of test volume is the volume expired in the last 0.5 seconds. tRISE The time between 10% and 90% of PEF.
  • Page 25 In2itive - Instructions for Use 09160 Issue 3 Base FVC Interpretations algorithm. Page 25 of 56...

  • Page 26: Reporting

    A Global Leader in Respiratory Solutions Post FVC interpretation algorithm. 5.3. Reporting The device prints the reports to an external printer using the Device Studio application. To generate PDF reports from the device: 1. Use the USB cable supplied to connect the device to a computer running Device Studio.

  • Page 27: Calibration Verification

    In2itive - Instructions for Use 09160 Issue 3 Available assessments are shown on screen and may be selected and printed and/or saved. 5. Device Studio may also be used to print/save calibration verification reports, data back-up and restore and to update device firmware. Additional guidance on using Device Studio can be found in the Instruction for Use PN 09550 supplied on the USB flash drive PN 93002 and in the software help menu of the application.
  • Page 28 A Global Leader in Respiratory Solutions Verification option displays in the centre of the screen to remind the user to complete a daily Calibration Verification. To complete a Calibration Verification, press the green forward button and then follow the instructions from step 5 below. 4. To access the option from the main screen menu, select ‘Configuration’ and then select ‘Calibration Verification’ option.

  • Page 29: Connection To Electronic Medical Records (Emr) Via Vitalograph Connect

    In2itive - Instructions for Use 09160 Issue 3 Outside 3%, 6% or 25% (purple syringe, and shows >3%, >6% or >25% in top right corner of screen). The % it is out by indicates the severity of the issue. Over 3%, repeat calibration verification.
  • Page 30 The wireless security measures will be determined by the local IT infrastructure, the available options for the In2itive are None (open network), WPA-PSK, WPA-EAP, IEEE8021X. 3. Press the green forward button to save. 4. To test the connection, re-select the ‘Connect Config’ option and press the ‘Test Connection’...

  • Page 31: Passcode

    In2itive - Instructions for Use 09160 Issue 3 session. 5.5.3. Open Orders The ‘Open Orders’ tab shows a list of orders allocated to the device which have not yet had a test completed. These remain on the list until they are processed. To process an open order, select it from the list and follow the same instructions as for new orders in section 5.5.2 above.

  • Page 32: Incentives

    Note: Ensure the version of Spirotrac running is 6.7 or later and device is updated to v1.05 or later. 2. Once switched on and in the main screen, the Vitalograph In2itive device is ready for use with Spirotrac. 5.8.2. Uploading subject(s) from Spirotrac to Vitalograph In2itive Note: Ensure the device is on the main screen.
  • Page 33 Create new Subject – this will add a new subject to the device. c. Skip – no subject demographics is transferred to the device. 5.8.3. Downloading subject(s) from Vitalograph In2itive to Spirotrac Note: Ensure the device is on the main screen. 1. On Spirotrac select Download/Upload from left hand menu.

  • Page 34: Cybersecurity Considerations

    A Global Leader in Respiratory Solutions 2. The “No device connected” icon displays until a successful connection has been established. Once connection is established, the device name and serial number are displayed. 3. Select Download Sessions. 4. To find the sessions required for download to Spirotrac, there are 2 quick search options and a custom search option.

  • Page 35: Security Recommendations

    09160 Issue 3 and is the only user interface to the device. The OS has a configured firewall to protect against any unauthorised access over the communications ports, only Vitalograph PC based applications can access the device over a secure connection. No further controls are required to be applied by users to secure the device. The device will timeout and auto power down after 5 minutes of inactivity.

  • Page 36: Battery Pack

    9.2. Battery replacement should be carried out only by the manufacturer, the approved importer or by Service Agents approved by Vitalograph. Note: When charging the device using the 5V Power Supply, ensure it is plugged into an accessible socket so that it may be easily disconnected from the mains supply if required.

  • Page 37: Battery Power Indications

    8. Cleaning & Hygiene 8.1. Preventing Cross-Contamination of Subjects A spirometer is not designed or supplied as a ‘sterile’ device. Vitalograph intends that a new Bacterial Viral Filter (BVF) be used for every subject to prevent cross contamination. Using a new BVF provides a significant level of protection of the subject, the device and the user against cross contamination during spirometry manoeuvres.

  • Page 38: Inspection Of The Vitalograph In2Itive

    ‘Cleaning and Hygiene’ on the Vitalograph website. 8.2. Inspection of the Vitalograph In2itive No inspection of the device is required by the subject. The device is used under the supervision of a healthcare professional.
  • Page 39 Examine the Fleisch element and replace if damaged. If it is suspected that the flowhead has become contaminated or where user risk assessment identifies a need for higher level of decontamination, then it should be cleaned as per the instructions on ‘Cleaning and Hygiene’ on the Vitalograph website. It is recommended that a calibration verification is carried out following cleaning and re-assembly as recommended in the ATS/ ERS 2019 guidelines...

  • Page 40: Fault Finding Guide

    A Global Leader in Respiratory Solutions 9. Fault Finding Guide Problem Fault • Calibration verification variations > +/-3% Symptoms: • False readings suspected Possible Cause/ • The % error indicates the severity of Solution: (In the issue. Over 3%, repeat calibration probable order) verification. Over 6% may indicate the device requires cleaning or maintenance.
  • Page 41 In2itive - Instructions for Use 09160 Issue 3 Problem Fault • Tests begin automatically Symptoms: • Volume accumulates automatically without the subject blowing • Very small VC or FVC test displayed Possible Cause/ • Device (or if using remote flowhead, the Solution: (In flowhead) is not stationary at the start of probable order) test.

  • Page 42: Software Check

    9.1. Software Check Information about the device 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 , select ‘Configuration’...

  • Page 43: Customer Service

    In2itive - Instructions for Use 09160 Issue 3 The clock may reset to a default time and date on power down if the 3V coin cell battery has depleted. Vitalograph recommend changing the battery during routine service. 10. Customer Service Service and repairs should be carried out only by the manufacturer, or by Service Agents approved by Vitalograph.

  • Page 44: Disposal

    A Global Leader in Respiratory Solutions 12. Disposal The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste. Used BVFs constitute minimally soiled waste from human healthcare. BVFs are made from recyclable material and should be disposed of in line with local requirements.

  • Page 45: Description Of The Vitalograph In2Itive

    Do not re-use 14. Description of the Vitalograph In2itive The Vitalograph 2120 In2itive is a spirometer designed for lung function testing in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centres. It is a handheld, portable device.

  • Page 46: Technical Specification

    15. Technical Specification Product Vitalograph 2120 In2itive Model 2120 Flow Detection Fleisch type pneumotachograph Principal...
  • Page 47 In2itive - Instructions for Use 09160 Issue 3 Accuracy when Flow ±10% operated in operating Max. flow rate ±16 L/s temperature range Min. flow rate ±0.02 L/s conditions Operating ISO 26782 limits: 17 – 37ºC temperature range Design limits: 10 – 40ºC Operating humidity 30% – 75% range Ambient pressure 850hPa –...
  • Page 48 A Global Leader in Respiratory Solutions Wireless technology WiFi 802.11bgn Module: WL1831MOD Wi-Fi Texas Instruments Certified/ approved FCC, IC, ETSI/CE, Japan MIC. FCC ID: Z64-WL18SBMOD IC: 451I-WL18SBMOD MIC (Japan): 201-135370 Frequency 2.4-GHz (2412 – 2484 MHz). Maximum RMS output power measured at 1dB: 17.3dBm Power Supply 5V, 2A DC power supply 3,7V, 3Ahr Lithium Polymer battery...

  • Page 49: Ce Notice

    16. CE Notice Marking by the symbol indicates compliance of the Vitalograph 2120 In2itive to the Medical Devices Directive of the European Community. The device is intended for and suitable for use in a variety of professional healthcare environments, e.g. primary care, hospital...
  • Page 50 A Global Leader in Respiratory Solutions EN 60601-1-2: 2015 + A1:2021 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Coexistence: ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
  • Page 51 In2itive - Instructions for Use 09160 Issue 3 Electrical fast ±2kV for power +/- 2kV transient/burst IEC supply lines 61000-4-4 Surge ± 0.5 kV, ±1kV +/- 0.5 kV, 1kV IEC 61000-4-5 differential mode Device is identified as Class II unearthed equipment therefore common mode testing is omitted.

  • Page 52: Fda Notice

    EMC and needs to be installed and put into service according to the EMC information provided. The Model 2120 In2itive is a Spirometer and so the performance deemed to be essential is the output of the flow transducer. WARNING: No modification of this equipment is allowed.

  • Page 53: Eu Declaration Of Conformity

    09160 Issue 3 18. EU Declaration of Conformity Product: Vitalograph 2120 In2itive Vitalograph hereby ensures and declares that the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards: •...

  • Page 54: Guarantee & Free Five Year Warranty

    A Global Leader in Respiratory Solutions 19. Guarantee & Free Five Year Warranty Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its option replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials.
  • Page 55 8. To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph® equipment. 9. This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.

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