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of 44

09360 Issue 2

Vitalograph micro - Instructions for Use

with the BVF, are the contact points for the subject during

a spirometry session. There are no adverse effects if the

subject comes into contact with any other part of the device.

3. Main Components of the Vitalograph micro

The micro is a standalone spirometer. Device Studio software

allows the micro to generate reports to a computer after testing is

complete, but it is not required for the device to function. The main

components of the micro are:

Figure 1 Vitalograph micro Components

USB Flash Drive containing Device Studio Software and
manuals

Power (On/Off) Button

Micro USB Port

Plinth

Flowhead

Flowhead Cone

LCD/Touch Panel Display

Battery Compartment (4 x 1.5V AAA batteries)

Note:

Computer shown for illustration purposes only and not

supplied.

Содержание micro 6300

Страница 1: ...micro Instructions for Use MODEL 6300 Copyright Vitalograph 2022 Current Edition Issue 2 29 Jun 2022 Cat No 09360...

Страница 2: ...ermany Tel 49 40 547391 0 Fax 49 40 547391 40 E mail info vitalograph de www vitalograph de Technical Support Telefon 49 40 547391 14 E mail support vitalograph de Vitalograph Inc 13310 West 99th Stre...

Страница 3: ...4 Calibration Verification 17 5 5 Configuration Options 19 6 Power Management 23 6 1 Battery Power Indications 23 6 2 Power Save Mode 24 7 Cleaning Hygiene 24 7 1 Preventing Cross Contamination of Sub...

Страница 4: ...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...

Страница 5: ...able liquids or gases dust sand or any other chemical substances 14 All Spirometry standards recommend completing a calibration verification of lung function measuring devices daily with a 3 L syringe...

Страница 6: ...ome other persons touching part of the system can occur 25 Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 1...

Страница 7: ...spirometer Device Studio software allows the micro to generate reports to a computer after testing is complete but it is not required for the device to function The main components of the micro are F...

Страница 8: ...owered using the USB cable supplied Connect one end of the USB cable into a USB port on a computer and the other end into the micro USB connector on the device 3 Press the On Off switch to turn the de...

Страница 9: ...e end to device cap 2 and the other end to the remote flowhead adaptor 4 See Figure 2 The tubing is keyed so it will only connect one way Figure 2 micro with remote flowhead 1 micro Device 2 Device Ca...

Страница 10: ...indicating a Post test has been performed 5 1 Entering Subject Data 1 Select New Subject on the Main Menu 2 The available information fields available are Date of Birth Height Birth Sex Weight Populat...

Страница 11: ...in any details for the subject but this is not recommended 3 Fit a disposable BVF to the flowhead A disposable noseclip may also be used 4 Select the test option VC or FVC Instruct and demonstrate th...

Страница 12: ...hows the VC of the last blow The number of blows is shown next to the last test VC 7 The best three tests are shown on the graph in order of rank best 1 2 3 etc A legend at the top of the graph explai...

Страница 13: ...ort until completely full The manoeuvre is now complete remove the mouthpiece from the mouth 6 Listen for two beeps The device is now ready for the next blow 7 Repeat for a minimum of three manoeuvres...

Страница 14: ...ion 14 To delete the current blow Select the Delete option from the side menu Two Delete icons will appear Delete green Press to confirm the deletion Delete red Press to cancel the deletion To clear d...

Страница 15: ...Note A Post Test may only be selected if an FVC pre test has been completed When leaving the Post FVC test screen and returning to the main menu the user will not be able to select either the VC or FV...

Страница 16: ...ional information may be added such as name user interpretation and comments 6 Device Studio may also be used to print save calibration verification reports and download print all assessments The sett...

Страница 17: ...spirometer and the volume pumped into the spirometer from a syringe is within 3 To complete a calibration verification 1 Select the Configuration button on the main menu screen 2 Select the calibratio...

Страница 18: ...event the result is outside 3 or non reproducible anerror icon will display Successful verification green syringe with a tick Non reproducible syringe strokes red syringe with information in centre a...

Страница 19: ...tion should be repeated If the error continues to show contact Vitalograph using the contact information at the start of this document Note To exit the Calibration Verification screen without performi...

Страница 20: ...Predicted or Z score The parameter selected will then be displayed in the results screen Audio turn audio off and put the micro into silent mode User Passcode use to lock the device so that any user w...

Страница 21: ...5 of the FVC L sec EVC Expiratory vital capacity L IVC Inspiratory vital capacity L FIVC Forced inspiratory vital capacity L FIVC FVC Ratio FIVC of FVC FEV 5 Forced expiratory volume after 0 5 seconds...

Страница 22: ...VC FIV1 FVC Ratio FIV1 of FIVC FIV1 Forced inspiratory volume after 1 second L FIV1 FIVC Ratio FIV1 of FIVC PIF L min Peak inspiratory flow L min FIF25 Forced inspiratory flow at 25 of the FVC L sec F...

Страница 23: ...ber 6300 Serial number of the device the Software reference number date of the last Calibration Verification and date of Service completion 6 Power Management The device may be powered from a computer...

Страница 24: ...When running off the USB the device screen will go blank if left unused for 5 minutes The device will not auto power down if powered by USB Pressing the screen or on Off button will bring the device...

Страница 25: ...alcohol impregnated cloth provides a suitable form of cleaning The exposure time for low level disinfection using 70 IPA wipes is 1minute 3 Screen Clean For the screen lightly wipe the surface with c...

Страница 26: ...ead 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 in Cleaning and Hygiene on the Vitalog...

Страница 27: ...t assembly sealing O rings damaged Contact support Flowhead Fleisch element assembly blocked Contact support Cold syringe Ensure syringe is in its test environment for at least an hour before use EMI...

Страница 28: ...pressed The batteries may be low plug in USB cable attached to a computer or replace the batteries Electronics failure Contact support Problem Fault Symptoms Reversed or no volume measurements Possibl...

Страница 29: ...fore a service is recommended at 10 years or when product useful life checks dictate it is required 9 Customer Service Service and repairs should be carried out only by the manufacturer or by Service...

Страница 30: ...roducts or the batteries as unsorted municipal waste they should be disposed of in line with local requirements Used BVFs constitute minimally soiled waste from human healthcare BVFs are made from rec...

Страница 31: ...Limits Non sterile Recycle Keep dry QR code matrix bar code Rx Only Restricted to sale by or on the order of a physician MR Unsafe Do not use this device in an MRI environment 13 Description of the Vi...

Страница 32: ...0 02 L s PEF Accuracy 10 or 10L min of the reading ISO 23747 2015 Back pressure Less than 0 1kPa L sec 14L sec ATS ERS 2019 Operating temperature range ISO 26782 limits 17 35 C Design limits 10 40 C...

Страница 33: ...or 10 L min with 3 or 3L min allowed for test apparatus ISO 23747 Service life The recommended service life of the device is 10 years or when the product life checks dictate it is required The batter...

Страница 34: ...curve The operating conditions specified apply to the device plus accessories The device flowhead and BVF are classified as type BF applied parts An applied part is a part of the equipment which in n...

Страница 35: ...1 2015 Medical electrical equipment Part 1 11 General requirements for basic safety and essential performance collateral standard Requirement for medical electrical equipment and medical electrical sy...

Страница 36: ...residential areas EN 60601 1 2 2015 A1 2021 Immunity tests Immunity test Test level Compliance level Reached Electrostatic discharge ESD EN 61000 4 2 Contact 8 kV Air 2 kV 4 kV 8kV 15 kV Contact 8 kV...

Страница 37: ...re use that no interference is evident or possible Loss or degraded performance due to EMI that exceeds the test levels in immunity test tables above will result in a failed calibration verification R...

Страница 38: ...device is classified as IIa per Annex IX of the MDD also meets the provisions of the Essential Requirements Annex I via compliance with Annex II of the Medical Devices Directive as per Article 11 sec...

Страница 39: ...ser installable modules is guaranteed for 90 days from the date of purchase 4 The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner des...

Страница 40: ...has any authority to vary the terms or conditions of this guarantee 8 To the maximum extent permitted by law the Company does not accept liability for any consequential damages arising out of the use...

Страница 41: ...ENG 41 Page of 44 09360 Issue 2 Vitalograph micro Instructions for Use...

Страница 42: ...ENG 42 Page of 44 DT_0006 Issue 16 A Global Leader in Respiratory Solutions...

Страница 43: ...ENG 43 Page of 44 09360 Issue 2 Vitalograph micro Instructions for Use...

Страница 44: ......

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