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A Global Leader in Respiratory Diagnostics

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DT_0006 Issue 15

1. Main Components

The main components are:

Figure 1.a

Figure 1.b

Flowhead

Touchscreen display

Micro SD card connector

On/Off button

Printer door release button

Printer

USB connector

Ethernet connector

Power supply input

Flowhead tubing connector (device)

Flowhead tubing connector (flowhead)

Содержание alpha 6000

Страница 1: ...ALPHA Instructions for Use MODEL 6000 Copyright Vitalograph 2021 Current Edition Issue 1 27 Jan 2021 Cat No 09060...

Страница 2: ...Support Telefon 49 40 547391 14 E mail support vitalograph de Vitalograph Inc 13310 West 99th Street Lenexa Kansas 66215 USA Toll Free 800 255 6626 Tel 913 730 3200 Fax 913 730 3232 E mail contact vi...

Страница 3: ...attery Pack 20 5 2 Battery Power Indications 20 5 3 Power Save Mode 21 6 Cleaning Hygiene 21 6 1 Preventing Cross Contamination of Subjects 21 6 2 Inspection of the Vitalograph Model 6000 Alpha 22 7 F...

Страница 4: ...s The main components are Figure 1 a Figure 1 b A Flowhead B Touchscreen display C Micro SD card connector D On Off button E Printer door release button F Printer G USB connector H Ethernet connector...

Страница 5: ...the socket on the rear of the device Plug the mains plug into a suitable socket press the On Off switch on the side of the instrument The device is ready for use 6 The device is fitted with rechargea...

Страница 6: ...e Calibration Verification prompt displays in the centre of the screen when the device has just been powered on if a calibration verification has not been completed that day To complete a calibration...

Страница 7: ...inter see section 3 3 Reporting 6 Configuration allows the user to carry out a calibration verification Section 3 4 configure reports Section 3 3 configure parameters for test Section 3 2 configure th...

Страница 8: ...completed recently refer to section 3 4 Calibration Verification 2 Select a subject and ensure subject details are entered 3 Wash hands operator and subject 4 Fit a disposable BVF to the flowhead The...

Страница 9: ...to normal breathing g The manoeuvre is now complete Remove the BVF from the mouth h Listen for two beeps The device is now ready for the next blow i Repeat for a minimum of three manoeuvres up to a m...

Страница 10: ...U 0 acceptable AND 1 usable N A N A F 0 acceptable and 0 usable N A N A Or 10 of the highest value whichever is greater applies for age 6 years or younger only Table 1 Grades 3 2 2 Bronchodilator Resp...

Страница 11: ...oss the screens First screen is the bar graph second is the V t graph third is the Results screen All other viewing is as per section 3 2 3 3 2 5 Saving and ending the Test Session The device has capa...

Страница 12: ...he device facing forward press the printer button to open the door Remove the tape from the new paper roll unroll a small amount of paper and load it into the paper holder with the blue writing facing...

Страница 13: ...sessments are shown on screen and may be selected and printed and or saved see Fig 5 b Figure 5 b 4 Device Studio may also be used to print save calibration verification reports and to update device f...

Страница 14: ...n on the main menu select Calibration Verification option 3 Enter syringe details serial number syringe volume will default to 3L pressure altitude and humidity At a minimum the serial number syringe...

Страница 15: ...ved for the calibration verification if required see section 3 3 Reporting If the procedure was followed correctly and the error icon is showing the calibration verification may be repeated If the err...

Страница 16: ...tab is selected the device searches all available networks 2 Select the required network and enter passkey The Advanced option allows the user to add edit the advanced network details if required 3 Pr...

Страница 17: ...MAC address Connection method DHCP or Static IP address Netmask Figure 8 Example set up for Connect wired 2 When connected a wired Ethernet symbol displays in the status bar top left Once Connect is c...

Страница 18: ...ocated 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...

Страница 19: ...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 minu...

Страница 20: ...ours testing with 5 reports from the internal printer Note With the power supply plugged in the device will continue to charge even if it auto powers down after 5 minutes of inactivity The recommended...

Страница 21: ...noeuvres The interior of a Vitalograph flowhead does not require decontamination where a new BVF is used for each subject The outside surfaces of the device and flowhead tube may be cleaned with a 70...

Страница 22: ...flow conditioning mesh filter for damage or contamination If it is damaged or blocked it should be replaced with a new part Examine the Fleisch element and replace if damaged If you suspect the flowh...

Страница 23: ...pressure ports on device is blocked Contact support Electronics failure Contact support Problem Fault Symptoms Printout is blank Cannot print to internal printer Possible Cause Solution In probable o...

Страница 24: ...life Vitalograph recommends checking the flowhead and the batteries The flowhead may be checked with the daily calibration verification to be completed by the clinician healthcare professional and du...

Страница 25: ...67252 USB A to USB B cable 42175 Flowhead Connection Tube 65054 Alpha 12V PSU SL Power MPN ME20A1200805 part 65055 Alpha 12V PSU Spare EU AU US SL Power MPN ME20A1200805 part 69128 6000 Alpha feet set...

Страница 26: ...recyclable material and should be disposed of in line with local requirements 11 Explanation of Symbols Symbol Description Type B equipment Class II VA Power rating Direct current Instructions for Use...

Страница 27: ...metry may support or exclude diagnosis but it cannot make one Spirometers are also used in non clinical settings such as occupational health screening where no clinical judgment is made suspect findin...

Страница 28: ...ume accuracy 2 5 Voltage frequency Power supply Input 100 240V 50 60Hz 0 5A Output 12V 1 5A Battery 7 2V 2 2Ahr Accuracy when operated in operating temperature range conditions Flow 10 Max flow rate 1...

Страница 29: ...splayed are expressed as BTPS values Take care not to block the cone with the tongue or teeth A spitting action or coughing will give false readings Time zero is determined using the back extrapolated...

Страница 30: ...k between tests A max test completed message will appear after eight manoeuvres 9 All values displayed are expressed as BTPS values 10 Time zero is determined using the back extrapolated method from t...

Страница 31: ...time when exposed to light or heat If a permanent record is required photocopy the thermal printout or send the report to the Device Studio Utility 21 Use of accessories and cables other than those sp...

Страница 32: ...environment The device was tested in accordance with EN 60601 1 2006 A1 2013 with US deviations Medical electrical equipment Part 1 General requirements for basic safety and essential performance EN...

Страница 33: ...4 11 100 drop 0 5 cycles 0o 45o 90o 135o 180o 225o 270o 315o 100 dip 1 cycle 30 dips 25 30 cycles 240V AC 50Hz 100V AC 50Hz 100 drop 0 5 cycles 0o 45o 90o 135o 180o 225o 270o 315o 100 dip 1 cycle 30 d...

Страница 34: ...vice and result in improper operation Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part...

Страница 35: ...s 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 section 3a e...

Страница 36: ...rature and user manuals The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above provided that the failure can be recreated and the...

Страница 37: ...09060 Issue 1 37 Page of 40 EN Alpha Instructions for Use...

Страница 38: ...A Global Leader in Respiratory Diagnostics 38 Page of 40 EN DT_0006 Issue 15...

Страница 39: ...09060 Issue 1 39 Page of 40 EN Alpha Instructions for Use...

Страница 40: ......

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