Vitalograph alpha 6000 Instructions For Use Manual Download Page 2

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A Global Leader in Respiratory Diagnostics

Page

of 40

DT_0006 Issue 15

Vitalograph Ltd, UK

Maids Moreton, Buckingham

MK18 1SW

England

Tel:

01280 827110

Fax:

01280 823302

E-mail:

[email protected]

www.vitalograph.co.uk

Technical Support

Tel:

01280 827177

Email:

[email protected]

Vitalograph Ltd, International

Maids Moreton, Buckingham

MK18 1SW

England

Tel:

+44 1280 827120

Fax:

+44 1280 823302

E-mail:

[email protected]

www.vitalograph.eu

Technical Support

Tel:

+353 65 6864111

Email:

[email protected]

Vitalograph GmbH

Rellinger Straße 64a

D-20257 Hamburg

Germany

Tel:

+49 40 547391-40

Fax:

+49 40 547391-40

E-mail: [email protected]

www.vitalograph.de

Technical Support

Telefon:

+49 40 547391-14

E-mail:

[email protected]

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:

[email protected]

www.vitalograph.com

Technical Support

Tel:

(913) 730-3205

Email:

[email protected]

Vitalograph (Ireland) Ltd

Gort Road Business Park

Ennis, Co Clare, V95 HFT4

Ireland

Tel:

+353 65 6864100

Fax:

+353 65 6829289

E-mail:

[email protected]

www.vitalograph.ie

Technical Support

Tel:

+353 65 6864111

Email:

[email protected]

Vitalograph Ltd, Hong Kong/China

P.O. Box 812

Shatin Central Post Office

Hong Kong

E-mail:

[email protected]

www.vitalograph.cn

Technical Support

Tel:

+353 65 6864111

Email:

[email protected]

Current Edition (Issue 1, 27-Jan-2021)

Cat. No. 09060

Vitalograph

is a registered trademark.

Vitalograph Branch Addresses

Summary of Contents for alpha 6000

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

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

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

Page 40: ......

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