lung monitor Serial

Model 4000

User Training Manual

Medical Devices Directive

93/42/EEC L169, Vol. 36.

EN ISO 13485

FDA QSR 21 CFR 820/803

Manufacturer: Vitalograph (Ireland) Ltd, Ennis, Ireland

UK Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: (01280) 827110
Fax: (01280) 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.co.uk

Export Sales
Vitalograph Ltd.
Maids Moreton, Buckingham, MK18 1SW, England
Phone: +44 1280 827120
Fax: +44 1280 823302
e-mail: sales@vitalograph.co.uk
www.vitalograph.eu

Vitalograph GmbH
Rellinger Straße 64a, 20257 Hamburg, Germany
Phone: (040) 54 73 91-0
Fax: (040) 547 391 40
e-mail: info@vitalograph.de
www.vitalograph.de

Vitalograph Inc.
13310 West 99th Street, Lenexa, Kansas 66215, U.S.A.
Toll Free: 800 255 6626
Phone: (913) 730-3200
Fax: (913) 730-3232
e-mail: vitcs@vitalograph.com
www.vitalograph.com

Vitalograph (Irl.) Ltd.
Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: (065) 6864100
Fax: (065) 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.ie

© Copyright Vitalograph 2013
Current Edition (Issue 4)
Cat. No. 07563

is a registered trademark

Table of Contents

1. WARNINGS AND ADVISORY NOTICES
2. MAIN COMPONENTS OF THE VITALOGRAPH LUNG MONITOR SERIAL
3. WHAT IS THE VITALOGRAPH LUNG MONITOR SERIAL USED FOR?
4. HOW TO USE THE VITALOGRAPH LUNG MONITOR SERIAL
   1. SETTING PERSONAL BEST (REFERENCE) VALUES
   2. SETTING MANAGEMENT ZONES
   3. PERFORMING THE TEST
   4. REVIEWING PREVIOUS RESULTS
   5. DELETING ALL RESULTS HISTORY
   6. SENDING TEST RESULTS TO VITALOGRAPH REPORTS
5. CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR SERIAL
   1. HOME USE CLEANING AND DISINFECTION OF THE VITALOGRAPH LUNG MONITOR SERIAL
   2. CLEANING AND DISINFECTING THE VITALOGRAPH LUNG MONITOR IN CLINIC USE
   1. Table of Materials Used & Cleaning/Disinfection Methods
   2. Removing the Flowhead for Cleaning and Disinfecting
6. CONSUMABLES, ACCESSORIES AND SPARE PARTS
7. EXPLANATION OF SYMBOLS
8. TECHNICAL SPECIFICATIONS
9. CE NOTICE
10. FDA NOTICE
11. DECLARATION OF CONFORMITY
12. GUARANTEE

1. WARNINGS AND ADVISORY NOTICES

Note: Please read all the information in this manual before using the Vitalograph lung monitor serial device. A full set of instructions, including cleaning instructions, is available at www.vitalograph.co.uk.

• The Vitalograph lung monitor is recommended for single patient use.
• The Vitalograph lung monitor should be only used under the supervision of a healthcare professional.
• Symptoms must take precedence over device measurements*.
• Before use, ensure that the batteries do not exceed their shelf life, as indicated on the batteries.
• Store in a clean dry place.

* If the patient at home thinks that the device is not reading correctly, they must advise the healthcare professional immediately.

2. Main Components of the Vitalograph Lung Monitor Serial

A	Keypad - Up, Down & Enter Button
B	LCD
C	Flowhead
D	Serial Connector
	On/Off Button
	Down Button
	Up Button
	Enter Button

3. WHAT IS THE VITALOGRAPH Lung Monitor Serial USED FOR?

The Vitalograph lung monitor serial is an easy to use home monitoring device designed to record key lung function parameters for those with respiratory conditions, including cystic fibrosis and transplant patients. The lung monitor can also be used in primary and secondary care, occupational health and clinical studies.

The primary features of the Vitalograph lung monitor are:

• Measures FEV1, FEV6 and the ratio
• Displays % of personal best FEV1
• Simple to use
• Electronic record, eliminating need for record cards
• Stores 200 test sessions
• Quality of blow indicator
• FEV1 zones can be personalized
• Uses disposable AAA batteries
  

4. HOW TO USE THE VITALOGRAPH LUNG MONITOR Serial

4.1. Setting Personal Best (Reference) Values

Personal Best (reference) values can be set for forced expiratory volume after 1 second (FEV1).

To set the Personal Best (reference) FEV1, follow these steps:

1. Turn the device on, .
2. When the device is ready for a test (), press the and buttons together for 3 seconds.
3. The reference FEV1 value is set by pressing the button and releasing when the value is reached. Press the to roll back. The values will increase/decrease in values of 0.10. If the button is kept depressed, the values will scroll faster.
   
4. Press ENTER to keep this reference FEV1 value. The device will return to the test screen.

Note: to de-activate zones, set the FEV1 reference value to 0.00.

4.2. Setting Management Zones

The Vitalograph lung monitor can be set for use with 3 or 4 zone management plans. The zone percentages are factory set to 2 boundaries, 95% & 90%, i.e. 3 Zones (95-100%, 90-95%, 0-90%). For 4 zones the middle boundary is set last. The colour systems for each zone type are as follows;

To set the boundary percentage values for 3 zones, follow these steps;

1. Turn the device on, .
   
2. When the device is ready for a test (), press the and buttons together for approximately 10 seconds.
   
3. The top (Green/Yellow) boundary can now be set. This is done by pressing the or button and releasing when the value is reached.
   
4. Press ENTER to set the top (Green/Yellow) boundary value.
   
5. The bottom (Yellow/Red) boundary can now be set. This is done by pressing the or button and releasing when the value is reached. Press to set the bottom(Yellow/Red) boundary value.
   
6. Only 2 boundaries are required for the 3 zone system, so the next value should be selected as 0% (default). Press . The device will return to the test screen.

To set the boundary percentage values for 4 zones, follow these steps;

1. First, set the top and bottom boundaries – see above procedure (steps 1 - 6).
   
2. The middle (Yellow/Orange) boundary can now be set. This is done by pressing the button and releasing when the middle boundary value is reached.
   The values will increase/decrease in values of 1% after an initial jump to the lower boundary value. If the button is kept depressed, the values will scroll faster. This boundary value cannot be set at a value that is greater than the top boundary value or less than the bottom boundary value.
   
3. Press to set the middle (Yellow/Orange) boundary value. The device will return to the test screen.

4.3. Performing the Test

1. Sit down when blowing into the device (unless the physician advises otherwise).
   
2. Turn the device on, . with the mouthpiece inserted. (Use a disposable SafeTway mouthpiece in clinic.)
   
3. When the device is ready for a test (), holding the head high, breathe in as deeply as possible, hold the Vitalograph lung monitor ready in front of the mouth.
   
4. Holding the breath, place the mouthpiece into the mouth, biting the mouthpiece lightly, and with the lips firmly sealed around it.
   
5. Blow out as HARD, as FAST and as LONG as possible (the device will stop taking readings after 6 seconds). Be careful not to block the mouthpiece with the tongue or teeth. A ‘spitting’ action will give false readings.
   
6. Following each blow and at the end of the test session, the FEV1 value will be displayed and below that, FEV1 % Personal Best results for that blow.
7. Pressing the button will show the FEV6 result.
8. Pressing the button again will show the FEV1/FEV6 result.
9. Pressing the button again will show the FEF25-75 result.
10. With the blow icon showing, blow again (). Usually 3 blows are required.
11. To view the best test in the session (best FEV1 and best FEV6), press the button. This is the value that is recorded for the session in the device history.
    

Note: if an exclamation mark ! appears, this means it was not a good quality blow and the subject should blow again. ! appears when: The Vext (extrapolated volume) is > 5% or 150mL of FEV6 or a cough is detected in the 1st second.

If the subject experiences dizziness or fatigue during the test session, wait until this passes before blowing again or terminate the session.

4.4. Reviewing Previous Results

The Vitalograph lung monitor can store up to 200 test sessions. In order to view previously performed test sessions, follow these steps:

1. Turn the device on, .
   
2. When the device is ready for a test (), press the button for approximately 3 seconds.
   
3. The most recent test session will now be displayed. The best FEV1 result will be displayed for approximately 3 seconds, followed by the best FEV6 result. The session number ‘1’ is also displayed, this is the latest session.
   
4. Earlier test sessions can also be viewed. Pressing the button once will show ‘2’ the previous test, and so on.
   
5. Press . The device will return to the test screen.

4.5. Deleting All Results History

Caution: Once the history has been deleted it cannot be recovered.

To delete the history entirely, i.e. all previously stored session results, follow these steps:

1. Turn the device on, .
   
2. When the device is ready for a test (), press the and buttons simultaneously for approximately 10 seconds.
   
3. A long beep will indicate success and the device will return to the test screen.
   

4.6. Sending Test Results to Vitalograph Reports

The test session may be transmitted to the Vitalograph Reports Utility on your PC where it can be stored as a PDF file and viewed or printed.

Before you can transmit you must first have the Vitalograph Reports Utility installed and running on your PC. If the ‘Snake V’ icon is showing in your PC System Tray then the utility is running, if not refer to Vitalograph Reports Utility instructions.

1. Connect the Vitalograph lung monitor Serial device to the PC using the serial cable supplied.
2. On Vitalograph Reports ensure ‘Vitalograph lung monitor’ is selected as the device.
3. There are two ways to print the test results from the lung monitor:
   
   1. When the device is ready for a test (), press the button for 3 seconds on the device will show the Report icon ().
      
   2. After completing the test session, press the or button until the print () screen is displayed. Press .
      
4. On the Vitalograph Reports enter the Subject Demographic details and Comments. Select ‘Continue’ on Vitalograph Reports when you are finished entering the information.
5. Select a location for the test report on your PC as requested by Vitalograph Reports. A PDF of the test results will appear and will also be stored to the PC.

5. CARE AND CLEANING OF THE VITALOGRAPH LUNG MONITOR Serial

5.1. Home use cleaning and disinfection of the Vitalograph lung monitor

The Vitalograph lung monitor should continue to give reliable measurements for up to three years in home use. Then replace it with a new device.

Keep it clean and dust free. If you suspect the device is damaged or is measuring incorrectly, contact the doctor immediately.

The mouthpiece is the only part of the device, which needs to be routinely cleaned in home use.

The outer surfaces should be thoroughly cleaned every week, more often if necessary. We recommend the use of an ordinary alcohol wipe, paying special attention to the mouthpiece area.

5.2. Cleaning and Disinfecting the Vitalograph lung monitor In Clinic Use

A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.

It is recommended that the device be regularly cleaned according to the guidelines of the user’s facility. The disinfection materials and procedures applied in the users’ facility may be more appropriate than the methods outlined below.

In the event of visible contamination of the flowhead element, it should be cleaned or disinfected as described in the accompanying table. The device should be replaced in the event of damage, or if visibly contaminated.

The frequency of cleaning and disinfecting is dependent on the facility’s risk assessment, usage, and test environment, but it should be at least monthly or every 100 subjects (300 blows).

It is recommended that the device be replaced annually or test and calibration serviced at least annually. There is no planned preventive maintenance for this medical device.

5.2.1. Table of Materials Used & Cleaning/Disinfection Methods

This listing of materials used is given to provide clinical users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device.

Part	Material	Clean/ Disinfect	Autoclave Possible?	Recommended Disinfectants
Plastic Mouthpiece	ABS	Do not use in clinic	No	Disinfect by immersion in sodium dichloroisocyanurate solution at 1000ppm concentration of free chlorine for 15 minutes
SafeTway mouthpiece or BVF	Cardboard/ ABS	Dispose – single use	No	Dispose – single use
Case Exterior	ABS	Clean	No	Wiping with a 70% isopropyl alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. This may be preceded by cleaning with an anti-static foam cleaner if necessary.
Fascia	PMMA/ PET	Clean	No
Removable flowhead	ABS, Stainless Steel	Clean	No	Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes (see following section for recommended cleaning/disinfection method for the flowhead) Maximum of 50 cleaning cycles allowed.

All external parts of the Vitalograph lung monitor require cleaning, i.e. the removal of visible particulate contamination. The parts of the device that make up the flowhead, which comes into contact with the breath of the subjects being tested, also require disinfecting. This device is not designated as a ‘sterile’ device.

Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment:

Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate, 1996”.

Recommendations for chemical disinfectants are derived from the PHLS publication “Chemical Disinfection in Hospitals” 1993.

 

5.2.2. Removing the Flowhead for Cleaning and Disinfecting

Flowhead Disassembled	Flowhead Assembled

1. Remove the flowhead from the body with a sharp pulling motion.
2. Clean the flowhead by washing in a mild detergent to remove particulate contamination, taking care not to touch the moving vanes. Swill vigorously in water with mild detergent. Do not attempt to “rub” or “scrub” in the area of the vanes. Rinse with clean water.
3. Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines. Rinse with warm water for faster drying.
4. Leave it to dry completely before reassembling. Drying the flowhead may require placing it in a warm place overnight. A drying cabinet is ideal.

 

Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection for the case exterior, display, screen surround and keys. Repeat this at least weekly to prevent a build-up of grime from normal handling and use.

Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment.

Reassemble the flowhead by pushing back on until it ‘clicks’ into position. Ensure that the flowhead is pushed fully home.

6. Consumables, Accessories AND SPARE PARTS

7. Explanation of Symbols

	Type BF equipment
	Class II
	Serial Connector
	Attention (reference relevant section in manual)
	Manufacturer
	Year of Manufacture
	The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste.

Other Labels

	Battery status Battery status Full Battery status Half Battery status Quarter Battery status Empty (flashing)
	Blow Now Symbol
!	Bad Test Symbol (Slow start or Cough)
	Transmit Report Symbol
	Memory 90% - 100% Full Icon Flashes when memory reaches 100%

8. Technical Specifications

9. CE Notice

Marking by the symbol indicates compliance of the Vitalograph 4000 Respiratory Monitor lung monitor device to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph 4000 Respiratory Monitor lung monitor device meets or exceeds the following technical standards:

Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities.

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided.

Portable and mobile RF communications equipment can affect medical electrical equipment.

10. FDA Notice

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

11. Declaration of Conformity

Product: Vitalograph 4000 Respiratory Monitor lung monitor

Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards:

• 

  European Medical Devices Directive {MDD} 93/42/EEC.

• This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the following provisions of Annex II of the Medical Devices Directive as per Article 11, section 3a, excluding point 4 of Annex II.

• This device complies with the EMC Directive 89/336/EC, conformance demonstrated by following standard EN60601-1-2:2001.

• Equipment classification: Residential.

Canadian Medical Device Regulation {CMDR}

FDA Quality System Regulation {QSR} 21 CFR 820.

EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory purposes.

Certifying Body {for 93/42/EEC and CMDR}: British Standards Institute {BSI}

Certificate Nos. CE 00772, MD 82182, FM 83550

Signed on behalf of Vitalograph (Ireland) Ltd.

B. R. Garbe.

Group Managing Director

12. Guarantee

Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its opinion replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials.

The conditions of this Guarantee are:

1. This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment, unless otherwise agreed in writing by the Company
   
2. Software (meaning computer software, or user installable modules) is guaranteed for 90 days from the date of purchase.
   
3. The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner described in the Company's literature 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 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 does not cover any faults caused by accident, misuse, neglect, tampering with the equipment, use of consumable items or parts not approved by the Company, or any attempt at adjustment or repair other than by personnel accredited by the Company, nor does it cover reinstatement of any configuration changes caused by the installation of any software.
   
5. If a defect occurs, please contact the supplier from whom it was purchased for advice. The Company does not authorise any person to create for it any other obligation or liability in connection with Vitalograph® equipment
   
6. This Guarantee is not transferable and no person, firm or company has any authority to vary the terms or conditions of this Guarantee.
   
7. 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.
   
8. This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.

This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.