Respiratory Monitor copd-6

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 (Ireland.) Ltd.
Gort Road Business Park,
Ennis, Co. Clare, V95 HFT4
Ireland
Phone: (065) 6864100
Fax: (065) 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.ie

© Copyright Vitalograph 2013
Current Edition 7
Cat. No. 07381

is a registered trademark

Table of Contents

1. WARNINGS AND ADVISORY NOTICES
2. MAIN COMPONENTS OF THE VITALOGRAPH COPD-6
3. WHAT IS THE VITALOGRAPH COPD-6 USED FOR?
4. HOW TO USE THE VITALOGRAPH COPD-6
1. Entering Subject Data
2. Performing the Test
3. Setting the Obstructive Index and COPD Classification Zones
4. Reviewing the Last Session Test Results
5. CARE AND CLEANING OF THE VITALOGRAPH COPD-6
   1. Daily Procedures
   2. Monthly Procedures
   3. Annual Procedures
   4. Table of Materials Used & Cleaning/Disinfection Methods
   5. Removing the Flowhead for Cleaning and Disinfecting
6. CONSUMABLES AND 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 copd-6 device.

• This Vitalograph device is intended to measure lung function for use in clinic with disposable mouthpieces or filters or for patient use at home under medical supervision.
• Take care not to block the mouthpiece with the tongue or teeth. A ‘spitting’ action or coughing will give false readings.
• If used at home 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 you suspect that a defect has occurred you should check the Vitalograph copd-6 device for operation.

2. MAIN COMPONENTS OF THE VITALOGRAPH COPD-6

3. WHAT IS THE VITALOGRAPH COPD-6 USED FOR?

The Vitalograph copd-6 is a device intended for measuring lung function. It can be used by a healthcare professional or assistant as a rapid pre-spirometry test to screen-out at-risk individuals that do not have COPD and indicate those that may be at risk of COPD at the presymptomatic stage of the disease. This “screening” or “case selection” for full spirometry examinations may result in earlier medical intervention and facilitate better clinical outcomes.

The Vitalograph copd-6 displays some key parameters for clinical interpretation:

• FEV1 and FEV1 % Predicted
• FEV6 and FEV6 % Predicted
• FEV1/FEV6 and FEV1/FEV6 % Predicted

If an abnormal result is indicated, arrows on the display show:

• Obstructive Index
• COPD Classification (stages I - IV)

4. HOW TO USE THE VITALOGRAPH COPD-6

4.1 Entering Subject Data

The subject’s physical data can be entered into the Vitalograph copd-6 in order to calculate predicted data.

To enter the subject data, follow these steps:

1. Turn the device on, .
2. The age can now be set ( ). This is done by pressing the or button and releasing when the age is reached. The values will increase/decrease in values of 1. If the button is kept depressed, the values will scroll faster. Press the button to set the age.
3. The height can now be set ( ). This is done by pressing the or button and releasing when the height is reached. The values will increase/decrease in values of 1. If the button is kept depressed, the values will scroll faster. Press the button to set the height.
   Note: if height values are set below 100, the device assumes height is in inches and that Weight will be in Ibs rather than Kg.
4. The gender can now be set ( ). This is done by pressing the or button and releasing when the correct gender is showing. (Male ( ); Female ( )) Press the button to set the gender. After gender is selected, the Vitalograph copd-6 will go to Test Mode, where the Blow Icon is showing. On some variants, an additional data field comes first (see below).
5. (This step may be omitted, depending on the variant) The Population Group (On some variants this is Weight instead) can now be set ( ). This is done by pressing the or button and releasing when the desired setting is reached. Press the button to set.

Set No.	Population Group
1	NHANES III Caucasian C
2	NHANES III African-American AA
3	NHANES III Hispanic-American HA

 

4.2 Performing the Test

1. The subject should sit down when blowing into the device (unless advised otherwise). Insert a new Bacterial Viral Filter (BVF) or disposable SafeTway mouthpiece into the device.
2. Turn the device on, (if not already ON). When the device is ready for a test the blow icon shows ( ).
3. Instruct the subject and demonstrate (using a mouthpiece) as follows:
   1. “Hold your head up, breathe in as deeply as possible, hold the device in front of your mouth”.
   2. “Hold your breath, place the mouthpiece into your mouth, like this, bite the mouthpiece lightly, and seal your lips firmly around it, like this”. I will demonstrate.
   3. “Blow out as HARD, and FAST as you can, like this, until I tell you to stop” (the unit will beep at end of test - after 6 seconds).
   4. “Be careful not to block the mouthpiece with your tongue or teeth. A ‘spitting’ action will give false readings”.
   5. “Now you do it – deep breath in – bite and seal – blast the air out…keep going – keep blowing”
   6. “Well done!” “Now, we need to do that three times. Rest for a while until you are ready to blow again”.
4. To view the result (the best values in the session), press the button.
   1. The COPD Classification will show on the right hand arrow.
      1. Green is NORMAL, negative for COPD. No need to refer this subject for spirometry.
      2. Any one of the blue zones, I, II, II or IV are not normal. This subject should be referred for spirometry.
   2. The Obstructive Index (OI) shows on the left hand arrow.
      1. 0 - Green is normal.
      2. 1, 2 or 3 – Yellow, amber or red are not normal. Refer for spirometry, but this is unlikely to be COPD.
      3. Note: If the right hand (COPD) arrow is not green, nor will the left hand (OI) arrow be green.
5. This is the end of the test, but if desired some test parameters may be viewed.
6. Following each blow and at the end of the test session, the FEV1 value will be displayed and below that, FEV1 % Predicted results for that blow, or for the best in session if the button has been pressed. Pressing again will toggle between best and last blow.
7. Pressing the button will show the FEV6 and FEV6 % Predicted results.
8. Pressing the button again will show the FEV1/FEV6 and FEV1/FEV6 % Predicted results
9. Press the button for a final time will show the estimated Lung Age ( )

Notes on testing:

1. During testing, if an exclamation mark ! appears, this means that the last blow was not a good quality blow and the user should blow again. Reasons for poor quality are;
   1. Slow Start of test: Vext (extrapolated volume) is > 5% or 150mL of FEV6
   2. Cough detected.
2. In the event that a test is < 3 seconds duration and has an abrupt end (change in volume is > 25ml in the last second of the test), the value FEV will be displayed instead of FEV6.
3. If the test subject experiences side effects such as dizziness or fatigue during the test procedure, stop testing until recovered.

4.3 Setting the Obstructive Index and COPD Classification Zones

The Vitalograph copd-6 Obstructive Index and COPD Classification zones are set by the manufacturer to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) standard and it is unlikely that a user will wish to change this – however if this is required please follow the following instructions:

The colour systems for each zone type are pre-set as follows:

FEV1% Pred.	Obstructive Index		COPD Classification	FEV1/FEV6 Ratio and FEV% Pred.
≥ 80%	0		Not COPD	FEV1/FEV6 > 0.7
		Top Boundary	Stage I	FEV1/FEV6 < 0.70 and FEV1 ≥ 80% Pred.
< 80%	1	Middle Boundary	Stage II	FEV1/FEV6 < 0.70 and FEV1 < 80% Pred.
< 50%	2	Bottom Boundary	Stage III	FEV1/FEV6 < 0.70 and FEV1 < 50% Pred.
< 30%	3		Stage IV	FEV1/FEV6 < 0.70 and FEV1 < 30% Pred.

 

To set the boundary percentage values for both the Obstructive Index and COPD Classification zones together, follow these steps;

1. Turn the device on, .
2. When the icon appears, press and hold the and buttons for approximately 3 seconds.
   
3. The top boundary can now be set. This is done by pressing the or button and releasing when the value is reached. The values will increase/decrease in values of 1%. If the button is kept depressed, the values will scroll faster.
4. Press to set the top boundary value.
   
5. The middle boundary can now be set. This is done by pressing the or button and releasing when the value is reached. The values will increase/decrease in values of 1%. If the button is kept depressed, the values will scroll faster.
   
6. Press to set the middle boundary value.
7. The bottom boundary can now be set. This is done by pressing the or button and releasing when the value is reached. The values will increase/decrease in values of 1%. If the button is kept depressed, the values will scroll faster.
   
8. Press to set the bottom boundary value.
   
9. Press . The device will return to the age entry screen.

 

4.4 Reviewing the Last Session Test Results

The Vitalograph copd-6 will always store the last test session, even after the device has powered itself down or has been switched OFF. In order to view the last test session, follow these steps:

1. Turn the device on, .
2. When the device is ready for age entry ( ), press the button for approximately 3 seconds. The last test session (best results) data will now show again.
3. When you have finished reviewing the data, press the OFF button for 3s. OR
4. Press . The device will return to the age entry screen ready for entering the next test subject’s data.

5. CARE AND CLEANING OF THE VITALOGRAPH COPD-6

5.1 Daily Procedures

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.

 

5.2 Monthly Procedures

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).

 

5.3 Annual Procedures

It is recommended that the device be replaced annually. There is no planned preventive maintenance for this medical device.

 

5.4 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
SafeTway mouthpiece or BVF	Cardboard / ABS	Dispose – single use	No	Dispose – single use
Case Exterior	PC/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	PC/ABS	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 copd-6 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.

 

5.5 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.

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"

 

 

6. Consumables, Accessories and spare parts

7. Explanation of Symbols

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

User Interface Symbols:

	Battery status Battery status Full Battery status Half Battery status Quarter Battery status Empty (flashing)
	Blow Now
!	Bad Test (Slow start or cough)
kglb	Unit of Weight /Measurement
	Lung Age
	Age Icon
	Height Icon
	Gender Icon

8. Technical Specifications

9. CE Notice

Marking by the symbol compliance of the Vitalograph 4000 Respiratory Monitor copd-6 device to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph 4000 Respiratory Monitor copd-6 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: 4000 Respiratory Monitor copd-6

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 SOR/98-282}
• FDA Quality System Regulation {QSR} 21 CFR 820.
• EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory purposes.

Canadian Medical Device Regulation {CMDR}

FDA Quality System Regulation {QSR} 21 CFR 820.

EN ISO 13485: 2012. 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.

Frank Keane

General Manager, Vitalograph (Ireland) Ltd.

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 VitalographÒ 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.