Vitalograph!

VITALOGRAPH micro
MODEL 6300
SERVICE MANUAL

CERTIFIED UNDER THE

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

Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany

Phone: (040) 54 73 91-0 Fax: (040) 547 391- 40
e-mail: info@vitalograph.de
th
Vitalograph Inc., 13310 West 99 St, Lenexa, Kansas 66215, U.S.A.
Phone: (913) 888-4221 Fax: (913) 888-4259
e-mail: vitcs@vitalograph.com

Vitalograph (Ireland) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: +353 (0)65 6864100 Fax: +353 (0)65 6829289
e-mail: sales@vitalograph.ie
www.vitalograph.com

 Copyright Vitalograph 1999, 2003, 2005

Current Edition (Issue 3)

Service Manual Cat. No. 07060

Vitalograph is a registered trademark.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 2

Table Of Contents

CHAPTER 1: INTRODUCTION........................................................................................................................................ 4
Vitalograph micro Display............................................................................................................................................... 5
Vitalograph micro Label.................................................................................................................................................. 5
CHAPTER 2: PRINCIPLE OF OPERATION..................................................................................................................... 6

CHAPTER 3: COMMISSIONING AND START-UP OF THE INSTRUMENT .................................................................. 7

Setting Up....................................................................................................................................................................... 7
To conduct a spirometry measurement:......................................................................................................................... 8
PRINTING TO THE PC UTILITY....................................................................................................................................... 8

CHAPTER 4: ACCURACY CHECK & CALIBRATION ..................................................................................................... 9

Accuracy Check ............................................................................................................................................................. 9
Calibration Adjustment ................................................................................................................................................. 10
Sample Accuracy Check History Log Sheet................................................................................................................. 11
CHAPTER 5: FUNCTIONAL CHECK ............................................................................................................................. 12

CHAPTER 6: CLEANING AND DISINFECTING............................................................................................................. 13

General Recommendation ........................................................................................................................................... 13
Routine Practice ........................................................................................................................................................... 13
Cleaning Instructions.................................................................................................................................................... 13
Cleaning/Disinfecting- Recommendations Chart ......................................................................................................... 13
Disassembling for Cleaning and Disinfecting............................................................................................................... 14
Reassembling the Fleisch Flowhead............................................................................................................................ 14
CHAPTER 7: TECHNICAL SPECIFICATIONS............................................................................................................... 15

CHAPTER 8: SERVICE SHEET..................................................................................................................................... 16

APPENDIX A: CIRCUIT DIAGRAM ................................................................................................................................ 17

APPENDIX B: FUNCTIONAL BLOCK DIAGRAM.......................................................................................................... 18

CUSTOMER SERVICE.................................................................................................................................................... 19

Copyright Vitalograph 1999, 2003, 2005 Issue 3 3

CHAPTER 1: INTRODUCTION

The Vitalograph micro is a portable and easy to use precision spirometer. It offers total confidence in rapid and
accurate spirometry measurements as a part of your routine physical examination.

The Vitalograph micro’s features include:-

• Flow detection principle – Fleisch type pneumotachometer, No. 2 size

• single breath calculation of a range of both expiratory and inspiratory parameters
• displays FVC, FEV1, FEV1% and PEF after each manoeuvre
• prints predicted values, results and graphs
• prints suggested interpretation
• small pocket size and light weight
• easy to use
• large, clear display
• on screen battery low indicator
• auto switch off after 2 minutes of no use
• long term stability with no moving parts
• flowhead, clips in and out for easy cleaning
• accuracy checking facility
• patented SafeTway™ mouthpiece for complete hygiene

The Vitalograph micro Service Manual should be used in conjunction with the Vitalograph micro User Manual (07056).

Flowhead

Down Arrow
Button
Flowhead
Release
Button
Up Arrow
Button
LCD Display
(see below)

Top Recess Button Enter

Button

On/Off
Button

Copyright Vitalograph 1999, 2003, 2005 Issue 3 4

Vitalograph micro Display

Displays digits and

segments Displays
units
Displays test
parameters
Displayed during
power on

Low Battery
Blow Now Symbol, indicates the
Symbol (see
unit is ready to do a test
Thumbs Up/Down Symbol, indicates table below)
successful/unsuccessful accuracy
check/calibration update

Vitalograph micro Label

Weight

Gender
Age
Height

Symbol Condition Result Action

(on or flashing)
Battery Low You can perform test Replace PP3 battery

Battery You cannot perform test Replace PP3 battery

Nearly Dead

Copyright Vitalograph 1999, 2003, 2005 Issue 3 5

CHAPTER 2: PRINCIPLE OF OPERATION

The Vitalograph micro measures a subject’s lung ventilation by using a flowhead containing a small Fleisch-type
Pneumotachograph capable of giving linear signals throughout the entire physiological range.

During testing, the airflow through the Pneumotach produces a very low-pressure differential. Internally this pressure is
applied to a pressure transducer, which produces an electric signal. This signal is converted into digital form so that the
unit can perform calculations and the results be displayed.

The following lung function parameters are displayed on the printout:

• FVC
• FEV1
• FEV1 / FVC
• FEV6
• PEF
• FEF25
• FEF75
• FEF25 – 75
Note: The display is always the last blow, but the printout will be the automatically selected best test (using
ATS/ERS:2005 criteria) from any number in a series.

The Vitalograph micro retains last best-test even when switched off (not overwritten until a blow occurs after switch-on)

The following graphs are displayed on the printout:

• Flow-Volume graph
• Volume-Time graph

Note: If an inspiratory section of the flow-volume graph is printed, this is only an indication that an Inspiratory test
has occurred and does not accurately represent the volume inspired.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 6

CHAPTER 3: COMMISSIONING AND START-UP OF THE INSTRUMENT

The Vitalograph micro is not supplied with its power source (9V PP3 type alkaline battery - recommended capacity of at
least 550mAh).

The battery should be fitted by attaching it to the connector in the battery compartment and locating the battery in the
slot provided. It is necessary to feed the excess connector cable back into the hole from which it exits to ensure that
the battery fits correctly. When the battery is fitted, the unit will power up immediately.

Note that it is recommended to remove the battery if you do not intend using the Vitalograph micro for several weeks.

Setting Up
Follow these instructions in sequence to set up the Vitalograph micro before you use it for the first time, or to change settings
later.

Step1: Entering configuration mode

1. Press .
Note that the Vitalograph micro turns itself off if not used within two minutes.

2. Press repeatedly until the time is displayed…

3. Press the top recess button and
at the same time.

Step 2: Set Units

1. Press
to change Thumbs Up/Down symbol.

means US format for date, means European format

2. Press to continue

Step 3: Set the Time

1. To select the correct hour press  or
. Note that pressing down continuously on the button changes the number
quickly.

2. Press

3. To select the correct minute press  or
.

4. Press

Step 4: Set the Date

1. To select the correct year press  or
.

2. Press

3. To select the correct month press  or
.

4. Press
Copyright Vitalograph 1999, 2003, 2005 Issue 3 7
5. To select the correct day press  or
.

6. Press to return to finish. Time and ‘blow icon’ are displayed.

To conduct a spirometry measurement:

The user is required to enter subject demographics by scrolling the number on the screen in the following sequence
height (cm), age (years), sex (Male 0; Female 1) and weight (kg).

After completion of the above, the Vitalograph micro is ready for testing. The time and the ‘blow now’ icon appears on
the screen, accompanied by a double beep.

The display shows the last test, but the best test is held in memory. Blows may be repeated when the ‘blow icon’ is
showing.

On completion of testing the user can attach a printer and print the current session. The best test in the session will be
printed.

PRINTING TO THE PC UTILITY

The PC Utility enables printing of a PDF file and/or to your PC Printer, follow the steps below:

Immediately after a test session is completed, plug the jack plug into the Vitalograph micro jack socket, which is located
on the side of the device.

Press  or
on the Vitalograph micro until the following screen is displayed.

Press . The screen should immediately go blank.

The Vitalograph micro will take about two minutes to download all the test data during which time it should not be
interfered with. After two minutes transmission, the device will ‘beep’ and briefly display ‘PRN’ again.

At this time the creation of the spirometry report begins in the PC Print Utility.
1
Depending on your settings, a PDF will be created and/or a print command will be sent to your designated printer .

Note: The best test in the session is printed, not necessarily the last test which is still showing on the LCD
screen.
To cancel at any time press and hold the switch for 15 seconds approx.

Figure 1 – Vitalograph Print Utility Product Perspective

1
If you installed the Print Utility with default settings, no print command will be sent but a PDF file will be created in the
following location: C:\Program Files\Vitalograph\VitalPrint\Data
Copyright Vitalograph 1999, 2003, 2005 Issue 3 8
Note: When the Vitalograph micro switches itself off, the best test from the last session is retained until the next blow.
This stored test may be printed at any time as long as no new blow is detected by the device. Switch ON, press Enter
repeatedly until the Blow Icon and time are displayed, then press  and
together to print.

CHAPTER 4: ACCURACY CHECK & CALIBRATION

Accuracy Check
Your Vitalograph micro is extremely stable and needs no calibration adjustment between the annual service intervals.
However, international guidelines such as ATS/ERS recommend that the accuracy of spirometers be checked ’at least
daily’ using a 3-L Precision Syringe.

The Vitalograph micro can be checked for accuracy easily using the following procedure, using a 3-L Precision
Syringe. Ensure that the syringe has been in the same temperature environment as the unit for at least an hour.

1. After switching the unit on, press the upper recess / Accuracy Check button with a suitably pointed object. The
display will look like …..

2. Press Up and Down to change the syringe stroke volume if you are not using a 3-L syringe. The ‘03’
represents the stroke volume of your precision syringe, not the total volume that will be delivered. It is very
important to set this up correctly, otherwise, the accuracy check will not function properly.
3. Press Enter. The display will look like …….

4. Ensure the syringe piston is fully withdrawn. At this point, connect the Vitalograph micro to the syringe using the
adaptor supplied. Leave the Vitalograph micro in a stable position - do not move the unit during this procedure.
5. With an even stroke, pump the air from the syringe through the device. The stroke must be at least one second in duration.
6. Wait for a double beep, withdraw the syringe piston fully and repeat step 5 several times until ‘five beeps’ occur in rapid
succession. It is very important to wait for the double beep before withdrawing the piston each time.
7. If there is a Thumbs Up on the LCD, then the unit is within the +/- 3% accuracy tolerance …

Note: with reference to step 6 above, the user will be prompted by means of a double beep for another stroke of the syringe when the
volume difference of the present stroke is not within 3% of the previous stroke. If the maximum of five strokes is executed, then the
five beeps will occur, signifying the end of the accuracy check.
1. End Of Procedure

If there is a Thumbs Down on the LCD, then the unit is outside the +/- 3% accuracy requirements. Check for
faulty assembly or procedure, then recheck accuracy. If still wrong contact Technical Support.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 9

Calibration Adjustment
It is very unlikely that calibration will be outside tolerance unless there is some damage to the device or there is a fault.
Please carefully inspect the unit and re-check accuracy before adjusting calibration.

IMPORTANT: If your Vitalograph micro has a current Certificate of Calibration Traceability, entering the calibration
adjustment procedure will invalidate this certificate. Any applied calibration traceability stickers should also be removed.

The calibration of the Vitalograph micro can be adjusted easily using the following procedure. A 3-L precision syringe
is recommended.

1. After switching the unit on, press the Calibration Adjust / lower recess button with a suitably pointed object.
The display will look like…

2. Press Up and Down only if your Precision Syringe is NOT a 3-L stroke volume. It is very important to set this to
the stroke volume of the syringe otherwise the calibration adjustment procedure will not function properly.
3. Press Enter. The display will look like…

4. Ensure the syringe piston is fully withdrawn. At this point, connect the unit to the syringe and leave it in a stable
position - do not move the unit during this procedure.
5. With an even stroke, pump the air from the syringe into the unit. The stroke must be at least one second in duration.
6. Wait for a double beep, withdraw the syringe piston fully and repeat step 5 until five beeps occurs. It is very important to wait for
the double beep before withdrawing the piston each time.
7. If there is a Thumbs Up on the LCD, then the unit has adjusted its calibration successfully…..

8. If there is a Thumbs Down on the LCD, then a problem was encountered while trying to adjust calibration.……

If this happens, refer to the Troubleshooting section or contact Technical Suppport.

9. Turn the unit off.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 10

Sample Accuracy Check History Log Sheet
Use a 1-L or a 3-L Precision Syringe to check your instrument, 3-L is recommended.
Ensure that your spirometer and precision syringe are left in the same temperature environment for approximately 1
hour.
Do not adjust calibration unless it falls outside the limits for the reference volume used, refer to product user manual for
calibration limits.
If calibration is adjusted, recheck accuracy and note findings in the REMARKS column.

When to check accuracy?

In accordance with your own established procedures/international guidelines.
After annual maintenance service.
After cleaning or disassembling spirometer for any reason.
After adjusting calibration.

SERIAL # ……………
YOUR UNIT’S ACCURACY CHECK HISTORY LOG

DATE TEMP PRECISION SYRINGE ACCURACY CHECK OPERATOR REMARKS

°C SERIAL NO RESULT INITIALS

Copyright Vitalograph 1999, 2003, 2005 Issue 3 11

CHAPTER 5: FUNCTIONAL CHECK
In order to determine whether the Vitalograph micro is functioning correctly the following steps should be carried out:

1. Turn on the unit; scroll to a height of 0 and press ‘Enter’. This will allow you to get to the ‘ready’ screen without
having to enter all the demographic data.
2. The time and the “Blow” symbol should appear after a few seconds.
3. Use a syringe to blow air through the flowhead. Check that a volume registers. (It may not be the same as the
displaced volume because BTPS correction will be applied in test mode.
4. If this seems to function properly, perform an accuracy check as detailed in Section E – Accuracy Check &
Calibration.

Fault condition: If the instrument is faulty, contact your Vitalograph service centre for advice,
service or repair.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 12

CHAPTER 6: CLEANING AND DISINFECTING

General Recommendation
®
To reduce the risk of cross infection the use of SafeTway mouthpieces is recommended.
A Risk Assessment should be carried out to assess the risks presented to both operator and subject, and an action
plan devised by the facility to minimise the chance of cross infection occurring, particularly where known-infectious or
immuno-deficient subjects are being tested.
An assessment should be made of methods of decontamination available to the operator, and their effectiveness
against potential risks - a table of materials used in the Vitalograph micro is provided below to assist in this.
It is recommended that in cases of high risk with no effective disinfection methods available, that the contaminated
parts are disposed of. For this device, the Flowhead Assembly: FLOWHEAD COMPLETE.

Routine Practice
A new mouthpiece (SafeTway mouthpiece) should be used for each subject. A period of at least 5 minutes should be
allowed between subjects to allow settling of aerosolised particles.
It is recommended that the Flowhead Assembly be regularly cleaned according to the guidelines of the user’s facility.
In the event of visible contamination to the FLOWHEAD - it should be cleaned and disinfected or replaced. It should
also be replaced in the event of damage.
It is recommended to replace the complete: FLOWHEAD as a part of the routine annual service.
All parts of the Vitalograph micro require cleaning, i.e. the removal of visible particulate contamination. The parts of
the Vitalograph micro that make up the flowhead also require disinfecting.

HYGIENE
It is vital for the user to set guidelines for protective hygiene measures whilst performing spirometry testing. There are
three main potential sources of cross contamination, skin contact; aerosolised particles and saliva/body fluids. By far
the most important is the last item – a minimum requirement is to use a new disposable mouthpiece for each subject
tested. We recommend using the SafeTway mouthpiece. We also recommend that a period of at least 5 minutes be
allowed between subjects. This allows aerosolised organisms to be removed by gravitational sedimentation between
tests. (Am J Respir Crit Care Med Vol 159. pp 610-612, 1999)

Cleaning Instructions
All parts of the Vitalograph micro require regular cleaning, i.e. the removal of visible particulate contamination. The
parts of the Vitalograph micro that make up the flowhead also require disinfecting. Vitalograph recommends that
cleaning and disinfecting should normally be carried out on a weekly basis. In addition to a weekly cleaning and
disinfection cycle, Vitalograph recommends cleaning and disinfection of equipment to be carried out after use on
infected subjects or prior to use on immuno-compromised subjects. The user must determine what level of disinfection
is appropriate and acceptable in any particular circumstance.

Cleaning/Disinfecting- Recommendations Chart

Part Material Clean/ Autoclave Recommended Disinfectants

Disinfect Possible?
Case Exterior ABS Clean No Wiping with a 70% Isopropyl
Alcohol impregnated cloth provides
a suitable form of cleaning and
low-level disinfection.
Do not immerse in liquid.
Display Glass Clean No
Keypad Rubber Clean No
Fleisch No2 Aluminium, Stainless Clean & Yes Disinfect by immersion in sodium
Flowhead Steel, ABS Disinfect dichloroisocyanurate solution at
1000 ppm concentration of free
chlorine for 15 minutes.
Hydrophilic filters Polyethylene Replace No Dispose
every year or
after water
ingress.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 13

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.

Disassembling for Cleaning and Disinfecting

1. Press in the two round ‘flowhead release buttons’.
2. Lift off the flowhead.
Clean the flowhead by washing in a mild detergent to remove particulate contamination. To clean the Fleisch
element, swill vigorously in water with mild detergent. Do not attempt to “rub” or “scrub” at capillaries. If the flow
conditioning meshes appear dirty or blocked the flowhead should be replaced.
Rinse with clean water.
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 hot water to aid drying.
Leave to dry completely before reassembling. Drying the Fleisch element assembly may require placing it in a
warm place overnight. A drying cabinet is ideal, alternatively another heat source could be used.
Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level
disinfection for the case exterior, display, screen, and keypad. Repeat at least weekly to prevent 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.

Flowhead
Hydrophilic Filters

Flowhead release
button

Reassembling the Fleisch Flowhead

1. Ensure that the hydrophilic filters are undamaged and dry.
2. Orient the two circular holes under the flowhead with the hydrophilic filters in the body.
3. Push the flowhead onto the body, making sure that the two buttons click into place.
4. It is advisable to check accuracy and perform a functional check after cleaning and disinfecting.

Copyright Vitalograph 1999, 2003, 2005 Issue 3 14

CHAPTER 7: TECHNICAL SPECIFICATIONS

Symbols Class II Equipment

Type BF Equipment
9V, PP3 Battery type - 9V PP3

Flow detection principle Fleisch type pneumotachometer No 2 size

Flow Impedence Meets ATS / ERS Guidelines

Volume measurement Flow integration

Maximum recorded flow rate 999 L/Min

Maximum recorded volume 9.99 Litres

Measuring accuracy +/- 3% or +/-0.05L volume whichever is greater and +/-10%
flow or +/-20L/Min whichever is greater

Test duration 30 seconds maximum

Operating temperature 15-37°C

Safety standards Certified to conform to ISO / EN60601-1

Radio Frequency Emissions Certified to conform to ISO / EN 60601-2

Spirometric standards ATS / ERS

Power supply Alkaline battery, 9V, PP3 (MN1604) (Recommended battery

capacity = 550 mAh or greater)

Unit dimensions 145mm x 70mm x 87mm

Unit weight 165g (without PP3 battery)

Storage Temperature : 0-50ºC

Relative Humidity : 10%-95%

Copyright Vitalograph 1999, 2003, 2005 Issue 3 15

CHAPTER 8: SERVICE SHEET
Planned Preventive Maintenance Service
Vitalograph micro Service Schedule Serial No:
ACCURACY CHECK RECORD Pre-Service ACCURACY CHECK RECORD Post-Service
Reference Volume L Reference Volume L
Volume Recorded L Volume Recorded L
Difference _____% Difference _____%
NOTE HERE IF SPIROMETER PRE-SERVICE
FLOWHEAD AND TUBING* ACCURACY CHECK OUT OF TOLERANCE
Replace Flowhead Previous Measurements were out by _____%
Replace Hydrophilic filters Over- Under- Reading (delete as applicable)
Dispose Flowhead and filters CLEANING & HYGIENE
Check pressure tappings flowhead / instrument Air dust PCB & all internals
ELECTRICAL SAFETY TESTING Clean & Disinfect outer casing
General Damage Check Check all breathing circuit components replaced
Check battery connectors for damage
Replace Battery* CALIBRATION & FUNCTIONAL TEST
Perform FVC test Procedure using syringe
ELECTRONICS & FIRMWARE Adjust Calibration for new flowhead
Check Version/Issue of Software Final Accuracy check
Inspect LCD Glass & Display Apply “Clinically Clean” Label
Check Contrast of LCD RECORD KEEPING
Check Operation of Keypad - 6 Buttons Issue Calibration Traceability Certificate
Ensure all screws & Fasteners are locked Calibration Traceability Certificate Precision Syringe
SPECIAL ADVICE TO USER: Affix Next Service due label to Spirometer
Complete Service Records
Customer’s Signature
PRECISION SYRINGE CERTIFICATION*
Customer’s Syringe S/No:
Nominal Volume L
Check Capacity: Adjust if necessary (ring) YES/NO
Check general condition
Traceable Tool (T5-36075) Serial No
Complete and Affix Calibration Label to Syringe
Software Upissued YES/NO User Advised YES/NO Technician’s Syringe Used - Serial No:
* Items are not part of the interim service

Vitalograph Trained Service Technician: I hereby Certify this instrumentation to be safe, clinically
clean and in proper working order.
Name:
Calibration of Spirometer & Syringe Certified as above.
Signature: Date:

Copyright Vitalograph 1999, 2003, 2005 Issue 3 16

APPENDIX A: CIRCUIT DIAGRAM

Copyright Vitalograph 1999, 2003, 2005 Issue 3 17

APPENDIX B: FUNCTIONAL BLOCK DIAGRAM

Flow
Sensor

Random
PRESSURE Access Memory
EEPROM Transduc
er
REAL
TIME
Micro Processor Clock
with 64K Read Only
9V PP3 Memory.
BATTERY Keypad

CUSTOMISED LIQUID
SERIAL Crystal Display
PORT BUZZER

Copyright Vitalograph 1999, 2003, 2005 Issue 3 18

CUSTOMER SERVICE
Servicing of the Vitalograph micro should be carried out only by qualified service technicians.

For the names and addresses of approved Vitalograph Service Agents, please contact any of the following offices or
your local Vitalograph distributor.

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England

Phone: (01280) 827110 Fax: (01280) 823302
e-mail: sales@vitalograph.co.uk

Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany

Phone: (040) 54 73 91-0 Fax: (040) 547 391 40
e-mail: info@vitalograph.de
th
Vitalograph Inc., 13310 West 99 St, Lenexa, Kansas 66215, U.S.A.
Phone: (913) 888-4221 Fax: (913) 888-4259
e-mail: vitcs@vitalograph.com

Vitalograph (Irl.) Ltd, Gort Road Business Park, Ennis, Co. Clare, Ireland
Phone: (065) 6829611 Fax: (065) 6829289
e-mail: sales@vitalograph.ie
Internet: www.vitalograph.com

Copyright Vitalograph 1999, 2003, 2005 Issue 3 19