Gold Standard Model 2150 User Instructions Issue 5

Vitalograph Ltd., Maids Moreton, Buckingham, MK18 1SW, England Phone: (01280) 827110 Fax: (01280) 823302 e-mail: [email protected] Vitalograph GmbH, Jacobsenweg 12, 22525 Hamburg, Germany Phone: (040) 54 73 91-0 Fax: (040) 547 391 40 e-mail: [email protected] Vitalograph Inc., 13310 West 99th Street, Lenexa, Kansas 66215, U.S.A. Phone: (913) 888-4221 Fax: (913) 888-4259 e-mail: [email protected] Vitalograph (Ireland) Ltd., Gort Road Business Park, Ennis, Co. Clare, Ireland Phone: (065) 6864100 Fax: (065) 6829289 e-mail: [email protected] www.vitalograph.com  Copyright Vitalograph 1997, 2004 Current Edition (Issue 5) Cat. No. 081003

Vitalograph is a registered trademark

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Table of Contents Description of the Vitalograph Gold Standard ... 4 Physical Features of the Vitalograph Gold Standard ... 4 Setting Up The Vitalograph Gold Standard... 4 Removing the Transit Clamp... 5 Connecting to a Power Source ... 5 Inserting the Breathing Tube and Mouthpiece or Filter ... 5 Adjusting the Chart Carrier... 6 Inserting the Vitalogram Chart ... 7 Adjusting the Stylus... 7 Checking Accuracy Of The Vitalograph Gold Standard ... 8 Checking Accuracy ... 8 Adjusting Calibration ... 8 Performing Tests ... 9 Instructing the Subject... 9 Performing a VC Test... 9 Performing an FVC Test ... 10 Performing an MVV Test... 11 Performing an Inspiratory Test... 11 Interpreting Test Results ... 12 Background ... 12 Features of the Chart ... 13 Features of the Flow Rate Calculator... 15 Interpreting Results ... 16 Routine Care ... 25 Cleaning and Disinfecting the Vitalograph Gold Standard ... 25 Breathing Tubes ... 26 Consumables/Accessories ... 27 Spare Parts ... 27 Trouble Shooting ... 28 Technical Specifications... 30 Regulatory Notices ... 31 Explanation of Symbols... 31 CE Notice ... 31 FDA Notice ... 31 Declaration of Conformity... 32 Customer Service ... 33 Guarantee ... 34

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DESCRIPTION OF THE VITALOGRAPH GOLD STANDARD The Vitalograph Gold Standard is a dry wedge bellows volume displacement spirometer designed to provide a permanent hard copy record of lung function test results. Its robust and reliable design makes it ideal for use in occupational health centres and other high usage environments.

Physical Features of the Vitalograph Gold Standard Stylus Start Point

Top Cover

Chart Carrier

Chart Clip

Stylus Arm Stylus

Power Switch

Record Switch Breathing Tube Entry Bacterial/Viral Filter

Figure 1: Front view of the Gold Standard

SETTING UP THE VITALOGRAPH GOLD STANDARD When you receive the Vitalograph Gold Standard and remove it from its packaging, it is important that you follow the set up procedures described in this section before you commence using the unit. Follow the set up procedures in this sequence: 1

Remove the transit clamp and rubber band from around the stylus.

2

Connect to the power supply provided.

3

Insert the breathing tube and either a disposable safetway mouthpiece or a bacterial viral filter.

4

Adjust the chart carrier.

5

Insert the Vitalogram chart, push to the left and clamp under chart clip.

6

Adjust the stylus.

Detailed instructions for performing these actions are described below. When the set up procedure is complete, you should check the accuracy in accordance with international recommendations for lung function testing equipment.

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Removing the Transit Clamp Stylus locking screw Transit clamp Stylus head

Figure 2: The stylus head

1

Remove the rubber band from around the stylus head and loosen the stylus locking screw.

2

Remove the stylus and lift out the transit clamp.

3

Replace the stylus and tighten the stylus locking screw.

4

Store the transit clamp so you can replace it if you need to transport the spirometer.

Connecting to a Power Source 1

Connect the power jack on the power supply cable into the rear panel of the Vitalograph Gold Standard.

2

Plug the mains lead into the free end of the PowerSAFE and connect it to a suitable mains supply outlet.

3

Only use the power supply provided with the Gold Standard.

Inserting the Breathing Tube and Mouthpiece or Filter Breathing Tube

Filter/mouthpiece

Figure 3: Inserting the breathing tube and filter

1

Insert the flexible end of the breathing tube provided into the front of the Vitalograph Gold Standard.

2

Insert a disposable SafeTway mouthpiece or bacterial viral filter into the plastic adaptor at the other end of the tubing. 5

Note: Vitalograph recommends the use of bacterial viral filters to provide maximum protection against the possibility of bellows contamination and inter-subject cross infection during testing.

Adjusting the Chart Carrier It is important for the accuracy of test results that the chart carrier should move as soon as the subject starts to blow. If the thumbscrew controlling the chart carrier is set too low, the chart carrier will move without the subject blowing. If it is set too high, there may be a time delay before the chart carrier starts to move. The start of movement sensitivity can be adjusted by turning the chart travel thumbscrew under the back of the Vitalograph Gold Standard.

Figure 4: The thumbscrew at the back of the Gold Standard

1

Press the Power switch to .

2

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

3

4

Inflate the bellows fully (either by blowing into it or with the aid of a precision syringe) and then allow it to deflate naturally by disconnecting the breathing tube. Press the Record switch to →.

5

Lift the Vitalograph Gold Standard slightly and turn the thumbscrew in the direction marked CONTINUOUS until the chart carrier starts to move.

6

Turn the thumbscrew in the opposite direction until the chart carrier stops. Continue turning the thumbscrew by one turn. This completes the chart carrier adjustment.

Should the chart carrier subsequently start before the stylus begins to move, it will be necessary to turn the thumbscrew a little further towards AUTO-START.

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Inserting the Vitalogram Chart

Figure 5: How to insert the chart

1

Insert the Vitalogram chart with the zero line at the top (i.e. upside down).

2

Keeping the chart flat and its sides under the carrier sides, feed the chart upwards on the carrier (if necessary, lift the stylus to allow the chart to pass underneath). Push back the chart clip sufficiently to lift it from the carrier surface.

3

Slide the chart under the clip until the chart rests against the top edge of the carrier and against the left edge of the carrier. The chart is now inserted correctly.

Adjusting the Stylus Stylus locking screw

Lock ring

Figure 6: The stylus head

1

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

2

Place the stylus on the Stylus Start position marked on the chart. Release the stylus locking screw if you need to move the stylus forward or backward, in order to position it correctly on the chart.

3

If you need to adjust the stylus pressure (trace not clear), release the lock ring and either screw the stylus clockwise to increase pressure or screw it counter-clockwise to reduce pressure. Tighten the lock ring when complete.

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CHECKING ACCURACY OF THE VITALOGRAPH GOLD STANDARD The Vitalograph Gold Standard should be accuracy checked at room temperature prior to performing tests. International standards on spirometry recommend that you check accuracy regularly. If the temperature of your testing environment remains stable (within ±4°C) it should never be necessary to adjust the calibration after the initial set-up. This user manual can be used to maintain a record of the 2150's accuracy check history (see the Accuracy Check and Maintenance Log section later in this chapter for further details). You will need a 1-Litre Precision Syringe (Cat. No. 20408) to enable you to check the accuracy of the Vitalograph 2150. A 3-L syringe may be used, but then linearity cannot be checked whilst checking accuracy. This procedure assumes only the use of a 1-L syringe.

Checking Accuracy 1

Ensure that the Vitalograph Gold Standard and the syringe are at the same temperature (±2°C).

2

Attach the Vitalograph 1-Litre Precision Syringe to the breathing tube.

3

Insert a chart in the chart carrier.

4

Set the stylus on the Stylus Start line at the base of the centre scale.

5

Switch the chart carrier switch to the stop position, i.e. the centre position.

6

Inject a steady flow of air into the Vitalograph Gold Standard making sure that the syringe piston travels fully to the end stop.

7

Mark the stylus position on the chart by gently tapping on the side of the stylus head.

8

Repeat steps 6 to 7 to check the accuracy litre by litre, up to the seven litre position. This litre by litre check confirms linearity of the spirometer.

Figure 7: The 1 litre syringe connected to the Gold Standard

If the results fall outside the shaded areas on the centre scale, after re-checking you should adjust the calibration as described in the next section. However, since adjusting calibration should never be necessary, check first for any fault on the device or with the accuracy check procedure.

Adjusting Calibration 1

Remove the top cover of the Vitalograph Gold Standard by loosening the three thumbscrews at the back of the unit. Tilt it forward slightly while lifting it up.

2

Loosen the two clamping screws and open the Velcro fasteners.

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3

If the unit is over reading slide the bellows plate (by use of the adjustment handles) towards the rear of the unit. Alternatively, if the unit is under reading slide the bellows plate towards the front of the unit.

4

Tighten the clamping screws and close the velcro fasteners.

Velcro fastener Clamping screw

Figure 8: The bellows assembly

5

Re-check the accuracy to ensure the bellows setting is correct. If not, repeat steps 2 to 5 until the required accuracy is achieved.

6

Replace the top cover.

PERFORMING TESTS Instructing the Subject It is important that you instruct the subject clearly in the procedure to follow to perform a test before each test begins. When you are testing, it is essential that you are enthusiastic in order to encourage the subject to make the maximum effort, especially when carrying out a forced expiratory test. Testing may be done either in the sitting or standing position. Indication of position is necessary on the report. The Standing position may not be appropriate in some circumstances, such as in hospitals where many patients may not be able to tolerate the standing position, especially when making forced manoeuvres. The selection of the position for testing is, therefore, an individual one. If the standing position is used, an appropriately shaped chair should be placed behind the patient/subject so he/she can quickly and easily be eased into a sitting position if he/she becomes light-headed during the manoeuvre.

Performing a VC Test 1

Press the Power switch to .

2

Insert a Vitalogram chart in the chart carrier.

3

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

4

Set the stylus on the Stylus Start point.

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5

Inform the subject that you are measuring how much air they can exhale after filling their lungs completely.

6

Read the following instructions to the subject so that testing is performed properly. a)

Hold the breathing tube in one hand away from your mouth.

b)

Breathe in and out normally.

c)

Inhale as deeply as possible, filling your lungs completely.

d)

Insert the mouthpiece into your mouth and close your lips around it making sure no air can leak out.

e)

Breathe out gently into the mouthpiece as completely as you can (Remember to keep encouraging the subject to blow throughout the manoeuvre).

7

Continue the test until the stylus ceases to rise.

8

Take the breathing tube from the subject and deflect it away from their face.

Note: If safetway mouthpieces are being used it will be necessary to remove the mouthpiece to empty the bellows prior to re-testing.

Performing an FVC Test 1

Press the Power switch to .

2

Insert a Vitalogram chart in the chart carrier. Fit a new disposable SafeTway mouthpiece or BVF.

3

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

4

Set the stylus on the Stylus Start point.

5

Inform the subject that you are measuring how much and how fast they can exhale after filling their lungs completely.

6

Press the Record switch to →.

7

Read the following instructions to the subject so that testing is performed properly. a)

Hold the breathing tube in one hand away from your mouth.

b)

Breathe in and out normally.

c)

Inhale as deeply as possible, filling your lungs completely.

d)

Insert the mouthpiece into your mouth and close your lips around it making sure no air can leak out.

e)

Breathe out into the mouthpiece as hard and fast as you can and exhale until I tell you to stop.

8

Continue the test until the stylus ceases to rise (a test can be considered complete if a two second plateau is observed prior to the chart stopping).

9

Tell the subject to stop when you are satisfied that they have expired their total air volume.

10

Take the breathing tube from the subject and deflect it away from their face.

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Note: If safetway mouthpieces are being used it will be necessary to remove the mouthpiece to empty the bellows prior to re-testing.

Performing an MVV Test There are two stages in an MVV test. Firstly, with the carrier control switch in the centre position the subject blows into the breathing tube until the stylus is half way down the chart. Secondly, after you have pressed the Record switch to →, the subject breathes in and out as hard and as fast as possible for twelve seconds until the stylus has run the length of the chart. 1

Press the Power switch to.

2

Insert a Vitalogram chart in the chart carrier.

3

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

4

Set the stylus on the Stylus Start line.

5

Inform the subject that you are measuring how much air they can breathe out when they breathe as deeply and rapidly as possible (this is not quite correct scientifically but describes the purpose of the test in terms that can be understood easily).

6

Read the following instructions to the subject so that testing is performed properly. a)

Stand up and hold the breathing tube in one hand away from your mouth.

b)

Breathe in and out normally.

c)

Inhale as deeply as possible, filling your lungs completely.

d)

Insert the mouthpiece into your mouth, and close your lips around it making sure no air can leak out.

e)

Exhale until I tell you to stop. (Do not read this out: Tell the subject to stop when the stylus is half way down the chart).

f)

Keep your lips around the mouthpiece so it is sealed. (Do not read this out: Press the Record switch to →).

g)

Breathe in and out of the mouthpiece as hard as you can until I tell you to stop.

7

Tell the subject to stop when the stylus has moved the length of the chart.

8

Take the breathing tube from the subject and deflect it away from their face.

Note: this test cannot be performed if using a safetway mouthpiece. A standard mouthpiece or a Bacterial/Viral Filter is required for any manoeuvre requiring inspiratory effort.

Performing an Inspiratory Test There are two stages in an Inspiratory test. Firstly, the subject performs an FVC test by blowing into the breathing tube until maximal exhalation is achieved. This FVC test should take approximately 6 seconds. Secondly, while the subjects' mouth is still sealed air-tight around the safetway mouthpiece they inhale as fast and as much as possible. 1

Press the Power switch to.

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2

Insert a Vitalogram chart in the chart carrier.

3

If the chart carrier is not in the start position, i.e. as far to the left as it can go, press the Record switch to ←.

4

Set the stylus on the Stylus Start line.

5

Press the Record switch to →.

6

Inform the subject that you are measuring how much they can inhale as quickly as possible.

7

Read the following instructions to the subject so that testing is performed properly.

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a)

Stand up and hold the breathing tube in one hand away from your mouth.

b)

Breathe in and out normally.

c)

Inhale as deeply as possible, filling your lungs completely.

d)

Insert the mouthpiece into your mouth, and close your lips around it making sure no air can leak out.

e)

Breathe out into the mouthpiece as hard and as fast as you can and exhale as much as possible.

f)

Inhale as fast as you can.

Take the breathing tube from the subject and deflect it from their face when you are satisfied that they have inspired completely.

Note: this test cannot be performed if using a safetway mouthpiece. A standard mouthpiece or a Bacterial/Viral Filter is required for any manoeuvre requiring inspiratory effort.

INTERPRETING TEST RESULTS Background A lung function test with the Vitalograph Gold Standard provides results which can determine, along with clinical experience, whether or not a subject's ventilatory function is normal. VC, FVC and FEV1 results are read directly from the chart whereas other results, e.g. FEF, are derived from the subject's FVC curve. The procedure which must be followed to derive results is described below for each parameter. A Flow Rate Calculator (Cat. No. 78685) is also available that will allow you to read results directly from the chart rather than having to calculate them.

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Features of the Chart

Figure 9: The Vitalogram Chart

The horizontal lines on the Vitalogram represent units of volume in litres. The vertical lines on the Vitalogram represent units of time in seconds. ATPS: ambient temperature and pressure, and fully saturated with water. BTPS: body temperature and pressure, and fully saturated with water. Note: The space at the base of the Vitalogram (between the Stylus Start and Zero Point lines) represents the calibration allowance for the folds of the bellows (0.04 litres). Air in the human lung is at 37°C saturated with water vapour. On expiration the air cools rapidly to room temperature (ATPS) and some saturated water vapour is lost through condensation. This decreases the volume of air (by approximately 8.5% at normal room conditions). The left and right hand scales of the Vitalogram are graduated in BTPS litres at 23°C ambient. The central scale is graduated in ATPS litres for spirometer calibration purposes. When testing is performed in ambient temperatures close to 23°C then results may be obtained directly from the BTPS scale. If testing is performed in other ambient conditions then the BTPS results can be obtained by multiplying the ATPS results by the relevant correction factor obtained from Table 1 below; 13

Mean atmospheric pressure

760

740

720

700

680

660

640

mmHg Approx.

m

0

200

420

680

900

1140

1400

Altitude

ft

0

656

1378

2165

2952

3739

4592

Temperature °C

°F

20

68.0

1.1020 1.1032 1.1046 1.1060 1.1075 1.1091 1.1108

21

69.8

1.0966 1.0978 1.0991 1.1004 1.1019 1.1034 1.1051

22

71.6

1.0911 1.0923 1.0935 1.0948 1.0962 1.0976 1.0992

23

73.4

1.0856 1.0867 1.0879 1.0891 1.0904 1.0918 1.0933

24

75.2

1.0800 1.0810 1.0822 1.0833 1.0846 1.0859 1.0873

25

77.0

1.0744 1.0753 1.0764 1.0775 1.0787 1.0799 1.0812

26

78.8

1.0686 1.0696 1.0705 1.0716 1.0727 1.0738 1.0751

27

80.6

1.0629 1.0637 1.0646 1.0656 1.0666 1.0677 1.0688

28

82.4

1.0570 1.0578 1.0586 1.0595 1.0604 1.0614 1.0625

29

84.2

1.0511 1.0518 1.0525 1.0533 1.0542 1.0551 1.0560

30

86.0

1.0450 1.0457 1.0463 1.0470 1.0478 1.0486 1.0495

31

87.8

1.0389 1.0395 1.0400 1.0407 1.0413 1.0420 1.0428

32

89.6

1.0327 1.0322 1.0337 1.0342 1.0347 1.0353 1.0360

33

91.4

1.0264 1.0268 1.0272 1.0276 1.0280 1.0285 1.0291

34

93.2

1.0199 1.0202 1.0206 1.0209 1.0212 1.0216 1.0220

35

95.0

1.0134 1.0136 1.0138 1.0141 1.0143 1.0145 1.0148

36

96.8

1.0068 1.0069 1.0070 1.0071 1.0072 1.0073 1.0075

37

98.6

1.0000

Table 1: Correction Coefficients - ATPS to BTPS

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Features of the Flow Rate Calculator

Figure 10: The flow rate calculator

A Percentage Scale Ruler is incorporated with the Flow Rate Calculator.

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Interpreting Results Note: This section should be used in conjunction with the section on Performing Tests. VC

Figure 11: Measurement of VC

During a VC test the stylus will move up along the vertical BTPS axis. The results can then be found by looking at the highest point on the vertical line and seeing what this point corresponds to on the BTPS scale.

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FVC When performing an FVC test the stylus arm will move upwards while the chart carrier will simultaneously move horizontally. The end result will be a trace similar to that shown below. The FVC result can be found by marking the highest point on the curve and drawing a horizontal line connecting this point to the BTPS scale.

Figure 12: Measurement of FVC

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FEVt In order to calculate FEVt the subject must perform an FVC test. The FEV for a specified time can then be derived as outlined below. The following instructions use the first second (FEV1) as an example.

Figure 13: Measurement of FEVt

1

Mark the point on the chart where the curve crosses the one second line.

2

Using a ruler, draw a horizontal line from the point you have marked to the vertical axis.

3

Read the FEV1 result on the BTPS scale.

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FEV% FEV% is derived using the FEV1 trace. To demonstrate how FEV% can be calculated the previous FEV1 graph will be used. 1

Place the 100% mark of the Flow Rate Calculator on the subject's FVC curve at the point where it intersects the 12 second vertical axis. (If the curve does not reach the vertical axis, draw a line from the highest point on the curve to the 12 second vertical axis and place the 100% mark where the line and the vertical axis intersect)

2

Swivel the Flow Rate Calculator until the 0% mark lies on the Zero Point line (not the Stylus Start line), keeping the 100% mark on the vertical axis.

3

Project a horizontal line from the FEV1 point to the ruler.

4

Read the % result from the Flow Rate Calculator at the intersection of the horizontal line with the ruler, i.e. FEV% = 72.2% on the sample chart.

Figure 14: Measurement of FEV%

FMEF FMEF can be calculated by using the FVC trace and the flow rate calculator. To derive the FMEF result, the following procedure should be followed. 1

Place the 100% mark of the Flow Rate Calculator on the subject's FVC curve at the point where it intersects the 12 second vertical axis.

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(If the curve does not reach the vertical axis, draw a line from the highest point on the curve to the 12 second vertical axis and place the 100% mark where the line and the vertical axis intersect) 2

Swivel the Flow Rate Calculator until the 0% mark lies on the Zero Point line (not the Stylus Start line), keeping the 100% mark on the vertical axis.

3

Mark the chart at the 25% point on the ruler.

4

Mark the chart at the 75% point on the ruler.

5

Project these two points horizontally until they intersect the subject's FVC curve.

6

Draw a line through these two points on the curve and project the line back to the vertical volume scale.

Figure 15: Measurement of FMEF

7

Place the zero point of the Flow Rate Calculator on the point where the projected line intersects the vertical axis. Note: To obtain accurate results, the line on the base of the Flow Rate Calculator must be parallel to the zero line on the chart.

8

Read the FMEF result from the Flow Rate Calculator where the line through the 25% and 75% points intersects with the calculator.

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