ACQUIDATA Production Setup & Calibration Guide Edition 3

CONTENTS 1.

Calibration Procedure ... 5

1.1 1.2 1.3

Equipment Under Test ... 5 Calibration Equipment ... 5 Test Equipment ... 5

2.

Application Software Setup ... 6

2.1.

Instructions to setup Uromac Application ... 7 2.1.1

2.1.2

2.1.3

Channel Setup ... 7 2.1.1.1 For 8 channel Uromac system with Pura option ... 7 2.1.1.2 For 8 channel Uromac system with Pura and EMG option ... 8 2.1.1.3 For 8 channel Uromac system without Pura option ... 8 2.1.1.4 For 8 channel Uromac system without Pura option but with EMG option ... 9 2.1.1.5 For 4 channel Uromac system without Pura option ... 9 2.1.1.6 For 4 channel Uromac system with Pura option ...10 Menu Setup ...11 2.1.2.1 File ...11 2.1.2.2 Edit ...11 2.1.2.3 Multimeter Window ...11 2.1.2.4 Patient Report ...12 2.1.2.5 Macro ...13 Channel Calibration Procedure ...14 2.1.3.1 2.1.3.1 2.1.3.3

2.1.4

Fill Volume Calibration ...14 Voided Flow Calibration...15 Pressure Channel Calibration ...17

Settings Files ...18

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2.2.

Instructions to setup Gastromac Application ...19 2.2.1 2.2.2 2.2.3 2.2.4

2.3

Channel Setup ...19 Menu Setup ...20 2.2.2.1 File ...20 2.2.2.2 Edit ...20 Channel Calibration Procedure ...21 2.2.3.1 Pressure Channel Calibration ...21 2.2.3.2 pH Channel Calibration ...22 Settings Files ...24

Instructions to setup Anomac Application ...25 2.3.1 Channel Setup ...25 2.3.2 Menu Setup ...26 2.3.2.1 File ...26 2.3.2.2 Edit ...26 2.3.3 Channel Calibration Procedure ...27 2.3.3.1 Pressure Channel Calibration ...27 2.3.4 Settings Files ...28

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Purpose This document assumes the user is very familiar with the use of the Acquidata Clinical Measuring system. It covers setup and calibration of the software for three clinical areas Urodynamics (Uromac), Gastroenterology (Gastromac) and Ano-rectal Mobility (Anomac). Disclaimer Statement While every endeavour is made to ensure that this manual is accurate and complete, no responsibility is taken for any errors or omissions. Please contact Neomedix Systems Technical Services Department if you find any fault in this manual. You can contact us either by phone, fax, e-mail or post; details of which appear in this manual. The recommended maximum calibration interval for Acquidata range of equipment is one year. If the system is frequently used, this interval may be shortened at your discretion. Transducers should also be checked and calibrated more frequently, depending on the usage. The system should also be subjected to electrical safety testing to ensure continued operator and patient safety. In Australia, the relevant Standards Australia documents are AS2500-1995 : Guide to safe use of electricity in patient care and AS3551-1996 : Acceptance testing and in-service testing - Electromedical Equipment. This can be either performed by Neomedix System, institution with in-house Biomedical Engineering Department or by a qualified third party contractor.

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1

CALIBRATION PROCEDURE

To complete the calibration procedure, it is assumed that the operator has the following equipment 1.1.

Equipment Under Test 4ch or 8ch AcquiAmplifier AcquiProcessor Catheter Fluid Filled - as per customer order Catheter Micro Transducer Tipped - as per customer order Receiving Chamber only Uromac Acquidata system Flow interface Unit only Uromac Acquidata system

1.2.

Calibrated Equipment Acquidata Calibration Kit includes

1.3.

• • • • • • • •

2 x 500gm weight Pressure infuser bag MX860 dome Catheter tube 30cm rule graduated burette with clamp stopcock 20mL syringe

• •

Computer NMS Application Software (Uromac, Gastromac or Anomac)

Test Equipment

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2

APPLICATION SOFTWARE SETUP

This section explains the steps required to perform software calibration and to create or modify a desired settings file. The user can either create a new settings file or modify an existing one. 1.

Turn on the Acquidata system with the transducers connected and let the system warm up and electrically stabilize for about 5-10 minutes prior to creating the settings file.

2.

Launch application software by double clicking the application Icon (Uromac/Gastromac/Anomac 3.5) or launch by selecting the desired settings file from the Uromac Calibration Folder located in the Apple Menu Items (). Follow the steps outlined below to create a new one or go the relevant section to calibrate the desired channel.

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INSTRUCTIONS TO SETUP UROMAC APPLICATION

2.1 2.1.1

Channel Setup Select the AcquiAmplifier dialogue box from the channel title menu and configure all the channels as given below.

2.1.1.1 For 8 channel Uromac System with Pura option. In this case there will be at least one factory default settings file. Ch

Parameter

Scale

No Cal. / Smooth / Derived/ Voided Volume

Multimeter

Colour

Window

1

Qvoid

-5 to 40mL sec-1

Smoothing 5 points

ON

Black

2

Vvoid*

-10 to 800 mL

OFF

Green

3

Pdet*

-15 to 80 cmH20

Voided Volume, Trigger on Qvoid = 2mL sec-1, post acquisition = 5 sec Derived

ON

Red

4

Pura

-5 to 120 cmH20

No Cal.

OFF

Dark Blue

5

Pves

-5 to 120 cmH20

No Cal.

OFF

Light Blue

6

Pabd

-5 to 120 cmH20

No Cal.

OFF

Pink

7

Puc*

-15 to 80 cmH20

Derived

ON

Red

8

Vfill

-10 to 800mL

No Cal.

ON

Green

Table 1 : 8ch default Uromac setup Note :

* indicates channels to be selected from the channel title box after the other channels are selected.

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2.1.1.2

For 8 channel Uromac System with Pura and EMG options. In this instance, there will be at least two settings file. Standard 8ch Settings file as previously created (table 1) 8ch with channel G configured as EMG. This configuration is shown in table below.

• •

Ch

Parameter

Scale -1

No Cal. / Smooth / Derived/ Voided Volume

Multimeter

Colour

Window

1

Qvoid

-5 to 40mL sec

Smoothing 5 points

ON

Black

2

Vvoid*

-10 to 800 mL

OFF

Green

3

Pdet*

-15 to 80 cmH20

Voided Volume, Trigger on Qvoid = 2mL sec-1, post acquisition = 5 sec Derived

ON

Red

4

Pura

-5 to 120 cmH20

No Cal.

OFF

Dark Blue

5

Pves

-5 to 120 cmH20

No Cal.

OFF

Light Blue

6

Pabd

-5 to 120 cmH20

No Cal.

OFF

Pink

7

EMG

Auto Range

No Cal.

OFF

Red

8

Vfill

-10 to 800mL

No Cal.

ON

Green

Table 2 : 8ch Uromac Setup with Pura and EMG option. 2.1.1.3 For 8 channel Uromac System without Pura option. Ch

Parameter

Scale -1

No Cal. / Smooth / Derived/ Voided Volume

Multimeter

Colour

Window

1

Qvoid

-5 to 40mL sec

Smoothing 5 points

ON

Black

2

Vvoid*

-10 to 800 mL

OFF

Green

3

Pdet*

-15 to 80 cmH20

Voided Volume, Trigger on Qvoid = 2mL sec-1, post acquisition = 5 sec Derived

ON

Red

4

-

-

-

-

-

5

Pves

-5 to 120 cmH20

No Cal.

OFF

Light Blue

6

Pabd

-5 to 120 cmH20

No Cal.

OFF

Pink

7

-

-

-

-

-

8

Vfill

-10 to 800mL

No Cal.

ON

Green

Table 3 : 6ch default Uromac setup without Pura option. Adjust the channel display by manually arranging the channels such that only 6 channels are visible.

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2.1.1.4 For 8 channel Uromac System without Pura but with EMG option. Ch

Parameter

Scale

No Cal. / Smooth / Derived/ Voided Volume

Multimeter

Colour

Window

1

Qvoid

-5 to 40mL sec-1

Smoothing 5 points

ON

Black

2

Vvoid*

-10 to 800 mL

OFF

Green

3

Pdet*

-15 to 80 cmH20

Voided Volume, Trigger on Qvoid = 2mL sec-1, post acquisition = 5 sec Derived

ON

Red

4

-

-

-

-

-

5

Pves

-5 to 120 cmH20

No Cal.

OFF

Light Blue

6

Pabd

-5 to 120 cmH20

No Cal.

OFF

Pink

7

EMG

Auto Range

No Cal.

OFF

Black

8

Vfill

-10 to 800mL

No Cal.

ON

Green

Table 4 : 7ch default Uromac setup without Pura option but with EMG option. Adjust the channel display by manually arranging the channels such that only 7 channels are visible. 2.1.1.5 For 4 channel Uromac System without Pura option. Select channel settings from Setup menu and select number of channels as 6. Configure the channels using the AcquiAmplifier dialogue box as shown below. Ch

Parameter

Scale -1

No Cal. / Smooth / Derived/ Voided Volume

Multimeter

Colour

Window

1

Qvoid

-5 to 40mL sec

Smoothing 5 points

ON

Black

2

Pves

-5 to 120 cmH20

No Cal.

OFF

Light Blue

3

Pabd

-5 to 120 cmH20

No Cal.

OFF

Pink

4

Vfill

-10 to 800mL

No Cal.

ON

Green

5

Pdet*

-15 to 80 cmH20

Derived

ON

Red

6

Vvoid*

-10 to 800 mL

Voided Volume, Trigger on Qvoid = 2mL sec-1, post acquisition = 5 sec

OFF

Green

Table 5 : 6ch default Uromac setup. 2.1.1.6 For 4 channel Uromac System with Pura option. In this instance, there will be at least two default settings files. •

6ch settings file as shown in Table 5.

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6ch settings file as shown below.

•

Ch

Parameter

Scale

No Cal. / Smooth / Derived/ Voided Volume

Multimeter

Colour

Window

1

Qvoid

-5 to 40mL sec-1

Smoothing 5 points

ON

Black

2

Pves

-5 to 120 cmH20

No Cal.

OFF

Light Blue

3

Pura

-5 to 120 cmH20

No Cal.

OFF

Pink

4

Vfill

-10 to 800mL

No Cal.

ON

Green

5

Puc*

-15 to 80 cmH20

Derived

ON

Red

6

Vvoid*

-10 to 800 mL

Voided Volume, Trigger on Qvoid = 2mL sec-1, post acquisition = 5 sec

OFF

Green

Table 6 : 6ch Uromac setup with Pura option. 2.1.2.

Menu Setup

2.1.2.1 File • •

Select Page Setup. Select Page size as A4, Faster Printing, Print comments at the end.

2.1.2.2 Edit • • •

•

Select Menu from Preferences option. Click on the right arrow till Setup is displayed. Untick the following options. ∗ Zero all input. ∗ Stimulator & Stimulator Panel. ∗ Timed Events. ∗ Auto comment. ∗ Trigger. ∗ Output Voltage. ∗ Configure Digital Output & Digital Output. Click till Macro Appears and untick Start Recording and separator line and click OK.

2.1.2.3 Multimeter Window

• • • • •

If monitor size ≥ 17” and/or 6ch settings file on a 15” monitor follow below steps, else go to the last step. Select Multimeter from Windows Menu and turn on Fill Flow Rate windows. Re-size the windows to smallest possible size and position it on LHS of Vfill channel. Position all relevant multimeters under the channel label area. For monitor size 15” and 8ch settings file, position the windows on the L.H.S. of screen in associated channel space and do not turn on Vfill.

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2.1.2.4 Patient Report

• •

Select Report Setup from Patient Report Menu. Click on Report Tab & complete options: Hospital / Inst - Name of Hospital Dept Name of Department Phy/Tech Name, if known

•

Set the following parameters ON in the graphics options: PT-QT Plots P-Q (Griffith / Abrams) Male Nomogram Thank You message

•

Click on Fill Tab - Set event off for: Strong Desire Pain First Leak Set the following parameters as Filling Medium Water Method Gravity or Pumped - depending on the order Rate Calculated

•

Click on U Empty Tab Infusion Rate 5mL sec-1 or N.A. (Utip) - depending on the order Profilomtr Speed 1.00 mm sec-1

•

Click on U Full Tab Infusion Rate 5mL sec-1 or N.A. (Utip) - depending on the order Profilomtr Speed 1.00 mm sec-1

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2.1.2.5 Macro

•

Select Function Key and configure them as shown below Key

Function

Shift

Option

F1 F2 F3 F4 F5 F6 F7 F8 F9 F10 F11 F12 F13 F14 F15

Default Default Default Default Default Default Default Default Default Default Default Default Default Default Default

Default Default Default Default Artefact Cough/Laugh Stand Instruct Stop Void Valsava Leak Point -

Second Fill Bag Defecate -

Table 7 : F-Key Setup Click on individual ‘TABS’ to enter or select the function key from the ‘SET’ button. Set the sampling speed to 40/s and compression ratio to 20:1. For EMG, go to Channel setup and select different sampling rate on each channel and set 200/s for EMG and 40/s for rest. Compress the display to 50:1. 2.1.3

Channel Calibration Procedure Configure the channels as per the above procedure.

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2.1.3.1 Fill Volume Calibration 1. 2. 3. 4. 5. 6.

Attach the hooked weight onto the Fill Volume transducer hook. Start the recording - press F11. Zero balance the system - press F12. Remove weight from the hook. Stop the chart - press F11. Highlight the entire waveform by holding down mouse and starting the selection from top left side of the waveform to bottom right hand side.

7. 8.

Select Unit Conversion from the Channel menu. Click on the baseline (near 4 in the above fig) and then click on the top arrow. This makes the lower limits as 0.0xx = 0. Change this figure manually so it now reads as 0.0mV = 0. 9. Click on the flat part of the waveform (near 5 in the above fig) and then click on the bottom arrow. This makes the upper limit as x.xmV = 1000 (or the actual weight put on the hook). This figure (1000) has to be manually entered. Note that xx represent a number eg. 3.5mV and it will be different for each case. 10. Click OK. 11. Test the calibration of the channel by removing or by adding the additional 500 gm weight.

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2.1.3.2 Voided Flow Calibration 1. 2. 3. 4. 5.

Attach a giving set enclosed in the pressure infuser bag to the calibrated Vfill transducer hook and inflate the bag to 150 mmHg of pressure. Start the application. Zero balance after the system stabilizes. Open the roller on the giving set and allow the water to flow into the receiving chamber. Ensure there is about 250mL of water initially present in the chamber for an air tight seal. Let it flow for 15-20 secs. Stop the application.

6. Drag the marker from bottom left hand corner and put it near the start of the Vfill Curve. 7. Move the cursor until you get the delta time ∆t≅10sec. 8. Get the delta value on the Vfill channel, ∆Vfill ≅152 mL. 9. Thus the average flow is ∆Vfill/∆t = 15.2 mL sec-1. Record this figure. 10. Highlight the Qvoid waveform in channel A and select Unit conversion from the Channel Menu.

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11. Click on the baseline (near 3 in the above diagram) and then on the top arrow. This gives the conversion values for Point 1. 12. Click on the flat part of the plateau on the waveform (near 4 in the above diagram) and then on the bottom arrow. This gives the conversion values for Point 2. Enter the value 15.2 manually (as previously calculated) as shown below.

13. Click OK.

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14. Verify the calibration of the Qvoid channel, by varying the flow rate, by adjusting the position of the roller on the giving set. 2.1.3.3 Pressure Channel Calibration 1. 2. 3. 4. 5. 6. 7.

Attach the MX 860 transducers to the respective pressure channels. Attach the syringe, stopcock & the tubing to the MX848 dome. Flush the tubing with water to remove any air bubble and close the stop cock. Start the application. Move the tubing to the transducer plate level and zero balance the channels. Raise the tubing to a known height using a ruler (30cm). Stop the application.

8. Select the entire pressure waveform. 9. Select Units Conversion from the Channel title box. 10. Click on the baseline (near 5 in the above figure) and then on the top arrow. This gives the conversion values for Point 1. 11. Click on the flat part of the plateau (near 6 in the above figure and then on the bottom arrow. This gives the conversion values for Point 2. Enter the value 30 (this number depends on the height to which the tube of water is raised) manually. 12. Verify the calibration by raising the tube to different heights 13. Perform the above steps for all the pressure channels. 14. If a microtip catheter is used, fill the graduated burette with water till the 0 mark. Start the application and zero balance the channels. 15. Insert the catheter to a depth of 30cm and stop the application. 16. Follow steps 8-11. Repeat the procedure for other pressure channels.

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2.1.4

Settings File Once the calibration and the setup procedure is completed, save the file as follows.

• • • • • • • •

Choose Save from File Menu. Change the file format from Data File to Settings File. Select the destination folder as Uromac Calibration folder located in the NMS Uromac Folder or Documents Folder. Type the name of the file with current date. Click Save. Quit the application. Restart the application by selecting the settings file recently created. The settings file is located in the Uromac Calibration Folder which can be selected from the from the Apple Menu Item  symbol located on top left hand corner. Verify the setup (channel configuration, scale, colour, Fkey operation, etc) of the settings file by clicking start. Stop the application and quit without saving the file, if all settings are correct. If not, make the appropriate changes required and again save the file as a settings file.

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INSTRUCTIONS TO SETUP GASTROMAC APPLICATION

2.2 1.

2. 3.

Double on application icon and launch Gastromac application or select the desired settings file from the Gastromac Calibration folder located in the Apple Menu Items (). Follow the steps outlined below to either create a new settings file or go the relevant section to calibrate the required channel. Depending on the system configuration, verify if EMG and pH options are present. Also note the type of pressure transducer ordered. If the transducers are one-use only setup the units conversion value as shown in steps 4 - 5. If the pressure transducers are re-useable (MX 860), then perform pressure channel calibration.

2.2.1

Channel Setup Select the AcquiAmplifier dialogue box from the channel title menu and configure all the channels as given below. Ch

Parameter

Scale

No Cal. / Smooth

Range

Colour

1

Pressure

-5 to 300mmHg

No Cal

10 mV

Default

2

Pressure

-5 to 300mmHg

No Cal

10 mV

Default

3

Pressure

-5 to 300mmHg

No Cal

10 mV

Default

4

pH

Default

No Cal

1V

Default

5

Pressure

-5 to 300mmHg

No Cal

10 mV

Default

6

Pressure

-5 to 300mmHg

No Cal

10 mV

Default

7

EMG

Auto Range

No Cal.

Auto

Black

8

Pressure

-5 to 300mmHg

No Cal

10 mV

Default

Table 8 : 8ch default Gastromac setup with pH and EMG option.

• •

For each AcquiAmplifier pressure channel, select the units tab and enter the following values: 0mV ⇒0 1.89mV ⇒ 74 Make sure the units is selected as mmHg instead of cmH2O.

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2.2.2.

Menu Setup

2.2.2.1 File • •

Select Page Setup. Select Page size as A4, Faster Printing, Print comments at the end.

2.2.2.2 Edit • • •

•

Select Menu from Preferences option. Click on the right arrow till Setup is displayed. Untick the following options: ∗ Zero all input. ∗ Stimulator & Stimulator Panel. ∗ Timed Events. ∗ Auto comment. ∗ Trigger. ∗ Output Voltage. ∗ Configure Digital Output & Digital Output. Click till Macro Appears and untick Start Recording and separator line and click OK.

Set the sampling speed to 40/s and compression ratio to 20:1. For EMG, go to Channel setup and select different sampling rate on each channel and set 200/s for EMG and 40/s for rest. Compress the display to 50:1

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2.2.3

Channel Calibration Procedure Configure all the channels as previously described.

2.2.3.1 Pressure Channel Calibration 1. 2. 3. 4. 5. 6. 7.

Attach the MX 860 transducers to the respective pressure channels. Attach the syringe, stopcock & the tubing to the MX848 dome. Flush the tubing with water to remove any air bubble and close the stop cock. Start the application. Move the tubing to the transducer plate level and zero balance the channels. Raise the tubing to a known height using a ruler (30cm). Stop the application.

8. Select the entire pressure waveform. 9. Select Units Conversion from the Channel title box. 10. Click on the baseline (near 5 in the above figure) and then on the top arrow. This gives the conversion values for Point 1. 11. Click on the flat part of the plateau (near 6 in the above figure and then on the bottom arrow. This gives the conversion values for Point 2. Enter the value 30 (this number depends on the height to which the tube of water is raised) manually. 12. Verify the calibration by raising the tube to different heights. 13. Perform the above steps for all the pressure channels. 14. If a microtip catheter is used, fill the graduated burette with water till the 0 mark. Start the application and zero balance the channels. 15. Insert the catheter to a depth of 30cm and stop the application. 16. Follow steps 8-11. Repeat the procedure for other pressure channels.

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