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UNIVERSITY OF MALTA

FACULTY OF MEDICINE & SURGERY

PHARMACY DEPARTMENT Ref. No. SOP/PD/227_01

STANDARD OPERATING PROCEDURE

TONOPORT V Valid for:

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1. Scope

This Standard Operating Procedure (SOP) applies to the staff and students using the

Tonoport V in the Pharmacy Practice Resource Unit (PPRU) at the Pharmacy

Department, University of Malta.

2. Objective

To describe the procedure for set-up, configuration, operation, recording and recalling

of results, quality control, maintenance and troubleshooting of the Tonoport V.

3. Definitions

3.1. ‘A 100’: Rechargeable batteries have a capacity of 100% (fully charged).

3.2. ‘b 50’: Alkaline batteries have a capacity of only 50% (half depleted).

3.3. Button: Displays most recent measurement results or most recent error

message, toggles between day and night phase.

3.4. Measurement Protocol: Includes 3 protocols; P1, P2 and P3

Protocol Day Phase

(7 a.m. – 10 p.m.)

Night Phase

(10 p.m. – 7 a.m.)

P1 Every 15 minutes Every 30 minutes



3.5. Performance check: Involves running a self-test of the device including all

symbols and segments on the LCD. It checks the batteries indicating the

remaining capacity. The device will emit an audio signal, if enabled. Upon

passing the self-test and completing the battery test, the device will display the

time of day, measuring phase (day /night ) and whether data is stored in

memory of the device (M).

3.6. Button: Starts and stops a measurement.

3.7. Tonoport V: A small-size, patient-borne blood pressure (BP) monitor for

ambulatory, non-invasive measurement of BP in adults and children for

periods of up to 30 hours. BP is measured by the oscillometric method.

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4. Responsibility

4.1. The members of the Department of Pharmacy (staff and students) are

responsible for following this SOP.

4.2. The designated Laboratory Officer or Laboratory Assistant is responsible for

ensuring that this SOP is followed.

5. Procedure

5.1. Diagram

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5.2. Set-Up

5.2.1. Slide the lid of the battery compartment open and pull upwards.

5.2.2. Place two AA size rechargeable nickel metal hybrid (NiMH) or

alkaline batteries in the battery compartment.

5.2.3. Turn the device ‘On’.

5.2.4. Slide the switch, located inside the battery compartment, to the right,

while looking at the display.

5.2.5. Wait for the time to be displayed.

5.2.6. Press six times; display shows ‘H6’.

5.2.7. Press ; display shows ‘AAAA’ when the device is set up for

rechargeable NiMH batteries and ‘bbbb’ when set up for alkaline

batteries.

5.2.8. Press to confirm the displayed information or press to

change the selection.

5.2.9. Press to confirm the new selection; device will briefly display the

capacity of the inserted batteries.

5.2.10. Place the lid on the battery compartment and close.

5.2.11. Before using the device on a patient:

5.2.11.1. Turn the device ‘On’

5.2.11.2. Clear memory (section 5.3)

5.2.11.3. Check date and time and adjust if required (section 5.4)

5.2.11.4. Select pressure unit (section 5.5).

5.2.11.5. Select measurement protocol (section 5.6)

5.2.11.6. Enable/disable audio signal (section 5.7).

5.3. Clearing Memory

5.3.1. Switch the device ‘Off’ and ‘On’ again.


5.3.3. Press ; display indicates ‘H1’.

5.3.4. Press ; display indicates ‘LLLL’.

5.3.5. Press again to delete data; display indicates “0000” followed by

the time.

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5.4. Setting Date and Time



5.4.3. Press twice; display indicates ‘H2’.

5.4.4. Press ; display indicates the year.

5.4.5. Confirm year with if indicated year is correct, or press to

correct year followed by to confirm.

5.4.6. Repeat 5.4.5 for month, day, hour and minute.

5.5. Setting Pressure Unit



5.5.3. Press eight times; display indicates ‘H8’.

5.5.4. Press ; display indicates ‘mmHg’ or ‘kPa’.

5.5.5. Confirm pressure unit with or select other unit with ;

confirm with .

5.6. Selecting Measurement Protocol



5.6.3. Press three times; display indicates ‘H3’.

5.6.4. Press ; display indicates ‘LLLL’.

5.6.5. Press ; display indicates ‘P1’; press to select ‘P2’ or ‘P3’.

5.6.6. Press to confirm measurement protocol.

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5.7. Enabling/Disabling Audio Signal



5.7.3. Press seven times; display indicates ‘H7’.

5.7.4. Press ; display indicates ‘0000’ when the audio signal is turned off

and ‘1111’ when audio signal is turned on.

5.7.5. Press to confirm the required setting or press to select the

alternate setting and press to confirm.

5.8. Applying the Cuff

5.8.1. Select appropriate cuff size.

5.8.2. Place cuff on the arm of the patient that is used less frequently during

normal daily activities; place cuff about 2 fingers’ breadth above the

bend of the elbow in adults and a little close to the bend of the elbow in

children.

5.9. Initiating a Trial Measurement

5.9.1. Turn device ‘On’ and place it in the carrying pouch.

5.9.2. Attach the pouch to the patient using the shoulder strap and belt.

5.9.3. Guide the pressure tubing around the patient’s neck as strain relief and

connect it to the BP cuff port on the device.

5.9.4. Instruct patient to stand or sit, but not to move, during measurement to

avoid an erroneous measurement.

5.9.5. Press to initiate the first measurement; measured data appears as

systolic reading (S), diastolic reading (D) and pulse rate.

5.9.6. Once successfully completing trial measurement, the device will

continue with automatic measurements.

5.10. Data Output

5.10.1. Turn device ‘Off’.

5.10.2. Connect device to the PC via cable when using the USB port of the

device.

5.10.3. Turn device ‘On’ and wait for time to be displayed on device.

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5.11. Software Installation

5.11.1. CardioSoft

5.11.1.1. Turn PC and monitor ‘On’ and exit all programs.

5.11.1.2. Insert CardioSoft CD in the CD ROM drive.

5.11.1.3. Start ‘setup.exe’ via Windows Explorer, if CD drive does

not automatically start up.

5.11.1.4. Follow the displayed prompts.

5.11.1.5. Confirm the two proposed directories with Next.

5.11.1.6. Enter the serial number from CD-ROM to install

CardioSoft.

5.11.1.7. Restart Windows.

5.11.2. USB Driver

5.11.2.1. Turn PC and monitor ‘On’ and exit all programs.

5.11.2.2. Insert the CD with the USB drivers in the CD ROM drive.

5.11.2.3. Start ‘setup.exe’ via Windows Explorer, if CD drive does

not automatically start up.

5.11.2.4. Follow the displayed prompts select Allow if the system

indicates that an unidentified program is being used.

5.11.2.5. Click Finish to complete the first part of the USB driver

installation procedure.

5.11.2.6. Turn device ‘On’ and connect it to the PC, using the USB

connection cable.

5.11.2.7. Follow any additional prompts that may be displayed.

5.11.2.8. Remove USB driver CD from the CD-ROM drive when

Windows indicates that the drivers were successfully

installed.

5.11.2.9. Turn device ‘On’ and connect its USB port to the PC to

verify USB port.

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5.12. Troubleshooting: Error Codes

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5.13. Cleaning and Disinfection

5.13.1. Device Surface

5.13.1.1. Turn device ‘Off’.

5.13.1.2. Wipe the device with a soft, lint-free cloth, using a mild

cleaning solution or dishwashing liquid in a low

concentration; do not allow liquid to enter the device.

5.13.2. Cuffs

5.13.2.1. Use a moist cloth to wipe cuffs which are only slightly

soiled.

5.13.2.2. Clean cuffs that are heavily contaminated by washing them

with soapy water or a suitable cleaning agent that contains a

disinfectant; do not machine-wash.

5.13.2.3. Ensure that no liquid penetrates into the cuff bladder or the

pressure tubing; remove bladder from the cuff before

cleaning top avoid this.

5.13.2.4. Rinse the cuff thoroughly with water after cleaning and

allow it to dry at room temperature for about 15 hours.

5.13.2.5. Disinfect the cuffs with 70% isopropyl alcohol or 70%

ethanol.

5.13.2.6. Rinse cuff thoroughly with tap water and air-dry after

disinfection.

5.13.3. Cables

5.13.3.1. Disconnect cables from device before cleaning.

5.13.3.2. Use a cloth moistened with soapy water to wipe the cables

clean.

5.13.3.3. Do not immerse the cables in liquid.

5.14. Maintenance

5.14.1. Check device and cables for signs of mechanical damage before each

use.

5.14.2. Carry out technical safety inspections annually to ensure functional

and operational safety.

5.14.3. The non-invasive pressure measurement system of the device should

be inspected every 2 years.

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5.15. Calibration

5.15.1. Connect a rubber bulb between pressure tubing and cuff, using a T-

adapter.

5.15.2. Roll up cuff tight.

5.15.3. Switch device ‘Off’ and ‘On’ again after a few seconds.

5.15.4. Wait for time to be displayed.

5.15.5. Press four times; display indicates ‘H4’.

5.15.6. Press ; display indicates an internal value that must be between

25 and 100.

5.15.7. Contact service technician if displayed value is outside this range.

5.15.8. Press again; display indicates ‘0’.

5.15.9. Generate a test pressure of 200mmHg and measure the pressure

decrease after waiting at least 30 seconds; pressure decreases between

3 and 5 mmHg are typical; a pressure decrease > 6mmHg indicates a

leak.

5.15.10. Contact service technician if a leak is present.

5.15.11. Press to exit the calibration mode.

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5.16. Flowcharts

5.16.1. Set-Up

Start

Place 2 AA size (rechargeable nickel metal hybrid (NiMH)

or alkaline batteries) in battery compartment

Turn device ‘On’

Wait for time to be displayed

Slide switch (located inside the battery compartment) to the right

Slide the lid of the battery compartment open and pull upwards

Press 6 times; display shows ‘H6’

Press ; display shows ‘AAAA’ when device is set up for rechargeable batteries

and ‘bbbb’ when set up for alkaline batteries

Press to confirm displayed information or press to change selection

Press to confirm new selection; device will briefly display capacity of batteries

Place lid on the battery compartment and close

End

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5.16.2. Clearing Memory


Start

Switch the device ‘Off’ and ‘On’ again

Press ; display indicates ‘H1’

Press ; display indicates ‘LLLL’

Press again to delete data; display indicates “0000” followed by time

End

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5.16.3. Setting Date and Time

Press twice; display indicates ‘H2’


Start


Press ; display indicates year

Repeat previous step for month, day, hour and minute

Confirm year with if indicated year is correct,

or press to correct year followed by to confirm

End

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5.16.4. Setting Pressure Unit


Start

Confirm pressure unit with or select other unit with ; confirm with


Press 8 times; display indicates ‘H8’

Press ; display indicates ‘mmHg’ or ‘kPa’

End

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5.16.5. Selecting Measurement Protocol



Start


Press ; display indicates ‘P1’; press to select ‘P2’ or ‘P3’

Press ; display indicates ‘LLLL’

Press to confirm measurement protocol

End

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5.16.6. Enabling/Disabling Audio Signal


End

Start



Press ; display indicates ‘0000’ when audio signal is turned Off

and ‘1111’ when audio signal is turned On

Press to confirm required setting or press to select

alternate setting and press to confirm

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5.16.7. Applying the Cuff

End

Start

Select appropriate cuff size

Place cuff on the patient’s arm that is used less frequently during normal daily

activities; place cuff about 2 fingers’ breadth above the bend of the elbow in adults

and a little close to the bend of the elbow in children

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5.16.8. Initiating a Trial Measurement

Turn device ‘On’ and place it in carrying pouch

Attach pouch to the patient using the shoulder strap and belt

Start

Guide pressure tubing around patient’s neck as strain relief

and connect it to BP cuff port on device

Instruct patient to stand or sit and not move during measurement

to avoid an erroneous measurement

Press to initiate first measurement

(measured data appears as systolic reading (S), diastolic reading (D) and pulse rate)

Once successfully completing trial measurement,

device will continue with automatic measurements

End

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5.16.9. Data Output

Turn device ‘Off’

Connect device to the PC via cable when using the USB port of the device

Turn device ‘On’ and wait for time to be displayed on device

End

Start

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5.16.10. Software Installation – Cardiosoft

Start

End

Turn PC and monitor ‘On’ and exit all programs

Enter the serial number from CD-ROM to install CardioSoft

Insert CardioSoft CD in the CD ROM drive

Start ‘setup.exe’ via Windows Explorer, if CD drive does not automatically start up

Confirm the two proposed directories with Next

Follow displayed prompts

Restart Windows

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5.16.11. Software Installation - USB

Turn PC and monitor ‘On’ and exit all programs

Insert the CD with the USB drivers in the CD ROM drive

Click Finish to complete first part of USB driver installation procedure

Start ‘setup.exe’ via Windows Explorer, if CD drive does not automatically start up

Follow displayed prompts; select Allow if the system indicates that

an unidentified program is being used

End

Start

Turn device ‘On’ and connect it to PC, using the USB connection cable

Follow additional prompts that may be displayed

Remove USB driver CD from the CD-ROM drive

when Windows indicates that the drivers were successfully installed

Turn device ‘On’ and connect its USB port to PC to verify USB port

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5.16.12. Calibration

Roll up cuff tight



Connect a rubber bulb between pressure tubing and cuff using T-adapter

Switch device ‘Off’ and ‘On’ again after a few seconds

End

Start

Press ; display indicates an internal value that must be between 25 and 100

Generate test pressure of 200 mmHg and measure pressure decrease after waiting at

least 30 seconds (pressure decreases between 3 and 5 mmHg are typical;

a pressure decrease > 6mmHg indicates a leak)

Contact service technician if a leak is present

Contact service technician if displayed value is outside this range

Press again; display indicates ‘0’

Press to exit calibration mode

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6. Precautions

6.1. Disconnect device from the patient when connecting to PC or other equipment.

6.2. Ensure that liquids do not enter the device; contact service technician before

use if liquid has entered the device.

6.3. Disconnect device from other equipment before cleaning.

6.4. Keep device away from magnetic and electrical fields capable of interfering

with proper performance of the device leading to incorrect measurements.

6.5. Ensure use of appropriate cuff size; when cuff is too small BP values will be

overrated and when cuff is too large BP values will be too low.

6.6. When applying the cuff, bending the arm must not change the cuff level.

6.7. Replace cuff on a regular basis as damaged velcro fasteners may cause

incorrect readings.

6.8. Instruct patient to terminate the measurement with , whenever cuff is not

deflated within about 2 minutes.

6.9. Instruct patient to remove cuff if it does not deflate after the activation of the

button as this could be due to kinked tubing.

6.10. Do not use phenol-based disinfectants or peroxide compounds to disinfect the

device.

7. Reference

GE Healthcare. Tonoport V Operator’s Manual. Berlin, Germany; 2009-2011.

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8. Appendices

SOP/PD/227_01/A1: Function of Button

9. Revision History

SOP/PD/227_01/A1: Function of Button

Version Number Amendments/ Reasons for change

01 Initial Release

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