UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
Page 1 of 24
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
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
P1
P2
P3
3.5.
Day Phase
(7 a.m. – 10 p.m.)
Every 15 minutes
Every 20 minutes
Every 30 minutes
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
memory of the device (M).
3.6.
3.7.
Night Phase
(10 p.m. – 7 a.m.)
Every 30 minutes
Every 40 minutes
Every 60 minutes
/night
) and whether data is stored in
Button: Starts and stops a measurement.
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.
Page 2 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
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
Page 3 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
5.2.
2 years from
approval
Set-Up
5.2.1.
5.2.2.
5.2.5.
Slide the lid of the battery compartment open and pull upwards.
Place two AA size rechargeable nickel metal hybrid (NiMH) or
alkaline batteries in the battery compartment.
Turn the device ‘On’.
Slide the switch, located inside the battery compartment, to the right,
while looking at the display.
Wait for the time to be displayed.
5.2.6.
Press
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
change the selection.
5.2.3.
5.2.4.
six times; display shows ‘H6’.
to
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.
5.2.11.2.
5.2.11.3.
5.2.11.4.
5.2.11.5.
5.2.11.6.
5.3.
Turn the device ‘On’
Clear memory (section 5.3)
Check date and time and adjust if required (section 5.4)
Select pressure unit (section 5.5).
Select measurement protocol (section 5.6)
Enable/disable audio signal (section 5.7).
Clearing Memory
5.3.1.
5.3.2.
Switch the device ‘Off’ and ‘On’ again.
Wait for the time to be displayed.
5.3.3.
Press
; display indicates ‘H1’.
5.3.4.
Press
; display indicates ‘LLLL’.
5.3.5.
Press
the time.
again to delete data; display indicates “0000” followed by
Page 4 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
5.4.
5.5.
Setting Date and Time
5.4.1.
5.4.2.
Switch the device ‘Off’ and ‘On’ again.
Wait for the time to be displayed.
5.4.3.
Press
5.4.4.
Press
5.4.5.
Confirm year with
5.4.6.
correct year followed by
to confirm.
Repeat 5.4.5 for month, day, hour and minute.
twice; display indicates ‘H2’.
; display indicates the year.
to
Setting Pressure Unit
5.5.1.
5.5.2.
Switch the device ‘Off’ and ‘On’ again.
Wait for the time to be displayed.
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
confirm with
5.6.
if indicated year is correct, or press
or select other unit with
.
Selecting Measurement Protocol
5.6.1.
5.6.2.
Switch the device ‘Off’ and ‘On’ again.
Wait for the time to be displayed.
5.6.3.
Press
5.6.4.
Press
; display indicates ‘LLLL’.
5.6.5.
Press
; display indicates ‘P1’; press
5.6.6.
Press
to confirm measurement protocol.
three times; display indicates ‘H3’.
Page 5 of 24
to select ‘P2’ or ‘P3’.
;
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
5.7.
Enabling/Disabling Audio Signal
5.7.1.
5.7.2.
Switch the device ‘Off’ and ‘On’ again.
Wait for the time to be displayed.
5.7.3.
Press
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
seven times; display indicates ‘H7’.
to confirm the required setting or press
alternate setting and press
5.8.
to select the
to confirm.
Applying the Cuff
5.8.1.
5.8.2.
5.9.
2 years from
approval
Select appropriate cuff size.
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.
Initiating a Trial Measurement
5.9.1.
5.9.2.
5.9.3.
5.9.4.
5.9.5.
5.9.6.
Turn device ‘On’ and place it in the carrying pouch.
Attach the pouch to the patient using the shoulder strap and belt.
Guide the pressure tubing around the patient’s neck as strain relief and
connect it to the BP cuff port on the device.
Instruct patient to stand or sit, but not to move, during measurement to
avoid an erroneous measurement.
Press
to initiate the first measurement; measured data appears as
systolic reading (S), diastolic reading (D) and pulse rate.
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.
Page 6 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
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.
Page 7 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
5.12. Troubleshooting: Error Codes
Page 8 of 24
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
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.
Page 9 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.15. Calibration
5.15.1. Connect a rubber bulb between pressure tubing and cuff, using a Tadapter.
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.
Page 10 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
5.16. Flowcharts
5.16.1. Set-Up
Start
Slide the lid of the battery compartment open and pull upwards
Place 2 AA size (rechargeable nickel metal hybrid (NiMH)
or alkaline batteries) in battery compartment
Turn device ‘On’
Slide switch (located inside the battery compartment) to the right
Wait for time to be displayed
Press
Press
Press
Press
6 times; display shows ‘H6’
; display shows ‘AAAA’ when device is set up for rechargeable batteries
and ‘bbbb’ when set up for alkaline batteries
to confirm displayed information or press
to change selection
to confirm new selection; device will briefly display capacity of batteries
Place lid on the battery compartment and close
End
Page 11 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.2. Clearing Memory
Start
Switch the device ‘Off’ and ‘On’ again
Wait for time to be displayed
Press
Press
Press
; display indicates ‘H1’
; display indicates ‘LLLL’
again to delete data; display indicates “0000” followed by time
End
Page 12 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
5.16.3. Setting Date and Time
Start
Switch the device ‘Off’ and ‘On’ again
Wait for time to be displayed
twice; display indicates ‘H2’
Press
Press
; display indicates year
Confirm year with
or press
if indicated year is correct,
to correct year followed by
to confirm
Repeat previous step for month, day, hour and minute
End
Page 13 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
5.16.4. Setting Pressure Unit
Start
Switch the device ‘Off’ and ‘On’ again
Wait for time to be displayed
Press
Press
Confirm pressure unit with
8 times; display indicates ‘H8’
; display indicates ‘mmHg’ or ‘kPa’
or select other unit with
End
Page 14 of 24
; confirm with
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
5.16.5. Selecting Measurement Protocol
Start
Switch the device ‘Off’ and ‘On’ again
Wait for time to be displayed
Press
Press
Press
3 times; display indicates ‘H3’
; display indicates ‘LLLL’
; display indicates ‘P1’; press
Press
to select ‘P2’ or ‘P3’
to confirm measurement protocol
End
Page 15 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
TONOPORT V
5.16.6. Enabling/Disabling Audio Signal
Start
Switch the device ‘Off’ and ‘On’ again
Wait for time to be displayed
Press
Press
Press
7 times; display indicates ‘H7’
; display indicates ‘0000’ when audio signal is turned Off
and ‘1111’ when audio signal is turned On
to confirm required setting or press
alternate setting and press
End
Page 16 of 24
to confirm
to select
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.7. Applying the Cuff
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
End
Page 17 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.8. Initiating a Trial Measurement
Start
Turn device ‘On’ and place it in carrying pouch
Attach pouch to the patient using the shoulder strap and belt
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
Page 18 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.9. Data Output
Start
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
Page 19 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.10. Software Installation – Cardiosoft
Start
Turn PC and monitor ‘On’ and exit all programs
Insert CardioSoft CD in the CD ROM drive
Start ‘setup.exe’ via Windows Explorer, if CD drive does not automatically start up
Follow displayed prompts
Confirm the two proposed directories with Next
Enter the serial number from CD-ROM to install CardioSoft
Restart Windows
End
Page 20 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.11. Software Installation - USB
Start
Turn PC and monitor ‘On’ and exit all programs
Insert the CD with the USB drivers in the CD ROM drive
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
Click Finish to complete first part of USB driver installation procedure
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
End
Page 21 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
5.16.12. Calibration
Start
Connect a rubber bulb between pressure tubing and cuff using T-adapter
Roll up cuff tight
Switch device ‘Off’ and ‘On’ again after a few seconds
Wait for time to be displayed
Press
Press
4 times; display indicates ‘H4’
; display indicates an internal value that must be between 25 and 100
Contact service technician if displayed value is outside this range
Press
again; display indicates ‘0’
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
Press
to exit calibration mode
End
Page 22 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
6. Precautions
6.1.
6.2.
6.3.
6.4.
6.5.
6.6.
6.7.
6.8.
6.9.
Disconnect device from the patient when connecting to PC or other equipment.
Ensure that liquids do not enter the device; contact service technician before
use if liquid has entered the device.
Disconnect device from other equipment before cleaning.
Keep device away from magnetic and electrical fields capable of interfering
with proper performance of the device leading to incorrect measurements.
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.
When applying the cuff, bending the arm must not change the cuff level.
Replace cuff on a regular basis as damaged velcro fasteners may cause
incorrect readings.
Instruct patient to terminate the measurement with
, whenever cuff is not
deflated within about 2 minutes.
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.
Page 23 of 24
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/227_01
STANDARD OPERATING PROCEDURE
Valid for:
TONOPORT V
2 years from
approval
8. Appendices
SOP/PD/227_01/A1: Function of
Button
9. Revision History
Version Number
01
SOP/PD/227_01/A1: Function of
Amendments/ Reasons for change
Initial Release
Button
Page 24 of 24