UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
Page 1 of 11
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
Valid for:
2 years from
approval
1. Scope
This Standard Operating Procedure (SOP) applies to the staff and students
using the PainMatcher® in the Pharmacy Practice Resource Unit (PPRU) at the
Pharmacy Department, University of Malta.
2. Objective
To describe the procedure for the operation and maintenance of the
PainMatcher®.
3. Definitions
3.1.
Lab Mode: Allows the user to take measurements to familiarise
patients with the device without actually storing them and filling up
memory.
3.2.
Memory: Stores the latest 99 sessions.
3.3.
Pain Magnitude Matching: When the amount of stimulation produced
by the device is as intense as the patient’s own physical pain.
3.4.
PainMatcher®: A point-of-care medical device that compares actual
pain with stimulated pain generated by the device itself in the form of
electrical impulses. It is also capable of measuring both sensory and
pain thresholds.
3.5.
Pain Threshold: The weakest amount of stimulation one considers
painful.
3.6.
Sensory Threshold: The faintest stimulation one is able to feel.
3.7.
Session: Includes from 1 to 3 measurements together with the date and
time.
3.8.
Settings Mode: Allows user to decide whether to show or hide the
results during operation and also to set the date and time.
3.9.
Special Functions Menu: Consists of 3 mains modes which are the
Settings Mode, the Results Mode and the Measurement Mode.
Page 2 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
Valid for:
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 of PainMatcher®
Page 3 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
5.2.
Valid for:
2 years from
approval
Operation
5.2.1.
Lab Mode
5.2.1.1.
5.2.1.2.
5.2.1.3.
5.2.1.4.
5.2.1.5.
5.2.1.6.
5.2.2.
Press the On/Off button to switch on the device.
Press and hold the VIEW button for 3 seconds to
access lab mode.
Grasp the electrodes firmly with the thumb and index
finger of the left hand to start stimulation.
Release both fingers when the current feels as
intense as the actual physical pain being experienced.
Wait until the result automatically appears on the
display.
Press and hold the VIEW button for 3 seconds to exit
the lab mode.
Measurement Mode
5.2.2.1.
5.2.2.2.
5.2.2.3.
5.2.2.4.
5.2.2.5.
5.2.2.6.
5.2.2.7.
Press the On/Off button to switch on the device.
Grasp the electrodes firmly with the thumb and index
finger of the left hand to start stimulation.
Release both fingers as soon as a current is felt to
measure the sensory threshold.
Release both fingers as soon as the slightest bit of
pain from the current is felt to measure the pain
threshold.
Release both fingers when the current feels as
intense as the actual physical pain being experienced
to obtain reading for pain magnitude matching.
Press the VIEW button to view and store
measurement readings whenever a session includes
only one of the 3 types of measurements i.e. sensory
threshold, pain threshold and pain magnitude
matching.
Wait until measurement results are stored
automatically whenever a session includes all 3
measurement readings.
Page 4 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
5.2.3.
Result Mode
5.2.3.1.
5.2.3.2.
5.2.3.3.
5.2.3.4.
5.2.3.5.
5.2.3.6.
5.2.3.7.
5.2.4.
Valid for:
2 years from
approval
Press the On/Off button to switch on the device.
Press and hold the On/Off button for 3 seconds to
access the special functions menu.
Repeatedly press the VIEW button until [Results] is
displayed.
Press the On/Off button to select [Results].
Repeatedly press the VIEW button to scroll through
the saved measurements.
Press and hold the VIEW button for 3 seconds to
delete results that are being displayed.
Press and hold the On/Off button for 3 seconds to
exit the special functions menu.
Setting Mode
5.2.4.1.
5.2.4.2.
5.2.4.3.
5.2.4.4.
5.2.4.5.
5.2.4.6.
5.2.4.7.
5.2.4.8.
5.2.4.9.
Press the On/Off button to switch on the device.
Press and hold the On/Off button for 3 seconds to
access the special functions menu.
Repeatedly press the VIEW button until [Settings] is
displayed.
Press the On/Off button to select [Settings].
Use the VIEW button to scroll between modes to
decide whether to show or to hide the results being
obtained.
Press the On/Off button to confirm the selected
mode.
Use the VIEW button to change the Date and Time.
Press the On/Off button to confirm the inputted date
and time settings.
Press the On/Off button for 3 seconds to exit the
special functions menu.
Page 5 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
5.3.
Valid for:
2 years from
approval
Maintenance
5.3.1.
5.3.2.
5.3.3.
Change batteries (two 1.5-V AAA) whenever the battery
indicator lights up.
Change the electrodes after every 6 months of operation.
Change the electrodes before six months if the device indicates
excessive resistance (see section 5.1).
5.3.3.1.
5.3.3.2.
5.3.3.3.
5.3.3.4.
5.3.3.5.
Check that the device is switched off.
Grasp the left edge of each electrode and pull them
off.
Attach the electrode marked “1” on the front.
Attach the electrode marked “2” at the back.
Fix the rectangular part of the new electrode first and
then press the round part on.
Page 6 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
PAINMATCHER®
5.4.
Flow Charts
5.4.1.
Operation
Start
1
Press the On/Off button to switch device on
No
Yes
Press and hold VIEW button for 3 seconds
No
No
Use device in
lab mode
Use device in
measurement mode
Use device in
result mode
Yes
Yes
Grasp electrodes firmly with thumb and index
finger of left hand to start stimulation
Press and hold On/Off button for 3 seconds
Grasp electrodes firmly with thumb and index
finger of left hand to start stimulation
No
Repeatedly press VIEW button
until [Results] is displayed
Need to measure
sensory threshold
Release both fingers when current feels as
intense as the actual physical pain
Press On/Off button to select [Results]
Yes
Release both fingers as
soon as a current is felt
2
Wait until result automatically
appears on display
No
Need to measure
pain threshold
Press and hold VIEW button for
3 seconds to exit lab mode
Yes
Release both fingers as soon
as the slightest pain is felt
Press VIEW button to view and store
measurement readings whenever a session
includes only one type of reading
Wait until measurement results are stored
automatically whenever a session includes all
3 measurement readings
1
Page 7 of 11
Release both fingers when current feels as
intense as the actual experienced pain to
obtain reading for pain magnitude matching
3
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
PAINMATCHER®
3
2
Repeatedly press VIEW button to
scroll through the saved readings
Press and hold VIEW button for 3
seconds to delete displayed results
Use device in
setting mode
Yes
Press and hold On/Off button for 3 seconds
Press and hold On/Off button for 3
seconds to exit result mode
Repeatedly press VIEW button
until [Settings] is displayed
Press the On/Off button
Use VIEW button to scroll between modes to
decide whether to show or hide results
Press the On/Off button to
confirm selected mode
Use VIEW button to change date and time
Press On/Off button to confirm
Press On/Off button for 3 seconds
to exit setting mode
End
Page 8 of 11
No
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
PAINMATCHER®
5.4.2.
Maintenance
Start
Change batteries (two 1.5-V AAA)
when battery indicator light up
No
No
Electrodes used for
> 6 months
Device indicating
excessive resistance
Yes
Yes
Change electrodes
Check that device is switched off
Grasp left edge of each electrode and pull off
Attach new electrode marked “1” on the front
Attach new electrode marked “2” at the back
Fix rectangular part of new electrode
first and then press round part on
End
Page 9 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
Valid for:
2 years from
approval
6. Precautions
6.1.
Medical Device
6.1.1.
6.1.2.
6.1.3.
6.1.4.
6.1.5.
6.2.
Protect the device from temperature fluctuations, humidity, dust
and sunlight.
Leave the electrodes attached to the device between sessions.
Store the device in its original packaging in a suitable locked
cabinet.
Remove any batteries before storing the device to prevent any
leakages.
Do not use benzene, thinner or any other aggressive chemicals
on the device.
Accurate Measurement
6.2.1.
6.2.2.
6.2.3.
6.2.4.
6.2.5.
6.2.6.
Ensure that this device is used only on patients that have
complete sensory capabilities and full motor ability in their
fingers.
Do not use the device on patients who have a pacemaker, an
intracardiac defibrillator or any other form of active implant.
Do not use the device on patients who are connected to high
frequency surgical equipment.
Do not operate the device in the vicinity of short wave
equipment such as mobile phones since this can affect the
output power of the device.
Ensure that the patient is holding the electrodes tightly enough.
Ensure that the patient is holding the device in a pincer grasp if
the excessive resistance indicator is lit.
7. Reference
Cefar Medical AB. PainMatcher® user’s guide. Lund: Cefar Medical AB;
2002. P. 12-19.
8. Appendices
N/A
Page 10 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/204_02
STANDARD OPERATING PROCEDURE
PAINMATCHER®
Valid for:
2 years from
approval
9. Revision History
Version Number
01
02
Page 11 of 11
Amendments/ Reasons for change
Initial Release
Inclusion of subheading titles of
Procedure section in Table of Contents