UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
Page 1 of 11
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
Valid for:
2 years from
approval
1. Scope
This Standard Operating Procedure (SOP) applies to the staff and students
using the Force TEN® FDX in the Pharmacy Practice Resource Unit (PPRU)
at the Pharmacy Department, University of Malta.
2. Objective
To describe the procedure for the set-up, operation and calibration of the Force
TEN® FDX.
3. Definitions
3.1.
Auto-Calibration: To return the device to the specified accuracy when
establishing that the gauge is out of tolerance after carrying out a
calibration verification test.
3.2.
ON/OFF Key: To turn the device on or off.
3.3.
Calibration Verification: A verification test carried out using certified
weights used to determine whether a calibration procedure for the
device is necessary.
3.4.
ESCAPE Function: An additional function of the UNITS key used to
cancel and return to the previous menu option and to exit menu set-up.
3.5.
Force TEN® FDX: A digital gauge designed for routine hand-held
force testing. It continually captures both peak tension and peak
compression forces. May also be used as an algometer to test pain
threshold, pain tolerance, trigger and tender points as well as to
monitor treatment progress.
3.6.
Non-Peak Mode: The device will display the instantaneous force
being applied. Used to monitor the applied force as it is being varied.
3.7.
PEAK Key: To activate peak mode and recall peak readings.
3.8.
Peak Memory: The saved peak readings.
3.9.
Peak Mode: The device will display the highest peak tension or
compression force being applied since the last time peak memory was
Page 2 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
Valid for:
2 years from
approval
deleted. If additional tests are run after the first initial test, without
clearing peak memory, the peak value displayed will always be the
highest peak from the series of tests carried out.
3.10. SCROLL Function: An additional function of the PEAK key used to
review menu options and to review selections within each option.
3.11. SELECT Function: An additional function of the ZERO key used to
select the displayed item and to save the selection.
3.12. UNITS Key: To select the units of measurement i.e. lbf (pound-force),
kgf (kilogram-force), N (Newton) or ozf (ounce-force).
3.13. ZERO Key: Reverts the display back to zero in non-peak and peak
mode.
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.
Set-Up
5.1.1.
5.1.2.
Press the ON/OFF key to switch on the device.
Repeatedly press the UNITS key until the desired unit of
measurement has an arrow pointing towards it.
5.1.3. Press the ON/OFF key to switch off the device.
5.1.4. Press and hold the ZERO key.
5.1.5. Press and hold the ON/OFF key.
5.1.6. Release the ON/OFF key first and the ZERO key afterwards.
5.1.7. Wait until [AoFF] is displayed.
5.1.8. Repeatedly press the SCROLL key until the desired review
option is displayed (see SOP/PD/206_01/A1).
5.1.9. Press the SELECT key.
5.1.10. Repeatedly press the SCROLL key until the desired setting is
displayed.
Page 3 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
Valid for:
2 years from
approval
5.1.11. Press the SELECT key to choose and save the selection. [donE]
will be displayed and set-up menu will be available once again.
5.1.12. Press the ESCAPE key to exit the set-up menu at any time
during the set-up procedure.
5.2.
Operation
5.2.1.
Non-Peak 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.
Peak Mode
5.2.2.1.
5.2.2.2.
5.2.2.3.
5.2.2.4.
5.2.2.5.
5.3.
Press the ON/OFF key to switch on the device.
Repeatedly press the PEAK key until the arrow
pointing at [PEAK] disappears.
Press the ZERO key to clear any peak readings.
Apply the necessary push or pull force to either the
compression head or the steel hook respectively.
Read off the applied force from the display.
Press the PEAK key to display the compression and
tension peaks.
Press the ZERO key to clear peak memory.
Ensure that arrows are pointing at [C] and [PEAK] to
perform a compression test. If not, repeatedly press
the PEAK key until this is achieved.
Ensure that arrows are pointing at [T] and [PEAK] to
perform a tension test. If not, repeatedly press the
PEAK key until this is achieved.
Apply the necessary push or pull force to either the
compression head or the steel hook respectively.
Press the PEAK key repeatedly to display the
respective compression and tension peaks.
Calibration
5.3.1.
Calibration Verification
5.3.1.1.
5.3.1.2.
5.3.1.3.
Press the ON/OFF key to switch on the device.
Allow a warm-up time of 2-3 minutes.
Obtain standard weights that are equal to 20%, 40%,
60%, 80% and 100% of the capacity of the gauge.
Page 4 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
5.3.1.4.
5.3.1.5.
5.3.2.
Valid for:
2 years from
approval
Apply each weight consecutively in both tension and
compression.
If the displayed weight differs by > +/- 0.3% of the
full scale +/-1 least significant figure, the device is
out of tolerance and requires auto-calibration (see
section 5.3.2).
Auto-Calibration
5.3.2.1.
Repeatedly press the UNITS key until the arrow is
pointing towards lbf since all calibration procedures
are to be performed in pounds.
5.3.2.2. Keep the device in a still position.
5.3.2.3. Enter the Set-Up Menu (see 5.1.3 to 5.1.7).
5.3.2.4. Repeatedly press the SCROLL key until [L CAL] is
displayed.
5.3.2.5. Press the SELECT key twice to display the force cell
capacity.
5.3.2.6. If the displayed force cell capacity does not match
with that of the force cell module, repeatedly press
the SCROLL key until the correct force cell capacity
is displayed.
5.3.2.7. Apply the test weight that is equal to the displayed
full-scale capacity weight.
5.3.2.8. Press the SELECT key.
5.3.2.9. Wait until the device displays the applied weight to
indicate that the calibration process was successful.
5.3.2.10. If [uuuuu] “under” or [nnnnn] “over” is displayed,
the weight used was not equal to the full-scale
capacity of the force cell module and autocalibration must be repeated with an appropriate
standard weight.
Page 5 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
5.4.
Flow Charts
5.4.1.
Set-Up
Start
Press ON/OFF key to switch on device
Repeatedly press UNITS key until
desired unit of measurement
has arrow pointing towards it
Press ON/OFF key to switch off device
Press and hold ZERO key
Press and hold ON/OFF key
Release ON/OFF key first
and the ZERO key afterwards
Wait until [AoFF] is displayed
Repeatedly press SCROLL key until
desired review option is displayed
(see SOP/PD/206_01/A1)
Press SELECT key
Repeatedly press SCROLL key until
desired setting is displayed
Press SELECT key to choose
and save selection
Press ESCAPE key to exit set-up menu at
any time during set-up procedure
End
Page 6 of 11
Valid for:
2 years from
approval
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
FORCE TEN® FDX
5.4.2.
Operation
Start
Press ON/OFF key to switch on device
No
Need to use device
in non-peak mode
Use device in peak mode
Yes
Press ZERO key to clear peak memory
Repeatedly press PEAK key until arrow
pointing at [PEAK] disappears
No
Need to perform
compression test
Press ZERO key to clear
any peak readings
Perform tension test
Yes
No
Apply necessary push or
pull force to either compression head
or steel hook respectively
Repeatedly press PEAK key
until this is achieved
Are arrows pointing
at [C] and [PEAK]
Yes
Read off applied force from display
Apply necessary push force
to the compression head
Press PEAK key to display compression
and tension peaks
No
Are arrows pointing
at [T] and [PEAK]
Yes
Apply necessary pull force to steel hook
Read of applied force from display
Repeatedly press PEAK key to display
compression / tension peaks
End
Page 7 of 11
Repeatedly press
PEAK key until
this is achieved
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
FORCE TEN® FDX
5.4.3.
Calibration
Start
Press ON/OFF key to
switch on algometer
Allow warm up time of 2-3 minutes
Obtain standard weights that are
equal to 20%, 40%, 60% 80% and 100%
of the capacity of the gauge
Apply each weight consecutively in
both tension and compression
Displayed weight
differs by > +/- 0.3%
of full scale +/- 1
least significant
figure
Yes
Device is out of tolerance and
requires auto-calibration
Repeatedly press UNITS key until an
arrow is pointing at lbf (pounds)
Keep device in a still position
3
Enter Set-Up menu (see section 5.4.1)
Repeatedly press SCROLL key
until [L CAL] is displayed
2
Page 8 of 11
No
1
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
FORCE TEN® FDX
2
Press SELECT key twice to display
force cell capacity of gauge
Does the displayed
force cell capacity
match with that of
force cell module
No
Repeatedly press SCROLL key until
correct force cell capacity is displayed
Yes
Apply test weight that is equal to
the displayed full-scale capacity weight
Press SELECT key
No
No
[uuuuu] is displayed
[nnnnn] is displayed
Wait until device displays the applied
weight to indicate that calibration
process was successful
Yes
Yes
Used weight is lower than the full
capacity of the force cell module
1
Used weight is higher than the full
capacity of the force cell module
End
HEauto-calibration with a
Repeat
standard weight equal to the full
capacity of the force cell module
3
Page 9 of 11
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
FORCE TEN® FDX
Valid for:
2 years from
approval
6. Precautions
6.1.
6.2.
6.3.
6.4.
6.5.
6.6.
Attach the device to its AC adapter when an arrow is seen pointing at
[LO BAT].
Switch on the AC adapter to start charging the device, which with a 10
hour charge, will provide up to 50 hours of continuous usage.
Avoid excessive overloads or impact loading as this may cause
permanent damage to the device.
Do not continue to apply force if [StoP] is displayed as this will cause
damage to the force cell module.
Stop using the device when [HELP] is displayed since this indicates
that the force cell module is not securely connected or that it is
overloaded or damaged.
Only apply loads in an axial position and not from any other angle as
this may cause the load shaft to twist.
7. Reference
Wagner Instruments. FORCE TEN® FDX Operation Manual. Greenwich:
Wagner Instruments.
8. Appendices
SOP/PD/206_02/A1 – Review Options Table
9. Revision History
Version Number
01
02
Page 10 of 11
Amendments/ Reasons for change
Initial Release
Inclusion of subheading titles of
Procedure section in Table of Contents
UNIVERSITY OF MALTA
FACULTY OF MEDICINE & SURGERY
PHARMACY DEPARTMENT
Ref. No.
SOP/PD/206_02
STANDARD OPERATING PROCEDURE
Valid for:
2 years from
approval
FORCE TEN® FDX
SOP/PD/206_02/A1 – Review Options Table
Review Option
Automatic Off
Display
AoFF
Function
[30] - To switch off the device after 30 minutes
of inactivity to conserve battery power
[No] - To disable Automatic Off function
Peak Sampling
Rate and Filter
[100] - Peak sampling rate of 100/sec for
slowly occurring events and to significantly
reduce battery power consumption
PSS
[1000] - Peak sampling rate of 1000/sec for
rapidly occurring events and break tests
[null] – no auto-calibration
Auto-Calibration
L CAL
[xxx] – the different force cell capacities
available
Page 11 of 11