ForaCare POCT S10a User manual

ABOUT THIS PRODUCT
Thank you for choosing ForaCare POCT S10 Blood Glucose
Monitoring System. Please use with ForaCare POCT S10 Blood
Glucose Test Strips only.
This easy-to-use POCT system provides fast, accurate results,
including automatic upload of test results to hospital and laboratory
information systems which enables powerful data management.
This POCT system also reduces risks of operator errors and allows
one hand operation by hospital professionals through simple steps.
Integrated barcode scanning helps reduce the risk of manual data
entry errors as well. There is no subjective calibration procedure
required.
This manual contains important information about the system.
Please read it thoroughly and carefully, and keep it for future
reference. If you have further questions about this system, please
contact the Customer Service for assistance.
Version 1.0 10/2011 311-4258200-002

IMPORTANT SAFETY INSTRUCTIONS
READ THIS BEFORE USE
The following basic safety precautions should always be taken.
1. Only the healthcare providers who have trained for this system
should operate.
2. Use the device only for the intended use described in this
manual.
3. Make sure to properly setup the system and pass the training
test before performing any tests.
4. Keep the equipment and its flexible cord away from hot
surfaces.
5. Do not use the equipment where aerosol sprays are being
used, or where oxygen is being administered.
6. Do not use the device if it is not working properly or damaged.
7. Before using this product to test blood glucose, read all
instructions thoroughly and practice the test. Do all quality
control checks as directed.
8. Always wear gloves when performing tests and follow your
facility’s infection control policy and procedures.
9. Pleasedonotuseaccessorieswhicharenotspeciedbythe
manufacturer.
10. Users need to adhere to Standard Precautions when handling
or using this device. All parts of the glucose monitoring system
should be considered potentially infectious and are capable
of transmitting blood-borne pathogens between patients
and healthcare professionals. For more information, refer to
“Guideline for Isolation Precautions: Preventing Transmission
of Infectious Agents in Healthcare Settings 2007”, http://www.
cdc.gov/hicpac/2007ip/2007isolationprecautions.html .

11. The meter should be disinfected after use on each patient.
This Blood Glucose Monitoring System may only be used for
testing multiple patients when Standard Precautions and the
manufacturer’s disinfection procedures are followed. Please refer
to section Taking Care of the Meter & Strips for cleaning and
disinfection procedures.
12. Only auto-disabling, single use lancing devices may be used with
this device.
KEEP THESE INSTRUCTIONS

TABLE OF CONTENTS
IMPORTANT SAFETY INSTRUCTIONS 02
INTRODUCTION 06
Intended Use 06
Important Information 06
Contents of System 07
THE SYSTEM 08
Appearance of the Meter 08
Meter Function 09
Test Strip 10
BEFORE USE 11
Battery Setup & Recharge 11
Setup Mode 12
Barcode Scanning Procedure 13
Calibration 13
TRAINING 14
CONTROL TEST 16
Guidelines for Control Solution Testing 16
Control Test Procedure 17
PATIENT TEST 20
Collecting Blood Samples 21
Patient Test Procedure 22
Results Indicators 25
MEMORY MODE 26
Reviewing Test Results 26
Reviewing Test Results by All Records 28
Reviewing Test Results by Patient Record 29
Reviewing Test Results by Operator Record 30
Reviewing Test Results by Search by Value 31
Reviewing QC Data 32
Reviewing QC Data by All QC Records 33
Reviewing QC Data by Search by Level 34
Reviewing QC Data by Search by Strip 35
ReviewingProciencyData  36

5
TAKING CARE OF THE METER & STRIP 37
Disinfecting Procedures 38
Storage 40
ERROR MESSAGES 42
SPECIFICATIONS 43
Performance Characteristics 44

6
Intended Use
This system is intended for use in the quantitative determination
ofglucoselevelsinfreshcapillarywholebloodfromthengerand
venous whole blood samples. It is indicated for multiple patients
use by health care professionals in health care facilities as an aid
in monitoring the effectiveness of diabetes control program.
This system is only used with single-use lancing devices. It is not
intended for the diagnosis of or screening for diabetes mellitus. It
is not intended for use on neonates.
Important Information
Before you start, there are a few important things to remember.
Before performing patient tests, please read this Operator’s
Manual carefully.
The ForaCare POCT S10 Blood Glucose Monitoring System
mustbeproperlysetup(congured)beforeperformingpatientor
qualitycontroltests.Congurationscanbesetuponthemeteror
through POCT Management System according to each facility’s
requirements. Please refer to POCT Management System Opera-
tor’s Manual for more information.
You should always wear gloves and follow your facility’s infection
control procedures when handling blood-contaminated items.
If you need help when using the meter or during the testing, please
read this manual carefully. If you still have a question, please con-
tact 1-866-469-2632 or 1-888-307-8188 for assistance.
INTRODUCTION

7
Meter
Control solutions
Docking station
mini USB cable
Battery
Operator’s manual
POCT Management System Operator’s Manual
Contents of System
The ForaCare POCT S10 Blood Glucose Monitoring System
includes the following items:
1
2
3
4
5
6
7
1234
567
Note
1. Please make sure that all components listed above are
included in the kit before using this system. If you find any of
these missing or damaged, please return the whole kit to the
place of purchase.
2. Please note that control solutions for other levels are
supplied separately. Please contact local customer service
for availability.

8
Appearance of the Meter
1 2 3
4 5 6
7 8 9
10 11 12
13
USBport(forminiUSBcable)
LCM Panel
Up Button
Down Button
Barcode Scanner
Recharge Indicator
Battery Compartment
Scan Button
Return Button
Strip Ejection Button
Reset Key
On/Off Button
Number Key
1
23
4
5
6
7
8
9
10
11
12
13
THE SYSTEM

9
Meter Function
When the meter is turned on by pressing On/Off button, there
are four modes on the main menu: Measure Mode, QC Mode,
Memory Mode, Urgent Mode and Setup Mode. User can select
each mode simply by pressing Up button or Down button and
enter the desired mode by pressing S button.
Main Menu
Measure Mode
Test Results
Y1
All QC Record
All Record Setting Unit
Operator Record Training
QC Mode
QC Data
W2
Search by Level
Patient Record Setting Date
Search by Value Backlight Control
Memory Mode Urgent Mode
ProciencyData
B3
Search by Strip Lot
Setup Mode

10
The test strip consists of the following parts:
Absorbent Hole
Apply a drop of blood here and the blood will be
sucked up automatically. The minimum required
blood volume is 0.7 microliter.
Conrmation Window
Thisiswhereyouconrmifenoughbloodhas
been applied to the absorbent hole of the strip.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Contact Bars
Insert this end of the test strip into the meter.
Pushitinrmlyuntilitwillgonofurther.
Test Strip
Yoursystemmeasurestheamountofsugar(glucose)inwhole
blood. Blood is applied to the absorbent hole of the test strip and
is automatically drawn into the reaction cell where the reaction
takes place.

11
Battery Setup & Recharge
This meter uses one Li-ion rechargeable battery. Please follow
the instructions below to setup the meter.
1)Pressandpushthebatterycoveronthebackofthemeter
outward, and then remove the cover.
2)Readtheinstructionsonthebatteryrst.Thenputinthebattery
and push it to the right side of the compartment and insert the
battery appropriately.
3)Totakeoutthebattery,pleasepresstheclickerontheleftside
of the compartment. The battery will be automatically ejected
and can be easily removed.
When the battery is low, a battery symbol will display on the
screen, which means it is about time to recharge the battery.
For example,
To recharge the battery, please connect the USB cable to the
USB port of the meter and to the computer. The recharge indica-
tor will light up in red when the battery is recharging. When the
battery is fully recharged, the indicator will turn green.
If using AC/DC power adapter to recharge the meter, please con-
nect the USB cable to an electrical outlet and the meter. After the
battery is fully recharged, the recharge indicator will be green.
BEFORE USE
2008/06/20
Setup Mode
QC Mode
Measure Mode
12:59 AM
1/4
1/5
Note
One fully charged battery is expected to last for approximately
2000 measurements.

12
Setup Mode
Please follow the step-by-step instructions below to setup your
ForaCare POCT S10 Meter.
1.) Setting the year, month, and date
Press On/Off button to turn on the
meter. After press Up/Down button to
select” Setup Mode”, press S button.
The screen will display “Setting Date”,
press S button to the next step.
Press Up/Down button to select the
desired date expression. Press S but-
ton to the next step.
Press Up/Down button to select the
desired year, month or day. Press S
button to the next step.
2.) Setting the hour
Press Up/Down button to select 12H
or24H(hourmode).PressSbuttonto
the next step.
2008/06/20
Training
Setting Unit
Setting Date
12:59 AM
1/4
Date Setting YY/MM/DD
2008 / 06 / 23
Time Expression
12H / 24H
1/5
DD / YY

13
Barcode Scanning Procedure
Press and hold the S button with the bottom of the meter fac-
ing the barcode until hearing a short beep. The operator’s ID,
patient’s ID, and the strip lot number will automatically saved in
the meter.
Calibration
Whenusingthesystemforthersttime,orbeforeusinganew
vial of test strips, you will need to calibrate the meter. After scan-
ning the valid operator ID and patient ID, make sure to scan the
barcodeontheteststripvial(theTestStripID).Simplypress
S button and scan the barcode, the meter will automatically
calibrate with the test strip. It is necessary to take this action
before you proceed to the testing. Failure to do so may lead
to inaccurate test results.
Press Up/Down button to select the
desired “hour” and “minute”. Press S
button to the next step.
3.) Setting the unit of blood glucose
The screen returns to “Setup Mode”
menu. Press Up/Down button to
select “Measurement Unit” and then
press Up/Down button to select
“mmol/L” or “mg/dL”. Press S button to
the next step.
4.) Setting the backlight
The screen returns to “Setup Mode”
menu, press Up/Down button to se-
lect “Backlight Ctrl”. Press Up/Down
button to adjust the backlight. Press S
button to complete this setup.
Setting time
05 : 32 AM
Measurement unit
mmol/L
mg/dL
2008/06/20
Setting Unit
Training
BackLight Ctrl
12:59 AM
3/4
3/5
mmol/L
Measurement unit
mg/dL

14
2008/06/20
BackLight Ctrl
Setting Date
Training
12:59 AM
4/4
Training Test Procedure
Please follow the steps below to access Training Mode.
Each operator has to pass a training test through Training Mode
beforeperformingmeasurementsforpatients(MeasureMode).
This ForaCare POCT S10 system will evaluate the examinee’s
training by simple testing and only successful trainees will be-
comeprocientoperatortoaccessMeasureMode.
Training
1.)PresstheOn/Offbuttontoturnon
the meter, and select setup mode.
2.)
Press Up/Down button to select
Training Mode, then press S button.
3.)Scanormanuallyentertheexam-
inee’s ID via the keypad.
4.)PerformControlTest.
Please refer to the Control Test Procedure section to perform
control tests.
5.)PerformPatientTest.
Please refer to the Patient Test Procedure section to perform
patient tests.
2008/06/20
Memory Mode
Measure Mode
Setup Mode
12:59 AM
4/4
Enter examinee ID
examinee ID:
:Back :Enter
5/5

15
6.)Thetrainingdatacanbeuploadedto
the POCT Management System by
connecting to PC via a USB cable.
For detailed information about the POCT Management System,
please refer to ForaCare POCT Management System Operator’s
Manual.
Note
If the examinee passes the evaluation, he/she will become a
“ProcientOperator”andonly“ProcientOperator”canac-
cess the Measure Mode.
PC Mode

16
This section explains how to take a control solution test in order
to verify the performance of ForaCare POCT S10 Blood Glucose
Monitoring System.
Thequalitycontrolprocedureofthemetercanbecustomizedtot
the requirements of each facility. For example:
Tests of Y1, W2, and B3 control solutions or other variation of
quality control testing depend on the facility’s policy.
Controlsolutiontestsareperformedregularly,orinspecictime
intervals, or with the number of patient test results.
Control test results can appear as numeric or Pass/Fail.
Guidelines for Control Solution Testing
Please follow the guidelines below to obtain optimal quality control
results when using ForaCare POCT S10 Blood Glucose Monitoring
System.
Only use the control solutions for ForaCare POCT S10 test strips.
When using a new bottle of control solution, write the opening
date on the bottle label. Each bottle of control solution is stable
forusewithin3monthsafterrstopened(replacecaptightlyaf-
teruseeachtime).Discardallremainingsolutionsafteropened
more than 3 months.
Shake the control solution bottle up side down for several times
before use.
Use the control solution by the expiration date printed on the
bottle and the box. ForaCare POCT S10 Blood Glucose Meter
does not accept expired control solutions.
Performqualitycontroltestingrstwhenusewitheachnewlot
and each new vial of strips, and once per day. A minimum of 2
levels control solution testing are required.
Control Test

17
Control Test Procedure
Use the following procedure to perform control tests.
1.)PressOn/Offbuttontoturnonmeter.
2.)PressUp/DownbuttontoselectQC
Mode.
3.)PressSbuttontoscantheOperator
ID barcode, or manually enter the
Operator ID via the keypad.
4.)PressSbuttontoscantheTestStrip
ID barcode, or manually enter the
Test Strip ID via the keypad.
5.)PressSbuttontoscanY1control
solution lot number or manually enter
the control solution lot number via
the keypad.
6.)Withthecontactbarsfacingup,
insert the test strip into the test strip
slot.
Note
Note
The “Apply Sample” screen will appear.
Users should follow local, state and federal regulations for
quality control testing since the test system is considered
CLIA moderately complex.
2008/06/20
Measure Mode
Memory Mode
QC Mode
12:59 AM
2/4
Operator:
Control solution:
Test strip Lot :
Operator ID
Op. :A100000029
Control solution:
Test strip Lot :
Level 1 C.S.
Insert strip
Op. :A100000029
C.S.:08A23110001
Test strip Lot :
Test strip ID
Test strip Lot:
Test strip Lot:
Lot:
Y1 C.S.
Control Solution:
Control Solution:
Control Solution:
2/5
Test strip ID

18
7.)Applyadropofcontrolsolutionto
the absorbent hole of the test strip
untiltheconrmationwindowis
fully covered with blood.
8.)Waitforthemetertonishanalyz-
ing the sample and display the test
result.
9.)Makesurethetestresultfalls
within the acceptable range.
Note
The meter will produce a beep sound and then begin to count
down. The results will display on the screen and automatically
saved in the meter.
Note
Control test results can appear as numeric or PASS/FAIL,
which depends on how the meter is set.
Apply sample to strip
Y1
Y1
Pass
Y1

19
11.)Ifthetestresultfails,theoperator
may select one of the following :
0. Cancel
1. Repeat test
2. Finish test
If the test result passes, the operator
may select one of the following:
0. Repeat test
1. W2 test
2. Comment code
3. Cancel
If you select “Repeat Test”, the Scan or Enter Strip Lot screen
will appear. Return to step 5 to repeat the test.
If you select “QC” for W2 control solution test, you may perform
the test by returning to step 4.
10.)PushuptheStripEjectionbutton
and the strip will be ejected, and the
meter will shut down automatically.
Note
Comment code of 01 - 09 can be set for healthcare profes-
sionals use and can help to manage the patient records ef-
fectively.Itcanbeconguredaccordingtotheneedsofeach
facility.
Y1
Y1
W2
Pass

20
Patient Test
This section explains how to perform a measurement on patients
by ForaCare POCT S10 Blood Glucose Monitoring System.
The followings are precautions we strongly recommended to
ensure operators have the most reliable and accurate test results.
Always wear gloves and follow your facility’s biohazard control
policy and procedures when performing tests involving patient
blood samples.
Use a new pair of gloves when performing a patient test.
Change gloves between patients.
Wear protective glasses and/or other protective clothing if
necessary.
Use control solutions approved for ForaCare POCT S10 Blood
Glucose test strips use only to ensure the performance of Fora-
Care POCT S10 Blood Glucose test strips and meter.
Test strips should be used before their expiration date.
Do not use wet, bent, scratched, or damaged test strips.
After the blood is applied to the test strip and the count down
begins, do not remove the test strip.
Use a new test strip for a new test.
Read instructions before using test strips. Please refer to the
strip manual included in the kit.
Only an auto-disabling, single use lancing device should be used.
Please refer to the following practice guidelines for more informa-
tion about the correct procedure:
BiosafetyinMicrobiologicalandBiomedicalLaboratories(BMBL)
found at http://www.cdc.gov/biosafety/publications/bmbl5/
“Protection of Laboratory Workers From Occupationally Acquired
Infections; Approved Guideline-Third Edition” Clinical and Labora-
toryStandardsInstitute(CLSI)M29-A3.