New Element Medical Equipment Technology Development PFES-1TNB REMOTE & MOBILE BLOOD GLUCOSE MONITORING AND DIABETES PATIENT FOLLOW-UP SYSTEM User Manual

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Date Submitted	2011-04-18 00:00:00
Date Available	2011-04-18 00:00:00
Creation Date	2011-04-12 08:54:22
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Document Title	Users Manual
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Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
Table of Contents
Components ............................................................................................................. 1
Overview .................................................................................................................. 3
2.1 BG Monitoring Devices ................................................................................................ 3
2.1.1 BG Meter............................................................................................................. 3
2.1.2 Sterile Lancet ..................................................................................................... 12
2.1.3 Lancing Device ................................................................................................... 13
2.1.4 Test Strip ........................................................................................................... 15
2.2 Health Mobile Phone ................................................................................................. 19
Measuring BG Value ............................................................................................... 22
3.1 Preparing for Obtaining a Blood Sample .................................................................... 22
3.2 Preparing the BG Meter ............................................................................................. 23
3.3 Starting Testing .......................................................................................................... 24
Operations on the Phone...................................................................................... 27
4.1 Typing BG Value ......................................................................................................... 29
4.2 Viewing BG Trend ...................................................................................................... 31
4.3 Viewing Follow-Up Scheme ....................................................................................... 32
4.4 Viewing Health Advice ............................................................................................... 33
4.5 Complaint ................................................................................................................... 35
II
Precautions ............................................................................................................ 36
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
1 Components
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
collects daily blood glucose (BG) value by BG meter, and transmits the data to the health
mobile phone via Bluetooth. Then, the mobile phone sends the data to the server through
GPRS. A doctor remotely views the BG variation of a patient, and carries out timely
treatment after analysis and diagnosis. The doctor can also interact with the patient through
the server. The patient can view doctor advice on the mobile phone as well.
The system consists of BG meter and software (software on health mobile phone and
server).
2
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
2 Overview
2.1 BG Monitoring Devices
The BG monitoring devices can measure BG value anywhere and anytime, and transmit the
data to health mobile phone via Bluetooth. The system consists of BG meter, lancing
device, test strips and sterile lancet.
2.1.1 BG Meter
The BG meter owns functions of data transmission and BG test. The following figure
shows the structure of the BG meter, and Table 1 describes functions of each button.
1. Test slot
2.
Front
Left side
Bluetooth
indicator
5.
Test
ejector
3. Display
4. Mode button
strip
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
Back
Right side
6. SET button
7.
Battery
compartment
8.
Bluetooth
button
Table 1
No.
Name
Test slot
Function
Inserting the test strip
Bluetooth
Indicating data transmission and working status
indicator
Display
Displaying the results, and symbols guiding your test
Mode button
Turning on/off the meter; browsing and setting modes.
Test strip
Ejecting the used strip by pushing up this button.
ejector
SET button
Entering and confirming the meter settings.
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
Battery
Holding the batteries. AAA alkaline batteries only.
compartment
Bluetooth
button
Pushing up the button when the meter is off to enable the
Bluetooth connection.
Data collected by the BG meter are transmitted to the mobile phone when the meter is
powered off. The Bluetooth indicator indicates the data transmission status. See Table 2.
Table 2
No.
Indicator Status
Description
Off
Bluetooth is disabled.
Flashing blue
Bluetooth is enabled and
under connecting.
Normally on in
Bluetooth connection is set up
blue
successfully.
2.1.11. Replacing Batteries
If the battery symbol appears on the display, it means low battery. Please replace with two
new AAA alkaline batteries. If the symbol begins to flash, it means the remaining power is
not enough for a test. Replace batteries at No.7 Battery compartment in Figure 3.1.
1.Power off the BG meter. Press and then lift up the fibula to remove the cover.
2.Remove the used batteries, or pat the meter with your palm softly. Do not knock the
meter with hard objects.
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
3.Load two new AAA alkaline batteries. Make sure the anodes and cathodes of the
batteries respectively point at the "+" and "-" symbols in the compartment.
4.Insert the two hinges of the compartment cover into the slots and press softly until
they fit the fibula.
Caution: Use AAA alkaline batteries only. Do not use rechargeable batteries.
2.1.12. Settings
After loading batteries correctly, press the Mode button to start the meter. See the
following figure and Table 3 for system interface and description of each button.
Set the meter as follows:
1.Press the SET button. Item to be set is flashing.
2.Press the Mode button to set values for the flashing items. Press once to enter fine
adjustment (the flashing value increases by +1 after each pressing of Mode button). Press
and hold the Mode button to enter quick change.
3.After finishing the preceding setting, press the Mode button again to proceed. Item
to be set is flashing.
10
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
Table 3
Code
Measurement unit
Blood drop symbol
10
Memory symbol
Test strip symbol
11
Measurement mode
Low battery symbol
12
Control solution mode
Test result
13
Reminder alarm
Error warning
14
Day average
Ketone warning
15
Time
Face/Low/High symbol
16
Date
11
2.1.2 Sterile Lancet
It is used to prick your finger to obtain blood samples. The sterile lancet consists of
protective cap, lancet and base. Pull off the cap before use. The appearance is shown in the
following figure.
Protective cap
Lancet
Base
Caution: Never share a sterile lancet. The sterile lancet is for single use only. Always
12
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
use a new sterile lancet each time when doing a test.
2.1.3 Lancing Device
The lancing device is used together with the lancet to obtain blood samples. The following
figure shows the appearance of the lancing device, and Table 4 describes the functions.
13
Table 4
No.
Name
Adjustable cap
Depth indicator
Function
Turning the cap to adjust the penetration depth.
The longer the depth indicator is, the deeper the
penetration is, and vice versa.
14
Arrow
Lancet holder
Securing the lancet by inserting it into the lancet holder.
Release button
Pressing the button to prick your finger.
Cocking control
Pull the cocking control to get ready for prick.
Identifying the depth of penetration.
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
2.1.4 Test Strip
1. Absorbent
hole
The BG meter can measure the BG
value of whole blood by obtaining
blood samples with the test strip.
The absorbent hole is close to the
blood sample, and will absorb the
2. Confirmation
window
3.
Test
handle
strip
sample into the test strip when the
blood sample is applied.
The figure on the right shows the
4. Contact
bars
15
front of the test strip, and the following table describes the functions.
Table 5
No.
Name
Absorbent hole
Function
Close to the sample, and absorbing the sample into test
strip.
Confirmation window
Checking whether the sample is sufficient through the
confirmation window.
16
Test strip handle
Contact bars
Handling the test strip
Inserting the end into the test slot on the BG meter.
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
Store the test strips in their original vial, which contains desiccant inside, and keeps the test
strips from moisture. Code number and optional color chart are printed on the test strip vial.
Table 6 describes the functions.
Table 6
No.
Name
Function
Code
Used for calibrating the BG meter.
number
17
After reading the test result, you can directly compare the
color on the test strip with the color chart on the test strip
Optional
color chart
vial.
The chart presents blue colors in two depths, respectively
standing for glycopenia (2.8 mmol/L) and hyperglycemia
(19.4 mmol/L). White shadow stands for unused test strips.
18
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
2.2 Health Mobile Phone
The figure on the right shows the
appearance of the health mobile phone;
Table 7 describes the function and usage
of the health mobile phone keys.
19
Table 7
No.
Name
Function
Power
Powering on/off the mobile phone; Pressing the button to awake
button
the phone when it is standby.
Talk key
Dialing numbers
Navigation
Navigation and confirmation.
key
e+Health
Pressing the key to start the system and display the interface when
key
20
End key
the interface is hidden.
Press the key to end a call or hide the interface.
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
No.
Name
Function
e+Health
shortcut
See e+Health key
icon
21
3 Measuring BG Value
Before measuring, prepare a clean, dry table and all necessary items (including BG meter,
lancing device, sterile lancet, test strips, alcohol and cotton swabs).
3.1 Preparing for Obtaining a Blood Sample
1.Pull off the cap of the lancing device. Insert the lancet into the lancet holder of the
lancing device. Push down the lancet until it is secured in the lancet holder.
2.Twist the protective disk off the lancet, and then replace the cap of the lancing
device.
Note: You can adjust the depth of penetration as needed.
3.Pull the cocking control back until it clicks.
22
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
4.Wash your hands with soap and warm water. Clean your hands and sterilize the
puncture site with cotton swab and alcohol.
Note: Rub your hand from the wrist to fingertip two or three times to stimulate blood
perfusion.
3.2 Preparing the BG Meter
1.Insert the test strip facing up into the test slot. The BG meter automatically starts.
Note: Make sure no test strip is inserted in the BG meter before operation.
2.The BG meter automatically displays code number. You can start measuring when
the displayed code number is the same as that on the test strip vial.
23
3.3 Starting Testing
1.Press the lacing device's tip firmly against the lower side of your fingertip. Choose a
different spot each time you test to prevent soreness and calluses.
2.Press the release button of the lancing device. If needed, you can rub your finger
softly from the pad of finger to fingertip to stimulate blood perfusion.
3.Make sure a new test strip is inserted into the BG meter. Use the absorbent hole of
test strip to touch the blood sample. Blood will be drawn in. You can check whether the
sample is sufficient through the confirmation window. If the blood is deficient, the blood
drop symbol flashes.
4.When the BG meter is reading the result, the clock symbol flashes on the display.
24
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
The result is displayed in approximately 5 seconds.
5.The test result is stored in the memory.
6.Push up the test strip ejector. The test strip is ejected, and the BG meter
automatically switches itself off. If no push-up operation is performed, the BG meter
switches off automatically three minutes after displaying the test result.
7.Enable the software on the health mobile phone.
8.Pushing up the Bluetooth button when the meter is turned off to enable the
Bluetooth connection. The connection of mobile phone and BG meter succeeds when the
Bluetooth indicator keeps on. You can upload data then.
Note: Discard the used test strip into a disposal container.
25
9.Pull off the cap of the lancing device. Take off the lancet from the lancet holder.
10.Discard the lancet into a disposal container for sharp items.
Note: Follow the instructions of dismantling and discarding the used lancet strictly to
prevent accidental puncture.
26
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
4 Operations on the Phone
Press the e+Health key or click the shortcut icon on
the phone screen. The interface of healthcare
monitoring platform is displayed. See the figure on
the right:
27
Click Diabetes Follow-Up on the interface. The
main interface of diabetes patient follow-up is
displayed. See the figure on the right.
Diabetes
follow-up
includes
BG
monitoring,
follow-up scheme, health advice, complaint, device
management, settings and update.
28
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
4.1 Typing BG Value
Select
on the main interface of BG
monitoring. The BG monitoring interface is
displayed. See the figure on the right:
You can enter BG monitoring data, view BG
trend and analysis report here. Two methods are
available for BG value input: BG meter
transmission and manual input. You can
29
change the input method by selecting different options.
1.BG Meter Transmission
The BG meter transmits data to the health mobile phone after automatically
connecting to the latter. If the health mobile phone enables GPRS, it automatically sends
data to the server.
2.Manual Input
The patient enters data on the mobile phone after measuring the BG value with BG
meter.
Historical data: viewing stored BG data.
Upload: uploading stored but not uploaded data to the server.
30
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
Storage: storing the BG value after the user inputs the data.
4.2 Viewing BG Trend
Select
on the main interface of BG
monitoring. The BG monitoring interface is displayed.
See the figure on the right:
Click BG Trend. Then select the start time and end
time. The BG trend chart during the required period is
displayed.
31
4.3 Viewing Follow-Up Scheme
Select
on the main interface of BG
monitoring. The follow-up scheme interface is
displayed. See the figure on the right:
The patient can download, enter, view and upload
follow-up scheme here. The patient checks each
parameter
according
to
the
follow-up
scheme
downloaded from the server, and then records the
values to the follow-up information. After saving the
32
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
information, the patient can upload it to the server.
4.4 Viewing Health Advice
Select
on the main interface of BG
monitoring. The interface of health advice is displayed.
See the figure on the right:
The doctor can send health advice through the server;
the patient can view health advice on the mobile phone.
33
Click
to download the latest advice. Reminders are
displayed periodically if you do not download the advice. Click
delete the health advice.
34
to update or
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
4.5 Complaint
Click
on the main interface of diabetes
patient follow-up. The interface of complaint is
displayed. See the figure on the right:
The patient can send the feedback to the server when
not feeling well by clicking Complaint. The doctor
can also view the complaint through the server.
35
Click Upload after filling in relevant information to save it to the phone, and then upload it
to the server.
5 Precautions

The power indicator flashing red slowly indicates low battery. Please replace the
AAA alkaline batteries with two new ones. Do not use rechargeable batteries.

Make sure the distance between the BG meter and mobile phone is between 5 cm and
10 m when uploading BG data.

When entering data, press the power button on the top of the health mobile phone to
enable it if it is in power-saving state.

36
If the follow-up interface is hidden or covered by other software interfaces, press
Remote & Mobile Blood Glucose Monitoring and Diabetes Patient Follow-Up System
on the lower right to return to the follow-up interface.
Additional Information:

Figures and descriptions in the operation guide are only for demonstration. Please
adhere to actual products in case of any discrepancy.

Please contact relevant hospital personnel for any questions during operation.
FCC NOTE:
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions:(1)this device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
The manufacturer is not responsible for any radio or TV interference caused by unauthorized
modifications to this equipment. Such modifications could void the user's authority to operate
the equipment.
37

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