Sooil Dana Diabecare R User manual

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DANA Diabecare R
User Manual

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Table of Contents
1. Introduction...........................................................................5
1.1 DANA Diabecare R Insulin Pump Introduction .............................................................................5
1.2 Explanation of Warning Symbols .........................................................................................................6
1.3 Indications for Use......................................................................................................................................6
1.4 Precautions for Insulin Pump.................................................................................................................7
2. Getting Started.......................................................................8
Components of DANA Diabecare R System..............................................................................8
2.1 Getting to know the Insulin Pump .....................................................................................................9
DANA Diabecare R Insulin Pump ...................................................................................................9
2.2 Installing a battery................................................................................................................................... 10
Check the DANA Battery: ................................................................................................................ 11
2.3 Display Screen............................................................................................................................................ 12
Initial Screen .......................................................................................................................................... 12
2.4 Patient Education...................................................................................................................................... 13
About Doctor Mode .......................................................................................................................... 13
3. Programming the Insulin Pump ...........................................15
Structure of DANA DIABECARE R INSULIN PUMP MENU ............................................... 15
3.1 Setting the time and date.................................................................................................................... 16
3.2 Setting the Basal Rate............................................................................................................................ 17
Description of Basal Graph:............................................................................................................ 18
How to edit the Basal Rate: ........................................................................................................... 19
3.3 Changing Basal Profile ........................................................................................................................... 21
3.4 Setting Bolus .............................................................................................................................................. 22
Preset Bolus ........................................................................................................................................... 23
3.5 Setting User Options .............................................................................................................................. 24
3.6 CIR/CF Setting............................................................................................................................................ 27

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4. Loading Insulin into the Pump .............................................30
4.1 Preparation .................................................................................................................................................. 30
4.2 Filling the Reservoir with Insulin....................................................................................................... 31
4.3 Adjust the length of link-screw with Easy Setter....................................................................... 33
Using DANA Easy Setter :................................................................................................................ 34
4.4 Inserting the Reservoir into the Insulin Pump ........................................................................... 35
4.5 Connecting the Infusion Set to the Insulin Pump .................................................................... 37
4.6 Refill ................................................................................................................................................................ 38
Prime the Infusion Set Tubing....................................................................................................... 39
4.7 Inserting Infusion Set ............................................................................................................................. 40
Recommending insertion site location ..................................................................................... 41
5. Delivering a Bolus ................................................................42
Three type of Bolus Delivery ......................................................................................................... 42
5.1 Bolus (Step Bolus) .................................................................................................................................... 43
How to start the (Quick) bolus delivery:.................................................................................. 43
Stop delivery during bolus: ............................................................................................................ 44
5.2 Bolus Calculator (Smart Bolus)........................................................................................................... 45
6. Advanced features within Pump...........................................47
6.1 Temporary Basal Rates........................................................................................................................... 47
Starting a Temporary Basal Rate.................................................................................................. 47
Review & Stopping Temporary Basal......................................................................................... 48
6.2 Suspend ........................................................................................................................................................ 49
6.3 Button Lock ................................................................................................................................................. 50
6.4 HISTORY : Displays all the Pump History ..................................................................................... 51
Review Menu......................................................................................................................................... 51
6.5 More Information ..................................................................................................................................... 54
6.6 Extended Bolus.......................................................................................................................................... 55
Start Extended Bolus.......................................................................................................................... 55
Review & Stopping an Extended Bolus .................................................................................... 56
6.7 Dual Pattern Bolus ................................................................................................................................... 57

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Starting a Dual Pattern Bolus ........................................................................................................ 57
Review & Stopping a Dual Pattern Bolus ................................................................................ 58
6.8 Discovery...................................................................................................................................................... 59
7. Alarms and Error Messages ..................................................60
WARNING Message ........................................................................................................................... 61
ERROR Message................................................................................................................................... 63
ALARM Message.................................................................................................................................. 64
8. Troubleshooting ...................................................................67
8.1 Hypoglycemia (low blood sugar)...................................................................................................... 67
What is hypoglycemia (low blood sugar)?.............................................................................. 67
Reasons for Hypoglycemia ............................................................................................................. 67
What to do in case of hypoglycemia ........................................................................................ 67
Hypoglycemia Troubleshooting.................................................................................................... 68
8.2 Hyperglycemia (high blood sugar)................................................................................................... 69
What is hyperglycemia (high blood sugar)? .......................................................................... 69
Reasons for Hyperglycemia ............................................................................................................ 69
What to do in case of High Blood Sugar................................................................................ 69
Troubleshooting for Hyperglycemia ........................................................................................... 70
8.3 Occlusion Alarm........................................................................................................................................ 71
Real Occlusion (Usually within the Cannula or tube)......................................................... 71
Occlusion caused by external factor .......................................................................................... 72
8.4 Troubleshooting ........................................................................................................................................ 73
8.5 Battery for DANA Insulin Pump ........................................................................................................ 74
9. Maintenance of the devices ..................................................75
9.1 Caring for the Insulin Pump................................................................................................................ 75
Transport and Storage Condition ................................................................................................ 76
Cleansing the pump & accessories ............................................................................................ 76

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10. Specification ........................................................................77
10.1 Insulin Pump............................................................................................................................................... 77
10.2 Infusion Sets ............................................................................................................................................... 78
10.3 Prime Volume of Infusion Sets........................................................................................................... 79
10.4 Delivery accuracy...................................................................................................................................... 80
10.5 Classification and Compliance with Standards........................................................................... 80
10.6 Declaration of EMC compatibility..................................................................................................... 81
10.7 Explanation of Universal Symbols..................................................................................................... 85
11. Index ...................................................................................87
12. Warranty ..............................................................................89

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1. Introduction
1.1 DANA Diabecare R Insulin Pump Introduction
The DANA Diabecare R Insulin Pump herein after will be referred to as ‘Insulin
Pump’ throughout the manual.
Warning The DANA Diabecare R system is only to be used by patients who
have received training from a certified diabetes educator and/or insulin pump
trainer and by advice from a physician.
For safety and optimum benefits read the entire user manual before using the
system.
Caution Read these instructions for use carefully and completely before using
this device for the first time. Especially, users who have used other pumps should
be cautious.

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1.2 Explanation of Warning Symbols
Warning Indicates the presence of a hazard which can cause severe personal
injury, death or substantial property damage if the warning is ignored.
Caution Indicates the presence of a hazard which will or can cause minor
personal injury or property damage if the warning is ignored.
Notice Advises the user of installation, operation or maintenance information
which is important but not hazard related.
1.3 Indications for Use
The DANA Diabecare R Insulin Pump is intended for the subcutaneous delivery
of insulin for the treatment of diabetes mellitus. The device is not intended for
use with blood or blood products.

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1.4 Precautions for Insulin Pump
1. Pump users need more than 4 blood glucose measurements per day, and
vision and hearing to get the pump alarm.
2. Patients must not open the Pump housing or handle any internal
components.
3. The DANA Diabecare R Insulin Pump is intended for use with a proprietary
Infusion Set, reservoir and other accessories specified in this booklet. DO
NOT use the Pump with any other infusion system or accessories.
4. Press buttons with the pad of the finger. DO NOT use fingernails or any
sharp objects.
5. The Insulin Pump comes with factory default settings and alarms, maximum
daily totals, basal and bolus doses. These settings can be adjusted by a
healthcare professional.
Glucose Check Alarm
120 min
Maximum Daily Total
80 u
Maximum Bolus
40 u
Maximum Basal
3.3 u/h
6. The reservoir and Infusion Set are supplied with sterile and intended for
single use only. DO NOT reuse.
7. Change the reservoir and the Infusion Set regularly, as recommended by
your healthcare professional. DO NOT use for longer than 72 hours.
8. Check the expiration dates and dispose of any expired accessories.
9. Avoid impact damage such as dropping. If there is any known damage of
pump and accessory, contact your healthcare professional or technical
support from the local Insulin Pump distributor.
10. For any trouble with any of the system components, turn off the Insulin
Pump by removing the battery and contact your healthcare professional or
your Insulin Pump trainer.
11. Remove the battery for long-term storage.

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2. Getting Started
To make proper use of Dana Diabecare R Insulin pump, the accessories and
other devices are necessarily needed. And Components of DANA Diabecare R KIT
makes you feel a lot more comfortable when using Dana Insulin Pump.
Components of DANA Diabecare R System
Notice
For Battery, Infusion set and Reservoir, carefully check the expiration date
before use.
Additional accessories may be purchased separately.

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2.1 Getting to know the Insulin Pump
DANA Diabecare R Insulin Pump
① Reservoir Compartment: Turn the
reservoir cap clockwise to open. The
reservoir with linking screw are inserted
in this compartment.
② Battery Compartment: Turn the battery
cap counterclockwise to open. The battery
is inserted in this compartment.
③ Reservoir Window: You can check
visually the remaining insulin amount
through this window.
④ Control Panel: It has the four buttons to
control this device. For example, increase
or decrease of bolus or basal insulin
delivery rates. Select and execute of
various functions.
⑤ LCD screen: It is a display screen for all
the functions and messages for the users.
Control Panel
Press to increase values and to move previous
icon
Press to decrease values / return to previous
screen
Press to move to the next menu option
Press to select or confirm

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2.2 Installing a battery
For Insulin Pump
①Open the battery cap by inserting the Battery
key into the battery cap slot and turning
counter clock-wise.
②Insert the battery with the positive end down
into the Insulin Pump.
③Replace the battery cap and press down
whilst turning it clock-wise.
④Completed when the cap is tight and flush
with the top of the insulin pump.
Warning Change the battery in a clean dry environment to prevent water/
ingress from entering the pump case. The battery cap is correctly installed and
tightened when the battery cover is level with the Insulin Pump case. This
prevents water/ingress.
Notice
Be careful about the opening direction of battery cap
If the O-ring with battery cap is frayed, torn, or worn out, contact your
healthcare professional or your insulin pump trainer to replace it. If it is
damaged, its waterproof ability to prevent from inflow could be impaired.

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Check the DANA Battery:
Caution
Use of battery other than the 1/2AA size 3.6V battery manufactured
exclusively for the DANA Insulin pump will void the Insulin pump warranty.
DO NOT attempt to change the battery while a bolus is in progress.
Dispose of used batteries in an environmentally friendly way at a collection
depot or through the insulin pump dealer.
It is recommended to keep 2 spare batteries as backup.
For accurate reading of the remaining battery charge, check the battery
display following the delivery of a bolus
Notice More information of battery, refer to chapter 8.5 Battery for DANA Insulin
Pump.

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2.3 Display Screen
Initial Screen
Battery status
Displays remaining battery charge as,
Notice If 0% the battery icon will flash as a
warning of low battery
Bluetooth Status
The smart phone application connection status
Button lock
Appears on the screen when it is locked.
Insulin remaining volume
Displays volume of insulin in the reservoir.
Date & Time
Displays current time, date and year
Current Basal rate
Basal rate and temporary basal percentage
Extended Bolus Status
This icon will be displayed only when extended
bolus is active.
Allowable Daily Max
This icon is displayed when the total daily dose
is high and nearing the allocated daily
maximum set. Remaining units displayed from
less than 20u (default) displayed.

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2.4 Patient Education
Follow up education is recommended for all insulin pump user.
1. When starting on insulin pump therapy, the patient should have daily
contact with the pump trainer and/or medical professional.
2. Visit with the Endocrinologist, Diabetologist or Advanced Practice Nurse
within 3-7 days.
3. At first schedule weekly/biweekly consults then periodically as needed and
advised.
4. Visit specialist monthly until pump regimen is established and then at least
once every three months or intervals advised by your medical professional.
About Doctor Mode
DOCTOR MODE is a configuration menu accessed only by healthcare
professionals and certified insulin pump trainers. These settings are generally
related to safety and to insulin dosages about individual patients.
Preset Bolus
Glucose Check Alarm
Bolus Block
Bolus Increment
Basal Increment
Ideal BG (Blood Glucose)
Decrease Ratio (Active Insulin)
Maximum Basal
Maximum Bolus
Maximum Daily Total
Block Sensitive
You are required to contact your healthcare professional in order to change
these settings.

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3. Programming the Insulin Pump
The Programming in this Chapter can apply to the Insulin Pump
Structure of DANA DIABECARE R INSULIN PUMP MENU

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3.1 Setting the time and date
Setting the correct date and time is necessary for accurate basal insulin delivery
and for retaining an accurate record of all insulin delivery.
1. Move to SETTING on MAIN MENU and press .
2. Select CLOCK SETTING on SETTING MENU.
3. Use to move between month, day, year, hour
and minute.
Use and to make the changes.
Caution Ensure ’AM’ and ’PM’ are correct.
4. After making any changes, press to save.
On pop-up screen with a question of “SETTING
SAVE?”, select YES.
Notice Changing 12 or 24hour clock format refer to 3.5 Setting User Options

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3.2 Setting the Basal Rate
Basal settings must be programed before using the insulin pump.
Basal insulin is required to maintain an ideal glucose level while fasting.
Basal insulin infusion rates are specific to individual patients. There are 24
hourly rates each day, these may increase or decrease to match personal insulin
resistance and other factors. The healthcare professional will advise what the
initial rates need to be set at the start.
Notice It is only possible to EDIT the current (selected) Basal Profile. Default
profile is #1. (To change Basal Profile refer to 3.3 Changing Basal Profile)
Step.1
Choose the Basal
Profile 1, 2, 3, 4
Step.2
EDIT Basal Setting

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Description of Basal Graph:
①Basal rate bar graph per hour
The graph consists of 24 bars, and each bar
represents each hourly basal rate. In the graph,
this bar starts with 00 and display until 24
(12:00AM).
When the specific time period is selected, the color
of that bar changes to black.
BASAL SET #1
②Basal Profile Letter
The active basal profile is in the title line.
The example indicates that Basal Profile #1 is
selected. (Refer to 3.3 Changing Basal Profile)
TB : 04.80
③TB (Total Basal)
TB is total insulin which will be delivered during 24
hours from the basal.
Example, Total daily dose(basal) is 4.80 units.
12PM – 01PM
④Starting and ending time
The first is starting time of each hourly basal
delivery, and second is ending time.
The example indicates the basal between 12PM
and 01PM (12 - 13) is 0.2u.
0.20 u
⑤Basal Rate
In the example the basal rate between 12PM and
01PM (12 - 13) is 0.20 u/h
Notice
Edit basal is only available in 24-hour format.
Basal increments can be changed by the pump trainer.