Sooil Dana Diabecare RS User manual

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Table of Contents
1. Introduction...........................................................................5
1.1 DANA Diabecare RS Insulin Pump Introduction ........................................................................ 5
1.2 Explanation of Warning Symbols...................................................................................................... 6
1.3 Indications for Use..................................................................................................................................6
1.4 Precautions.................................................................................................................................................7
2. Getting Started.......................................................................9
➢Components of DANA Diabecare RS System.........................................................................9
2.1 Getting to know the DANA Insulin Pump ..................................................................................10
➢DANA Diabecare RS Insulin Pump............................................................................................10
➢Control Panel......................................................................................................................................10
2.2 Installing a battery................................................................................................................................11
➢Check the DANA Battery:..............................................................................................................12
2.3 Display Screen ........................................................................................................................................13
➢Initial Screen.......................................................................................................................................13
➢Remote control mode ....................................................................................................................15
➢Additional Options...........................................................................................................................15
2.4 Patient Education ..................................................................................................................................16
➢About Doctor Mode........................................................................................................................16
3. Programming the Insulin Pump ...........................................17
➢Structure of DANA DIABECARE RS Menu: .............................................................................17
3.1 Setting the time and date .................................................................................................................18
3.2 Setting the Basal Rate.........................................................................................................................19
➢Description of Basal Graph:..........................................................................................................20
➢How to edit the Basal Rate:.........................................................................................................21
3.3 View Basal Rate......................................................................................................................................23
3.4 Setting User Options ...........................................................................................................................24
➢User Options ......................................................................................................................................25
3.5 More Information Screen...................................................................................................................28

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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...................................................................36
4.6 Refill ............................................................................................................................................................37
4.7 Prime the Infusion Set Tubing .........................................................................................................38
➢PRIME procedure:.............................................................................................................................39
4.8 Prime the Cannula ................................................................................................................................41
➢Connection of Pump & Reservoir .............................................................................................43
4.9 Inserting Infusion Set ..........................................................................................................................44
➢Recommending insertion site location....................................................................................45
5. Delivering a Bolus ................................................................47
➢Bolus calculation parameter.........................................................................................................47
➢Three type of Bolus Delivery .......................................................................................................48
5.1 Bolus (Quick Bolus)...............................................................................................................................49
➢How to start the (Quick) bolus delivery: ................................................................................49
➢Stop delivery during bolus:..........................................................................................................50
5.2 BG Bolus Calculator (Smart Bolus).................................................................................................51
5.3 Bolus Setting ...........................................................................................................................................53
➢Bolus Setting ......................................................................................................................................54
➢Pre-set Bolus ......................................................................................................................................56
6. Advanced features within Pump...........................................58
6.1 Temporary Basal Rates........................................................................................................................58
➢Starting a Temporary Basal Rate................................................................................................58
➢Review Temporary Basal Rate Whilst in Operation............................................................59
➢Stopping a Temporary Basal Rate .............................................................................................60
6.2 Suspend.....................................................................................................................................................61

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6.3 Button Lock..............................................................................................................................................62
6.4 Basal Profile .............................................................................................................................................63
6.5 HISTORY : Displays all the Pump History....................................................................................64
➢Review Menu......................................................................................................................................64
6.6 SHIPPING INFORMATION ..................................................................................................................67
6.7 Airplane mode........................................................................................................................................68
6.8 Extended Bolus.......................................................................................................................................69
➢Start Extended Bolus (Quick Bolus) ..........................................................................................69
➢Review Extended Bolus ..................................................................................................................70
➢Stop an Extended Bolus.................................................................................................................70
6.9 Dual Pattern Bolus ................................................................................................................................71
➢Starting a Dual Pattern Bolus......................................................................................................71
➢Stopping a Dual Pattern Bolus....................................................................................................72
7. Alarms and Error Messages ..................................................73
➢WARNING Message.........................................................................................................................74
➢ERROR Message................................................................................................................................77
➢ALARM Message...............................................................................................................................77
8. Troubleshooting ...................................................................81
8.1 Hypoglycemia (low blood sugar)....................................................................................................81
➢What is hypoglycemia (low blood sugar)? ............................................................................81
➢Reasons for Hypoglycemia...........................................................................................................81
➢What to do in case of hypoglycemia.......................................................................................81
➢Hypoglycemia Troubleshooting..................................................................................................82
8.2 Hyperglycemia (high blood sugar) ................................................................................................83
➢What is hyperglycemia (high blood sugar)?.........................................................................83
➢Reasons for Hyperglycemia..........................................................................................................83
➢What to do in case of High Blood Sugar ..............................................................................83
➢Troubleshooting for Hyperglycemia .........................................................................................84
8.3 Occlusion Alarm.....................................................................................................................................85
➢Real Occlusion (Usually within the Cannula or tube)........................................................85

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➢Occlusion caused by external factor ........................................................................................86
8.4 Troubleshooting the Insulin Pump.................................................................................................87
8.5 Battery for DANA Insulin Pump......................................................................................................88
9. Maintenance of Pump & Accessory .......................................89
9.1 Caring for the Insulin Pump .............................................................................................................89
➢Transport and Storage Condition ..............................................................................................90
➢Cleansing the pump & accessories ..........................................................................................90
10. Specification ........................................................................92
10.1 Insulin Pump ...........................................................................................................................................92
10.2 Infusion Sets............................................................................................................................................93
10.3 Prime Volume of Infusion Sets ........................................................................................................94
➢Prime tube...........................................................................................................................................94
➢Cannula prime ...................................................................................................................................94
10.4 Delivery accuracy...................................................................................................................................95
10.5 Classification and Compliance with Standards .........................................................................95
10.6 Declaration of EMC compatibility...................................................................................................96
10.7 Explanation of Universal Symbols ............................................................................................... 101
11. Index .................................................................................103
12. Warranty ............................................................................105

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1. Introduction
1.1 DANA Diabecare RS Insulin Pump Introduction
The DANA Diabecare RS Insulin Pump herein after will be referred to as ‘Insulin
Pump’ throughout the manual.
Warning The DANA Diabecare RS 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 RS 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
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 RS 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
160 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.

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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 RS Insulin pump, the accessories and
other devices are necessarily needed. And Components of DANA Diabecare RS
KIT makes you feel a lot more comfortable when using Dana Insulin Pump.
➢Components of DANA Diabecare RS System
Notice
⚫For Battery, Infusion set and Reservoir, please carefully check the expiration
date before use.
⚫Additional accessories may be purchased separately.

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2.1 Getting to know the DANA Insulin Pump
➢DANA Diabecare RS Insulin Pump
①Reservoir Cap
The reservoir and linking screw are
inserted in this compartment. Turn the
reservoir cap clockwise to open.
②Battery Cap
The battery is inserted in this
compartment. Turn the battery cap
counter-clockwise to open.
③Reservoir Window
Reservoir volume can be visually
verified here.
④Control Panel
Includes the four buttons which are
used to navigate the insulin pump
menus, adjust settings and select
functions.
⑤LCD screen
Displays the pump status, system
features and system messages. This is
the user interface for operation of the
Insulin Pump. Lights automatically when
buttons are pressed.
➢Control Panel
Press to increase values
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
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
⚫Check the new battery manufacturing date and use it within 6 months from
the date of manufacture.
⚫More information of battery, refer to chapter 8.5 Battery for DANA Insulin
Pump.

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2.3 Display Screen
➢Initial Screen
The initial screen is the first menu display. Enter by depressing any key from
battery save mode
Current date and time
Time system option 12/24 available
Month/day hh:mm am/pm
Refer to 3.1 Setting the time and date
Notice When the time is set to ‘12’, “AM/PM”
will be shown.
Basal active
This icon symbol flashes when basal is
active.
Temporary basal active
This icon symbol flashes when a
temporary basal is active.
Current basal rate
Any number less than or greater than 100
indicates a temporary basal is active.
Refer to 6.1 Temporary Basal
*100% is normal basal delivery state.
*u/h = units/hour
Battery status
Displays remaining battery charge as,
100%, 75%, 50%, 25%, 0%
Notice If 0% the battery icon will flash as a
warning of low battery.

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Button lock
Appears on the screen when it is locked.
Refer 6.3 Button Lock
Insulin remaining volume
Displays volume of insulin in the reservoir.
Notice Low Reservoir indicator will flash
when insulin volume remaining is low.
Refer to chapter 7. Alarms and Error messages.
Extended bolus status
This icon (EXTENDED 1.20u/h) will be displayed
only when extended bolus is active.
Refer to 6.8 Extended Bolus
Dual bolus status
This icon (DUAL 2.20u/h) will be displayed only
when a dual pattern bolus is active.
Refer to 6.9 Dual Pattern Bolus
No delivery
This screen will be displayed when pump does
not deliver insulin.
Refer to chapter.7 Alarms and Error messages.

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➢Remote control mode
Remote control mode
When the smartphone with app installed is
connected to the pump, the pump screen is
displayed as shown in the figure.
In this state, the button of the pump does not
work.
Notice You can disconnect by pressing the
key for more than 5 seconds.
Airplane mode
This icon will be displayed only when airplane
mode is ON. The Bluetooth function is interrupted.
Refer to 6.7 Airplane Mode.
➢Additional Options
Bolus block
This icon is displayed when bolus Block
is active. This prevents a bolus repetition
during the pre-set block time period.
Allowable Daily max
This icon (M:19u) 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.
Notice
⚫Additional options are configured by the Healthcare Provider or Insulin Pump
Trainer.
⚫To save battery power the screen will automatically revert to blank after one
minute without any button depressed. Pressing any button will illuminate the
display and also activate the backlight for 10 seconds. (Refer to chapter 3.4
Setting User Options- “LCD on(s)” and “Backlight on(s)”)

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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
➢Structure of DANA DIABECARE RS Menu:
Warning Follow the training and advice of a pump specialist Healthcare
professional and certified Insulin pump trainer whilst inputting the initial
settings. Incorrect settings may cause serious harm.

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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. Select OPTION in main menu and press
2. Select CLOCK SETTING, press button.
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..
Notice Changing 12 or 24hour clock format refer to 3.4 Setting User Options.