SOOIL Dana-i Advanced Therapeutics User Guide

Guide guide

This quick reference guide is an easy to follow step by step guide to the most common and frequently used features within the Diabecare DANA-i Insulin Pump.The `Quick Reference Guide’ (QRG) is supplementary to the IFU (Instruction For Use).

Warning: All precautions and warnings within the IFU must be read and adhered to always. Read the entire IFU before commencing or using the Diabecare DANA-i Insulin Pump.

Refer to the DANA-i Manual for advanced features instruction and more complex operation of the Diabecare DANA-i Insulin Pump.

Inserting a battery and turning the pump on

1. Open the battery compartment with coin.
2. Place a new AAA alkaline battery into the hole with the positive(+) at top and insert the negative(-) into the pump
3. Place the battery cap back onto the pump and tighten Firmly.

Once the battery is correctly inserted, the pump turns on automatically and performs “self-checks” to make sure all the systems are working properly.
Notice: Altaline AAA batteries are recommended.

The Pump Buttons

This picture shows how the buttons are used to navigate through the menus.

Press to increase insulin dosages, time, and date.
Press to decrease insulin dosages, time, and date or to exit to the previous menu. (cancel/stop button)
Press to move to the next function on the LCD screen or to scroll to the right in menus.
Press to select the function highlighted on the LCD screen. Confirmation button to confirm settings or start a bolus.

The DANA-i insulin pump has a new and improved UI. The button does not operate as a backward button. The new UI menu works in a circular rotation through the menu’s using.

Pump initial screen

This image shows what is displayed on the DANA-i home/initial screen.

1. Date (MM/DD/YYYY)
2. Current Time
3. Current basal rate in units per hour. The flashing B indicates the basal is active
4. Percentage of basal rate. (100% is normal basal delivery without a temporary rate active)
5. Battery Status
6. Insulin remaining volume

Structure of the Pump Menu

Loading an Insulin Reservoir

Preparation – things to get ready before starting

• Analog Insulin (room temperature)
• DANA Reservoir (3ml)
• Auto Setter
• Linking Screw
• DANA Infusion Set and Alcohol Swab (if required)
• DANA Insulin Pump

Procedure

1. Remove the round cap at the bottom (back) end of the Insulin Reservoir and discard.
2. Remove the thin white plastic cap from within the reservoir (place aside for using once full of insulin).
3. Holding the reservoir plunger barrel firmly ­ attach the linking screw, ensure that it fits firmly and the teeth are aligned and engaged.
4. Push the linking screw (and barrel of the reservoir) to the top ­ ready to fill with insulin. This process ensures that the double Oring is moving freely and will not cause an occlusion within the pump.
5. Remove the needle protective cap and insert into the 3ml vial of room temperature insulin.
6. Using the needle protective cap ­ push the insulin plunger down so that the insulin is slowly pushed into the DANA 3ml reservoir. Draw the last bit out by pulling on the linking screw and barrel.
7. Place the clear needle protective cover back onto the needle. Gently tap the reservoir with your finger in order to make the air bubbles rise to the top of the reservoir. And push the plunger up gently to remove the air bubbles from the reservoir.
8. Twist and pull to remove the needle from the reservoir and use the small white plastic stopper put aside earlier to seal the top of the reservoir.
9. Insert the reservoir into the Auto Setter. (the reservoir will protrude from the top of the Auto Setter)
10. Press the button on the Auto Setter to start measuring. The reservoir will wind down and then count the volume.
11. Remove the reservoir from Auto Setter. (Be gentle and do not move the plunger or adjust the linking screw).
12. Insert the reservoir into the pump and screw the reservoir cap down tightly.
13. The pump will automatically display correct refill volume. Press OK to save and go to Refill-Prime menu and attach the new Infusion set tube to the pump. Start the prime…
14. Stop or suspend the prime when the tube is full of insulin and there are no air bubbles visible in the tube. Using the (-) key will pause the prime. (5cm of insulin tube = 1 unit insulin)
15. If using a Teflon (plastic) cannula select the prime cannula menu, this fills the empty needle within the cannula after it has been inserted and after the tubing has been connected.

Priming of new infusion set tube is very important ­ it displaces air within the tube with insulin ready for infusion. If this is not properly completed it is likely that the pump will not deliver insulin as accurately as expected. Ensure that during PRIME insulin can be seen moving through the tube and that a puddle/droplet of insulin is displaced from the end of the infusion set tubing.

Setting Basal Rates

Select the Basal’ option from main menu ![SOOIL Dana-i Advanced Therapeutics--Basal](https://manuals.plus/wp- content/uploads/2021/11/SOOIL-Dana-i-Advanced-Therapeutics-Basal.jpg)Select theEdit Basal’ option from within the `Basal’ menu
Confirm the current Basal profile.
Adjust the start time and end time for the section (period) being changed or amended.
(Note: TDB = Total Daily Basal)
Next adjust the Basal rate (u/hr) for the period selected.
When press to save, a ‘SETTING SAVED’ screen appears. Press to finish the setting, or press to move to the start time to set next Basal rate.

To confirm changes, select

Setting up and personalizing the DANA pump

Select the Option’ from main menu ![SOOIL Dana-i Advanced Therapeutics-Select the](https://manuals.plus/wp- content/uploads/2021/11/SOOIL-Dana-i-Advanced-Therapeutics-Select- the.jpg)Select theUser Option’ from within the `Setting’menu

Within the `User Option’ menu there are 14 options that can be personalized and configured. These options are specific to individual preferences ­ such as pump alerts as beep or vibration and clock display as 12 or 24 hour format?

Note ­ it is necessary to scroll through all options (even if no changes are made, and confirm and/all changes by selected Exit’ and confirmingYES’ to save options configured. When setting or changing any of the selected options the or key changes the selected option. The key moves to the next option. confirms exit from option (15) exit.

DANA pump Setup ­ User Options menu

Top RH  button moves through this menu, or changes individual option. Select Exit at bottom to save any/all changes.

1. Time display 12 or 24 hour clock
2. Button Scroll On or Off ­ enables button press and hold to change levels or dial up Carbohydrate ­ scrolling quickly.
3. Beep On or Off ­ this is individual key depression beeps
4. Alarm Sound, Vibration or Both
5. LCD On Time that LCD display remains active before defaulting to sleep mode
6. Backlight On Time that LCD backlight remains on (in-between button press)
7. Language Default language options for pump operation and menu
8. Glucose Unit mmol/L or mg/dL ­ usually default setting based upon country of origin
9. Shutdown Time setting before pump alarms due to no button presses. If alarm not acknowledged ­ basal will suspend
10. Low Reservoir Personalized low volume level for alarm, 10, 20 30 units in 10u increments
11. Password Enables change to the password for unlocking the Pump
12. Cannula Vol Enables the preset volume for filling cannula to be pre-set (max 0.9 unit)
13. Modify Rate Change the volume of insulin within the pump reservoir.
14. Ideal BG Ideal/Target BG value from the `BG Bolus Calculator’.
15. Exit Use this to save any/all changes made

DANA pump Setup ­ Personalizing CIR and CF

CIR = Carbohydrate to Insulin Ratio
CF = Correction Factor

Select the Bolus’ option from main menu ![SOOIL Dana-i Advanced Therapeutics--From the main](https://manuals.plus/wp- content/uploads/2021/11/SOOIL-Dana-i-Advanced-Therapeutics-From-the- main.jpg)Select theBolus Setting’ option from Bolus Option menu
Select the first option = `CIR/CF’ from setting menu. Set and personalize CF and CIR ratios for each specific time of day.

A Healthcare Professional and or Insulin Pump trainer will configure some additional settings within the DANA `Dr. Mode’. These include daily, hourly and bolus maximums, Basal and Bolus increments, decreasing ratio (duration of active insulin) and target or Ideal BG.

Quick Bolus – delivering a Food Bolus without a Correction

(This bolus ignores any residual Active Insulin)

From the main menu select Bolus’ ![SOOIL Dana-i Advanced Therapeutics--From the main](https://manuals.plus/wp- content/uploads/2021/11/SOOIL-Dana-i-Advanced-Therapeutics-From-the- main.jpg)SelectBolus’ to deliver a standard food bolus without including a correction dose and without reducing the dose for Active Insulin.
If enabled (extended bolus) in user options the pump will offer a range of bolus types.

1. Step’ is a standard bolus.
2. `Extended’ enables the bolus to be delivered over a long period.
3. `Dual Pattern’ is a combination of both above bolus types.

Select to start the delivery.

Delivering a Food Bolus with a Correction

Select the Bolus’ option from the main menu. ![SOOIL Dana-i Advanced Therapeutics-the main](https://manuals.plus/wp- content/uploads/2021/11/SOOIL-Dana-i-Advanced-Therapeutics-the-main.jpg)Select theBG Bolus Calculator’ option from the Bolus menu.
Input actual BG and grams of carbohydrate in meal. The next screen shows the preprogrammed Ideal BG, Carb to Insulin ratio and Correction factor. Each of these can be altered or select (OK) to confirm settings. The pump calculates the suggested dose. (G + C ­ A) This can be adjusted up or down if change is needed.

Select to start the delivery.
DANA Insulin Pumps are set to display Blood Glucose in either mmol/L or mg/dL ­ depending upon the region they are sold, some regions the option can be changed from within the `user option menu’.

Temporary Rate Start and Stop

Starting a new temporary rate
Select TEMPORARY BASAL from the main menu.

Select the duration of the intended temporary rate and the percentage of standard basal rate.
Ex) 150% is a 50% increase in standard rate. 80% is a 20% reduction in standard rate

Select to start the TEMP. RATE
Stopping a temporary rate
Select TEMPORARY BASAL from the main menu.
The TEMP. STATE screen is displayed, press to STOP the TEMPORARY RATE.
Confirm the STOP TEMP. RATE with .

Flying with an Insulin Pump

1. Refill the pump before flight.
   a. Ensure there is no air in reservoir.
   b. Only load enough insulin for 1 or 2 days (preferably only about 1ml).

2. Upon aircraft take off ­ disconnect pump for ½ hour or until cruising altitude is reached.

3. Prior to aircraft decent ­ disconnect pump and prime the tubing
   once landed before reconnecting.

4. Always carry plenty of supplies and spare insulin.

5. In the event of a mid-air emergency and if the oxygen masks fall
   ­ disconnect the pump. Reconnect after departing from the aircraft or when normal cabin pressure is achieved.

6. Take a medical certificate advising use of an Insulin Pump.

7. Ensure to test BG levelsfrequently ­ especially during long haul flights.

8. On all flights carry non-liquid hypo treatment in accessible carryon luggage.

9. Get comprehensive travel insurance and ensure that it covers diabetes and wearing an Insulin Pump and make sure it is named/listed on the policy.

10. Change the pump time to destination time once at cruising altitude ­ Complete this for each separate flight with successive long haul flights.

11. Take at least one spare glucose meter, batteries and test strips. Change the time on the glucose meter at the same time as pump.

12. Before departure, enquire about how to get supplies from each destination travelling to. If necessary, ensure someone back at home knows exactly what supplies and medication is required and make arrangements so they can freight extra supplies if required.

SOOIL Development Co., Ltd.
62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Republic of Korea

MT Promedt Consulting GmbH
Altenhofstrasse 80, 66386 St. Ingbert Germany

IUQ-130-EN (rev.0_200622)
SOOIL DEVELOPMENT CO., LTD

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