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Sooil Diabecare DANA-i User Manual

Insulin pump
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Summary of Contents for Sooil Diabecare DANA-i

  • Page 1 User Guide.
  • Page 2 This page left blank intentionally...

  • Page 3: Table Of Contents

    Sooil LLC 9919 Hibert Street, Suite C, San Diego, CA 92131 2. Getting Started Tel: 1-866-747-6645 * Components of Diabecare DANA-i System Getting to know the DANA Insulin Pump *Diabecare DANA-i Insulin Pump ProMedT Germany Regulatory Agency Details…. * Control Panel...
  • Page 4 Connecting the Infusion Set to the Insulin Pump * ERROR Message Refill * ALARM Message Prime the Infusion Set Tubing * PRIME procedure: 8. Troubleshooting Prime the Cannula * Connection of Pump & Reservoir Hypoglycemia (low blood sugar) Inserting Infusion Set * What is hypoglycemia (low blood sugar)? * Recommending insertion site location * Reasons for Hypoglycemia...

  • Page 5: Introduction

    1. Diabecare DANA-i Insulin Pump Introduction This Insulin Pump is indicated for use in 2years of age and greater. (USA Only) The Diabecare DANA-i Insulin Pump herein after will be referred to as ‘Insulin Pump’ throughout the manual. 4. Contradiction...

  • Page 6: Precautions

    Insulin Pump trainer. 3. The Diabecare DANA-i 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 11.

  • Page 7: Getting Started

    2. Getting Started To make proper use of Diabecare DANA-i Insulin pump, the accessories and other components are required * Components of Diabecare DANA-i System Insulin pump ⑴ Instruction for Use ⑴ Syringe Cap ⑴ Battery Cap ⑴ Linking Screw ⑵...

  • Page 8: Getting To Know The Dana Insulin Pump

    1. Getting to know the DANA Insulin Pump * Control Panel * Diabecare DANA-i Insulin Pump Press to increase values Press to decrease values / return to previous screen 1. Reservoir Cap Press to move to the next menu option...

  • Page 9: Installing A Battery

    2. Insert the battery with the positive at top and insert the (-) into the Insulin Notice Pump. • The Diabecare DANA-i Insulin Pump is powered by an external (AAA) Battery Notice 3. Replace the battery cap turning it counter clock-wise.

  • Page 10: Display Screen

    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 Button lock Time system option 12/24 available Appears on the screen when it is locked. Month/day/Year hh:mm am/pm Refer 6.3 Button Lock 03/10/2019...

  • Page 11: Remote Control Mode

    * Remote control mode 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 Remote control mode without any button depressed. Pressing any button will illuminate the display and also When the smartphone with app installed is activate the backlight for 10 seconds.

  • Page 12: Patient Education

    Follow up education is recommended for all insulin pump users. 1. When starting on insulin pump therapy, the patient should have daily contact with the * Structure of DIABECARE DANA-i Menu: pump trainer and/or medical professional. 2. Visit with the Endocrinologist, Diabetologist or Advanced Practice Nurse within 3-7 days.

  • Page 13: Setting The Basal Rate

    Samoa + 12 hour New Zealand Notice Changing 12 or 24hour clock format refer to 3.4 Setting User Options. Notice The Diabecare DANA-i Insulin Pump has UTC time. Setting the date and time is only completed within the Dr Mode.

  • Page 14: Description Of Basal Graph

    * Description of Basal Graph: EDIT A ② TDD : 05.60 ③ - 19 ④ 0.30u ⑤ ① 1. Basal rate bar graph per hour Select time The graph consists of 24 bars, and each bar represents 23-24 each hourly basal rate. In the graph, this bar starts with 00 and display until 24 (12:00AM).

  • Page 15: How To Edit The Basal Rate

    * How to edit the Basal Rate: EDIT A 6. Use the to adjust the End time. TDD : 04.80 14 - press to move to the Basal rate. -.--u MAIN MENU BASAL EDIT A 7. Use the and buttons to adjust the Basal rate TDD : 05.20 for the selected time.

  • Page 16: View Basal Rate

    3. View Basal Rate 4. Setting User Options The view basal rate is used to view the current profile's time-specific settings. The user can change the settings related to pump usage through the User option. MAIN MENU MAIN MENU BASAL OPTION SUB MENU SUB MENU...

  • Page 17: User Options

    * User Options 8. GLUCOSE UNIT 1. TIME DISPLAY USER OPTION Adjust the unit of measure for Glucose results Adjust the time display as 12hour or 24hour. 1.TIME DISPLAY:12 between ML (mmol/L) or MG (mg/dL). 2.BUTTON SCROLL:ON 2. BUTTON SCROLL 3.BEEP:ON Warning Using wrong unit of measure could lead to...

  • Page 18: More Information Screen

    * User Options 5. More Information Screen The More Information screen provides a quick review of: • Active Insulin from a previous bolus. 12. CANNULA VOLUME: USER OPTION • Extended bolus information (if active). Soft needle cannula has a pre-assigned volume 11.PASSWORD •...

  • Page 19: Loading Insulin Into The Pump

    • The room temperature in this manual is 15℃(59℉) ~ 30℃(86℉) • The following insulin has been tested by Sooil Development Co., Ltd. and found to be safe for use in Diabecare DANA-i Insulin Pump: Novolog (do not use beyond "Timeframe").

  • Page 20: Filling The Reservoir With Insulin

    2. Filling the Reservoir with Insulin 1. Remove the round cap at the backend of the 6. Place the clear needle protective cover back Reservoir Cap reservoir plunger and discard. A small white onto the needle. Gently tap the reservoir with reservoir cap needs to be removed from the your finger in order to make the air bubbles rise plunger–keep this cap for later use.

  • Page 21: Adjust The Length Of Linking Screw With Auto Setter

    3. Adjust the length of linking screw with Auto Setter * Using DANA Auto Setter : The DANA Auto Setter is intended for adjusting the length of linking screw, measuring the amount of insulin in the reservoir and sending it to the pump with the wireless communication.

  • Page 22: Inserting The Reservoir Into The Insulin Pump

    4. Inserting the Reservoir into the Insulin Pump 5. Connecting the Infusion Set to the Insulin Pump 1. Insert the reservoir with linking screw into the Attach the Infusion Set Tube counter clockwise Insulin Pump as shown. into the reservoir compartment until it is firmly in place.
  • Page 23 6. Prime the Infusion Set Tubing Prime every new Infusion set tube to displace air from within the tubing. Visually confirm that all bubbles are primed from the Infusion Set tubing. Upon completion of refill process confirm the basal is active and correct. Warning Warning It is important to properly prime the Tube and ensure all air is removed from...
  • Page 24 * PRIME procedure: 6. The PRIMING display will show the volume of insulin delivered. MAIN MENU Notice During PRIME the pump may BEEP or REFILL VIBRATE after every unit of Insulin is primed. 7. When droplets of Insulin appear at the end of the TUBE press to PAUSE.
  • Page 25 7. Prime the Cannula When using an infusion set with a soft needle/cannula, the hollow area within the cannula SAVE CANNULA PRIME? requires PRIME CANNULA after completing tube prime. 5. Press to confirm. :YES MAIN MENU REFILL PRIME CANNULA 6. The PRIME CANNULA window displays the 0.1 u delivery.
  • Page 26 8. Reloading the pump * Connection of Pump & Reservoir The previous instructions from (4.1 Loading the Pump) provide details for loading the The following is structure of pump and reservoir through linking screw. insulin pump. After usage – prior to loading it is necessary remove the old reservoir by opening the reservoir compartment.
  • Page 27 * Recommending insertion site location 5. Delivering a Bolus The DANA Insulin Pump can deliver a bolus of insulin using different user input parameters to calculate the bolus volume. * Bolus calculation parameter •Step Bolus (Quick): This standard bolus option can be calculated by either. ✓...
  • Page 28 * Three type of Bolus Delivery 1. Bolus (Quick Bolus) After selecting one of the options on previous page to assist with calculating the required This bolus can be used to cover the carbohydrate in a meal or snack. dosage - the DANA Insulin Pump can deliver three types of bolus: MAIN MENU After a suggested bolus amount is shown press BOLUS...
  • Page 29 * How to start the (Quick) bolus delivery: * Stop delivery during bolus: 1. During the BOLUS delivery press the button. BOLUS STOP Confirm the STOP with . BOLUS? 1. Select BOLUS from the BOLUS Sub menu press . :YES BOLUS 2.
  • Page 30 2. BG Bolus Calculator (Smart Bolus) DELIVER This type of BOLUS will calculate an estimate of insulin required for a correction bolus and/ BOLUS? 4. Start the BOLUS with button. or food bolus and adjusts the suggested dose to compensate for residual Active Insulin :YES from previous Bolus delivery.
  • Page 31 3. Bolus Setting The Bolus Setting menu enables personalization of all Bolus features within the insulin pump. MAIN MENU BOLUS SUB MENU BOLUS BG BOLUS BOLUS CALCULATOR SETTING BOLUS 1. Select BOLUS SETTING from within the BOLUS MENU press . This page left blank intentionally BG BOLUS CALCULATOR BOLUS SETTING...
  • Page 32 * Bolus Setting * Bolus Setting BOLUS SETTING BOLUS SETTING 2. EXTENDED BOLUS 1. CIR/CF SETTING 9.EXIT 1.CIR/CF SETTING 1.CIR/CF SETTING Adjust between extended and dual bolus ON/FF. Select 2.EXTENDED BOLUS:OFF 2.EXTENDED BOLUS:OFF CIR or CF 3.BOLUS CAL.:CARB. SELECT 4.BOLUS RATE Press the button to adjust the CF (correction CIR OR CF...
  • Page 33 * Pre-set Bolus 6. Advanced features within Pump The value of pre-set bolus is a default value which will first appear in the bolus menu. Set the size for breakfast, lunch and dinner bolus’s as an option within Bolus setting menu. 1.
  • Page 34 * Review Temporary Basal Rate Whilst in Operation * Stopping a Temporary Basal Rate 03/10/2019 10:04 AM MAIN MENU 1. From the Home Screen a flashing indicates 1. Select TEMPORARY BASAL from the main 0.20 u/h 100% that a Temporary Rate is active. menu.
  • Page 35 2. Suspend 3. Button Lock To stop the Insulin Pump with the suspend function. Suspend stops all insulin delivery Button lock prevents accidental Insulin Pump keypad presses. including basal and bolus. The Suspend must be off to resume basal delivery or to deliver It is particularly useful for: a bolus.
  • Page 36 4. Basal Profile 5. HISTORY : Displays all the Pump History The adjusted basal rates can be saved as 4 different profiles. These are useful for sport History and pump memory can be viewed either on the Insulin Pump days, sick days or specific events that may affect your insulin sensitivity. MAIN MENU MAIN MENU BASAL...
  • Page 37 * Review Menu 1. BOLUS HISTORY CARBO H. 6. CARBOHYDRATE HISTORY Record of the most recent 300 BOLUSES 03/10 05:04PM History of carbohydrate used for bolus delivery A. DATE (mm/dd) B. TIME (hh:mm) 03/10 01:35PM calculations. Grams of CHO 03/09 07:22AM BOLUS H.
  • Page 38 7. Airplane mode This displays the country that the pump was originally shipped to after manufacture. Also Diabecare DANA-i is designed for remote control in conjunction with smartphone app. displayed is the date of manufacture, pump serial number and the software version However, since it always transmits Bluetooth signal, it is necessary to switch to airplane installed.
  • Page 39 8. Extended Bolus * Start Extended Bolus (Quick Bolus) Extended or Dual bolus can be used for: • Meals with slow absorption (high fat) i.e. pizza or lasagne 03/10/2019 10:04 AM EXTENED 1.20u/h • Insulin Pump users who have other conditions such as gastroparesis which can delay/slow the 1.
  • Page 40 9. Dual Pattern Bolus * Stopping a Dual Pattern Bolus Dual Pattern bolus delivers a combination of a Step Bolus followed by an Extended Bolus. To stop the extended part of a Dual Bolus from the EXT Bolus status menu. A Dual Pattern bolus is useful for meals with a combination of fast and slow absorbed carbohydrate.
  • Page 41 This chapter describes insulin pump alarms and error messages and how to solve them. The low battery screen will appear when the battery level is not sufficient to operate Diabecare DANA-i alarms and error messages are as follows. the pump and deliver insulin. A continuous alarm will be activated with both sound and vibration.
  • Page 42 * WARNING Message SHUTDOWN The Pump will automatically give an alarm sound if no WARNING LOW RESERVOIR buttons are pressed after the pre-set shutdown period WARNING SHUTDOWN When the reservoir volume is below the 'Low Reservoir' is exceeded. If no acknowledgment of the alarm is warning configured in the user options, this screen will received (button press) following the audible alarm - RESERVOIR...
  • Page 43 * ERROR Message * ALARM Message SUSPEND WARNING CHECK ERROR Select any menu related to infusion (insulin delivery) ALARM This alarm occurs if the Insulin Pump suspects an CHECK whilst the Insulin Pump is in Suspend Mode, you are ERROR internal signal defect.
  • Page 44 * ALARM Message ALARM DELIVERY LESS THAN BASAL SET RATE ALARM PRIME AMOUNT IS NOT ENOUGH If the basal is skipped and delivered less than 80% of DELIVERY LESS THAN This alarm/alert message will be displayed if the PRIME AMOUNT BASAL SET RATE the basal setting, this alarm will be generated.
  • Page 45 * ALARM Message ※ Reason of NO DELIVERY ALARM CHECK GLUCOSE 03/10/2019 10:04 AM If prime is not completed or was less than 7u CHECK This alarm is to remind you to check blood glucose level GLUCOSE (minimum) to fill tube. Refer to 4.7 Prime the after a bolus.
  • Page 46 * Hypoglycemia Troubleshooting 8. Troubleshooting 1. Hypoglycemia (low blood sugar) POSSIBLE CAUSE SUGGESTED RESPONSE Consult with a healthcare professional to make * What is hypoglycemia (low blood sugar)? adjustments for increased physical activity. Increased physical activity Hypoglycemia occurs when the blood sugar level is low. Anyone using insulin should be Use or modify temporary basal rates or decrease meal familiar with the symptoms and treatment of hypoglycemia.
  • Page 47 2. Hypoglycemia (low blood sugar) * Troubleshooting for Hyperglycemia * What is hyperglycemia (high blood sugar)? POSSIBLE CAUSE SUGGESTED RESPONSE Hyperglycemia (high blood sugar) can occur due to any interruption in the delivery of Visually check display screen for remaining insulin and also insulin.
  • Page 48 3. Occlusion Alarm * Occlusion caused by external factor The causes of occlusion alarms are very variety. The tube may be blocked by uncertain materials or may be caused by other external factors. The various causes of occlusion are described as follows. OCCLUSION CAUSES WHAT TO DO Wash linking screw in warm water with mild...
  • Page 49 4. Troubleshooting the Insulin Pump Taking care of the System 5. Cleaning the System PROBLEM CORRECTIVE ACTION Use a soft cloth or tissue to wipe the exterior of the Insulin Pump. If necessary, a small amount of mild alcohol on a soft cloth or tissue may be used. Organic solvents such as An abnormal LCD can occur when the battery charge is low.
  • Page 50 Consult a healthcare provider for instructions for disposal of devices containing electronic For safe transport and storage of the Diabecare DANA-i Insulin Pump system avoid the waste such as you pump and for instructions for disposal of potentially bio hazardous following conditions: materials such as used cartridges, needles, syringes, and infusion sets.
  • Page 51 2. Infusion Sets 9. Specification 1. Insulin Pump SPEC INSULIN PUMP Size 3.8× 1.8× 0.8 inch (97 × 47 × 22mm) **including reservoir cap Net Weight 75g (without battery), 86g (including battery) Soft-Release-0 DANA Inset II Insulin Reservoir 3mL(300 Units) insulin compatible reservoir Meal Bolus Setting 0 - 80u Soft-Release-0...
  • Page 52 3. Prime Volume of Infusion Sets New unopened Infusion Sets are sterile and the tubing is filled with air/empty. Once connected to the Insulin Pump it is necessary to prime the tubing (fill it with insulin and remove the air) before the tube is connected to the Cannula or Patient. The following shows the estimated volume of insulin required to fill tubing for each of the Infusion Sets below: Notice...
  • Page 53 5. Classification and Compliance with Standards Delivery Intervals: 4 minutes when a basal setting is not lower than 0.1u/h • The Diabecare DANA-i is classified as an internal powered equipment BF type under 60 minutes when basal delivery setting is 0.04 - 0.09u/h the standard of IEC 60601-1 Delivery Accuracy: ±...
  • Page 54 6. Essential Performance * Declaration of EMC compatibility The Diabecare DANA-i insulin pump is intended for use in the electromagnetic environment The Insulin infusion pump maintains insulin delivery accuracy in the specified environmental conditions. and comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility.
  • Page 55 Conducted RF 3 Vrms discharge(ESD) ±15㎸ air ±15㎸ air discharge that might occur part of the Diabecare DANA-i IEC 61000-4-6 150 ㎑ to 80 ㎒ applicable IEC 61000-4-2 under normal conditions of use. insulin pump, including cables, than the recommended ±2㎸...
  • Page 56 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Diabecare DANA-i where P is the maximum output...
  • Page 57 Recommended separation distance between portable and mobile RF communications equipment and the Diabecare DANA-i The Diabecare DANA-i insulin pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Diabecare DANA-i insulin pump can help prevent electromagnetic...
  • Page 58 8. Explanation of Universal Symbols On the packaging and on the type plate of Diabecare DANA-i System you may encounter the following symbols shown here with their meanings: Follow instructions for use Sterilized with ethylene oxide Caution. Refer to safety-related notes in the manual...
  • Page 59 10. Index Accessories 9 Easy Setter 33 Occlusion Warning 76, 85 User option 25 Active Insulin 52 Edit Basal 21 Option 24 Airplane Mode 68 Error message 77 Alarm and Error 73 Extended Bolus 69 View Basal Rate 23 Password 26 Volume of infusion set 94 Preset Bolus 56 Basal Profile 63...
  • Page 60 • Modifications or changes to the System by the user or any other person after the date of manufacture. • A force majeure or other event beyond the control of SOOIL or acts of negligence, misuse, or mishandling of the System by the user or any other person including but not limited to physical abuse of the product such as dropping or otherwise damaging the Diabecare DANA System.
  • Page 61 IFU-130-EN (rev.0_000000) SOOIL DEVELOPMENT Co.,LTD...

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