User Guide.
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Table of Contents Sooil Development Co.,Ltd. 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Republic of Korea. Tel: 82-2-3463-0041 Fax: 82-2-3463-7707 E-mail: sooil@sooil.com http://www.sooil.com MT Promedt Consulting GmbH Altenhofstrasse 80, 66386 St. Ingbert, Germany Tel : 49-6894-581020 Local Distributor / pump specialist 1. Introduction 6 1. Diabecare DANA-i Insulin Pump Introduction 2. Explanation of Warning Symbols 3. Indications for Use 4. Contradiction 5.
5. Connecting the Infusion Set to the Insulin Pump 6. Refill 7. Prime the Infusion Set Tubing * PRIME procedure: 8. Prime the Cannula 9. Reloading the pump * Connection of Pump & Reservoir * Recommending insertion site location 41 42 43 44 46 48 49 50 5. Delivering a Bolus 51 * Bolus calculation parameter * Three type of Bolus Delivery 1. Bolus (Quick Bolus) * How to start the (Quick) bolus delivery: * Stop delivery during bolus: 2. BG Bolus Calculator (Smart Bolus) 3.
1. Introduction 1. Diabecare DANA-i Insulin Pump Introduction The Diabecare DANA-i Insulin Pump herein after will be referred to as ‘Insulin Pump’ throughout the manual. Warning Warning The Diabecare DANA-i 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.
. Precautions 1. Pump users need more than 4 blood glucose measurements per day, and vision and hearing to receive any pump alarm. 2. Patients must not open the Pump housing or handle any internal components. 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 other infusion system or accessories. 9. Avoid impact damage such as dropping.
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 DANA Auto Setter (1) Syringe Cap ⑴ Battery Cap ⑴ Linking Screw ⑵ 1/2AA Size Battery (1) This page left blank intentionally Manual ⑴ Notice • Additional accessories may be purchased separately.
1. Getting to know the DANA Insulin Pump * Diabecare DANA-i Insulin Pump 1. Reservoir Cap The reservoir and linking screw are inserted in this compartment. Turn the reservoir cap clockwise ¼ turn to open. 1. Reservoir Cap 2. Battery Cap 3. Reservoir Window 4. Control Panel 5. LCD screen * 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 2. Battery Cap The battery is inserted in this compartment.
2. Installing a battery Battery Cap With O-ring 1. Open the battery cap and turning clock-wise 45 degrees. 2. Insert the battery with the positive (+) at top and insert the negative (-) into the Insulin Pump. A A A 3. Replace the battery cap turning it counter clock-wise. 4. Completed when the cap is firmly locked with insulin pump. Open Caution Caution • DO NOT attempt to change the battery while a bolus is in progress.
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/Year hh:mm AM/PM Refer to 3.1 adjust the time Current date and time 03/10/2019 10:04 AM B 0.20 u/h 100% 245u Basal active Notice When the time is set to ‘12’, “AM/PM” will be shown. Basal active This icon B symbol flashes when basal is active.
* Remote control mode * Additional Options 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. 03/10/2019 10:04 AM B 0.20 u/h 100% 245u 18 Airplane mode This icon will be displayed only when airplane mode is ON. The Bluetooth function is interrupted Refer to 6.7 Airplane Mode.
4. 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 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.
1. Adjust the time Setting the correct time is necessary for accurate basal insulin delivery and for retaining an accurate record of all insulin delivery. MAIN MENU OPTION SUB MENU CLOCK SETTING TIMEZONE : 00 UTC TIME 01/01/2019 00:00:00 LOCAL TIME 01/01/2019 00:00:00 UTC = 0 -1 hour -2 hour -3 hour -4 hour -5 hour -6 hour -7 hour -8 hour -9 hour -10 hour -11 hour USER OPTION AIRPLANE MODE From within the Clock Setting menu – adjust the time using the or key. Press to save the setting.
2. Setting the Basal Rate Basal settings must be programmed before using the insulin pump. Basal insulin is required to maintain an ideal glucose level while fasting. * Description of Basal Graph: EDIT A TDB : 05.20 18 - 19 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.
* How to edit the Basal Rate: EDIT A TDB : 04.80 14 - 18 -.--u MAIN MENU BASAL EDIT A TDB : 05.20 14 - 18 0.30u SUB MENU EDIT BASAL VIEW BASAL RATE CHANGE PROFILE SETTING SAVED TDB : 05.20 14 - 18 MAIN MENU 0.30u 1. Within MAIN MENU scroll through and select BASAL with . BASAL EDIT A PROFILE A CHANGED BASAL 2. Select EDIT BASAL and press 6. Use the and to adjust the End time. press to move to the Basal rate. 7. Use the and buttons to adjust the Basal rate for the selected time.
3. View Basal Rate The view basal rate is used to view the current profile's time-specific settings. MAIN MENU 4. Setting User Options The user can change the settings related to pump usage through the User option. MAIN MENU BASAL SUB MENU EDIT BASAL VIEW BASAL RATE OPTION CHANGE PROFILE BASAL CLOCK SETTING USER OPTION AIRPLANE MODE MAIN MENU VIEW BASAL RATE 1. Select VIEW BASAL RATE in BASAL's sub menu and press . VIEW PROFILE A REVIEW A TDB : 05.60 05PM - 06PM 0.20u 1.
* User Options USER OPTION 1. TIME DISPLAY Adjust the time display as 12hour or 24hour. 2. BUTTON SCROLL When ON holding the value quickly. USER OPTION 1.TIME DISPLAY:12 2.BUTTON SCROLL:ON 3.BEEP:ON 4.ALARM:SOUND 5.LCD ON(S):60 6.BACKLIGHT ON(S):10 7.LANGUAGE:EN 8.GLUCOSE UNIT:MG 9.SHUTDOWN:0 10.LOW RESERVOIR:20 11.PASSWORD 12.CANNULA VOL.:0.4 13.ADJ. RES. VOL.:245U 14.IDEAL BG:100 15.EXIT or buttons adjusts the 3. BEEP Key Beep ON/OFF enables an audio tone when buttons are depressed. 4.
* User Options USER OPTION 11.PASSWORD 12.CANNULA VOL.:0.4 13.ADJ. RES. VOL.:245U 5. More Information Screen 12. CANNULA VOLUME: Soft needle cannula has a pre-assigned volume that needs to be filled with insulin before delivery. Set the pre-set the required volume here for the specific cannula used. (Refer to 10.3 Prime Volume of infusion sets) The More Information screen provides a quick review of: • Active Insulin from a previous bolus. • Extended bolus information (if active).
4. Loading Insulin into the Pump 1. Preparation Loading and refilling the Insulin Pump with insulin is a technical process which involves medication (insulin) and sterile components. Warning Warning Disconnect the insulin pump from the infusion set and body before opening or starting any of the refill procedure. Insulin could be unintentionally delivered if the pump is opened while still connected. Notice Do not reuse parts or all of an old infusion set or reservoir.
2. Filling the Reservoir with Insulin Reservoir Cap 1. Remove the Reservoir cap at the backend of the reservoir plunger. A small white reservoir cap needs to be removed from the plunger–keep this cap for later use. Pull back on the plunger to the line marked with the 3 ml. 2. Loosen the linking screw until the shaft cap part is covered up by the head part (blue part). This is important to adjust the length accurately.
3. Adjust the length of linking screw with 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. DANA Auto Setter * Using DANA Auto Setter : 1. Loosen the linking screw until the shaft cap part is covered by the head part (blue part). This is important to adjust the length accurately. 2.
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 Insulin Pump as shown. TIP! When inserting the reservoir, rotate the reservoir 90 degrees until the notch on the side of the reservoir slide into place within the pump. Gently let the reservoir and linking screw fall into place. 2. Position the reservoir cap stright line with the guide line, and turning clock-wise 45-degrees.
6. Refill 7. Prime the Infusion Set Tubing With the refill input, pump get to know exactly what the insulin amount is. 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. MAIN MENU REFILL Warning Warning It is important to properly prime the Tube and ensure all air is removed from the system.
* PRIME procedure: 6. The PRIMING display will show the volume of insulin delivered. Notice During PRIME the pump may BEEP or VIBRATE after every unit of Insulin is primed. MAIN MENU REFILL SUB MENU REFILL PRIME 7. When droplets of Insulin appear at the end of the TUBE press to PAUSE. Check the entire length of TUBE for any bubbles. Press to finish the PRIME. PRIME CANNULA MAIN MENU 1. From the main menu select REFILL and press . 12.5 u REFILL REFILL - :EXIT 2.
8. Prime the Cannula When using an infusion set with a soft needle/cannula, the hollow area within the cannula requires PRIME CANNULA after completing tube prime. START CANNULA PRIME? - :NO 5. Press to confirm. OK :YES MAIN MENU REFILL PRIME CANNULA 0.1 u SUB MENU REFILL PRIME PRIME CANNULA 1. After inserting the cannula into the body (following the cannula instructions) connect the infusion set tube to the infusion set after priming all bubbles out from the tube. MAIN MENU 6.
9. Reloading the pump The previous instructions from (4.1 Preparation) provide details for loading the insulin pump. After usage – prior to loading it is necessary remove the old reservoir by opening the reservoir compartment. * Connection of Pump & Reservoir The following is structure of pump and reservoir through linking screw. 1. Disconnect the insulin pump tube at the infusion set. Caution Ensure the infusion site is disconnected from the pump tubing – before opening the Insulin Pump.
* Recommending insertion site location Recommended Possible It is recommended to rotate the location of your Infusion Set sites to minimize skin damage and enable longer healing times. Consult your healthcare professional about the infusion site rotation.
* Three type of Bolus Delivery 5. Delivering a Bolus After selecting one of the options on previous page to assist with calculating the required dosage - the DANA Insulin Pump can deliver three types of bolus: The DANA Insulin Pump can deliver a bolus of insulin using different user input parameters to calculate the bolus volume. BOLUS MENU * Bolus calculation parameter •Step Bolus (Quick): This standard bolus option can be calculated by either. ✓ CARBO.
1. Bolus (Quick Bolus) This bolus can be used to cover the carbohydrate in a meal or snack. INSULIN INJECT INJECTED TARGET 2.70 u 3.20 u - :STOP MAIN MENU BOLUS STEP BOLUS SUB MENU BOLUS BG BOLUS CALCULATOR 3.20U DELIVERED BOLUS SETTING * How to start the (Quick) bolus delivery: 1. Select BOLUS from the BOLUS Sub menu press 80 g 25 3.20 u STEP BOLUS BOLUS 3.20 u SPEED 12 sec/u BOLUS DELIVER BOLUS? - :NO 54 OK :YES 6.
2. BG Bolus Calculator (Smart Bolus) This type of BOLUS will calculate an estimate of insulin required for a correction bolus and/ or food bolus and adjusts the suggested dose to compensate for residual Active Insulin from previous Bolus delivery. DELIVER BOLUS? - :NO 4. Start the BOLUS with button. OK :YES MAIN MENU BOLUS Within the BOLUS review display the following values are displayed SUB MENU BOLUS BOLUS BG BOLUS CALCULATOR BOLUS SETTING 1. From BOLUS select BG BOLUS CALCULATOR with button.
3. Bolus Setting The Bolus Setting menu enables personalization of all Bolus features within the insulin pump. * Bolus Setting BOLUS SETTING 9.EXIT 1.CIR/CF SETTING 2.E+D BOLUS MAIN MENU SELECT CIR OR CF BOLUS - :CF OK :CIR CIR SET SUB MENU BOLUS BG BOLUS CALCULATOR BOLUS SETTING BOLUS BG BOLUS CALCULATOR CF SET 1. Select BOLUS SETTING from within the BOLUS MENU press . BOLUS SETTING 9.EXIT 1.CIR/CF SETTING 2.E+D BOLUS 2.
* Bolus Setting BOLUS SETTING 1.CIR/CF SETTING 2.DUAL/EXT. BOLUS 3.BOLUS CAL.:CARB. 4.BOLUS RATE 5.MISSED BOLUS1:OFF 6.MISSED BOLUS2:OFF 7.MISSED BOLUS3:OFF 8.MISSED BOLUS4:OFF 9.EXIT BOLUS SETTING 11.00 u BOLUS * Pre-set Bolus 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. 2. DUAL/EXT. BOLUS Adjust between extended and dual bolus ON/FF. 3.
6. Advanced features within Pump 1. Temporary Basal Rates The temporary basal rate feature is useful to manage blood glucose levels during unexpected and unusual short-term activities (sport or exercise) or conditions of illness or stress. Using the temporary basal rate enables changes to be temporary and to automatically revert to usual rates upon completion. MAIN MENU TEMPORARY BASAL * Starting a Temporary Basal Rate MAIN MENU This page left blank intentionally TEMPORARY BASAL 1.
* Review Temporary Basal Rate Whilst in Operation 03/10/2019 10:04 AM 1. From the Home Screen a flashing that a Temporary Rate is active. T B 0.30 u/h 150% T indicates 245u MAIN MENU 2. Select TEMPORARY BASAL from the MAIN MENU. * Stopping a Temporary Basal Rate MAIN MENU TEMPORARY BASAL TEMP. BASAL 00:35 00:35 00:25 150% 2. The TEMP. STATE screen is displayed, press to STOP the TEMPORARY RATE. 150% TEMPORARY BASAL TEMP. BASAL 00:25 1. Select TEMPORARY BASAL from the main menu. A B 3.
2. Suspend To stop the Insulin Pump with the suspend function. Suspend stops all insulin delivery including basal and bolus. The Suspend must be off to resume basal delivery or to deliver a bolus. MAIN MENU SUSPEND MAIN MENU 1. Select SUSPEND from the MAIN MENU. SUSPEND 03/10/2019 10:04 AM This page left blank intentionally SUSPEND 245u 03/10/2019 10:04 AM 2. The display changes on the initial screen to alternate between SUSPEND and NO DELIVERY. NO DELIVERY 245u MAIN MENU SUSPEND OFF 3.
3. Button Lock 4. Basal Profile Button lock prevents accidental Insulin Pump keypad presses. It is particularly useful for: • Pediatric patients who are not able to program their own pump. • Patients whilst sleeping. The adjusted basal rates can be saved as 4 different profiles. These are useful for sport days, sick days or specific events that may affect your insulin sensitivity. MAIN MENU BASAL MAIN MENU BUTTON LOCK SUB MENU MAIN MENU EDIT BASAL 1. Select BUTTON LOCK from the MAIN MENU.
5. HISTORY : Displays all the Pump History History and pump memory can be viewed either on the Insulin Pump * Review Menu MAIN MENU BOLUS H. (u) REVIEW A B C 03/08 17:13 s 03/09 09:12 E 0:00 2.20 1:00 3.20 SUB MENU MORE INFORMATION REVIEW HISTORY SHIPPING INFORMATION 1. Select REVIEW from the MAIN MENU then select HISTORY from the REVIEW sub menu. HISTORY BOLUS H. (u) 03/08 17:13 s 03/09 09:12 E 0:00 2.20 1:00 3.20 2. The and Use scroll up/down. button to next menu. BOLUS AVG.
* Review Menu 6. SHIPPING INFORMATION CARBO H. (u) 03/10 03/10 03/09 05:04PM 01:35PM 07:22AM 180 250 228 B. GLUCOSE (mg/dL) 03/10 03/09 03/09 10:02AM 09:35PM 06:22PM 180 223 105 6. CARBOHYDRATE HISTORY History of carbohydrate used for bolus delivery calculations. Grams of CHO 7. BLOOD GLUCOSE HISTORY History of Blood Glucose using the BG Bolus calculator. Date, Time, BG Result in mg/dL or mmol/L This displays the country that the pump was originally shipped to after manufacture.
7. Airplane mode Diabecare DANA-i is designed for remote control in conjunction with smartphone app. However, since it always transmits Bluetooth signal, it is necessary to switch to airplane mode when it is necessary to turn off the electronic signals such as when boarding on an airplane. MAIN MENU OPTION SUB MENU CLOCK SETTING OPTION AIRPLANE MODE 03/10/2019 USER OPTION AIRPLANE MODE 1. Select OPTION from the MAIN MENU then select AIRPLANE MODE from the OPTION's sub menu.
8. Extended Bolus Extended or Dual bolus can be used for: • Meals with slow absorption (high fat) i.e. pizza or lasagne • Insulin Pump users who have other conditions such as gastroparesis which can delay/slow the absorption of carbohydrate. Refer to a Healthcare Professional about this condition and treatment. • Insulin delivery where a meal has been eaten over a long period of time or with extended snacking. * Start Extended Bolus 03/10/2019 10:04 AM EXTENDED 3.20u/h B 0.20 u/h 100% 1.
9. Dual Pattern Bolus Dual Pattern bolus delivers a combination of a Step Bolus followed by an Extended Bolus. A Dual Pattern bolus is useful for meals with a combination of fast and slow absorbed carbohydrate. BOLUS 03/10/2019 DUAL 1.60u/h 10:04 AM 1. From MAIN MENU select BOLUS From BOLUS sub menu select BOLUS icon. 1. Dual state shown on the initial screen. 245u EXT. BOLUS BOLUS CAL. 80 g 25 3.20 u BOLUS CAL. DUAL PATTERN BOLUS DUAL PATTERN STEP 1.60 u EXTEND 1.
7. Alarm, Error and Alert This chapter describes insulin pump Alarm, Error, Alert messages and how to solve them. Type ALARM (High Priority) ERROR (Medium Priority) ALERT (Low Priority) Message LOW BATTERY EMPTY RESERVOIR SHUTDOWN OCCLUSION CHECK ERROR SYSTEM ERROR PRIME INCOMPLETE BASAL MAX DAILY MAX LOW RESERVOIR SUSPEND DELIVERY LESS THAN BASAL SET RATE MISSED BOLUS PRIME AMOUNT IS NOT ENOUGH CHECK GLUCOSE CONFIRM PAIRING NO DELIVERY Notice •Alarm is a critical alarm that can affect safety.
* ALARM Message EMPTY RESERVOIR When the reservoir volume is zero (0u), all delivery is stopped and this screen will be shown with a sound alarm. ALARM EMPTY RESERVOIR How to solve: Silence the alarm by pressing any button. Immediately replace the reservoir and refill the pump Warning The pump displaying "NO DELIVERY/EMPTY RESERVOIR" is unable to not only deliver basal and bolus but access to any delivery function. Notice This alarm will repeat every 5 minutes until a complete refill is completed.
* ALARM Message CHECK ERROR This alarm occurs if the Insulin Pump suspects an internal signal defect. ALARM SYSTEM ERROR This alarm occurs when the Insulin Pump detects any unusual movement of the controller. ALARM CHECK ERROR SYSTEM ERROR How to solve: If/when either of these alarms, removal of the battery will silence the alarm. Reinsert the battery after 10 seconds and the pump will perform a full self-check procedure. DANA Insulin pump is monitoring all operation for safety.
* ERROR Message LOW RESERVOIR When the reservoir volume is below the 'Low Reservoir' warning configured in the user options, this screen will be shown with either beep or vibrates. ERROR LOW RESERVOIR How to solve: The pump will revert to the Initial Display and the reservoir icon will blink/flash. After checking the actual remaining insulin volume of the reservoir in your pump, replace the reservoir and refill the pump if necessary.
* ALERT Message MISSED BOLUS If a bolus was missed during the time period you had set, the Insulin Pump will give you an alert together with an message. Refer to 5.3 Bolus Setting-MISSED BOLUS ALERT MISSED BOLUS 01:00PM - 02:00PM How to solve: Silence the alert by pressing any button. Follow the prompt by determining if a food bolus was missed and administer if necessary. PRIME AMOUNT IS NOT ENOUGH This alert message will be displayed if the volume delivered for tubing prime is less than 7 units.
* ALERT Message NO DELIVERY The pump cannot deliver insulin for one or more of different reasons. This message is shown on initial display and may blink/flash with additional information 03/10/2019 10:04 AM NO DELIVERY 245u How to solve: A detail message will blink alternately. Refer to following reason of NO DELIVERY. ※ Reason of NO DELIVERY 03/10/2019 10:04 AM If prime is not completed fill tube. Refer to 4.7 Prime the infusion set tubing. NO PRIME 245u 03/10/2019 10:04 AM 0.
8. Troubleshooting 1. Hypoglycemia (low blood sugar) * What is hypoglycemia (low blood sugar)? Hypoglycemia occurs when the blood sugar level is low. Anyone using insulin should be familiar with the symptoms and treatment of hypoglycemia.
2. Hyperglycemia (hige blood sugar) * What is hyperglycemia (high blood sugar)? Hyperglycemia (high blood sugar) can occur due to any interruption in the delivery of insulin. It is important to know that if there is no insulin delivery you may experience an increase in blood sugar which, if undetected or untreated, may cause DKA (diabetic ketoacidosis).
3. Occlusion Alarm The causes of occlusion alarms are very variety. The tubing may be blocked by uncertain materials or may be caused by other external factors. The various causes of occlusion are described as follows. * Real Occlusion (Usually within the Cannula or tube) OCCLUSION CAUSES Use of the reservoir or Infusion Set for longer than intended usage. Infusion Sets or reservoir is re-used.
4. Troubleshooting the Insulin Pump PROBLEM CORRECTIVE ACTION An abnormal LCD can occur when the battery charge is low. Check the remaining battery charge after you administer a bolus dose. Abnormal LCD The life span of the battery is between 3-6 weeks, but varies among users. Some batteries are known to still show a full charge after two months.
9. Taking care of the System 1. Cleaning the System 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 benzene, acetone and household industrial cleaners can cause irreparable damage to the Insulin Pump. 1. The outside of the Insulin Pump and Accessory should be cleaned monthly. 2.
2. Infusion Sets 10. Specification 1. Insulin Pump SPEC Size INSULIN PUMP Net Weight Insulin Reservoir 3.8× 1.8× 0.8 inch (97 × 47 × 22mm) **including reservoir cap 75g (without battery), 86g (including battery) 3mL(300 Units) insulin compatible reservoir Meal Bolus Setting Basal Rate Setting Basal Profile Minimum Basal Rate Minimum Increment 0 - 80u 0, 0.04 ~ 16.0 u/h 4 Types of 24 hours period 0.04 u/h 0.01 unit Motor Swiss Micro DC motor (3V, 5.
3. Prime Volume of Infusion Sets 4. Delivery accuracy 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. Delivery Intervals: 4 minutes when a basal setting is not lower than 0.1u/h 60 minutes when basal delivery setting is 0.04 - 0.09u/h Delivery Accuracy: ± 4% Trumpet Curve for Delivery Accuracy (-1.
5. Classification and Compliance with Standards • The Diabecare DANA-i is classified as an internal powered equipment BF type under the standard of IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety). • It is not suitable for use in the presence of a flammable anesthetic mixture by the standard of IEC 60601-1. • The System will continuously operate according to the user defined settings. 6.
7. Wireless communication * DATA Security The Diabecare DANA-i system ensure data security via proprietary means and ensure data integrity using error checking processes, such as cyclic redundancy checks. * Declaration of EMC compatibility The Diabecare DANA-i insulin pump is intended for use in the electromagnetic environment and comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility.
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 International Protection Code. Dustproof degree: 6 / Waterproof degree:8 Caution.
11.
FCC Information SOOIL Development Company Limited warrants that the Diabecare DANA-i System is free from defects in material and workmanship under normal use and conditions and will warrant this for a period of four (4) years from the date of purchase by the original purchaser. This limited warranty extends only to the original purchaser. Should the System fail to operate properly due to defect in material or workmanship during the warranty period, it may be returned to SOOIL Development Co. Ltd.
IFU-130-EN (rev.0_191104) SOOIL DEVELOPMENT Co.
