User Guide.
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Sooil Development Co.,Ltd. 2725 Nambusunhwan-ro, Gangnam-gu Seoul, Korea, 06274, Koear Tel: 82-2-3463-0041 Fax: 82-2-3463-7707 E-mail: sooil@sooil.com http://www.sooil.com Sooil LLC 9919 Hibert Street, Suite C, San Diego, CA 92131 Tel: 1-866-747-6645 Customer Support Table of Contents 1. Introduction 6 1. Diabecare DANA-i Insulin Pump Introduction 2. Explanation of Warning Symbols 3. Indications for Use 4. Contradiction 5. Potential Risks 6. Airport Security (Only for US manual) 7.
5. Connecting the Infusion Set to the Insulin Pump 6. Refill 7. Prime the Infusion Set Tubing * PRIME procedure: 8. Prime the Cannula * Connection of Pump & Reservoir 9. Inserting Infusion Set * Recommending insertion site location 43 44 46 47 49 51 53 55 5. Delivering a Bolus 57 * 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.
7. 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 This page left blank intentionally Instruction for Use ⑴ Syringe Cap ⑴ Battery Cap ⑴ Linking Screw ⑵ DANA Auto Setter (1) 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 A A A Insulin Pump 1. Open the battery cap by inserting the into the battery cap slot and turning clock-wise ¼ turn. 2. Insert the battery with the positive at top and insert the (-) into the Insulin Pump. 3. Replace the battery cap turning it counter clock-wise. 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 Setting the time and date 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 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 • 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.
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. OPTION 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 Basal settings must be programed before using the insulin pump. Basal insulin is required to maintain an ideal glucose level while fasting.
* Description of Basal Graph: EDIT A TDD : 05.60 18 - 19 ① Select time 00-01 EDIT A 23-24 0.30u ② ③ ④ ⑤ 1. Basal 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. 2. Basal Profile Letter The active basal profile Letter# is in the title line. The example indicates that Basal Profile #A is selected.
* How to edit the Basal Rate: EDIT A TDD : 04.80 14 - 18 -.--u MAIN MENU BASAL EDIT A TDD : 05.20 14 - 18 0.30u SUB MENU EDIT BASAL VIEW BASAL RATE CHANGE PROFILE SETTING SAVED TDD : 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 TDD : 05.60 05PM - 06PM 0.20u 1.
* User Options 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.RES. VOL. MOD: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.RES. VOL. MOD: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 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. Loading and refilling the Insulin Pump with insulin is a technical process which involves medication (insulin) and sterile components.
2. Filling the Reservoir with Insulin Reservoir Cap 1. Remove the round cap at the backend of the reservoir plunger and discard. 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 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. Turn (counterclockwise) the Insulin Pump Reservoir Cap so that it is firmly locked in place.
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 the system. The pump may not properly deliver insulin without this.
* 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 .
7. 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. SAVE 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.
8. Reloading the pump The previous instructions from (4.1 Loading the Pump) 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 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. ✓ CARBO.: Inputting grams of carbohydrate to be consumed. The pump will estimate the dosage based on the CIR specific to the time of the day the bolus is being delivered.
* Three type of Bolus Delivery 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: 1. Bolus (Quick Bolus) This bolus can be used to cover the carbohydrate in a meal or snack. MAIN MENU BOLUS MENU STEP BOLUS BOLUS MENU EXTENDED BOLUS After a suggested bolus amount is shown press to select the bolus type: • Step Bolus (Refer to chapter 5.1) • Extended Bolus (Refer to chapter 6.
* How to start the (Quick) bolus delivery: BOLUS 1. Select BOLUS from the BOLUS Sub menu press . BOLUS CAL. 80 g 25 3.20 u STEP BOLUS BOLUS 3.20 u SPEED 12 sec/u BOLUS DELIVER BOLUS? - :NO INSULIN INJECT 2.70 u 3.20 u - :STOP STEP BOLUS 3.20U DELIVERED 54 2. Adjust the grams of carbohydrate with or . Move down the menu using to adjust the CIR. Press for next step. 1. During the BOLUS delivery press the Confirm the STOP with . button. OK :YES STEP BOLUS 2.70U DELIVERED 2.
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.
3. Bolus Setting The Bolus Setting menu enables personalization of all Bolus features within the insulin pump. MAIN MENU BOLUS SUB MENU BOLUS BOLUS BG BOLUS CALCULATOR BOLUS SETTING 1. Select BOLUS SETTING from within the BOLUS MENU press . BG BOLUS CALCULATOR This page left blank intentionally BOLUS SETTING 9.EXIT 1.CIR/CF SETTING 2.EXTENDED BOLUS:OFF 2. The bolus setting menu is shown BOLUS SETTING 1.CIR/CF SETTING 2.EXTENDED BOLUS:OFF 3.BOLUS CAL.:CARB. 4.BOLUS RATE 5.MISSED BOLUS1:OFF 6.
* Bolus Setting BOLUS SETTING 9.EXIT 1.CIR/CF SETTING 2.EXTENDED BOLUS:OFF SELECT CIR OR CF - :CF OK :CIR CIR SET 23-24 CIR:20 00-01 CIR:20 01-02 CIR:20 02-03 CIR:20 03-04 CIR:20 04-05 CIR:20 05-06 CIR:20 * Bolus Setting 1. CIR/CF SETTING Select CIR or CF Press the button to adjust the CF (correction factor) or press the button to adjust the CIR (carb to insulin ratio).
* 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. BOLUS SETTING 9.00 u BREAKFAST BOLUS SETTING 12.00 u Pre-set meal boluses are set following by these time periods. • BREAKFAST = 01:00 - 09:59 (1:00 am - 9:59 am) • LUNCH = 10:00 - 14:59 (10:00 am - 2:59 pm) • DINNER = 15:00 - 00:59 (3:00 pm - 12:59 am) 6. Advanced features within Pump 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 0.20 u/h 100% 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. 3. Button Lock 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. MAIN MENU MAIN MENU BUTTON LOCK SUSPEND 1. Select SUSPEND from the MAIN MENU.
4. Basal Profile 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 5. HISTORY : Displays all the Pump History History and pump memory can be viewed either on the Insulin Pump MAIN MENU BASAL REVIEW SUB MENU SUB MENU EDIT BASAL BASAL VIEW BASAL RATE CHANGE PROFILE 1. Select BASAL PROFILE from the BASAL sub menu. CHANGE PROFILE 03/10/2019 2.
* Review Menu BOLUS H. (u) A B C 03/08 17:13 s 03/09 09:12 E 0:00 2.20 1:00 3.20 D E 1. BOLUS HISTORY Record of the most recent 300 BOLUSES A. DATE (mm/dd) B. TIME (hh:mm) C. BOLUS Type S = Step E = Extended DS = Dual Step DE = Dual Extended D. Duration of Bolus (hh:mm) E. Bolus amount (units) BOLUS AVG. (u) AVG AVG AVG 10.2 12.3 11.5 DAILY TOTAL. (u) 03/10 03/09 03/18 2.5/10.4 2.5/12.3 2.1/14.8 REFILL H. (u) 03/08 03/05 03/02 09:02PM 05:32PM 11:55AM 240 220 210 PRIME H.
6. SHIPPING INFORMATION This displays the country that the pump was originally shipped to after manufacture. Also displayed is the date of manufacture, pump serial number and the software version installed. 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.
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 (Quick Bolus) 03/10/2019 10:04 AM EXTENED 1.20u/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 1. From MAIN MENU select BOLUS From BOLUS sub menu select Bolus icon. * Stopping a Dual Pattern Bolus To stop the extended part of a Dual Bolus from the EXT Bolus status menu. 03/10/2019 10:04 AM EXTENED 1.20u/h B 0.20 u/h 100% BOLUS 245u BOLUS CAL. CARBO CIR BOLUS 80 g 25 3.
7. Alarms and Error Messages This chapter describes insulin pump alarms and error messages and how to solve them. Diabecare DANA-i alarms and error messages are as follows.
* WARNING Message LOW RESERVOIR When the reservoir volume is below the 'Low Reservoir' warning configured in the user options, this screen will be shown with an alarm. WARNING 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. Notice The pump has a Low Reservoir alarm.
* ERROR Message * ALARM Message CHECK ERROR This alarm occurs if the Insulin Pump suspects an internal signal defect. WARNING SYSTEM ERROR This alarm occurs when the Insulin Pump detects any unusual movement of the controller. WARNING CHECK ERROR SYSTEM ERROR How to solve: If/when either of these alarms, removal of the battery will silence the alert. 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.
* ALARM Message PRIME AMOUNT IS NOT ENOUGH This alarm/alert message will be displayed if the volume delivered for tubing prime is less than 7 units. ALARM PRIME AMOUNT IS NOT ENOUGH How to solve: Properly priming the infusion set tube is necessary to ensure all air is displaced and insulin is ready for infusion. Even the shortest infusion set tube will require more than 7 units to properly prime - so for safety the Insulin Pump has a minimum required Prime volume of 7 units. Refer to 10.
* ALARM Message CHECK GLUCOSE This alarm is to remind you to check blood glucose level after a bolus. ※ Reason of NO DELIVERY ALARM CHECK GLUCOSE 03/10/2019 NO PRIME How to solve: Silence the alarm by pressing any button. In this case, insulin is not delivered until prime is properly completed. Refer to 4.7 Prime the infusion set tubing. Notice The default is 2 hours and can be adjusted by a health care professional in the Dr. Mode. 03/10/2019 - :NO 0.00 u/h 100% 245u If basal setting is 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. Hypoglycemia (low 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 tube 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. Taking care of the System 5. Cleaning the System Use a soft cloth or tissue to wipe the exterior of the Insulin Pump.
6. Disposing of Pump and System. Consult a healthcare provider for instructions for disposal of devices containing electronic waste such as you pump and for instructions for disposal of potentially bio hazardous materials such as used cartridges, needles, syringes, and infusion sets. 7. Storing the System For safe transport and storage of the Diabecare DANA-i Insulin Pump system avoid the following conditions: • Storage Temperatures below -20°C (-4°F) or above 50°C (122°F).
2. Infusion Sets 9. 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 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.
4. Delivery accuracy 5. Classification and Compliance with Standards 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 (-1.94 %) at the basal setting of 8u/h (the intermediate rate) • 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).
6. Essential Performance The Insulin infusion pump maintains insulin delivery accuracy in the specified environmental conditions. 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.
Electromagnetic immunity – for all ME equipment and ME systems Emissions test IEC 60601 test level Compliance Electromagnetic environment The Diabecare DANA-i should ±8㎸ contact not be affected by electrostatic ±15㎸ air discharge that might occur under normal conditions of use.
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Radiated RF IEC 61000-4-3 10 V/m 80 ㎒ to 2.7 ㎓ a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
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.
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 accompanying this instrument Adhesive plaster Date of manufacture Tubing length (1100mm, 700mm, 550mm / 43inch, 27inch, 22inch) Manufacturer International Protection Code.
10.
11. Warranty 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_000000) SOOIL DEVELOPMENT Co.
