Sooil Dana Diabecare R User Manual
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Sooil Dana Diabecare R User Manual

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Summary of Contents for Sooil Dana Diabecare R

  • Page 2 DANA Diabecare R User Manual...

  • Page 3: Table Of Contents

    Patient Education............................13  About Doctor Mode .......................... 13 Programming the Insulin Pump ........... 15  Structure of DANA DIABECARE R INSULIN PUMP MENU ..........15 Setting the time and date ........................16 Setting the Basal Rate ..........................17  Description of Basal Graph: ......................18 ...
  • Page 4 Loading Insulin into the Pump ..........30 Preparation ..............................30 Filling the Reservoir with Insulin ....................... 31 Adjust the length of link-screw with Easy Setter ............... 33  Using DANA Easy Setter :........................ 34 Inserting the Reservoir into the Insulin Pump ................35 Connecting the Infusion Set to the Insulin Pump ..............
  • Page 5  Starting a Dual Pattern Bolus ......................57  Review & Stopping a Dual Pattern Bolus ................58 Discovery ..............................59 Alarms and Error Messages ..........60  WARNING Message ........................... 61  ERROR Message ........................... 63  ALARM Message ..........................64 Troubleshooting ..............
  • Page 6 10. Specification ................ 77 10.1 Insulin Pump ............................... 77 10.2 Infusion Sets ............................... 78 10.3 Prime Volume of Infusion Sets......................79 10.4 Delivery accuracy ............................80 10.5 Classification and Compliance with Standards ................80 10.6 Declaration of EMC compatibility ..................... 81 10.7 Explanation of Universal Symbols .....................

  • Page 7: Introduction

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

  • Page 8: Explanation Of Warning Symbols

    1.3 Indications for Use The DANA Diabecare R 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.

  • Page 9: Precautions For Insulin Pump

    Patients must not open the Pump housing or handle any internal components. The DANA Diabecare R 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.

  • Page 10: Getting Started

    2. Getting Started To make proper use of Dana Diabecare R Insulin pump, the accessories and other devices are necessarily needed. And Components of DANA Diabecare R KIT makes you feel a lot more comfortable when using Dana Insulin Pump.

  • Page 11: Getting To Know The Insulin Pump

    2.1 Getting to know the Insulin Pump  DANA Diabecare R Insulin Pump ① Reservoir Compartment: Turn the reservoir cap clockwise to open. The reservoir with linking screw are inserted in this compartment. ② Battery Compartment: Turn the battery cap counterclockwise to open. The battery is inserted in this compartment.

  • Page 12: Installing A Battery

    2.2 Installing a battery For Insulin Pump Open the battery cap by inserting the Battery ① key into the battery cap slot and turning counter clock-wise. Insert the battery with the positive end down ② into the Insulin Pump. Replace the battery cap and press down ③...

  • Page 13: Check The Dana Battery

     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. ...

  • Page 14: Display Screen

    2.3 Display Screen  Initial Screen Displays remaining battery charge as, Battery status Notice If 0% the battery icon will flash as a warning of low battery The smart phone application connection status Bluetooth Status Button lock Appears on the screen when it is locked. Insulin remaining volume Displays volume of insulin in the reservoir.

  • Page 15: Patient Education

    2.4 Patient Education Follow up education is recommended for all insulin pump user. When starting on insulin pump therapy, the patient should have daily contact with the pump trainer and/or medical professional. Visit with the Endocrinologist, Diabetologist or Advanced Practice Nurse within 3-7 days.
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  • Page 17: Programming The Insulin Pump

    3. Programming the Insulin Pump The Programming in this Chapter can apply to the Insulin Pump  Structure of DANA DIABECARE R INSULIN PUMP MENU...

  • Page 18: Setting The Time And Date

    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. Move to SETTING on MAIN MENU and press 2. Select CLOCK SETTING on SETTING MENU. 3.

  • Page 19: Setting The Basal Rate

    3.2 Setting the Basal Rate Basal settings must be programed before using the insulin pump. Basal insulin is required to maintain an ideal glucose level while fasting. 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.

  • Page 20: Description Of Basal Graph

     Description of Basal Graph: 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.

  • Page 21: How To Edit The Basal Rate

     How to edit the Basal Rate: 1. Move to SETTING on MAIN MENU and press 2. Select BASAL SETTING on SETTING MENU and press 3. Press to move between the 24 hourly-rate-bars in a basal profile. If you choose an hourly-rate-bar, it will be highlighted and the corresponding chronological time will appear in the right corner.
  • Page 22  Group Editing: When you want to change the basal rates for certain consecutive times. 1. Press and hold for a few seconds until the highlighted hourly-rate-bar change into more thicker (to make a block) and cover 2 hourly-rate-bars. 2. Adjust the block size while pressing until the block covers the time periods you desire.

  • Page 23: Changing Basal Profile

    3.3 Changing Basal Profile The basal rates can be saved as 4 different profiles. 1. Move to BASAL PROFILE on MAIN MENU and press 2. Choose a profile you want by pressing button and press 3. On the confirmation screen, select YES to save the settings.

  • Page 24: Setting Bolus

    3.4 Setting Bolus The Bolus Setting menu enables the default bolus size to be adjusted to a personal amount. This setting can apply to both the insulin pump. 1. Select SETTING by pressing on MAIN MENU. 2. Select BOLUS SETTING on SETTING MENU. 3.

  • Page 25: Preset Bolus

     Preset 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 is as an option within Bolus setting menu. Pre-set boluses are set following by these time periods.

  • Page 26: Setting User Options

    3.5 Setting User Options The user can change the settings related to pump usage through the User option. 1. Select SETTING in MAIN MENU and press 2. Select USER OPTION on SETTING MENU and press 3. Use the buttons to set the user option. to move to next item.
  • Page 27  User Options 1. TIME DISPLAY Adjust the time display as 12hour or 24hour. 2. BUTTON SCROLL When ON holding the buttons adjusts the value quickly. 3. BEEP Key Beep ON/OFF enables an audio tone when buttons are depressed. 4. ALARM Change between SOUND, VIBRATION or BOTH for alerts and pump alarms.
  • Page 28 9. GLUCOSE UNIT Adjust the unit of measure for Glucose results between MMOL (mmol/L) or MG (mg/dL). Warning Using wrong unit of measure could lead to Glucose results being misinterpret. 10. SHUTDOWN This is a safety setting, where if no buttons are depressed after the time set (0 –...

  • Page 29: Cir/Cf Setting

    3.6 CIR/CF Setting Used in the Bolus Calculator and the Bolus menu (when calculation is activated) to accurately calculate the appropriate bolus to deliver. 1. Select SETTING on MAIN MENU and press 2. Select CIR/CF SETTING on SETTING MENU and press 3.
  • Page 30 CIR = Carbohydrate to Insulin Ratio CIR and CF are ratio's - so they each reflect how much 1u of insulin will cover. CIR is a setting based on the amount of carbohydrate in grams per 1u of insulin requirement. CF = Correction Factor CF is a setting based on the expected change in Blood Glucose in mg/dl or mmol/L per 1u of insulin.
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  • Page 32: Loading Insulin Into The Pump

    4. Loading Insulin into the Pump 4.1 Preparation Loading and refilling the Insulin Pump with insulin is a technical process which involves medication (insulin) and sterile components. It is recommended that: Retrieve the insulin vial from the refrigerator and let it warm up to room ...

  • Page 33: Filling The Reservoir With Insulin

    Filling the Reservoir with Insulin 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.
  • Page 34 6. 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.

  • Page 35: Adjust The Length Of Link-Screw With Easy Setter

    4.3 Adjust the length of link-screw with Easy Setter The DANA Easy Setter is intended for adjusting the length of linking screw ready for the reservoir to be loaded into the pump. DANA Easy Setter Insert a battery into Easy Setter Open the battery compartment.

  • Page 36: Using Dana Easy Setter

     Using DANA Easy 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. Insert a reservoir filled with insulin into the DANA Easy Setter.

  • Page 37: Inserting The Reservoir Into The Insulin Pump

    4.4 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.
  • Page 38  Connection of Pump & Reservoir The following is structure of pump and reservoir through linking screw. Connection Success Connection Fail If after a new refill, insulin pump If the linking screw is too short, it primes the tubing properly and won’t engage with the pump insulin droplets appear at the motor and insulin delivery fails.

  • Page 39: Connecting The Infusion Set To The Insulin Pump

    4.5 Connecting the Infusion Set to the Insulin Pump Attach the Infusion Set Tube counter clockwise into the reservoir compartment until it is firmly in place. TIP! The DANA insulin pump uses a proprietary LH(Left Hand) lure connection between the insulin pump and the Infusion Set tubing.

  • Page 40: Refill

    4.6 Refill With the refill input, pump get to know exactly what the insulin amount is. 1. Move to REFILL on MAIN MENU, press 2. Adjust the insulin amount directly using the buttons and press buttons. Notice The 250 units are the default amount. 3.

  • Page 41: Prime The Infusion Set Tubing

     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 It is important to properly prime the Tube and ensure all air is removed from the system.

  • Page 42: Inserting Infusion Set

    4.7 Inserting Infusion Set 1. Choose an insertion site on your abdomen at least 5 cm away from the navel. Clean the site with an alcohol swab and dry off the site completely. 2. Hold the infusion set with your fingers as the guiding drawing.

  • Page 43: Recommending Insertion Site Location

     Recommending insertion site location 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. It is recommended that good rotation between 4 separate areas on the body –...

  • Page 44: Delivering A Bolus

    5. Delivering a Bolus The DANA Insulin Pump can deliver a bolus of insulin using different user input parameters to calculate the bolus volume. Step Bolus (Quick): This standard bolus option can be calculated by either.  Bolus Calculator (Smart Bolus): This smart bolus option uses the bolus ...

  • Page 45: Bolus (Step Bolus)

    5.1 Bolus (Step Bolus) This bolus can be used to cover the carbohydrate in a meal or snack.  How to start the (Quick) bolus delivery: 1. Move to BOLUS on MAIN MENU, and press 2. Choose whether calculate bolus amount with carbohydrate or not prior to bolus process.

  • Page 46: Stop Delivery During Bolus

    7. The DELIVERY… screen displays during the delivery and you will hear the sound of motor run as the bolus is being delivered. Notice You will hear the Insulin Pump beep or vibrate for every 1.0 unit while a bolus is being delivered.

  • Page 47: Bolus Calculator (Smart Bolus)

    5.2 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. 1. Move to BOLUS CALCULATOR on MAIN MENU, and press 2.
  • Page 48 5. Start the BOLUS by selecting YES. Within the BOLUS review display the following values are displayed Is the Bolus dose to adjust Glucose = (BG-IDEAL)/CF Is the Bolus dose to cover Carbohydrate in the meal = CARBO/CIR Is the residual Active insulin calculated from previous boluses. It is called "Active Insulin"...

  • Page 49: Advanced Features Within Pump

    6. Advanced features within Pump 6.1 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.

  • Page 50: Review & Stopping Temporary Basal

     Review & Stopping Temporary Basal 1. If the Temporary basal is active the basal status will be changed according to the setting of the temporary basal. 2. Select TEMPORARY BASAL from the MAIN MENU. 3. TEMP. BASAL Status is displayed. ①...

  • Page 51: Suspend

    6.2 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. 1. Move to SUSPEND on MAIN MENU, and press 2.

  • Page 52: Button Lock

    6.3 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.  1. Move to BUTTON LOCK on MAIN MENU, and press 2.

  • Page 53: History : Displays All The Pump History

    6.4 HISTORY : Displays all the Pump History History and pump memory can be viewed either on the Insulin Pump 1. Move to REVIEW on MAIN MENU, and press 2. The Use scroll up/down. button to next menu.  Review Menu 1.
  • Page 54 3. DAILY TOTAL HISTORY History of last 60 day’s delivery totals Displayed as date with Basal / Basal +Bolus 4. REFILL HISTORY History of when pump has been refilled, time and volume of Insulin loaded. 5. PRIME HISTORY History of Pump Prime’s, Date, Time, Volume 6.
  • Page 55  Review Menu 10. TEMP. BASAL History of Temporary Basal rates Date, Time of when Temporary rate is started (ON) or stopped (OFF). 11. BASAL HISTORY Review of hourly basal delivery. Scrolling back hour by hour of delivered basal up to 60days history.

  • Page 56: More Information

    6.5 More Information The More Information screen provides a quick review of: Active Insulin from a previous bolus.  Extended bolus information (if active).  The most recent bolus delivery information including how many minutes  ago the bolus was delivery and the volume of the bolus. Move to MORE INFORMATION on MAIN MENU, and press ACTIVE INSULIN...

  • Page 57: Extended Bolus

    6.6 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 your Healthcare Professional about this condition and treatment.

  • Page 58: Review & Stopping An Extended Bolus

     Review & Stopping an Extended Bolus 1. Extended state shown on the initial screen. 2. If you want to review or stop the extended bolus, enter the Extended Bolus menu again by selecting BOLUS menu from Main Menu. 3. The EXT. BOLUS displays the current active Extended Bolus.

  • Page 59: Dual Pattern Bolus

    6.7 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.  Starting a Dual Pattern Bolus 1.

  • Page 60: Review & Stopping A Dual Pattern Bolus

     Review & Stopping a Dual Pattern Bolus 1. Dual state shown on the initial screen. 2. If you want to review or stop the extended bolus, enter the Dual Pattern Bolus again by selecting BOLUS menu from Main Menu. 3.

  • Page 61: Discovery

    6.8 Discovery The DISCOVERY feature allow the insulin pump to connect with other Bluetooth devices. 1. Move to SETTING on MAIN MENU, and press 2. Select DISCOVERY on SETTING MENU and press 3. Discovery icon( ) will blink for 60 seconds. 4.

  • Page 62: Alarms And Error Messages

    7. Alarms and Error Messages This chapter describes insulin pump alarms and error messages and how to solve them. DANA Diabecare R alarms and error messages are as follows. Type Alarm and Error Message LOW BATTERY WARNING OCCLUSION (High Priority)

  • Page 63: Warning Message

     WARNING Message LOW BATTERY The low battery screen will appear when the battery level is not sufficient to operate the devices. A continuous alarm will be activated with both sound and vibration. How to solve: Remove the battery from the devices and replace with a new battery. Low Battery warning step Step.1 Recommended to change: When battery energy is below 5%, an...
  • Page 64 OCCLUSION This warning occurs if your Insulin Pump has an occlusion or a problem which disturbs insulin delivery. How to solve: An occlusion alarm will occur when the Insulin Pump detects a blockage and cannot deliver insulin. Check for blocked or folded areas and replace the reservoir or infusion set if necessary.

  • Page 65: Error Message

    WARNING Message  SHUTDOWN The Pump will automatically give an alarm sound if no buttons are pressed after the pre-set shutdown period is exceeded. If no acknowledgment of the alarm is received (button press) following the audible alarm - the pump will suspend all insulin delivery.

  • Page 66: Alarm Message

     ALARM Message SUSPEND When you try to select any menu related to infusion (insulin delivery) whilst the Insulin Pump is in Suspend Mode, you are alerted with this message. Refer to 6.2 SUSPEND. How to solve: Turn the Suspend Mode off prior to continuing in any of the infusion (insulin delivery) menu's.
  • Page 67  ALARM Message CHECK GLUCOSE This alarm is to remind you to check your blood glucose level after a bolus. How to solve: A melody will play for 30 seconds. You can silence by depressing any button. Notice The default is 2 hours and can be adjusted by your health care professional in the Doctor Mode.
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  • Page 69: Troubleshooting

    8. Troubleshooting 8.1 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. The symptoms are: Headache and dizziness ...

  • Page 70: Hypoglycemia Troubleshooting

     Hypoglycemia Troubleshooting POSSIBLE CAUSE SUGGESTED RESPONSE Consult with your healthcare professional to make Increased physical adjustments for increased physical activity. You may activity choose to use or modify temporary basal rates or decrease meal boluses prior to activity. Consult with your healthcare professional to adjust basal Eating less rates or meal boluses to more accurately reflect your current intake.

  • Page 71: Hyperglycemia (High Blood Sugar)

    8.2 Hyperglycemia (high 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 your blood sugar which, if undetected or untreated, may cause DKA (diabetic ketoacidosis).

  • Page 72: Troubleshooting For Hyperglycemia

     Troubleshooting for Hyperglycemia POSSIBLE CAUSE SUGGESTED RESPONSE Visually check display screen for remaining insulin and Empty reservoir also visually check reservoir in Pump. Replace reservoir if required. Examine infusion site to make sure that there is no Insulin leakage at leakage.

  • Page 73: Occlusion Alarm

    8.3 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 WHAT TO DO Use of the reservoir or Infusion Set for...

  • Page 74: Occlusion Caused By External Factor

     Occlusion caused by external factor OCCLUSION CAUSES WHAT TO DO Wash linking screw in warm water Linking screw has previously been with mild detergent, thoroughly dry affected by insulin leakage. (seldom) then reinstall the linking screw into the pump. Adjust and fully loosen the linking The end of insulin delivery.

  • Page 75: Troubleshooting

    Remove the battery and reinsert it into the pump. Cannot Refill Notice The DANA Diabecare R Insulin Pump is allowed only 2 times of Refill process in one day for user safety. Warning In case of device malfunction, stop using the Insulin Pump...

  • Page 76: Battery For Dana Insulin Pump

    8.5 Battery for DANA Insulin Pump DANA Insulin Pump Battery is a Lithium ½ AA size. Caution Do not store or transport the unpackaged battery with any conductor such as coin, metal key or metal clip. The Battery has a high-risk of starting a fire if the battery poles are shorted.

  • Page 77: Maintenance Of The Devices

    9. Maintenance of the devices 9.1 Caring for the Insulin Pump Use a soft cloth or tissue to wipe the exterior of the devices. 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 devices.

  • Page 78: Transport And Storage Condition

     Transport and Storage Condition For safe transport and storage of the DANA Diabecare R Insulin Pump avoid the following conditions: Storage Temperatures below -20°C (-4°F) or above 50°C (122°F).  Operation Temperatures below 1°C (34°F) or above 40°C (104°F).

  • Page 79: Specification

    10. Specification 10.1 Insulin Pump SPEC INSULIN PUMP Size 91× 45.5× 20 mm (3.6× 1.8× 0.8inch) **including reservoir cap Net Weight 61g (including battery) Insulin Reservoir 3mL(300 Units) insulin compatible reservoir Meal Bolus Setting 0 - 80u Basal Rate Setting 0, 0.04 ~ 16.0 u/h Basal Profile 4 Types of 24 hours period...

  • Page 80: Infusion Sets

    10.2 Infusion Sets Easy Soft- Soft- Easy Super Line Release Ⅱ Release-o Release-ST Release Needle gauge Stainless Stainless Stainless Needle type Teflon Teflon Steel Steel Steel Insertion 90° 15-30° 0°, 90° 90° 90° angle Disconnect Notice Each type of Infusion Set is unique. Healthcare Professional and your Insulin Pump Trainer will help provide assistance with the most appropriate Infusion Set to use.

  • Page 81: Prime Volume Of Infusion Sets

    10.3 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 82: Delivery Accuracy

    Trumpet Curve for Delivery Accuracy (-1.94 %) at the basal setting of 8u/h (the intermediate rate) 10.5 Classification and Compliance with Standards The DANA Diabecare R is classified as an internal powered equipment BF type  under the standard of IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety).

  • Page 83: Declaration Of Emc Compatibility

    10.6 Declaration of EMC compatibility The DANA Diabecare R insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the DANA Diabecare R insulin pump should assure that it is used in such an environment.
  • Page 84 Electromagnetic immunity – for all ME equipment and ME systems Electromagnetic Emissions test IEC 60601 test level Compliance environment The DANA Diabecare R should not be ±8㎸ Electrostatic affected by ±8㎸ contact contact discharge(ESD) electrostatic discharge ±15㎸ air IEC 61000-4-2 that might occur ±15㎸...
  • Page 85 Portable and mobile RF communications equipment should be used no closer to any part of the DANA Diabecare R insulin pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 86 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 DANA Diabecare R insulin pump is used exceeds the applicable RF compliance level above, the DANA Diabecare R insulin pump should be observed to verify normal operation.

  • Page 87: Explanation Of Universal Symbols

    10.7 Explanation of Universal Symbols On the packaging and on the type plate of DANA Diabecare R System you may encounter the following symbols shown here with their meanings: Follow instructions for use Caution. Refer to safety-related notes in the manual...
  • Page 88 Adhesive plaster Tubing length (1100mm, 700mm, 550mm / 43inch, 27inch, 22inch) International Protection Code. IP28 Dustproof degree: 2 / Waterproof degree:8 Direct current Disposal (WEEE marking) Non-Pyrogenicity Keep dry Storage temperature range Do not use if package is damaged Storage humidity range Atmospheric pressure limitation...

  • Page 89: Index

    11. Index Accessories Easy Setter Active Insulin Edit Basal Alarm and Error Error message Extended Bolus Basal Profile Basal Setting Glucose Unit Change Battery Group Editing Installing a battery Battery for Insulin pump Bolus Step Bolus(Quick) History BG Bolus Calculator(Smart) Hyperglycemia Bolus Setting Hypoglycemia...
  • Page 90 Occlusion Warning 62, 71 User option Option Volume of infusion set Password Preset Bolus Prime the infusion sets Warning message Refill procedure Reservoir (Fling with insulin) 31 Review Shipping Information Specification Structure of Menu Suspend Symbol Temporary basal Time and date setting Transport and storage Troubleshooting...

  • Page 91: Warranty

    • 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 DANA Diabecare System.
  • Page 93 IFU-180-EN (rev.15_190705) P502400ENXX0401XX01X...

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