SOOIL Development DANAIIS DANA Diabecare IISR Insilin Pump User Manual

SOOIL Development Co., Ltd. DANA Diabecare IISR Insilin Pump Users Manual

Users Manual

DANA DiabecareⓇIISR User Manual#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지1 001 Acrobat™ PDFWriter 300DPI 60LPI
Thank you for choosing the DANA DiabecareⓇIISR Insilin Pump. SOOIL Development Co., Ltd. has been committed to making scientific advancements in the developmentand production of innovative medical solutions for the management, treatment and cure of diabetesthroughout the world since 1979. Your DANA DiabecareⓇIISR has been designed and built with the mostadvanced technology available to create a high quality and very reliable device for the subcutaneous deliveryof insulin. When used properly, your DANA DiabecareⓇIISR will give you years of improved blood glucosecontrol while enhancing your quality of life. The welfare of the patient has been the cornerstone of our company’s philosophy since 1979 when Dr.Soo-Bong Choi and his father, Dr. Hyun Choi, designed their first insulin pump for patients in their diabetescenter. There are now more than 50,000 people throughout the world managing their diabetes with theDANA Diabecare line of insulin infusion pumps. The DANA DiabecareⓇIISR Insulin Pump is the only pump that adds simplicity to the complex technology ofthe device.We welcome your comments and look forward to being key members of your diabetes team.SOOIL Development Co., Ltd.Soo-Bong Choi, M.D., Ph.D.CEO SOOIL Development Co., Ltd.W a r n i n gPlease note, US law restricts this device to use by or on order of a physician.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지2 001 Acrobat™ PDFWriter 300DPI 60LPI
DANA DiabecareⓇIISR User Manual#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지3 001 Acrobat™ PDFWriter 300DPI 60LPI
Co n t e n t s1. Before using your DANA DiabecareⓇIISR insulin pump, infusion set and reservoir•Indications for use•Safety precautions •Cleaning your DANA DiabecareⓇIISR insulin pump•Explanation of “W a r n i n g”, “C a u t i o n”, and “N o t e”s y m b o l s•Contents of DANA DiabecareⓇIISR insulin pump kit •Identification and description of your pump features •Infusion Sets2. Set-up and basic functions•Explanation of display screens- Initial display- Basic display•Inserting the battery•Setting bolus doses, basal rates and the clock - Setting a bolus- Setting the basal rate- Setting the clock•Checking bolus doses, basal rates and reviewing memory data•Suspending the pump•User Setting3. Filling and inserting a new reservoir•Changing the reservoir- Preparation - Filling the reservoir with insulin- Instructions for use of DANA Easy SETTER- Inserting the reservoir into the pump- Connecting the infusion set to your pump - Priming the infusion set- Inserting the infusion set•Infusion sets- EasyRelease- EasyRelease II- Soft-Release-R445556788891 01 11 31 41 51 71 82 12 12 22 32 32 42 42 62 72 73 03 3#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지4 001 Acrobat™ PDFWriter 300DPI 60LPI
3 63 94 04 65 35 35 45 55 55 65 75 96 06 16 36 46 46 46 46 46 56 56 66 7- Soft-Release-ST•General Precautions for All Infusion Sets4. Bolusing and temporary basal rates •B o l u s•Temporary basal 5. Remote Control•Synchronize the Remote Control with the Pump•B o l u s•Lock Setting•Setting the Clock•Disconnect Remote Control and Insulin Pump•Checking your blood glucose level•Calculating your bolus dosage•Glucose meter related error messages and troubleshooting6. Troubleshooting•When hypoglycemia (low blood sugar) occurs•When hyperglycemia (high blood sugar) occurs•Problem / Correction Action7. List of alarms and audible signals•Low reservoir •ERROR screen •Daily remainder •Daily max •Low battery8. Specifications, symbols, warranty•General specifications•Classification and compliance with standards•Universal symbols•Warranty #다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지5 001 Acrobat™ PDFWriter 300DPI 60LPI
41. Before using your DANA DiabecareⓇIISR Insulin Pump,infusion set and reservoirIndications for UseThe DANA DiabecareⓇIISR insulin pump, infusion set and reservoir are intended for the continuous delivery of insulin for themanagement of diabetes mellitus. It is not intended for the delivery of blood or blood products.Safety Precautions1. Patients must not open the pump housing or handle any internal components.2. The DANA DiabecareⓇIISR insulin pump is intended for use with a proprietary infusion set, reservoir, and other accessoriesspecified in this booklet. Do not use the pump with any other infusion system or accessories.3. If you experience any trouble with the pump, switch the pump off immediately and contact your healthcare provider or yoursales representative.4. Use the pad of your finger to press the buttons. DO NOT use your fingernails or any sharp objects to press the buttons.5. Avoid the following conditions for safe storage and transport of the DANA DiabecareⓇI I S R :1) Temperatures below -0.5°C or above 40°C .2) Atmospheric pressure below 500mmHg or above 1060mmHg.3) Humidity above 95%.4) Exposure to excessive dust or a salty environment.5) Exposure to explosive gas.6) Exposure to direct sunlight.7) Environments where an electromagnetic field is generated by a medical device.6. The pump must not be used in the presence of intense electromagnetic fields, such as those generated by certainelectrically powered medical devices. The pump should be removed prior to the user having a CT Scan, MRI or X-ray.7. The pump comes with factory default settings for alarms, maximum daily totals, basal and bolus doses. These settingsmay be modified by a healthcare professional.8. Remove the battery for long-term storage.9. The reservoir and infusion set are intended for single use only. Do not reuse either the reservoir or infusion set.10. Change the reservoir and the infusion set regularly, as recommended by your healthcare professional. Do not use eitherfor longer than 72 hours.11. The shelf life of the reservoir and the infusion set is 3 years. Please check the expiration dates regularly and dispose ofany expired accessories.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지4 001 Acrobat™ PDFWriter 300DPI 60LPI
1. indicates the presence of a hazard which can cause severe personal injury, death or substantial propertydamage if the warning is ignored.2. Caution indicates the presence of a hazard which will or can cause minor personal injury or property damage ifthe warning is ignored.3. Note advises the user of installation, operation or maintenance information which is important but not hazard-r e l a t e d .51. Before using your DANA DiabecareⓇIISR insulin pump, infusion set and reservoirCleaning your DANA DiabecareⓇIISR insulin pump1. The outside of the pump should be cleaned monthly.2. When cleaning the pump, use a cloth moistened with water or a neutral pH detergent and wipe it with a dry cloth.3. Do not use thinner, alcohol, benzene or similar solvents.Explanation of “W a r n i n g ,”“C a u t i o n ,”and “N o t e”S y m b o l sContents of the Dana DiabecareⓇIISR Insulin Pump KitINSULIN PUMP REMOTE CONTROL RESERVOIR (6) INFUSION SETS (6)DANA EASY SETTER (1)LINKING SCREW (2) BATTERY (2) ADHESIVE TAPEB E L T BATTERY KEY (2) LEATHER CASE (2) BRA POUCH SHOWER POUCH SHOULDER POUCH TEGADERM MEFIX W a r n i n gC a u t i o nN o t eN o t e Additional accessories may be purchased separatelyN o t e MEFIX is not available in Canada™#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지5 001 Acrobat™ PDFWriter 300DPI 60LPI
6Identification and Description of the DANA IISRThe DANA DiabecareⓇIISR insulin pump, infusion set and reservoir are intended for the continuous delivery of insulin for themanagement of diabetes mellitus. It is not intended for the delivery of blood or blood products.①Reservoir C o m p a r t m e n t②B a t t e r yC o m p a r t m e n t⑦B a t t e r yC o m p a r t m e n t③Reservoir Window④Control Panel⑤L C D⑥Blood Glucose Meter Test Port①Reservoir Compartment: The reservoir and linking screw areinserted in this compartment. Turn cap clockwise to open.②Battery Compartment: The battery is inserted in thiscompartment. Turn cap counterclockwise to open.⑦Battery Compartment: Push the cover of the battery tothe arrow direction to open. ③Reservoir Window: Remaining insulin amount can bevisually verified here.⑥Blood Glucose Meter Test Port: Test strips are insertedhere for glucose monitoring.④Control Panel: Contains the four buttons which are usedto increase and decrease settings, switch screens andselect functions.⑤LCD: Displays status of system features and systemmessages and serves as the user interface with pumpsoftware. Lights automatically when any button is pressed.①Press to increase insulin dosages, time and date.②Press to decrease insulin dosages, time and date.③Press to move to the next choice on the LCD.④Press to select the function highlighted on the LCD.①②③④N o t e Buttons will beep when pressed.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:43 PM 페이지6 001 Acrobat™ PDFWriter 300DPI 60LPI
71. Before using your DANA DiabecareⓇIISR insulin pump, infusion set and reservoirInfusion SetsSuperline (90°) E a s y R e l e a s e E a s y R e l e a s e I I S o f t - R e l e a s e - R S o f t - R e l e a s e - S T S u p e r l i n e - S TNeedle gauge 2 7 G 2 7 G 2 7 G 26G 26G 2 7 GNeedle type Stainless Steel Stainless Steel Stainless Steel Polyurethane(Soft cannula)Polyurethane(Soft cannula)Stainless Steel Insertion angle 9 0°9 0°9 0°9 0°0 ~ 3 0°9 0°D i s c o n n e c t N o Y e s Y e s Y e s Yes N oSuperline (90°)S u p e r l i n e - S TEasyRelease IIE a s y R e l e a s eS o f t - R e l e a s e - R S o f t - R e l e a s e - S TN o t e Infusion set specifications are as followsN o t e Product availability varies by country.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지7 001 Acrobat™ PDFWriter 300DPI 60LPI
82. Set-up and basic functionsExplanation of the display screensInitial Display ①Displays current time and date.②Displays remaining battery charge as 100%, 75%, 50%, 25%.③Displays the amount of insulin remaining in the reservoir in units.(1ml=100 units).①②③Basic Display ①CHECK/REVIEW icon - Choose the first icon (magnifying glass) tocheck basal rates, previous bolus doses, last bolus, previous dailytotals and prime history (see page 15 for reviewing the history).②BOLUS icon - Choose the second icon (syringe) to deliver bolus doses.③TEMPORARY BASAL icon - Choose the third icon (person) fortemporary changes in basal rates for exercising or other events.④SET/PROGRAM icon - Choose the fourth icon (sliding scale) toset basal rates, preset bolus doses and set clock.① ③② ④C a u t i o nFor accurate reading of the remaining battery charge,check the initial display immediately after delivering a bolusN o t e Push any button while viewing the initial display to bringup the basic display screen.N o t e The DANA DiabecareⓇIISR LCD screen will automatically go blank after one minute to conserve battery power.Any button press will also activate the backlight for 10 seconds. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지8 001 Acrobat™ PDFWriter 300DPI 60LPI
92. Set-up and basic functionsInserting the BatteryFollow these steps1) Open the battery compartment by inserting the battery key into the battery cap and turning counterclockwise.2) Insert the battery with the positive end down into the pump.3) Close the battery cap by turning the battery key clockwise until tight and flush with pump.C a u t i o n If the O-ring (see graphic ①) on the battery cover appears worn, frayed or torn, please contact your healthcareprovider or your sales representative.N o t e The battery cover is correctly inserted and tightened when the battery cover is level with the insulin pump casing.N o t e Do not attempt to change the battery while a bolus is in progress.N o t e The battery has a shelf life of 3 years. Please note “best before date (xx/xxx)”before useW a r n i n gChange the battery in a dry environment to prevent water from entering the casing.W a r n i n gUse of battery other than the 3.6V battery manufactured exclusively for SOOIL Development will result in the voidof pump warranty.O - r i n ggraphic ①#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지9 001 Acrobat™ PDFWriter 300DPI 60LPI
1 0Setting bolus doses, basal rates and the clock1) From the INITIAL DISPLAY screen, press any of the controlbuttons and the BASIC DISPLAY screen will appear.2) In the BASIC DISPLAY screen, press three timesconsecutively to highlight the S E T / P R O G R A Micon in figure 1.Then press . (figure 1)(figure 2)3) The SET/PROGRAM screen in figure 2 will appear. You can selectb o l u sor b a s a lrate or c l o c k.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지10 001 Acrobat™ PDFWriter 300DPI 60LPI
Setting a Bolus1. Pre-Setting Meal BolusesIf you pre-set meal boluses, the following time periods correlate to the following schedule:•Breakfast = 1:00 - 9:59 (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 - 0:59 am)1 12. Set-up and basic functionsB r e a k f a s t L u n c h D i n n e r(figure 1)(figure 2)①Indicates that you are setting a bolus for Breakfast (Brfst), Lunchor Dinner. ②US indicates the amount of insulin used since midnight. MAindicates the maximum amount of insulin allowed daily. ③Time and amount of the previous bolus. ④Amount of current bolus.⑤□indicates set mode.① ② ⑤④ ③2) While in the BREAKFAST BOLUS SETTING screen, select the proper insulin dose by using and . Theinsulin dose appears in units in the bottom right hand corner.3) Press to go to the LUNCH BOLUS screen and repeat step 2. Press to advance to the DINNER BOLUSscreen and repeat the step 2. 4) After setting all of your meal boluses press to store the meal the meal bolus settings in the DANA memory.1) From the BASIC DISPLAY screen, go to the SET/PROGRAM screen.In SET/PROGRAM press when the B O L U Sh i g h l i g h t e d(figure 1). The bolus setting screen will appear as shown in figure 2.N o t e Make sure to press after the bolus dose is set to save the setting.N o t e You may confirm your bolus settings by using the C H E C K / R E V I E Wmenu option (see page 15). N o t eThe settings are the amount of insulin that you will deliver each time you bolus during the time periods indicated above.N o t e You may increase or decrease your bolus prior to delivery, but the preset bolus dose setting will not change unlessyou change it in the S E T / P R O G R A Mscreen. S#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지11 001 Acrobat™ PDFWriter 300DPI 60LPI
1 22. Setting a Bolus①Indicates that you are setting a bolus. ②US indicates the amount of insulin used since midnight. MAindicates the maximum amount of insulin allowed daily.③Time and amount refers to the previous bolus.④Amount of the bolus.⑤□indicates set mode.(figure 1)(figure 2)① ② ⑤③④2) While in the BOLUS SETTING screen select the proper insulin dose by using and . The insulin doseappears in units in the bottom right hand corner.3) After setting your bolus press to store the preset meal bolus.1) From the BASIC DISPLAY screen, go to the SET/PROGRAM screen.In SET/PROGRAM press when bolus icon is highlighted(figure 1). The bolus setting screen will appear as shown in figure 2.N o t e Make sure to press after the bolus dose is set to save the setting.N o t e You may confirm your bolus settings by using the C H E C K / R E V I E Wmenu option (see page 15). N o t e This setting is the amount of insulin that the pump will deliver the next time you bolus. N o t e Please talk to your health care professional if you wish to preset your meal boluses.N o t e You may increase or decrease your bolus prior to delivery but the default bolus setting will not change unless youchange it in the S E T / P R O G R A Mscreen. S#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지12 001 Acrobat™ PDFWriter 300DPI 60LPI
1 32. Set-up and basic functions(figure 1)①Basal Profile, which shows basal rates in a graph from midnight tomidnight. ②Chronological time which corresponds to the highlighted sectionof the basal profile. ③Total basal amount programmed for delivery in a 24 hour period.④Basal Rate for the time period shown in ②. ⑤□indicates set mode.(figure 2)① ② ⑤④③Setting and Adjusting Basal Rates1) From the BASIC DISPLAY screen, go to the SET/PROGRAMscreen. Press when the B A S A Licon is highlighted (figure 1)in the SET/PROGRAM screen. The BASAL RATE SETTING screenwill appear as in figure 2.2) The Basal Profile appears in the lower left side of the screen. Use to move between the 24 rates. The corresponding chronological time will appear in the upper right corner. Use the and buttons tochange the basal rate for the highlighted time period.3) After basal rates are set, press to save the settings in the DANA memory.N o t e Basal rates can be adjusted in units per hour.N o t e Figure 2 shows a basal profile that has been set in units per hour(u/h). N o t e You may confirm your basal settings by using the C H E C K / R E V I E Wmenu option (see page 15). S#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지13 001 Acrobat™ PDFWriter 300DPI 60LPI
1 4Setting the Clock1) From the BASIC DISPLAY, go to the SET/PROGRAM screen. Press to highlight the CLOCK icon and press (figure 1). TheCLOCK SETTING screen will appear as shown in figure 2.2) U s e to move between the year and month and date, as wellas hours and minutes. Use a n d to make the desiredchanges. (figure 1)(figure 2)3) After making the changes press to save the setting and returnto the BASIC DISPLAY screen.C a u t i o n You must set a.m. and p.m. correctly. If the clock shows 03:00 p.m. and you want 03:00 a.m. you must press until the screen reflects your desired change.N o t e The pump can be programmed in either 12 hour or 24 hour format.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지14 001 Acrobat™ PDFWriter 300DPI 60LPI
1 52. Set-up and basic functions(figure 1)(figure 2)(figure 3)(figure 4)Checking Bolus Doses, Basal Rates and Reviewing Memory Data1) In the BASIC DISPLAY screen press until the C H E C K / R E V I E Wicon is highlighted as in figure 1. Then press .2) The Review icon will be highlighted as in figure 2 (if not, pressto change the highlighted icon). Then press . 3) The BASAL PROFILE screen (figure 3) will appear. Press tomove between basal profiles and confirm settings. To review theprevious meal bolus press .4) The MEAL BOLUS screen (figure 4) will appear. Press tomove from one meal period to the next. Press to review thehistory of the previous 500 boluses.N o t eThe CHK icon is used for reviewing both basal rates and bolus settings.N o t e □indicates check mode.N o t e If your bolus and basal dose rate settings are incorrect please return to the BASIC DISPLAY and choose theSET/PROGRAM icon to make adjustments.C#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지15 001 Acrobat™ PDFWriter 300DPI 60LPI
1 6(figure 5)BOLUS HISTORY1: 1/4 13:00 -4 . 52: 1/4 07:30 -5 . 0(figure 6)DAILY TOTAL HIST.1: 1/4 -1 5 . 0 U2: 1/3 -1 4 . 0 U(figure 7)PRIME HISTORY1: 1/4 10:00 -2 3 52: 1/1 20:30 -2 2 5(figure 8)CARBO HISTORY1: 9/24 14:59 802: 9/13 12:09 72(figure 9)SHIPPING INFO1. S/N : AGJ00019GF2. COUNTRY : KOR3. DATE : 12/SEP, 20065) Use and to review the Bolus History including date,time and amount delivered (figure 5). Press to review the 500previous Daily Totals.6) Use and to review the Daily Total History including dateand the total amount of insulin (figure 6). Press to review the500 previous Prime Amounts. 7) U s e a n d to review the Prime History including date,time andamount (figure 7). Pressto review the 500 previous Carbohydrate amount.8) Use and to review the Carbo History including date,time andamount (figure 8). Press to review the Shipping info screen.9) In the Shipping Info(fugure 9)press to return to the basic display.N o t e - Bolus History: Date, time and amount of past bolus deliveries.- Daily Total History: Total bolus and basal delivery amount for each day.- Prime History: Date and time of past primes, including theamount of insulin left in the reservoir following each prime.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지16 001 Acrobat™ PDFWriter 300DPI 60LPI
1 72. Set-up and basic functions(figure 1)(figure 2)(figure 3)(figure 4)Suspending the pump선택선택1) In the BASIC DISPLAYscreen press to highlight theCHECK/REVIEW icon. Then press .2) Press to highlight the S U S P E N Dicon (figure 2). Then press .선택선택3) The pump will give an audible tone and the screen will indicate thepump is suspended (figure 3).선택선택4) To take the pump out of SUSPEND, press You will hear anaudible indicator and the BASIC DISPLAY will appear as shown infigure 4.C a u t i o n Always keep at least one power kit (2 batteries) available for backup.N o t e When you suspend the pump it will beep 3 times every 4 minutes to remind you insulin is not being delivered.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지17 001 Acrobat™ PDFWriter 300DPI 60LPI
1 8User Setting(figure 1)(figure 2)1) Press the three buttons ( + + ) at once toenter the PIN code screen for USER SETTING from the initial screen.2) Input the PIN code “4 3 2 1”by the use of a n d b u t t o n s .3) You can enter the USER SETTING mode by pressing b u t t o nonce the PIN code is inputted.S e t t i n g①HOUR DISPLAY TYPE- You can adjust time display as 12 hour or 24 hour format.②L O C K- You can choose whether or not to utilize the key pad lock out function.- How to unlock(see page 19)③BUTTON SCROLL- You can choose whether or not to utilize the button scroll function.④SOUND MODE- You can choose the method of alert among sound.⑤DISPLAY SET(see page 19)⑥EXTENDED MENU(see page 19)⑦STRIP CHECK (see page 20)⑧E X I T- Saves adjustment and returns to the previous level.USER SETTING1. HOUR DISPLAY TYPE : 122. LOCK : On3. BUTTON SCROLL : On4. SOUND MODE : R/V5. DISPLAY SET6. EXTENDED MENU7. STRIP CHECK 8. EXIT▶(figure 1)1) Use o r to modify settings. Use to advance to the next settings.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지18 001 Acrobat™ PDFWriter 300DPI 60LPI
1 92. Set-up and basic functionsN o t e How to unlock①If the lock out feature is on, the following screen will appear.(figure 1)②To unlock the pump, in the exact order press , , , .③The following screen will appear(figure 2).④Enter 1, 2, 3, 4 by using the up arrow and next key.⑤The pump will return to the basic display.(figure 1)(figure 2)⑤DISPLAY SET1. LCD on time- Adjust the duration of the LCD display by seconds.2. EL on time- Adjust the duration of the Backlight by seconds.3. Language- You can choose a language.4. E X I T- Saves adjustment and returns to the previous level.DISPLAY SET1. LCD ON TIME(S) : 602. EL ON TIME(S) : 103. LANGUAGE : KO4. EXIT⑥EXTENDED MENU1. EXTENDED BOLUS- Choose whether or not to utilize the Extended Bolus function.2. U T I L I T Y- Choose whether or not to utilize the Utility function.3. NO CARBO MODE- If the “NO CARBO MODE”was selected as “O f f”, a pop-up windowwill display to perform the carbohydrate counting function, once youchecked your BG level by the DANA IISG pump. If the “NO CARBOM O D E”was selected as “O n”, the pop-up window will not be activatedafter the checking BG level.4. E X I T- Saves adjustment and returns to the previous level.EXTENDED MENU1. EXTENDED BOLUS : On2. UTILITY : Off3. NO CARBO MODE : Off4. EXIT(figure 3)(figure 4)▶▶#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지19 001 Acrobat™ PDFWriter 300DPI 60LPI
2 0⑦STRIP CHECK - This is the menu for check whether or not the glucose meter of DANADiabecare IISG operates normally.1. Insert the “Check Strip”into the Glucose Meter Port when the “Strip C h e c k”displays (figure 1).2. In case “O K”displayed, the meter is normal (figure 2).3. In case “E R R O R”displayed, the meter is abnormal (figure 3).STRIP CHECK(figure 1)(figure 2)(figure 3)STRIP CHECKE R R O RSTRIP CHECKO K#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지20 001 Acrobat™ PDFWriter 300DPI 60LPI
2 13. Filling and inserting a new reservoir3. Filling and inserting a new reservoirChanging the reservoirP r e p a r a t i o n1) Retrieve the insulin vial from the refrigerator and let it warm up to room temperature for 15-30 minutes. 5) Wash your hands.2) Suspend the pump and remove the old infusion set.3) Remove the old reservoir.4) Place all materials on a clean dry surface.Materials: DANA DiabecareⓇIISR Insulin Pump, fast acting insulin, reservoir, infusion set, DANA Easy SETTER, linking screw, alcohol swab, etc.C a u t i o n The reservoir must be changed every 3 days, regardless of the amount left in the reservoir. C a u t i o n The reservoir must be changed when there is less than 20u remaining.C a u t i o n Always remember to change the reservoir and infusion set at the same time.C a u t i o n Failing to warm the insulin sufficiently may result in air bubbles in the reservoir.W a r n i n gUse only fast acting insulin in your pump. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지21 001 Acrobat™ PDFWriter 300DPI 60LPI
2 2Filling the reservoir with insulin1) Remove the round cap at the end of the reservoir plunger anddiscard. A thin white reservoir cap will fall out of the plunger - keepthis cap for later use (figure 1). Pull back on the plunger to the linemarked with the number 3 and push up and down 3-4 times toproperly lubricate the reservoir.2) Insert and fit the plastic component of the linking screw into thecavity of the plunger (figure 2).3) Wipe the lid of the insulin vial with an alcohol swab. Carefully removethe clear needle protective cover and draw out the desired amount ofinsulin (figure 3). 5) Remove the needle from the reservoir and cover with the thin whitereservoir cap (figure 5). Please dispose of the needle properly.4) Place the clear needle protective cover back on the needle. Removeany bubbles from the inside of the reservoir by gently tapping on thesides, making the bubbles rise to the top of the syringe. Gently pushon the plunger to remove the bubbles at the top (figure 4).(figure 1)(figure 2)(figure 3)(figure 4)(figure 5)N o t e Pull the plunger down until you are at the desired amount ofinsulin needed. Insert the needle into the insulin vial and inject theair from the syringe into the vial. Draw out the desired amount ofinsulin. N o t e Total fill amount: (Daily requirement x 3-4 days) + extra 30u#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지22 001 Acrobat™ PDFWriter 300DPI 60LPI
2 33. Filling and inserting a new reservoirInserting the reservoir into the pump1 )Insert the reservoir with linking screw into the DANA DiabecareⓇI I S Rinsulin pump as shown in figure 1. When inserting the reservoir,rotate the reservoir back and forth until the notch fittings on the sideof the reservoir slide into place. Gently let the reservoir and linkingscrew fall into place. Next, screw (counterclockwise) the pump’sreservoir compartment cap in place and remove the small whitereservoir cap from the end of the reservoir. (figure 1)N o t e If attempts to reinsert the reservoir fail, try a new reservoir.C a u t i o nDo not push and/or force the reservoir into the pump. This could damage the motor drive and linking screw of the pumpand could result in the loss of insulin from the reservoir. (figure 2)(figure 1)(figure 3)󰦜N o t e The DANA Easy SETTER operates with the SOOIL 3.6V batteryInstructions for use of DANA Easy SETTER1 )Insert a battery into Easy SETTER as instructed below:①Open the battery compartment.②Insert a battery positive side up.③Close battery compartment.2) Insert a syringe filled with insulin into the DANA Easy SETTER (figure 2).4) Retrieve the adjusted syringe from the DANA Easy SETTER.N o t e The end (hexagonal part) of the connecting screw should beplaced into the hexagonal hole of DANA Easy SETTER.3) Push the button on DANA Easy SETTER.N o t e When the button is pushed, you can see the syringe slide in.Push 2~3 more seconds until the syringe is fully inserted into theEasy SETTER(Figure 3).#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지23 001 Acrobat™ PDFWriter 300DPI 60LPI
2 4Priming the infusion set1) Press to take the pump out of SUSPEND mode. The BASICDISPLAY will appear.Connecting the infusion set to the DANA IISR1) Hold the pump upside down and remove the white cap. Screw theinfusion set connector counterclockwise into the reservoircompartment until it is firmly in place. (figure 1)2) In the BASIC DISPLAY screen, highlight the C H E C K / R E V I E Wi c o nand press (figure 1).3) Press in the C H E C K / R E V I E Wscreen to highlight the PRIMEicon as shown in figure 2. Then press .4) You will now see the FILLING SCREEN display as shown in figure3. Use and to adjust the amount of insulin (in cc’s) inthe new reservoir placed in the DANA pump. Then press .(figure 1)(figure 2)(figure 3)N o t e Remember to adjust this setting up or down to the amount you have actually placed in the reservoir.N o t e The 2.5 cc is a preset default setting. C a u t i o n If the pump is not held upside down while removing the white cap and connecting the infusion set, insulin maydrip down into the pump.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지24 001 Acrobat™ PDFWriter 300DPI 60LPI
2 53. Filling and inserting a new reservoir6) You will hear the pump begin to infuse insulin into the infusion set.The insulin amount on the PRIME screen will increase slowly and“b u b b l e s”will appear at the end of the reservoir on the display as infigure 5. You will see the insulin move towards the needle end of theinfusion set.7) When you see a drop of insulin appear at the end of the infusion set needle, pressto stop the priming sequence. (figure 5)5) The prime screen will appear as in figure 4. Press twice tobegin priming the infusion set. (figure 4)N o t e Press once and the word “P R I M E”will be replaced by“U P”a second later. The two words will flash back and forthevery two seconds. In order to commence priming you mustpress the second time while the screen displays the word “U P”.N o t e You will hear the pump beep for every 1.0 unit while priming is in progress. N o t eThe DANA DiabecareⓇIISR insulin pump will allow 2 prime sequences every 12 hours (0:00 - 12:00, 12:00 -N o t e It is recommended that the pump be primed a minimum of 15 units.N o t e You may pause the prime temporarily by pressing . Press twice to resume the priming sequence.C a u t i o n Make sure the needle is faced downwards so that insulin does not come in contact with the infusion set dressing.C a u t i o n Always check and confirm all basal and bolus settings after changing the insulin reservoir. Visually confirm there isno air in the infusion set tubing. W a r n i n gMake sure to prime when you use a new infusion set or remove air from the tubing. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지25 001 Acrobat™ PDFWriter 300DPI 60LPI
2 6Inserting the infusion set1) Choose an insertion site on your abdomen at least 5 cm away fromthe navel (figure 1).2) Clean the site with an alcohol swab and allow to dry (figure 1).5) Tape the infusion set to the body with adhesive tape 2~5 cm awayfrom the insertion site. 3) Hold the infusion set in your fingers at the guide as shown in figure 2.Carefully remove the needle’s protective cover and the paperbacking from the adhesive dressing. 4) With your other hand pinch the tissue around the insertion sitebetween your thumb and finger as in figure 3. Push the needle firmlyinto this tissue and secure with the adhesive dressing. (figure 1)(figure 2)(figure 3)(figure 4)N o t e You should not feel pain when you touch the insertion area afterthe needle has been inserted. You may feel some pain at theinsertion site if the infusion set is not secured well to your body. N o t e See page 32 for Soft-Release-ST inserting. W a r n i n gDo not use the infusion set if its package has been damaged, inadvertently opened or wet. W a r n i n gMake sure to prime when you use a new infusion set orremove air from the tubing. N o t e Try to avoid any recent insertion sites, scars, scar tissue or bruising.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지26 001 Acrobat™ PDFWriter 300DPI 60LPI
2 73. Filling and inserting a new reservoirInfusion SetsThe EasyRelease Infusion SetThe EasyRelease Infusion Set is a stainless steel needle set. A needle is inserted at 90°into the skin. The adhesive of theEasyRelease allows the needle to be fixed firmly in place. ①Needle Cover ②Needle Hub③N e e d l e④Needle Guide with Adhesive⑤Site Connector⑥Infusion Set Connector⑦Connection Needle⑧C o l l a r⑨T u b i n g⑩Pump Connector⑪Site Connector Cover⑫Infusion Set Connector Cover#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지27 001 Acrobat™ PDFWriter 300DPI 60LPI
1. Prior to Inserting the EasyRelease Infusion Set1) Wash your hands before handling the infusion set. 2) Take out the EasyRelease Infusion Set from its package. Be careful not to touch the connector to any object that wouldbreach its sterility.3) Screw the Pump Connector counterclockwise into the reservoir compartment until it is firmly in place. 4) Push the Set Connector firmly into the Site Connector and pull theCollar back to secure the connection(figure 1).2. Inserting the EasyRelease Infusion Set1) Choose an insertion site on your abdomen at least 5 cm away fromthe navel. Clean the site with an alcohol swab and allow to dry(figure 2).2) Prime the infusion set by following the instructions on page 23. Airremoval is complete when a drop of insulin appears at the end ofthe needle (figure 3).3) Carefully remove the needle’s protective cover (figure 4), and thepaper backing from the adhesive dressing (figure 5). 4) With your other hand pinch the tissue around the insertion sitebetween your thumb and finger. Push the needle firmly into thetissue (figure 6). 5) Secure the needle with the adhesive dressing (figure 7). 6) Tape the infusion set to the body with adhesive tape 2~5 cm awayfrom the insertion site (figure 8). 2 8I n s t r u c t i o n s(figure 1) (figure 2)(figure 3) (figure 4)(figure 5) (figure 6)(figure 7) (figure 8)N o t e Try to avoid any recent insertion sites, scars, scar tissue or bruising.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지28 001 Acrobat™ PDFWriter 300DPI 60LPI
2 93. Filling and inserting a new reservoir3. Disconnecting the EasyRelease Infusion Set1) Place the pump in SUSPEND (see page 17).2) Push the Collar forward and pull the Infusion Set Connector out ofthe Site Connector (figure 9).3) Push the Infusion Set Connector Cover onto the ConnectionNeedle (figure 10). Make sure that this is done without bending the Connection Needle. Thisprevents insulin from dripping out at the release site and keeps the Connection Needle clean. 4) Insert the Site Connector Cover into the Site Connector (figure 11).5) Put your pump in a clean and safe place until you are ready to reconnect.4. Reconnecting the EasyRelease Infusion Set1) Wipe the tip of the Site Connector with an alcohol swab after removing the Site ConnectionCover (figure 12).2) Remove the Infusion Set Connector Cover from the Infusion Set Connector (figure 12).3) Take pump out of SUSPEND (see page 17).4) Before reconnecting, program the pump to bolus 0.5~1 unit of insulin (see page 39) andwatch to ensure that a drop is visible from the Connection Needle tip (figure 14).5) Gently slide the Infusion Set Connector into the Site Connector, and pull the Collar back tosecure the connection (figure 15).5. Removing the EasyRelease Infusion Set1) Place the pump in SUSPEND (see page 17). 2) Carefully remove the adhesive tape from the Tubing and needle insertion site.3) Grab the Needle Guide in the same manner as if you were inserting it. Use your other hand toapply slight pressure on the tissue around the insertion area. Gently pull out the needle.4) Remove the infusion set from the pump by turning the Pump Connector clockwise andpulling upwards.(figure 10)(figure 9)(figure 11)(figure 12)(figure 13)(figure 14)( f i g u r e 1 5 )#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지29 001 Acrobat™ PDFWriter 300DPI 60LPI
3 0The EasyRelease II Infusion SetThe EasyRelease II Infusion Set is a stainless steel needle set. A needle is inserted at 90°into the skin. The adhesive of theEasyRelease II allows the needle to be fixed firmly in place. ①Needle Cover ②Needle Hub③N e e d l e④Needle Guide with Adhesive⑤Site Connector⑥Infusion Set Connector⑦Connection Needle⑧Spring Clip⑨T u b i n g⑩Pump Connector⑪Site Connector Cover⑫Infusion Set Connector Cover#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지30 001 Acrobat™ PDFWriter 300DPI 60LPI
3 13. Filling and inserting a new reservoir1. Prior to Inserting the EasyRelease II Infusion Set1) Wash your hands before handling the infusion set. 2) Take out the EasyRelease II Infusion Set from its package. Be careful not to touch the connector to any object thatwould breach its sterility.3) Screw the Pump Connector counterclockwise into the reservoircompartment until it is firmly in place. 4) Push the Set Connector firmly into the Site Connector and pull theCollar back to secure the connection(figure 1).2. Inserting the EasyRelease II Infusion Set1) Choose an insertion site on your abdomen at least 5 cm away fromthe navel. Clean the site with an alcohol swab and allow to dry(figure 2).2) Prime the infusion set by following the instructions on page 23. Airremoval is complete when a drop of insulin appears at the end ofthe back side of needle (figure 3).3) Carefully remove the needle’s protective cover (figure 4), and thepaper backing from the adhesive dressing (figure 5). 4) With your other hand pinch the tissue around the insertion sitebetween your thumb and finger. Push the needle firmly into thetissue (figure 6). 5) Secure the needle with the adhesive dressing (figure 7). 6) Tape the infusion set to the body with adhesive tape 2~5 cm away from the insertion site (figure 8). I n s t r u c t i o n s(figure 1) (figure 2)(figure 3) (figure 4)(figure 5) (figure 6)(figure 7) (figure 8)N o t e Try to avoid any recent insertion sites, scars, scar tissue or bruising.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지31 001 Acrobat™ PDFWriter 300DPI 60LPI
3 23. Disconnecting the EasyRelease II Infusion Set1) Place the pump in SUSPEND (see page 17).2) Grasp each side of the Infusion Set Connector, pressing gently onthe Spring Clips. Pull the Infusion Set Connector out of the SiteConnector (figure 11).3) Push the Infusion Set Connector Cover onto the Connection Needle(figure 12). Make sure that this is done without bending theConnection Needle. This prevents insulin from dripping out at therelease site and keeps the Connection Needle clean. 4) Insert the Site Connector Cover into the Site Connector (figure 13).5) Put your pump in a clean and safe place until you are ready tor e c o n n e c t .4. Reconnecting the EasyRelease II Infusion Set1) Wipe the tip of the Site Connector with an alcohol swab afterremoving the Site Connection Cover (figure 14).2) Remove the Infusion Set Connector Cover from the Infusion SetConnector (figure 15).3) Take the pump out of SUSPEND(See page 17).4) Before reconnecting, program the pump to bolus 0.5~1 unit ofinsulin (see page 39) and watch to ensure that a drop is visible fromthe Connection Needle tip (figure 16).5) Gently slide the Infusion Set Connector into the Site Connector, bypressing lightly on the Spring Clips on either side of the Infusion SetConnector (figure 17).5. Removing the EasyRelease II Infusion Set1) Place the pump in SUSPEND (see page 17). 2) Carefully remove the adhesive tape from the Tubing and needle insertion site.3) Grab the Needle Guide in the same manner as if you were inserting it. Use your other hand to apply slight pressure onthe tissue around the insertion area. Gently pull out the cannula.4) Remove the infusion set from the pump by turning the Pump Connector clockwise and pulling upwards.(figure 9) (figure 10)( f i g u r e 1 1 ) (figure 12)(figure 13) (figure 14)(figure 15)#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지32 001 Acrobat™ PDFWriter 300DPI 60LPI
3 33. Filling and inserting a new reservoirThe Soft-Release-R Infusion SetThe Soft-Release-R is a soft cannula infusion set and is inserted at a 90°angle. The needle is removed after insertion andonly the cannula remains under the skin.①Needle Protective Cover for disposal②Cannula Hub③Teflon (Soft Cannula) ④Needle Guide with Adhesive⑤Needle Hub⑥Introducer Needle⑦Bypass Needle⑧Site Connector⑨Infusion Set Connector⑩Connection Needle⑪Spring Clip⑫T u b i n g⑬Pump Connector⑭Site Connector Cover⑮Infusion Set Connector Cover#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지33 001 Acrobat™ PDFWriter 300DPI 60LPI
3 41. Prior to Inserting the Soft-Release-R Infusion Set1) Wash your hands before handling the infusion set. 2) Take out the Soft-Release-R Infusion Set from its package. Be careful not to touch the connector to any object thatwould breach its sterility.3) Screw the Pump Connector counterclockwise into the reservoircompartment until it is firmly in place. 4) Connect the Infusion Set Connector with the Site Connector (figure 1).2. Inserting the Soft-Release-R Infusion Set1) Choose an insertion site on your abdomen at least 5 cm away from thenavel. Clean the site with an alcohol swab and allow to dry (figure 2).2) Prime the infusion set by following the instructions on page 23. Airremoval is complete when a drop of insulin appears at the end of theback side of needle (figure 3).3) Hold the infusion set in your fingers at the Needle Guide andcarefully remove the needle’s protective cover (figure 4), and removethe paper backing from the adhesive dressing (figure 5). 4) With your other hand pinch the tissue around the insertion sitebetween your thumb and finger. Insert the needle quickly, at a 90°angle straight into the infusion site (figure 6). Watch the Teflon (softcannula) during insertion to assure that it goes in smoothly withoutkinking or crimping. 5) Before withdrawing the Introducer needle, you may want to ensurethat the cannula is firmly taped (figure 7). 6) To remove the Introducer Needle, place one finger on each side ofthe Needle Guide with Adhesive and one on either side of theIntroducer Needle. Pull the needle straight out (figure 8). 7) Dispose of the Introducer Needle in a safe manner by using theneedle Protective Cover (figure 9). 8) Tape the infusion set to the body with adhesive tape 2~5 cm awayfrom the insertion site (figure 10).(figure 2)(figure 1)(figure 4)(figure 3)(figure 6)(figure 5)(figure 8)(figure 7)(figure 10)(figure 9)N o t e Try to avoid any recent insertion sites, scars, scar tissue or bruising.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지34 001 Acrobat™ PDFWriter 300DPI 60LPI
3 53. Filling and inserting a new reservoir3. Disconnecting the Soft-Release-R Infusion Set1) Place the pump in SUSPEND (see page 17).2) Grasp each side of the Infusion Set Connector, pressing gently onthe Spring Clips. Pull the Infusion Set Connector out of the SiteConnector (figure 11).3) Push the Infusion Set Connector Cover onto the Connection Needle(figure 12). Make sure that this is done without bending theConnection Needle. This prevents insulin from dripping out at therelease site and keeps the Connection Needle clean. 4) Insert the Site Connector Cover into the Site Connector (figure 13).5) Put your pump in a clean and safe place until you are ready tor e c o n n e c t .4. Reconnecting the Soft-Release-R Infusion Set1) Wipe the tip of the Site Connector with an alcohol swab afterremoving the Site Connection Cover (figure 14).2) Remove the Infusion Set Connector Cover from the Infusion SetConnector (figure 15).3) Take the pump out of SUSPEND(See page 17).4) Before reconnecting, program the pump to bolus 0.5~1 unit ofinsulin (see page 39) and watch to ensure that a drop is visible fromthe Connection Needle tip (figure 16).5) Gently slide the Infusion Set Connector into the Site Connector, bypressing lightly on the Spring Clips on either side of the Infusion SetConnector (figure 17).5. Removing the Soft-Release-R Infusion Set1) Place the pump in SUSPEND (see page 17). 2) Carefully remove the adhesive tape from the Tubing and needle insertion site.3) Grab the Needle Guide in the same manner as if you were inserting it. Use your other hand to apply slight pressure onthe tissue around the insertion area. Gently pull out the cannula.4) Remove the infusion set from the pump by turning the Pump Connector clockwise and pulling upwards.(figure 11) (figure 12)( f i g u r e 1 3 ) (figure 14)(figure 15) (figure 16)(figure 17)#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지35 001 Acrobat™ PDFWriter 300DPI 60LPI
3 6The Soft-Release-ST Infusion SetThe Soft-Release-ST is a soft cannula infusion set. It may be inserted at any angle between 15°and 30°, depending onyour body type, comfort and instructions from your healthcare professional. The needle is removed after insertion and onlythe cannula remains under the skin.①Needle Cover②Site Connector③Teflon (Soft Cannula) ④Needle Guide with Adhesive⑤Needle Hub⑥Introducer Needle⑦Infusion Set Connector⑧Connection Needle⑨Spring Clips⑩T u b i n g⑪Pump Connector⑫Site Connector Cover⑬Infusion Set Connector Cover#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지36 001 Acrobat™ PDFWriter 300DPI 60LPI
3 73. Filling and inserting a new reservoir1. Prior to Inserting the Soft-Release-ST Infusion Set1) Wash your hands before handling the infusion set. 2) Take out the Soft-Release-ST Infusion Set from its package. Becareful not to touch the connector to any object that would breach itss t e r i l i t y .3) Screw the Pump Connector counterclockwise into the reservoircompartment until it is firmly in place. 2. Inserting the Soft-Release-ST Infusion Set1) Choose an insertion site on your abdomen at least 5 cm away from thenavel. Clean the site with an alcohol swab and allow to dry (figure 1).2) Hold the infusion set in your fingers at the Site Connector andcarefully remove the needle’s protective cover (figure 2), and removethe bottom portion of the paper backing from the adhesive dressing(figure 3). 3) With your other hand pinch the tissue around the insertion sitebetween your thumb and finger. Insert the needle quickly, at a 15°-3 0°angle straight into the infusion site (figure 4). Watch the Teflon(soft cannula) during insertion to ensure that it goes in smoothlywithout kinking or crimping. 4) Once the bottom portion of the adhesive has been fixed, remove thetop portion of the paper backing and apply the entire dressing.Ensure that the cannula is firmly taped (figure 5). 5) To remove the Introducer Needle, place one finger on each side ofthe Site Connector and one on either side of the Spring Clips of theNeedle Hub. Pull the needle straight out (figure 6). 6) Dispose of the Introducer Needle in a safe manner by using theneedle Protective Cover (figure 7). 7) Prime the infusion set by following the instructions on page 23. Air removal is complete when a drop of insulin appearsat the end of the Connection Needle (figure 8).8) Gently slide the Infusion Set Connector into the Site Connector so that the two units firmly snap together (figure 9). 9) Tape the infusion set to the body with adhesive tape 2~5 cm away from the insertion site (figure 10).(figure 2)(figure 1)(figure 4)(figure 3)(figure 6)(figure 5)(figure 8)(figure 7)(figure 10)(figure 9)#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지37 001 Acrobat™ PDFWriter 300DPI 60LPI
3 83. Disconnecting the Soft-Release-ST Infusion Set1) Place the pump in SUSPEND (see page 17).2) Grasp each side of the Infusion Set Connector, pressing gently onthe Spring Clips. Pull the Infusion Set Connector out of the SiteConnector (figure 11).3) Push the Infusion Set Connector Cover onto the Connection Needle(figure 12). Make sure that this is done without bending theConnection Needle. This prevents insulin from dripping out at therelease site and keeps the Connection Needle clean. 4) Insert the Site Connector Cover into the Site Connector (figure 13).5) Put your pump in a clean and safe place until you are ready tor e c o n n e c t .4. Reconnecting the Soft-Release-ST Infusion Set1) Wipe the tip of the Site Connector with an alcohol swab afterremoving the Site Connection Cover (figure 14).2) Remove the Infusion Set Connector Cover from the Infusion SetConnector (figure 15).3) Take the pump out of SUSPEND (see page 17).4) Before reconnecting, program the pump to bolus 0.5~1 unit ofinsulin (see page 39) and watch to ensure that a drop is visible fromthe Connection Needle tip (figure 16).5) Gently slide the Infusion Set Connector into the Site Connector, bypressing lightly on the Spring Clips on either side of the Infusion SetConnector (figure 17).5. Removing the Soft-Release-ST Infusion Set1) Place the pump in SUSPEND (see page 17). 2) Carefully remove the adhesive tape from the Tubing and needle insertion site.3) Grab the Needle Guide in the same manner as if you were inserting it. Use your other hand to apply slight pressure onthe tissue around the insertion area. Gently pull out the cannula.4) Remove the infusion set from the pump by turning the Pump Connector clockwise and pulling upwards.(figure 11) (figure 12)(figure 13) (figure 14)(figure 15) (figure 16)(figure 17)N o t e Try to avoid any recent insertion sites, scars, scar tissue or bruising.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지38 001 Acrobat™ PDFWriter 300DPI 60LPI
3 93. Filling and inserting a new reservoirGeneral Precautions for All Infusion Sets1. Change the reservoir and the infusion set regularly as recommended by your healthcare professional. Do not use either forlonger than 72 hours.2. The reservoir and infusion set are intended for single use only. Do not reuse either the reservoir or infusion set.3. Do not use the reservoir or infusion set if the package has been damaged, inadvertently opened or wet.4. The shelf life of the reservoir and the infusion set is 3 years. Please check expiration dates regularly and dispose of anyexpired accessories.5. Do not disconnect from your pump for more than one hour without discussing with your healthcare professional on howyou should compensate for missed insulin. Please remember that while disconnected from the pump, no insulin is beinginfused. Carefully monitor blood glucose levels during periods of disconnection and after reconnection.6. Check the infusion site often for redness, irritation and inflammation.7. Remember to prime at least 15 units when you change your reservoir and infusion set to permit the pump to perform anadditional series of safety checks. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지39 001 Acrobat™ PDFWriter 300DPI 60LPI
4 04. Bolusing, temporary basal rates, calculating your bolusdosage and dose automationB o l u sWhen Extended Bolus is set to OFF-Delivering a Bolus1) Press any button while in the INITIAL DISPLAY screen to bring up theBASIC DISPLAY screen.(figure 1)(figure 2)2) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . The BOLUS screen willappear as in figure 2.3) Confirm the amount of insulin to be delivered in the bottom rightcorner of the BOLUS screen. If the insulin dose is not correct you maymake the desired adjustments to the bolus setting by usinga n d . N o t e Remember the adjustment will not change the default bolus setting. It will only change the bolus that you arecurrently delivering.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지40 001 Acrobat™ PDFWriter 300DPI 60LPI
4 14. Bolusing, temporary basal rates, calculating your bolus dosage and dose automationWhen Extended Bolus is set to ON-The BOLUS OPTION Screen(figure 1)(figure 2)(figure 3)4) Press twice to begin delivery. The screen in figure 3 will appearand you will hear the motor run as the bolus is being delivered.5) The pump will make a beep and return to the INITIAL DISPLAY screen upon conclusion of bolus delivery.1) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . 2) Choose the first icon to access the NORMAL BOLUS screen, thesecond icon to access the EXTENDED BOLUS screen, and thethird icon to access the DUAL PATTERN BOLUS s c r e e n .N o t e Press once and the word “B O L U S”(or BRFST, LUNCH,D I N N E R )”will be replaced by “S E L E C T”a second later. In order tocommence the bolus sequence you must press again while thescreen is showing “S E L E C T”.N o t e You will hear the pump beep for every 1.0 unit while a bolus is being delivered. N o t e Press to return to Basic Display screen.W a r n i n gYou must eat your meal after the meal bolus has been delivered. N o t e Press or once to stop a bolus during delivery.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지41 001 Acrobat™ PDFWriter 300DPI 60LPI
4 2(figure 3)(figure 4)4) Use to highlight ‘Y E S’and press . - Dual Bolus1) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . (figure 1)(figure 1)- Extended Bolus1) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . 2) Use to highlight the middle icon and press .(figure 2)3) Use to toggle between BOLUS amount and BOLUS Periodand make the necessary adjustments with and thenpress .#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지42 001 Acrobat™ PDFWriter 300DPI 60LPI
4 34. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation(figure 4)(figure 5)4) Use to highlight ‘Y E S’and press . (figure 2)(figure 3)2) Use to highlight the rightmost icon and press .N o t e To verify that Extended Bolus is in effect, while in the BASICDISPLAY screen use to highlight the BOLUS icon andpress . The EXTENDED BOLUS STATUS screen willappear. N o t e The time may be adjusted in 30 minute increments within therange of 30 minutes - 8 hours.N o t e The bolus amount may be set to any amount within the rangeof 0 - bolus max.3) Use to toggle between STEP BOLUS and EXTEND BOLUSand BOLUS Period and make the necessary adjustments withand than press .#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지43 001 Acrobat™ PDFWriter 300DPI 60LPI
4 4-Extended Bolus Cancellation1) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . 3) Use to highlight ‘Y E S’and press . The currentExtended Bolus sequence will be cancelled and you will be returnedto the BASIC DISPLAY screen. (figure 1)(figure 2)2) Press to invoke the cancellation prompt. - Extended Bolus Status1) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . 2) The screen will show how much time has elapsed since the start of theExtended Bolus, how much time is left until the completion of theExtended Bolus, amount delivered so far, and amount left to be delivered. (figure 1)(figure 2)EEN o t e □means Extended Bolus.E#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지44 001 Acrobat™ PDFWriter 300DPI 60LPI
4 54. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation(figure 3)(figure 4)N o t e To verify the Extended Bolus has been cancelled, while in theBASIC DISPLAY screen, use to highlight the BOLUS iconand press . You will see the BOLUS OPTION screen ifExtended Bolus was successfully cancelled (figure 3). N o t e If cancellation was not successful, the EXTENDED BOLUSSTATUS screen will appear as in figure 4. C a u t i o n Extended Bolus delivery is recorded in the bolus history. The time stamp of the entry corresponds to the date andtime of Extended Bolus conclusion.C a u t i o n Infusion occurs on 4 minutes past the hour, 8 minutes past thehour, 12 minutes past the hour, 16 minutes past the hour, and soon, in multiples of 4. N o t e Insulin is delivered every four minutes when the Dana IISR utilizes the extended bolus feature. While in extendedbolus mode, insulin delivery will be halted during the following four events:1) Start of a bolus2) Delivery of a bolus3) Priming the infusion set4) Delivery of basal ratesTherefore, the actual delivered amount displayed in the extended bolus status screen may differ from the actualdelivered amount.E#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지45 001 Acrobat™ PDFWriter 300DPI 60LPI
4 6Temporary Basal When Utility is set to OFF-Programming Temporary Basal Rates1) Press any button while in the INITIAL DISPLAY screen to bring up theBASIC DISPLAY screen.(figure 1)(figure 3)2) In the BASIC DISPLAY screen press until the TEMPORARYBASAL icon is highlighted as in figure 1. Then press . TheTEMPORARY BASAL screen will appear as in figure 2.①This number indicates the number of hours during which thetemporary basal rate will remain in effect.②This number indicates the desired increase/decrease in basal delivery.3) Use to toggle between the number of hours and basal ratioand make the necessary adjustments with and .(figure 2)①②N o t e No temporary basal rate will take effect if you press whileeither the number of hours is set at “0”, or the rate is set at “1 0 0 %”.N o t eFor instance, a temporary basal rate of “5 0 %”for “1 hour”will changethe basal rate to half of your regular basal rate for the next hour. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지46 001 Acrobat™ PDFWriter 300DPI 60LPI
4 74. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation(figure 4)(figure 6)4) P r e s s after making the desired adjustments to commencetemporary basal. Upon pressing you will be returned to theBASIC DISPLAY screen and a “v”mark will appear in the TEMPORARYBASAL icon to indicate that the temporary basal rate is in effect.6) To cancel a temporary basal rate currently in effect, pressand a cancellation prompt will appear as in figure 6.5) If you would like to check the status of a temporary basal rate that iscurrently in effect, use to highlight the TEMPORARY BASALicon with “v”mark in the BASIC DISPLAY screen and press .The TEMPORARY BASAL STATUS screen will appear as in figure 5. ①Time elapsed②Time remaining③Temporary basal rate7) P r e s s to highlight “Y E S”, then press if you would liketo cancel temporary basal. The temporary basal rate in effect will becancelled and you will be returned to the BASIC DISPLAY screen. (figure 5)①③②N o t e Highlight “N O”and press at the cancellation prompt to return to the BASIC DISPLAY screen withoutcanceling temporary basal.N o t e Adjust the rate to “1 0 0 %”and time to “0 hours”if you wish to return to your regular basal rate. N o t e The ratio may be adjusted between 0-200% in increments of 10% for up to 12 hours.C a u t i o n Please consult your healthcare professional about the temporary basal feature.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지47 001 Acrobat™ PDFWriter 300DPI 60LPI
4 8When Utility is set to ON-UTILITY MENU screen1) In the BASIC DISPLAY screen, use to highlight the Utility icon(Computer). Then press . -Bolus Calculator1) In the BASIC DISPLAY screen, use to highlight the UTIL icon.Then press.(figure 1)( f i g u r e 1 )(figure 1)(figure 2)(figure 3)2) If Temporary Basal is not activated your UTILITY MENU screen willappear as in figure 2.3) If Temporary Basal is in effect your UTILITY MENU screen will appearas in figure 3.N o t eSelect the leftmost icon for the Bolus Calculator, middle icon forTemporary Basal, and rightmost icon for Dose Automation. (figure 2)2) While in the UTILITY MENU screen, press to access theBOLUS CALCULATOR screen.(figure 2)3) In the BOLUS CALCULATOR screen, Use to move the cursoron CARBO to adjust the amount of Carbohydrate with the use ofo r button. (figure 3)①Displays current blood glucose level.②Indicates the carbohydrate(g) to be consumed after Bolus delivery.(figure 3)①②#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지48 001 Acrobat™ PDFWriter 300DPI 60LPI
4 94. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation①Indicates your target blood glucose level. ②Amount of carbohydrates capable of being processed by 1u (unit) of insulin. (Carb/insulin ratio)③Indicates Correction factor.4) U s e to move between “Ideal Blood Glucose”, “C I R”, and‘C F’, and use a n d to make the necessaryadjustments. Then press . The BOLUS CALCULATORRESULTS screen will appear as in figure 4.①Indicates the amount of insulin required according to your presentblood glucose level. ②Indicates the amount of insulin required to process the amount ofcarbohydrates specified. ③Indicates the amount of insulin remaining in your body from yourprevious bolus amount(active insulin). ④Indicates the calculated bolus amount. (figure 4)③①②(figure 5)④②①③5) P r e s s twice to commence bolus delivery. You will hear themotor run and the screen will show that a bolus is being delivered.(figure 6)N o t e You will hear the pump beep for every 1.0 unit while a bolus is beingdelivered. N o t e Press once and the word “B O L U S”will be replaced by “S E L E C T”a second later. The two words will flashback and forth every two seconds. In order to commence the bolus sequence you must press again whilethe screen is showing “S E L E C T”.N o t e Press or once to stop a bolus during delivery.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지49 001 Acrobat™ PDFWriter 300DPI 60LPI
5 0- Temporary basal1) In the BASIC DISPLAY screen, use to highlight the UTIL icon.Then press . 2) While in the UTILITY MENU screen, use to highlight theTEMPORARY BASAL ICON. Then press .3) U s e to toggle between the number of hours and basal rate,and make the necessary adjustments with a n d .(figure 1)(figure 2)(figure 3)(figure 4)(figure 5)4) Once temporary basal has been set, a “v”mark will appear in theTEMPORARY BASAL icon at the UTILITY MENU screen to indicate a temporary basal rate is in effect. N o t e To confirm that temporary basal is in effect, use in theUTILITY MENU screen to highlight the TEMPORARY BASAL iconand press . The TEMPORARY BASAL STATUS screen willappear. N o t e The percentage rate shown in figure 5 corresponds to the rate atwhich basal infusion will occur while temporary basal is active. Thepercentage calculation is based on your regular basal rate. Forinstance, if your regular basal rate is 4 units per hour and thepercentage rate is set to 150%, the temporary basal rate would be6 units per hour.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지50 001 Acrobat™ PDFWriter 300DPI 60LPI
5 14. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation- Temporary Basal Cancellation 1) In the BASIC DISPLAY screen, use to highlight the UTIL icon(Computer) and press . The UTILITY MENU screen will appear.(figure 1)2) U s e to highlight the TEMPORARY BASAL icon and pressto access the TEMPORARY BASAL STATUS screen. 4) U s e to highlight “Y E S”and press to cancel temporarybasal. You will be returned to the BASIC DISPLAY screen uponp r e s s i n g . (figure 2)(figure 3)(figure 4)3) Press to invoke the cancellation prompt. N o t e If you do not wish to cancel, choose “N O”and press at thecancellation prompt. You will be returned to the BASIC DISPLAYscreen upon pressing .#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지51 001 Acrobat™ PDFWriter 300DPI 60LPI
5 25) Use to highlight “Y E S”and press . - Dose Automation 1) In the BASIC DISPLAY screen, use to highlight the UTIL iconand press . (figure 1)(figure 2)2) U s e to highlight the rightmost icon and press t oaccess the DOSE AUTOMATION screen. 4) U s e to confirm the time and rates. Use a n d t ochoose the desired basal pattern and press . (figure 3)(figure 4)(figure 5)N o t e You may verify your bolus and basal rates through the CHECK/REVIEWmenu option. N o t e The Daily Total can be set to any value within the range of 0-Daily Max.N o t e The percentage rate can be adjusted within the range of 0-100%. 3) Use to toggle between Daily total and Bolus and Basal andmake the necessary adjustments with and then press .N o t e □indicates pattern number. 4 different basal profiles are available fors e l e c t i o n .1#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지52 001 Acrobat™ PDFWriter 300DPI 60LPI
5 3N o t e An icon with four antennas will be displayed on the remote controlwhile the synchronization is attempting.N o t e An icon with six antennas will be displayed on the remote controlonce the synchronization is completed.5. Remote Control5. Remote ControlSynchronize the Remote Control with the Pump(figure 1)(figure 2)(figure 3)(figure 1)B o l u s2) While in the BOLUS SETTING screen, select the proper insulin doseby using and . The insulin dose appears in units in thebottom right hand corner.1) In the BASIC DISPLAY screen press until the BOLUS icon ishighlighted as in figure 1. Then press . Then press . 1) Select the menu of connect icon at the basic menus display tosynchronize the remote control with the pump (figure 1).#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지53 001 Acrobat™ PDFWriter 300DPI 60LPI
5 4(figure 2)(figure 3)(figure 1)(figure 2)(figure 3)2) To unlock, press in order of , , , and then,a display like figure 3 will be displayed. Input PIN code 1234 by useof or buttons.Lock Setting3) Press twice to begin delivery. The screen in figure 2 will appearand you will hear the motor run as the bolus is being delivered.N o t e Press once and the word “B O L U S”will be replaced by“S E L E C T”a second later. In order to commence the bolussequence you must press again while the screen is showing“S E L E C T”(figure 3)N o t e Press or once to stop a bolus during delivery.1) Move to the program setting screen from the basic screen (figure 1),press button once an icon of LOCK is displayed, and then theLOCK icon will be displayed like figure 2.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지54 001 Acrobat™ PDFWriter 300DPI 60LPI
5 55. Remote ControlSetting the ClockDisconnect Remote Control and Insulin Pump(figure 1)(figure 2)(figure 1)(figure 2)(figure 3)1) Select the menu of disconnect icon at the basic menus display todisconnect remote control.N o t e The antenna icon will be disappeared once the remote controld i s c o n n e c t e d .N o t e A disconnect icon will be displayed on the pump.1) From the BASIC DISPLAY, go to the SET/PROGRAM screen. Press to highlight the CLOCK icon and press (figure 1). TheCLOCK SETTING screen will appear as shown in figure 2.2) U s e to move between the year and month and date, as wellas hours and minutes. Use a n d to make the desiredchanges. 3) After making the changes press to save the setting and returnto the BASIC DISPLAY screen.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지55 001 Acrobat™ PDFWriter 300DPI 60LPI
5 61) After washing your hands, insert a DANA blood glucose strip into theblood glucose meter test port (figure 1).4) Clean your fingertip with an alcohol swab. Obtain a blood samplewith a blood sampling needle (figure 4). 2) The STRIP CODE SETTING screen will appear as in figure 2. Set theSTRIP CODE and press .3) Verify that the display shows the OBTAIN BLOOD screen as in figure 3.5) Apply the sample blood on the end of the strip (figure 5). (figure 2)(figure 3)Checking your blood glucose level(figure 1)(figure 4)(figure 5)N o t e The STRIP CODE range is between 0 and 49. You must use thecode indicated on the DANA glucose strip packaging foraccurate results. N o t e If the strip is removed from the test port while the display screenappears as in figure 1 or figure 2, you will be returned to theBASIC DISPLAY screen. C a u t i o n Please leave the DANA Diabecare IISG insulin pump and its teststrips for 30 minutes in room temperature before use.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지56 001 Acrobat™ PDFWriter 300DPI 60LPI
5 75. Remote Control(figure 6)(figure 7)(figure 8)6) A 5 second countdown will appear as in figure 6. Once thecountdown concludes the BLOOD GLUCOSE TEST RESULTscreen will appear (date, time, blood glucose level) as in figure 7.1) While in the BLOOD GLUCOSE TEST RESULT screen, pressand the CARB COUNTER prompt will appear as in figure 8. 2) If you would like to calculate your bolus dosage, use tohighlight ‘Y E S”and press . The initial BOLUS CALCULATIONscreen will appear as in figure 9. Calculating your bolus dosage(figure 9)①②①Indicates your present blood glucose test result. ②Indicates the amount of carbohydrates to be consumed priorto bolus delivery. BG ▶ 1 0 0CARBO ▶ 2 5 0N o t e If you press . you will be returned to the BASIC DISPLAY screen.N o t e If you press while ‘N O’is highlighted, you will be returnedto the BASIC DISPLAY screen.3) Use to move between ‘Blood Glucose’and ‘C a r b o s’, and use and to make the necessaryadjustments. Press to move to the next screen (figure 10). #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지57 001 Acrobat™ PDFWriter 300DPI 60LPI
5 8(figure 10)③①②①Indicates your target blood glucose level.②Amount of carbohydrates capable of being processed by 1u of insulin. ③Indicates insulin action rate4) Use to move between ‘Target Blood Glucose’, ‘C I R’, and ‘C F’, and use and to make thenecessary adjustments. Then press . The CARB COUNTER RESULTS screen will appear as in figure 11. IDEAL ▶ 1 0 0CIR 25CF 50N o t e Press once and the word “B O L U S”will be replaced by “S E L E C T”a second later. The two words will flashback and forth every two seconds. In order to commence the bolus sequence you must press the secondtime while the screen is showing “S E L E C T”.N o t e You will hear the pump beep for every 1.0 unit while a bolus is being delivered. N o t e Press or twice to stop a bolus during delivery.(figure 11)③④① ②①Indicates the amount of insulin required according to your presentblood glucose level. ②Indicates the amount of insulin required to process the amount ofcarbohydrates specified. ③Indicates the amount of insulin remaining in your body from yourprevious bolus amount. ④Indicates the calculated bolus amount. G. 2.0U C. 10.0UA. 2.0U1 0 . 0 U5) Press twice to commence bolus delivery. You will hear the motor run and the screen will show that a bolusis being delivered.6) The pump will make a beep and return to the INITIAL DISPLAY screen upon conclusion of bolus delivery.W a r n i n gYou must eat your meal after the meal bolus has been delivered.N o t e The DANA Diabecare IISG insulin pump will deliver an audio reminder 30 minutes after bolus delivery. To stop thealert, push any button once. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지58 001 Acrobat™ PDFWriter 300DPI 60LPI
5 95. Remote ControlGlucose meter related error messages and troubleshootingS C R E E N P R O B L E M CORRECTIVE ACTIONStrip has been used more than once.ERROR 1 Retest with a new strip.Blood was applied prior to beingp r o m p t e d .ERROR 2 Retest with a new strip.Test environment is not within theallowed temperature range.ERROR 3 Retest with new strip in 30 minutes inadequate temperature.Blood viscosity is exceedingly high orblood sample size is not sufficient fort e s t i n g .ERROR 4Retest with a new strip. If the sameerror message repeatedly appears,contact your healthcare professional. N o t e Please refer to the following in the event of a measurement error. W a r n i n gBlood Glucose meter precautions- Do not use a bent or damaged strip.- Blood must not be applied to the strip prior to being prompted by the OBTAIN BLOOD screen.- The blood sample size must be sufficiently large to ensure an accurate reading. - Used strips cannot be reused. - Glucose testing must be conducted within the allowed temperature rage (10~40°C, 00-00F). In the event of asudden temperature change, allow at least 30 minutes for the device to adjust to the ambient temperature. - Test result may not be accurate if the viscosity of the blood sample is exceedingly high or the sample size is toosmall. #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지59 001 Acrobat™ PDFWriter 300DPI 60LPI
6 06. Troubleshooting When hypoglycemia (low blood sugar) occursWhat is hypoglycemia (low blood sugar)?Hypoglycemia occurs when the blood sugar level is low. Anyone using insulin should be familiar with the symptoms andtreatment of hypoglycemia.What to do in case of hypoglycemia1) Place the pump in SUSPEND mode. 2) Check your blood sugar level.3) If the blood sugar level turns out to be low, treat with carbohydrates in accordance with the instructions of your diabetesp r o f e s s i o n a l .4) Check your blood sugar level again in 15-20 minutes. If it returns to normal, no immediate action is needed and you maytake the pump out of SUSPEND.5) If not, refer to step 2 and retest in 15 minutes.6) If hypoglycemia appears prior to a meal, consider bolusing while you consume your meal.The main symptoms of hypoglycemia•Headache and dizziness•S w e a t i n g•S h a k i n g•H u n g e r•Tingling / numbness•Nausea or vomiting•Fast heart rate•C o n f u s i o nN o t e If hypoglycemia does not resolve contact your health care professional.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지60 001 Acrobat™ PDFWriter 300DPI 60LPI
6 1When Hyperglycemia (high blood sugar) occursWhat 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 ifthere is no insulin delivery you may experience an increase in your blood sugar which if undetected or untreated may causeDKA (diabetic ketoacidosis).The main symptoms of DKA:•N a u s e a•Vomiting •Increased drowsiness•Difficulty breathing•D e h y d r a t i o n•Abdominal painPOSSIBLE CAUSE SUGGESTED RESPONSEConsult with your diabetes professional to make adjustments for increased physicalactivity. You may choose to use or modify temporary basal rates or decrease mealboluses prior to activity.Increased physical activityConsult with your diabetes professional to adjust basal rates or meal boluses tomore accurately reflect your current intake.Eating lessPlease refrain from consuming alcohol. Alcohol consumptionCheck and review your bolus history and basal rates. Check with your diabetesprofessional to make sure that your bolus is properly calculated as well as yourbasal rates.User error or programming errorCheck your blood sugar regularly and check with your diabetes professional tomake sure that your bolus is properly calculated as well as your basal rates.Incorrect settings6. Troubleshooting #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지61 001 Acrobat™ PDFWriter 300DPI 60LPI
6 2What to do in case of high blood sugar:1) Check your blood sugar level.2) Check your pump for any problems.3) If your blood sugar remains high, take an injection of fast-acting insulin and contact your diabetes professional.POSSIBLE CAUSE SUGGESTED RESPONSEVisually check display screen for remaining insulin and also visually check reservoirin pump. Replace reservoir immediately.Empty reservoirExamine infusion site to make sure that there is no leakage. Also examine theconnection of the infusion set to the pump and the infusion set connector.Insulin leakage at infusion site,disconnection site or connection to pumpChange the infusion set.Pinched or obstructed infusion setCheck your blood sugar regularly and check with your diabetes professional tomake sure that your bolus is properly calculated as well as your basal rates.Incorrect settingsCheck to see if the pump is in SUSPEND or if there is enough insulin in thereservoir. Check your bolus/basal settings, history, and time. Check the remainingbattery charge and replace if necessary.Programming or user error#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지62 001 Acrobat™ PDFWriter 300DPI 60LPI
6 3Contact technical supportCannot change bolus/basals e t t i n g sContact technical support.Pump does not functionfollowing CT or MRI scanThe DANA DiabecareⓇIISR insulin pump will allow 2 prime sequences every 12hours (0:00 - 12:00, 12:00 - 24:00).Pump will not primeP r o b l e m Corrective ActionAn abnormal LCD can occur when the battery charge is low. Check the remainingbattery charge after you administer a bolus dose. The life span of the battery isusually 1 or 2 months, but varies among users. Some batteries are known to stillshow a full charge after two months even though they are low on charge. To avoidany battery mishaps we recommend that you change the battery every twomonths or whenever there is a display problem with your screen.Abnormal LCDProblem / Correction ActionW a r n i n gIn case of device malfunction, stop using the pump immediately and contact technical support.6. Troubleshooting #다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지63 001 Acrobat™ PDFWriter 300DPI 60LPI
6 4LOW RESERVOIR screen appearsThe low reservoir screen will appear when there are approximately 20 units remaining. The pump will alarmevery 30 seconds. Make a visual confirmation of remaining insulin through the reservoir cavity window on the side of pump. After confirming that the reservoir is low, insert a new reservoir filled with insulin.Daily RemainderThe daily remainder will appear if (Daily max-Daily infusion amount) < 10u. For instance if the daily maxis set to 100 units and the total infusion amount for one day exceeds 90 units the remainder will appearon the screen. Daily MaxAppears when the total infusion amount for one day has reached the daily max setting. If you requiremore insulin per day, please consult your healthcare professional to extend the daily max setting. ERROR screen appearsSuspend the pump, remove the infusion set and check your blood sugar, then check the reservoir amount. If lessthan 10 to 15 units of insulin remain in the reservoir, replace it. If this does not correct the error, check for occlusion ofthe infusion set. Visually check for any possible occlusion of the infusion set and take corrective measures (unkinktubing, check for air bubbles, etc.). If this does not resolve the problem change both the reservoir and infusion set.7. List of alarms and audible signalsLow BatteryThe low battery screen will appear when the remaining battery charge is no longer sufficient for the pumpto operate. Please change the battery.W a r n i n gFor safety we recommend that you change the reservoir when there are 10 to 15 units of insulin remaining. N o t eA continuous alarm will sound.Check Glucose Time to check your blood glucose level.N o t e A melody will play for 30 seconds.W a r n i n gIf ERROR screen persists, contact technical support.#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지64 001 Acrobat™ PDFWriter 300DPI 60LPI
6 5Classification and compliance with standards•The DANA DiabecareⓇIISR 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 pump will continuously operate according to the user defined settings.8. Specifications, symbols, warrantyDANA DiabecareⓇIISR Insulin Pump General Specifications3 . 0 4×1 . 7 8×0.79inch (77×4 5×2 0 m m )61g (including battery)3 mL (300 Units), insulin compatible reservoirS i z eNet WeightInsulin Syringe0 - 8 0 u0-16.0 u/h24 SettingsMeal Bolus SettingBasal Rate SettingBasal ProfileSwiss Micro DC motor12 seconds3.6V DCM o t o rBolus Duration for 1 UnitPower SupplySleep Mode, Screen Saver4 minute intervalsDual microprocessors for continuous cross checkingEnergy SaverBasal Delivery IncrementsIntegrated Circuit7. List of alarms and audible signals / 8. Specifications, symbols, warranty#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지65 001 Acrobat™ PDFWriter 300DPI 60LPI (2) this device must accept any interference received, including interference that may cause undesired operation.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and.Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
6 6Universal SymbolsS Y M B O L D E F I N I T I O NRead instructions for use.Sterilized with ethylene oxideManufacture dateLot numberExpiration date (Use by date)CE Marking (SGS UK)Do not re-useAdhesive plasterSerial numberIsolated patient connection (IEC 60601-1 BF type) Tubing length (43 inch, 27 inch / 1100 ㎜, 700 ㎜)#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지66 001 Acrobat™ PDFWriter 300DPI 60LPI
6 7W A R R A N T YSOOIL Development Company Limited warrants that the DANA Diabecare insulin pump is free from defects in material andworkmanship under normal use and conditions and will warrant this for a period of four (4) years from the date of purchaseby the original purchaser. This limited warranty extends only to the original purchaser.Should the pump fail to operate properly due to defect in material or workmanship during the warranty period, it may bereturned to SOOIL Development Co. Ltd., by shipment to its designated Distributor. The pump will be repaired or replaced atS O O I L’s option without charge to the purchaser. Freight and other charges, where applicable, incurred in shipping a pumpfor repair date is covered under this warranty. The warranty period shall not be extended from the original purchase.This limited warranty is valid only if the DANA Diabecare insulin pump is used in accordance with all of the manufacturer’sinstructions. Note that this warranty does not extend to damage as a result of the following:•Service or repairs performed by any person or entity other than a SOOIL authorized technician.•Modifications or changes to the pump 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 pump bythe user or any other person including but not limited to physical abuse of the product such as dropping or otherwisedamaging the DANA Diabecare pump.•Failure to follow the manufacturer’s instructions, including those for storage, transport or cleaning for the DANA Diabecareinsulin pump.•This warranty does not cover batteries, infusion sets, cartridges or other accessories of the DANA Diabecare insulin pump.WARNING: Use of infusion sets, cartridges and batteries not specifically indicated by the manufacturer may result in harm orinjury to the user or the device. Please consult owner’s manual for full instructions.Except as expressly set forth in this limited warranty, all other warranties are expressly disclaimed and excluded including,without limitation, any warranties of fitness or merchantability for a particular purpose.The remedies provided herein are the exclusive remedies available in the event of any breach hereof. Except for suchremedies, SOOIL Development Co. Ltd., its distributors, suppliers and agents shall not be liable for any losses, liabilities,claims, or damages of any kind or nature whatsoever including, without limitation any indirect, consequential, incidental orspecial damages caused by or arising from a defect of the insulin pump.SOOIL Development Co., Ltd.:196-1, Dogok-dong Kangnam-gu, Seoul, KOREA 135-270Tel:+82(2)3463-0041 F a x : + 8 2 ( 2 ) 3 4 6 3 - 7 7 0 7Email: sooil@sooil.com h t t p : / / w w w . s o o i l . c o m7. Specifications, symbols, warranty#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지67 001 Acrobat™ PDFWriter 300DPI 60LPI
w w w . s o o i l . c o mIU-E-21 rev.0#다나2SR영문메뉴얼 rev.0 2007.7.3 5:44 PM 페이지68 001 Acrobat™ PDFWriter 300DPI 60LPI

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