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1. gt Reconnecting the Soft Release ST Infusion Set gt Wipe the tip of the Site Connector with an alcohol swab after removing the Site Connection Cover gt Remove the Infusion Set Cover from the Infusion Set Connector Figure 13 Before reconnecting program the pump to bolus 0 5 1 Unit of insulin and watch to ensure that a drop is visible from the Connection Needle tip Repeat the bolus as necessary until you see the insulin gt Gently slide the Infusion Set Connector over the Site Connector pressing lightly on the Spring Clips on either side of the Infusion Set Connector The Connection Needle should glide into the Site Connector and the two units should snap together Figure 13 Removing the Soft Release ST Infusion Set _ Place the pump in SUSPEND Carefully remove adhesive tape from the tubing and needle insertion site Grab the Soft Release STNeedle Guide in the same way as if you were inserting it Use your other hand to apply slight pressure on the tissue around the insertion area Gently pull the cannula out Remove the infusion set from the pump by turning the Pump Connector clockwise and pulling upwards Please dispose of the used infusion set according to your local regulations P Ollest 200 5 10 11 54 AM Page 32 Soft Release R O Ollast 2007 5 10 11 54 AM Page 33 Instructions g Connecting the Soft Release R Infus
2. set according to your local regulations Ollast 2007 5 10 11 54 AM Page 28 an Soft Release ST Ollast 2007 5 10 11 54 AM Page 29 an Instructions Inserting Disconnecting and Reconnecting the Soft Release ST Infusion Set __ 1 Wash your hands before assembling the supplies Use sterile technique when inserting the infusion set 2 Choose an insertion site on your abdomen at least 2 inch away from the navel Clean the site with an alcohol swab and allow to dry Figure 1 Figure 2 7 3 Hold the infusion set in your fingers at the guide Carefully remove the Fe Needle Cover and Paper backing on the adhesive Figure 2 3 Figure 3 4 With your other hand pinch the tissue around the insertion site between your thumb and finger Push the needle deeply into this tissue Figure 4 Figure 4 5 To remove the Introducer Needle place a finger on each side of the Needle Guide one on either side of the Introducer Needle To make withdrawing the Introducer Needle easier Figure 5 rotate the needle a half turn then pull the needle straight out Figure 5 and discard properly Figure 6 6 Secure the Needle Guide to the insertion site with adhesive tape Figure 7 Figure 6 Figure 7 Ollast 2007 5 10 11 54 AM Page 30 APY Follow the instructions on page 23 to prime the Soft Release ST which removes air in the tubing When a drop of insulin ap
3. 55 AM Page 46 SIZE NETWEIGHT INSULIN SYRINGE MEALBOLUS SETTING BASALRATE SETTING BASALPROFILE MOTOR FLOW RATE BOLUS DURATION FOR ONE UNIT POWER SUPPLY ENERGYSAVER DELIVERY INCREMENTS INTEGRATED CIRCUIT WATER RESISTANT INSULIN CONCENTRATION CLOCK FORMAT ALARM SAFETYSETTINGS Specification Symbols Warranty General specifications DANA Diabecare IT Insulin Pump 2 95 X 1 77 X74 mm 1 8 oz empty 3ml 300 units plastic impact resistant insulin compatible reservoir 1 to 40 units factory default settings 0 to 87 units 0 1 to 16 0 units hour 24 Settings Swiss micro DC motor 0 1 units hour minimum 13 seconds 3 6 V DC Screen sleep mode 4 minute intervals Dual microprocessors for continuous cross checking Meets the IPX8 double drop standard watertight U 100 unit ml AM PM standard or Military Audible tone beep Maximum bolus Maximum basal Maximum daily total Low reservoir Occlusion Low battery Classification and compliance with standards The pump is classified as an internal powered equipment BF type under the standard of IEC 60601 1 Medical Electrical Equipment General Requirements for Safety gt It is not suitable for use in the presence of a flammable anesthetic mixture by the standard ofEC 60601 1 Double drop standard watertight indicates pump may be immersed in water for prolonged periods The pump
4. always prime when you do this 1 Turn on the pump screen by pressing any button Press i to enter the BASIC DISPLAY screen as shown in figure 1 Highlight and press EL 2 In the CHECK REVIEW screen press ES k to highlight fas shown in figure 2 Then press SEL 3 You will now see the FILLING screen display i qa DO as shown in figure 3 Usd fena DOWN to adjust the amount of insulin in cc s FILLING SCREEN in the new reservoir you just filled and placed in the DANA pump DAA The 2 5 cc is a preset default setting Remember to adjust this setting up or down to the amount you actually have placed in the reservoir according to the insulin scale tray Ollast 2007 5 10 11 54 AM Page 23 4 Connecting your infusion set to the pump Take the infusion set from its package Be careful not to touch the connector to any object that would breach its sterility Screw the Pump Connector counterclockwise into the reservoir compartment until it is firmly in place 5 Press serana stand the pump on end as in figure 4 The PRIME screen will now appear as in figure 5 he infusion set in twice on the pump 6 Take the needle eng one hand and press with the other hand 7 You will hear the pump begin to infuse insulin into the infusion set The insulin amount on the PRIME screen as in figure 2 6 will increase slowly and bubbles will appear at t
5. battery life and remaining insulin amount 17 e How to fill and insert a new reservoir 1 ee eens 21 Filling the reservoir with insulin 2 1 0 0 0 cece cece ene 19 Inserting the linking screw into the reservoir and into the Dana pump 20 Use of the DANADiabecare II pump and infusion set Easy Release e Priming the infusion set 2 2 scaua a tect aan cece oe dn Radanoedd Mee wae 22 e Inserting disconnecting and reconnecting infusion set 00 23 Inserting the infusion set ccens0eeece edness na 25 Disconnecting the infusion set 0 0 cece eee nee 30 Reconnecting the infusion set 0 0 cece eee ee ees 34 Delivering a DOUS xc b4 00cdd ae eee wd wise Uae when Yaudee E eax ne 28 e Programming temporary basal rates during exercise illness menses or stress 29 e Removing the infusion set 2 266555 445 ea teases PhGeeeeimyesadoeencs 27 Soft Release ST e Indications TO Use srrrrrersr iirin EEEE NEEE ET EO E 28 SPE aO er eer r a EE EAEE 32 e nsitruciions seruire a xe anii secs emt An E E wah glen de deere a REE E 33 Connecting the Soft Release ST infusion set to the reservoir 33 Use of the DANA Diabecare II pump and Soft Release ST infusion set 33 Using the disconnect feature nnnnnna nuana 34 Removing the infusion set 0 cece teens 35 P Ollast 2007 5 10 11 54 AM Page 2 D Soft Release R e Indications Or USC sas
6. before a meal check with your diabetes professional to adjust basal rates or meal planning d 4 If hypoglycemia does not resolve contact your health care professional POSSIBLE CAUSE SUGGESTED RESPONSE i Consult with your diabetes professional to make adjustments for increase Increased physical activity activity You may choose to use or modify temporary basal rate or decrease meal bolus prior to activity Eating less Consult with your diabetes professional to adjust basal rates or meal boluses to more accurately reflect your current intake Alcohol consumption When alcohol is consumed make sure that food is also consumed Alcohol may cause hypoglycemia Test your blood sugar more frequently Low blood sugar after Verify that connection and disconnection were performed in accordance with disconnecting infusion set manufacturer s instruction Remember to verify insulin at the needle by bolusing 0 5 units before reconnecting User error or programming Check and review your bolus history and basal rates Check with your diabetes error professional to make sure that your bolus is properly calculated as well as your basal rates P Ollast 2007 5 10 11 55 AM Page 42 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
7. cesraneseaami aani eaae E E E E es 36 SPO O a EEEREN EES EEA EERE 37 SO peere a ERA 38 Connecting the Soft Release R Infusion set to the reservoir 38 Use of the DANADtabecare II pump and Soft Release R Infusion set 38 Using the disconnect feature 2 1 ect e es 39 Removing the infusion set 2 0 ccc cee eens 40 Locking te p mp ssssrersierirrirda 268 ces deen ee BOR seeni 40 4 Troubleshooting e When hypoglycemia low blood sugar occurs 0 0c cee eee ee eee 41 e When hyperglycemia high blood sugar occurs 0 0 0 c eee eee 42 e Problems corrective actions x16ccnieessncdsesavaes suhadeenanaes wwe 43 e List of alarms and audible signals 0 0 0 0 0 cece eee eens 45 5 Specifications Symbols Warranty e General specifications 0 ec cette tenet ene ees 46 e Classification and compliance with standards 0 0 cece eee eee 46 gt e Universal Symbols 0 0 0 0 0 c cece cece ees 47 OV ei a m 24 Gee e enone ede cat eoubes yan eden ates EE ans 48 Ge 2 82 GC RPP REE REE RRR Raa aaa ttt Ollast 2007 5 10 11 54 AM Page 3 ae C _ DANADiabecare II pump infusion set and reservoir Indications for Use yy Federal US law restricts this device to sale by or on the order of a physician INDICATIONS FOR USE The DANA Diabecare II insulin pump infusion set and reservoir are intended for the continuous delivery of insulin for th
8. ed three times consecutively to i BASIC DISPLAY SCREEN 2 The SET PROGRAM screen in figure 2 appears You can select bolus or SET PROGRAM SCREEN Ollast 2007 5 10 11 54 AM Page 11 D Setting a bolus 1 From the BASIC DISPLAY screen go to the SET PROGRAM screen In SET PROGRAM press sex when the Q The bolus setting screen will appear as shown in figure 2 2 While in the BOLUS SETTING screen 3 After setting your bolus doses presser select the proper insulin dose by usin and The bolus settings will be saved in the DANA a The insulin dose appears in unitS M the memory bottom right hand corner ETI We recommend you confirm that your bolus setting is saved to memory by using the CHECK REVIEWmode of the DANA Diabecare II See page 17 Ollast 2007 5 10 11 54 AM Page 12 a Pre setting meal boluses If you pre set meal boluses the following time periods correlate to the following schedule Breakfast 1 00 am 9 59 am Lunch 10 00 am 2 59 pm Dinner 3 00 pm 12 59 am Any bolus given during the breakfast period will be pre set for the amount selected for breakfast If you have a snack or multiple meals within a time DINNER BOLUS SCREEN period remember to adjust your bolus accordingly Ollast 2007 5 10 11 54 AM Page 13 D 1 From the BASIC DISPLAY screen go to the SET PROGRAM screen In SET PROGRAM
9. in the window of your pump If there are bubbles change the remove the reservoir and recheck placement in your filling tray page 21 Adjust if necessary and reinsert Attach tubing and prime again If the pump still will not prime contact Technical Support at 1 866 326 2832 Contact technical support to review programmed maximums for daily total bolus and basal amounts gt Make sure the pump is suspended and reinsert the battery If you experience any other abnormal operation of your pump that is not described above discontinue use immediately and contact Technical Support at 1 866 326 2832 P Ollast 2007 5 10 11 55 AM Page 45 ae List of alarms and audible signals Event Warning Depleted battery alarm Continuous beep Pressing control panel input button Beep Bolus dose completed Long beep Infusion of bolus dose One Short beep per unit Prime One Short beep per unit 30 minutes after bolus delivery optional Melody Error alarm Press to silence Low reservoir 20 beeps every 30 seconds after gt low reservoir screen disappears 4 Pump suspended Screen disappears and the pump gives 3 short beeps every 4 minutes Removing pump from suspend Melody Placing pump in suspend Short beeps followed melody OE INTERNATIONALALARM CODES R after number Remain remaining of insulin amount B Low Battery O Occlusion D Daily Total Ollast 2007 5 10 11
10. will continuously operate according to the user defined settings Ollast _2007 5 10 11 55 AM Page 47 Meaning A C Eon IPX 8 66 5 LOT gt STERILE ED ZK Read instruction for use Isolated patient connection IEC 60601 1 TYPE BF Do not Re use Sterilized with ethylene oxide Expiration date Use by date
11. Ollast 2007 5 10 VISEWIA jy 77 Il 11 54 AM ntents l N SS Page 1 P Before using your DANA Diabecare II pump infusion set and reservoir e Indications for USE cc204 208045650004 60404 beeen oe LEADER RES 3 a Sdicly PleCdUNOUS ose cee sae wae teaee bade bee eee ees E NAE oes x gt e Cleaning your DANADiabecare JI insulin pump 005 5 e Explanation of Warning Caution and Note Symbols 5 e Contents of DANADiabecare II insulin pump kit 0005 6 e Identification and description of your pump features nnna nunnana 7 e Easy Release Infusion Sef orses cerirrrereruriecirswi e ri esini wiecti 9 Set up and basic functions e Inserting the battery 2 ccc cece eee nes 8 e Suspending the pump by programming 0 cee eee eee 18 e Explanation of display screens 0 0 ccc cece 9 S1MANGICBIAy serere iernare meade eas eenadues car eneene se 10 s Dabe ABP 2o5 5 64a hee 5G ote eA eae St bene ENES 10 e Setting bolus doses basal rates and the clock 0 0 0 e cee ee eee 10 See a DOUS 23 usnrergcamsnteeevebiadndeeetede a ud es 1 Pre setting meal boluses 0 0 cee eee en ees 12 Seting the Dasal Tae ou dneweuiahenx daa shure EE DVE EEEE 14 Seting the clock seeicrrrerassrird iiri Erns oe here bedar esee es 15 e Checking bolus doses basal rates and reviewing memory data 16 e Checking the
12. SPLAY 1 Displays current time and date 12 16 AW 09 59 67 ah LLE 2 Displays remaining battery charge 4 L TSK o as 100 75 50 25 or 0 The remaining battery charge is updated i only after you deliver a bolus 3 Displays the amount of insulin remaining in the reservoir in units 1ml 100 units e 1 CHECK REVIEW icon Choose the picture of a magnifying glass to check basal rates previous bolus doses the last bolus previous daily totals and prime history e 2 BOLUS icon Choose the icon of a syringe to deliver meal bolus doses e 3 TEMPORARY BASAL icon Choose the picture of a person for temporary changes in basal rates for exercising or other events e 4 SET PROGRAM icon Choose the picture of a sliding scale to set basal rates and preprogrammed bolus doses DAA The DANA Diabecare II LCD screen will automatically go blank after one minute to conserve battery power Push any of the control buttons to return to the INITIAL DISPLAY Any button press will also activate the backlight for 10 seconds P Ollast 2007 5 10 11 54 AM Page 10 an Setting bolus doses basal rates and the clock You cannot see the magnifying glass icon in first box that says from the INITIAL DISPLAY screen press any of the control buttons and the BASIC DISPLAY screen will appear ra 1 In the BASIC DISPLAY screen press e to change the highlighted icon Press
13. al period The 1s added to or subtracted from your TEMPORARY BASAL SCREEN regular basal rate For example if your basal rate is 4 units an hour a temporary basal of 75 will give you 3 units per hour a rate of 150 will give you 6 units per hour After making the desired adjustment Ollast 2007 52 10 11 55 AM Page 39 A ey 3 i and Ea program the number of hours temporarily change the basal rate figure 3 After making the desired adjustment pres set 4 The temporary basal ratewill remain in effect for the TEMPORARY BASALSCREEN desired number of hours and will be indicated in thebasic display by the v mark in the EXERCISE TEMPORARY BASAL icon figure 4 5 If you want to cancel the temporary basal choose pin the basic display and pres Adjust the hour setting to 0 and press The BASIC DISPLAY screen in figure 5 will appear Note that the v is no longer on ir basal rate will automaticall 9 return to 100 DAZ If you reset the clock after setting a temporary BASIC DISPLAY without basal you must reset the temporary basal TEMPORARY BASAL SCREEN BASIC DISPLAY with val TEMPOR BASAL SCREEN Ollast 2007 5 10 11 55 AM Page 40 P Locking and unlocking the pump This function may be used to prevent an accidental change in settings It is recommended for children or anyone who want or needs to be prevented from ina
14. ate settings are 25 70 7 t incorrect please return to the BASIC DISPLAY and ii aE i i l Dinner 11 Qu Setting Bolus Doses and Basal Rates DINNER BOLUS SCREEN choose to make adjustments see page 13 Ollast 2007 5 10 11 54 AM Page 17 an ey 5 Use Li Jane fou to review the Bolus 6 Geeft fan a to review the Daily History ding date time and amount Total Sry including date and the total delivered Press a to review the 50 amount of insulin Press sex to review previous Daily Totals the 50 previous Prime Amounts 7 Use and 120 to review the Prime History uding date time and amount g Press se to return to the Press o check factory ship date and BASIC DISPLAY serial number Checking the battery life and remaining insulin amount 7 12 18 AM 09 59 51 S T G ood U To INITIAL DISPLAY SCREEN The battery life and remaining insulin amount can be confirmed in the INITIALDISPLAY screen The INITIALDISPLAY in figure 1 shows that 250 units of insulin remain in the reservoir and that the battery is 100 charged This screen is automatically display any time a button is pressed to activate the screen Ollast 2007 5 10 11 54 AM Page 18 aR Suspending the pump When you suspend the pump it will beep 3 times every 4 minutes to remind you that no insulin is being delivered 1 In the CHECK REVIEW SCREEN x press vex hig
15. dvertantly changing settings 1 In the CHECK REVIEW screen pressi highlight Then press icon as shown in figure 1 2 The screen will indicate the pump is locked as shown in figure 2 3 To unlock the pump press sex Reena exfyuentially The Lock out screen appears as shown in figure 3 4 Select the proper code Default 1234 by using gt of and S as shown in figure 4 5 Press sex The pump is now unlocked MAA When the pump is locked basal delivery continues You cannot set or deliver a bolus however Ollast 2007 5 10 11 55 AM Page 41 lt When hypoglycemia low blood sugar occurs 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 main symptoms of hypoglycemia Headache and dizziness Tingling numbness Sweating gt Nausea or vomiting Shaking Fast heart rate Hunger Confusion What to do in case of hypoglycemia 1 Check your blood sugar level 2 If the blood sugar level turns out to be low treat with carbohydrates in accordance with the instructions of your diabetes professional 3 Check your blood sugar level again in 15 20 minutes If it recovers to normal no immediate action is needed 4 If not refer to step 2 and retest in 15 minutes 5 If hypoglycemia appears several hours
16. e management of diabetes mellitus It is not intended for the delivery of blood or blood products Other infusion sets may be used if DANA Diabecare Universal Adaptor is utilized gt Please contact 1 866 342 2322 for details L The DANA Diabecare II is classified as an internal powered equipment BF type in accordance with standard IEC 60601 1 Medical Electrical Equipment General Requirements for Safety Patients must not open the pump housing or handle any internal components The DANA Diabecare II 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 If you experience any trouble with the pump remove the battery from the pump immediately and contact your sales representative Use the pad of your finger to press the buttons DO NOT use sharp objects to press the buttons P Ollast 2007 5 10 11 54 AM Page 4 P gt Avoid the following conditions for safe storage and transport of theDANA Diabecare II Temperatures below 32 9 F or above 104 F Humidity above 90 Exposure to dirt or excessive dust Exposure to salty environment Exposure to explosive nn Exposure to rough handling Exposure to direct sunlight Atmospheric pressure below 500mmHg or above 1060mmHg The pump must not be used in the presence of intense electro
17. e tip of the Site Connector with an alcohol swab after removing the Site Connection Cover 2 Remove the Infusion Set Cover from the Infusion Set Connector 3 Before reconnecting program the pump to bolus 0 5 1Unit of insulin and watch to ensure that a drop is visible from the Connection Needle tip 4 Repeat the bolus as necessary until you see the insulin See detailed instructions in the Dana Diabecar II User Manual 5 Gently slide the Infusion Set Connector over the Site Connector pressing lightly on the a N Spring Clips on a either side of the Infusion Set Connector The Connection Needle should glide into the Site Connector and the two units will snap together Figure 12 Figure 12 P Ollast 2007 5 10 11 54 AM Page 35 an WZ Removing the Soft Release R Infusion Set 1 Place the pump in SUSPEND Carefully remove the adhesive tape from the Tubing and needle insertion site 2 Grab the Soft Release R Needle Guide in the same way as if you were inserting it Use your other hand to apply slight pressure on the tissue around the insertion area Gently pull the needle out 3 Remove the infusion set from the pump by turning the Pump Connector clockwise and pulling upwards 4 Please dispose of the used infusion set according to your local regulations Locking and unlocking the pump This function may be used to prevent an accidental change in settings It is recommended for children or anyone w
18. he end of the reservoir on the display screen as in figure 6 When you see several drops of insulin appear at the end of the infusion set press fto PRIME SCREEN stop the flow of insulin DAA The pump must be primed 10 units for a the proper safety checks to be performed Prime 8 2 U 8 Press sei to return to the BASIC DISPLAY a d Always check and confirm all basal and bolus settings after changing the insulin reservoir page 19 Visually confirm there is no air in the infusion set tubing DAA Do not allow insulin to come in contact the infusion set dressing DAA The DANA pump will only allow two automatic prime sequences in 12 hours See Troubleshooting page 44 DAZ Make sure to prime when you use a new infusion set or to remove air from the tubing If you prime to remove air from the tubing make sure you are disconnected P Ollast 2007 5 10 11 54 AM Page 24 D Easy Release Infusion Set Easy Release Luer Connector Ollast 2007 5 10 11 54 AM Page 25 A ey Inserting disconnecting and reconnecting the EasyRelease Infusion Set 1 Wash your hands before assembling __ amp a the supplies Use sterile technique when Inserting the infusion set inserting the infusion set 2 Choose an insertion site on your abdomen at least 2 inch away from the navel Clean the site with an alcohol swab and allow to dry 3 Follow the instructi
19. he reservoir by gently tapping on the sides making the bubbles rise to the top of the syringe Gently push on the plunger to remove the bubble at the top 5 Remove the needle from the reservoir and cover with the thin white Use only short acting insulin in reservoir cap Please dispose of the needle properly Uy your pump Ollast 2007 5 10 11 54 AM Page 20 Inserting the linking screw into the reservoir and into the Dana Pump 1 Insert and fit the plastic component of the linking screw into the cavity of the plunger LAZ The screw must lie in the groove of the tray s neck as in figure 1 In some cases you must manually adjust the screw length to match the neck before putting the reservoir in the tray 2 Place the filled reservoir with the attached linking screw into the insulin scale tray as shown in figure 1 3 Rotate until the end of the linking screw fits into the notch as shown in figure 1 L LDAA Be sure to note the amount of insulin in the reservoir as indicated on the insulin scale tray and not on the reservoir body itself You will need this number when you remove air from the infusion set by priming page 24 The scale is in 0 2 cc increments LUAZ The tip of the linking screw with the hexagonal 6 sided end should enter the notch to point indicated by the red line and no further FIGURE 2 4 Suspend your pump now and remove the old reservoir if you haven t already done
20. hlight fas shown in figure 1 Then press set CHECK REVIEW SCREEN 2 The pump will give an audible tone and the screen will indicate the pump is suspended 3 To take the pump out of suspend press sex you will again hear an audible indicator and the BASIC DISPLAY will TE BASIC DISPLAY appear as shown in figure 2 Ollast 2007 5 10 11 54 AM Page 19 Filling and inserting a new reservoir Insulin Insulin Pump Reservoir Scale Tray Infusion Set Transparent Linking Screw Insulin Reservoir Battery Key Case Cap We recommend that you change the reservoir when there are 15 to 20 units of insulin remaining Filling the reservoir with insulin 1 Place all materials on a clean dry surface 2 Remove the round cap at the end of the reservoir plunger and discard Athin white reservoir cap will fall out of the plunger keep this cap for later use Pull back on plunger to the line marked with the number 3 and push up and down three to four times to properly lubricate the reservoir 3 Carefully remove the clear needle protective cover Pull plunger down until you are at the desired amount of insulin needed then m z insert needle into the insulin vial and inject the air in the syringe into the vial Draw out the desired amount of insulin Withdraw the needle from the vial and place the clear needle protective cover back on the needle 4 Remove any bubbles from the inside of t
21. ho wants or needs to be prevented from inadvertently changing settings 1 In the CHECK REVIEW screen pressa highlight Then press s icon as shown in figure 1 2 The screen will indicate the pump is locked as shown 7 uigure 2 hy 3 To unlock the pump pres l l and bow sequentially Then the Lock out screen appears as shown in figure 3 4 Select the proper code Default 1234 by using Pand gt as shown in figure 4 AA When the pump is locked basal delivery continues You cannot set or deliver a bolus however 6 3 08 38 20 B B 10 US 8ua 160 a 235 Mm 100 af 1234 LIA To remove this option refer to the Guided Management Healthcare Professional Manual Ollast 2007 5 10 11 54 AM Page 36 a General Precautions for all infusion sets 1 Change the reservoir and the infusion set regularly as recommended by your healthcare professional Do not use either for longer 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 become wet 4 The shelf life of the reservoir and the infusion set is 3 years Please check the expiration dates regularly and dispose of any expired accessories 5 Do not disconnect from your pump for more than one hour without discussing with your healthcare professi
22. hted section of the basal profile 2 TB 32 9 is the basal calculator for a 24 hour period 3 Basal Profile which shows basal rates in a graph from midnight to midnight BASALRATE SETTING SCREEN 4 Basal Rate for the time period shown in and graphed in 14 Ollast 2007 5 10 11 54 AM Page 15 A ey 2 The Basal Profile appears in the lower right side 3 After basal rates are set press sex to save of the screen Usei to move between the 24 the setting in the DANA memory rates available the corresponding chronological time will appear in the upper right corner Use the fa ee to change the basal rate ted time period for the hi DAZ Make sure to press se after the basal profile is set to save the settings DAA We recommend that you confirm all adjusted settings are saved to memory by using the CHECK REVIEW mode of DANA Dhiabecare II See page 17 Setting the clock _ 1 From the BASIC DISPLAY go to the SET PROGRAM screen Press ex1 to highlight J and press sex 2 The CLOCK SETTING screen will appear as shown in figure 1 3 Use fad to move between the year and month DAA You must set a m and p m correctly If the a clock shows 3 00 p m and you want 3 00 as well as hours and minutes and UP a m you must continue to press UP untill and DOWN to make the desired changes the screen reflects your desired change z Failure to do so might result i
23. if undetected or untreated may cause DKA diabetic ketoacidosis The main symptoms of DKA Nausea Vomiting Increased drowsiness Difficulty breathing Dehydration Abdominal pain eeeeet e eeee8 What to do in case of high blood sugar Check your blood sugar level If your blood sugar is above 240 check urine for ketones Check your pump to see what might be the cause If your blood sugar remains high take an injection of fast acting insulin and contact your diabecare professional KONN II DONON SUGGESTED RESPONSE Empty reservoir Visually check display screen for remaining insulin and also visually check reservoir in pump Replace reservoir immediately PE oe Insulin leakage at infusion site or Examine infusion site to make sure that there is no leakage Also examine the disconnection site or connection connection of the infusion set to the pump and the infusion set connector to pump Pinched or obstructed infusion set Change the infusion set Incorrect programming Verify the basal bolus delivery and verify memory including temporary basal Make sure there are no air bobbles in reservoir Monitor your blood sugar Programming or user error frequently and verify that basal programming and bolus programming are correct Make sure cartridge is not empty and make sure the clock settings are correct Check for leaking at the infusion site the disconnect site and the connection to the pump Check battery
24. indicator and replace battery if needed Examine infusion set for pinching or blockage Look and listen to see if the pump is in suspend Verify that insulin is clear and if cloud or past an expiration date change reservoir and infusion set immediately P Ollast 2007 25 10 11755 AM Page 43 a 4 The user should never be connected to the pump during troubleshooting PROBLEMS TROUBLESHOOTING PUMPMESSAGES AND FUNCTIONS 1 LCD Abnormal Power Low gt REPLACE BATTERY An abnormal LCD can occur when the Screen will not display or displays battery charge is low Check the remaining battery charge after only partially you administer a bolus dose Figure 1 If the remaining charge is 25 or less please change the battery The life span of the battery is usually to 2 months but varies among users Some batteries are known to still show a full charge after two months even though they are low on 12 16 AM 09 59 51 charge To avoid any battery mishaps we recommend that you change the NU aa battery every two months or whenever there is a display problem with 224 U ih your screen 2 LOW RESERVOIR screen gt CHANGE RESERVOIR The low reservoir screen in figure 2 will appear appears when there are approximately 20 units remaining The pump will alarm Make a visual confirmation of remaining insulin through the reservoir ee cavity window on the side of pump After confirming that the reservoir is low insert a new reservoir in
25. infusion set 8 Basal and meal bolus settings will not change 9 Pump has been taken into an MRI or CT scan room 10 Pump will not prime 11 LIMIT or DAILY MAX FULL appears on display 12 After inserting a new battery it displays less than 100 yy an PROBLEM CORRECTIVE ACTION gt REFER TO PAGE 23 AND ATTEMPT TO INSERT RESERVOIR AGAIN When inserting the reservoir slightly rotate right and left until notch fittings on side of reservoir slide into place Let the reservoir and linking screw fall into the reservoir compartment of the pump gently A not push and or force the reservoir into the pump This could mage the motor drive and linking screw or could result in the loss of insulin from the reservoir If attempts to reinsert the reservoir fail try a new reservoir If the new reservoir also does not fit contact technical support at 1 866 326 2832 DISCONNECT FROM PUMP Prime to remove air from reservoir and tubing If this does not correct the problem change the reservoir and infusion set Contact technical support to review programmed maximums for daily total bolus and basal amounts DISCONNECT FROM THE PUMP AND CONTACT TECHNICAL SUPPORTAT 1 866 326 2832 The Dana pump will only allow 2 automatic prime sequences in 12 hours Remove battery to reboot the pump Reinsert after several seconds and attempt to prime following instructions on page23 If this fails check for bubbles
26. ion Set to the Reservoir l Take out the Soft Release R Infusion Set from its package Be careful not to touch the connector to any object that would breach its sterility Screw the Pump Connector counterclockwise into the reservoir compartment until it is firmly in place gt Connect the site connector to the infusion set connector Inserting Disconnecting and Reconnecting the Soft Release R Infusion Set 1 Wash your hands before using the supplies Use sterile technique when inserting the infusion set 2 Choose an insertion site on your abdomen at least 2 inch away from the navel Clean the site with an alcohol swab and allow to dry Figure 1 A 3 Follow the Dana Diabecar II Insulin pump user manual to prime the Figure 1 Figure 2 Soft Release R for removing air in the infusion set When a drop of insulin appears at Bypass Needle air removing is complete Figure 2 4 Hold the infusion set in your fingers at the Needle Guide Carefully remove the Needle Cover Figure 3 and paper backing of the self adhesive Figure 4 5 With your other hand pinch the tissue around the insertion site between your thumb and finger Insert the needle quickly at a 90 angle straight into infusion site Watch the Teflon soft cannula during insertion to assure that it goes in smoothly without kinking or crimping Figure 5 6 Before withdrawing the Introducer Needle place the tape over the Soft Release R 7 To remove the Introduce
27. magnetic fields such as those generated by certain electrically powered medical devices The pump should be removed prior to the user having a CTScan MRI or X ray gt The pump comes with factory default settings for alarms maximum daily totals basal and bolus doses These settings may be modified by a healthcare professional or the user through the Guided Management Programming Mode gt Remove the battery for long term storage The reservoir and infusion set are intended for single use only Do not reuse either the reservoir or infusion set gt Change the reservoir and the infusion set regularly as recommended by your healthcare professional Do not use either for longer than 72 hours gt The shelf life of the reservoir and the infusion set is 3 years Please check the expiration dates regularly and dispose of any expired accessories P Ollast 2007 5 10 11 54 AM Page 5 ae gt The outside of the pump should be cleaned monthly gt When cleaning the pump use a cloth moistened with water or a neutral pH detergent and wipe it with a dry cloth gt Do not use thinner alcohol benzene or similar solvents Please rinse your pump off with clean water after swimming or after exposure to dust soot or other material that adheres to the pump gt Never insert a cloth or liquid into the battery compartment Ifthe linking screw appears discolored discard and use a new one Contact technical
28. n inappropriate After making the changes press sex to basal insulin delivery for that time period return to the BASIC DISPLAY screen LAZ If you or your healthcare professional have chosen the 24HR option in Guided Management your CLOCK SETTING screen will appear as shown in figure 2 Ollast 2007 5 10 11 54 AM Page 16 A 1 In the BASIC DISPLAY screen press S until the icon is highlighted as in figure 1 Then press 2 The icon will be highlighted as in figure 2 if not pressi to change the highlighted icon Then press SEL CHECK REVIEW SCREEN a oe LIEI The Hen is used for reviewing both basal rates and bolus settings pS Do not select Afshin is immediately to the right If you selected this in error press 0 return to the BASIC DISPLAY and go back to step 2 3 The BASAL PROFILE screen figure 3 will appear Presinto move between basal profiles and confirm settings To review the previous meal bolus press BASAL PROFILE SCREEN 4 The BOLUS screen figure 4 or MEAL BOLUS screen figure 5 will appear The number will be US 27 MA 160 Ep evoa 5 0u Bolus fiu BOLUS SCREEN the default bolus figure 4 or pre set meal bolus figure 5 Press to move from one meal period to the next Press s EL to review the history of the previous 50 boluses US 24 WA 160 PH Ti DAA If your bolus and basal dose r
29. ndicated in thebasic display by the v mark in the EXERCISE TEMPORARY BASAL icon figure 4 BASIC DISPLAY with TEMPOR BASAL SCREEN 5 If you want to cancel the temporary basal choose SEL Adjust the hour setting to 0 and press The BASIC DISPLAY screen in figure 5 will appear Note that the v a T is in the basic display and pres is no longer on A The basal rate will automatically TEMPORARY BASALSCREEN return to 100 DAZ If you reset the clock after setting a temporary basal you must reset the temporary basal Ollast 2007 5 10 11 55 AM Page 38 lt 7 A iS 3 Press SEL When you see the word select on the BOLUS screen press again to begin delivery The screen in figure 4 will Deliver appear DELIVERY SCREEN ay You must eat your meal after the meal bolus has been delivered regular insulin users after 30 minutes fast acting insulin users immediately The DANA pump can be programmed in Guided Management to deliver a reminder melody after the bolus delivery To stop the melody push any button once Note If you want to stop a bolus during delivery you may push or ran button Then press 2 Use ae Peo temporarilychange the basal rate figure Z The number in the bottom right corner of the screen 200 175 150 125 100 75 50 25 0 indicates the amount of insulin which will be infused during the temporary bas
30. needle end of the disconnected tubing the end still connected to the pump Press the rubber cap onto the tubing connected to you You may need to compensate for missed insulin Reconnecting Wipe the tip of tubing connected to you with an alcohol swab after removing the rubber cap Remove the rubber stopper from the tubing connected to the pump Before reconnecting program the pump to bolus 0 5 units of insulin and watch to ensure that a drop is visible from the needle tip Repeat as necessary until you see insulin Push together the two ends of the easy release tubings and slide the ring collar back tightly Check your blood sugar level Do not disconnect from your pump for more than one hour without disconnect guidelines from your healthcare team Continue to check blood glucose levels while disconnected and after reconnecting E Ollast 2007 5 10 11 54 AM Page 27 cb Removing the infusion set 1 Suspend the pump See page 11 Carefully remove all adhesive tape from the infusion line and needle insertion site 2 Grab the needle guide in the same way as if you were inserting it Use your other hand to put slight pressure on the tissue around the insertion ra area Gently pull the needle out as in figure 1 3 Remove the infusion set from the pump by turning the connector clockwise and pulling upwards as in figure 2 4 Please dispose of the used infusion
31. onal on how you should compensate for any the missed insulin or medication Please remember that while disconnected from the pump no insulin is being infused Carefully monitor blood glucose F levels during the period of detachment and after reattachment a 6 Check the infusion site often for redness irritation and inflammation 7 Remember to prime at least 10 unites to permit the pump to perform an additional series of safety checks O Soft Release ST Catalogue Number Catalogue number SR102 SR112 Ollast 2007 5 10 11 54 AM Page 37 WE 1 In the BASIC DISPLAY screen press S until the A icon is highlighted as BASIC DISPLAY SCREEN in figure 1 Then press SEL US 27 MA 160 PP os 00 5 0 2 Confirm the amount of insulin to be delivered in the bottom right corner of the BOLUS screen figure 2 and figure 3 If the insulin dose is not correct you may make the desired adjustments to the bolus setting by m 5nd Remember the adjustment ot change the setting It will only change the bolus that you are delivering immediately Bolus fiu BOLUS SCREEN US 24 MA 160 T PM 01 25 70 Dinner 11 0u DINNER BOLUS SCREEN 3 Use andj PO to program the number of hours to temporarily change the basal rate figure 3 After making the desired adjustment press 4 The temporary basal ratewill remain in effect for the desired number of hours and will be i
32. ons on page 23 to prime the Easy Release infusion set which removes air in the tubing 4 Hold the infusion set in your fingers at the guide as shown in picture 2 Carefully remove the need s protective cover and the paper backing from the adhesive dressing 5 With your other hand pinch the tissue around the insertion site between your thumb and finger as shown in picture3 Push the needle deeply into this tissue and secure with adhesive dressing 6 Tape the infusion set to the body with adhesive tape 1 to 2 inches away from the insertion site safety loop This prevents accidental dislodging of the infusion set Note 1 You should not feel pain when you touch the insertion area after the needle has been inserted 2 You may feel some pain at the insertion site if the infusion set is not secured well to your body d d Do not use the infusion set if its package has been damaged inadvertently opened or become wet ei Do not reuse the infusion set Reinsertion could cause tearing of the cannula that would result in unreliable insulin delivery P Ollast 200 fede LO yy 11 54 AM Page 26 Disconnecting the EasyRelease Set Allow the pump to continue basal delivery or place your pump in suspend if your diabetes professional advises Grasp the disconnect portion of the Easy Release tubing and slide the ring collar back towards the pump Press the rubber stopper onto the
33. pears at the Connection Needle priming is complete Figure 8 gt Gently slide the Infusion Set Connector over the Site Connector pressing lightly on the Spring Clips on either side of the Infusion Set Connector The Connection Needle should glide into the Site Connector and the two units should snap together Figure 9 Tape the infusion set to the body with adhesive tape to 2 inches away from the insertion site safety loop This prevents accidental dislodging of the infusion set d 4 Do not cover the Catheter Hub with tape If the Catheter Hub is covered with tape the release or disconnect feature cannot be used Disconnecting the infusion set Place the pumpin SUSPEND unless your healthcare professional instructs you otherwise See page 19 gt Grasp each side of the Infusion Set Connector pressing gently on the Spring Clips Pull the Infusion Set Connector Cover into the Site Connector Figure 10 gt Push the Infusion Set Connector Cover onto the Connection Needle Figure 10 Make sure that this is done without bending the Connection Needle Figure 11 This prevents insulin from dripping out at the release site and keeps the Connection Needle clean hii Insert the Site Connector Cover into the Site Connector Figure 12 Figure 11 gt Put your pump in a safe place until you are ready to reconnect Figure 12 SS 8 Qliest 2007 35 10 11 54 AM Page 31
34. press sev when he fs highlighted figure 1 The bolus setting screen will appear as shown SET PROGRAM SCREEN in figure 2 4 After setting all of your meal boluses pres Sr The meal bolus settings will be saved in the DANA memory 2 While in the BREAKFAST BOLUS screen select the DOWN The insulin proper insulin dose by using dose appears in units in the bottom right hand corner 3 Press exi to go to the LUNCH BOLUS screen EVAZ We recommend that you confirm that all adjusted settings were saved to memory by using the CHECK REVIEW mode of the DANA Diabecare H Press gt to go to the DINNER BOLUS screen and See page 17 and follow step 2 follow the same steps Ollast 2007 5 10 11 54 AM Page 14 an Make sure to press sex after the meal boluses are set to save the settings The settings are the amount of insulin that you will deliver each time you bolus during the time periods indicated on page 13 They become the default bolus settings on your pump for each of these time periods You may increase or decrease your meal boluses prior to delivery but the meal bolus settings will not change unless you change them in the SET PROGRAM screen B gt 1 Press SEL when Es highlighted figure 1 in the SET PROGRAM screen The BASAL RATE SETTING screen will appear as in figure 2 SET PROGRAM 1 Chronological time which corresponds to the highlig
35. r Needle place a finger on each side of the Needle Guide with Adhesive one on either side of the Introducer Needle To make withdrawing the Introducer Needle easier rotate the needle a half turn pull the needle straight out 8 Dispose introduce needle in a safe manner You may use the Needle Protective Cover for dispose provided to cover the steel needle The Introduce Needle and Needle Protective Cover are made to lock together Figure 7 9 Tape the infusion set to the insertion site with adhesive tape at This prevents accidental dislodging of the infusion set Figure 8 Figure 7 Figure 8 y Figure 3 Figure 4 P Ollast 20072510 11 54 AM Page 34 Disconnecting the Soft Release R Infusion Set 1 Place the pump in SUSPEND unless your healthcare professional instructs you otherwise see page 19 2 Grasp each side of the Infusion Set Connector pressing gently on the Spring Clips Pull the Infusion Set Connector out of the Site Connector Figure 9 3 Push the Infusion Set Connector Cover onto the Connection Needle Make sure that this 1s done without bending the Connection Needle This prevents insulin from dripping out at the release site and keeps the Connection Needle clean Figure 10 4 Insert the Site Connector Cover into the Site Connector Figure 1 5 Put your pump in a safe place until you are ready to reconnect Figure 11 Reconnecting the infusion set 1 Wipe th
36. so 5 Remove the reservoir and linking screw unit from the insulin tray 20 P Ollast 2007 45 10 11 54 AM Page 21 an ey 6 Insert the reservoir and linking screw unit into the DANA Diabecare II pump as shown in figure 3 When inserting the reservoir slightly rotate right and left until the notch fittings on the side of the reservoir slide into place Gently let the reservoir and linking screw fall into place Next screw counterclockwise the pump s reservoir compartment cap in place and remove the small white reservoir cap from the end of the reservoir Notch Fittings F a Do not push and orforce the reservoirinto the pump This could damage the motor 4 drive and linking screw of the pump and could result in the loss of insulin from the reservoir LAZ If attempts to reinsert the reservoir fail try a new reservoir 7 Remove the infusion set from its package Be careful not to touch the connector to any object that would breach its sterility 8 Screw the connector counterclockwise into the reservoir compartment until it is firmly in place figure 4 LZA You will quickly get accustomed to turning the reservoir compartment cap and connector counterclockwise P Ollast 2007 5 10 11 54 AM Page 22 Ais ay lt Diabecare II Pump and Infusion Set Priming the infusion set ay 1 Always remember to change the reservoir and the infusion set at the same time 2 You must
37. support at 1 866 326 2832 if additional screws are needed gt Explanation of Warning Caution and Note Symbols q Warning indicates the presence of a hazard which can cause severe personal injury death or substantial property damage if the warning is ignored Vy Sy Caution indicates the presence of a hazard which will or can cause minor personal injury or property damage if the warning is ignored nm Note advises the user of installation operation or maintenance information which is important but not hazard related P Ollast 2007 5 10 11 54 AM Page 6 A 4 Contents of the DANA Diabecare IInsulin Pump Kit RESERVOIR INFUSION SETS INSULIN ADHESIVE TAPE RESERVOIR 6 SCALE TRAY 1 CAP INSULIN PUMP 6 BATTERY LINKING SCREW BATTERY BLACK CLOTH LEATHER CASES COMPARTMENTKEY 2 2 BELT TRANSPARENTCASE 2 2 4 i T l MEFIX SHOWER TEGADERM 3 POUCH 2 BRAPOUCH USER MANUAL Additional accessories may be purchased separately Ollast 2007 5 10 11 54 AM Page 7 a Identification and Description of Your Pump Features Reservoir Compartment 1 Reservoir Compartment The reservoir and linking screw are inserted in this compartment Turn cap clockwise to open Battery Compartment 2 Battery Compartment The battery is inserted in this compartment Turn cap Control Panel counterclock
38. the pump following the instructions on page 2 20u For safety we recommend that you change the reservoir when there are 15 to L 20 units of insulin remaining gt SUSPEND THE PUMP REMOVE INFUSION SET CHECK YOUR BLOOD SUGAR AND CHECK THE FOLLOWING 1 Check for low battery charge Change battery if charge is 25 or less If this does not correct the error go to step two 2 Check the reservoir amount If less than z 10 to 15 units of insulin remain in the reservoir replace it If this does not i correct the error go to step three 3 Check for occlusion of the infusion set Visually check for any possible occlusion of the infusion set and take Error 3 Error screen appears corrective measures unink tubing check for air bubbles etc If this does not resolve the problem change the reservoir and infusion set 4 SYSTEM ERROR gt Take out battery and reinsert If the Error message continues to appear after taking all of the above Sy Measures remove the pump and contact 1 866 326 2832 5 PUMP WILL NOT PRIME gt If you are using the Easy Release needle infusion set and you cannot prime beyond the disconnect simply do the following Disconnect at the disconnect site then reconnect Make sure you do not slide the o ring up too tightly P Ollast 4 2007 5 10 11 55 AM Page 44 6 Insulin reservoir cannot be inserted into reservoir compartment 7 Air in the reservoir and or
39. wise to open 3 Control Panel Contains the four buttons which are used to increase and decrease LCD Screen settings switch screens and select functions 4 LCD Screen Displays status of system features and system messages and serves as the user interface with pump software Lights automatically when any button is pressed a Press to increase insulin dosages time and date and Guided Management functions Press to decrease insulin dosages ES time and date and Guided Management functions l J Press to move to the next choice on the LCD Press to select the function highlighted on the LCD Ollast 2007 5 10 11 54 AM Page 8 P C _ functions Inserting the Batte Follow these ste Open the battery compartment by inserting the battery key into the battery cap and turning counterclockwise Insert the battery with the positive end down into the pump Close the battery cap by turning the battery key clockwise until tight and flush with the pump Failure to tighten the battery cap may result in water entering the battery compartment caus ng the pump to malfunction Alway keep at least one power kit 2 batteries available for backup TEE The date on the battery is the manufacture date The battery has a guaranteed shelf life of ten years P Ollast 2007 5 10 11 54 AM Page 9 a Explanation of the display screens INITIAL DI

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