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1. Before using your DANA Diabecare

®

II pump, infusion set and reservoir

• Indications for use  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
• Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
• Cleaning your DANADiabecare

®

II insulin pump  . . . . . . . . . . . . . . . . . . . . . . . 5

• Explanation of “Warning”, “Caution”, and “Note” Symbols . . . . . . . . . . . . . . . . 5
• Contents of DANADiabecare

®

II insulin pump kit   . . . . . . . . . . . . . . . . . . . . . .6

• Identification and description of your pump features . . . . . . . . . . . . . . . . . . . . . .7
• Easy Release Infusion set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

2. Set-up and basic functions

• Inserting the battery  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
• Suspending the pump by programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
• Explanation of display screens  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

- Initial display   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
- Basic display  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10           

• Setting bolus doses, basal rates and the clock . . . . . . . . . . . . . . . . . . . . . . . . . . 10

- Setting a bolus   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
- Pre-setting meal boluses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
- Setting the basal rate  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
- Setting the clock  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15        

• Checking bolus doses, basal rates and reviewing memory data  . . . . . . . . . . . . .16
• Checking the battery life and remaining insulin amount  . . . . . . . . . . . . . . . . . .17
• How to fill and insert a new reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

- Filling the reservoir with insulin   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
- Inserting the linking screw into the reservoir and into the Dana pump  . . . . .20

3. Use of the  DANADiabecare

®

II  pump and infusion set

.

[Easy Release]

• Priming the infusion set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
• Inserting, disconnecting and reconnecting infusion set . . . . . . . . . . . . . . . . . . . 25 

- Inserting the infusion set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
- Disconnecting the infusion set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
- Reconnecting the infusion set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

• Delivering a bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
• Programming temporary basal rates during exercise, illness, menses or stress   .29
• Removing the infusion set   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

.

[Soft-Release-ST ]

• Indications for use  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
• Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
• Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
- Removing the infusion set  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35 

C

ontents

01last  2007.5.10  11:54 AM  Page 1

Содержание Diabecare II

Страница 1: ...ata 16 Checking the battery life and remaining insulin amount 17 How to fill and insert a new reservoir 21 Filling the reservoir with insulin 19 Inserting the linking screw into the reservoir and into the Dana pump 20 3 Use of the DANADiabecare II pump and infusion set Easy Release Priming the infusion set 22 Inserting disconnecting and reconnecting infusion set 25 Inserting the infusion set 25 Di...

Страница 2: ...onnect feature 39 Removing the infusion set 40 Locking the pump 40 4 Troubleshooting When hypoglycemia low blood sugar occurs 41 When hyperglycemia high blood sugar occurs 42 Problems corrective actions 43 List of alarms and audible signals 45 5 Specifications Symbols Warranty General specifications 46 Classification and compliance with standards 46 Universal Symbols 47 Warranty 48 01last 2007 5 1...

Страница 3: ...n accordance withstandardIEC60601 1 MedicalElectricalEquipment GeneralRequirementsforSafety Patients must not open the pump housing or handle any internal components The DANADiabecare IIinsulin 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 tro...

Страница 4: ...o the user having a CTScan MRI or X ray 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 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 ...

Страница 5: ...nd Note Symbols Theoutsideofthepumpshouldbecleanedmonthly When cleaning the pump use a cloth moistened with water or a neutral pH detergent and wipe it with a dry cloth Donotusethinner alcohol benzeneorsimilarsolvents Please rinse your pump off with clean water after swimming or after exposure to dust soot or other material that adheres to the pump Never insert a cloth or liquid into the battery c...

Страница 6: ...care IIInsulin Pump Kit RESERVOIR 6 INFUSION SETS 6 INSULIN SCALE TRAY ADHESIVE TAPE 1 RESERVOIR CAP LEATHER CASES 2 TRANSPARENTCASE BLACK CLOTH BELT BATTERY 2 LINKING SCREW 2 BRAPOUCH TEGADERM 2 SHOWER POUCH MEFIX 3 BATTERY COMPARTMENTKEY 2 TM USER MANUAL 6 01last 2007 5 10 11 54 AM Page 6 ...

Страница 7: ...ressed Press to move to the next choice on the LCD Press to select the function highlighted on the LCD Press to increase insulin dosages time and date and Guided Management functions Press to decrease insulin dosages time and date and Guided Management functions Reservoir Compartment Battery Compartment Control Panel LCD Screen Identification and Description of Your Pump Features 3 Control Panel C...

Страница 8: ...se until tight and flush with the pump 2 Set up and basic functions Inserting the Battery Alway keep at least one power kit 2 batteries available for backup The date on the battery is the manufacture date The battery has a guaranteed shelf life of ten years Follow these steps Failure to tighten the battery cap may result in water entering the battery compartment causing the pump to malfunction 8 0...

Страница 9: ...rogrammed bolus doses 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 1 Displays current time and date 3 Displays the amount of insulin remaining in the reservoir in units 1ml 100 units 2 Displaysremainingbatterych...

Страница 10: ...ighted icon Press three times consecutively to transfer from to as shown in figure1 Then press 2 The SET PROGRAM screen in figure 2 appears You can select bolus or basal rate or clock Press to change the highlight from to or to fig 1 fig 2 Set Setting bolus doses basal rates and the clock SET PROGRAM SCREEN BASIC DISPLAY SCREEN The CHECK REVIEW icon will be highlighted NEXT NEXT SEL NEXT 10 01last...

Страница 11: ...en will appear as shown in figure 2 fig 2 fig 1 3 After setting your bolus doses press The bolus settings will be saved in the DANA memory 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 Setting a bolus 2 While in the BOLUS SETTING screen select the proper insulin dose by using and The insulin dose appears in un...

Страница 12: ... your healthcare professional have chosen the pre set option in Guided Management your BOLUS screen will appear differently This option permits you to pre set boluses for breakfast lunch and dinner 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 p...

Страница 13: ...lowed daily insulin amount 4 Time and amount refer to the previous bolus 1 2 3 4 2 While in the BREAKF AST BOLUS screen select the proper insulin dose by using and The insulin dose appears in units in the bottom right hand corner 4 After setting all of your meal boluses press The meal bolus settings will be saved in the DANAmemory 3 Press to go to the LUNCH BOLUS screen and follow step 2 Press to ...

Страница 14: ...ppear as in figure 2 Setting the basal rates TB 32 9 Set 4 2 1 3 SET PROGRAM BASALRATE SETTING SCREEN Make sure to press 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 o...

Страница 15: ...o to the SET PROGRAM screen Press to highlight and press 3 Use to move between the year and month as well as hours and minutes and and to make the desired changes After making the changes press to return to the BASIC DISPLAY screen 2 The CLOCK SETTING screen will appear as shown in figure 1 fig 2 fig 1 You must set a m and p m correctly If the clock shows 3 00 p m and you want 3 00 a m you must co...

Страница 16: ...hted icon Then press 1 In the BASIC DISPLAY screen press until the icon is highlighted as in figure 1 Then press fig 3 Checking bolus doses basal rates and reviewing memory data Bolus US 27 MA 160 PM09 00 5 0u TB 32 9 BASAL PROFILE SCREEN BASIC DISPLAY SCREEN 3 The BASAL PROFILE screen figure 3 will appear Press to move between basal profiles and confirm settings To review the previous meal bolus ...

Страница 17: ...emaining insulin amount INITIAL DISPLAY SCREEN 5 Use and to review the Bolus History including date time and amount delivered Press to review the 50 previous Daily Totals 6 Use and to review the Daily Total History including date and the total amount of insulin Press to review the 50 previous Prime Amounts 7 Use and to review the Prime History including date time and amount Press to check factory ...

Страница 18: ...ulin is being delivered Suspending the pump 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 you will again hear an audible indicator and the BASIC DISPLAY will appear as shown in figure 2 fig 1 fig 2 Chk CHECK REVIEW SCREEN BASIC DISPLAY NEXT SEL SEL 18 01last 2007 5 10 11 54 AM Page 18 ...

Страница 19: ...nsulin 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 the 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 t...

Страница 20: ...oir 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 5 Remove the reservoir and linking screw unit from the insulin tray 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 fig 1 fig 2 R...

Страница 21: ... push and orforce the reservoirinto the pump This could damage the motor drive and linking screw of the pump and could result in the loss of insulin from the reservoir fig 3 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 f...

Страница 22: ...ge the reservoir and the infusion set at the same time 2 You must always prime when you do this Priming the infusion set Refill 2 In the CHECK REVIEW screen press to highlight as shown in figure 2 Then press Chk BASIC DISPLAY SCREEN CHECK REVIEW SCREEN FILLING SCREEN 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 rese...

Страница 23: ...ppear as in figure 5 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 fig 4 Always check and confirm all basal and bolus settings after changing the insulin reservoir page 19 Visuall...

Страница 24: ...or Tubing Needle Needle guide Easy Release The Easy Release Infusion Set is available in several tubing lengths and needle lengths Your healthcare professional will help you select which is best for you 24 01last 2007 5 10 11 54 AM Page 24 ...

Страница 25: ...he needle has been inserted Do not use the infusion set if its package has been damaged inadvertently opened or become wet 4 Hold the infusion set in your fingers at the guide as shown in picture 2 Carefully remove the needl 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...

Страница 26: ...with an alcohol swab after removing the rubber cap 2 Remove the rubber stopper from the tubing connected to the pump 3 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 4 Repeat as necessary until you see insulin 5 Push together the two ends of the easy release tubings and slide the ring collar back tightly 6 Check you...

Страница 27: ...if you were inserting it Use your other hand to put slight pressure on the tissue around the insertion area Gently pull the needle out as in figure 1 fig 1 fig 2 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 set according to your local regulations 27 01last 2007 5 10 11 54 AM Page 27 ...

Страница 28: ...ending on your body type comfort and instructions from your healthcare professional 1 Needle Guide withAdhesive 2 Needle Cover 3 Teflon SoftCannula 4 Introducer Needle 5 Site Connector 6 Infusion Set Connector 7 Spring Clip 8 Connection Needle 9 Tubing 10 Pump Connector 11 Site Connector Cover 12 Infusion Set Connector Cover 28 01last 2007 5 10 11 54 AM Page 28 ...

Страница 29: ...acking on the adhesive Figure 2 3 4 With your other hand pinch the tissue around the insertion site between your thumbandfinger Push the needle deeply into this tissue Figure 4 5 To remove the Introducer Needle place a finger on each side of the Needle Guide one on either side of theIntroducerNeedle TomakewithdrawingtheIntroducerNeedleeasier rotate the needle a half turn then pull the needle strai...

Страница 30: ...ur healthcare professional instructs you otherwise See page 19 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 Push the Infusion Set Connector Cover onto the Connection Needle Make sure that this is done without bending the Connection Needle Figure 11 This prevents insulin from dripping out at...

Страница 31: ...nnectionNeedleshouldglideintotheSiteConnector and the two units should snap together Figure 13 Reconnecting 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...

Страница 32: ...ula 4 Introducer Needle 5 Site Connector 6 Infusion Set Connector 7 Spring Clip 8 Connection Needle 9 Tubing 10 Pump Connector 11 Site Connector Cover 12 Infusion Set Connector Cover 13 Needle Protective Cover for dispose 14 Bypass Needle 32 01last 2007 5 10 11 54 AM Page 32 ...

Страница 33: ...esive Figure 4 5 With your other hand pinch the tissue around the insertion site between yourthumbandfinger Inserttheneedlequickly ata90 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 Introducer N...

Страница 34: ...o reconnect Disconnecting the Soft Release R Infusion Set 1 WipethetipoftheSiteConnectorwithanalcoholswabafterremovingtheSiteConnectionCover 2 RemovetheInfusionSetCoverfromtheInfusionSetConnector 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...

Страница 35: ... 3 fig 4 When the pump is locked basal delivery continues You cannot set or deliver a bolus however To remove this option refer to the Guided Management Healthcare Professional Manual 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...

Страница 36: ...ispose of any expired accessories 5 Do not disconnect from your pump for more than one hour without discussing with your healthcare professional 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 levels during the period of detachment and after reattachment 6 Check t...

Страница 37: ... BASAL SCREEN TEMPORARY BASALSCREEN BASIC DISPLAY without TEMPORARY BASALSCREEN If you reset the clock after setting a temporary basal you must reset the temporary basal UP DOWN SEL SEL SEL 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 ...

Страница 38: ...150 125 100 75 50 25 0 indicates the amount of insulin which will be infused during the temporary basal period The is added to or subtracted from your 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 press fig 2 Temp You must eat your meal afte...

Страница 39: ...ant to cancel the temporary basal choose in the basic display and press Adjust the hour setting to 0 and press TheBASIC DISPLAYscreen in figure 5 will appear Note that the v is no longer on The basal rate will automatically return to 100 fig 5 fig 3 Temp BASIC DISPLAY with TEMPOR BASAL SCREEN TEMPORARY BASALSCREEN BASIC DISPLAY without TEMPORARY BASAL SCREEN UP DOWN SEL SEL SEL If you reset the cl...

Страница 40: ...changing settings 2 The screen will indicate the pump is locked as shown in figure 2 3 To unlock the pump press and sequentially The Lock out screen appears as shown in figure 3 4 Select the proper code Default 1234 by using and as shown in figure 4 5 Press The pump is now unlocked fig 1 fig 2 fig 3 fig 4 When the pump is locked basal delivery continues You cannot set or deliver a bolus however NE...

Страница 41: ... reflect your current intake When alcohol is consumed make sure that food is also consumed Alcohol may cause hypoglycemia Test your blood sugar more frequently Verify that connection and disconnection were performed in accordance with manufacturer s instruction Remember to verify insulin at the needle by bolusing 0 5 units before reconnecting Check and review your bolus history and basal rates Che...

Страница 42: ...r bobbles in reservoir Monitor your blood sugar 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 indicator and replace battery if needed Examine infusion set for pinching or blockage Look ...

Страница 43: ... reservoir is low insert a new reservoir in the pump following the instructions on page 21 figure 2 3 Error screen appears figure 3 Error 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 10 to 15 units o...

Страница 44: ...d maximums for daily total bolus and basal amounts 9 Pump has been taken into an MRI or CT scan room DISCONNECT FROM THE PUMP AND CONTACT TECHNICAL SUPPORTAT 1 866 326 2832 10 Pump will not prime 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 c...

Страница 45: ...d Placing pump in suspend Warning Continuous beep Beep Long beep One Short beep per unit One Short beep per unit Melody Press tosilence 20 beeps every 30 seconds after low reservoir screen disappears Screen disappears and the pump gives 3 short beeps every 4 minutes Melody Shortbeepsfollowed melody SEL INTERNATIONALALARM CODES R after number Remain remaining of insulin amount B Low Battery O Occlu...

Страница 46: ...NT INSULINCONCENTRATION CLOCK FORMAT ALARM SAFETYSETTINGS 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 E...

Страница 47: ...solated patient connection IEC 60601 1 TYPE BF Do not Re use Sterilized with ethylene oxide Lot number DC Expiration date Use by date Manufacture date Universal Symbols 0120 2 LOT STERILE ED Waterproof level IPX 8 47 01last 2007 5 10 11 55 AM Page 47 ...

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