SOOIL Development DANAIIS DANA Diabecare IISR Insilin Pump User Manual

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Document Description	Users Manual
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Document Type	User Manual
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Date Submitted	2007-07-27 00:00:00
Date Available	2007-07-27 00:00:00
Creation Date	2007-07-03 17:43:54
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Document Lastmod	2007-07-25 09:16:52
Document Title	Users Manual

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DANA Diabecare IISR User Manual
Ⓡ
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Thank you for choosing the DANA DiabecareⓇ IISR Insilin Pump.
SOOIL Development Co., Ltd. has been committed to making scientific advancements in the development
and production of innovative medical solutions for the management, treatment and cure of diabetes
throughout the world since 1979. Your DANA DiabecareⓇ IISR has been designed and built with the most
advanced technology available to create a high quality and very reliable device for the subcutaneous delivery
of insulin. When used properly, your DANA DiabecareⓇ IISR will give you years of improved blood glucose
control 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 diabetes
center. There are now more than 50,000 people throughout the world managing their diabetes with the
DANA Diabecare line of insulin infusion pumps.
The DANA DiabecareⓇ IISR Insulin Pump is the only pump that adds simplicity to the complex technology of
the 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.
Warning Please note, US law restricts this device to use by or on order of a physician.
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DANA Diabecare IISR User Manual
Ⓡ
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C ontents
1. 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“Warning
”
,“Caution
”
, and“Note”symbols
•Contents of DANA DiabecareⓇ IISR insulin pump kit
•Identification and description of your pump features
•Infusion Sets
2. 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
10
11
- Setting the basal rate
13
- Setting the clock
14
•Checking bolus doses, basal rates and reviewing memory data
15
•Suspending the pump
17
•User Setting
18
3. Filling and inserting a new reservoir
•Changing the reservoir
- Preparation
21
21
- Filling the reservoir with insulin
22
- Instructions for use of DANA Easy SETTER
23
- Inserting the reservoir into the pump
23
- Connecting the infusion set to your pump
24
- Priming the infusion set
24
- Inserting the infusion set
•Infusion sets
26
27
- EasyRelease
27
- EasyRelease II
30
- Soft-Release-R
33
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- Soft-Release-ST
•General Precautions for All Infusion Sets
36
39
4. Bolusing and temporary basal rates
•Bolus
40
•Temporary basal
46
5. Remote Control
•Synchronize the Remote Control with the Pump
53
•Bolus
53
•Lock Setting
54
•Setting the Clock
55
•Disconnect Remote Control and Insulin Pump
55
•Checking your blood glucose level
56
•Calculating your bolus dosage
57
•Glucose meter related error messages and troubleshooting
59
6. Troubleshooting
•When hypoglycemia (low blood sugar) occurs
60
•When hyperglycemia (high blood sugar) occurs
61
•Problem / Correction Action
63
7. List of alarms and audible signals
•Low reservoir
64
•ERROR screen
64
•Daily remainder
64
•Daily max
64
•Low battery
64
8. Specifications, symbols, warranty
•General specifications
65
•Classification and compliance with standards
65
•Universal symbols
66
•Warranty
67
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1. Before using your DANA DiabecareⓇ IISR Insulin Pump,
infusion set and reservoir
Indications for Use
The DANA DiabecareⓇ IISR insulin pump, infusion set and reservoir are intended for the continuous delivery of insulin for the
management of diabetes mellitus. It is not intended for the delivery of blood or blood products.
Safety Precautions
1. 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 accessories
specified 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 your
sales 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
IISR:
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 certain
electrically 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 settings
may 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 either
for 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 of
any expired accessories.
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1. Before using your DANA Diabecare IISR insulin pump, infusion set and reservoir
Ⓡ
Cleaning your DANA DiabecareⓇ IISR insulin pump
1. 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
“Warning”
“C
, aution”
,and“Note”Symbols
1. Warningindicates the presence of a hazard which can cause severe personal injury, death or substantial property
damage if the warning is ignored.
2. CautionCaution indicates the presence of a hazard which will or can cause minor personal injury or property damage if
the warning is ignored.
3.
Note Note advises the user of installation, operation or maintenance information which is important but not hazardrelated.
Contents of the Dana DiabecareⓇ IISR Insulin Pump Kit
INSULIN PUMP
BELT
REMOTE CONTROL
BATTERY KEY (2)
RESERVOIR (6)
LEATHER CASE (2)
INFUSION SETS (6) DANA EASY SETTER (1) LINKING SCREW (2)
BATTERY (2)
BRA POUCH
TEGADERM
Note
Additional accessories may be purchased separately
Note
MEFIX is not available in Canada
SHOWER POUCH
SHOULDER POUCH
™
ADHESIVE TAPE
MEFIX
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Identification and Description of the DANA IISR
The DANA DiabecareⓇ IISR insulin pump, infusion set and reservoir are intended for the continuous delivery of insulin for the
management of diabetes mellitus. It is not intended for the delivery of blood or blood products.
①Reservoir
Compartment
② Battery
Compartment
① Reservoir Compartment: The reservoir and linking screw are
inserted in this compartment. Turn cap clockwise to open.
②Battery Compartment: The battery is inserted in this
compartment. Turn cap counterclockwise to open.
③Reservoir Window
④Control Panel
③Reservoir Window: Remaining insulin amount can be
visually verified here.
④Control Panel: Contains the four buttons which are used
to increase and decrease settings, switch screens and
select functions.
⑤ LCD
⑥Blood Glucose
Meter Test Port
⑤LCD: Displays status of system features and system
messages and serves as the user interface with pump
software. Lights automatically when any button is pressed.
⑥Blood Glucose Meter Test Port: Test strips are inserted
here for glucose monitoring.
⑦ Battery
Compartment
①
⑦Battery Compartment: Push the cover of the battery to
the arrow direction to open.
①
Press to increase insulin dosages, time and date.
②
Press to decrease insulin dosages, time and date.
③
Press to move to the next choice on the LCD.
④
Press to select the function highlighted on the LCD.
③
④
②
Note
Buttons will beep when pressed.
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1. Before using your DANA Diabecare IISR insulin pump, infusion set and reservoir
Ⓡ
Infusion Sets
Superline (90°
EasyRelease
Soft-Release-R
Soft-Release-ST
Note
Product availability varies by country.
Note
Infusion set specifications are as follows
Superline (90°
EasyRelease II
EasyRelease
EasyReleaseII
Superline-ST
Soft-Release-R Soft-Release-ST
26G
26G
Superline-ST
Needle gauge
27G
27G
27G
27G
Needle type
Stainless Steel
Stainless Steel
Stainless Steel
Insertion angle
90°
90°
90°
90°
0~30°
90°
Disconnect
No
Yes
Yes
Yes
Yes
No
Polyurethane(Soft cannula)Polyurethane(Soft cannula) Stainless Steel
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2. Set-up and basic functions
Explanation of the display screens
Initial Display
①Displays current time and date.
②Displays remaining battery charge as 100%, 75%, 50%, 25%.
Caution For accurate reading of the remaining battery charge,
①
check the initial display immediately after delivering a bolus
②
③Displays the amount of insulin remaining in the reservoir in units.
(1ml=100 units).
Note
③
Push any button while viewing the initial display to bring
up the basic display screen.
Basic Display
①
①CHECK/REVIEW icon - Choose the first icon (magnifying glass) to
③
check basal rates, previous bolus doses, last bolus, previous daily
totals and prime history (see page 15 for reviewing the history).
② BOLUS icon - Choose the second icon (syringe) to deliver bolus doses.
③TEMPORARY BASAL icon - Choose the third icon (person) for
temporary changes in basal rates for exercising or other events.
④SET/PROGRAM icon - Choose the fourth icon (sliding scale) to
②
Note
④
set basal rates, preset bolus doses and set clock.
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.
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2. Set-up and basic functions
Inserting the Battery
O-ring
graphic ①
Follow these steps
1) 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.
WarningChange the battery in a dry environment to prevent water from entering the casing.
Note
The battery cover is correctly inserted and tightened when the battery cover is level with the insulin pump casing.
Caution If the O-ring (see graphic ①) on the battery cover appears worn, frayed or torn, please contact your healthcare
provider or your sales representative.
WarningUse of battery other than the 3.6V battery manufactured exclusively for SOOIL Development will result in the void
of pump warranty.
Note
Do not attempt to change the battery while a bolus is in progress.
Note
The battery has a shelf life of 3 years. Please note
“best before date (xx/xxx)”before use
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Setting bolus doses, basal rates and the clock
1) From the INITIAL DISPLAY screen, press any of the control
buttons and the BASIC DISPLAY screen will appear.
2) In the BASIC DISPLAY screen, press
three times
consecutively to highlight the SET/PROGRAMicon in figure 1.
Then press
(figure 1)
3) The SET/PROGRAM screen in figure 2 will appear. You can select
bolusor basalrate or clock.
(figure 2)
10
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2. Set-up and basic functions
Setting a Bolus
1. Pre-Setting Meal Boluses
If 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)
Breakfast
Lunch
Dinner
•Lunch = 10:00 - 14:59 (10:00 am - 2:59 pm)
•Dinner = 15:00 - 00:59 (3:00 pm - 0:59 am)
1) From the BASIC DISPLAY screen, go to the SET/PROGRAM screen.
In SET/PROGRAM press
when the BOLUShighlighted
(figure 1). The bolus setting screen will appear as shown in figure 2.
①
②
⑤
(figure 1)
①Indicates that you are setting a bolus for Breakfast (Brfst), Lunch
or Dinner.
②US indicates the amount of insulin used since midnight. MA
indicates the maximum amount of insulin allowed daily.
③Time and amount of the previous bolus.
④Amount of current bolus.
④ (figure 2)
③
⑤□indicates
set mode.
2) While in the BREAKFAST BOLUS SETTING screen, select the proper insulin dose by using
and
. The
insulin 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 BOLUS
screen 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.
Note
Make sure to press
after the bolus dose is set to save the setting.
Note
Note
Note
You may confirm your bolus settings by using the CHECK/REVIEW
menu option (see page 15).
The settings are the amount of insulin that you will deliver each time you bolus during the time periods indicated above.
You may increase or decrease your bolus prior to delivery, but the preset bolus dose setting will not change unless
you change it in the SET/PROGRAMscreen.
11
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2. Setting a 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.
(figure 1)
①
② ⑤
①Indicates that you are setting a bolus.
②US indicates the amount of insulin used since midnight. MA
indicates the maximum amount of insulin allowed daily.
③Time and amount refers to the previous bolus.
④
③ (figure 2)
④Amount of the bolus.
⑤□indicates
set mode.
2) While in the BOLUS SETTING screen select the proper insulin dose by using
and
. The insulin dose
appears in units in the bottom right hand corner.
3) After setting your bolus press
to store the preset meal bolus.
Note
Make sure to press
after the bolus dose is set to save the setting.
Note
You may confirm your bolus settings by using the CHECK/REVIEW
menu option (see page 15).
Note
This setting is the amount of insulin that the pump will deliver the next time you bolus.
Note
You may increase or decrease your bolus prior to delivery but the default bolus setting will not change unless you
change it in the SET/PROGRAMscreen.
Note
12
Please talk to your health care professional if you wish to preset your meal boluses.
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2. Set-up and basic functions
Setting and Adjusting Basal Rates
1) From the BASIC DISPLAY screen, go to the SET/PROGRAM
screen. Press
when the BASALicon is highlighted (figure 1)
in the SET/PROGRAM screen. The BASAL RATE SETTING screen
(figure 1)
will appear as in figure 2.
①
②
①Basal Profile, which shows basal rates in a graph from midnight to
⑤
midnight.
③
②Chronological time which corresponds to the highlighted section
of the basal profile.
③Total basal amount programmed for delivery in a 24 hour period.
(figure 2)
④Basal Rate for the time period shown in ②.
④
⑤□indicates
set mode.
Note
Basal rates can be adjusted in units per hour.
Note
Figure 2 shows a basal profile that has been set in units per hour(u/h).
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 to
change the basal rate for the highlighted time period.
3) After basal rates are set, press
Note
to save the settings in the DANA memory.
You may confirm your basal settings by using the CHECK/REVIEW
menu option (see page 15).
13
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Setting the Clock
1) From the BASIC DISPLAY, go to the SET/PROGRAM screen. Press
to highlight the CLOCK icon and press
(figure 1). The
CLOCK SETTING screen will appear as shown in figure 2.
(figure 1)
2) Use
to move between the year and month and date, as well
as hours and minutes. Use
and
to make the desired
changes.
(figure 2)
3) After making the changes press
to save the setting and return
to the BASIC DISPLAY screen.
Caution 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.
Note
14
The pump can be programmed in either 12 hour or 24 hour format.
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2. Set-up and basic functions
Checking Bolus Doses, Basal Rates and Reviewing Memory Data
1) In the BASIC DISPLAY screen press
until the CHECK/REVIEW
icon is highlighted as in figure 1. Then press
(figure 1)
2) The Review icon will be highlighted as in figure 2 (if not, press
to change the highlighted icon). Then press
Note
The CHK icon is used for reviewing both basal rates and bolus settings.
(figure 2)
3) The BASAL PROFILE screen (figure 3) will appear. Press
to
move between basal profiles and confirm settings. To review the
previous meal bolus press
Note
(figure 3)
□indicates
check mode.
4) The MEAL BOLUS screen (figure 4) will appear. Press
move from one meal period to the next. Press
to
to review the
history of the previous 500 boluses.
(figure 4)
Note
If your bolus and basal dose rate settings are incorrect please return to the BASIC DISPLAY and choose the
SET/PROGRAM icon to make adjustments.
15
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5) Use
and
to review the Bolus History including date,
time and amount delivered (figure 5). Press
to review the 500
BOLUS HISTORY
1: 1/4
2: 1/4
13:00 - 4.5
07:30 - 5.0
previous Daily Totals.
(figure 5)
6) Use
and
to review the Daily Total History including date
and the total amount of insulin (figure 6). Press
to review the
DAILY TOTAL HIST.
1: 1/4 - 15.0U
2: 1/3 - 14.0U
500 previous Prime Amounts.
7) Use
and
(figure 6)
to review the Prime History including date,time and
amount (figure 7). Press
to review the 500 previousCarbohydrate amount.
PRIME HISTORY
1: 1/4
2: 1/1
10:00 - 235
20:30 - 225
(figure 7)
8) Use
and
to review the Carbo History including date,
time and
CARBO HISTORY
amount (figure 8). Press
to reviewthe Shipping info screen.
1: 9/24 14:59
2: 9/13 12:09
80
72
(figure 8)
9) In the Shipping Info(fugure 9)press
Note
to return to the basic display.
- 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 the
amount of insulin left in the reservoir following each prime.
16
SHIPPING INFO
1. S/N
: AGJ00019GF
2. COUNTRY : KOR
3. DATE
: 12/SEP, 2006
(figure 9)
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2. Set-up and basic functions
Suspending the pump
1) In the BASIC DISPLAYscreen press
CHECK/REVIEW icon. Then press
2) Press
to highlight the
to highlight the SUSPENDicon (figure 2). Then press
(figure 1)
선택
선택
3) The pump will give an audible tone and the screen will indicate the
pump
is suspended (figure 3).
선택
선택
Note
(figure 2)
When you suspend the pump it will beep 3 times every 4 minutes to remind you insulin is not being delivered.
4) To take the pump out of SUSPEND, press
You will hear an
audible
indicator and the BASIC DISPLAY will appear as shown in
선택
선택
figure 4.
(figure 3)
Caution Always keep at least one power kit (2 batteries) available for backup.
(figure 4)
17
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User Setting
1) Press the three buttons (
) at once to
enter the PIN code screen for USER SETTING from the initial screen.
2) Input the PIN code“4321”by the use of
and
buttons.
3) You can enter the USER SETTING mode by pressing
(figure 1)
button
once the PIN code is inputted.
(figure 2)
Setting
1) Use
or
to modify settings. Use
①HOUR DISPLAY TYPE
USER SETTING
▶ 1. HOUR DISPLAY TYPE : 12
2. LOCK
3. BUTTON SCROLL
4. SOUND MODE
5. DISPLAY SET
6. EXTENDED MENU
7. STRIP CHECK
(figure 1)
to advance to the next settings.
: On
: On
: R/V
- You can adjust time display as 12 hour or 24 hour format.
② LOCK
- You can choose whether or not to utilize the key pad lock out function.
8. EXIT
- 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)
⑧ EXIT
- Saves adjustment and returns to the previous level.
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2. Set-up and basic functions
Note
How to unlock
①If 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.
(figure 1)
⑤The pump will return to the basic display.
(figure 2)
DISPLAY SET
▶ 1. LCD ON TIME(S) : 60
2. EL ON TIME(S)
: 10
3. LANGUAGE
: KO
4. EXIT
(figure 3)
EXTENDED MENU
▶ 1. EXTENDED BOLUS : On
2. UTILITY
: Off
3. NO CARBO MODE : Off
4. EXIT
(figure 4)
⑤DISPLAY SET
1. 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. EXIT
- Saves adjustment and returns to the previous level.
⑥EXTENDED MENU
1. EXTENDED BOLUS
- Choose whether or not to utilize the Extended Bolus function.
2. UTILITY
- Choose whether or not to utilize the Utility function.
3. NO CARBO MODE
- If the“NO CARBO MODE”was selected as“Off”
, a pop-up window
will display to perform the carbohydrate counting function, once you
checked your BG level by the DANA IISG pump. If the
“NO CARBO
MODE”was selected as“On”
, the pop-up window will not be activated
after the checking BG level.
4. EXIT
- Saves adjustment and returns to the previous level.
19
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⑦STRIP CHECK
STRIP CHECK
- This is the menu for check whether or not the glucose meter of DANA
Diabecare IISG operates normally.
1. Insert the“Check Strip”into the Glucose Meter Port when the
“Strip
Check”displays (figure 1).
(figure 1)
2. In case“OK”displayed, the meter is normal (figure 2).
3. In case“ERROR”displayed, the meter is abnormal (figure 3).
STRIP CHECK
OK
(figure 2)
STRIP CHECK
ERROR
(figure 3)
20
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3. Filling and inserting a new reservoir
3. Filling and inserting a new reservoir
Changing the reservoir
Caution The reservoir must be changed every 3 days, regardless of the amount left in the reservoir.
Caution The reservoir must be changed when there is less than 20u remaining.
Caution Always remember to change the reservoir and infusion set at the same time.
WarningUse only fast acting insulin in your pump.
Preparation
1) Retrieve the insulin vial from the refrigerator and let it warm up to room temperature for 15-30 minutes.
Caution Failing to warm the insulin sufficiently may result in air bubbles in the reservoir.
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.
5) Wash your hands.
21
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Filling the reservoir with insulin
1) Remove the round cap at the end of the reservoir plunger and
discard. A thin white reservoir cap will fall out of the plunger - keep
this cap for later use (figure 1). Pull back on the plunger to the line
marked with the number 3 and push up and down 3-4 times to
properly lubricate the reservoir.
(figure 1)
2) Insert and fit the plastic component of the linking screw into the
cavity of the plunger (figure 2).
3) Wipe the lid of the insulin vial with an alcohol swab. Carefully remove
(figure 2)
the clear needle protective cover and draw out the desired amount of
insulin (figure 3).
Note
Pull the plunger down until you are at the desired amount of
insulin needed. Insert the needle into the insulin vial and inject the
air from the syringe into the vial. Draw out the desired amount of
(figure 3)
insulin.
Note
Total fill amount: (Daily requirement x 3-4 days) + extra 30u
4) Place the clear needle protective cover back on the needle. 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
(figure 4)
on the plunger to remove the bubbles at the top (figure 4).
5) Remove the needle from the reservoir and cover with the thin white
reservoir cap (figure 5). Please dispose of the needle properly.
(figure 5)
22
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3. Filling and inserting a new reservoir
Instructions for use of DANA Easy SETTER
1)Insert a battery into Easy SETTER as instructed below:
①Open the battery compartment.
②Insert a battery positive side up.
③Close battery compartment.
Note
(figure 1)
The DANA Easy SETTER operates with the SOOIL 3.6V battery
2) Insert a syringe filled with insulin into the DANA Easy SETTER (figure 2).
Note
The end (hexagonal part) of the connecting screw should be
placed into the hexagonal hole of DANA Easy SETTER.
(figure 2)
3) Push the button on DANA Easy SETTER.
Note
When the button is pushed, you can see the syringe slide in.
Push 2~3 more seconds until the syringe is fully inserted into the
Easy SETTER(Figure 3).
4) Retrieve the adjusted syringe from the DANA Easy SETTER.
(figure 3)
Inserting the reservoir into the pump
1)Insert the reservoir with linking screw into the DANA DiabecareⓇ IISR
insulin pump as shown in figure 1. When inserting the reservoir,
rotate the reservoir back and forth 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’
reservoir compartment cap in place and remove the small white
(figure 1)
reservoir cap from the end of the reservoir.
Note
If attempts to reinsert the reservoir fail, try a new reservoir.
Caution Do not push and/or force the reservoir into 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.
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Connecting the infusion set to the DANA IISR
1) Hold the pump upside down and remove the white cap. Screw the
infusion set connector counterclockwise into the reservoir
compartment until it is firmly in place.
(figure 1)
Caution If the pump is not held upside down while removing the white cap and connecting the infusion set, insulin may
drip down into the pump.
Priming the infusion set
1) Press
to take the pump out of SUSPEND mode. The BASIC
DISPLAY will appear.
2) In the BASIC DISPLAY screen, highlight the CHECK/REVIEW
icon
and press
3) Press
(figure 1)
(figure 1).
in the CHECK/REVIEW
screen to highlight the PRIME
icon as shown in figure 2. Then press
(figure 2)
4) You will now see the FILLING SCREEN display as shown in figure
3. Use
and
to adjust the amount of insulin (in cc’
s) in
the new reservoir placed in the DANA pump. Then press
(figure 3)
24
Note
Remember to adjust this setting up or down to the amount you have actually placed in the reservoir.
Note
The 2.5 cc is a preset default setting.
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3. Filling and inserting a new reservoir
5) The prime screen will appear as in figure 4. Press
twice to
begin priming the infusion set.
Note
Press
once and the word
“PRIME”will be replaced by
(figure 4)
“UP”a second later. The two words will flash back and forth
every two seconds. In order to commence priming you must
press
the second time while the screen displays the word
“UP”
6) You will hear the pump begin to infuse insulin into the infusion set.
The insulin amount on the PRIME screen will increase slowly and
“bubble”
swill appear at the end of the reservoir on the display as in
(figure 5)
figure 5. You will see the insulin move towards the needle end of the
infusion set.
Note
You will hear the pump beep for every 1.0 unit while priming is in progress.
Note
You may pause the prime temporarily by pressing
. Press
twice to resume the priming sequence.
7) When you see a drop of insulin appear at the end of the infusion set needle, press
to stop the priming sequence.
Caution Make sure the needle is faced downwards so that insulin does not come in contact with the infusion set dressing.
WarningMake sure to prime when you use a new infusion set or remove air from the tubing.
Note
The DANA DiabecareⓇ IISR insulin pump will allow 2 prime sequences every 12 hours (0:00 - 12:00, 12:00 -
Caution Always check and confirm all basal and bolus settings after changing the insulin reservoir. Visually confirm there is
no air in the infusion set tubing.
Note
It is recommended that the pump be primed a minimum of 15 units.
25
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Inserting the infusion set
WarningMake sure to prime when you use a new infusion set or
remove air from the tubing.
1) Choose an insertion site on your abdomen at least 5 cm away from
the navel (figure 1).
(figure 1)
2) Clean the site with an alcohol swab and allow to dry (figure 1).
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 paper
(figure 2)
backing from the adhesive dressing.
4) With your other hand pinch the tissue around the insertion site
between your thumb and finger as in figure 3. Push the needle firmly
into this tissue and secure with the adhesive dressing.
(figure 3)
5) Tape the infusion set to the body with adhesive tape 2~5 cm away
from the insertion site.
Note
You should not feel pain when you touch the insertion area after
the needle has been inserted. You may feel some pain at the
(figure 4)
insertion site if the infusion set is not secured well to your body.
WarningDo not use the infusion set if its package has been damaged, inadvertently opened or wet.
26
Note
See page 32 for Soft-Release-ST inserting.
Note
Try to avoid any recent insertion sites, scars, scar tissue or bruising.
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3. Filling and inserting a new reservoir
Infusion Sets
The EasyRelease Infusion Set
The EasyRelease Infusion Set is a stainless steel needle set. A needle is inserted at 90°
into the skin. The adhesive of the
EasyRelease allows the needle to be fixed firmly in place.
①Needle Cover
⑤Site Connector
⑨ Tubing
②Needle Hub
⑥Infusion Set Connector
⑩Pump Connector
③ Needle
⑦Connection Needle
⑪Site Connector Cover
④Needle Guide with Adhesive
⑧ Collar
⑫Infusion Set Connector Cover
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Instructions
1. Prior to Inserting the EasyRelease Infusion Set
1) 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 would
breach 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 the
Collar back to secure the connection(figure 1).
2. Inserting the EasyRelease Infusion Set
1) Choose an insertion site on your abdomen at least 5 cm away from
the navel. Clean the site with an alcohol swab and allow to dry
(figure 2).
(figure 1)
(figure 2)
(figure 3)
(figure 4)
(figure 5)
(figure 6)
(figure 7)
(figure 8)
2) Prime the infusion set by following the instructions on page 23. Air
removal is complete when a drop of insulin appears at the end of
the needle (figure 3).
3) Carefully remove the needle’
s protective cover (figure 4), and the
paper backing from the adhesive dressing (figure 5).
4) With your other hand pinch the tissue around the insertion site
between your thumb and finger. Push the needle firmly into the
tissue (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).
Note
28
Try to avoid any recent insertion sites, scars, scar tissue or bruising.
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3. Filling and inserting a new reservoir
3. Disconnecting the EasyRelease Infusion Set
1) Place the pump in SUSPEND (see page 17).
2) Push the Collar forward and pull the Infusion Set Connector out of
the Site Connector (figure 9).
3) Push the Infusion Set Connector Cover onto the Connection
(figure 9)
(figure 10)
Needle (figure 10). Make sure that this is done without bending the Connection Needle. This
prevents 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.
(figure 11)
4. Reconnecting the EasyRelease Infusion Set
1) Wipe the tip of the Site Connector with an alcohol swab after removing the Site Connection
Cover (figure 12).
2) Remove the Infusion Set Connector Cover from the Infusion Set Connector (figure 12).
(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) and
watch to ensure that a drop is visible from the Connection Needle tip (figure 14).
(figure 13)
5) Gently slide the Infusion Set Connector into the Site Connector, and pull the Collar back to
secure the connection (figure 15).
5. Removing the EasyRelease Infusion Set
1) Place the pump in SUSPEND (see page 17).
(figure 14)
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 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 and
pulling upwards.
(figure15)
29
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The EasyRelease II Infusion Set
The EasyRelease II Infusion Set is a stainless steel needle set. A needle is inserted at 90°
into the skin. The adhesive of the
EasyRelease II allows the needle to be fixed firmly in place.
30
①Needle Cover
⑤Site Connector
⑨ Tubing
②Needle Hub
⑥Infusion Set Connector
⑩Pump Connector
③ Needle
⑦Connection Needle
⑪Site Connector Cover
④Needle Guide with Adhesive
⑧Spring Clip
⑫Infusion Set Connector Cover
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3. Filling and inserting a new reservoir
Instructions
1. Prior to Inserting the EasyRelease II Infusion Set
1) 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 that
would breach 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 the
Collar back to secure the connection(figure 1).
(figure 1)
(figure 2)
(figure 3)
(figure 4)
(figure 5)
(figure 6)
(figure 7)
(figure 8)
2. Inserting the EasyRelease II Infusion Set
1) Choose an insertion site on your abdomen at least 5 cm away from
the navel. Clean the site with an alcohol swab and allow to dry
(figure 2).
2) Prime the infusion set by following the instructions on page 23. Air
removal is complete when a drop of insulin appears at the end of
the back side of needle (figure 3).
3) Carefully remove the needle’
s protective cover (figure 4), and the
paper backing from the adhesive dressing (figure 5).
4) With your other hand pinch the tissue around the insertion site
between your thumb and finger. Push the needle firmly into the
tissue (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).
Note
Try to avoid any recent insertion sites, scars, scar tissue or bruising.
31
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3. Disconnecting the EasyRelease II Infusion Set
1) Place the pump in SUSPEND (see page 17).
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 11).
3) Push the Infusion Set Connector Cover onto the Connection Needle
(figure 12). Make sure that this is done without bending the
(figure 9)
(figure 10)
(figure11)
(figure 12)
(figure 13)
(figure 14)
Connection Needle. This prevents 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 13).
5) Put your pump in a clean and safe place until you are ready to
reconnect.
4. Reconnecting the EasyRelease II Infusion Set
1) Wipe the tip of the Site Connector with an alcohol swab after
removing the Site Connection Cover (figure 14).
2) Remove the Infusion Set Connector Cover from the Infusion Set
Connector (figure 15).
3) Take the pump out of SUSPEND(See page 17).
4) Before reconnecting, program the pump to bolus 0.5~1 unit of
insulin (see page 39) and watch to ensure that a drop is visible from
the Connection Needle tip (figure 16).
5) Gently slide the Infusion Set Connector into the Site Connector, by
pressing lightly on the Spring Clips on either side of the Infusion Set
Connector (figure 17).
5. Removing the EasyRelease II Infusion Set
(figure 15)
1) 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 on
the 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.
32
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3. Filling and inserting a new reservoir
The Soft-Release-R Infusion Set
The Soft-Release-R is a soft cannula infusion set and is inserted at a 90°
angle. The needle is removed after insertion and
only the cannula remains under the skin.
① Needle Protective Cover for disposal
⑥Introducer Needle
⑪Spring Clip
②Cannula Hub
⑦Bypass Needle
⑫ Tubing
③Teflon (Soft Cannula)
⑧Site Connector
⑬Pump Connector
④Needle Guide with Adhesive
⑨Infusion Set Connector
⑭Site Connector Cover
⑤Needle Hub
⑩Connection Needle
⑮Infusion Set Connector Cover
33
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1. Prior to Inserting the Soft-Release-R Infusion Set
1) 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 that
would breach its sterility.
3) Screw the Pump Connector counterclockwise into the reservoir
compartment 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 Set
(figure 1)
(figure 2)
(figure 3)
(figure 4)
(figure 5)
(figure 6)
(figure 7)
(figure 8)
(figure 9)
(figure 10)
1) Choose an insertion site on your abdomen at least 5 cm away from the
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. Air
removal is complete when a drop of insulin appears at the end of the
back side of needle (figure 3).
3) Hold the infusion set in your fingers at the Needle Guide and
carefully remove the needle’
s protective cover (figure 4), and remove
the paper backing from the adhesive dressing (figure 5).
4) 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 the infusion site (figure 6). Watch the Teflon (soft
cannula) during insertion to assure that it goes in smoothly without
kinking or crimping.
5) Before withdrawing the Introducer needle, you may want to ensure
that the cannula is firmly taped (figure 7).
6) To remove the Introducer Needle, place one finger on each side of
the Needle Guide with Adhesive and one on either side of the
Introducer Needle. Pull the needle straight out (figure 8).
7) Dispose of the Introducer Needle in a safe manner by using the
needle Protective Cover (figure 9).
8) Tape the infusion set to the body with adhesive tape 2~5 cm away
from the insertion site (figure 10).
34
Note
Try to avoid any recent insertion sites, scars, scar tissue or bruising.
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3. Filling and inserting a new reservoir
3. Disconnecting the Soft-Release-R Infusion Set
1) Place the pump in SUSPEND (see page 17).
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 11).
3) Push the Infusion Set Connector Cover onto the Connection Needle
(figure 12). Make sure that this is done without bending the
(figure 11)
(figure 12)
(figure13)
(figure 14)
(figure 15)
(figure 16)
Connection Needle. This prevents 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 13).
5) Put your pump in a clean and safe place until you are ready to
reconnect.
4. Reconnecting the Soft-Release-R Infusion Set
1) Wipe the tip of the Site Connector with an alcohol swab after
removing the Site Connection Cover (figure 14).
2) Remove the Infusion Set Connector Cover from the Infusion Set
Connector (figure 15).
3) Take the pump out of SUSPEND(See page 17).
4) Before reconnecting, program the pump to bolus 0.5~1 unit of
insulin (see page 39) and watch to ensure that a drop is visible from
the Connection Needle tip (figure 16).
5) Gently slide the Infusion Set Connector into the Site Connector, by
pressing lightly on the Spring Clips on either side of the Infusion Set
Connector (figure 17).
5. Removing the Soft-Release-R Infusion Set
(figure 17)
1) 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 on
the 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.
35
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The Soft-Release-ST Infusion Set
The Soft-Release-ST is a soft cannula infusion set. It may be inserted at any angle between 15°
and 30°
, depending on
your body type, comfort and instructions from your healthcare professional. The needle is removed after insertion and only
the cannula remains under the skin.
36
①Needle Cover
⑥Introducer Needle
⑪Pump Connector
②Site Connector
⑦Infusion Set Connector
⑫Site Connector Cover
③Teflon (Soft Cannula)
⑧Connection Needle
⑬Infusion Set Connector Cover
④Needle Guide with Adhesive
⑨Spring Clips
⑤Needle Hub
⑩ Tubing
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3. Filling and inserting a new reservoir
1. Prior to Inserting the Soft-Release-ST Infusion Set
1) Wash your hands before handling the infusion set.
2) Take out the Soft-Release-ST Infusion Set from its package. Be
careful not to touch the connector to any object that would breach its
sterility.
3) Screw the Pump Connector counterclockwise into the reservoir
(figure 1)
(figure 2)
(figure 3)
(figure 4)
(figure 5)
(figure 6)
(figure 7)
(figure 8)
(figure 9)
(figure 10)
compartment until it is firmly in place.
2. Inserting the Soft-Release-ST Infusion Set
1) Choose an insertion site on your abdomen at least 5 cm away from the
navel. Clean the site with an alcohol swab and allow to dry (figure 1).
2) Hold the infusion set in your fingers at the Site Connector and
carefully remove the needle’
s protective cover (figure 2), and remove
the bottom portion of the paper backing from the adhesive dressing
(figure 3).
3) With your other hand pinch the tissue around the insertion site
between your thumb and finger. Insert the needle quickly, at a 15°
30°angle straight into the infusion site (figure 4). Watch the Teflon
(soft cannula) during insertion to ensure that it goes in smoothly
without kinking or crimping.
4) Once the bottom portion of the adhesive has been fixed, remove the
top 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 of
the Site Connector and one on either side of the Spring Clips of the
Needle Hub. Pull the needle straight out (figure 6).
6) Dispose of the Introducer Needle in a safe manner by using the
needle 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 appears
at 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).
37
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3. Disconnecting the Soft-Release-ST Infusion Set
1) Place the pump in SUSPEND (see page 17).
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 11).
3) Push the Infusion Set Connector Cover onto the Connection Needle
(figure 12). Make sure that this is done without bending the
(figure 11)
(figure 12)
(figure 13)
(figure 14)
(figure 15)
(figure 16)
Connection Needle. This prevents 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 13).
5) Put your pump in a clean and safe place until you are ready to
reconnect.
4. Reconnecting the Soft-Release-ST Infusion Set
1) Wipe the tip of the Site Connector with an alcohol swab after
removing the Site Connection Cover (figure 14).
2) Remove the Infusion Set Connector Cover from the Infusion Set
Connector (figure 15).
3) Take the pump out of SUSPEND (see page 17).
4) Before reconnecting, program the pump to bolus 0.5~1 unit of
insulin (see page 39) and watch to ensure that a drop is visible from
the Connection Needle tip (figure 16).
5) Gently slide the Infusion Set Connector into the Site Connector, by
pressing lightly on the Spring Clips on either side of the Infusion Set
Connector (figure 17).
5. Removing the Soft-Release-ST Infusion Set
1) Place the pump in SUSPEND (see page 17).
(figure 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 on
the 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.
38
Note
Try to avoid any recent insertion sites, scars, scar tissue or bruising.
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3. Filling and inserting a new reservoir
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 wet.
4. The shelf life of the reservoir and the infusion set is 3 years. Please check 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 professional on how
you should compensate for missed insulin. Please remember that while disconnected from the pump, no insulin is being
infused. 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 an
additional series of safety checks.
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4. Bolusing, temporary basal rates, calculating your bolus
dosage and dose automation
Bolus
When Extended Bolus is set to OFF
-Delivering a Bolus
1) Press any button while in the INITIAL DISPLAY screen to bring up the
BASIC DISPLAY screen.
2) In the BASIC DISPLAY screen press
until the BOLUS icon is
(figure 1)
highlighted as in figure 1. Then press
. The BOLUS screen will
appear as in figure 2.
3) Confirm the amount of insulin to be delivered in the bottom right
corner of the BOLUS screen. If the insulin dose is not correct you may
(figure 2)
make the desired adjustments to the bolus setting by using
and
Note
Remember the adjustment will not change the default bolus setting. It will only change the bolus that you are
currently delivering.
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4. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation
4) Press
twice to begin delivery. The screen in figure 3 will appear
and you will hear the motor run as the bolus is being delivered.
Note
Press
once and the word
“BOLUS”(or BRFST, LUNCH,
DINNER”
) will be replaced by“SELECT”a second later. In order to
commence the bolus sequence you must press
(figure 3)
again while the
screen is showing“SELECT”
Note
You will hear the pump beep for every 1.0 unit while a bolus is being delivered.
Note
Press
or
Note
Press
to return to Basic Display screen.
once to stop a bolus during delivery.
5) The pump will make a beep and return to the INITIAL DISPLAY screen upon conclusion of bolus delivery.
WarningYou must eat your meal after the meal bolus has been delivered.
When Extended Bolus is set to ON
-The BOLUS OPTION Screen
1) In the BASIC DISPLAY screen press
highlighted as in figure 1. Then press
until the BOLUS icon is
(figure 1)
2) Choose the first icon to access the NORMAL BOLUS screen, the
second icon to access the EXTENDED BOLUS screen, and the
third icon to access the DUAL PATTERN BOLUS screen.
(figure 2)
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- Extended Bolus
1) In the BASIC DISPLAY screen press
highlighted as in figure 1. Then press
until the BOLUS icon is
(figure 1)
2) Use
to highlight the middle icon and press
(figure 2)
3) Use
to toggle between BOLUS amount and BOLUS Period
and make the necessary adjustments with
press
and
then
(figure 3)
4) Use
to highlight
‘YES’and press
(figure 4)
- Dual Bolus
1) In the BASIC DISPLAY screen press
highlighted as in figure 1. Then press
until the BOLUS icon is
(figure 1)
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4. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation
2) Use
to highlight the rightmost icon and press
3) Use
to toggle between STEP BOLUS and EXTEND BOLUS
(figure 2)
and BOLUS Period and make the necessary adjustments with
and
than press
4) Use
Note
to highlight
‘YES’and press
To verify that Extended Bolus is in effect, while in the BASIC
DISPLAY screen use
press
to highlight the BOLUS icon and
. The EXTENDED BOLUS STATUS screen will
appear.
Note
(figure 3)
(figure 4)
The time may be adjusted in 30 minute increments within the
range of 30 minutes - 8 hours.
Note
The bolus amount may be set to any amount within the range
of 0 - bolus max.
(figure 5)
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- Extended Bolus Status
1) In the BASIC DISPLAY screen press
highlighted as in figure 1. Then press
until the BOLUS icon is
(figure 1)
2) The screen will show how much time has elapsed since the start of the
Extended Bolus, how much time is left until the completion of the
Extended Bolus, amount delivered so far, and amount left to be delivered.
Note
(figure 2)
□means
Extended Bolus.
-Extended Bolus Cancellation
1) In the BASIC DISPLAY screen press
highlighted as in figure 1. Then press
until the BOLUS icon is
(figure 1)
2) Press
to invoke the cancellation prompt.
3) Use
to highlight
‘YES’and press
. The current
Extended Bolus sequence will be cancelled and you will be returned
to the BASIC DISPLAY screen.
(figure 2)
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4. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation
Note
To verify the Extended Bolus has been cancelled, while in the
BASIC DISPLAY screen, use
and press
to highlight the BOLUS icon
. You will see the BOLUS OPTION screen if
Extended Bolus was successfully cancelled (figure 3).
(figure 3)
Note
If cancellation was not successful, the EXTENDED BOLUS
STATUS screen will appear as in figure 4.
Caution Infusion occurs on 4 minutes past the hour, 8 minutes past the
hour, 12 minutes past the hour, 16 minutes past the hour, and so
on, in multiples of 4.
(figure 4)
Note
Insulin is delivered every four minutes when the Dana IISR utilizes the extended bolus feature. While in extended
bolus mode, insulin delivery will be halted during the following four events:
1) Start of a bolus
2) Delivery of a bolus
3) Priming the infusion set
4) Delivery of basal rates
Therefore, the actual delivered amount displayed in the extended bolus status screen may differ from the actual
delivered amount.
Caution Extended Bolus delivery is recorded in the bolus history. The time stamp of the entry corresponds to the date and
time of Extended Bolus conclusion.
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Temporary Basal
When Utility is set to OFF
-Programming Temporary Basal Rates
1) Press any button while in the INITIAL DISPLAY screen to bring up the
BASIC DISPLAY screen.
(figure 1)
2) In the BASIC DISPLAY screen press
until the TEMPORARY
BASAL icon is highlighted as in figure 1. Then press
. The
①
TEMPORARY BASAL screen will appear as in figure 2.
②
①This number indicates the number of hours during which the
(figure 2)
temporary basal rate will remain in effect.
② This number indicates the desired increase/decrease in basal delivery.
3) Use
to toggle between the number of hours and basal ratio
and make the necessary adjustments with
and
(figure 3)
Note
For instance, a temporary basal rate of
“50%”for“1 hour”will change
the basal rate to half of your regular basal rate for the next hour.
Note
No temporary basal rate will take effect if you press
while
either the number of hours is set at
“0”
, or the rate is set at“100%”
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4. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation
4) Press
after making the desired adjustments to commence
temporary basal. Upon pressing
you will be returned to the
BASIC DISPLAY screen and “v”
a mark will appear in the TEMPORARY
(figure 4)
BASAL icon to indicate that the temporary basal rate is in effect.
5) If you would like to check the status of a temporary basal rate that is
currently in effect, use
to highlight the TEMPORARY BASAL
icon with“v”mark in the BASIC DISPLAY screen and press
①
②
The TEMPORARY BASAL STATUS screen will appear as in figure 5.
③
①Time elapsed
(figure 5)
②Time remaining
③Temporary basal rate
6) To cancel a temporary basal rate currently in effect, press
and a cancellation prompt will appear as in figure 6.
7) Press
to highlight“YES”
, then press
if you would like
to cancel temporary basal. The temporary basal rate in effect will be
(figure 6)
cancelled and you will be returned to the BASIC DISPLAY screen.
Note
Highlight“NO”and press
at the cancellation prompt to return to the BASIC DISPLAY screen without
Note
Adjust the rate to“100%”and time to“0 hours”if you wish to return to your regular basal rate.
Note
The ratio may be adjusted between 0-200% in increments of 10% for up to 12 hours.
canceling temporary basal.
Caution Please consult your healthcare professional about the temporary basal feature.
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When Utility is set to ON
-UTILITY MENU screen
1) In the BASIC DISPLAY screen, use
(Computer). Then press
to highlight the Utility icon
(figure1)
2) If Temporary Basal is not activated your UTILITY MENU screen will
(figure 2)
appear as in figure 2.
3) If Temporary Basal is in effect your UTILITY MENU screen will appear
(figure 3)
as in figure 3.
Note
Select the leftmost icon for the Bolus Calculator, middle icon for
Temporary Basal, and rightmost icon for Dose Automation.
(figure 1)
-Bolus Calculator
1) In the BASIC DISPLAY screen, use
Then press
to highlight the UTIL icon.
.(figure 1)
(figure 2)
2) While in the UTILITY MENU screen, press
to access the
BOLUS CALCULATOR screen.(figure 2)
3) In the BOLUS CALCULATOR screen, Use
to move the cursor
①
②
on CARBO to adjust the amount of Carbohydrate with the use of
or
button. (figure 3)
①Displays current blood glucose level.
48
②Indicates the carbohydrate(g) to be consumed after Bolus delivery.
(figure 3)
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4. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation
4) Use
to move between“Ideal Blood Glucose”
,“CIR”
, and
‘CF’
, and use
and
①
to make the necessary
adjustments. Then press
②
. The BOLUS CALCULATOR
③
RESULTS screen will appear as in figure 4.
(figure 4)
①Indicates your target blood glucose level.
②Amount of carbohydrates capable of being processed by 1u (unit) of insulin. (Carb/insulin ratio)
③Indicates Correction factor.
①Indicates the amount of insulin required according to your present
①
blood glucose level.
②
②Indicates the amount of insulin required to process the amount of
carbohydrates specified.
③
③Indicates the amount of insulin remaining in your body from your
④
previous bolus amount(active insulin).
④Indicates the calculated bolus amount.
5) Press
(figure 5)
twice to commence bolus delivery. You will hear the
motor run and the screen will show that a bolus is being delivered.
Note
You will hear the pump beep for every 1.0 unit while a bolus is being
(figure 6)
delivered.
Note
Press
once and the word
“BOLUS”will be replaced by“SELECT”a second later. The two words will flash
back and forth every two seconds. In order to commence the bolus sequence you must press
again while
the screen is showing“SELECT”
Note
Press
or
once to stop a bolus during delivery.
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- Temporary basal
1) In the BASIC DISPLAY screen, use
Then press
to highlight the UTIL icon.
(figure 1)
2) While in the UTILITY MENU screen, use
TEMPORARY BASAL ICON. Then press
3) Use
to highlight the
to toggle between the number of hours and basal rate,
and make the necessary adjustments with
and
(figure 2)
4) Once temporary basal has been set, a
“v”mark will appear in the
TEMPORARY BASAL icon at the UTILITY MENU screen to indicate
(figure 3)
a temporary basal rate is in effect.
Note
To confirm that temporary basal is in effect, use
in the
UTILITY MENU screen to highlight the TEMPORARY BASAL icon
and press
. The TEMPORARY BASAL STATUS screen will
appear.
Note
(figure 4)
The percentage rate shown in figure 5 corresponds to the rate at
which basal infusion will occur while temporary basal is active. The
percentage calculation is based on your regular basal rate. For
instance, if your regular basal rate is 4 units per hour and the
percentage rate is set to 150%, the temporary basal rate would be
6 units per hour.
50
(figure 5)
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4. Bolusing, temporary basal rates, calculating your bolus dosage and dose automation
- Temporary Basal Cancellation
1) In the BASIC DISPLAY screen, use
(Computer) and press
to highlight the UTIL icon
. The UTILITY MENU screen will appear.
(figure 1)
2) Use
to highlight the TEMPORARY BASAL icon and press
to access the TEMPORARY BASAL STATUS screen.
(figure 2)
3) Press
4) Use
to invoke the cancellation prompt.
to highlight“YES”and press
to cancel temporary
basal. You will be returned to the BASIC DISPLAY screen upon
pressing
Note
(figure 3)
If you do not wish to cancel, choose
“NO”and press
at the
cancellation prompt. You will be returned to the BASIC DISPLAY
screen upon pressing
(figure 4)
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- Dose Automation
1) In the BASIC DISPLAY screen, use
and press
to highlight the UTIL icon
(figure 1)
2) Use
to highlight the rightmost icon and press
to
access the DOSE AUTOMATION screen.
3) Use
to toggle between Daily total and Bolus and Basal and
make the necessary adjustments with
and
(figure 2)
then press
4) Use
to confirm the time and rates. Use
and
to
(figure 3)
choose the desired basal pattern and press
5) Use
Note
to highlight“YES”and press
□indicates
pattern number. 4 different basal profiles are available for
(figure 4)
selection.
Note
You may verify your bolus and basal rates through the CHECK/REVIEW
menu option.
52
Note
The Daily Total can be set to any value within the range of 0-Daily Max.
Note
The percentage rate can be adjusted within the range of 0-100%.
(figure 5)
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5. Remote Control
5. Remote Control
Synchronize the Remote Control with the Pump
1) Select the menu of connect icon at the basic menus display to
synchronize the remote control with the pump (figure 1).
(figure 1)
Note
An icon with four antennas will be displayed on the remote control
while the synchronization is attempting.
Note
An icon with six antennas will be displayed on the remote control
once the synchronization is completed.
(figure 2)
Bolus
1) In the BASIC DISPLAY screen press
highlighted as in figure 1. Then press
until the BOLUS icon is
. Then press
(figure 3)
2) While in the BOLUS SETTING screen, select the proper insulin dose
by using
and
. The insulin dose appears in units in the
bottom right hand corner.
(figure 1)
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3) Press
twice to begin delivery. The screen in figure 2 will appear
and you will hear the motor run as the bolus is being delivered.
(figure 2)
Note
Press
once and the word
“BOLUS”will be replaced by
“SELECT”a second later. In order to commence the bolus
sequence you must press
again while the screen is showing
“SELECT”(figure 3)
(figure 3)
Note
Press
or
once to stop a bolus during delivery.
Lock Setting
(figure 1)
1) Move to the program setting screen from the basic screen (figure 1),
press
button once an icon of LOCK is displayed, and then the
LOCK icon will be displayed like figure 2.
(figure 2)
2) To unlock, press in order of
and then,
a display like figure 3 will be displayed. Input PIN code 1234 by use
of
or
buttons.
(figure 3)
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5. Remote Control
Setting the Clock
1) From the BASIC DISPLAY, go to the SET/PROGRAM screen. Press
to highlight the CLOCK icon and press
(figure 1). The
CLOCK SETTING screen will appear as shown in figure 2.
2) Use
(figure 1)
to move between the year and month and date, as well
as hours and minutes. Use
and
to make the desired
(figure 2)
changes.
3) After making the changes press
to save the setting and return
to the BASIC DISPLAY screen.
(figure 1)
Disconnect Remote Control and Insulin Pump
1) Select the menu of disconnect icon at the basic menus display to
disconnect remote control.
Note
(figure 2)
The antenna icon will be disappeared once the remote control
disconnected.
Note
A disconnect icon will be displayed on the pump.
(figure 3)
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Checking your blood glucose level
1) After washing your hands, insert a DANA blood glucose strip into the
blood glucose meter test port (figure 1).
(figure 1)
2) The STRIP CODE SETTING screen will appear as in figure 2. Set the
STRIP CODE and press
Note
The STRIP CODE range is between 0 and 49. You must use the
code indicated on the DANA glucose strip packaging for
(figure 2)
accurate results.
Note
If the strip is removed from the test port while the display screen
appears as in figure 1 or figure 2, you will be returned to the
BASIC DISPLAY screen.
Caution Please leave the DANA Diabecare IISG insulin pump and its test
strips for 30 minutes in room temperature before use.
(figure 3)
3) Verify that the display shows the OBTAIN BLOOD screen as in figure 3.
(figure 4)
4) Clean your fingertip with an alcohol swab. Obtain a blood sample
with a blood sampling needle (figure 4).
5) Apply the sample blood on the end of the strip (figure 5).
(figure 5)
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5. Remote Control
6) A 5 second countdown will appear as in figure 6. Once the
countdown concludes the BLOOD GLUCOSE TEST RESULT
screen will appear (date, time, blood glucose level) as in figure 7.
(figure 6)
Calculating your bolus dosage
1) While in the BLOOD GLUCOSE TEST RESULT screen, press
and the CARB COUNTER prompt will appear as in figure 8.
Note
If you press
. you will be returned to the BASIC DISPLAY screen.
2) If you would like to calculate your bolus dosage, use
highlight‘YES”and press
(figure 7)
to
. The initial BOLUS CALCULATION
screen will appear as in figure 9.
Note
If you press
while
‘NO’is highlighted, you will be returned
(figure 8)
to the BASIC DISPLAY screen.
3) Use
to move between
‘Blood Glucose’and‘Carbos’
, and use
adjustments. Press
and
to make the necessary
to move to the
next screen (figure 10).
①Indicates your present blood glucose test result.
BG
▶
100
①
②Indicates the amount of carbohydrates to be consumed prior
CARBO ▶
250
②
to bolus delivery.
(figure 9)
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4) Use
to move between
‘Target Blood Glucose’
,‘CIR’
, and‘CF’
, and use
necessary adjustments. Then press
and
to make the
. The CARB COUNTER RESULTS screen will appear as in figure 11.
①Indicates your target blood glucose level.
② Amount of carbohydrates capable of being processed by 1u of insulin.
③Indicates insulin action rate
100
①
CIR
25
②
CF
50
③
IDEAL ▶
(figure 10)
5) Press
twice to commence bolus delivery. You will hear the motor run and the screen will show that a bolus
①
is being delivered.
②
①Indicates the amount of insulin required according to your present
G. 2.0U C. 10.0U
blood glucose level.
②Indicates the amount of insulin required to process the amount of
carbohydrates specified.
③Indicates the amount of insulin remaining in your body from your
previous bolus amount.
④Indicates the calculated bolus amount.
Note
Press
③
A. 2.0U
10.0U
④
(figure 11)
once and the word
“BOLUS”will be replaced by“SELECT”a second later. The two words will flash
back and forth every two seconds. In order to commence the bolus sequence you must press
the second
time while the screen is showing
“SELECT”
Note
You will hear the pump beep for every 1.0 unit while a bolus is being delivered.
Note
Press
or
twice to stop a bolus during delivery.
6) The pump will make a beep and return to the INITIAL DISPLAY screen upon conclusion of bolus delivery.
WarningYou must eat your meal after the meal bolus has been delivered.
Note
The DANA Diabecare IISG insulin pump will deliver an audio reminder 30 minutes after bolus delivery. To stop the
alert, push any button once.
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5. Remote Control
Glucose meter related error messages and troubleshooting
Note
Please refer to the following in the event of a measurement error.
SCREEN
ERROR 1
ERROR 2
ERROR 3
ERROR 4
PROBLEM
CORRECTIVE ACTION
Strip has been used more than once.
Retest with a new strip.
Blood was applied prior to being
Retest with a new strip.
prompted.
Test environment is not within the
Retest with new strip in 30 minutes in
allowed temperature range.
adequate temperature.
Blood viscosity is exceedingly high or
Retest with a new strip. If the same
blood sample size is not sufficient for
error message repeatedly appears,
testing.
contact your healthcare professional.
WarningBlood 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 a
sudden 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 too
small.
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6. Troubleshooting
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
• Sweating
• Shaking
• Hunger
•Tingling / numbness
•Nausea or vomiting
•Fast heart rate
• Confusion
What to do in case of hypoglycemia
1) 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 diabetes
professional.
4) Check your blood sugar level again in 15-20 minutes. If it returns to normal, no immediate action is needed and you may
take 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.
Note
60
If hypoglycemia does not resolve contact your health care professional.
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6. Troubleshooting
POSSIBLE CAUSE
SUGGESTED RESPONSE
Consult with your diabetes professional to make adjustments for increased physical
Increased physical activity
activity. You may choose to use or modify temporary basal rates or decrease meal
boluses prior to activity.
Eating less
Alcohol consumption
User error or
programming error
Incorrect settings
Consult with your diabetes professional to adjust basal rates or meal boluses to
more accurately reflect your current intake.
Please refrain from consuming alcohol.
Check and review your bolus history and basal rates. Check with your diabetes
professional to make sure that your bolus is properly calculated as well as your
basal rates.
Check your blood sugar regularly and check with your diabetes professional to
make sure that your bolus is properly calculated as well as your basal rates.
When Hyperglycemia (high blood sugar) occurs
What is Hyperglycemia (high blood sugar)?
Hyperglycemia (high blood sugar) can occur due to any interruption in the delivery of insulin. It is important to know that if
there is no insulin delivery you may experience an increase in your blood sugar which if undetected or untreated may cause
DKA (diabetic ketoacidosis).
The main symptoms of DKA:
• Nausea
•Vomiting
•Increased drowsiness
•Difficulty breathing
• Dehydration
•Abdominal pain
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What 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
Empty reservoir
Insulin leakage at infusion site,
disconnection site
or connection to pump
Pinched or obstructed
infusion set
SUGGESTED RESPONSE
Visually check display screen for remaining insulin and also visually check reservoir
in pump. Replace reservoir immediately.
Examine infusion site to make sure that there is no leakage. Also examine the
connection of the infusion set to the pump and the infusion set connector.
Change the infusion set.
Check to see if the pump is in SUSPEND or if there is enough insulin in the
Programming or user error
reservoir. Check your bolus/basal settings, history, and time. Check the remaining
battery charge and replace if necessary.
Check your blood sugar regularly and check with your diabetes professional to
Incorrect settings
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make sure that your bolus is properly calculated as well as your basal rates.
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6. Troubleshooting
Problem / Correction Action
Problem
Corrective Action
An abnormal LCD can occur when the battery charge is low. Check the remaining
battery charge after you administer a bolus dose. The life span of the battery is
Abnormal LCD
usually 1 or 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 charge. To avoid
any battery mishaps we recommend that you change the battery every two
months or whenever there is a display problem with your screen.
Cannot change bolus/basal
settings
Pump does not function
following CT or MRI scan
Pump will not prime
Contact technical support
Contact technical support.
The DANA DiabecareⓇ IISR insulin pump will allow 2 prime sequences every 12
hours (0:00 - 12:00, 12:00 - 24:00).
WarningIn case of device malfunction, stop using the pump immediately and contact technical support.
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7. List of alarms and audible signals
LOW RESERVOIR screen appears
The low reservoir screen will appear when there are approximately 20 units remaining. The pump will alarm
every 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.
Warning For safety we recommend that you change the reservoir when there are 10 to 15 units of insulin remaining.
ERROR screen appears
Suspend the pump, remove the infusion set and check your blood sugar, then check the reservoir amount. If less
than 10 to 15 units of insulin remain in the reservoir, replace it. If this does not correct the error, check for occlusion of
the infusion set. Visually check for any possible occlusion of the infusion set and take corrective measures (unkink
tubing, check for air bubbles, etc.). If this does not resolve the problem change both the reservoir and infusion set.
Daily Remainder
Warning If ERROR screen persists, contact technical support.
The daily remainder will appear if (Daily max-Daily infusion amount) < 10u. For instance if the daily max
is set to 100 units and the total infusion amount for one day exceeds 90 units the remainder will appear
on the screen.
Daily Max
Appears when the total infusion amount for one day has reached the daily max setting. If you require
more insulin per day, please consult your healthcare professional to extend the daily max setting.
Low Battery
The low battery screen will appear when the remaining battery charge is no longer sufficient for the pump
to operate. Please change the battery.
Note
A continuous alarm will sound.
Check Glucose
Time to check your blood glucose level.
Note
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A melody will play for 30 seconds.
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7. List of alarms and audible signals / 8. Specifications, symbols, warranty
8. Specifications, symbols, warranty
DANA DiabecareⓇ IISR Insulin Pump General Specifications
Size
3.04×1.78×0.79inch (77×45×20mm)
Net Weight
61g (including battery)
Insulin Syringe
3 mL (300 Units), insulin compatible reservoir
Meal Bolus Setting
0-80u
Basal Rate Setting
0-16.0 u/h
Basal Profile
24 Settings
Motor
Swiss Micro DC motor
Bolus Duration for 1 Unit
12 seconds
Power Supply
3.6V DC
Energy Saver
Sleep Mode, Screen Saver
Basal Delivery Increments
4 minute intervals
Integrated Circuit
Dual microprocessors for continuous cross checking
Classification 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.
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
(2) this device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
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Universal Symbols
SYMBOL
DEFINITION
Read instructions for use.
Sterilized with ethylene oxide
Manufacture date
Lot number
Expiration date (Use by date)
CE Marking (SGS UK)
Do not re-use
Adhesive plaster
Serial number
Isolated patient connection (IEC 60601-1 BF type)
Tubing length (43 inch, 27 inch / 1100 ㎜, 700 ㎜)
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7. Specifications, symbols, warranty
WARRANTY
SOOIL Development Company Limited warrants that the DANA Diabecare insulin pump is free from defects in material and
workmanship under normal use and conditions and will warrant this for a period of four (4) years from the date of purchase
by the original purchaser. This limited warranty extends only to the original purchaser.
Should the pump fail to operate properly due to defect in material or workmanship during the warranty period, it may be
returned to SOOIL Development Co. Ltd., by shipment to its designated Distributor. The pump will be repaired or replaced at
SOOIL’
s option without charge to the purchaser. Freight and other charges, where applicable, incurred in shipping a pump
for 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’
instructions. 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 by
the user or any other person including but not limited to physical abuse of the product such as dropping or otherwise
damaging the DANA Diabecare pump.
•Failure to follow the manufacturer’
s instructions, including those for storage, transport or cleaning for the DANA Diabecare
insulin 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 or
injury 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 such
remedies, 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 or
special damages caused by or arising from a defect of the insulin pump.
SOOIL Development Co., Ltd.:
196-1, Dogok-dong Kangnam-gu, Seoul,
KOREA 135-270
Tel:+82(2)3463-0041
Fax:+82(2)3463-7707
Email: sooil@sooil.com
http://www.sooil.com
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IU-E-21 rev.0
www.sooil.com

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