DANA Diabecare II User manual

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
Contents
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.[Soft-Release-R ]
• Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
•Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
•Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
- Connecting the Soft-Release-R Infusion set to the reservoir . . . . . . . . . . . . .38
- Use of the DANADiabecare®II pump and Soft-Release-R Infusion set . . . .38
- Using the disconnect 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
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Before using yourDANADiabecare®II pump, infusion set and reservoir
INDICATIONS FOR USE: The DANA Diabecare®II 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.
Other infusion sets may be used if DANA Diabecare Universal Adaptor is utilized.
Please contact 1-866-342-2322 for details.
Indications for Use
➤The DANA Diabecare®II is classified as an internal powered equipment BF type in accordance
with standard IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety). Patients
must not open the pump housing or handle any internal components.
➤The DANADiabecare®II insulin pump is intended for use with a proprietary infusion set, reservoir,
and other accessories specified in this booklet. Do not use the pump with any other infusion system or
accessories.
➤If you experience any trouble with the pump, remove the battery from the pump immediately and
contact your sales representative.
➤Use the pad of your finger to press the buttons.DO NOTuse sharp objects to press the buttons.
Safety Precautions
Federal (US) law restricts this device to sale by or on the order of a physician.
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➤Avoid the following conditions for safe storage and transport of theDANA
Diabecare®II :
◆
Temperatures below 32.9° F or above 104° F.
◆
Humidity above 90%.
◆
Exposure to dirt or excessive dust.
◆
Exposure to salty environment.
◆
Exposure to explosive gas.
◆
Exposure to rough handling.
◆
Exposure to direct sunlight.
◆
Atmospheric pressure below 500mmHg or above 1060mmHg.
➤The pump must not be used in the presence of intense electromagnetic fields, such as those generated
by certain electrically powered medical devices. The pump should be removed prior to the user having
a CTScan, MRI or X-ray.
➤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 infusion set.
➤Change the reservoir and the infusion set regularly, as recommended by your healthcare professional.
Do not use either for longer than 72 hours.
➤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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“Warning” indicates the presence of a hazard which can cause severe personal injury,
death or substantial property damage if the warning is ignored.
“Caution” indicates the presence of a hazard which will or can cause
minor personal injury or property damage if the warning is ignored.
“Note” advises the user of installation, operation or maintenance information which is
important but not hazard-related.
Explanation of “Warning,” “Caution,” and “Note” Symbols
➤The outside of the pump should be cleaned monthly.
➤When cleaning the pump, use a cloth moistened with water or a neutral pH detergent and wipe it
with a dry cloth.
➤Do not use thinner, alcohol, benzene or similar solvents.
➤Please rinse your pump off with clean water after swimming, or after exposure to dust,
soot or other material that adheres to the pump.
➤Never insert a cloth or liquid into the battery compartment.
➤If the linking screw appears discolored, discard and use a new one. Contact technical
support at 1-866-326-2832 if additional screws are needed.
Cleaning your DANA Diabecare®IIinsulin pump
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Additional accessories
may be purchased separately.
INSULIN PUMP
Contents of the DANA Diabecare®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
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1. Reservoir Compartment: The reservoir
and linking screw are inserted in this
compartment. Turn cap clockwise to open.
2. Battery Compartment :The battery is
inserted in this compartment. Turn cap
counterclockwise to open.
4. LCD Screen: Displays status of system
features and system messages, and serves as
the user interface with pump software.
Lights automatically when any button is
pressed.
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.
➀
Reservoir Compartment
②
Battery Compartment
➂
Control Panel
➃
LCD Screen
Identification and Description of Your Pump Features
3. Control Panel: Contains the four buttons
which are used to increase and decrease
settings, switch screens and select functions.
UP
➃
➂
②
➀
➀
②
NEXT
SEL
DOWN
UP
DOWN
NEXT
➂
SEL
➃
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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 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.
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BASIC DISPLAY
INITIAL DISPLAY
1. CHECK/REVIEW icon - Choose the picture of a
magnifying glass to check basal rates, previous bolus
doses, the last bolus, previous daily totals and prime
history.
2. BOLUS icon - Choose the icon of a syringe to
deliver meal bolus doses.
3. TEMPORARY BASAL icon - Choose the picture of a
person for temporary changes in basal rates for exercising
or other events.
4. SET/ PROGRAM icon - Choose the picture of a sliding
scale to set basal rates and preprogrammed 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. Displays remaining battery charge
as 100%, 75%, 50%, 25%, or 0%.
The remaining battery charge is updated
only after you deliver a bolus.
Explanation of the display screens
Push any of the control buttons while viewing the INITIAL DISPLAY
and the BASIC DISPLAY will appear.
➀
②
②
➂
➀
➂ ➃
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You cannot see the magnifying glass icon in
first box that says ‘from the INITIAL
DISPLAY screen press any of the control
buttons and the BASIC DISPLAY screen
will appear’.
1. In the BASIC DISPLAY screen press
to change the highlighted 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
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