Nimbus Water Systems EU User manual

Nimbus™ EU
Ambulatory Infusion Pump
Patient Manual
Read this entire manual prior to operating the Nimbus™ EU Ambulatory Infusion Pump.

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2 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Contents
Section 1: General Description......................................................4
Indications for use............................................................................. 4
Symbols............................................................................................ 4
Warnings........................................................................................... 7
Device Diagrams............................................................................. 10
Keypad Diagram ............................................................................. 11
LCD Screen Symbols...................................................................... 12
Section 2: Get familiar with your NimbusTM EU Ambulatory
Infusion Pump:............................................................................13
Infusion Mode.................................................................................. 13
Pause Mode.................................................................................... 13
Options:........................................................................................... 14
Pump Set Up and Programming...................................................... 14
Section 3: Operating your Pump .................................................15
Start or Resume the Infusion........................................................... 15
Demand Bolus –if enabled ............................................................. 15
Delay Start Infusion –if enabled...................................................... 15
Cancel a Delay Start ....................................................................... 15
Retrieving and selecting the Current Rx.......................................... 16
Resume Infusion / New Infusion Menu............................................ 16
Infusion Display screen ................................................................... 17
Acknowledge an Alert...................................................................... 17
Stop or Pause the Infusion.............................................................. 18
Infusion Complete ........................................................................... 18
Power off the Pump......................................................................... 18
Power the Pump back on and Resume the Infusion:....................... 19

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 3
Pack and Wear Pouch..................................................................... 20
Section 4: Battery Replacement..................................................21
Authorized Battery........................................................................... 21
Section 5: Troubleshooting..........................................................22

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4 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Section 1: General Description
Indications for use
The Nimbus™ EU Ambulatory Infusion Pump is intended to deliver medications
and/or fluids to a patient under the direction or supervision of a physician or
other certified healthcare professional in clinical or nonclinical environments,
such as homes. The device is intended for subcutaneous, percutaneous,
perineural, epidural and intravenous infusion, including but not limited to
patient-controlled analgesia (PCA) delivery.
Symbols
Symbol
Standard
Reference
number and
title of symbol
Description of
symbol
ISO 15223-1:2012
Medical devices -- Symbols to
be used with medical device
labels, labelling and information
to be supplied -- Part 1: General
requirements
5.4.3
Consult
instruction for
use
Indicates the
need for the user
to consult the
instructions for
use.
ISO 15223-1:2012
Medical devices -- Symbols to
be used with medical device
labels, labelling and information
to be supplied -- Part 1: General
requirements
5.4.4
Caution
Indicates the
need for the user
to consult the
instructions for
use for important
cautionary
information such
as warnings and
precautions that
cannot, for a
variety of
reasons, be
presented on the
medical device
itself.
IEC 60417:2002 DB
Graphical symbols for use on
equipment
5333
Type BF
applied part
To identify a type
BF applied part
complying with
IEC 60601-1.

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 5
Symbol
Standard
Reference
number and
title of symbol
Description of
symbol
ISO 15223-1:2012
Medical devices --
Symbols to be used
with medical device
labels, labelling and
information to be
supplied -- Part 1:
General requirements
5.3.4
Keep dry
Indicates a medical
device that needs
to be protected
from moisture.
ISO 15223-1:2012
Medical devices --
Symbols to be used
with medical device
labels, labelling and
information to be
supplied -- Part 1:
General requirements
5.3.2
Keep away
from sunlight
Indicates a medical
device that needs
protection from
light sources.
ISO 15223-1:2012
Medical devices --
Symbols to be used
with medical device
labels, labelling and
information to be
supplied -- Part 1:
General requirements
5.3.7
Temperature
limit
Indicates the
temperature limits
to which the
medical device can
be safely exposed.
ISO 15223-1:2012
Medical devices --
Symbols to be used
with medical device
labels, labelling and
information to be
supplied -- Part 1:
General requirements
5.1.7
Serial number
Indicates the
manufacturer's
serial number so
that a specific
medical device can
be identified
Rx Only
N/A
Prescription
only
Federal (U.S.A) law
restricts this device
to sale by or on the
order of a
physician.

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6 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
ISO 7010: 2011
Graphical Symbols –
Safety Colours and
Safety Signs –
Registered Safety Signs
–Part 5: Registered
Safety Signs
M002
Refer to
instruction
manual /
booklet
Indicates that
failure to follow
operating
instructions could
place the PATIENT
or OPERATOR at
risk.
MDD 93/42/EEC Annex
XII
CE Marking of
Conformity
Indicates the
device meets
essential
requirements of
MDD 93/42/EEC

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 7
Warnings
A Warning ( ) alerts you to a potentially hazardous condition, safety hazard or
equipment damage.
Read the entire Clinician Manual prior to operating the NimbusTM EU
Ambulatory Infusion Pump. InfuTronix assumes no responsibility for
incidents that may occur if its product is not used in accordance with its
product labeling.
This Manual and the Clinician Quick Reference Guide are not intended
for patient use. These documents contain information regarding
programming and locking functions not contained in the Patient’s
Manual or Patient Quick Reference Guides.
If a patient or caregiver is to operate the NimbusTM EU pump without
the direct supervision of a medical professional, the patient or caregiver
should be trained by a medical professional to operate the pump. This
training should include all necessary operations of the pump. The
patient or caregiver should have the means to contact the patient’s
health care provider at all times when not under direct supervision.
As applicable, provide the patient or caregiver with instructions for
proper handling and/or disposal of the pump, the
cassette/administration set, and the pouch.
If the NimbusTM EU pump is used to provide medication or fluid therapy
to any patient under the age of 18, that patient should, during therapy
and while having physical access to the pump and administration set,
be under the direct supervision of an adult caregiver trained to operate
the pump.
If the mental or physical condition of a patient or caregiver could
interfere with or preclude the proper operation or safe use of the
NimbusTM EU pump, an alternate means of therapy should be utilized.
The pump is not to be used for delivery of blood or cellular blood
products.
The pump is not intended for delivery of life-sustaining medication.
If the pump is used to deliver critical medication, a backup pump should
be available.
Do not use the pump or cassette/administration set to administer any
infusion to the epidural space unless the medication and/or fluid
infused is indicated for epidural administration.
Do not use the pump in or near a MRI (Magnetic Resonance Imaging)
device.

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8 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Warnings, continued
Do not expose the pump to X-Rays, Gamma Rays, or other Radiation.
Operating the pump near equipment that radiates high-energy radio
frequencies (electrosurgical/cauterizing equipment, etc.) may cause
false alarm conditions. If this happens, reposition the device away from
the source of interference or use an appropriate clinical alternative.
Do not operate this pump in the presence of flammable anesthetics
mixture with air, oxygen, or nitrous oxide.
Do not operate the pump at temperatures below 5°C or above 40°C.
Incorrect device handling may lead to allergen exposure and patient
allergic response.
Only use InfuTronix approved cassettes/administration sets with the
pump.
Do not use a cassette/administration set beyond its expiration date.
Each cassette/administration set is to be used with a single
medication/fluid container.
Always read and follow the instructions that accompany the fluid
container you are using.
Only use the pump and cassette/administration set with a non-vented
collapsible reservoir or syringe.
Attach the medication/fluid container to the cassette/administration set
before attaching the cassette to the pump.
Prime the cassette/administration set according to the instructions
provided in this manual prior to connecting the cassette/administration
set to the pump. Ensure that the entire fluid path is free of all air before
connecting to the patient.
Carefully follow the instructions in this document for loading and
removing the cassette/administration set. A detached or improperly
attached cassette could result in unregulated gravity infusion of
medication from the fluid container. Replace the administration set
according to the set label or by following the facility protocol.
When attaching the cassette to the pump, press and hold the cassette
latch lock button to properly make the attachment.
Attach the cassette/administration set to the pump before connecting
the administration set to a patient.
Prior to use, always verify the proper function of the display, audible,
and visual alerts during Power On Self-Test (POST).
Always verify the displayed infusion parameters (Rate, VTBI, Time)
with the prescription before starting infusion. A two-person verification
is recommended.
Do not over-program the VTBI. Program the actual amount of the fluid
in the medication/fluid container.

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 9
Warnings, continued
Always confirm that the established infusion route matches the
intended administration route prior to the start of the infusion.
Clearly differentiate established administration routes when using the
pump with a patient that has multiple administration routes established.
Do not operate the pump outside of the environmental limits detailed in
the pump specifications.
Upon starting an infusion, the slide clamp should be opened.
Before packaging the drug/fluid bag and pump into the pouch, check
the fluid path for kinks, closed clamp or other occlusions.
Do not put excessive pressure on the pump that may cause the device,
bag or tubing to compress (i.e. leaning against pouch, sleeping on
pouch, etc.).
Do not leave the pump or cassette/administration set unattended at
home or other places where children or pets may come in contact with
the device.
Disconnect the administration set from the patient before removing the
cassette from the pump.
Always close the slide clamp before removing the cassette from the
pump.
Do not store the pump with a cassette/administration set attached.
Do not place objects over the pump that may muffle the pump.
If the pump is not functioning as expected, the pump should not be
used, and should be returned for inspection or repair.
There are no user serviceable parts inside the pump. Refer all services,
repairs, and calibrations to qualified technical personnel. Do not make
unauthorized modifications to the infusion pump.
Avoid spills on the pump. Follow the instructions specified in Section 6
of this manual for cleaning and disinfection of the pump.
To avoid mechanical or electronic damage, do not steam, autoclave, or
immerse the pump in any fluids or cleaning solutions, and do not spray
such fluids directly on the pump.
Failure to properly follow the cleaning instructions may result in an
electrical hazard, damage to the pump, and voided warranty coverage.
Do not use this device for neonates.
If the pump is dropped or hit, inspect the pump for damage.
Immediately stop using the pump if it is physically damaged or not
functioning properly. Contact distributor to return the pump.
Avoid using and/or storing the pump where it may come in contact with
excessive lint, dust, direct sunlight, heat and moisture.

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10 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Device Diagrams
Front View
Rear View
Liquid Crystal Display (LCD)
Keypad
LED Indicator
Cassette
Cassette Latch
Cassette Latch Lock (Black)
Battery Compartment
Product Labels

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 11
Keypad Diagram
Key
Name
Description
ON/OFF
Hold for 3 seconds to power on or off the device.
RUN/STOP
Press to start or resume the infusion.
Hold for 3 seconds to pause the infusion.
BOLUS
Press and release the BOLUS key to request a
Demand Bolus delivery.
Hold the BOLUS key for 3 seconds to cancel a Delay
Start infusion.
Note: The pump has additional functions beyond those shown above. These
functions are intended to be used by medical professionals only. Do not attempt
to use these functions unless specifically instructed to do so and trained to do
so by a physician or other certified healthcare professional.

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12 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
LCD Screen Symbols
Item
Name
Symbol
Description
1
Therapy Mode
The fluid bag symbol displays when the
pump is infusing.
2
Configuration
Mode
Displays when the pump is in the
configuration mode.
3
Battery Level
Indicator
This symbol indicates a full battery
level.
This symbol indicates a medium battery
level.
This symbol indicates a low battery
level.
This symbol indicates an empty battery
level.
4
Alert
This symbol will display if an alert
condition is present.
5
Prescription
mode
The pump is in Prescription mode.
6
Pause
The infusion is paused.
Note: This table includes references to functions that are intended to be used
by medical professionals only. Do not attempt to use these functions unless
specifically instructed and trained to do so by a physician or other certified
healthcare professional.

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 13
Section 2: Get familiar with your NimbusTM EU Ambulatory
Infusion Pump:
Infusion Mode
When the pump is infusing medication, there will
always be information available on the screen to
assure you that the pump is functioning properly.
The LCD will display the infusion rate in
mL/Hr at the center of the screen.
The medication bag symbol will display while the pump is infusing
your medication.
A green LED light will show at the top right corner of your pump
indicating the infusion is running, then it will turn off after 10 minutes to
save battery power.
After any button press, the green LED will turn on again for 10 more
minutes to inform you the infusion is delivering before the LED powers
off again. This is normal.
Along the bottom of the screen, additional information is displayed about your
infusion:
The letters “VTBI” followed by a number will tell you the remaining
Volume To Be Infused (VTBI) before the therapy ends.
The letters “VINF” followed by a number will tell you how much
medication has been infused so far during your infusion.
“Next AB” followed by a time will indicate when the next Auto-Bolus
dose is scheduled to be infused.
“Next DB” followed by a time will indicate the lockout time remaining
before the next Demand Bolus will be allowed.
From time to time, you may hear a sound as the motor turns to infuse
the numbing medication.
Pause Mode
If the fluid bag icon is missing from the display and a yellow LED light is
showing, these signals indicate that the pump is in pause mode and is not
infusing medication. If after 10 minutes the infusion is not resumed, the pump
will sound an audible alert and the screen will display a “Pump Unattended”
message to tell you it is in standby mode waiting to be told what to do next.

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14 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Options:
Press the RUN/STOP key to silence the
alert and return to the main programming screen.
To resume your infusion, press and release the
RUN/STOP key again to perform an
automatic review of the prescription.
Press OK key to confirm the prescription and begin the infusion.
Or, to turn the pump off, press and hold the ON/OFF key for 3
seconds.
Pump Set Up and Programming
The NimbusTM EU Ambulatory Infusion Pump should be set up and
programmed by a member of your clinical care team. Do not attempt to perform
any of these functions unless specifically instructed and trained to do so by a
member of your clinical care team.
Your pump can be programmed to infuse medication using any combination of
the following methods:
Basal Rate- A continuous, low-volume infusion of medication.
Bolus- A bolus dose of medicine that is delivered quickly. A bolus can
be programmed to function 2 different ways:
Demand Bolus- When enabled, a patient can press the BOLUS key to
request an extra “bonus” dose of medication.
Auto Bolus- A bolus that is scheduled to infuse repeatedly over a
preset period of time.
Delayed Infusion Start- A delay start can be programmed to extend
the duration of your therapy up to 24hrs longer without adding extra
medicine to the IV bag.
If delay start is activated, the pump will automatically begin infusing the
medicine when the timer counts down to zero. Additionally, you will be
instructed on how to cancel the timer and start your infusion immediately if
needed.

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 15
Section 3: Operating your Pump
Note: Any values in the screenshots provided are for general guidance only
and may not match specific configurations.
Start or Resume the Infusion
To start the infusion, press the RUN/ STOP
key. A fluid bag icon will be displayed on the
screen to indicate the infusion is running; The LED
will show a green light and will be on for 10 minutes,
then the LED will turn off until the next key press.
Demand Bolus –if enabled
Press the blue Bolus key to request an extra (bolus) dose of medication. If
allowed in your prescription, a bar displays on the screen to countdown the
Bolus volume indicating the medicine is being delivered.
Delay Start Infusion –if enabled
A delay start feature can be activated to extend the duration of therapy up to 24
hours longer without adding extra medicine to the IV bag. The delay start
function places the pump on hold to run in standby mode. When the timer
counts down to zero, the infusion will automatically run without requiring any
user intervention.
Note: While a Delay Start is active, the LCD screen
will display a timer counting down the hours and
minutes that remain before the programmed infusion
is scheduled to begin.
Cancel a Delay Start
To override the Delay Start, as instructed by your support team, press and hold
the BOLUS key for 3 seconds to cancel the delay timer. The delay
countdown will be cancelled. A bolus (if enabled) will be delivered immediately,
followed by the infusion therapy as prescribed by your clinical care team.

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16 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Retrieving and selecting the Current Rx
The saved prescription can be retrieved at any time in the future to program
and deliver a Current Rx.
To proceed with a therapy using the current prescription:
1. Access the main menu by either powering on
the pump to start fresh or pressing the INFO
key to scroll backward through one or
more screens if necessary.
2. Press the ENTER key
The user will be redirected to the main screen.
Resume Infusion / New Infusion Menu
The user can be prompted start an infusion in two different manners:
1. Resume Infusion: Can be selected if a therapy
was interrupted and the choice is to continue.
The pump picks up where it left off and continues
the therapy.
2. New Infusion: Can be selected to infuse a new
Rx. All the therapy parameters are set to infuse
from the beginning of the therapy.
Note: The pump will detect from the infusion history whether or not a previous
infusion was interrupted and left incomplete. If completed or never run, New
Infusion will be the sole option displayed on the menu. Alternatively when an
infusion has previously been interrupted and left incomplete the pump will
display a second option for the user to resume from the point it was stopped.
Highlight Resume Infusion and press the ENTER key to continue
an unfinished therapy from the point it was last stopped.
Or, highlight New Infusion and press the ENTER key to set the
pump to run a new prescription from the beginning of the therapy.

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 17
Infusion Display screen
While the infusion is running and medication is delivered, the screen will never
go blank. The protocol name will show at the top left corner of the screen and
the Basal Rate will display in the center. Additional therapy specific information
such as VTBI, VINF, Next Intermittent Bolus (PCA), PCA Bolus Lockout (PCA),
and Dose Infused will alternate along the bottom of the LCD screen during the
infusion.
The drug/fluid bag icon will display at the top right corner of the screen. A
green LED light will display for 10 minutes indicating the infusion is actively
running.
Note: The LED will turn off after 10 minutes of operation and will remain off
until any new key is pressed or an alert condition is detected. This is normal.
Acknowledge an Alert
In the event a condition that could interrupt an
infusion is detected, the screen will change to
display an alert message. The LED will flash a red
light. An audible signal may also sound. Please
refer to Section 5: Trouble Shooting for detailed
explanations of the error message and
corresponding user response.
Note: Press the RUN/STOP key to acknowledge the alert. The audible
alert, if present, will be silenced for 10 minutes.

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18 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Stop or Pause the Infusion
If the user chooses to pause the infusion, hold the RUN/STOP key for 3
seconds to stop the active infusion.
The drug/fluid bag icon will disappear from the display screen,
replaced by the pause icon indicating the infusion has stopped.
The LED will turn yellow and the infusion will be paused. The pump will
display the programming screen.
To resume the infusion, press the RUN/STOP key again to
perform a new automatic review
Press the ENTER key to confirm the Rx and begin the infusion.
Or, to turn the pump off, press and hold ON/OFF key for 3
seconds.
Infusion Complete
When the infusion is completed, the VTBI reaches 0
mL and the pump stops infusing. The LCD screen
displays the screen shown on the right, indicating that
the end-of-infusion state has been reached. Three
beeps of audio alert will sound and the LED flashes a
red light. The alert symbol will also display on the
screen.
Press the RUN/ STOP key to acknowledge the condition and silence the
audio alert. At this time, the user is returned to the main menu that displays
therapy options.
Power off the Pump
If no further infusion is needed, the pump may be powered off. Hold the
ON/OFF key for 3 seconds to power off the pump.

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NimbusTM EU Patient Manual --560-IFU-IT1098, Rev. A 19
Power the Pump back on and Resume the Infusion:
Hold ON/OFF key for 3 seconds to power on the pump.
Highlight Current Rx, then press OK key to adance.
Press OK key to select Resume Infusion.
Press RUN/STOP key initiating a review of the prescription, and
then press OK key to confirm and resume the infusion.

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20 NimbusTM EU Patient Manual –560-IFU-IT1098, Rev. A
Pack and Wear Pouch
Warning: Before packaging the drug/fluid bag and pump into the pouch,
check the fluid path for kinks, closed clamp or other occlusions. An undetected
occlusion may result in under-infusion or non-delivery of medication and cause
an undesirable outcome.
Open the pump pouch and place it flat on a table.
Open the Velcro strap, position the pump against the clear window with the
display screen facing out, and then close the Velcro straps tightly to hold the
pump securely in the window.
Place the drug/fluid bag in the bag chamber with the bag spike pointing left.
Fold the bag spike over the top of the medicine bag and route the upstream
end of the tubing between drug/fluid bag and pump carefully so that the tubing
does not have kinks or occlusions.
Route the downstream end of the tubing carrying fluid to the patient through the
tubing outlet. Close the pouch cover and zip closed.
Secure the pouch around the patient’s waist or over the patient’s shoulder. The
carry strap may be adjusted for size.
Caution: Leave the pump inside the carry pouch at all times except for
programming, loading and unloading the cassette/administration set, or
troubleshooting.