InfuTronix Nimbus II PainPRO User manual

Nimbus™ II PainPRO
Ambulatory Infusion Pump
Patient Manual
PCA Mode Infusions
Read this entire manual prior to operating the Nimbus™II PainPRO Ambulatory Infusion

_______________________________________________________________
2 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
Table of Contents
Section 1: General Description............................................................................3
Indications for use...........................................................................................3
Warnings.........................................................................................................5
Device Diagrams.............................................................................................7
Keypad Diagram .............................................................................................8
LCD Screen Symbols......................................................................................9
Section 2: Your Nimbus™ II PainPRO Ambulatory Infusion Pump ..................10
Upper Extremity Blocks:................................................................................10
Lower Extremity Blocks:................................................................................10
Get familiar with your Nimbus™ II PainPRO Ambulatory Infusion Pump: ....11
Infusion Mode................................................................................................11
Pause Mode..................................................................................................11
Options:.........................................................................................................12
Pump Set Up and Programming...................................................................12
Section 3: Operating your Pump.......................................................................13
Start or Resume the Infusion ........................................................................13
Cancel a Delay Start.....................................................................................13
Demand Bolus –(if enabled) ........................................................................14
Stop or Pause the Infusion............................................................................14
Acknowledge an Alert ...................................................................................14
Infusion Complete.........................................................................................15
Power off the Pump.......................................................................................15
Power the Pump back on and Resume the Infusion....................................15
Pack and Wear Pouch ..................................................................................16
Section 4: Troubleshooting................................................................................17
Section 5: Battery Replacement.......................................................................19
Authorized Battery.........................................................................................19

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 3
Section 1: General Description
Indications for use
The NimbusTM II PainPRO 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.

_______________________________________________________________
4 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
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.
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.

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 5
Note: A Note highlights information that helps explain a concept or procedure.
Caution: Indicates a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury or product damage.
Warnings
A warning ( ) alerts you to a condition that could potentially interrupt
the medication delivery.
Read the entire Patient’s Manual prior to operating the Nimbus™ II
PainPRO Ambulatory Infusion Pump. InfuTronix assumes no
responsibility for incidents that may occur if its product is not used in
accordance with its product labeling.
Only use the pump as directed by a physician or other certified health
care professional.
If you have any questions regarding the use of the pump or experience
any problems using the pump, contact your anesthesia care team for
further instructions.
Do not use the pump in or near a MRI (Magnetic Resonance Imaging)
device.
If the pump is dropped, inspect it for damage before continuing the
infusion. Stop using the pump and call your anesthesia care team if it is
damaged or is not functioning properly.
There are no user serviceable parts inside. Refer all service, repair,
and calibration to qualified technical personnel. Do not make
unauthorized modifications.
The Nimbus™ II PainPRO Ambulatory Pump and
cassette/administration set should only be manipulated and/or operated
by a patient or caregiver under the direction or supervision of a
physician or other certified health care professional
If a patient or caregiver is to operate the Nimbus II Ambulatory Infusion
pump without the direct supervision of a medical professional, the
patient or caregiver should have the means to contact the patient’s
health care provider at all times.
If the Nimbus™ II PainPRO Ambulatory Infusion 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 a

_______________________________________________________________
6 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
physician or other certified health care professional or an adult
caregiver trained by a medical professional to operate the pump.
Only use InfuTronix approved cassettes/administration sets with the
pump.
Before packaging the drug/fluid bag and pump into the pouch, check
the fluid path for kinks, closed clamp or other occlusions.
Clamp the administration set before removing the cassette from the
pump.
The pump is not to be used for delivery of blood or cellular blood
products.
Warnings, continued
Avoid spills on the Nimbus II ambulatory pump; consult your health
care provider should this occur.
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.
Small objects may cause choking if swallowed. Keep all small parts
and objects away from children.

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 7
Device Diagrams
Front View
Rear View
Liquid Crystal Display (LCD)
Keypad
LED Indicator
Cassette
Cassette Latch
Cassette Latch Lock (Black)
Battery Compartment
Product Labels

_______________________________________________________________
8 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
Keypad Diagram
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.
Key
Name
Description
RUN/STOP
Press to start or resume the infusion.
Press and hold for 3 seconds to pause the infusion.
ON/OFF
Press and hold the ON/OFF key for 3 seconds to
power on or off the device.
BOLUS
Press to request a patient demand bolus or hold for
3 seconds to cancel a delayed infusion start

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 9
LCD Screen Symbols
Item
Name
Symbol
Description
1
Therapy Mode
The symbol displays when the pump is
infusing.
2
Configuration
Mode
The pump is in configuration mode.
3
Programming
Lockout
Clinician code is required to change
parameter values.
No clinician code needed to change
parameter values.
4
Battery Level
Indicator
The symbol indicates a full battery
level.
The symbol indicates a medium battery
level.
The symbol indicates a low battery
level.
The symbol indicates an empty battery
level.
5
Alert
The symbol will display if an alert
condition is present.
6
Setting
The pump is in the setting mode.
7
Pause
The pump is in Pause mode.
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.

_______________________________________________________________
10 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
Section 2: Your Nimbus™ II PainPRO Ambulatory Infusion
Pump
Your surgeon has prescribed a NimbusTM II PainPRO Ambulatory Infusion
Pump to assist you with your pain management needs after surgery. The
PainPRO is an electronic pump that delivers a numbing medication, not a
narcotic, to the nerves that control the feeling and movement to the area
where you had surgery. The medicine delivered by the Pump will not make
you feel drowsy, nauseated, or dizzy, allowing you to feel better faster, resume
normal activities sooner, and have the potential for a quicker recovery.
Since the surgical extremity will be numb (decreased sensation), it is at
greater risk of injury. The following safety precautions are recommended to
reduce the risk of injury and provide a more pleasant surgical experience.
Upper Extremity Blocks:
• Support your arm by wearing a sling properly; ensuring your wrist is fully
supported.
• Use a pillow to pad and support your numb extremity.
• Avoid placing hot or cold packs directly on your numb extremity.
• If a dressing, cast, or brace is provided, check your fingernails
frequently and alert your surgeon of any change in color.
Lower Extremity Blocks:
• Use crutches or a walker since you will not be able to bear weight on the
numb extremity. After full sensation returns, follow your surgeons’ weight
bearing instructions.
• If a knee brace is provided, do not attempt to walk without it.
• Check your toenails frequently and alert your surgeon of any
change in color.
• The numb extremity should be carefully padded and routinely
repositioned. This practice will promote good circulation.
If shortness of breath, ringing in the ears, or a metallic taste in your mouth
occurs, turn the pump off immediately and contact your anesthesiologist

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 11
Get familiar with your Nimbus™II PainPRO 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 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 and then power off. 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 dose 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.

_______________________________________________________________
12 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
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 the 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 II PainPRO Ambulatory Infusion Pump should be set up and
programmed by a member of your anesthesia care team. Do not attempt to
perform any of these functions unless specifically instructed and trained to do
so by a member of your anesthesia care team.
Your pump can be programmed to infuse the local anesthetic using any
combination of the following methods:
Basal Rate –A continuous, low-volume infusion of medication.
Bolus –A bolus is a dose of medicine that is delivered quickly to help
relieve your pain. 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 numbing medicine for rapid pain
relief.
Auto Bolus –is a bolus that is scheduled to infuse repeatedly over a
preset period of time.
Delayed Infusion Start –If the pain after your surgery is expected to
last several days, a delay start can be programmed to extend the
duration of your therapy up to 24 hours longer without adding extra
medicine to the IV bag.
If a 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 you
begin to feel the post-surgical pain.

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 13
Section 3: Operating your Pump
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.
Cancel a Delay Start
If a delay start is set to run at the beginning of your
therapy, a countdown timer will be displayed on the
screen to show the time that remains before the
pump automatically starts the infusion. If your pain
is at a tolerable level after the surgery, the pump will
count down to zero and start the infusion without
any action from you. However, if during the delay period you start to feel
uncomfortable due to the pain, you can choose to override the Delay Start
feature to begin the infusion immediately.
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.
• The pump immediately starts the infusion as set by your anesthesia care team.

_______________________________________________________________
14 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
Demand Bolus –(if enabled)
If you experience pain during the infusion, you can press the blue Bolus
key to request an extra (bolus) dose of numbing medication. If allowed in your
prescription, a bar displays on the screen to countdown the Bolus volume
indicating the medicine is being delivered.
Stop or Pause the Infusion
If at any time you want to stop the infusion, hold the RUN/STOP key for 3
seconds and the infusion will be paused until further action is taken.
• The LED light will turn amber.
• The therapy mode sign will disappear from the display screen to be
replaced by a pause icon, indicating that the infusion has been stopped.
If no action is taken to resume the infusion or power off the pump, after 10
minutes an alert will sound to indicate the pump is on but not infusing medicine.
• 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
beginning an automatic review of the prescription.
• Press the OK key to confirm and begin the infusion.
• Or, to turn the pump off press and hold the ON/OFF key for 3 seconds
Acknowledge an Alert
If at any time during an infusion the pump senses a
condition that could interrupt the medication delivery,
an alert message will be displayed on the LCD screen
along with a red flashing LED light. An audible alert
may also sound.
Press the RUN/STOP key to acknowledge the condition and silence the
audible alert. Contact your healthcare provider for further instructions.

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 15
Infusion Complete
Your infusion will be complete on the day indicated by
your anesthesiologist or when the pump is empty,
whichever happens first. If the bag runs until empty,
the LCD screen displays the message shown on the
right, indicating that the end-of-infusion has been
reached. The audio alert will sound three beeps 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. Follow the instructions given to you by your anesthesia care team
regarding the steps to follow at the end of your therapy.
Power off the Pump
Press and hold the ON/OFF key for 3 seconds to power off the pump.
Power the Pump back on and Resume the Infusion:
Hold for 3 seconds to power on the pump.
Highlight Current Rx then press to advance.
Press to select Resume Infusion.
Press initiating a review of the prescription, and then press to
confirm and resume the infusion.

_______________________________________________________________
16 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
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 pain relief 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.
Fluid bag
Clear Viewing
Window
Pump Holder
Carrying
Strap
Carrying
Pouch Cover
Patient Luer
Lock

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 17
Section 4: Troubleshooting
When a condition is detected by the pump that could interrupt the infusion, the
pump will alert with an audio and visual signal to indicate the presence of the
condition. If this occurs, contact your anesthesia care team for support.
Note: The following table is included for reference only. You can press the
RUN/STOP key to acknowledge the condition and silence the audible tone. Do
not attempt to perform other functions unless specifically instructed to do so by
a member of your support team.
Alert
Message
Indication
Signal
Cassette
Loading Error
The cassette may not be
attached properly or has
become dislodged.
Note: The infusion will be
stopped.
The screen displays “Cassette
Loading Error”; the LED flashes a
red light; the audio alarm sounds.
Upstream
Occlusion
A decrease in pressure is
sensed in the supply line
between the pump and
medication bag.
Note: The infusion will be
stopped.
The screen displays “Upstream
Occlusion”; the LED flashes a red
light; the audio alert will sound after
3 minutes if the upstream occlusion
is not resolved.
Note: When resolved, the infusion
will resume automatically.
Downstream
Occlusion
An increase in pressure is
detected in the line between the
pump and the patient’s catheter.
Note: The infusion will be
stopped.
The screen displays “Downstream
Occlusion”; the LED flashes a red
light; the audio alert will sound after
15 minutes, if the downstream
occlusion is not resolved.
Note: When resolved, the infusion
will resume automatically.
Pump
Unattended
The pump is standing by and
not infusing for more than 10
minutes.
The screen displays “Pump
Unattended”; the LED shows a solid
yellow light; the audio alert sounds.
Follow instructions on pg. 13 to
acknowledge an alert.
Note: The audible alarm will return
after 10 minutes if no further action
is taken after acknowledging the
condition.

_______________________________________________________________
18 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
Infusion
Complete
The infusion is completed.
The screen displays “Infusion
Complete”; the LED flashes a red
light; the audio alert sounds.
Follow the instructions on pg. 14 to
silence the alert and power off the
pump.
Battery
Depleted
The infusion will continue for 30
minutes prior to shutting down.
The screen displays “Battery
Depleted” for 5 seconds and
repeats displaying every 20
seconds; the empty battery level
indicator symbol flashes; the LED
shows a solid yellow light; the audio
alert sounds.
Follow the instructions on pg. 18 to
replace the battery and resume the
infusion.
Power Off and
Replace
Battery
This battery has been used for
over 240 hours /infusion volume
has reached 1500 mL. The
pump has reached the end of its
performance life.
The screen displays “Power Off and
Replace Battery”, the LED flashes a
red light; the audio alert sounds.
Follow the instructions on pg. 14 to
silence the alert and power off the
pump. Contact your anesthesia care
team for further instructions.
Invalid
Infusion
Parameter
An infusion parameter has been
entered that exceeds the
remaining pump life.
The screen displays “Invalid
Infusion Parameter”;
the LED flashes a red light;
the audio alert sounds.
System Error
The pumping mechanism may
not work properly.
Note: The infusion will be
stopped.
The screen displays “System Error”;
the LED flashes a red light; the
audio alarm sounds.
Firmware
Error
The system fails to operate in a
controlled fashion.
Note: The infusion will be
stopped.
The screen displays “Firmware
Error”; the LED flashes a red light;
the audio alarm sounds.

______________________________________________________________
NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E 19
Max Vol
Reached,
Pump
Standby
The pump has reached a
maximum volume per hour or
interval limit.
The screen displays “Max Vol
Reached, Pump Standby” until the
new hour or interval is reached
when the infusion can begin again;
the LED shows a solid yellow light.
Note: The infusion will be stopped
automatically.
Section 5: Battery Replacement
The battery should be replaced if the pump alerts the user and displays the
message “Battery Depleted”.
Authorized Battery
Only use batteries authorized by the manufacturer.
The quality of the battery is a significant factor in determining battery life
and runtime. Use of batteries from any other brands may yield unexpected
performance and will invalidate the warranty.
To replace the battery:
Please contact your anesthesia care team for battery replacement.
European Authorized Representative
For Nimbus II PainPRO Ambulatory Infusion Pumps in operation within the
European Union, InfuTronix LLC’s European Authorized Representative is
Emergo Europe B.V. with place of business located at Prinsessegracht 20,
2514 AP The Hague, The Netherlands.

_______________________________________________________________
20 NimbusTM II PainPRO Patient IFU –520-IFU-IT1050, Rev. E
How to Load the Cassette
1. Engage the cassette “fingers” with the pump hinge.
2. Press the cassette latch lock down and firmly push the cassette towards the
pump.
3. Release the cassette latch lock.
4. Confirm that the 3 hooks on the cassette latch are fully engaged with the
cassette.