Nutricia Flocare Infinity III User manual

INSTRUCTIONS FOR USE
Manufacturer:
Nutricia Medical Devices BV,
Taurusavenue 167, 2132 LS Hoofddorp,
The Netherlands,
www.nutriciaflocare.com
EN
400014_A
Date of issue April 2023
ZMNL900895 • Flocare Infinity III Pump digital • 400014_A • 110 x 155 mm• 25/04/2023 • Black
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1. INTRODUCTION .................................................................................................................................. 5
2. INTENDED USE .................................................................................................................................... 5
3. SAFETY INFORMATION.................................................................................................................... 5
3.1. GENERAL SAFETY .................................................................................................................. 5
3.2. WARNINGS AND PRECAUTIONS......................................................................................... 6
4. QUICK REFERENCE OVERVIEW .................................................................................................10
5. USER INTERFACE .............................................................................................................................11
5.1. BUTTONS.................................................................................................................................11
5.1.1. Home button ....................................................................................................11
5.1.2. Snooze button ..................................................................................................11
5.1.3. Information button ...........................................................................................12
5.1.4. Start/pause button ..........................................................................................12
5.1.5. Fill set button ......................................................................................................12
5.1.6. Settings button .................................................................................................12
5.1.7. Therapy button .................................................................................................12
5.1.8. On/Off button.....................................................................................................12
5.1.9. Soft buttons...............................................................................................................12
5.2. PUMP STATUS INDICATOR.................................................................................................13
5.3. DISPLAY ...................................................................................................................................13
5.4. HOME SCREEN.......................................................................................................................13
5.4.1. Status bar ..................................................................................................................14
5.4.2. Icons ...........................................................................................................................14
5.4.3. Progress bar ............................................................................................................14
5.4.4. Running indicator ....................................................................................................14
6. PUMP SETUP ......................................................................................................................................15
6.1. ATTACHING TO THE POLE CLAMP (OPTIONAL)...........................................................15
6.2. CONNECT TO THE AC POWER PLUG ...............................................................................15
6.3. SWITCH THE PUMP ON........................................................................................................15
6.4. SET THE LANGUAGE ............................................................................................................15
6.5. SET THE TIME AND DATE ...................................................................................................15
6.6. SWITCH THE PUMP OFF......................................................................................................16
7. OPERATING INSTRUCTIONS ........................................................................................................16
7.1. LOAD THE FLOCARE INFINITY GIVING SET....................................................................16
8. ADVANCED SETTINGS
9. ALARMS, WARNING MESSAGES AND TROUBLE SHOOTING
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7.2. PAUSE / RUNNING MODE ...................................................................................................16
7.3. FILL THE FLOCARE INFINITY GIVING SET.......................................................................16
7.4. SETTINGS MENU ...................................................................................................................16
7.4.1. Define therapy list....................................................................................................16
7.4.2. Personalise therapies.............................................................................................17
7.4.3. Therapy lock.............................................................................................................17
7.4.4. Reset patient data ...................................................................................................17
7.4.5. Sound .........................................................................................................................17
7.4.6. Therapy completed.................................................................................................18
7.4.7. Display........................................................................................................................18
7.4.8. Time and date...........................................................................................................18
7.4.9. Language...................................................................................................................18
7.4.10. About this pump....................................................................................................19
7.5. PROGRAMMING THE PUMP................................................................................................19
7.5.1. Program a VOLUME - RATE therapy...................................................................19
7.5.2. Program a RATE therapy (not recommended for volume
sensitive patients)................................................................................................................20
7.5.3. Program an INTERMITTENT therapy..................................................................20
7.5.4. Change the parameters of an active therapy....................................................21
7.5.5. Program a PERSONALISE THERAPY .................................................................21
7.5.6. Editing of a PERSONALISE THERAPY................................................................21
7.6. LAST FEEDING INCOMPLETE.............................................................................................21
7.7. INFORMATION & MEMORY FUNCTIONS.........................................................................22
7.7.1. Therapy information ...............................................................................................22
7.7.2. Portions information ...............................................................................................22
7.7.3. 30-day history graph...............................................................................................22
7.7.4. Reset progress bar..................................................................................................22
7.8. KEYPAD LOCK ........................................................................................................................22
7.9. CONNECT TO A NURSE CALL OR PDMS SYSTEM........................................................23
7.10. BATTERY ..............................................................................................................................23
8. ADVANCED SETTINGS....................................................................................................................23
8.1. COMMUNICATIONS MODE..................................................................................................24
8.2. CHANGE PIN CODE ...............................................................................................................24
8.3. FACTORY RESET....................................................................................................................24
8.4. LIVE SENSOR VALUES.........................................................................................................24
9. ALARMS, WARNING MESSAGES AND TROUBLE SHOOTING ......................................24
9.1. PROBLEM SOLVER CHART.................................................................................................25
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10. CLEANING, INSPECTION & SERVICING GUIDELINES ....................................................28
10.1. SWITCHING BETWEEN PATIENTS .................................................................................28
10.2. CLEANING & DISINFECTION............................................................................................28
10.3. INSPECTION .........................................................................................................................29
10.3.1. Housing ...................................................................................................................29
10.3.2. Keypad.....................................................................................................................29
10.3.3. Rotor ........................................................................................................................29
10.3.4. AC power plug.......................................................................................................30
10.3.5. Electrical .................................................................................................................30
10.4. SERVICING............................................................................................................................30
10.5. ACCESSORIES .....................................................................................................................30
10.6. RECYCLING & DISPOSAL..................................................................................................31
11. SPECIFICATIONS ...........................................................................................................................31
11.1. PERFORMANCE...................................................................................................................31
11.2. ELECTRICAL / MECHANICAL .........................................................................................32
11.3. OPERATING .........................................................................................................................32
11.4. TRANSPORT & STORAGE.................................................................................................32
11.5. EMC.........................................................................................................................................33
11.6. VOLUMETRIC ACCURACY.................................................................................................33
11.7. ALARM RESPONSE TIMES...............................................................................................34
12. GLOSSARY OF TERMS .................................................................................................................35
13. SYMBOLS ...........................................................................................................................................36
14. WARRANTY........................................................................................................................................37
1.
The Flocare® Infinity™ III pump is a rotary peristaltic enteral feeding pump. The pump provides
a variety of options that allow for customisation for each patient and a flexible approach to
enteral feeding therapy.
2.
The Flocare Infinity III is intended to be used to administer enteral nutrition or hydration fluids
in a safe, controlled and intuitive manner into the gastrointestinal tract of a patient who is
unable to eat or drink normally. The pump will operate in a clinical environment or home care
setting and can be used by trained care givers and patients for bedside as well as for mobile
use.
MEDICAL INDICATION
Enteral feeding through enteral pump assisted feeding is indicated to patients at nutritional
risk or malnourished who:
INTENDED TARGET GROUPS
The Flocare Infinity III pump system is intended for adult and/or paediatric patients.
CONTRA-INDICATIONS
Do not use:
Enteral feeding may not be appropriate for some patients depending on the Individual’s
diagnosis (e.g., intestinal obstruction).
3.
3.1. GENERAL SAFETY
•
•
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1. INTRODUCTION
The Flocare® Infinity™ III pump is a rotary peristaltic enteral feeding pump. The pump provides
a variety of options that allow for customisation for each patient and a flexible approach to
enteral feeding therapy.
2. INTENDED USE
The Flocare Infinity III is intended to be used to administer enteral nutrition or hydration fluids
in a safe, controlled and intuitive manner into the gastrointestinal tract of a patient who is
unable to eat or drink normally. The pump will operate in a clinical environment or home care
setting and can be used by trained care givers and patients for bedside as well as for mobile
use.
MEDICAL INDICATION
Enteral feeding through enteral pump assisted feeding is indicated to patients at nutritional
risk or malnourished who:
- cannot meet their nutrients requirements by normal dietary intake
- have a functioning gastrointestinal tract.
INTENDED TARGET GROUPS
The Flocare Infinity III pump system is intended for adult and/or paediatric patients.
CONTRA-INDICATIONS
Do not use:
- if enteral feeding is contraindicated
- for Intravenous administration (Parenteral Nutrition)
Enteral feeding may not be appropriate for some patients depending on the Individual’s
diagnosis (e.g., intestinal obstruction).
3. SAFETY INFORMATION
3.1. GENERAL SAFETY
• Read the entire instructions for use before using the Flocare Infinity III enteral feeding
pump.
• The user should be trained in the operation of the Flocare Infinity III and its accessories.
• The Flocare Infinity III enteral feeding pump shall only be used in combination with
Flocare® Infinity™ giving sets. The use of non-Flocare Infinity giving sets will generate
unforeseen hazards and will not provide the required functionality and safety. Consult
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your local Nutricia sales representative for information on available Flocare Infinity giving
sets.
• Replace the Flocare Infinity giving set every 24 hours to maintain delivery accuracy,
functionality, allow proper system performance and prevent potential retrograde growth
of bacteria. Do not program volume and rate combinations which exceed a 24-hour feed
regimen.
• Enteral pump fed patients should be regularly monitored and supervised. Specific patient
groups require consistent and controlled administration of enteral nutrition as well as
simultaneous application of medication (e.g. insulin administration). In these cases,
regular and frequent checks, as determined by the attending healthcare professional,
should be carried out to ensure correct administration of nutrition throughout the therapy
period.
• Strangulation hazard: avoid leaving AC power plug cord and Flocare Infinity giving set
tubing where infants or young children can become caught around the neck.
• Choking hazard: caution should be taken as the Flocare Infinity giving sets contains loose
parts which may be dangerous for young children.
• Using the Flocare Infinity III pump’s VOLUME function is recommended to program as
good practice.
• The healthcare giver should verify that the patient can tolerate the programmed volume
and flow rate.
• Do not use the pump in strong magnetic fields. e.g. MRI (Magnetic Resonance Imaging)
environments.
• Notice: any serious incident that has occurred in relation to the device should be reported
to Nutricia and the local competent authority.
3.2. WARNINGS AND PRECAUTIONS
General warnings
• Warning: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper operation.
• Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in the
accompanying documents.
• Warning: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the Flocare Infinity III, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
• Warning: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
•
•
•
•
•
•
•
Precautions
Before using or setting a feeding regimen, check the integrity of the pump for the items below:
•
•
•
•
•
•
Caution: Do not use the pump if it is damaged.
•
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your local Nutricia sales representative for information on available Flocare Infinity giving
Replace the Flocare Infinity giving set every 24 hours to maintain delivery accuracy,
functionality, allow proper system performance and prevent potential retrograde growth
of bacteria. Do not program volume and rate combinations which exceed a 24-hour feed
Enteral pump fed patients should be regularly monitored and supervised. Specific patient
groups require consistent and controlled administration of enteral nutrition as well as
simultaneous application of medication (e.g. insulin administration). In these cases,
regular and frequent checks, as determined by the attending healthcare professional,
should be carried out to ensure correct administration of nutrition throughout the therapy
Strangulation hazard: avoid leaving AC power plug cord and Flocare Infinity giving set
Choking hazard: caution should be taken as the Flocare Infinity giving sets contains loose
Using the Flocare Infinity III pump’s VOLUME function is recommended to program as
The healthcare giver should verify that the patient can tolerate the programmed volume
Do not use the pump in strong magnetic fields. e.g. MRI (Magnetic Resonance Imaging)
Notice: any serious incident that has occurred in relation to the device should be reported
Warning: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper operation.
Medical electrical equipment needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in the
Warning: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the Flocare Infinity III, including cables specified by the manufacturer. Otherwise,
Warning: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
• A leaking enteral feeding system might compromise the pump's ability to detect an
occlusion. Ensure the enteral feeding system is installed and connected properly. During
a feeding therapy, ensure there is no leakage observed within the system. In case of any
leakage, tighten the connectors and closure caps and verify whether leakage stopped. In
case the leakage still occurs, replace the Flocare Infinity giving set.
• In the event of malfunction of the pump or changes in its performance, please consult your
local Sales Representative or care giver for a pump service inspection or replacement as
required.
• Plug the pump charger into the mains to charge the battery before commencing enteral
feeding.
• Use only approved cleaning agents, using non-approved cleaning agents might harm the
pump.
• To avoid electrical shock, switch the pump off and remove the plug from the mains before
cleaning the pump.
• Make sure the Infinity AC power adapter is completely dry before plugging into the mains.
• Do not cover the speaker at the back of the pump as to ensure any alarm is readily
noticed.
Precautions
Before using or setting a feeding regimen, check the integrity of the pump for the items below:
• No cracks on the pump housing.
• The power pins of the AC adaptor socket of the pump are of equal length, not bent and not
corroded.
• The keypad is not cut or damaged and the text is legible.
• Scratches on the display that affects display legibility.
• Inspect the rotor; verify that the rollers are not damaged, perpendicularly in relation to the
rotor and turn freely by hand.
• Verify that the AC power adapter including housing and cord is clean and not damaged.
Caution: Do not use the pump if it is damaged.
• The health care professional is responsible to determine the therapy setting and clinical
needs, as well as the appropriate surveillance scheme and its frequency. If the required
surveillance scheme cannot be guaranteed by the care giver, then it is to be discussed
with the healthcare professional, who can advise the patient an alternative therapy
solution.
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• For volume and nutrients sensitive patients (e.g. children with metabolic conditions using
overnight and/or unmonitored therapy) where a constant nutrition delivery is vital and/
or connected with consequential therapies (e.g. an insulin delivery pump):, additional
surveillance is recommended to be put in place to verify good functioning of the enteral
feeding system and programmed therapy.
• The sound level of the Infinity pumps audible alarm is to be set in ‘HIGH’ if the pump is
operated in a noisy environment or the health carer is not nearby the pump, such as at
night, to ensure the alarm is readily noticed when an alarm is activated. The intended
operator position is in front of the pump.
• Nutricia recommends using ready to feed tube nutrition as this is developed for the
intended delivery specifications of the pump.
• Any nutrition added into the enteral feeding line must be of a homogeneous nature and
should remain homogeneous during the feeding regimen.
• Use only feeding solutions prescribed by the responsible clinician, registered dietician,
registered nurse or other licensed practitioner.
• Before commencing any enteral feeding therapy, proper consideration is given to the
feed appropriateness for tube feeding (thickness, homogeneity, selection of nasogastric
tube Ch size, etc.), as to avoid occlusion or any other unexpected pump system behavior.
The condition and appropriateness of the nutrition can be addressed with the healthcare
professional, who knows the clinical situation and needs of the patient and can best guide
the patient in the selection of appropriate feed.
• Non-liquid food ingredients and mixed or reconstituted foods may tend to occlude the
flow within the feeding tube and Flocare Infinity giving set. Clinicians and caregivers
should carefully monitor the pump during use with these types of feeds.
• Users must ensure that any substrate used for any mixed or reconstituted powdered
nutrition is indicated as suitable for enteral tube feeding delivery (refer to instructions for
use on nutrition / substrate added).
• Mixed or reconstituted nutrition may have foam. If using this type of nutrition, allow it to sit
for some time until the foam has been dissolved before pouring it into a feeding reservoir.
This will reduce the chance of an ‘AIR in giving set’ alarm.
• If other forms than a standard, ready to feed formula (i.e. commercially available pre-
packed or commercially prepared feeding solutions) are prescribed as enteral tube feed, it
should be done with caution and aligned with the healthcare professional. Feeds supplied
as tube feeds must be of a homogenous nature and should remain homogeneous during
the feeding regimen as bigger particles or high viscous foods might result in blockages in
the feeding line. It is noted that for instance ‘home-made’ – mixed tube feeds might give
rise to issues when given as an enteral tube feed as the mixture will not stay in emulsion
for a longer period
•
•
•
•
•
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For volume and nutrients sensitive patients (e.g. children with metabolic conditions using
overnight and/or unmonitored therapy) where a constant nutrition delivery is vital and/
or connected with consequential therapies (e.g. an insulin delivery pump):, additional
surveillance is recommended to be put in place to verify good functioning of the enteral
The sound level of the Infinity pumps audible alarm is to be set in ‘HIGH’ if the pump is
operated in a noisy environment or the health carer is not nearby the pump, such as at
night, to ensure the alarm is readily noticed when an alarm is activated. The intended
Nutricia recommends using ready to feed tube nutrition as this is developed for the
Any nutrition added into the enteral feeding line must be of a homogeneous nature and
Use only feeding solutions prescribed by the responsible clinician, registered dietician,
Before commencing any enteral feeding therapy, proper consideration is given to the
feed appropriateness for tube feeding (thickness, homogeneity, selection of nasogastric
tube Ch size, etc.), as to avoid occlusion or any other unexpected pump system behavior.
The condition and appropriateness of the nutrition can be addressed with the healthcare
professional, who knows the clinical situation and needs of the patient and can best guide
Non-liquid food ingredients and mixed or reconstituted foods may tend to occlude the
flow within the feeding tube and Flocare Infinity giving set. Clinicians and caregivers
Users must ensure that any substrate used for any mixed or reconstituted powdered
nutrition is indicated as suitable for enteral tube feeding delivery (refer to instructions for
Mixed or reconstituted nutrition may have foam. If using this type of nutrition, allow it to sit
for some time until the foam has been dissolved before pouring it into a feeding reservoir.
If other forms than a standard, ready to feed formula (i.e. commercially available pre-
packed or commercially prepared feeding solutions) are prescribed as enteral tube feed, it
should be done with caution and aligned with the healthcare professional. Feeds supplied
as tube feeds must be of a homogenous nature and should remain homogeneous during
the feeding regimen as bigger particles or high viscous foods might result in blockages in
the feeding line. It is noted that for instance ‘home-made’ – mixed tube feeds might give
rise to issues when given as an enteral tube feed as the mixture will not stay in emulsion
• In using any mixed, reconstituted powdered nutrition or breast milk, we advise users
to ensure the nutrition is prepared and dissolved properly as to avoid particles, foam
accumulation or films in the Flocare Infinity giving set potentially hampering pump
performance and a normal feeding regimen.
• If patients are advised by their healthcare professional to use a mixture of feeds, the feed
must be given when there is direct supervision (e.g. parents) to ascertain the feeding
therapy is running normally and to ensure proper actions are taken in case there is a
pump failure or unexpected behaviors caused by the mix.
• Do not modify this equipment. Modification of this device or its accessories can result in
physical hazards including delayed therapy, over delivery, under delivery, electrocution
and fire. These hazards could result in patient injury or death.
• Do not use the Infinity alarm systems to trigger actions related to secondary (electrical)
medical devices (e.g. a volumetric or syringe pump).
• Do not use pump functions for any other purpose than described in this manual. e.g. FILL
SET function to overcome an occlusion or the AIR in giving set alarm to indicate end of
therapy.
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4. QUICK REFERENCE OVERVIEW
5. USER INTERFACE
5.1.1.
The HOME [
whichever screen you are in.
Additionally, the HOME [
Note: the HOME
5.1.2.
The alarm SNOOZE [
is in an alarm state.
This gives you the opportunity to investigate and addresses the indicated alarm without being
distracted by the audio alarm signal.
5.1 BUTTONS
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APump status indicator HOcclusion OUT sensor OENPlus® connector
BColour display IAC power plug PENFit®connector
CDoor JAC power socket QMedication port
DPump rotor KAC charging light RCassette
ECharger plug LSpeaker SDrip chamber
FOcclusion IN sensor MPole clamp interface TDetachable AC plug
GAir sensor NPole clamp
1Home button 5Fill set button 9SOFT button 2
2Snooze button 6Settings button
10
SOFT button 3
3Information button 7Therapy button
11
ON/OFF button
4Start/pause button 8SOFT button 1
5. USER INTERFACE
5.1.1. Home button
The HOME [ ] button navigates back to the home screen or dashboard, in 1 touch from
whichever screen you are in.
Additionally, the HOME [ ] button acknowledges an alarm or warning.
Note: the HOME [ ] button does not act as a back button to move one level up in a menu.
5.1.2. Snooze button
The alarm SNOOZE [ ] button silences the audio alarm signal for 2 minutes when the pump
is in an alarm state.
This gives you the opportunity to investigate and addresses the indicated alarm without being
distracted by the audio alarm signal.
5.1 BUTTONS
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Note: the alarm remains visible. The [ ] symbol on the display indicates that the alarm sound
is snoozed.
5.1.3. Information button
The INFORMATION [ ] button (i-button) provides help and additional information about the
actual pump state at any given time.
Examples:
– In a running mode, the information button provides information about the status of
the therapy.
– In pause mode, the information button will give recommendations how to program a
therapy depending on your selected therapy.
– In an alarm state, the information button [ ] provides recommendations on how to
solve the indicated alarm by providing potential solutions.
5.1.4. Start/pause button
The START/PAUSE [ ] button starts or pauses a programmed therapy.
5.1.5. Fill set button
The FILL SET button primes the Flocare Infinity giving set to ensure that air within the
system has been purged.
5.1.6. Settings button
The SETTINGS button provides access to the pump settings.
See chapter 7.4 ‘Settings menu’ for full button functionality
5.1.7. Therapy button
With the THERAPY [ ] button, you can select your desired therapy.
See also chapter 7.5 ‘Programming the pump’, 7.4.1 ‘Define therapy list’ and 7.5.5 ’Program
a PERSONALISE THERAPY’.
5.1.8. On/Off button
The ON/OFF button switches the pump ON and OFF.
Note: to avoid unintended button presses, the ON/OFF button needs to be pressed for
2 seconds for both switching the pump ON or OFF.
5.1.9. Soft buttons
The soft buttons relate to the function on the screen which has an action indicated by the
“<, >, ,,,,+,–”. symbol.
Note: the SOFT buttons are only active when accompanied with the abovementioned symbols,
if no symbol appears, the button is inactive.
5.2. PUMP STATUS INDICATOR
The pump status indicator provides a visual indication of the actual pump status.
5.3. DISPLAY
The Flocare Infinity III will perform a display test during each pump start. Carefully check for
any sections or pixels that do not appear during the display test.
Caution: In case of any missing sections or pixels, the pump should not be used and to be send
to an authorised service centre for inspection.
5.4. HOME SCREEN
The home screen lay-out corresponds with your selected therapy VOLUME / RATE, RATE or
INTERMITTENT. The grey lines separate the panels in PAUSE mode, and are a visual indicator
that the navigation and selection buttons are active.
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symbol on the display indicates that the alarm sound
] button (i-button) provides help and additional information about the
In a running mode, the information button provides information about the status of
In pause mode, the information button will give recommendations how to program a
] provides recommendations on how to
button primes the Flocare Infinity giving set to ensure that air within the
7.5.5 ’Program
Note: to avoid unintended button presses, the ON/OFF button needs to be pressed for
The soft buttons relate to the function on the screen which has an action indicated by the
Note: the SOFT buttons are only active when accompanied with the abovementioned symbols,
if no symbol appears, the button is inactive.
5.2. PUMP STATUS INDICATOR
The pump status indicator provides a visual indication of the actual pump status.
– A green light indicates that the pump is in running mode and working normally.
– An orange light indicates that the pump is in pause mode and waits for user input.
– A red light indicates an alarm state; immediate action from the user is required.
5.3. DISPLAY
The Flocare Infinity III will perform a display test during each pump start. Carefully check for
any sections or pixels that do not appear during the display test.
Caution: In case of any missing sections or pixels, the pump should not be used and to be send
to an authorised service centre for inspection.
5.4. HOME SCREEN
The home screen lay-out corresponds with your selected therapy VOLUME / RATE, RATE or
INTERMITTENT. The grey lines separate the panels in PAUSE mode, and are a visual indicator
that the navigation and selection buttons are active.
Therapy lock
Mains connected
Battery
Remaining
therapy time
PDMS
Nurse call
Volume panel
Running indicator
Status bar
Progress bar
Rate panel
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5.4.1. Status bar
The status bar shows the system status by presenting icons at the top of the screen.
Note: icons are shown in home screen view only and can change the status bar order.
5.4.2. Icons
xThe Nurse call icon indicates that the pump is set to Nurse Call mode
xThe PDMS icon indicates that the pump is set to PDMS mode
xThe Therapy lock icon indicates that the current active therapy has been locked and
cannot be modified unless unlocked.
xThe Plug icon indicates whether the pump is connected to the mains.
xThe Battery icon indicates the charged capacity in percentage.
5.4.3. Progress bar
The progress bar provides a quick overview about the amount of delivered tube feed since the
last time the progress bar was cleared.
Note: refer to chapter 7.7.4 ‘Reset progress bar’ for a manual reset of the progress bar.
VOLUME - RATE
When a volume - rate therapy has been programmed, the progress bar is fully outlined and
gives real-time information of the administered volume on the left side.
RATE
When a rate therapy has been programmed, the progress bar fades out at the end of the
graph indicating that no volume has been programmed. The graph is static and shows only
the administered volume since the last time it was cleared.
INTERMITTENT
When an intermittent therapy has been programmed, the progress bar is separated into the
number of programmed portions. The progress bar is capable to show up to 3 portions, if
more portions are programmed, they will appear automatically after the previous administered
portions has been delivered.
Progress of each individual portion is indicated by filling in real-time the programmed portion
comparable to volume-rate.
5.4.4. Running indicator
The running indicator symbol becomes active after pressing the START/PAUSE [ ]. button.
The indicator shows 6 dots moving from the left to right and represents an active programmed
therapy.
In PAUSE mode, only 3 static dots are visible.
6. PUMP SETUP
6.1. ATTACHING TO THE POLE CLAMP (OPTIONAL)
1. Connect the Flocare Infinity III pole clamp (N) to a pole stand by rotating the black star
shaped bolt clockwise.
2. Connect the Flocare Infinity III to the pole clamp interface (M) by rotating the grey wheel
shaped disk clockwise until the pole clamp is fully connected to the pump without any
clearance.
6.2. CONNECT TO THE AC POWER PLUG
Connect the AC power adapter by gently pressing the charger plug (E) into the pump (J).
The charger plug is designed to fit in only one way. When the pump is connected to the mains,
the blue AC charging light (K) should be on and the plug icon to be appeared next to the
battery icon.
Note: The Flocare Infinity III is equipped with Lithium/Ion battery technology and needs to be
fully charged for a period of 6 hours prior to first use.
6.3. SWITCH THE PUMP ON
Turn the pump ON by pressing and holding the ON/OFF button for approximately 2 seconds
until the start-up sound can be heard.
The pump will perform a self-test and inform the user when the device is ready to use, the
home screen will be shown after the self-test.
Note: When a previous therapy has not been administered completely before the pump was
turned OFF, the pump will show the warning message ‘Last feeding incomplete’.
Refer to chapter
6.4. SET THE LANGUAGE
Set the language by pressing the SETTINGS [
preferred language.
Note: at first pump start up or after a factory reset, the pump will guide you automatically
through the language selection.
6.5. SET THE TIME AND DATE
Set the date and time by pressing the SETTINGS [
set these to your local time zone. The pump will not change to daylights savings automatically
nor will it change to other time zones during travelling.
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The Therapy lock icon indicates that the current active therapy has been locked and
The progress bar provides a quick overview about the amount of delivered tube feed since the
When a volume - rate therapy has been programmed, the progress bar is fully outlined and
When a rate therapy has been programmed, the progress bar fades out at the end of the
graph indicating that no volume has been programmed. The graph is static and shows only
When an intermittent therapy has been programmed, the progress bar is separated into the
number of programmed portions. The progress bar is capable to show up to 3 portions, if
more portions are programmed, they will appear automatically after the previous administered
Progress of each individual portion is indicated by filling in real-time the programmed portion
]. button.
The indicator shows 6 dots moving from the left to right and represents an active programmed
6. PUMP SETUP
6.1. ATTACHING TO THE POLE CLAMP (OPTIONAL)
1. Connect the Flocare Infinity III pole clamp (N) to a pole stand by rotating the black star
shaped bolt clockwise.
2. Connect the Flocare Infinity III to the pole clamp interface (M) by rotating the grey wheel
shaped disk clockwise until the pole clamp is fully connected to the pump without any
clearance.
6.2. CONNECT TO THE AC POWER PLUG
Connect the AC power adapter by gently pressing the charger plug (E) into the pump (J).
The charger plug is designed to fit in only one way. When the pump is connected to the mains,
the blue AC charging light (K) should be on and the plug icon to be appeared next to the
battery icon.
Note: The Flocare Infinity III is equipped with Lithium/Ion battery technology and needs to be
fully charged for a period of 6 hours prior to first use.
6.3. SWITCH THE PUMP ON
Turn the pump ON by pressing and holding the ON/OFF button for approximately 2 seconds
until the start-up sound can be heard.
The pump will perform a self-test and inform the user when the device is ready to use, the
home screen will be shown after the self-test.
Note: When a previous therapy has not been administered completely before the pump was
turned OFF, the pump will show the warning message ‘Last feeding incomplete’.
Refer to chapter 7.5.4 ‘Change the parameters of an active therapy’ for more information.
6.4. SET THE LANGUAGE
Set the language by pressing the SETTINGS [ ] button, navigate to LANGUAGE and select your
preferred language.
Note: at first pump start up or after a factory reset, the pump will guide you automatically
through the language selection.
6.5. SET THE TIME AND DATE
Set the date and time by pressing the SETTINGS [ ]button, navigate to TIME AND DATE and
set these to your local time zone. The pump will not change to daylights savings automatically
nor will it change to other time zones during travelling.
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Note: at first pump start up or after a factory reset, the pump will guide you automatically
through the date and time setting.
6.6. SWITCH THE PUMP OFF
Switch the pump OFF by pressing and holding the ON/OFF button for approximately 2 seconds
until you hear the turn-off sound
7. OPERATING INSTRUCTIONS
7.1. LOAD THE FLOCARE INFINITY GIVING SET
Follow the instructions for use of the Flocare Infinity giving set, for setting up the enteral
feeding system.
1. Open the door
2. Position the purple looped section of the cassette (R) around the pump rotor (D)
3. Gently stretch (do not over stretch) and manually press the giving set into position
by pressing the cassette downwards into the pump top housing. The cassette is
designed to fit into the pump one way
4. Close the pump door
5. Pump is now ready to be programmed
7.2. PAUSE / RUNNING MODE
The Flocare Infinity III is either in pause mode waiting for user instructions or is in running
mode delivering a therapy to a patient. The pause or running modes are controlled by the
START/PAUSE [ ].
Note: when the pump has been untouched for 3 minutes or more in PAUSE mode, the pump
will display the ‘Pump needs attention’ alarm message.
7.3. FILL THE FLOCARE INFINITY GIVING SET
The FILL SET function is used to prime a (new) Flocare Infinity giving set with nutrition or water
and needs to be commenced before starting a feeding therapy. Ensure the Flocare Infinity
giving set is disconnected from the patient feeding tube. Prime the set by press and hold the
FILL SET button for 2 seconds to activate the FILL SET function and release the FILL SET
button as soon as the pump generates a beep and automatically starts. The FILL SET can
be manually stopped by pressing STOP in case the giving set is over filled.
Note: when the FILL SET function is activated, all alarms are temporary deactivated helping
avoid alarms being inadvertently triggered (e.g. air alarm).er filled.
7.4. SETTINGS MENU
7.4.1. Define therapy list
DEFINE THERAPY LIST controls the list of available therapies that are visible when the
THERAPY [
green switch symbol.
Personalised therapies are shown in the list of available Therapies once they have been
enabled and programmed. 2 examples are shown below.
7.4.2. Personalise therapies
PERSONALISE THERAPIES provide the functionality to pre-program therapies that are
often used. Once programmed, it automatically appears in the list when the THERAPY
[
Note: Personalise therapies can be hidden using Define Therapy list.
7.4.3. Therapy lock
The THERAPY LOCK will lock an active therapy to avoid therapy tampering. It is not possible to
select a new therapy or reprogram the active therapy when the THERAPY LOCK is activated,
however it is possible to restart a locked therapy. Clearing the progress bar is still possible.
A therapy lock can be activated in PAUSE mode only by pressing SETTINGS THERAPY LOCK
and a valid PIN code must be entered. When a therapy is locked, a lock symbol appears in the
status bar. Unlocking a therapy is done via the same procedure.
Note: In case the therapy parameters need modification, consult your care giver.
7.4.4. Reset patient data
Reset patient data is designed to erase all collected patient data (nonpersonal). The following
data will reset: Therapy parameters, Progress bar, Patient history data, Personalise therapies,
Define therapy list, Sound settings and Display settings.
Note: The internal LOG file will not be erased, data can be recovered upon request by Nutricia
or an authorised repair centre.
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Note: at first pump start up or after a factory reset, the pump will guide you automatically
Switch the pump OFF by pressing and holding the ON/OFF button for approximately 2 seconds
Follow the instructions for use of the Flocare Infinity giving set, for setting up the enteral
The Flocare Infinity III is either in pause mode waiting for user instructions or is in running
mode delivering a therapy to a patient. The pause or running modes are controlled by the
Note: when the pump has been untouched for 3 minutes or more in PAUSE mode, the pump
The FILL SET function is used to prime a (new) Flocare Infinity giving set with nutrition or water
and needs to be commenced before starting a feeding therapy. Ensure the Flocare Infinity
giving set is disconnected from the patient feeding tube. Prime the set by press and hold the
button for 2 seconds to activate the FILL SET function and release the FILL SET
button as soon as the pump generates a beep and automatically starts. The FILL SET can
Note: when the FILL SET function is activated, all alarms are temporary deactivated helping
7.4. SETTINGS MENU
7.4.1. Define therapy list
DEFINE THERAPY LIST controls the list of available therapies that are visible when the
THERAPY [ ] button is pressed. Therapies that are currently enabled are marked with a
green switch symbol.
Personalised therapies are shown in the list of available Therapies once they have been
enabled and programmed. 2 examples are shown below.
7.4.2. Personalise therapies
PERSONALISE THERAPIES provide the functionality to pre-program therapies that are
often used. Once programmed, it automatically appears in the list when the THERAPY
[] button is pressed. A personalise therapy can be created, edited or erased.
Note: Personalise therapies can be hidden using Define Therapy list.
7.4.3. Therapy lock
The THERAPY LOCK will lock an active therapy to avoid therapy tampering. It is not possible to
select a new therapy or reprogram the active therapy when the THERAPY LOCK is activated,
however it is possible to restart a locked therapy. Clearing the progress bar is still possible.
A therapy lock can be activated in PAUSE mode only by pressing SETTINGS THERAPY LOCK
and a valid PIN code must be entered. When a therapy is locked, a lock symbol appears in the
status bar. Unlocking a therapy is done via the same procedure.
Note: In case the therapy parameters need modification, consult your care giver.
7.4.4. Reset patient data
Reset patient data is designed to erase all collected patient data (nonpersonal). The following
data will reset: Therapy parameters, Progress bar, Patient history data, Personalise therapies,
Define therapy list, Sound settings and Display settings.
Note: The internal LOG file will not be erased, data can be recovered upon request by Nutricia
or an authorised repair centre.
Define therapy list Define therapy listTherapy list result Therapy list result
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7.4.5. Sound
The Flocare Infinity III supports 3 AUDIO VOLUMES, ‘Low, Medium and High’ and can be set
by the user. For safety reasons the alarm volume is automatically escalated to "High" in both
settings ‘Low’ and ‘Medium’ after 3 min. This safety feature cannot be turned off.
7.4.6. Therapy completed
Notice: This menu option is only available from software version 1.07.0088 onwards. The
Flocare Infinity III can give a notification once the delivery of the programmed therapy is
completed. This VOLUME DELIVERED alarm supports three different user-configurable audio
options.
‘CONTINUOUS’ is activated by default and the pump will generate a visual warning and a
recurring audio alarm.
‘ONLY ONCE’ A single audio alarm once the delivery of the programmed therapy is completed.
‘OFF’ If no notification on programmed therapy is required, the VOLUME DELIVERED alarm
can be switched off.
Caution: consult your care giver before disabling the VOLUME DELIVERED alarm.
7.4.7. Display
The DISPLAY BRIGHTNESS can be set to a convenient level depending on the ambient
conditions. It is recommended to set the DISPLAY BRIGHTNESS to maximal when used in
bright sunlight as to ensure full visibility. This display illumination can be set to AUTO DIMMING
mode when connected to the mains. When AUTO DIMMING is ON, the display will be dimmed
after 2 min. When AUTO DIMMING is OFF, the display will always be illuminated.
Note: When the pump is running on battery power only, the display will always be dimmed after
2 min. in order to preserve battery life
7.4.8. Time and date
The Flocare Infinity III uses real time and dates in reporting the administered volumes in 30-day
HISTORY as well as in the THERAPY DETAILS screens. To ensure accuracy of data, the actual
time and date according to your local time zone must be set. Set the time and date by pressing
the SETTINGS button, navigate to TIME AND DATE and set these to your local time zone.
Note: Daylight savings are not automatically performed
7.4.9. Language
Set the language by pressing the SETTINGS button, navigate to LANGUAGE and select
your preferred language.
Note: at first pump start up or after a factory reset, the Flocare Infinity III will guide you
automatically through the language selection
7.4.10. About this pump
Information concerning the pump is gathered in the ABOUT THIS PUMP screen where you can
check: Serial number, Manufacturing date, PCBA hardware revision, Software version, current
Date and time settings, communication mode, Battery state of health, Total operating hours
and Total delivered volume.
Note: This information can be helpful for support reasons
7.5. PROGRAMMING THE PUMP
Caution: Before programming the pump, always ensure that your selected therapy and its
parameters are correct. In case of any doubts, consult your care giver.
Therapies are programmed via the THERAPY [
The Flocare Infinity III supports the following therapies:
Volume – Rate
Rate
Intermittent
7.5.1. Program a VOLUME - RATE therapy
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The Flocare Infinity III supports 3 AUDIO VOLUMES, ‘Low, Medium and High’ and can be set
by the user. For safety reasons the alarm volume is automatically escalated to "High" in both
Notice: This menu option is only available from software version 1.07.0088 onwards. The
Flocare Infinity III can give a notification once the delivery of the programmed therapy is
completed. This VOLUME DELIVERED alarm supports three different user-configurable audio
‘CONTINUOUS’ is activated by default and the pump will generate a visual warning and a
‘ONLY ONCE’ A single audio alarm once the delivery of the programmed therapy is completed.
‘OFF’ If no notification on programmed therapy is required, the VOLUME DELIVERED alarm
The DISPLAY BRIGHTNESS can be set to a convenient level depending on the ambient
conditions. It is recommended to set the DISPLAY BRIGHTNESS to maximal when used in
bright sunlight as to ensure full visibility. This display illumination can be set to AUTO DIMMING
mode when connected to the mains. When AUTO DIMMING is ON, the display will be dimmed
Note: When the pump is running on battery power only, the display will always be dimmed after
The Flocare Infinity III uses real time and dates in reporting the administered volumes in 30-day
HISTORY as well as in the THERAPY DETAILS screens. To ensure accuracy of data, the actual
time and date according to your local time zone must be set. Set the time and date by pressing
button, navigate to TIME AND DATE and set these to your local time zone.
button, navigate to LANGUAGE and select
Note: at first pump start up or after a factory reset, the Flocare Infinity III will guide you
automatically through the language selection
7.4.10. About this pump
Information concerning the pump is gathered in the ABOUT THIS PUMP screen where you can
check: Serial number, Manufacturing date, PCBA hardware revision, Software version, current
Date and time settings, communication mode, Battery state of health, Total operating hours
and Total delivered volume.
Note: This information can be helpful for support reasons
7.5. PROGRAMMING THE PUMP
Caution: Before programming the pump, always ensure that your selected therapy and its
parameters are correct. In case of any doubts, consult your care giver.
Therapies are programmed via the THERAPY [ ].
The Flocare Infinity III supports the following therapies:
Volume – Rate Administering of a programmed VOLUME (mL) with a programmed
RATE (mL/h).
Rate Administering with a programmed RATE (mL/h) but without a
programmed VOLUME (mL)
Intermittent Administering of a programmed VOLUME (mL) divided over different
portions with a programmed RATE (mL/h) with programmed PAUSE
(interval) times.
7.5.1. Program a VOLUME - RATE therapy
xFrom the home screen press the THERAPY [ ] button
xSelect VOLUME – RATE by pressing the associated soft button.
xPress the VOLUME soft button
xChange the Volume using the '+' and '-' buttons, and press the '>' button to accept
the value.
IMPORTANT:
Therapies RATE and INTERMITTENT are disabled by default, if a desired therapy does
not appear when the THERAPY button is pressed, you can enable them by selecting:
SETTINGS -> DEFINE THERAPY LIST
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xPress the RATE soft button
xChange the Rate using the '+' and '-' buttons, and press the '>' button to accept the
value.
xCheck your total therapy time underneath the VOLUME or RATE panel for additional
safety.
xPress the START/PAUSE [ ] ]button to start your VOLUME-RATE therapy.
7.5.2. Program a RATE therapy (not recommended for volume sensitive patients)
xFrom the home screen press the THERAPY [ ]button
xEnter the RATE soft button
xChange the Rate using the '+' and '-' buttons, and press the '>' button to accept the
value.
xPress the START/PAUSE [ ] button to start your RATE therapy.
7.5.3. Program an INTERMITTENT therapy
The INTERMITTENT therapy has a step- by step approach where all parameters need to be
entered and validated prior to return to the home screen. The Flocare®Infinity™ III shows
resulting parameters based on the user input for safety and convenience reasons.
Note: after each step, the Flocare Infinity III guides you to the next programming step.
xFrom the home screen press the THERAPY [ ]button
xSelect INTERMITTENT by pressing the associated soft button.
xPress the TOTAL VOLUME soft button
xChange the Volume using the '+' and '-' buttons, and press the '>' button to accept
the value.
xPress the PORTIONS soft button
xChange the required Portions using the '+' and '-' buttons, and press the '>' button
to accept the value.
xPress the RATE soft button
xChange the Rate using the '+' and '-' buttons, and press the '>' button to accept the
value.
xPress the PAUSE soft button
xChange the required Pause time using the '+' and '-' buttons, and press the '>' button
to accept the value.
xScroll up and down with soft button 1 and 3 through all programmed settings and
verify the input
xScroll to CONFIRM and validate the input by pressing soft button 2.
xPress the START/PAUSE [ ] button to start your INTERMITTENT therapy.
Note: When the pump is in the NEXT PORTION mode, the home screen will differ, indicating
and counting down the time until the next portion. The running indicator will remain active
during the count down.
7.5.4. Change the parameters of an active therapy
Changes to an active therapy are possible regardless whether a manual programmed or a
personalised therapy is active. To change an active therapy, make sure the pump is in PAUSE
mode.
Volume
Rate
Intermittent
7.5.5. Program a PERSONALISE THERAPY
TheFlocare
and store them into the pump memory for later use. Programming a personalise therapy is
considered as a pump setting rather than a THERAPY itself. To program a personalise therapy,
navigate from the HOME screen to SETTINGS
7.5.6. Editing of a PERSONALISE THERAPY
To EDIT or to DELETE a PERSONALISE THERAPY navigate from the HOME screen to
SETTINGS PERSONALISE THERAPIES and select the therapy that needs editing or deletion.
Note: deleting a therapy will erase all stored previous programmed therapy settings and
make the personalise therapy available for re-programming a new personalise therapy
7.6. LAST FEEDING INCOMPLETE
OFF, the pump will show the warning message: ‘Last feeding incomplete’. You either have
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