Nutricia Flocare Infinity III User manual

Instructions For Use - Infinity III - Rev 0-18 –23 August 2017
Instructions for Use
Nutricia Flocare® Infinity™ III

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1Introduction ..................................................................................................................................... 3
2Intended use ..................................................................................................................................... 3
3Safety information ........................................................................................................................... 3
3.1 General safety ..................................................................................................................................................................... 3
3.2 Warnings, precautions and contra indications.............................................................................................................. 3
4Quick reference overview ............................................................................................................... 7
5User interface................................................................................................................................... 8
5.1 Buttons.................................................................................................................................................................................. 8
5.1.1 Home button..................................................................................................................................................... 8
5.1.2 Snooze button.................................................................................................................................................... 8
5.1.3 Information button ........................................................................................................................................... 8
5.1.4 Start/pause button........................................................................................................................................... 9
5.1.5 Fill set button....................................................................................................................................................... 9
5.1.6 Settings button .................................................................................................................................................. 9
5.1.7 Therapy button ................................................................................................................................................. 9
5.1.8 On/Off button .................................................................................................................................................... 9
5.1.9 Soft buttons ............................................................................................................................................................ 9
5.2 Pump status indicator ........................................................................................................................................................ 9
5.3 Display................................................................................................................................................................................... 9
5.4 Home screen......................................................................................................................................................................10
5.4.1 Status bar...............................................................................................................................................................10
5.4.2 Icons .......................................................................................................................................................................10
5.4.3 Progress bar ..........................................................................................................................................................11
5.4.4 Running indicator.................................................................................................................................................11
6Pump setup ..................................................................................................................................... 11
6.1 Attaching to the pole clamp (optional) .........................................................................................................................11
6.2 Connect to the AC power plug ......................................................................................................................................11
6.3 Switch the pump on .........................................................................................................................................................11
6.4 Set the language................................................................................................................................................................12
6.5 Set the time and date.......................................................................................................................................................12
6.6 Switch the pump off.........................................................................................................................................................12
7Operating Instructions................................................................................................................... 12
7.1 Load the Flocare Infinity giving set ...............................................................................................................................12
7.2 Pause / running mode......................................................................................................................................................12
7.3 Fill the Flocare Infinity giving set...................................................................................................................................12
7.4 Settings menu ....................................................................................................................................................................13
7.4.1 Define therapy list ...............................................................................................................................................13
7.4.2 Personalised therapies........................................................................................................................................13
7.4.3 Therapy lock .........................................................................................................................................................13
7.4.4 Reset patient data................................................................................................................................................13
7.4.5 Sound .....................................................................................................................................................................13
7.4.6 Display ...................................................................................................................................................................13
7.4.7 Time and date.......................................................................................................................................................14
7.4.8 Language ...............................................................................................................................................................14
7.4.9 Airplane mode ......................................................................................................................................................14
7.4.10 About this pump ..................................................................................................................................................14
7.5 Programming the pump ...................................................................................................................................................14
7.5.1 Program a VOLUME - RATE therapy ..............................................................................................................14
7.5.2 Program a RATE therapy (not recommended for volume sensitive patients) .........................................15
7.5.3 Program an INTERMITTENT therapy..............................................................................................................15
7.5.4 Change the parameters of an active therapy.................................................................................................15
7.5.5 Program a PERSONALISED THERAPY ...........................................................................................................15
7.5.6 Editing of a PERSONALISED THERAPY .........................................................................................................16
7.6 Last feeding incomplete ..................................................................................................................................................16

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7.7 Information & memory functions ..................................................................................................................................16
7.7.1 Therapy information ...........................................................................................................................................16
7.7.2 Portions information ...........................................................................................................................................16
7.7.3 30-day history graph...........................................................................................................................................16
7.7.4 Reset progress bar ...............................................................................................................................................16
7.8 Keypad lock........................................................................................................................................................................16
7.9 Connect to a Nurse call or PDMS system....................................................................................................................17
7.10 Battery..........................................................................................................................................................................17
8Advanced settings .......................................................................................................................... 17
8.1 Communications mode ....................................................................................................................................................17
8.2 Change PIN code ..............................................................................................................................................................17
8.3 Factory reset......................................................................................................................................................................18
9Alarms, warning messages and trouble shooting ......................................................................... 18
9.1 Problem solver chart ........................................................................................................................................................18
10 Cleaning, inspection & servicing guidelines ................................................................................. 20
10.1 Switching between patients.....................................................................................................................................20
10.2 Cleaning & disinfection .............................................................................................................................................20
10.3 Inspection ....................................................................................................................................................................21
10.3.1 Housing..................................................................................................................................................................21
10.3.2 Keypad ...................................................................................................................................................................21
10.3.3 Rotor.......................................................................................................................................................................21
10.3.4 AC power plug......................................................................................................................................................21
10.3.5 Electrical ................................................................................................................................................................21
10.4 Servicing.......................................................................................................................................................................22
10.5 Repair............................................................................................................................................................................22
10.6 Spare parts...................................................................................................................................................................22
10.7 Accessories ..................................................................................................................................................................23
10.8 Recycling & disposal ..................................................................................................................................................23
11 Specifications ................................................................................................................................. 23
11.1 Performance................................................................................................................................................................23
11.2 Electrical / Mechanical..............................................................................................................................................23
11.3 Operating .....................................................................................................................................................................24
11.4 Storage .........................................................................................................................................................................24
11.5 EMC ..............................................................................................................................................................................24
11.6 Volumetric accuracy ..................................................................................................................................................24
11.7 occlusion response times..........................................................................................................................................24
12 Glossary of terms ........................................................................................................................... 25
13 Symbols .......................................................................................................................................... 25
14 Warranty ........................................................................................................................................ 25

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1INTRODUCTION
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.
The Flocare Infinity III pump provides better care while maintaining the accurate and safe performance you would
expect. The Flocare Infinity III pump can provide individual tailored therapies for nutrition delivery.
2INTENDED 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.
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.
3SAFETY 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.
It is recommended to follow the on-line training tool or get trained by an experienced and qualified trainer
▪The Flocare Infinity III enteral feeding pump should only be used in combination with the appropriate Flocare®
Infinity™ giving sets. The use of non-Flocare® Infinity™ giving sets will generate unforeseen hazards and will
not provide the same functionality and safety. Consult 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 Flocare Infinity III can be used for adult and paediatric patients, it is the responsibility of the healthcare
giver to 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.
3.2 WARNINGS, PRECAUTIONS AND CONTRA INDICATIONS
General warnings / getting started
▪Only use the Flocare Infinity III enteral feeding pump for delivery of enteral feeding solutions or hydration fluids.
Do not use for intravenous administration.
▪A leaking enteral feeding system might compromise the pumps 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, the Flocare Infinity giving set should be replaced.
•If the pump has been stored for any period of time, it should be plugged into the mains to recharge the battery
before commencing enteral feeding. The battery will be completely charged after approximately 6 hours.
•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.

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Before using or setting a feeding regimen, check the integrity of the pump for the items below.
▪There are no cracks anywhere 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 the AC power socket pins are not bent or corroded.
▪Verify that the AC power adapter incl. housing and cord is clean and not damaged.
Caution: Do not use the pump if it is damaged.
Use of home brew tube feed / Powder based tube feed
▪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.
▪Nutricia recommend using ready to feed tube nutrition as this is developed for the intended delivery
specifications of the pump.
▪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.
▪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.
Technical & EMC
▪The manufacturer recommends an inspection of the pump every 2 years by an authorised service centre or a
trained and qualified technician.
▪If a technical failure occurs or if the pump is dropped, the pump should be checked by an authorised service
centre or a trained and qualified technician.
▪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.
▪The use of other accessories, adaptors and cables than listed within this manual may result in increased
emissions or decreased immunity of the equipment of the Flocare® Infinity™ pump.
▪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.
▪Portable and mobile RF communications equipment (cellular telephones) can affect medical electrical
equipment.
▪If the Flocare® Infinity™ pump is used adjacent to or stacked with other equipment, the pump should be
observed to verify normal operation.

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Alarm usage
▪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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4QUICK REFERENCE OVERVIEW
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Pump status indicator Air sensor Pole clamp interface
Colour display Occlusion OUT sensor Pole clamp
Door AC power plug ENPlus® connector
Pump rotor AC power socket ENFit® connector
Charger plug AC charging light Medication port
Occlusion IN sensor Speaker Cassette
Drip chamber
5USER INTERFACE
5.1 BUTTONS
Home button Fill set button SOFT button 2
Snooze button Settings button SOFT button 3
Information button Therapy button ON/OFF button
Start/pause button SOFT button 1
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.
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.
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-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 PERSONALISED
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 above-mentioned 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 delivery 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.