Nutricia Flocare Infinity III User manual

Flocare®Infinity™ III pump Instructions for Use
Manufacturer information
Nutricia Medical Devices BV
Taurusavenue 167
2132LS HOOFDDORP
The Netherlands
www.nutriciaflocare.com
www.nutricia.com 59512_C / Date of publication April 2021
ZMNL900901 • Flocare Infinity Pump IFU New • 59512_C • 148,5 x 210 mm• July 2021 • PMS268C
ZMNL900901_DE.indb 1ZMNL900901_DE.indb 1 15.07.21 10:1215.07.21 10:12

‒ 2 ‒
EN
Nutricia CONTACT ADDRESSES
Headquarters
Nutricia Medical Devices B.V.
Taurusavenue 167
2132 LS Hoofddorp, The Netherlands
P.O. Box: 75538
Tel nr.:[phone]
Argentina
Commercial Office
Moreno 877 Piso 4
(C1091AAQ) CABA
Phone number
([phone]
Australia
Nutricia Australia Pty Limited
PO Box 1007
NORTH RYDE BC NSW 1670
Phone number 1800 245 580
Netherlands
Nutricia Nederland B.V.
PO Box 445
2700 AK Zoetermeer
The Netherlands
Phone Number: +31 800 – 022 33 22
Belgium
N.V. Nutricia België
Werkhuizenkaai 160
1000 Brussel
Phone Number: [phone]
Brazil
Av. Paulista, 2300
20th floor
São Paulo - SP
CEP 01310-300
Phone number + 55 11 3896 7600
China
39F,1155 Fand Dian Road
Pudong, Shanghai
Zip code 201204
Phone Number [phone]
Hungary
Numil Kft.
Váci út 35.
1134 Budapest
Phone number [phone]
Germany
Nutricia Milupa GmbH
Postfach 100359
D-60003 Frankfurt
Kontakt Nutricia Milupa D-A-CH:
00800-70050000
Austria
Nutricia Milupa GmbH
Halleiner Landesstraße 58
A-5412 Puch bei Hallein
Kontakt Nutricia Milupa D-A-CH: 00800-70050000
Switzerland
Nutricia Milupa SA
Hardturmstrasse 135
CH-8005 Zürich
Kontakt Nutricia Milupa D-A-CH:
00800-70050000
France
NUTRICIA Nutrition Clinique,
17/19 rue des deux gares,
CS 50149,
92565 Rueil-Malmaison Cedex.
Numéro de téléphone
[phone]
Indonesia
PT Nutricia Medical Nutrition
Cyber 2 Building, 16th Floor
Jl. HR Rasuna Said Block X-5, No.13
Jakarta 12950
Phone number [phone]
Italy
Distribuito da
Danone Nutricia S.p.A. Società Benefit
via C. Farini 41
20159 Milano
Phone number [phone]
Per informazioni 800-822096 -
www.nutricia.it
Greece - Ελλάδα
Διεύθυνση
Numil Hellas Α.Ε.
Παράδρομος 17
ο
χλμ. Ε.Ο. Αθηνών-Λαμίας & Καλαμάτας 2
Τ.Κ. 145 64 Νέα Κηφισιά, Αθήνα
Τηλέφωνο [phone]
Spain - España
Danone Nutricia S.R.L.
C/ Torrelaguna, 77, 6
a
plta.
28043 Madrid, España
Tel: [phone]
www.nutricia.es
www.sonda-nutricion.es
Middle East & South Africa
Nutricia Middle East DMCC
P.O. Box 487993
Jumeirah Lakes Towers,
Cluster W Bld. JBC5,
3802 Dubai, UAE
Phone number [phone]
Denmark
Nutricia A/S
Rørmosevej 2A
DK-3450 Allerød
Telefon: [phone]
Finland
Nutricia Medical Oy
Linnankatu 26 A
FI-20100 TURKU
Puhelinnumero [phone]
Norway
Nutricia Norge AS
Drammensveien 123
0277 Oslo
Tlf: [phone]
Sweden
Nutricia Nordica AB
Gårdsvägen 14
169 70 Solna
Tel: [phone]
Poland
Nutricia Polska Sp. z o.o.,
ul. Bobrowiecka 8,
00-728 Warszawa
Tel.: [phone]
www.flocare.pl
Portugal
Danone Nutricia Unipessoal, Lda.
Apartado 8106,
EC Cabo Ruivo,
1802-001 Lisboa, Portugal
Telef: 214 259 600
Russia
Nutricia LLC
9km Novorizhskoe highway
BC Riga Land, bld. 1
Moscow region, 143 421
Phone number [phone]
South Africa
Nutricia Southern Africa (Pty) Ltd
Danone Building C
199 Bryanston Drive
Johannesburg 2191
Phone Number [phone]
Thailand
PT Nutricia Medical Nutrition - DUMEX
359 Moo17, Theparak Rd.
Bangsaothong Samutprakarn 10540
Phone Number + 66 2740 3300
Turkey - Türkiye
Numil Gıda Ürünleri San. ve Tic. A.Ş.
Yapı Kredi Plaza B Blok No:1B
Kat:8-9 Cömert Sok.
Levent Mah. Beşiktaş-İSTANBUL
Telefon: + 90 212 385 26 00
United Kingdom
Nutricia Ltd.
Newmarket Avenue
Whitehorse Business Park
Trowbridge, Wiltshire
BA14 0XQ
Phone number 0800 093 3672
Ireland
Nutricia Advanced Medical Nutrition
Block 1
Deansgrange Business Park
Deansgrange,
Co. Dublin
Phone number [phone]
New Zealand
Nutricia Limited
PO Box 62523
Greenlane
Auckland 1546
Phone Number 0800 222 430
Czech Republic
Nutricia a. s.
Vparku 2294/2
148 00 Praha 4 – Chodov
Czech Republic
Phone Number: +420800110 001
ZMNL900901_DE.indb 2ZMNL900901_DE.indb 2 15.07.21 10:1215.07.21 10:12

‒ 3 ‒
EN
Nutricia CONTACT ADDRESSES
Headquarters
Nutricia Medical Devices B.V.
Taurusavenue 167
2132 LS Hoofddorp, The Netherlands
P.O. Box: 75538
Tel nr.:[phone]
Argentina
Commercial Office
Moreno 877 Piso 4
(C1091AAQ) CABA
Phone number
([phone]
Australia
Nutricia Australia Pty Limited
PO Box 1007
NORTH RYDE BC NSW 1670
Phone number 1800 245 580
Netherlands
Nutricia Nederland B.V.
PO Box 445
2700 AK Zoetermeer
The Netherlands
Phone Number: +31 800 – 022 33 22
Belgium
N.V. Nutricia België
Werkhuizenkaai 160
1000 Brussel
Phone Number: [phone]
Brazil
Av. Paulista, 2300
20th floor
São Paulo - SP
CEP 01310-300
Phone number + 55 11 3896 7600
China
39F,1155 Fand Dian Road
Pudong, Shanghai
Zip code 201204
Phone Number [phone]
Hungary
Numil Kft.
Váci út 35.
1134 Budapest
Phone number [phone]
Germany
Nutricia Milupa GmbH
Postfach 100359
D-60003 Frankfurt
Kontakt Nutricia Milupa D-A-CH:
00800-70050000
Austria
Nutricia Milupa GmbH
Halleiner Landesstraße 58
A-5412 Puch bei Hallein
Kontakt Nutricia Milupa D-A-CH: 00800-70050000
Switzerland
Nutricia Milupa SA
Hardturmstrasse 135
CH-8005 Zürich
Kontakt Nutricia Milupa D-A-CH:
00800-70050000
France
NUTRICIA Nutrition Clinique,
17/19 rue des deux gares,
CS 50149,
92565 Rueil-Malmaison Cedex.
Numéro de téléphone
[phone]
Indonesia
PT Nutricia Medical Nutrition
Cyber 2 Building, 16th Floor
Jl. HR Rasuna Said Block X-5, No.13
Jakarta 12950
Phone number [phone]
Italy
Distribuito da
Danone Nutricia S.p.A. Società Benefit
via C. Farini 41
20159 Milano
Phone number [phone]
Per informazioni 800-822096 -
www.nutricia.it
Greece - Ελλάδα
Διεύθυνση
Numil Hellas Α.Ε.
Παράδρομος 17
ο
χλμ. Ε.Ο. Αθηνών-Λαμίας & Καλαμάτας 2
Τ.Κ. 145 64 Νέα Κηφισιά, Αθήνα
Τηλέφωνο [phone]
Spain - España
Danone Nutricia S.R.L.
C/ Torrelaguna, 77, 6
a
plta.
28043 Madrid, España
Tel: [phone]
www.nutricia.es
www.sonda-nutricion.es
Middle East & South Africa
Nutricia Middle East DMCC
P.O. Box 487993
Jumeirah Lakes Towers,
Cluster W Bld. JBC5,
3802 Dubai, UAE
Phone number [phone]
Denmark
Nutricia A/S
Rørmosevej 2A
DK-3450 Allerød
Telefon: [phone]
Finland
Nutricia Medical Oy
Linnankatu 26 A
FI-20100 TURKU
Puhelinnumero [phone]
Norway
Nutricia Norge AS
Drammensveien 123
0277 Oslo
Tlf: [phone]
Sweden
Nutricia Nordica AB
Gårdsvägen 14
169 70 Solna
Tel: [phone]
Poland
Nutricia Polska Sp. z o.o.,
ul. Bobrowiecka 8,
00-728 Warszawa
Tel.: [phone]
www.flocare.pl
Portugal
Danone Nutricia Unipessoal, Lda.
Apartado 8106,
EC Cabo Ruivo,
1802-001 Lisboa, Portugal
Telef: 214 259 600
Russia
Nutricia LLC
9km Novorizhskoe highway
BC Riga Land, bld. 1
Moscow region, 143 421
Phone number [phone]
South Africa
Nutricia Southern Africa (Pty) Ltd
Danone Building C
199 Bryanston Drive
Johannesburg 2191
Phone Number [phone]
Thailand
PT Nutricia Medical Nutrition - DUMEX
359 Moo17, Theparak Rd.
Bangsaothong Samutprakarn 10540
Phone Number + 66 2740 3300
Turkey - Türkiye
Numil Gıda Ürünleri San. ve Tic. A.Ş.
Yapı Kredi Plaza B Blok No:1B
Kat:8-9 Cömert Sok.
Levent Mah. Beşiktaş-İSTANBUL
Telefon: + 90 212 385 26 00
United Kingdom
Nutricia Ltd.
Newmarket Avenue
Whitehorse Business Park
Trowbridge, Wiltshire
BA14 0XQ
Phone number 0800 093 3672
Ireland
Nutricia Advanced Medical Nutrition
Block 1
Deansgrange Business Park
Deansgrange,
Co. Dublin
Phone number [phone]
New Zealand
Nutricia Limited
PO Box 62523
Greenlane
Auckland 1546
Phone Number 0800 222 430
Czech Republic
Nutricia a. s.
Vparku 2294/2
148 00 Praha 4 – Chodov
Czech Republic
Phone Number: +420800110 001
ZMNL900901_DE.indb 3ZMNL900901_DE.indb 3 15.07.21 10:1215.07.21 10:12

‒ 4 ‒
EN
Nutricia CONTACT ADDRESSES.............................................................................................................................................................................................................. 2
1. INTRODUCTION .......................................................................................................................................................................................................................... 5
2. INTENDED USE ............................................................................................................................................................................................................................ 5
3. SAFETY INFORMATION............................................................................................................................................................................................................... 5
3.1. GENERAL SAFETY ........................................................................................................................................................................................................ 5
3.2. WARNINGS, PRECAUTIONS AND CONTRA INDICATIONS......................................................................................................................................... 5
4. QUICK REFERENCE OVERVIEW................................................................................................................................................................................................ 6
5. USER INTERFACE........................................................................................................................................................................................................................ 7
5.1. BUTTONS......................................................................................................................................................................................................................... 7
5.1.1. Home button ......................................................................................................................................................................................... 7
5.1.2. Snooze button ...................................................................................................................................................................................... 7
5.1.3. Information button................................................................................................................................................................................. 7
5.1.4. Start/pause button ................................................................................................................................................................................ 7
5.1.5. Fill set button........................................................................................................................................................................................... 7
5.1.6. Settings button ..................................................................................................................................................................................... 7
5.1.7. Therapy button ..................................................................................................................................................................................... 7
5.1.8. On/Off button......................................................................................................................................................................................... 8
5.1.9. Soft buttons.................................................................................................................................................................................................. 8
5.2. PUMP STATUS INDICATOR ........................................................................................................................................................................................... 8
6. PUMP SETUP................................................................................................................................................................................................................................ 8
6.1. ATTACHING TO THE POLE CLAMP (OPTIONAL)......................................................................................................................................................... 8
6.2. CONNECT TO THE AC POWER PLUG [e-IFU] ............................................................................................................................................................. 8
6.3. SWITCH THE PUMP ON [e-IFU]...................................................................................................................................................................................... 8
6.4. SET THE LANGUAGE..................................................................................................................................................................................................... 8
6.5. SET THE TIME AND DATE [e-IFU].................................................................................................................................................................................. 8
6.6. SWITCH THE PUMP OFF................................................................................................................................................................................................ 8
7. OPERATING INSTRUCTIONS [e-IFU] .......................................................................................................................................................................................... 8
7.1. LOAD THE FLOCARE INFINITY GIVING SET................................................................................................................................................................ 8
7.2. PAUSE / RUNNING MODE [e-IFU] .................................................................................................................................................................................. 8
7.3. FILL THE FLOCARE INFINITY GIVING SET [e-IFU] ...................................................................................................................................................... 8
7.4. SETTINGS MENU [e-IFU] ................................................................................................................................................................................................ 9
7.4.1. Reset patient data........................................................................................................................................................................................ 9
7.4.2. Sound [e-IFU]................................................................................................................................................................................................ 9
7.5. PROGRAMMING THE PUMP.......................................................................................................................................................................................... 9
7.5.1. Program a VOLUME - RATE therapy.......................................................................................................................................................... 9
7.5.2. Program a RATE therapy (not recommended for volume sensitive patients)........................................................................................ 9
7.6. LAST FEEDING INCOMPLETE....................................................................................................................................................................................... 9
7.7. INFORMATION & MEMORY FUNCTIONS [e-IFU].......................................................................................................................................................... 9
7.7.1. 30-day history graph....................................................................................................................................................................................9
7.7.2. Reset progress bar...................................................................................................................................................................................... 9
7.8. BATTERY [E-IFU]............................................................................................................................................................................................................. 9
8. ADVANCED SETTINGS [e-IFU] .................................................................................................................................................................................................. 10
9. ALARMS, WARNING MESSAGES AND TROUBLE SHOOTING [e-IFU].................................................................................................................................. 10
10. CLEANING, INSPECTION & SERVICING GUIDELINES [e-IFU]............................................................................................................................................... 10
ACCESSORIES ........................................................................................................................................................................................................................................ 10
RECYCLING & DISPOSAL....................................................................................................................................................................................................................... 10
11. SPECIFICATIONS [e-IFU] ........................................................................................................................................................................................................... 10
11.1. PERFORMANCE............................................................................................................................................................................................................ 10
11.2. OPERATING................................................................................................................................................................................................................... 10
11.3. STORAGE ...................................................................................................................................................................................................................... 10
12. SYMBOLS [e-IFU]........................................................................................................................................................................................................................ 11
13. WARRANTY ................................................................................................................................................................................................................................ 11
Instructions for Use
UK-IE • This Instructions for Use manual is enclosed with each pump and informs the user of the device of its safe and proper use, its expected performances and
of precautions to take. It includes information on how to start up the device as well as basic operations and set up of the pump as to enable users and carers, whom
received pump training, to set up their therapies themselves.
More details and elaborate information can be found in the ‘electronic Instructions for Use’ (e-IFU) accessible via nutriciaflocare.com. In case a printed version of this
e-IFU is required, this can be obtained via the local Nutricia affiliates.
For quick reference, this Instructions for Use follows the same structure and table of contents as the e-IFU. The notion ‘[e-IFU]’ ’indicates that more information on the
topic is available.
Furthermore, the built-in ‘INFORMATION button [ ]’ of the pump provides help and additional information about the actual pump status at any given time. Amongst
others, the INFORMATION button [ ] can provide suggestions on the display to solve an alarm or warning condition.
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.
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.
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.
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.
3. SAFETY INFORMATION
3.1. GENERAL SAFETY
• Read the 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 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.
• 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.
Prior to each feeding regimen, verify the cleanliness and integrity of the pump as referred to in chapter 10.2 ‘cleaning and disinfection’ and chapter 10.3 ‘inspection’.
Caution: Do not use the pump if it is damaged.
Use of home brew tube feed / Powder based tube feed [e-IFU]
• Nutricia recommend 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.
ZMNL900901_DE.indb 4ZMNL900901_DE.indb 4 15.07.21 10:1215.07.21 10:12

‒ 5 ‒
EN
Nutricia CONTACT ADDRESSES.............................................................................................................................................................................................................. 2
1. INTRODUCTION .......................................................................................................................................................................................................................... 5
2. INTENDED USE ............................................................................................................................................................................................................................ 5
3. SAFETY INFORMATION............................................................................................................................................................................................................... 5
3.1. GENERAL SAFETY ........................................................................................................................................................................................................ 5
3.2. WARNINGS, PRECAUTIONS AND CONTRA INDICATIONS......................................................................................................................................... 5
4. QUICK REFERENCE OVERVIEW................................................................................................................................................................................................ 6
5. USER INTERFACE........................................................................................................................................................................................................................ 7
5.1. BUTTONS......................................................................................................................................................................................................................... 7
5.1.1. Home button ......................................................................................................................................................................................... 7
5.1.2. Snooze button ...................................................................................................................................................................................... 7
5.1.3. Information button................................................................................................................................................................................. 7
5.1.4. Start/pause button ................................................................................................................................................................................ 7
5.1.5. Fill set button........................................................................................................................................................................................... 7
5.1.6. Settings button ..................................................................................................................................................................................... 7
5.1.7. Therapy button ..................................................................................................................................................................................... 7
5.1.8. On/Off button......................................................................................................................................................................................... 8
5.1.9. Soft buttons.................................................................................................................................................................................................. 8
5.2. PUMP STATUS INDICATOR ........................................................................................................................................................................................... 8
6. PUMP SETUP................................................................................................................................................................................................................................ 8
6.1. ATTACHING TO THE POLE CLAMP (OPTIONAL)......................................................................................................................................................... 8
6.2. CONNECT TO THE AC POWER PLUG [e-IFU] ............................................................................................................................................................. 8
6.3. SWITCH THE PUMP ON [e-IFU]...................................................................................................................................................................................... 8
6.4. SET THE LANGUAGE..................................................................................................................................................................................................... 8
6.5. SET THE TIME AND DATE [e-IFU].................................................................................................................................................................................. 8
6.6. SWITCH THE PUMP OFF................................................................................................................................................................................................ 8
7. OPERATING INSTRUCTIONS [e-IFU] .......................................................................................................................................................................................... 8
7.1. LOAD THE FLOCARE INFINITY GIVING SET................................................................................................................................................................ 8
7.2. PAUSE / RUNNING MODE [e-IFU] .................................................................................................................................................................................. 8
7.3. FILL THE FLOCARE INFINITY GIVING SET [e-IFU] ...................................................................................................................................................... 8
7.4. SETTINGS MENU [e-IFU] ................................................................................................................................................................................................ 9
7.4.1. Reset patient data........................................................................................................................................................................................ 9
7.4.2. Sound [e-IFU]................................................................................................................................................................................................ 9
7.5. PROGRAMMING THE PUMP.......................................................................................................................................................................................... 9
7.5.1. Program a VOLUME - RATE therapy.......................................................................................................................................................... 9
7.5.2. Program a RATE therapy (not recommended for volume sensitive patients)........................................................................................ 9
7.6. LAST FEEDING INCOMPLETE....................................................................................................................................................................................... 9
7.7. INFORMATION & MEMORY FUNCTIONS [e-IFU].......................................................................................................................................................... 9
7.7.1. 30-day history graph....................................................................................................................................................................................9
7.7.2. Reset progress bar...................................................................................................................................................................................... 9
7.8. BATTERY [E-IFU]............................................................................................................................................................................................................. 9
8. ADVANCED SETTINGS [e-IFU] .................................................................................................................................................................................................. 10
9. ALARMS, WARNING MESSAGES AND TROUBLE SHOOTING [e-IFU].................................................................................................................................. 10
10. CLEANING, INSPECTION & SERVICING GUIDELINES [e-IFU]............................................................................................................................................... 10
ACCESSORIES ........................................................................................................................................................................................................................................ 10
RECYCLING & DISPOSAL....................................................................................................................................................................................................................... 10
11. SPECIFICATIONS [e-IFU] ........................................................................................................................................................................................................... 10
11.1. PERFORMANCE............................................................................................................................................................................................................ 10
11.2. OPERATING................................................................................................................................................................................................................... 10
11.3. STORAGE ...................................................................................................................................................................................................................... 10
12. SYMBOLS [e-IFU]........................................................................................................................................................................................................................ 11
13. WARRANTY ................................................................................................................................................................................................................................ 11
Instructions for Use
UK-IE • This Instructions for Use manual is enclosed with each pump and informs the user of the device of its safe and proper use, its expected performances and
of precautions to take. It includes information on how to start up the device as well as basic operations and set up of the pump as to enable users and carers, whom
received pump training, to set up their therapies themselves.
More details and elaborate information can be found in the ‘electronic Instructions for Use’ (e-IFU) accessible via nutriciaflocare.com. In case a printed version of this
e-IFU is required, this can be obtained via the local Nutricia affiliates.
For quick reference, this Instructions for Use follows the same structure and table of contents as the e-IFU. The notion ‘[e-IFU]’ ’indicates that more information on the
topic is available.
Furthermore, the built-in ‘INFORMATION button [ ]’ of the pump provides help and additional information about the actual pump status at any given time. Amongst
others, the INFORMATION button [ ] can provide suggestions on the display to solve an alarm or warning condition.
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.
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.
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.
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.
3. SAFETY INFORMATION
3.1. GENERAL SAFETY
• Read the 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 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.
• 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.
Prior to each feeding regimen, verify the cleanliness and integrity of the pump as referred to in chapter 10.2 ‘cleaning and disinfection’ and chapter 10.3 ‘inspection’.
Caution: Do not use the pump if it is damaged.
Use of home brew tube feed / Powder based tube feed [e-IFU]
• Nutricia recommend 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.
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EN
Technical & EMC
• The manufacturer recommends an inspection of the pump by an authorised service centre or a trained and qualified technician in the following cases:
• In between patient usage
• In case of any change in performance characteristics or pump alarm messages/warnings
• In case the pump has been dropped
• If no other inspections have been performed, minimally once every 3 years
• 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.
• If the Flocare Infinity III pump is used adjacent to or stacked with other equipment, the pump should be observed to verify normal operation.
4. QUICK REFERENCE OVERVIEW
A
Pump status indicator
G
Air sensor
M
Pole clamp interface
B
Colour display
H
Occlusion OUT sensor
N
Pole clamp
C
Door
I
AC power plug
O
ENPlus®connector
D
Pump rotor
J
AC power socket
P
ENFit®connector
E
Charger plug
K
AC charging light
Q
Medication port
F
Occlusion IN sensor
L
Speaker
R
Cassette
S
Drip chamber
5. USER INTERFACE
5.1. BUTTONS
1
Home button
5
Fill set button
9
SOFT button 2
2
Snooze button
6
Settings button
10
SOFT button 3
3
Information button
7
Therapy button
11
ON/OFF button
4
Start/pause button
8
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.
• 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 7.4.1 ‘Reset patient data
M
8
A
310
2
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9
11
C
B
D
E
F
G
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O
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Q
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S
T
ZMNL900901_DE.indb 6ZMNL900901_DE.indb 6 15.07.21 10:1215.07.21 10:12

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EN
Technical & EMC
• The manufacturer recommends an inspection of the pump by an authorised service centre or a trained and qualified technician in the following cases:
• In between patient usage
• In case of any change in performance characteristics or pump alarm messages/warnings
• In case the pump has been dropped
• If no other inspections have been performed, minimally once every 3 years
• 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.
• If the Flocare Infinity III pump is used adjacent to or stacked with other equipment, the pump should be observed to verify normal operation.
4. QUICK REFERENCE OVERVIEW
A
Pump status indicator
G
Air sensor
M
Pole clamp interface
B
Colour display
H
Occlusion OUT sensor
N
Pole clamp
C
Door
I
AC power plug
O
ENPlus®connector
D
Pump rotor
J
AC power socket
P
ENFit®connector
E
Charger plug
K
AC charging light
Q
Medication port
F
Occlusion IN sensor
L
Speaker
R
Cassette
S
Drip chamber
5. USER INTERFACE
5.1. BUTTONS
1
Home button
5
Fill set button
9
SOFT button 2
2
Snooze button
6
Settings button
10
SOFT button 3
3
Information button
7
Therapy button
11
ON/OFF button
4
Start/pause button
8
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.
• 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 7.4.1 ‘Reset patient data
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EN
Reset patient data is designed to erase all collected patient data (non-personal)
The following data will reset: Therapy parameters, Progress bar, Patient history data, Personalised therapies, Define therapy list, Sound settings and Display settings.
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.
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 [e-IFU]
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 battery needs to be fully charged for a period of 6 hours prior to or during first use.
6.3. SWITCH THE PUMP ON [e-IFU]
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.
Caution: Carefully check for any sections or pixels that do not appear during the display test. In case of missing sections or pixels, the pump should not be used and
send to an authorised service centre for inspection.
6.4. SET THE LANGUAGE
At first pump start up or after a factory reset, the pump will guide you automatically through the language selection. Set the language by pressing the SETTINGS
button, navigate to LANGUAGE and select your preferred language.
6.5. SET THE TIME AND DATE [e-IFU]
At first pump start up or after a factory reset, the pump will guide you automatically through the date and time setting. Set the date and time by pressing the
SETTINGS button, navigate to TIME AND DATE and set these to your local time zone.
6.6. SWITCH THE PUMP OFF
Turn 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 [e-IFU]
7.1. LOAD THE FLOCARE INFINITY GIVING SET
Follow the instructions for use enclosed with the Flocare Infinity giving set, for setting up the enteral system.
1. Open the pump door
2. Position the purple looped section of the cassette (R) around the pump rotor (D)
3. Gently stretch (do not over stretch) and seat the cassette into the pump 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 [e-IFU]
The Flocare Infinity III is either in pause mode waiting for user instructions or it is in running mode delivering a therapy to a patient. The pause or running modes are
controlled by the START/PAUSE [ ] button.
7.3. FILL THE FLOCARE INFINITY GIVING SET [e-IFU]
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.
7.4. SETTINGS MENU [e-IFU]
‘Define Therapy list’ controls the available therapies that are visible when the THERAPY [ ] button is pressed. Therapies that are currently enabled are marked
with a green switch symbol.
7.4.1. Reset patient data
Reset patient data is designed to erase all collected patient data (non-personal)
The following data will reset: Therapy parameters, Progress bar, Patient history data, Personalised therapies, Define therapy list, Sound settings and Display settings.
7.4.2. Sound [e-IFU]
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 will be automatically escalated to High in both settings ‘Low’ and ‘Medium’ after 3 min. This safety feature cannot be turned off.
The THERAPY COMPLETED ALARM is activated by default and the pump will generate an audio and visual warning. If it is not desired to be disturbed by the audio
warning, the THERAPY COMPLETED ALARM can be switched OFF.
7.5. PROGRAMMING THE PUMP
Caution: Before programming the pump, always be convinced that your selected therapy and its parameters are correct. In case of any doubts, consult your care giver.
Therapies are programmed via the THERAPY [ ] button. 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. [e-IFU]
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. [e-IFU]
7.5.1. Program a VOLUME - RATE therapy
• From the home screen press the THERAPY [ ] button
• Select VOLUME – RATE by pressing the associated soft button.
• Press the VOLUME soft button
• Change the Volume using the ‘+’ and ‘-’ buttons and press the ‘>’ button to accept the value.
• Press the RATE soft button
• Change the Rate using the ‘+’ and ‘-’ buttons and press the ‘>’ button to accept the value.
• Check your total therapy time underneath the VOLUME or RATE panel for additional safety.
• Press the START/PAUSE [ ] button to start your VOLUME-RATE therapy.
7.5.2. Program a RATE therapy (not recommended for volume sensitive patients)
• From the home screen press the THERAPY [ ] button
• Enter the RATE soft button
• Change the Rate using the ‘+’ and ‘-’ buttons and press the ‘>’ button to accept the value.
• Press the START/PAUSE [ ] button to start your RATE therapy.
7.6. LAST FEEDING INCOMPLETE
When a therapy has not been administered completely whilst the pump has been turned OFF, the pump will show the warning message: ‘Last feeding incomplete’.
You either have the option to RESTART the active therapy where the progress bar will be reset or you can RESUME the delivery of the active therapy.
7.7. INFORMATION & MEMORY FUNCTIONS [e-IFU]
7.7.1. 30-day history graph
The Flocare Infinity III stores all administered therapies for a maximum period of 30 days.
The daily administered volume can be accessed by pressing SOFT BUTTON 1 from the home screen and pressing HISTORY. With the arrow buttons, you can
navigate to earlier or later days. By pressing the + magnifying symbol you can zoom in on your selected day by showing a table of individual therapies.
7.7.2. Reset progress bar
The Progress bar is automatically cleared after completion of each therapy where a VOLUME was programmed.
When there is a need to manually clear the Progress bar, navigate from the HOME screen to SOFT BUTTON 1 RESET PROGRESS BAR.
7.8. BATTERY [E-IFU]
The Flocare Infinity III is equipped with a 3.7V, 3200 mAh Lithium Ion battery and needs to be fully charged for a period of 6 hours prior to or during first use, this will
maximise the battery life time.
Note: The battery capacity is an estimate. If you are unsure that enough battery capacity remains for your intended therapy, connect to the AC power adapter until
recharged.
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EN
Reset patient data is designed to erase all collected patient data (non-personal)
The following data will reset: Therapy parameters, Progress bar, Patient history data, Personalised therapies, Define therapy list, Sound settings and Display settings.
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.
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 [e-IFU]
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 battery needs to be fully charged for a period of 6 hours prior to or during first use.
6.3. SWITCH THE PUMP ON [e-IFU]
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.
Caution: Carefully check for any sections or pixels that do not appear during the display test. In case of missing sections or pixels, the pump should not be used and
send to an authorised service centre for inspection.
6.4. SET THE LANGUAGE
At first pump start up or after a factory reset, the pump will guide you automatically through the language selection. Set the language by pressing the SETTINGS
button, navigate to LANGUAGE and select your preferred language.
6.5. SET THE TIME AND DATE [e-IFU]
At first pump start up or after a factory reset, the pump will guide you automatically through the date and time setting. Set the date and time by pressing the
SETTINGS button, navigate to TIME AND DATE and set these to your local time zone.
6.6. SWITCH THE PUMP OFF
Turn 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 [e-IFU]
7.1. LOAD THE FLOCARE INFINITY GIVING SET
Follow the instructions for use enclosed with the Flocare Infinity giving set, for setting up the enteral system.
1. Open the pump door
2. Position the purple looped section of the cassette (R) around the pump rotor (D)
3. Gently stretch (do not over stretch) and seat the cassette into the pump 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 [e-IFU]
The Flocare Infinity III is either in pause mode waiting for user instructions or it is in running mode delivering a therapy to a patient. The pause or running modes are
controlled by the START/PAUSE [ ] button.
7.3. FILL THE FLOCARE INFINITY GIVING SET [e-IFU]
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.
7.4. SETTINGS MENU [e-IFU]
‘Define Therapy list’ controls the available therapies that are visible when the THERAPY [ ] button is pressed. Therapies that are currently enabled are marked
with a green switch symbol.
7.4.1. Reset patient data
Reset patient data is designed to erase all collected patient data (non-personal)
The following data will reset: Therapy parameters, Progress bar, Patient history data, Personalised therapies, Define therapy list, Sound settings and Display settings.
7.4.2. Sound [e-IFU]
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 will be automatically escalated to High in both settings ‘Low’ and ‘Medium’ after 3 min. This safety feature cannot be turned off.
The THERAPY COMPLETED ALARM is activated by default and the pump will generate an audio and visual warning. If it is not desired to be disturbed by the audio
warning, the THERAPY COMPLETED ALARM can be switched OFF.
7.5. PROGRAMMING THE PUMP
Caution: Before programming the pump, always be convinced that your selected therapy and its parameters are correct. In case of any doubts, consult your care giver.
Therapies are programmed via the THERAPY [ ] button. 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. [e-IFU]
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. [e-IFU]
7.5.1. Program a VOLUME - RATE therapy
• From the home screen press the THERAPY [ ] button
• Select VOLUME – RATE by pressing the associated soft button.
• Press the VOLUME soft button
• Change the Volume using the ‘+’ and ‘-’ buttons and press the ‘>’ button to accept the value.
• Press the RATE soft button
• Change the Rate using the ‘+’ and ‘-’ buttons and press the ‘>’ button to accept the value.
• Check your total therapy time underneath the VOLUME or RATE panel for additional safety.
• Press the START/PAUSE [ ] button to start your VOLUME-RATE therapy.
7.5.2. Program a RATE therapy (not recommended for volume sensitive patients)
• From the home screen press the THERAPY [ ] button
• Enter the RATE soft button
• Change the Rate using the ‘+’ and ‘-’ buttons and press the ‘>’ button to accept the value.
• Press the START/PAUSE [ ] button to start your RATE therapy.
7.6. LAST FEEDING INCOMPLETE
When a therapy has not been administered completely whilst the pump has been turned OFF, the pump will show the warning message: ‘Last feeding incomplete’.
You either have the option to RESTART the active therapy where the progress bar will be reset or you can RESUME the delivery of the active therapy.
7.7. INFORMATION & MEMORY FUNCTIONS [e-IFU]
7.7.1. 30-day history graph
The Flocare Infinity III stores all administered therapies for a maximum period of 30 days.
The daily administered volume can be accessed by pressing SOFT BUTTON 1 from the home screen and pressing HISTORY. With the arrow buttons, you can
navigate to earlier or later days. By pressing the + magnifying symbol you can zoom in on your selected day by showing a table of individual therapies.
7.7.2. Reset progress bar
The Progress bar is automatically cleared after completion of each therapy where a VOLUME was programmed.
When there is a need to manually clear the Progress bar, navigate from the HOME screen to SOFT BUTTON 1 RESET PROGRESS BAR.
7.8. BATTERY [E-IFU]
The Flocare Infinity III is equipped with a 3.7V, 3200 mAh Lithium Ion battery and needs to be fully charged for a period of 6 hours prior to or during first use, this will
maximise the battery life time.
Note: The battery capacity is an estimate. If you are unsure that enough battery capacity remains for your intended therapy, connect to the AC power adapter until
recharged.
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EN
8. ADVANCED SETTINGS [e-IFU]
These settings are only intended to be set by qualified caregivers or qualified technicians.
9. ALARMS, WARNING MESSAGES AND TROUBLE SHOOTING [e-IFU]
The Flocare Infinity III is equipped with several sensors and safety features linked to clear visual and audio alarms and warning messages on the display.
In case any of the alarms occur, the pump will generate an audible and visual alarm and stops administering. The back light of the display automatically switches on.
Exception to this is the low battery alarm, in this situation the pump continues working.
If an alarm or warning message appears on the display:
• The HOME [ ] button acknowledges an alarm or warning state and dismisses the alarm or warning message.
• The SNOOZE [ ] button snoozes the alarm or warning audio signal for 2 minutes whilst the alarm or warning message remains on the display. A
suppressed audio icon will appear on the display indicating that the audio signal has been snoozed.
• The INFORMATION button [ ] can provide suggestions on the display to solve an alarm or warning condition.
Note: during an alarm or warning, all other buttons are disabled. The HOME [ ]button is the only button that acknowledge and dismiss an alarm or warning
message.
10. CLEANING, INSPECTION & SERVICING GUIDELINES [e-IFU]
For optimum and safe pump operation, the pump should be kept clean and free from debris. It is recommended to clean the pump with a wet cloth after every
completed feeding regimen.
It is recommended to clean the pump regularly under (running) warm tap water with standard washing up liquid in line with local cleaning and hygiene policies in
place.
Disconnect the pump from the mains before cleaning. To avoid electrical shock, never clean the pump with AC power adapter plugged
into an outlet or when pump is on.
Do not immerse the pump in water.
Do not use aggressive cleaners or disinfectants such as acetone, benzene or iodine.
The pump is not intended to be cleanevd using a dishwasher.
Do not sterilize the pump, e.g. by irradiation, EtO, steam or in an autoclave.
Before using or setting a feeding regimen, check the integrity of the pump, the AC power plug and its accessories. Do not use the pump if it is damaged.
ACCESSORIES
Dedicated carry bags and pump stands are available for the Flocare Infinity III pump. Please contact your local Nutricia sales representative for availability and
ordering information of the respective parts.
RECYCLING & DISPOSAL
The pump and its electrical accessories (AC power plug, PDMS cable, Nurse Call cable), should be disposed according to local standards and regulations governing
the disposal of electronic waste (e-waste). Other accessories can be disposed of or recycled as standard non-hazardous waste.
Note: In case of pump scrapping, always notify your Nutricia sales unit of the pumps serial number.
11. SPECIFICATIONS [e-IFU]
11.1. PERFORMANCE
Volumetric accuracy ±5%
Battery life ~24h @ 125mL/h, ~12h @ 250mL/h
Air bubble detection > 1.5 mL of air in giving set after the pump set
Upstream occlusion pressure -34 kPa ± 21 kPa for 5 sec.
Downstream occlusion pressure 84 kPa ± 21 kPa for 30 sec. / 103 kPa ± 21kPa for 5 sec.
11.2. OPERATING
Atmospheric pressure 65 – 106 kPa
Temperature 5° – 40°C
Humidity 15 – 95%, non-condensing
11.3. STORAGE
Atmospheric pressure 50 – 106 kPa
Temperature -20° – 60°C
Humidity 10 – 95%, non-condensing
Shelf life None. A normal expected use life is 5 years. The battery life degrades over time and should be charged before any use
Note: Time to recover from maximum and minimum storage temperature to operating temperature is ~30 min.
12. SYMBOLS [e-IFU]
Manufacturer Consult instructions for use
Serial number Not for IV use (enteral use only)
Mechanical and fluid ingress CE mark and Notified Body identification number
13. WARRANTY
All service and repair activities should only be carried out by an approved service centre, authorised repair centre or a Nutricia qualified Technician / BMET.
The warranty is for a period of 36 months for customers from the date of delivery. Warranty includes the Flocare Infinity III pump, pole clamp, and AC power plug and
covers replacement, within the period for normal wear and tear.
Limitations on warranty
Warranty will be void if the product has been misused, tampered with or the performance specifications have been altered. Warranty will be void if the product is used
outside of the recommendations contained with the IFU / e IFU or in case any repairs are conducted by a non-authorised centre.
Manufacturer information
Nutricia Medical Devices BV
Taurusavenue 167
2132LS HOOFDDORP
The Netherlands
www.nutriciaflocare.com
www.nutricia.com
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8. ADVANCED SETTINGS [e-IFU]
These settings are only intended to be set by qualified caregivers or qualified technicians.
9. ALARMS, WARNING MESSAGES AND TROUBLE SHOOTING [e-IFU]
The Flocare Infinity III is equipped with several sensors and safety features linked to clear visual and audio alarms and warning messages on the display.
In case any of the alarms occur, the pump will generate an audible and visual alarm and stops administering. The back light of the display automatically switches on.
Exception to this is the low battery alarm, in this situation the pump continues working.
If an alarm or warning message appears on the display:
• The HOME [ ] button acknowledges an alarm or warning state and dismisses the alarm or warning message.
• The SNOOZE [ ] button snoozes the alarm or warning audio signal for 2 minutes whilst the alarm or warning message remains on the display. A
suppressed audio icon will appear on the display indicating that the audio signal has been snoozed.
• The INFORMATION button [ ] can provide suggestions on the display to solve an alarm or warning condition.
Note: during an alarm or warning, all other buttons are disabled. The HOME [ ]button is the only button that acknowledge and dismiss an alarm or warning
message.
10. CLEANING, INSPECTION & SERVICING GUIDELINES [e-IFU]
For optimum and safe pump operation, the pump should be kept clean and free from debris. It is recommended to clean the pump with a wet cloth after every
completed feeding regimen.
It is recommended to clean the pump regularly under (running) warm tap water with standard washing up liquid in line with local cleaning and hygiene policies in
place.
Disconnect the pump from the mains before cleaning. To avoid electrical shock, never clean the pump with AC power adapter plugged
into an outlet or when pump is on.
Do not immerse the pump in water.
Do not use aggressive cleaners or disinfectants such as acetone, benzene or iodine.
The pump is not intended to be cleanevd using a dishwasher.
Do not sterilize the pump, e.g. by irradiation, EtO, steam or in an autoclave.
Before using or setting a feeding regimen, check the integrity of the pump, the AC power plug and its accessories. Do not use the pump if it is damaged.
ACCESSORIES
Dedicated carry bags and pump stands are available for the Flocare Infinity III pump. Please contact your local Nutricia sales representative for availability and
ordering information of the respective parts.
RECYCLING & DISPOSAL
The pump and its electrical accessories (AC power plug, PDMS cable, Nurse Call cable), should be disposed according to local standards and regulations governing
the disposal of electronic waste (e-waste). Other accessories can be disposed of or recycled as standard non-hazardous waste.
Note: In case of pump scrapping, always notify your Nutricia sales unit of the pumps serial number.
11. SPECIFICATIONS [e-IFU]
11.1. PERFORMANCE
Volumetric accuracy ±5%
Battery life ~24h @ 125mL/h, ~12h @ 250mL/h
Air bubble detection > 1.5 mL of air in giving set after the pump set
Upstream occlusion pressure -34 kPa ± 21 kPa for 5 sec.
Downstream occlusion pressure 84 kPa ± 21 kPa for 30 sec. / 103 kPa ± 21kPa for 5 sec.
11.2. OPERATING
Atmospheric pressure 65 – 106 kPa
Temperature 5° – 40°C
Humidity 15 – 95%, non-condensing
11.3. STORAGE
Atmospheric pressure 50 – 106 kPa
Temperature -20° – 60°C
Humidity 10 – 95%, non-condensing
Shelf life None. A normal expected use life is 5 years. The battery life degrades over time and should be charged before any use
Note: Time to recover from maximum and minimum storage temperature to operating temperature is ~30 min.
12. SYMBOLS [e-IFU]
Manufacturer Consult instructions for use
Serial number Not for IV use (enteral use only)
Mechanical and fluid ingress CE mark and Notified Body identification number
13. WARRANTY
All service and repair activities should only be carried out by an approved service centre, authorised repair centre or a Nutricia qualified Technician / BMET.
The warranty is for a period of 36 months for customers from the date of delivery. Warranty includes the Flocare Infinity III pump, pole clamp, and AC power plug and
covers replacement, within the period for normal wear and tear.
Limitations on warranty
Warranty will be void if the product has been misused, tampered with or the performance specifications have been altered. Warranty will be void if the product is used
outside of the recommendations contained with the IFU / e IFU or in case any repairs are conducted by a non-authorised centre.
Manufacturer information
Nutricia Medical Devices BV
Taurusavenue 167
2132LS HOOFDDORP
The Netherlands
www.nutriciaflocare.com
www.nutricia.com
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