Nutricia Flocare Infinity III Instructions For Use Manual
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Nutricia Flocare Infinity III Instructions For Use Manual

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ZMNL900895 • Flocare Infinity III Pump digital • 400014_A • 110 x 155 mm• 25/04/2023 • Black
Manufacturer:
Nutricia Medical Devices BV,
Taurusavenue 167, 2132 LS Hoofddorp,
The Netherlands,
www.nutriciaflocare.com
208_r2.indd 1
208_r2.indd 1
INSTRUCTIONS FOR USE
EN
400014_A
Date of issue April 2023
25/04/23
25/04/23

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  • Page 1 ZMNL900895 • Flocare Infinity III Pump digital • 400014_A • 110 x 155 mm• 25/04/2023 • Black INSTRUCTIONS FOR USE Manufacturer: Nutricia Medical Devices BV, Taurusavenue 167, 2132 LS Hoofddorp, 400014_A The Netherlands, Date of issue April 2023 www.nutriciaflocare.com 208_r2.indd 1 208_r2.indd 1...

  • Page 2: Table Of Contents

    1. INTRODUCTION ..........................5 2. INTENDED USE ............................ 5 3. SAFETY INFORMATION ........................5 3.1. GENERAL SAFETY ........................5 3.2. WARNINGS AND PRECAUTIONS ..................6 4. QUICK REFERENCE OVERVIEW ....................10 5. USER INTERFACE ..........................11 5.1. BUTTONS ..........................11 5.1.1. Home button ....................11 5.1.2.
  • Page 3 7.2. PAUSE / RUNNING MODE ....................16 7.3. FILL THE FLOCARE INFINITY GIVING SET ...............16 7.4. SETTINGS MENU ........................16 7.4.1. Define therapy list ....................16 7.4.2. Personalise therapies .....................17 7.4.3. Therapy lock ......................17 7.4.4. Reset patient data ....................17 7.4.5. Sound .........................17 7.4.6. Therapy completed ....................18 7.4.7.
  • Page 4 10. CLEANING, INSPECTION & SERVICING GUIDELINES ............28 10.1. SWITCHING BETWEEN PATIENTS .................28 10.2. CLEANING & DISINFECTION ....................28 10.3. INSPECTION .........................29 10.3.1. Housing ........................29 10.3.2. Keypad ........................29 10.3.3. Rotor ........................29 10.3.4. AC power plug .......................30 10.3.5. Electrical .........................30 10.4. SERVICING ..........................30 10.5.

  • Page 5: Introduction

    2. INTENDED USE The Flocare Infinity III is intended to be used to administer enteral nutrition or hydration fluids in a safe, controlled and intuitive manner into the gastrointestinal tract of a patient who is unable to eat or drink normally. The pump will operate in a clinical environment or home care setting and can be used by trained care givers and patients for bedside as well as for mobile use.

  • Page 6: Warnings And Precautions

    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. •...
  • Page 7 equipment and the other equipment should be observed to verify that they are operating normally. • A leaking enteral feeding system might compromise the pump's ability to detect an occlusion. Ensure the enteral feeding system is installed and connected properly. During a feeding therapy, ensure there is no leakage observed within the system.
  • Page 8 • For volume and nutrients sensitive patients (e.g. children with metabolic conditions using • overnight and/or unmonitored therapy) where a constant nutrition delivery is vital and/ or connected with consequential therapies (e.g. an insulin delivery pump):, additional surveillance is recommended to be put in place to verify good functioning of the enteral feeding system and programmed therapy.
  • Page 9 • 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.

  • Page 10: Quick Reference Overview

    4. QUICK REFERENCE OVERVIEW - 10 - 208_r2.indd 10 208_r2.indd 10 25/04/23 25/04/23...

  • Page 11: User Interface

    Pump status indicator Occlusion OUT sensor ENPlus connector ® Colour display AC power plug ENFit connector ® Door AC power socket Medication port Pump rotor AC charging light Cassette Charger plug Speaker Drip chamber Occlusion IN sensor Pole clamp interface Detachable AC plug Air sensor Pole clamp...

  • Page 12: Information Button

    Note: the alarm remains visible. The [ ] symbol on the display indicates that the alarm sound is snoozed. if n 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: –...

  • Page 13: Pump Status Indicator

    – 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.

  • Page 14: Status Bar

    5.4.1. Status bar The status bar shows the system status by presenting icons at the top of the screen. Note: icons are shown in home screen view only and can change the status bar order. 5.4.2. Icons x The Nurse call icon indicates that the pump is set to Nurse Call mode x The PDMS icon indicates that the pump is set to PDMS mode x The Therapy lock icon indicates that the current active therapy has been locked and cannot be modified unless unlocked.

  • Page 15: Pump Setup

    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.

  • Page 16: Switch The Pump Off

    5. Pump is now ready to be programmed 7.2. PAUSE / RUNNING MODE The Flocare Infinity III is either in pause mode waiting for user instructions or is in running mode delivering a therapy to a patient. The pause or running modes are controlled by the...

  • Page 17: Settings Menu

    Define therapy list Therapy list result Define therapy list Therapy list result 7.4. SETTINGS MENU 7.4.1. Define therapy list DEFINE THERAPY LIST controls the list of available therapies that are visible when the THERAPY [ ] button is pressed. Therapies that are currently enabled are marked with a green switch symbol.

  • Page 18: Sound

    7.4.5. Sound The Flocare Infinity III supports 3 AUDIO VOLUMES, ‘Low, Medium and High’ and can be set by the user. For safety reasons the alarm volume is automatically escalated to "High" in both settings ‘Low’ and ‘Medium’ after 3 min. This safety feature cannot be turned off.

  • Page 19: About This Pump

    Note: at first pump start up or after a factory reset, the Flocare Infinity III will guide you automatically through the language selection 7.4.10. About this pump Information concerning the pump is gathered in the ABOUT THIS PUMP screen where you can...

  • Page 20: Program A Rate Therapy (Not Recommended For Volume Sensitive Patients)

    Infinity™ III shows ® resulting parameters based on the user input for safety and convenience reasons. Note: after each step, the Flocare Infinity III guides you to the next programming step. x From the home screen press the THERAPY [ ]button x Select INTERMITTENT by pressing the associated soft button.

  • Page 21: Change The Parameters Of An Active Therapy

    Note: When the pump is in the NEXT PORTION mode, the home screen will differ, indicating and counting down the time until the next portion. The running indicator will remain active during the count down. 7.5.4. Change the parameters of an active therapy Changes to an active therapy are possible regardless whether a manual programmed or a personalised therapy is active.

  • Page 22: Information & Memory Functions

    7.7. INFORMATION & MEMORY FUNCTIONS 7.7.1. Therapy information When a ‘VOLUME – RATE’ or ‘RATE’ therapy has been programmed, the Flocare Infinity III provides useful information concerning your active therapy when the THERAPY INFORMATION button is pressed. This function can be accessed from the HOME SCREEN, SOFT BUTTON 1, THERAPY INFORMATION.

  • Page 23: Connect To A Nurse Call Or Pdms System

    PDMS system. 7.10. BATTERY The Flocare Infinity III is equipped with Lithium/Ion battery technology and needs to be fully charged for a period of 6 hours prior to or during its first use, this will maximise the battery life time.

  • Page 24: Communications Mode

    8.3. FACTORY RESET This will reset all user settings and brings the Flocare Infinity III to its original state. Note: after a factory reset, the Flocare Infinity III shall ask to set the language and time and date. 8.4. LIVE SENSOR VALUES The live sensor values are intended to be used for inspection and maintenance activities by qualified service centers and BMETs.

  • Page 25: Problem Solver Chart

    x The HOME [ ] button acknowledges an alarm or warning state and dismisses the alarm or warning message. x 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.
  • Page 26 PROBLEM SOLVER CHART Alarm description Cause Solution Battery empty The battery charge is Connect the pump to the AC power critically low adapter and mains to recharge the battery immediately for 6 hours. During charging the pump can be used. Charging please wait The battery is Wait until the battery is charged.
  • Page 27 PROBLEM SOLVER CHART Alarm description Cause Solution Occlusion out The pump has Check the Flocare Infinity giving set detected an between the pump and feeding tube occlusion between for kinks or other obstructions and the pump and the correct if found. patient.

  • Page 28: Cleaning, Inspection & Servicing Guidelines

    PROBLEM SOLVER CHART Alarm description Cause Solution Therapy completed The pump has Pump has completed the delivery of completed the the programmed therapy. delivery of the programmed therapy. Volume not set No volume has been Program a Volume (mL) programmed when starting a therapy.

  • Page 29: Inspection

    pump paying particular attention to the sensor area on the top housing, the rotor including its rollers and in the corners of the keypad and screen. Then dry the pump with a clean cloth. After cleaning, the pump can be disinfected using a mild, diluted disinfectant or cleaning solution and damp cloth Follow local policies for cleaning and disinfection of medical equipment.

  • Page 30: Ac Power Plug

    5 years 10.5. ACCESSORIES The following ancillaries and accessories are available for the Flocare Infinity III pump, please contact your local Nutricia sales representative for availability and ordering information of the respective parts.

  • Page 31: Recycling & Disposal

    Note: In case of pump scrapping, always notify your Nutricia sales representative of the pump serial number. 11. SPECIFICATIONS MEDICAL EQUIPMENT Nutricia Flocare Infinity III Enteral Feeding pump 11.1. PERFORMANCE Volumetric accuracy (1) ± 5 % Flow rate 1-600 mL/h in 1 mL/h increments...

  • Page 32: Electrical / Mechanical

    11.2. ELECTRICAL / MECHANICAL Pumping mechanism Rotary peristaltic Dimensions ~ 154mm x 120mm x 49mm (L, W, H) Weight ~ 432 g Ingress protection (pump) IP25 (washable under running tap water) Ingress protection (AC power adapter) IP22 (protection to dripping water) Battery 3.7V;...

  • Page 33: Emc

    Electromagnetic emissions may affect the operation of any electronic medical device, including enteral feeding pumps. The Flocare Infinity III will not be affected by electromagnetic emissions in most environments. However, some electromagnetic fields produced by personal communication equipment, household appliances, or occupational tools may cause electromagnetic interference (EMI) which can affect the pump's essential performance.

  • Page 34: Alarm Response Times

    Head height impact <1.5% per 152 mm Back pressure impact <0.5% per 6.9 kPa 11.7. ALARM RESPONSE TIMES Maximum time to alarm (mm:ss) Occlusion alarm Flow rate 1 ml/h 5 ml/h 50 ml/h 100 ml/h 300 ml/h 600 ml/h Upstream 8:00 2:30 1:20...

  • Page 35: Glossary Of Terms

    12. GLOSSARY OF TERMS BMET Biomedical Equipment Technician Electromagnetic compatibility Instructions for Use IP25 IP Code, International Protection Marking. IP rating determines how resistant something is to environmental elements. For a medical device, as per the IEC 60529 standard. Occlusion A blockage of the system preventing a flow causing a downstream pressure to increase or an upstream pressure to decrease, activating the pump occlusion out or occlusion in alarm.

  • Page 36: Symbols

    13. SYMBOLS Manufacturer Catalogue number Serial number Consult instructions for use Caution Consult accompanying documents Type BF Shock protection Class II equipment CE mark and Notified Body Mechanical and fluid ingress identification number Waste Electrical and Electronic Not for IV use Equipment Battery Direct current...

  • Page 37: Warranty

    14. 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.
  • Page 38 APPENDIX A: GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC COMPATIBILITY Test Limit Electromagnetic environment - guidance Conducted emission CISPR 11, Group 1, Device uses RF energy only for its Class B internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 39 Test Limit Electromagnetic environment - guidance Proximity fields 385 MHz; Pulse Portable and mobile RF form RF wireless Modulation: 18 Hz; communications equipment should communications 27 V/m be used no closer to any part of the equipment 450 MHz, FM + 5 Hz device, including cables, than the (IEC 61000-4-3) deviation: 1 kHz sine;...
  • Page 40 Test Limit Electromagnetic environment - guidance Rated power frequency 30 A/m, 50 Hz Power frequency magnetic fields magnetic fields should be at levels characteristic of a typical location in a typical commercial (IEC 61000-4-8) or hospital environment. Voltage dips / Voltage 0 % UT for 0.5 Mains power quality should be that of interruptions...
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