Fresenius Kabi agilia User manual

Drop Sensor
ENG Instructions For Use
FRA Notice d’Utilisation From page 1 to page 9
De la page 10 à la page 16
DEU Gebrauchsanweisung Von Seite 17 bis Seite 23
ITA Istruzioni d’Uso
SPA Manual De Usuario
Dalla pagina 24 alla pagina 30
De la página 31 a la página 37
NL Gebruikershandleiding Van pagina 38 tot pagina 44
CES Návod k použití
DAN Brugervejledning
FIN Käyttöohjeet
NOR Bruksanvisning
SWE Bruksanvisning
POL Instrukcja obsługi
Od strany 45 po stranu 51
Fra side 52 til side 58
Sivulta 59 sivulle 65
Fra side 66 til side 72
Från sidan 73 till sidan 79
Od strony 80 do 87
SLK Návod na používanie Od strany 88 po stranu 94

12352-1_IFU_Drop_Sensor_EU1 3
Symbols description
The UDI (Unique Device Identifier) is represented in AIDC (Automatic Identification and Data Capture) and readable
text:
(01) Product Identifier GTIN (Global Trade Identification Number)
(21) Product Lot Number
(11) Date of Manufacture
(240) Product Reference
(10) Manufacturing order
Table of contents
Introduction3
DESCRIPTION4
PACKAGING4
DROP SENSOR installation4
CLEANING AND DISINFECTING5
Technical CHARACTERISTICs 7
Guidance and manufacturer’s declaration on EMC 7
RecYCLING AND DISPOSAL 7
DROP SENSOR TEST7
LIFE CYCLE7
Product reference / part number Product lot number
Output terminal - connector Input terminal – connector
Warning
(Refer to the Instructions for Use) Direct Current
Refer to the Instructions for Use
Part included in a recycling process Name and address of the manufacturing
facility
CE mark Name and address of the manufacturer /
Date of manufacture
Warning of a potential hazard that could
result in serious personal injury and/or
product damage if the written instructions are
not followed
Recommendations to be followed.
0123

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1 Introduction
The Drop Sensor is intended to be connected to Volumetric infusion pumps from Fresenius Kabi. For a
list of compatible Volumetric infusion pumps, refer to the compatibility section in this document.
Using a Drop Sensor is recommended if the actual volume of the fluid container is not known accurately.
1.1 Scope
These Instructions For Use (IFU) are applicable to the Drop Sensor accessory.
The user must adhere to the instructions specified in this document. Failure to observe these instructions
may result in damage to the equipment, injury to patients or injury to users.
1.2 Intended Use
The Drop Sensor is intended to detect drops in the administration set drip chamber when connected to
a compatible volumetric pump. It is intended for use by healthcare professionals in healthcare facility on
a daily basis and continuously.
1.3 Intended Users
The Drop Sensor is intended for use by qualified healthcare professionals.
The Drop Sensor is intended to be used by the same population as the compatible Volumetric infusion
pumps.
For more information, please refer to the Instructions for Use and the System Components booklet
accompagnying the Agilia VP pumps before operating with the Drop Sensor.
1.4 Intended Patients
The Drop Sensor is intended to be used on the same population as the compatible Volumetric infusion
pumps. For more information, please refer to the Agilia VP Instructions for Use.
1.5 Use environment
The Drop Sensor is intended for use in healthcare environments.
Operating temperature range: 5°C to 40°C.
Operating pressure range: 700 hPa (525 mmHg / 10.15 PSI) to 1060 hPa (795 mmHg / 15.37 PSI).
Operating humidity range: 20% to 90%, no condensation.
Storage and transport temperature: -10°C to +60°C.
Storage and transport pressure: 500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg / 15.37 PSI).
Storage and transport humidity: 10% to 90%, no condensation.
Altitude: 3000m above sea-level.
1.6 Compatibility
The Drop Sensor is compatible with the Agilia VP pumps range from Fresenius Kabi and must be used
with the associated infusion sets recommended by Fresenius Kabi.
The use of the Drop Sensor modifies the pump behavior.
Information:
The Drop Sensor should be utilised under specified operational, storage and transport
conditions to ensure its proper performance.
Information:
Use ONLY Volumetric infusion pumps from Fresenius Kabi with the Drop Sensor. For
operating with these pumps or any further information, please contact our Technical
Service.

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2 Description
3 Packaging
The Drop Sensor packaging contains the following elements:
1 Drop Sensor,
1 printed copy of the Drop Sensor Instructions For Use (this document)
1 label indicating the Drop Sensor positioning:
4 Drop Sensor installation
All connection and disconnection operations must be executed by qualified staff only.
Ensure that the Drop Sensor is not damaged and that it is properly installed prior to use it.
Always connect a Drop Sensor when the Volumetric infusion pump is off.
The Volumetric infusion pump automatically detects the presence of a Drop Sensor. The presence of the
Drop Sensor can be set as mandatory in the Volumetric infusion pump options. Please refer to the
Volumetric infusion pump’s IFU.
Before powering on the pump, connect the Drop Sensor connector to the
connection socket on the back of the pump.
Information:
If the contents are incomplete or damaged, contact your Fresenius Kabi sales
representative.
1. Press the Drop Sensor clip.
2. Align the vertical part of the Drop Sensor with the drip chamber’s air vent.
3. Release the clip.
4. Confirm the following:
The Drop Sensor and the drip chamber are in a vertical position.
The Drop Sensor is correctly aligned with the drip chamber’s air vent.
There are no drops on the drip chamber walls.
Metal housing Coil cable
Clip Connector
Plastic housing

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5 Cleaning and Disinfecting
To avoid the risks of infection and microbial transmission, make sure to adequately clean and disinfect
the equipment.
5.1 When to Clean and Disinfect the Drop Sensor
Thoroughly clean and disinfect the Drop Sensor in the following cases:
 After each patient use,
Before any maintenance,
On a routine basis when the Drop Sensor is not in use,
In case of contamination by blood or bodily fluids when the Drop Sensor is in use,
Before storage.
5.2 Recommended Agents for Cleaning and Disinfecting
Didecyldimethylammonium chloride (example: Wip’Anios Excel by Anios).
The drip chamber is filled approximately 1/2 full and the level of liquid is below the Drop Sensor.
The pump and the Drop Sensor are correctly installed.
5. The Drop Sensor is equipped with two circular magnets.
You can use these magnets to fix the Drop Sensor and the drip chamber on the right side of the
Volumetric infusion pump from Fresenius Kabi.
Correct installation of the Drop Sensor on the drip chamber
Information:
Programming of the simple rate mode is recommended at the Drop Sensor detection.
Warning:
For transport during infusion, the pump with a Drop Sensor connected on it must be
installed on a rolling stand.
Warning:
The disinfecting procedure must be done immediately after cleaning. Disinfecting the Drop
Sensor without prior cleaning is not effective.
The Drop Sensor is not intended to be sterilized; sterilization may result in damage to it.
Standard Drip Chamber Drip Chamber with Central Ring
(example: VL ST00) (example: VL ON42)

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5.3 Instructions for Cleaning and Disinfecting
Follow the instructions provided to ensure effective cleaning and disinfecting of the equipment.
Use the agents according to the manufacturer's instructions. This may include wearing personal
protective equipment (gloves, lab coat, glasses, and so on), or diluting the agent according to the
manufacturer's guidelines.
For disinfectants, respect the contact time required for the antimicrobial agents to act (the time the
agent must be left on the Drop Sensor for disinfection to be effective).
The following information is provided to protect staff against electric shock, and to protect the Drop
Sensor from damage that can cause it to malfunction.
5.3.1 Cleaning instructions
Prerequisites
The cable of Drop Sensor is unplugged from the infusion pump.
The air is at room temperature (68 to 77 °F, or 20 to 25 °C).
The operator is wearing suitable protective equipment.
Protocol
1. Place the Drop Sensor on a cleaned surface or disposable underlay.
2. With a fresh ready-to-use wipe, remove gross filth and heavy soils loads. Then thoroughly clean all
exposed surfaces (plastic and metal housing, clip, cable and connector) of the Drop Sensor.
A minimum cleaning of 1 minute is recommended (allow to remain visibly wet for 1 minute), until all
organic matter is dissolved and removed.
Do not allow any part of the Drop Sensor to become saturated or submersed in liquid.
Do not permit liquids to run, leak, or drip inside of the Drop Sensor housing.
3. Allow the Drop Sensor to completely dry at ambient room temperature.
5.3.2 Disinfecting Instructions
Prerequisites
The cleaning protocol has been performed.
The cable of Drop Sensor is unplugged from the infusion pump.
The air is at room temperature (68 to 77 °F, or 20 to 25 °C).
The operator is wearing suitable protective equipment.
Protocol
1. Place the precleaned Drop Sensor on a cleaned surface or disposable underlay.
2. Wipe down all external precleaned surfaces of the Drop Sensor (same surfaces as cleaned in the
cleaning procedure).
Do not allow any part of the Drop Sensor to become saturated.
Do not permit liquids to run, leak, or drip inside of the Drop Sensor housing.
3. Using a new ready-to-use wipe, repeat the step 2 and ensure that the minimum contact time for this
step is 3 minutes for bactericide activity (surface remain visibly wet for 3 minutes).
Respect the indicated contact time from the manufacturer recommendations for the required
antimicrobial activity.
4. Allow the Drop Sensor to completely dry at ambient room temperature.
For cleaning and disinfecting of the infusion pumps, please refer to their relevant IFU, section Cleaning
and Disinfecting.
Information:
Only qualified staff can clean and disinfect the Drop Sensor.
Do not place the Drop Sensor in an autoclave or immerse it in liquid.
Do not spray liquids directly on connectors. Instead, use a cleaning cloth or disposable
wipes.

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6 Technical characteristics
7 Guidance and manufacturer’s declaration on EMC
Please refer to the instructions as per compatible Volumetric infusion pumps IFU, section Guidance and
manufacturer’s declaration on ElectroMagnetic Compatibility.
8 Recycling and Disposal
Devices with this label must not be disposed of with the general waste. They must be
collected separately and disposed of according to local regulations.
9 Drop Sensor test
To perform the Drop Sensor test (visual and functional tests), use the Agilia Partner maintenance
software. Please refer to the Agilia Partner IFU for further information.
10 Life cycle
The accessory can be used 10 years in normal conditions.
Connecting cable Composed of 4 wires (2 for emission, 2 for reception)
Type Coil cable
Spirals diameter ~ 0.14cm
Connector RJ11 type
Length From 0.5m to 3.5m
Weight ~ 0.080Kg
Compliance with standards IEC 60601-1 (Ed. 3) and collaterals
IEC 60601-2-24 (Ed. 2)
Information:
For more information on waste processing regulations, contact your Fresenius
Kabi representative or local distributor.

9
Local contacts for servicing
This document may contain inaccuracies or typographical errors.
Modifications may therefore be made and will be included in later editions.
Due to changing standards, legislation and material, the characteristics indicated by the text and the
images of this document are applicable only for the device that it accompanies.
This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi.
Agilia® is a registered trademark by Fresenius Kabi in selected countries.
Made in France
Revision date: May 2017
www.fresenius-kabi.com
Complete this box with your contacts:
Fresenius Kabi AG
61346 Bad Homburg
Germany
Fresenius Vial S.A.S
Le Grand Chemin
38590 Brézins
France
First CE Mark: 2017
0123

12352-1_IFU_Drop_Sensor_EU1 10
Description des symboles
L’UDI (Unique Device Identifier - identifiant unique de l’appareil) est représenté sous forme d’AIDC (Automatic
Identification and Data Capture) et dans un format de texte lisible :
• (01) Identifiant du produit GTIN (Global Trade Identification Number)
• (21) Numéro de lot du produit
• (11) Date de fabrication
• (240) Référence du produit
• (10) Référence de l’ordre de fabrication
Table des matières
1INTRODUCTION .....................................................................................................11
2DESCRIPTION ........................................................................................................12
3EMBALLAGE ...........................................................................................................12
4 INSTALLATION DU DETECTEUR DE GOUTTES..................................................12
5 NETTOYAGE ET DESINFECTION .........................................................................13
6 CARACTERISTIQUES TECHNIQUES................................................................... 15
7 RECOMMANDATIONS ET DECLARATION DU FABRICANT SUR LA CEM........ 15
8 RECYCLAGE.......................................................................................................... 15
9 TEST DU DETECTEUR DE GOUTTES ..................................................................15
10 DUREE DE VIE .......................................................................................................15
Numéro de référence ou de pièce du
produit Numéro de lot du produit
Port de communication de sortie Port de communication d’entrée
Avertissement
(consulter la notice d’utilisation) Courant continu (CC)
Consulter la notice d’utilisation
Contient des pièces recyclables
Nom et adresse du site de production
Marquage CE Nom et adresse du fabricant / Date de
fabrication
Avertissement face à un risque potentiel
susceptible de provoquer une blessure grave
ou d’endommager sérieusement l’équipement
si les instructions écrites ne sont pas
respectées
Recommandations à suivre.
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