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Related Manuals for Fresenius Kabi Exelia Combox 3.0
Summary of Contents for Fresenius Kabi Exelia Combox 3.0
- Page 1 Exelia Combox Pump management unit Software version 3.3 Instructions For Use...
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Page 2: Symbol Descriptions
Symbol descriptions Warning (Refer to the Instructions For Use) Refer to the Instructions For Use CE mark Product reference / part number Product serial number Medical Device Unique Device Identifier Name and address of the manufacturer / Date of Name and address of the manufacturing facility manufacture (Year-Month-Day) Index of protection against solid foreign objects IP22... -
Page 3: Table Of Contents
Table of contents 1 Introduction 1.1 Scope................................5 1.2 Exelia infusion system............................5 1.3 Intended purpose.............................5 1.4 Intended use..............................5 1.5 Clinical benefits..............................6 1.6 Side effects...............................6 1.7 Compatibility matrix............................6 2 Description 2.1 Front view.................................7 2.2 Side view................................7 2.3 Back view.................................7 2.4 Bottom view..............................8 2.5 LEDs.................................8 2.6 Packaging contents............................9 3 Installation and Getting started... - Page 4 7.2 Maintenance and service..........................25 7.3 Warranty.................................26 7.4 Storage................................26 7.5 Recycling and disposal...........................27 8 Data Communication 8.1 Cybersecurity..............................28 9 Specifications and Technical characteristics 9.1 Performance ..............................29 9.2 Specifications of Exelia Combox........................29 9.3 Specifications of Exelia Link...........................30 9.4 Specifications of Exelia ComAdaptor ......................31 9.5 Weights of the station components........................31 9.6 Compliance..............................32 9.7 Guidance and manufacturer's declaration on EMC..................32...
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Page 5: Introduction
Exelia Combox and Exelia ComAdaptor must only be used by qualified and trained healthcare professionals. User training, installation and configuration must only be performed by a product specialist trained by Fresenius Kabi. Computing and network connections related to the Exelia infusion system must be performed and maintained by IT... -
Page 6: Clinical Benefits
Kabi product specialist or by someone who is experienced with the equipment and can train you for the most important functions. For training, contact your Fresenius Kabi sales representative. See local contact details at the end of these Instructions for Use (IFU). -
Page 7: Description
2 Description 2.1 Front view Legend LEDs. From left to right: Power, Battery, Maintenance status. See LEDs on page 8 Grooves for attaching an Exelia Link Communication connector for the Exelia Link Centralized alarm LED for the Exelia infusion system. See Top LED page 8 Power outlet for the Exelia Link... -
Page 8: Bottom View
2.4 Bottom view Legend Device Identification Label Power inlet Power cord holder On the device identification label, the UDI (Unique Device Identifier) is presented in machine-readable form (AIDC - Automatic Identification and Data Capture - technology) and as text: (01) Product Identifier GTIN (21) Product Serial Number (11) Date of Manufacture (240) Product Reference... -
Page 9: Packaging Contents
■ 1 Quality Control Certificate ■ 1 Simplified Instructions For Use document If the packaging contents are incomplete or damaged, contact your Fresenius Kabi sales representative. The device packaging has the following characteristics: ■ Weight: approximately 640 g for Exelia Combox and 160 g for Exelia ComAdaptor ■... -
Page 10: Installation And Getting Started
The Exelia infusion system has been tested in combination with devices and accessories described in the section Ordering information on page 35. The use of other devices and accessories has not been tested and Fresenius Kabi cannot be held responsible for issues or potential safety hazards or potential degraded performance resulting from their use. -
Page 11: Exelia Infusion System Installation
It is the responsibility of the healthcare facility to ensure that the assembly and modifications of Exelia infusion system during its actual service life comply with the requirements of the IEC 60601-1 standard. To get support, contact your Fresenius Kabi Technical Service. 3.2.1 Installation at patient bedside... - Page 12 You can attach the power cord to the cord holder. WARNING ■ Only use the power cord distributed by Fresenius Kabi with the Exelia infusion system. Lower quality power cords can create disturbances during infusions and cause electrical hazards. ■ Do not use an extension cord or a multiple socket when connecting the device to the AC power supply.
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Page 13: Power Supply
2. Attach the Exelia Link to the top of the pole, and tighten the screw clamp. 3. Connect the Exelia Link for power and communication. a. Plug the Exelia Link into the power supply. b. Connect the communication cable to Exelia ComAdaptor (C6 connector) and to Exelia Combox (C3 or C4 connector). -
Page 14: Powering On And Off
■ First column: Exelia Combox (or the highest Exelia Link if there is no Exelia Combox), which is fed by the hospital power grid. ■ Second column: the highest Exelia Link in the column, which is fed by the hospital power grid. Each additional Exelia Link is powered by the device above it. - Page 15 Exelia Combox detects the top Exelia Link on each column. It then relies on the top Exelia Link to discover inserted modules and any racks connected below. In case of invalid configurations (for example, 4 racks in a column, or unsupported or malfunctioning modules), Exelia Combox rejects all communication from these devices.
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Page 16: Alarms And Safety Features
4 Alarms and Safety features 4.1 Alarms The Exelia infusion system can warn you of problems or potential problems relating to the following: ■ Infusion status (see Functional alarms on page 17) ■ Equipment malfunction (see Technical errors on page 19) Each device in the Exelia infusion system, except Exelia Link and the accessories, has its own set of alarm signals: ■... -
Page 17: Functional Alarms
Reacting to a technical error on page 19 or contact your qualified biomedical technician or your Fresenius Kabi Technical Service. ■ If the maintenance status LED is blinking red, it means that the current configuration of the infusion station is not correct or the Exelia Combox has a technical error. - Page 18 The alarm and its signals disappear as soon as the corresponding condition is solved. If the problem persists, a technical error is raised at startup, contact your qualified biomedical technician or your Fresenius Kabi Technical Service. Low-priority alarms Message...
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Page 19: Technical Errors
Message Emits a Stops Problem Resolution sound? infusion? The Exelia Combox received an unexpected message from the Message from module [X] module identified with number [X]. inconsistent Try to reconnect the module (you can try to reconnect it on another slot in the station). If the module is not infusing, unplug the module, restart it then re-install it. -
Page 20: Troubleshooting
1. Check the position of the screw clamp. 2. Check that the screw clamp is safely tightened on the pole. 3. Contact your qualified biomedical technician or your Fresenius Kabi Technical Service. Exelia Combox is damaged, noisy or with an 1. - Page 21 For more information on troubleshooting issues, contact your qualified biomedical technician or your Fresenius Kabi Technical Service.
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Page 22: Removal And Transport
6 Removal and Transport 6.1 Transport position The maximum configuration for transporting an infusion station on the Multi-Channel Rolling Stand is the following: ■ One Exelia Therapy Manager with the TM support ■ One Exelia Combox ■ One Exelia Link ■... - Page 23 2. Unplug the devices from the mains power supply. Depending on the configuration: ■ The highest Exelia Link ■ Exelia Combox ■ Exelia Therapy Manager 3. Disconnect all communication cables between the Exelia Therapy Manager and the Exelia Combox, and between the Exelia Combox and the Exelia ComAdaptor.
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Page 24: Cleaning, Maintenance, And Storage
7 Cleaning, Maintenance, and Storage 7.1 Cleaning and disinfecting Follow the instructions provided to ensure effective cleaning and disinfection of the equipment. The instructions and recommended agents are applicable to Exelia Combox and Exelia ComAdaptor. ■ To avoid risks of infection and microbial transmission, make sure that you adequately clean and disinfect the equipment. -
Page 25: Maintenance And Service
Maintenance operations are described in the technical manual. You can find the technical manual on Fresenius Kabi website: key2.fresenius-kabi.com. Search for the document type "Technical manual" and enter the device name and version as stated on the cover of this document. -
Page 26: Warranty
■ The serial number (ID/N°) must not have been altered, changed or erased. If one or more of these conditions have been violated, Fresenius Kabi will prepare a repair estimate covering all required parts and labour. To repair or return a device, contact your Fresenius Kabi sales representative. -
Page 27: Recycling And Disposal
Before disposal, make sure that a qualified technician removes the battery from the device according to the procedure described in the Technical Manual. For information on waste processing regulations and dismantling, contact your Fresenius Kabi sales representative. -
Page 28: Data Communication
For any question related to connectivity or updates of the Exelia devices, contact your biomedical department or your Fresenius Kabi representative. In case that you need to report any suspected cybersecurity event or vulnerabilities related to the Exelia devices , please contact your local Fresenius Kabi representative or submit a request to the Fresenius CERT (cert@fresenius.com). -
Page 29: Specifications And Technical Characteristics
9 Specifications and Technical characteristics 9.1 Performance The Exelia Combox, as a component of Exelia infusion system, participates in the infusion relay function which is an essential performance of the Exelia infusion system. The Exelia ComAdaptor has no essential performance of its own, as defined in the IEC 60601-1 standard. Refer to the Instructions For Use of Exelia SP for Infusion relay performance. -
Page 30: Specifications Of Exelia Link
Electric protection Class II with functional earth, with 3-wire power cord 9.2.5 Data communication connectors Communication connector Function Data communication and back-up power source output for Exelia Link. Connector to Exelia Link Custom female connector - 15 VDC below Communication protocol Proprietary USB connectors Function... -
Page 31: Specifications Of Exelia Comadaptor
Mains connector Standard appliance inlet IEC320 type C14 Power supply 100 - 240 VAC, 50-60 Hz Maximum power (with 4 215 - 255 VA modules) Protective fuses 2 fuses, 2 A time-delay fuses with high breaking capacity - T 2A H 250 V Fuseholder is not accessible externally. -
Page 32: Compliance
Weight of Exelia Combox Approximately 2.600 kg Weight of Exelia ComAdaptor Approximately 220 g Weight of Exelia Therapy Manager Approximately 1.700 kg Weight of TM support Approximately 1.780 kg 9.6 Compliance Compliant with the following IP22 Index of protection against ingress of water or standards: Electro-medical equipment particulate matter... - Page 33 INFORMATION The emission characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
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Page 34: A Glossary
A Glossary AIDC Automatic Identification and Data Capture DECT Digital Enhanced Cordless Telecommunications Electroencephalogram Electrocardiogram ExtraCorporeal Membrane Oxygenation ECMO Electromagnetic Compatibility GTIN Global Trade Item Number High Frequency H/W/D Height / Width / Depth Instructions For Use Information Technology Light Emitting Diode Limited Power Source MOPP Means Of Patient Protection... -
Page 35: B Ordering Information
INFORMATION Additional power cords and "Instructions for Use" documents must be ordered separately. Contact your Fresenius Kabi sales representative for ordering. B.2 Associated software Name Description... - Page 36 Index Alarms LEDs Functional alarms Priority levels Maintenance and service 9, Battery Characteristics Charge level Packaging Full charge time Powering on/off Battery life Power supply Cleaning Recycling Disassembling the system Storage Disinfecting Training Electromagnetic guidance Transport Events Move the infusion system History Troubleshooting EXELIA Combox...
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Page 37: Release Notes
This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Vigilant® and EXELIA® are registered trademarks in the name of Fresenius Kabi in selected countries. - Page 40 Local contacts for servicing 16311-2_ifu_exelia_cb_eng Fresenius Kabi AG Fresenius Vial S.A.S. Else-Kröner-Str. 1 Le Grand Chemin 61352 Bad Homburg - GERMANY 38590 Brézins - France Tel.: +49 (0) 6172 / 686-0 www.fresenius-kabi.com...
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