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Braun Intermedt ECOMix - User Manual

Braun Intermedt ECOMix
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Operating instructions ECOMix
Fully Automated Dialysis Concentrate Production System
Intermedt Medizin & Technik GmbH B. Braun Melsungen AG
Gewerbestraße-Süd 13 Carl-Braun-Straße 1
26842 Ostrhauderfehn 34212 Melsungen
Germany Germany
Tel.: +49 4952/82691-0 www.bbraun.com
Fax: +49 4952/82691-29
support@intermedt.de Contact data for your country
www.intermedt.de can be found in chapter 11
0044
State: April 2021
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021

Table of Contents

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Summary

Markings

Safety Instructions

Describes safety measures and potential risks associated with system operation.

Symbols: type plate and labels

Explains the meaning of various symbols found on the device's type plates and labels.

Symbols: Production protocol

Explains the symbols used within the production protocol documentation.

General Information

Manufacturers Notes

Manufacturer's responsibilities and general system notes for users.

Operator Qualifications

Specifies the necessary qualifications for authorized operating personnel.

Transport

Guidelines and precautions for safely transporting the system.

Designated Use

Defines the intended application and limitations of the ECOMix system.

Indication

Lists the medical indications for the concentrate produced by the system.

Improper Use

Lists actions considered improper operation and potential consequences.

Installation

Details installation procedures and responsibilities for setup.

Maintenance

Outlines maintenance requirements, intervals, and responsibilities.

Service and repairs

Describes procedures for system service and repair.

Calibration

Details calibration procedures and access methods.

Sterilization and Disinfection

Explains sterilization needs and disinfection procedures for the system.

Instructions of Users

Covers user instruction, authorization, and documentation requirements.

Failure

Guidance on handling system failures and contacting technical support.

Using the operating instructions

Guidance on how to effectively read and use the operating manual.

System Description

Description of Components

Details the system's main components and their functions.

Optional components

Lists available optional system parts and their respective functions.

Safety

Overall Hazards Assessment

Assesses potential hazards during intended system operation.

Chemicals Used

Lists the chemicals used in the concentrate production process.

General Safety Instructions

Basic safety guidelines and precautions for operating the system.

Protection from electrical hazards

Safety measures related to the system's electrical components.

Emissions;EMC

Information regarding electromagnetic compatibility standards.

Maintenance

Details specific maintenance requirements and checks.

Modifications of the equipment

Rules and permissions for altering or modifying the system.

Safe handling of ECOCarts

Guidelines for safely handling ECOCarts due to weight and contents.

Operation and Functionality of the ECOMix

System Overview

Provides a visual overview of the ECOMix system's layout and components.

Control Unit

Describes the system's control unit, buttons, and LCD display interface.

User Interface

Explains the system's main menu and navigation through its interface.

Automatic Production

Details the steps for initiating and performing automatic concentrate production.

Connect ECOCart

Step-by-step instructions for connecting the ECOCart to the system.

Scanning the bar code

Instructions for scanning the ECOCart barcode for identification.

Confirm production

Steps to confirm the production process after barcode scanning.

Checking of suitability of ECOTanks

Verifies ECOTank compatibility and availability for concentrate transfer.

Filling the ECOMix with permeate

Describes the process of filling the mixing tank with permeate.

Stopping after filling

Explains how to stop the filling process and enter standby mode.

Mixing process

Details the mixing phases, composition, and temperature monitoring.

Evacuating the ECOCart

Process of draining liquid from the connected ECOCart.

Release of concentrates

Process for releasing the produced concentrate after quality checks.

Alternative options to the release of a concentrate

Other actions available after the concentrate release.

Production protocol

Instructions for documenting the production process and its data.

Taking samples

Procedure for collecting samples for laboratory analysis.

Transfer of concentrates

Process for transferring concentrate into designated storage tanks.

Rinsing the ECOMix

Procedures for rinsing the system after production cycles.

Rinsing without rinsing bridge

Specific rinsing steps when not using a rinsing bridge.

Rinsing with rinsing bridge

Specific rinsing steps when using a rinsing bridge.

Rinsing process

Details the steps and duration of the system rinsing cycle.

Filter change

Procedures for changing system filters when their capacity is reached.

Settings

Accessing system settings and configuration menus.

Tank configuration

Configuring storage tanks and their associated concentrate contents.

Batch history

Accessing historical batch production data and records.

Protection of the system with simultaneous hot cleaning of the permeate line

Safety measures and procedures during hot cleaning of the permeate line.

Uncontrolled water inflow

Handling and response procedures for unexpected water inflow.

Short user instructions

Error messages

Density deviation and laboratory analysis

Interpretation of density deviations

Explains how to interpret density deviation readings from the system.

Validation of density measurement during the installation

Describes the initial validation of density measurement after installation.

Deviation from the validation scheme

Procedures for deviating from standard system validation protocols.

Implementation of the laboratory analysis

Steps for performing laboratory analysis on collected samples.

Scope of laboratory analysis

Defines which components should be analyzed during laboratory testing.

Identification of samples for analysis

Instructions on how to properly label samples for laboratory analysis.

Information required by the laboratory

Details the information required by the laboratory for analysis.

Dealing with density deviations

How to manage and handle density variations in the concentrate.

Authorisation of concentrates without laboratory analysis

Procedures for obtaining authorization without laboratory analysis.

Discarding of concentrates

Guidelines for when and how to discard concentrate batches.

Interpretation of laboratory results

How to understand and interpret laboratory analysis outcomes.

Values on the ECOCart label

Explains the composition data found on the ECOCart label.

Instructions of Users

Authorization for Instructions

Authorizing personnel responsible for conducting user training.

Execution of an instruction

How to conduct and structure user training sessions effectively.

Documentation

Recording training completion and participant details.

Authorisation of future instructors

Training participants to become qualified future instructors.

Forms for the instruction training

Information on obtaining and filing training course forms.

Technical data;materials

Technical data

System specifications, dimensions, and environmental operating data.

Electrical safety

Electrical safety classifications, protection types, and fuse details.

Materials used for the fluids system

Lists materials in contact with fluids, ensuring compatibility and safety.

Used guidelines and standards

Lists standards and guidelines used in the device's certification.

Name plate

Information presented on the device's nameplate.

Annex

Environmental conditions required for operation

Specifies required environmental conditions for operating the system.

Storage and transport

Guidelines and precautions for storing and transporting the system.

Setting up the system

Step-by-step instructions for setting up the ECOMix system.

Preparing the mixing system

Steps to prepare the mixing system before initial use.

Transferring the concentrate

Process for transferring concentrate into suitable storage tanks.

Filling of canisters

Procedures for filling canisters with concentrate.

Practical advice

Useful tips and recommendations for system operation.

Safety instructions

General safety guidelines for operational procedures.

Storage and shelf life

Guidelines for system downtime, storage, and shelf life.

Disposal

Procedures for disposing of the ECOMix system and its components.

Regular cleaning

Routine cleaning procedures for the ECOMix system.

Disposables

Information on available consumable items like ECOCarts and filters.

Accessories

List of available accessories for the ECOMix system.

Contact Adresses

Braun Intermedt ECOMix Specifications

General IconGeneral
BrandBraun
ModelIntermedt ECOMix
CategoryIndustrial Equipment
LanguageEnglish

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