B. Braun INTERMEDT ECOMix Revolution Operating Instructions Manual
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B. Braun INTERMEDT ECOMix Revolution Operating Instructions Manual

Fully automated dialysis concentrate production system
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Operating instructions ECOMix Revolution
Intermedt Medizin & Technik GmbH
Gewerbestraße-Süd 13
26842 Ostrhauderfehn
Germany
Tel.: +49 4952/82691-0
Fax: +49 4952/82691-29
support@intermedt.de
www.intermedt.de
13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024
Fully Automated Dialysis Concentrate Production System
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen
Germany
www.bbraun.com
Contact data for your country
can be found in chapter 11
EN
0044
State: 2024/07

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  • Page 1 Operating instructions ECOMix Revolution 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...
  • Page 2 Operating instructions ECOMix Revolution These operating instructions are part of the scope of delivery. They must be kept close at hand and must remain with the equipment even when the equipment is resold. We reserve the right to implement technical changes that may affect the information and images in these operating instructions.

  • Page 3: Table Of Contents

    Contents Table of contents List of figures Markings Safety Instructions ..........Symbols: type plate and labels .
  • Page 4 Operating instructions ECOMix Revolution 4.2 Starting the production process ....... . . 4.3 Fully automatic production .

  • Page 5: Table Of Contents

    Operating instructions ECOMix Revolution 10 Declaration of conformity 11 Contact adresses State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...

  • Page 6: List Of Figures

    List of Figures 2.1 ECOMix Revolution production system with salt cartridge (ECOCart) ..2.2 Overview ECOMix Revolutionsystem ......4.1 Main menu of the ECOMix Revolution .

  • Page 7: Markings

    Markings Safety Instructions The safety instructions below describe the special safety measures you need to take before using the ECOMix. By pointing out the possible risks, they increase operational safety and you must, therefore, read them carefully before beginning to use the product. DANGER Indicates an immediate risk that may cause serious in- juries.

  • Page 8: Additional Symbols: Production Protocol

    Operating instructions ECOMix Revolution 1-time-use only Corrosive Serial number Medical device Additional Symbols: Production protocol Center/Unit/Clinic Density deviation Date Lab test necessary Sample taken Transfered to tank no. Person responsible Authorization Performed filter change Signature State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...

  • Page 9: General Information

    1 General Information 1.1 Manufacturer’s Notes The user is responsible for: ensuring the proper operation of the system by qualified personnel; • providing technical training to the operators and ensuring operators are familiar with the op- • erating instructions of the system; ensuring compliance with the safety instructions and regulations;...
  • Page 10 Operating instructions ECOMix Revolution state. This treatment process, referred to herein for convenience as production, is the designated application of this certified medical device. The ECOMix Revolution production system may only be used for the production of acidic dialysis concentrates using the original ECOCart Revolution or ECOCart ToGo supplied by Intermedt (herein only referred to as ECOCart).

  • Page 11: Improper Use

    Operating instructions ECOMix Revolution Adverse Effects Hemodialysis can cause side effects such as hypotension, nausea, vomiting and cramping. • The choice of an ECOCart and thus the selection of a suitable acidic dialysis concentrate is the responsibility of the physician. Duration of treatment, frequency of treatment and dosage must be determined by the attending physician.

  • Page 12: Calibration

    Operating instructions ECOMix Revolution 1.9 Calibration Calibration of the ECOMix Revolution system must exclusively be performed by technicians au- thorized by Intermedt. Calibration or the check of the calibration is done during installation and maintenance and is described in the corresponding manuals. The calibration data is password pro- tected and is not accessible to normal users.

  • Page 13: System Description

    2 System Description The ECOMix Revolution production system is designed for producing sodium chloride based con- centrate, called concentrate in the following sections. The ECOMix Revolution production system consists of two functional modules: 1. Microprocessor-controlled mixing system 2. Salt cartridge (ECOCart) on rollable base/mini pallet The production system may also include optional tanks (ECOTanks) for storing the concentrates produced.

  • Page 14: Description Of Components

    Operating instructions ECOMix Revolution 2.1 Description of Components Microprocessor-controlled mixing system ECOMix Revolution: Integrated pump for mixing and transferring the produced concentrate • Sensor system to protect against dry runs and overload • Mixing tank capacity: up to 800 l of concentrate •...

  • Page 15: Optional Components

    Operating instructions ECOMix Revolution 2.2 Optional components ECOTanks to store the produced concentrates • Master module for the administration and monitoring of up to 4 ECOTanks • ECOTankmodule Rev for the administration and monitoring of up to 8 ECOTanks • Sewage pump for elevated drainage connections •...

  • Page 16: Safety

    3 Safety 3.1 Overall Hazards Assessment When the system is used as intended, there are no hazards. The ECOMix Revolution can start and stop automatically with no user intervention (fully automatic production). 3.2 Chemicals Used Acetic acid and citrate acid are used for the production of acidic dialysis concentrate. Warning Acetic acid can produce noxious fumes.

  • Page 17: Protection From Electrical Hazards

    Operating instructions ECOMix Revolution Inform technical support in case of obvious technical defects or external damage and do not put the device into operation. Call the Service-Hotline: see chapter 11 3.4 Protection from electrical hazards Work on electrical components should be performed only by experts. Always keep the cabinet closed.

  • Page 18: Safe Handling Of Ecocarts

    Operating instructions ECOMix Revolution 3.8 Safe handling of ECOCarts When fully loaded, ECOCarts weigh more than 200 kg. Therefore, the following instructions must be observed: Do not roll filled ECOCarts over slopes or uneven terrain; if this is necessary, however, take •...

  • Page 19: Operation And Functionality Of The Ecomix Revolution

    4 Operation and Functionality of the ECOMix Revolution 4.1 Main menu The ECOMix Revolution production system is operated through a touch display. The displayed menu and further choices depend on the current status of the machine. Main menu of the ECOMix Revolution Figure 4.1: In the main menu the user can see the fluid levels of the connected ECOTanks.

  • Page 20: Display Accepted Ecocart

    Operating instructions ECOMix Revolution 3. Take off the caps of the couplings on top of the ECOCart 4. With both hoses consecutively: Disconnect the hose from the rinsing bridge, pull the hose to the ECOCart, remove the seal and immediately place the hose in its place; lock the coupling by turning it clockwise for an turn (without using pressure from above).

  • Page 21: Fully Automatic Production

    Operating instructions ECOMix Revolution If an ECOCart is disconnected without producing it, it should be la- Caution belled with a note, when and why it was opened and why it was not produced. Couplings must be firmly connected to avoid contamination and the ECOCart must be produced as soon as possible.
  • Page 22 Operating instructions ECOMix Revolution Warning During mixing and emptying the ECOCart must not be disconnected from the ECOMix. The ECOMix Revolution does monitor the connec- tion but for technical reasons it might take several seconds until the pump has stopped and the valves have been closed, so that larger amounts of concentrate might be spilled.
  • Page 23 Operating instructions ECOMix Revolution Authorisation of the concentrate means in this context the confirmation that the concentrate has either been automatically released by the ECOMix (no laboratory test required) or the composition has been confirmed by a laboratory test (see also section 6).

  • Page 24: Production Protocol

    Operating instructions ECOMix Revolution 4.3.6 Displays during the production process Display during filling with permeate Display during mixing Manual tank selection Display during transfer Overview of displays during production Figure 4.3: 4.4 Production protocol The production protocol is used to document the use of the medical device and must be archived for a minimum of 10 years.

  • Page 25: Production Protocol Ecocart

    Operating instructions ECOMix Revolution Production protocol ECOCart Figure 4.4: State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...

  • Page 26: Filling Of Canisters

    Operating instructions ECOMix Revolution 4.5.1 Regular rinsing process – Disconnecting the ECOCart To start this process, the ECOCart must be disconnected from the system. The ECOMix displays a request to connect the hoses. Display Rinsing Figure 4.5: 4.5.2 Water inflow After connecting the hoses to the flushing bridge or after starting the Smartclean process, the device starts the rinsing program and the intake of approx.

  • Page 27: Routine Hot Water Treatment

    Operating instructions ECOMix Revolution Display canister filling Figure 4.6: Caution: The contents of the first canister (about 5 l) must be discarded, as there may be another type of concentrate in the concentrate feed to the ECOTanks. The facility is responsible for ensuring that the canisters are suitable for storing dialy- sis concentrate in terms of condition, hygiene, labelling and regulatory requirements.

  • Page 28: Changing The Filter

    Operating instructions ECOMix Revolution 4.8 Changing the filter 4.8.1 Changing the filter The filter in the ECOMix Revolution production system is intended for the filtration of the produced concentrate during the transfer into ECOTanks. Prior to starting a production process the ECOMix production system checks if the filter capacity is sufficient for another transfer process.

  • Page 29: Use Of Optional Functions

    Operating instructions ECOMix Revolution 5. Insert the adapter ring (in the picture: white) into the insert. Use the old adapter ring for this purpose. It does not need to be exchanged. 6. Mount the device again and tighten the union nut 7.

  • Page 30: Menu "Options

    Operating instructions ECOMix Revolution 4.9.1 Authorisation of optional functions From the main menu, you can access the menu for authorising the optional functions via “Settings” “Options”: Menu “Options” Figure 4.10: Option Number Description EC-Region x 1000, Predefined regions for ECOCarts from other production sites 1001 Special produc-...

  • Page 31: Menu "Authorisation

    Operating instructions ECOMix Revolution Menu “Authorisation” Figure 4.11: 4.9.3 Special production The special production option allows ECOCarts to be produced, if the ECOMix is able to recognize the cartridge but the production data cannot be read. In order to still allow a controlled dissolving, after activating the special production in the tank configuration, the required amount of water and the TC value for each concentrate must also be entered.

  • Page 32: Start Of The Special Production Procedure

    Operating instructions ECOMix Revolution As the ECOMix produces the concentrate exclusively based on the information in the tank, it is crucial for a special production that all values are entered correctly and that the composition of the ECOCart is checked before production is started. Selection of the concentrate type via the ECOTank Checking the production data before starting Start of the special production procedure...

  • Page 33: Settings

    Operating instructions ECOMix Revolution 4.10 Settings 4.10.1 Menu Settings The menu can be opened by pressing the button ’Settings’ in the main menu. The system allows to access several submenus. Menu Settings Figure 4.14: 4.10.2 General Settings In this menu the bicarbonate concentration, the filling of canisters and the self calibration can be configured.

  • Page 34: Menu Configuration Tanks

    Operating instructions ECOMix Revolution Explanation of the settings Option Explanation Bicarbonate Adjustment of bicarbonate value in the dialysis fluid Language Selection of the GUI language Time zone Setting for local time zone Valve type* Switch for the installed valve type Auto.

  • Page 35: Technicians' Programs

    Operating instructions ECOMix Revolution 4.10.4 Batch history All the concentrates produced with the ECOMix can be accessed from here. The arrow keys allow to see prior or later batches. Display batch history Figure 4.17: The person responsible for decanting is entered at the bottom left: EM2: Automatic process ECOMix: Successfully measured by ECOMix Other value: User input...

  • Page 36: Menu: Manual Mixing

    Operating instructions ECOMix Revolution The technicians’ programs are also used for testing and to help in case of faulty components. Because of this, the safety functions are partially switched off. The ECOMix must therefore be monitored during their use. 4.11.1 Manual mixing Press “Mixing EC”...

  • Page 37: Menu: Manual Measurement

    Operating instructions ECOMix Revolution 4.11.3 Manual measurement Press the “Measure” button to measure the concentrate density. The measurement takes a few minutes. The displayed density value is compensated to 20°C. To start measuring, either an ECOCart or the rinsing bridge must be connected. The “Pump max.”...

  • Page 38: Protective Functions

    Operating instructions ECOMix Revolution Menu: Manual transfer Figure 4.22: 4.12 Protective functions The ECOMix Revolution incorporates a few protective programs which protect the ECOMix as well as the storage tanks and the dialysis unit. In order to be able to use the security mechanisms of the ECOMix, the device must be switched on.

  • Page 39: Error Messages

    5 Error Messages The following list of possible errors with their error messages is used to assess errors. The service activities described, such as the replacement of components, may only be carried out by authorized technicians. The following error messages may occur. Most error messages are shown in the display in an orange field.

  • Page 40: Complaints

    Operating instructions ECOMix Revolution Error Error message Cause Explanation / Instruction ECOCart not connected Couplings connected Repeat the connection of both couplings ECOCart — ECOCart has already been ECOCart batch is already in the This ECOCart has already been used batch history used.

  • Page 41: Density Deviation And Laboratory Analysis

    6 Density deviation and laboratory analysis 6.1 Interpretation of density deviations The density deviation indicated by ECOMix is always the deviation from the target value. The absolute limit for the permissible density deviations is . Concentrates with a higher / 0.30 % deviation from the target value must never be used without a laboratory test.

  • Page 42: Dealing With Density Deviations

    Operating instructions ECOMix Revolution Environmental laboratories are rarely able to measure concentrates of this composi- tion with sufficient accuracy. Laboratories that specialize in blood samples can often achieve this with a slight change in their methodology (e.g. predilution). 6.3.1 Scope of laboratory analysis The ideal analysis includes a determination of the concentrations of all components contained in the concentrate, given in g/l (glucose) and mmol/l (all other ions).

  • Page 43: Transfer Of A Concentrate After Release Through The Laboratory Values

    Operating instructions ECOMix Revolution 6.4.1 Authorisation of concentrates without laboratory analysis If the ECOMix requests a laboratory control outside of the validation phase, this must be done and the result evaluated before the concentrate is used. If this is not possible for logistical reasons, the operator must contact an authorized technician who, in cooperation with the manufacturer Intermedt, will clarify whether the authorisation can be granted without a laboratory control.

  • Page 44: Interpretation Of Laboratory Results

    Operating instructions ECOMix Revolution 6.6 Interpretation of laboratory results For acidic dialysis concentrate the ISO 23500-4 allow the following deviations from the target value of each component. These must not be confused with the density deviations described above. of the target value Sodium / 2.5% mmol/l of the target value...
  • Page 45 Operating instructions ECOMix Revolution The composition of the finished dialysis fluid can be found in the lower area. Therefore, the sodium value also includes the sodium bicarbonate added in the dialysis machine. When you confirm the production, the ECOMix Revolution shows two values: a lower one for the concentrate and a higher one for the dialysis fluid.

  • Page 46: Instructions Of Users

    7 Instructions of Users The ECOMix can only be used by authorized personnel that has been formally instructed. 7.1 Authorization for Instructions The instructions must only be performed through authorized personnel. These consist of: Service technicians of Intermedt • Further authorized personnel of Intermedt: e.g Head of Service, Head of Development, Product •...

  • Page 47: Forms For The Instruction Training

    Operating instructions ECOMix Revolution The authorisation of an instructor is valid for 4 years, before it needs to be repeated. The instructions need to be documented in the form “Form instructor training ECOMix”. A duplicate of the document must be sent to Intermedt. This specialised training can be done in the course of an “ordinary”...

  • Page 48: Technical Data/Materials

    8 Technical data/materials 8.1 Technical data Designation Value/Designation/Unit Device ECOMix Revolution Dimensions production system HxWxD approx. 1950 mm x 880 mm x 1260 mm Weight (empty) approx. 180 kg Ambient temperature Transport, Storage: 10°C – 40°C Operation: 10°C – 40°C Humidity max.

  • Page 49: Materials Used For The Fluids System

    Operating instructions ECOMix Revolution 8.2 Materials used for the fluids system The following materials that come into contact with water and concentrates are physiologically harmless and do not release substances into the dialysis concentrate: – Silicone rubber (SI) – Teflon (PTFE) –...

  • Page 50: Annex

    9 Annex 9.1 Environmental conditions required for operation Clean and dust-free workspace. • Flat ground. • Humidity 80 %, non condensing. • Ambient temperature 10–40°C. • Floor drain. • 9.2 Storage and transport Store in a clean and dry place. •...

  • Page 51: Storage And Shelf Life Of Devices And Chemicals/Fluids

    Operating instructions ECOMix Revolution After a disinfection action, flush the entire system with sufficient quantities of RO water and • check for remnants of disinfection solution. Perform a maintenance by an authorized technician at least once per year. • This device is intended solely for use by medical professionals. The device is intended exclusively for operation in professional healthcare facilities.

  • Page 52: Regular Cleaning

    Operating instructions ECOMix Revolution 9.7 Regular cleaning Clean production system regularly with a damp, lint-free cloth • Replacement of the filter media • Regular disinfection of the ECOMix Revolution is not required. When it is necessary, it must be performed by an authorized technician. The process is described in the maintenance manual. For maintenance there is a separate manual, which is issued exclusively to authorized technicians.
  • Page 53 10 Declaration of conformity State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 54 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 55 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 56 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 57 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 58 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 59 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 60 Operating instructions ECOMix Revolution State: 2024/07 13.18.1., I Manual ECOMix Revolution (EN), 21, F: M. Lorek, 31.07.2024...
  • Page 61 Tel.: +385 (0)1 2356 797 Tel.: +385 91 5024 812 kmoric@medilab.hr mkoscevic@medilab.hr Czech Repub- B. Braun Medical s.r.o. Servisní centrum B. Braun Medical V Parku 2335/20 Okružní ulice 781 (areál Olymptoy) 148 00 Praha 4 25081 Nehvizdy Tel: +420 271 091 111...
  • Page 62 Kadaka tee 70b Kadaka tee 70b 12618 Tallinn 12618 Tallinn Estonia Estonia Finland Nina Ronkainen-Wolf B. Braun Medical Oy / Service Business Unit Manager Huopalahdentie 24 B. Braun Medical Oy 00350 Helsinki Huopalahdentie 24 huolto.fi@bbraun.com 00350 Helsinki +358 20 1772 710 nina.ronkainen-wolf@bbraun.com...
  • Page 63 Tlf. nr. +47 33 35 18 00 Tlf. nr. +47 33 35 18 00 kundeservice.no@bbraun.com kundeservice.no@bbraun.com Poland B. Braun Avitum Poland Sp. z o.o. B. Braun Avitum Poland Sp. z o.o. ul. Sienkiewicza 3 ul. Sienkiewicza 3 64-300 Nowy Tomysl...
  • Page 64 Mohamed Dioum Mohamed Dioum momodioum@gmail.com momodioum@gmail.com +221 777929250 +221 777929250 Singapore B. Braun Singapore Pte Ltd (Co. Reg. B. Braun Singapore Pte Ltd (Co. Reg. No. 198703127H) No. 198703127H) 600 North Bridge Road 600 North Bridge Road #15-05 Parkview Square...
  • Page 65 Operating instructions ECOMix Revolution Country Distributor Service contact United King- B Braun Avitum UK Ltd B Braun Avitum UK Ltd Thorncliffe Park Thorncliffe Park Sheffield S35 2PW Sheffield S35 2PW +44 (0) 7966 282506 +44 (0) 7585 601850 Vietnam B.Braun Viet Nam Ltd. B.Braun Viet Nam Ltd.

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