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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...
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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.
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Operating instructions ECOMix Declaration of conformity (EC) Class IIb medical product: Valid until: 20.02.2022 Intermedt Medizin & Technik GmbH Gewerbestraße-Süd 13 26842 Ostrhauderfehn Germany We hereby declare in our sole responsibility that ECOMix, ECOMix Revolution and ECOCart Dialysis-Concentrate-Production System complies with all the applicable requirements of the Directive 93/42/EEC (last revised by Directive 2007/47/EC).
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.
Operating instructions ECOMix Symbols: Production protocol Center/Unit/Clinic Density deviation Date Lab test necessary Observe the manual Sample taken Batch number Transfered to tank no. Person responsible Authorization Performed filter change Signature State: April 2021 4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021...
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; •...
Operating instructions ECOMix 1.4 Designated Use The ECOMix/ECOCart system is used for the fully automated preparation of an acid dialysis con- centrate: In a closed, validated and verified process dry concentrate process is converted into a liquid state. This treatment process, referred to herein for convenience as production, is the designated application of this certified medical device.
Operating instructions ECOMix • Adjustment of blood or plasma and body temperature Contraindication • Hyperkalemia when using hemodialysis concentrate with a potassium content that is too high • Hypokalemia when using hemodialysis concentrate with a potassium content that is too low •...
Operating instructions ECOMix 1.8 Service and repairs Service and repairs must exclusively performed by technicians authorized by Intermedt. The tasks are described in the maintenance manual. 1.9 Calibration Calibration of the ECOMix system must exclusively be performed by technicians authorized by Inter- medt.
2 System Description The ECOMix production system is designed for producing sodium chloride based concentrates, named concentrate in the following. The ECOMix production system consists of two functional modules: 1. Microprocessor-controlled mixing system 2. Salt cartridge (ECOCart) on rollable base The production system may also contain optional tanks (ECOTanks) for storing the prepared concentrates.
Operating instructions ECOMix 2.1 Description of Components Microprocessor-controlled mixing system: • With an integrated pump for mixing and decanting the concentrate to be produced • Sensor system for dry run and overload protection • Mixing tank capacity: up to 750 l of concentrate •...
3 Safety 3.1 Overall Hazards Assessment When the equipment is used as intended, there are no hazards. The ECOMix 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.
Operating instructions ECOMix • The software used has been checked for operational safety and no fault conditions should arise as long as the equipment is operated properly and runs correctly. Nevertheless, operators should regularly check that the program is running correctly and take the unit out of service in case of any possible faults and to inform technical support.
Operating instructions ECOMix Only use original spare and wear parts. Immediately replace any system components or functional modules that are not in perfect condition. 3.8 Safe handling of ECOCarts When fully loaded, ECOCarts weigh more than 200 kg. Therefore, the following instructions must be observed: •...
4 Operation and Functionality of the ECOMix 4.1 System Overview 1. Connecting tube for salt cartridge (ECOCart); 7. Control unit Flushing connection 2. Density measurement system 8. Main switch 3. Flow sensor 9. bar code scanner 4. Permeate connection 10. Concentrate outlet 5.
Operating instructions ECOMix 4.2 Control Unit The ECOMix production system is operated using buttons and the LCD. The functions assigned to the control buttons are displayed on the graphic LCD and depend on the current menu selection. The LCD has a resolution of 240 x 64 characters and is used for eight-line display in this system. In addition, each function key has an LED.
Operating instructions ECOMix Programs in the Main Menu F1: Automatic production of a concentrate F2: Special programs (settings to be made by the manufacturer) F3: Automatic flushing of the production system F4: Setting the storage tank ID/batch storage F5: Concentrate supply/settings F6: Service settings (with access code) 4.4 Automatic Production To start an automatic production, you have to press “F1”...
Operating instructions ECOMix 4.4.2 Connect ECOCart Request to connect the ECOCart Figure 4.5: A female and a male quick coupling which correspond to the two hoses of the ECOMix system are located on the ECOCart. Connect these to the ECOMix when the system asks you to. Because acidic acid fumes may escape even at room temperature, it is mandatory to adhere to the following steps when connecting an ECOCart to the ECOMix: 1.
Operating instructions ECOMix ECOCart with connected couplings Figure 4.6: Both quick connect couplings on the ECOCart must be safely shut before automatic production starts. It is also important to ensure that the quick-release couplings are hand-tightly screwed into the ECOCart(Please note, that there is a seal below the couplings).
Operating instructions ECOMix The ECOMix production system calculates all the parameters required for accurately producing the selected dialysis concentrate. The exact composition of the final concentrate, resulting from the salts & water in the mixing tank is displayed on the LCD display. After scanning, the LCD display does not show the ready-to-use dialysis solution, but the diluted composition of the concentrate.
Operating instructions ECOMix Display when scanning an invalid bar code Figure 4.9: Display of an accepted bar code Figure 4.10: If the mixing process of a ECOCart is aborted, the bar code of the replaced ECOCart has to be scanned again – as described in section 4.4.3. If the mixing process of a ECOCart is aborted, the already open ECOCart Caution should be marked with an indication that it has already been opened but...
Operating instructions ECOMix Second query to start production Figure 4.11: 4.4.5 Checking of suitability of ECOTanks Confirmation of automatic transfer Figure 4.12: If ECOTanks are connected to the ECOMix, it is automatically checked whether a corresponding storage tank is available. If the system is programmed for automatic transfer, this must be confirmed (Fig.
Operating instructions ECOMix Display in the case that all the ECOTanks still contain concentrate Figure 4.13: Display, if the composition is not recognized or a special concentrate is produced Figure 4.14: 4.4.6 Filling the ECOMix with permeate After starting the production, the water inlet valve of the ECOMix production system opens and osmosis water (permeate) flows into the mixing tank after a period of 10 seconds.
Operating instructions ECOMix Display while filling the system Figure 4.15: stopped and can be reactivated by pressing the “F1” key. If the required amount of water (actual value = target value) has been supplied, the water inflow stops automatically and the ECOMix production system starts the first mixing operation (if auto- matic production has been selected).
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Operating instructions ECOMix If the program “Fully automated production” has been selected, the production system automatically switches to “Automatic Production: Mixing” when the required water quantity has been reached. The system automatically starts the first mixing phase. This step can only be configured in the service menu. 4.4.8 Mixing process After starting the “Automatic Production: Mixing”...
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Operating instructions ECOMix Work flow of the program step “Automatic production: Mixing” Figure 4.18: The dissolution behaviour of the salts is temperature-dependent. For this reason it is possible that in a colder environment a 3 mixing process may be necessary. 4.4.9 Evacuating the ECOCart Display during evacuation of the ECOCart Figure 4.19:...
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Operating instructions ECOMix Display during density measurement Figure 4.20: measurement, the measuring time is controlled dynamically and the temperature of the concentrate is maintained by self-heating. The difference of the actual concentrate density from the target density is displayed, along with the measured temperature. At the end of the measurement process, the ECOMix production system will automatically decide whether a further mixing process is required and will switch back to the mixing menu.
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Operating instructions ECOMix Release display Figure 4.21: Display: (4 mixing operations) = The system has performed 4 mixing operations. At least two mixing operations are required before the product can be released. Caution: Laboratory tests required = The density deviation is outside the tolerances. A laboratory test must be performed.
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Operating instructions ECOMix Alternative options to the release of a concentrate Figure 4.22: 4.4.12 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. It is located on top of each ECOCart below the upper cover. On the right side next to the protocol is a sticker with the most important production data.
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Operating instructions ECOMix Production protocol Figure 4.23: State: April 2021 4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021...
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Operating instructions ECOMix Taking a lab sample Figure 4.24: 4.4.14 Transfer of concentrates Transfer of concentrates Figure 4.25: After the release, the production system automatically determines which of the connected storage tanks is available for decanting. The concentrate produced is assigned to an available storage tank. This is based on the allocation of storage tanks to the different formulations that was made when the system was commissioned and on the composition scanned before starting production to prevent any risk of a mixup.
Operating instructions ECOMix tank becomes available ( 48 h). The ECOMix needs to be switched on, until the concentrate is transferred. Caution: When filling containers, the contents of the first canister must be discarded (approx. 5 litres), as in the concentrate feed to ECOTanks yet another type of con- centrate can be located.
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Operating instructions ECOMix 4.5.1 Rinsing without rinsing bridge Rinsing without rinsing bridge Figure 4.26: The hoses of the ECOMix must be disconnected from the ECOCart and then short-circuited (see figure 4.27). Connected hoses of the ECOMix Figure 4.27: Confirm the connection by pressing the “F1” key. The device then switches to rinsing mode and approx.
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Operating instructions ECOMix 4.5.2 Rinsing with rinsing bridge Rinsing with rinsing bridge Figure 4.28: The hoses of the ECOMix must be disconnected from the ECOCart and then connected to the rinsing bridge (see figure 4.29). Hoses connected to the rinsing bridge Figure 4.29: Confirm the connection by pressing the “F1”...
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Operating instructions ECOMix the rinsing liquid from the mixing tank. Filling the ECOMix for rinsing Rinsing Draining the ECOMix after rinsing Request to remove residual water (only for systems without rinsing bridge) Display during the rinsing process Figure 4.30: Remove residual water (only for systems without rinsing bridge): Lift the connected hoses to the highest point, so the water can flow into the mixing tank.
Operating instructions ECOMix The ECOMix will return to the main menu after approx. 20 seconds. Allow the water to be drained completely. The automatic flushing operation cannot be interrupted. In order to be able to use the security mechanisms of the ECOMix, the device must be switched on.
Operating instructions ECOMix When changing the filter, please proceed as follows: • Empty the blue filter cartridges by opening the drain valves on the bottom of the housings. For models that do not have a filter drain, please place a suitably sized vessel underneath. •...
Operating instructions ECOMix acid in this field. A value of less than 2.00 mmol/l will be interpreted as citrate, a higher value as acetate. If the tank configuration for this tank is visited again, the display will now show the right acid according to these rules.
Operating instructions ECOMix 4.9 Uncontrolled water inflow The water inflow is controlled via the water inlet valve (solenoid valve) on the ECOMix system. If the solenoid valve fails, water could run in uncontrolled. When closed, the solenoid valve is monitored by the flow sensor.
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Operating instructions ECOMix Display: Draining if too much water was collected Figure 4.37: State: April 2021 4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021...
6 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. Error Cause Explanation / Instructions bar code cannot be scanned;...
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Operating instructions ECOMix Error Cause Explanation / Instructions Relay MV1 defective Pressure reducer defective Filling system; Mixing tank al- Deviation of the flow sensor Calibrate the flow sensor; Push most full; Error message: water or sensor on the left rising the capacity sensor up a bit supply stopped 0.00 l/min.
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Operating instructions ECOMix Error Cause Explanation / Instructions Transfer process; Concentrate Sensor overflow (top) on the Adjust the sensor on top of the is not transferred; error mes- tank active tank sage: Fill canisters? Authorisation menu; The Tube to the density sensor is Check the tube density of water is displayed blocked/defective...
7 Density deviation and laboratory analysis 7.1 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.
Operating instructions ECOMix batches must be tested and may only be authorized for use after the laboratory results have been received and evaluated. Compliance with the tolerances listed in section 7.5 for the individual components is decisive for the authorization. •...
Operating instructions ECOMix • In the event of complaints: Copy of the completed production protocol – Description of the complaint – 7.3.3 Information required by the laboratory Before taking a sample, discuss with your laboratory how much sample will be needed. This depends on the methods used and the scope of the analysis.
Operating instructions ECOMix 7.5 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...
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Operating instructions ECOMix Label ECOCart Figure 7.1: State: April 2021 4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021...
8 Instructions of Users The ECOMix can only be used by authorized personnel that has been formally instructed. 8.1 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 manager •...
Operating instructions ECOMix • The instructions must be done more in depth and frequent questions need to establish that the topics are understood in depth • The future instructor must present 6 topics from 3 blocks. The topics censity deviation and production protocol must always be explained.
9 Technical data/materials 9.1 Technical data Designation Value/Designation/Unit Device ECOMix 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 maxRel.
Operating instructions ECOMix • Mixing tank capacity: up to 750 litres • Decanting pump capacity approx. 6,000 litres/h (free outlet) • Dry running protection for pump • Motor protection switch for pump • Thermal protection switch for pump • Permissible operating pressure range of the RO water 2 to 5 bars •...
Operating instructions ECOMix 9.3 Used guidelines and standards The following guidelines and standards have been used in the certification of the device: – EU guideline 93/42/EEC – ISO 23500-1, -2, -3, -4, -5 – EU guideline 2014/30/EU – DIN EN ISO 15223-1 –...
10 Annex 10.1 Environmental conditions required for operation • Clean and dust-free workspace. • Flat ground. • Humidity 80 %, non condensing. • Ambient temperature 10–40°C. • Floor drain. 10.2 Storage and transport • Store in a clean and dry place. •...
Operating instructions ECOMix 10.5 Transferring the concentrate Before transferring the concentrate into a suitable storage tank, the filters in the system ECOMix must be checked (a suitable storage tank must have at least the capacity required for the concentrate to be decanted at the time of decanting). 10.6 Filling of canisters If canisters are to be filled, the basic recommendation is to fill a storage tank and fill the canisters from there.
Operating instructions ECOMix • Calibrate the density measurement and the flow sensor once per year. This device is intended solely for use by medical professionals. It may cause radio in- terference or may disrupt the operation of devices in the vicinity. It may be necessary to take appropriate remedial action, such as a new direction or a new arrangement of the ECOMix or the shield.
Operating instructions ECOMix 10.12 Disposables The current list of available ECOCarts for your country is available on request ECOCarts through info@intermedt.de. Intermedt 5.0 µm (coarse) media filters Filter types Intermedt 0.5 µm (fine) media filters All other interchangeable components will be replaced by authorized technicians as part of mainte- nance if required.
Fax +41 58 258 60 00 +49 495282691-288 info.bbmch@bbraun.com support@intermedt.de United King- Paul Dietz, Sales Specialist Dave Livesey, Service Manager B Braun Avitum UK Ltd B Braun Avitum UK Ltd Thorncliffe Park Thorncliffe Park Sheffield Sheffield S35 2PW S35 2PW...
List of Figures 2.1 ECOMix production system with salt cartridge (ECOCart) and storage tank (ECOTank) ..........4.1 Overview ECOMix system without rinsing bridge .
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