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 can be found in chapter 11

EN

0044
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 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.
Reprints, translations and reproductions in any form, whether in part or as a whole, require prior
approval by the publisher.
For information on the current status, please contact:
Intermedt Medizin & Technik GmbH
Gewerbestraße-Süd 13
26842 Ostrhauderfehn
Germany
Tel. +49 4952/82691-0
E-Mail: support@intermedt.de
Download of the manual: www.intermedt.de

This version of the manual refers to software version V1.6.x and V1.7.x.

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 Contents
Table of contents 5

List of figures 6

Markings 7
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Symbols: type plate and labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Additional Symbols: Production protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1 General Information 9
1.1 Manufacturer’s Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2 Operator Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4 Designated Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.5 Improper Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.6 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.8 Service and repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.9 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.10 Sterilization and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.11 Instructions of Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.12 Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.13 Using the operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2 System Description 13
2.1 Description of Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2 Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3 Safety 16
3.1 Overall Hazards Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Chemicals Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.4 Protection from electrical hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.5 Emissions/EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.7 Modifications of the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.8 Safe handling of ECOCarts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.9 IFU ECOCart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

4 Operation and Functionality of the ECOMix Revolution 19

4.1 Main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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 Operating instructions ECOMix Revolution

4.2 Starting the production process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.3 Fully automatic production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.4 Production protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.5 Rinsing process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.6 Filling of canisters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.7 Routine Hot Water Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.8 Changing the filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.9 Use of optional functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.10 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.11 Technicians’ programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.12 Protective functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

5 Error Messages 39
5.1 Complaints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

6 Density deviation and laboratory analysis 41

6.1 Interpretation of density deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.2 Validation of density measurement during the installation . . . . . . . . . . . . . . . . . 41
6.3 Implementation of the laboratory analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
6.4 Dealing with density deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.5 Transfer of a concentrate after release through the laboratory values . . . . . . . . . . 43
6.6 Interpretation of laboratory results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
6.7 Values on the ECOCart label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

7 Instructions of Users 46
7.1 Authorization for Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.2 Execution of an instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.3 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.4 Authorisation of future instructors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
7.5 Forms for the instruction training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

8 Technical data/materials 48
8.1 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8.2 Materials used for the fluids system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.3 Used guidelines and standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.4 Name plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

9 Annex 50
9.1 Environmental conditions required for operation . . . . . . . . . . . . . . . . . . . . . . . 50
9.2 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.3 Setting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.4 Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9.5 Storage and shelf life of devices and chemicals/fluids . . . . . . . . . . . . . . . . . . . . 51
9.6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
9.7 Regular cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
9.8 Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
9.9 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

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 Operating instructions ECOMix Revolution

10 Declaration of conformity 53

11 Contact adresses 61

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 List of Figures
2.1 ECOMix Revolution production system with salt cartridge (ECOCart) . . . . . . . . . 13
2.2 Overview ECOMix Revolutionsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.1 Main menu of the ECOMix Revolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

4.2 Display accepted ECOCart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.3 Overview of displays during production . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.4 Production protocol ECOCart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.5 Display Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.6 Display canister filling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.7 Hot water treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.8 Changing of the internal filter (Version A) . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.9 Changing of the internal filter (Version B) . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.10 Menu “Options” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.11 Menu “Authorisation” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.12 Entering the production data in the tank menu . . . . . . . . . . . . . . . . . . . . . . . 31
4.13 Start of the special production procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.14 Menu Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.15 Menu ’General Settings’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.16 Menu configuration tanks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.17 Display batch history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.18 Tech. menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4.19 Menu: Manual mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.20 Menu: Manual evacuation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.21 Menu: Manual measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.22 Menu: Manual transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

6.1 Label ECOCart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

8.1 Name plate ECOMix Revolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

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 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.

" WARNING Indicates a risk that may cause serious injuries.

" CAUTION Indicates a risk that may cause damage to the equip-
ment or incorrect operation unless prevented.


Information for safe operation.

Symbols: type plate and labels

Manufacturer Use before

Distributor Observe the manual

Production date Keep away from children

Batch number Storage standing upright

Article number Do not stack

Store between 4°C and 35°C Protect from heat and direct sun-
light

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 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

Yes No

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 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;
• ensuring work safety and accident prevention and making sure employees wear protective cloth-
ing;
• ensuring the proper operation of the system’s safety devices.
The provisions of the Work Equipment Usage Regulations apply.
These operating instructions have been prepared by the manufacturer based on his knowledge and
experience with design, manufacture and operation of this system.

1.2 Operator Qualifications

• Only authorised personnel of the dialysis unit may operate the system. The authorisation must
be done according to the instructions of the manufacturer. Operation by untrained staff and
or patients is not allowed.
• Operators must be informed of operating hazards and hazards caused by improper use.
• Any modifications to the equipment or its specifications require approval by Intermedt.
• Use of non-Intermedt spare parts requires approval by Intermedt.

" Caution Only persons authorised by Intermedt may install, commission, maintain,
perform safety checks or train operators.

1.3 Transport
The system is supplied ready for operation and installed and commissioned by personnel authorised
by Intermedt (service personnel).
• Risk of dropping! Equipment damage!
• Use only suitable means of transport or conveyors.
• Store frost-free.
Check content for completeness after unpacking. Refer to the delivery note.

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

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 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). This allows dialysis concentrates to be produced within the tolerances
specified by ISO 23500-4. Other uses or applications, especially the use of other media, may lead
to dangerous situations and must absolutely be avoided. The ECOMix/ECOCart system is not
intended for use in home dialysis.
Operation according to the designated use also includes observing safety instructions and operating
and maintenance activities prescribed by Intermedt.
Only use the system in a safe and microbiologically clean condition.


We only guarantee that we will manufacture to the ISO 23500-4 tolerances if an
original ECOCart is used and the manual is obeyed.

Microbiologically clean condition:

– Use of permeate according to the Ph. Eur. requirements
– Use of the flushing program
– Permeate has been in the mixing tank for less than 24 hours
– Sterile filters are used for aerating the tanks
– Drain equipped with a bacteria barrier to prevent retrograde contamination
– Original Intermedt media filter/observe replacement intervals
– Regular maintenance
– Only use permeate according to ISO 23500-3
– Monitor permeate according to ISO 23500-3 and current Ph.Eur.

Indication
The dialysis concentrates produced with the ECOMix Revolution are suitable for hemodialysis and
hemodiafiltration. The dialysis concentrate is for use with an alkaline bicarbonate hemodialysis
concentrate (NaHCO3 ) for a given dilution. The finished hemodialysis solution must be tested with a
suitable method before use. For safe use, refer to the manufacturer’s instructions for the hemodialysis
machine. Acid and alkaline bicarbonate hemodialysis concentrate should only be diluted immediately
before use.
The following fields of application only apply to the ready-to-use hemodialysis solution, prepared
according to the information given on the ECOCart:
• Acute kidney failure
• Chronic kidney failure
• Overhydration
• Poisoning
• Correction of acid-base household and electrolyte status
• 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
• Uncontrollable coagulation disorders

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 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.


ECOMix and ECOCart are not used directly on patients and are intended solely for
use by medical professionals. The concentrate produced by the ECOMix is used to
produce dialysis fluid which is then used on patients. In case of adverse effects, the
patient should consult a physician.


All serious incidents related to the device must be reported to the manufacturer and
the competent authority of the Member State in which the user and/or patient is
located.

1.5 Improper Use

The following uses and actions are considered improper:
• changing the specifications such that the permitted limits are exceeded;
• using components from other manufacturers that are not authorised by Intermedt;
• non-compliance with the operating instructions;
• operating the system with defective safety devices;
• disabling or overriding the safety devices.

" Caution The security measures of the ECOMix Revolution are only operational
when the system is turned on.

1.6 Installation
Assembly and installation of the ECOMix Revolution system must exclusively be planned and per-
formed by technicians authorized by Intermedt. A separate manual for the installation is issued
exclusively to authorized technicians. The installation manual also details the requirements for the
installation.

1.7 Maintenance
Maintenance of the ECOMix Revolution system must exclusively be performed by technicians au-
thorized by Intermedt. For maintenance, there is a separate manual which is issued exclusively to
authorized technicians.
Maintenance is required every 12 months. It takes place (starting after the installation with
an online maintenance) alternately as online maintenance and on-site maintenance, which includes
safety-related controls. Online maintenance can be replaced by on-site maintenance.

1.8 Service and repairs

Service and repairs must exclusively performed by technicians authorized by Intermedt. The steps to
be undertaken, are noted in the maintenance manual.
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 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. Login and password can be found in the installation
and maintenance manual.

1.10 Sterilization and Disinfection

Neither the ECOMix Revolution nor the ECOCart requires sterilisation. Disinfections of the
ECOMix are only necessary when the ECOMix Revolution has been in supplied with contami-
nated permeate or when the ECOMix has not produced an ECOCart for more than 10 weeks.
The disinfection must be performed by an authorized technician according to the instructions in the
maintenance manual.

1.11 Instructions of Users

All users must be instructed on how to operate the ECOMix. The instructions are performed by au-
thorized technicians during installation and when needed. All user instructions and the authorisation
for instructing users must be documented in the device log.
Instructions for this process can be found in chapter 7.

1.12 Failure
In case of failure, contact your local service technician. See chapter 11 for contact data for your
country or region.
Do not discard any concentrate batches without first consulting the technical service.
You can find an overview of possible error messages in chapter 5.

1.13 Using the operating instructions

These instructions describe the proper and safe use of the ECOMix Revolution production system.
They do not contain information on how the concentrates produced are used later.
The different operating steps are described and in some cases also illustrated with screen shots or
photos.

" Warning The user is responsible for the accuracy of the values entered and the
actions performed. If the values entered are not the desired values, do
not confirm the entry or abort.

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 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.

Figure 2.1: ECOMix Revolution production system with salt cartridge (ECOCart)

There are different options available for ECOCarts:

• ECOCart Revolution on a rollable base
• ECOCart ToGo on a mini pallet
The ECOCart is available in designs with a middle filler cap, with a laterally offset filler cap and
with a welded filler opening. When the filler cap is offset latteraly, the coupling with the filter is
integrated into the cap. The only difference in using these types of ECOCarts is to ensure that the
breaks of rollable bases are applied during production and storage.

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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
• Production and transfer process controller
• Quick couplings to connection the ECOCart
• End filtration of the concentrate prior to transfer into storage tanks or canisters
• Outlet for connection to storage tanks and/or nozzle filling canisters
• Functions for automated production
• Automatic transfer of concentrates to connected storage tanks
• Monitoring of fluid levels in storage tanks

Figure 2.2: Overview ECOMix Revolutionsystem

Salt cartridge (ECOCart) on a rollable base or mini pallet:

• ECOCart with quick connect couplings for connection to the production system
• Integrated fine filter for salt retention

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 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
• Fuel nozzle for canister filling


Without ECOTanks and the master module/ECOTankmodule Rev it is not possible
to transfer concentrates automatically and in a safe way.

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 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. Skin contact may cause acid
burns. Do not inhale the vapour. If the chemical gets into your eyes,
immediately rinse thoroughly with water. In case of an accident or if you
feel unwell, seek medical advice immediately.

Specifications:
– Acetic acid 100 % high purity Ph Eur., USP
– General Formula: C2 H4 O2
– Structural formula: CH3 COOH

" Warning In case of contact with eyes, rinse immediately with plenty of water.
Remove any existing contact lenses if possible. Continue rinsing. If eye
irritation persists, seek medical advice.

Specifications:
– Citric acid anhydride Ph.Eur., USP
– General Formula: C6 H8 O7
– Chemical formula: HOC(COOH)(CH2 COOH)2

3.3 General Safety Instructions

• The electrical safety devices are located in the control cabinet.
• Never bridge or override safety devices.
• In case of unusual noises, smells or leakages, monitor the equipment immediately and look for
causes.
• If necessary, decommission the equipment.
• 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 check regularly that the program is running correctly and take the unit out of service
in case of any possible faults. In this case they also should inform the technical support.
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 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. Access must be allowed to authorised personnel only.
For detailed information on electrical safety devices, see section Technical Data.

3.5 Emissions/EMC
The system does not cause vibration or dust.
The electronic components of the system are protected from disturbances, such as:
1. Pulse-type transients on supply lines
2. Interference pulses and high frequency fields
3. Electrostatic discharges


The ECOMix Revolution production system is designed according to EMC standards.
However, the influence of electromagnetic radiation or by other devices cannot be
ruled out.

3.6 Maintenance
Required maintenance and inspection work must be carried out in a timely manner.
The electrical safety devices should be checked regularly.
For maintenance purposes, the system must always be brought in a safe operating condition.


The ECOMix Revolution production system has sensitive control and monitoring
components that must be tested or calibrated at regular intervals.

3.7 Modifications of the Equipment

No changes, extensions or alterations to the system may be made without the manufacturer’s per-
mission.
The different functional modules may not be changed.
All changes to the system require the manufacturer’s written consent.


Only use original spare parts and consumables. Immediately replace any system
components or functional modules that are not in perfect condition.

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 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
special care.
• Push filled ECOCarts, don’t pull
• Exercise particular caution when lifting filled ECOCarts with lift systems
• Do not transport ECOCarts over steps
• Always secure filled ECOCarts in the rest position (e.g. storage, mixing process) using the
brake of the trolley
• ECOCarts contain acid. Handle damaged ECOCarts with care (see section 3.2)


Do not try to catch a falling ECOCart.


A fallen ECOCart or an ECOCart that shows traces of a recent fall may have
leaked without any noticeable cracks. Such a cartridge may only be produced under
supervision.

3.9 IFU ECOCart

Store frost-free. Avoid heat and direct sunlight. Store between 4°C and 35°C.
Keep out of reach of children. Use only clear solutions.
Only for use with the ECOMix production system. Only to be used by trained dialysis personnel.
The information, warnings and pieces of advice in the operating instructions of the ECOMix are
part of this information and must be observed. All serious incidents related to the device must be
reported to the manufacturer and the competent authority of the Member State in which the user
and/or patient is located.
Use only original sealed and undamaged containers. Do not use after the expiry date.
Open container only at the proper connection points and connect with production system.
Attention! When opening the couplings acetic acid vapours can escape. Acid may leak from
damaged ECOCarts. Treat damaged ECOCarts with caution.
For the electrolyte concentration, please refer to the product label.
Add a defined amount of purified water to produce an acidic dialysis concentrate designed for
extracorporeal bicarbonate haemodialysis, or bicarbonate haemodiafiltration. The ECOCart is not
intended for home dialysis. Water for the dissolution of the ECOCart must to adhere to the speci-
fications of the ISO 23500-3.
The dialysis concentrate produced is intended for use with an alkaline bicarbonate haemodialysis
concentrate (NaHCO3 ) for a given dilution.
The finished haemodialysis solution must be tested before use using a suitable method. For safe
use, observe the operating instructions of the manufacturer of the haemodialysis machines.
Acidic and alkaline bicarbonate haemodialysis concentrate should only be diluted immediately
before use.
Duration and frequency of treatment as well as dosage must be defined by the physician.

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 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.

Figure 4.1: Main menu of the ECOMix Revolution

In the main menu the user can see the fluid levels of the connected ECOTanks.

4.2 Starting the production process

The fully automated production can be started by switching to the production menu from the main
menu and connecting an ECOCart to the ECOMix. The ECOMix Revolution detects automatically,
when an ECOCart is connected to the ECOMix and will read the production data. If no ECOCart
can be detected this will be indicated.
If a filter change is necessary, this will be shown first. In this case please follow the instructions in
section 4.8.1.


The ECOCart comes with a production protocol on its top. You must start to fill it
in at the beginning of the production process.
For more information on the production protocol, see section 4.4.
Each ECOCart has two couplings on the top. To connect the ECOCart to the ECOMix please
follow these instructions:
1. Place the ECOCart in front of the ECOMix. The adhesive label on the side should face to
the right
2. Block the brakes of the rollable base (if the barrel is placed on a rollable base)
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 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 1/8 turn (without using pressure from above).

" Warning Some ECOCarts have a screw cap which is used to fill the ECOCart.
This cap must not be opened on an unproduced ECOCart to avoid the
risk of contaminating or polluting the contents of the ECOCart.

" Warning In case of ECOCarts with acetate, acetic acid vapour may escape when
you open the ECOCart. Please see the notes on page 16.
First-aid measures
After inhalation: Fresh air, consult a physician if necessary
After contact with the skin: Rinse with plenty of water. Dab with
polyethylene glycol 400
After contact with the eyes: Rinse eyes with plenty of water with the
eyelid open for at least 10 minutes


Both quick connect couplings on the ECOCart must be safely shut before automatic
production starts.
Once the ECOCart has been detected, the composition is displayed in the menu (see Fig. 4.2).
The operator should check the composition and, if necessary, remove the ECOCart and replace it
with another one. If no equivalent tank is available for the concentrate after production, or if no tank
is programmed for the concentrate, a warning message appears. The operator can stop production
in this case.
If the ECOCart should be produced, the production is started by pressing the button “Confirm”.
In fully automatic mode, the ECOMix will automatically start the production after 2 minutes,
provided that no error messages occur. A corresponding timer with 120 seconds runs in the upper
right corner of the display.

Figure 4.2: Display accepted ECOCart

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 Operating instructions ECOMix Revolution

" Caution If an ECOCart is disconnected without producing it, it should be la-

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.
The user is responsible to store this ECOCart safely in the meantime. If
there are any doubts that the ECOCart might be compromised, it must
not be produced.


If no ECOTanks but other storage tanks are used, the ECOMix Revolution cannot
monitor the fluid levels in these tanks.
In this case, it is not possible to transfer the concentrate automatically and the
operator needs to do this manually via the menu for filling canisters.

" Caution Expired ECOCarts must not be produced for the treatment of patients.
The user is responsible for using only ECOCarts with a valid shelf life.
The ECOMix has no monitoring function in this regard.

4.3 Fully automatic production

4.3.1 Filling the mixing tank with permeate
Before the actual filling process, there is a short cleaning phase that cannot be skipped. Then the
ECOMix is filled with permeate. The display shows the current amount, the target amount and the
water temperature (see section 4.3.6).


Permeate must not stay in the mixing tank for no more than 24 h.


During production, the ECOMix monitors relevant system parameters and switches
off the process in the event of an error. After confirming the error message, the
process can either be restarted or resumed.
Through the buttons “Stop” and“Abort” the processes can be stopped and aborted
manually.
If auto-calibration is activated, the ECOMix initiates the calibration 25 l before the filling process
is complete. Afterwards, filling continues.
If the target amount of water has been acquired the water inlet will be closed and the mixing
process starts automatically.

4.3.2 Mixing process

During the mixing process the density, the density deviation and the current temperature will be
displayed continuously. A mixing process will take between 2.5 and 9 h (see section 4.3.6).
At the end of the mixing process the ECOCart will be emptied automatically.


The dissolution behaviour of the salts is temperature dependent. Thus, a longer
mixing process may be required in a colder environment.


Even when the desired density has been achieved the mixing process will go on for
a time to ensure that no local anomaly was detected.
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 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.

4.3.3 Measuring the concentrate density

After the ECOCart has been emptied, a final measuring process will be performed to get a reliable
result. The density will also be compared to the theoretical value. The difference of the actual
concentrate density from the target density is displayed, along with the measured temperature.
If the deviation of the measured density is smaller than +/ − 0.30% the concentrate is cleared
automatically. The production system will automatically transfer the concentrate into a suitable
ECOTank. If no suitable tank is available, the menu for choosing a tank will be displayed.
Automatic clearance will be stored together with the date, the point of time, the density and the
density deviation in the batch history of the ECOMix Revolution and can be accessed therein.


To produce a concentrate in the limits defined by standard ISO 23500-4, the deviation
of the density of the produced concentrate from the theoretical value should not
exceed +/−0.30%. With the production system ECOMix Revolution normally better
results are achieved. In all other cases a laboratory analysis will be asked for.

" Warning The composition of the finial dialysis fluid must always be tested.

4.3.4 Manual clearance of concentrates

If a lab confirmation is necessary, the concentrate will not be cleared by the system. In these cases
the user is advised to take a sample. After the laboratory analysis has been done, the mixing process
can be done again or the concentrate can be discarded.
A density difference of +/ − 0.30% means that the concentrate is good to use according to the
applicable norms. Normally the ECOMix achieves more precise results.


The density difference displayed must be documented in the production log supplied.
The laboratory sample can only be omitted in case the density deviation is ≤ +/ −
0.30%.
To take samples approx. 200 ml must be drained through the sample tap (located either on the
left or the right of the mixing tank) and discarded to remove the residues of previous samples. After
this, the sample can be filled into a sample tube.

" Caution Before taking a sample, drain approx. 200 ml of the solution.
In order to avoid erroneous measurements, an analysis/measurement of
the sample can only be performed after 2 hours or more.
For more information on the release and validation of concentrates and the interpretation of
laboratory results, see chapter 6.


Before a concentrate is discarded due to a density error or a faulty laboratory sample,
you must always contact the manufacturer through your local technical service. If
the concentrate is discarded without any chance to investigate, it may not be possible
to investigate the occurrence afterwards.
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 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).

4.3.5 Transfer into storage tanks

After clearance, the production system automatically determines which of the connected storage
tanks is available for transfer and starts the process (see section 4.3.6).
If no suitable ECOTank is available or a manual release has been granted, however, the selection
must be confirmed by the user. After clicking on the “Transfer” button, all the tanks that are
programmed for the concentrate in question are offered in the touch display (see also Fig. 4.3.6).
Alternatively, you can leave the finished concentrate in the mixing tank until a suitable storage tank
is released. Manual transfer starts as soon as a suitable tank has been selected.
If the maximum fluid level of an ECOTank is reached during transfer, the ECOMix Revolution
will stop the transfer and recommends another ECOTank or canisters. Once the concentrate is fully
transfered, the process is stopped and any residues will be drained.
The transfer of 800 l concentrate takes approx. 20-30 min.


The ECOTanks are programmed for specific concentrate types during installation.
As the composition of the current concentrate is known by the ECOMix there is no
possibility to transfer a concentrate into the tank of another concentrate.


If the mixing of concentrate batches is not allowed through the settings, the ECOMix
will always wait for a concentrate tank to be empty, before another batch can be
transferred in this tank.
After the transfer process, a rinsing process is started automatically.
The liquid concentrate is stored in the connected ECOTanks. There is no ECOCart-specific
marking of the concentrate on the ECOTank. The traceability of the stored concentrate is guaranteed
both via the batch memory and via the filed production log. The concentrate type is indicated by
generic tank labels.


Liquid concentrates have a shelf life of 24 months.

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 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

Figure 4.3: Overview of displays during production

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. 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.
You must start to fill in the protocol at the start of the production process and complete it after
authorisation.


Liquid concentrates have a shelf life of 24 months.

4.5 Rinsing process

After transferring the concentrate, the system automatically switches to the rinse program. There
are two different rinsing programs that can be configured via the settings menu:
• For the regular rinsing, program the ECOCart has to be removed.
• In the Smartclean process, the ECOMix can also be flushed in the presence of a
ECOCartḢowever, the connecting hoses are not rinsed in this case.

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Figure 4.4: Production protocol ECOCart

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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.

Figure 4.5: Display Rinsing

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. 60 l of osmosis water is started.

4.5.3 Rinsing the ECOMix

After the specified amount has been reached, the production system automatically flushes the entire
system. This takes approx. 12 min. After flushing, the drain valve opens and the system discards
the rinsing liquid from the mixing tank.


The ECOMix will return to the main menu after finishing the rinsing process. The
automatic rinsing operation cannot be interrupted.


The ECOMix must be rinsed after each production process.

4.6 Filling of canisters

If canisters are to be filled, the basic recommendation is to fill a storage tank and fill canisters from
it. For the filling of the canisters the corresponding local regulations apply (e.g. regarding hygiene
and marking).
If, unlike this, canisters are to be filled directly from the ECOMix Revolution, there is a separate
program for canister filling:
• The nozzle with hose connection must be connected behind the last storage tank.
• The concentrate transfer is started by pressing the “Start” button.
• By pressing the button “Start” the feed is stopped (If the button is not pressed, the transfer
does not stop until the tank has run empty.)

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 Operating instructions ECOMix Revolution

Figure 4.6: Display canister filling


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.

4.7 Routine Hot Water Treatment

The ECOMix Revolution has been designed for hot water treatment. Timer functions are available
to flush the ECOMix Revolution during the hot water treatment of the osmosis loop. To activate
or configure the hot cleaning option, the following steps must be followed:
• Activation of the “Cleaning” option under “General Settings”
• Open the cleaning process (via “Settings”)
• Select “Configure”
• Select the desired day and program the time and duration
The routine cold-cleaning options were created but are not yet active.
If the machine is in the main menu at the programmed time, the water inlet valve and the drain
cock are opened. In this way, the water inlet can be rinsed with hot water.

Overview cleaning processes Programming the process

Figure 4.7: Hot water treatment

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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. This is
determined through internal measurements. The ECOMix will tell the operator when the filter has
to be changed.
The end filter has a length of 20 inches. It is used to hold back any solids during the transfer
process. To change the filter, the tap at the bottom of the filter cartridge has to be opened. After
the fluid has been drained out of the filter, the cartridge can be removed with the cartridge key and
the filter can be changed. Please look out for the correct fit of the sealing (the sealing must be on
top), when screwing the cartridge back on. After the tap at the bottom of the cartridge has been
closed again, the production process will be started by pressing ’Confirm’ in the menu.


To avoid leakage, all residues of concentrate and/or salts must be removed from the
screw thread of the cartridge with a clean cloth.

4.8.2 Replacing the internal filter

The “Intermedt minifilter” is located inside the ECOMix Revolution. The filter is changed during
maintenance. The change is only possible, if there is no liquid in the ECOMix. Both types are
described below.

Replacing the internal filter – Version A

Figure 4.8: Changing of the internal filter (Version A)

1. Remove the lower front panel of the ECOMix, by releasing the locks with a control cabinet
key
2. Unscrew the union nut (see picture)
3. Remove the old filter
4. Insert the filter into the insert

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 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. Go into the manual rinsing program via “Settings” > “Techn. Program” > “Rinsing”. Press
the button “Rinsing” to start a rinsing process.
8. After the flushing process, check that no leakage has occurred
9. Replace the front panel of the ECOMix Revolution.

Replacing the internal filter – Version B

Figure 4.9: Changing of the internal filter (Version B)

1. Remove the lower front panel of the ECOMix, by releasing the locks with a control cabinet
key
2. Unscrew the union nut (see picture)
3. Remove the old filter
4. Slide the new filter from the side into the plastic block
5. Put on the union nut and tighten it
6. Go to the manual rinsing program via "‘Settings"’ > "‘Techn. menu"’ > "‘Rinse"’. Press the
"‘Rinse"’ button to start a rinsing process.
7. After the flushing process, check that no leakage has occurred
8. Put the front panel of the ECOMix Revolution back in place.

4.8.3 Removing of filters in the coupling

Until April 2020, the ECOMix Revolution was delivered with filters in both couplings. Due to a
technical change, these will be removed during the next maintenance or repair. In case a user needs
to remove the filter, proceed as described below:
1. Remove the coupling from the rinse bridge.
2. Using a screwdriver or pliers, lift the filter out of the coupling with pressure. It is possible that
the old filter will be damaged. This is fine. You can dispose of it.
3. Connect the coupling to the flushing bridge

4.9 Use of optional functions

The optional functions are available from V1.7 on.

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4.9.1 Authorisation of optional functions

From the main menu, you can access the menu for authorising the optional functions via “Settings”
> “Options”:

Figure 4.10: Menu “Options”

Option Number Description

EC-Region x 1000, Predefined regions for ECOCarts from other production sites
1001
Special produc- 1002 Enables the production if the RFID scanner can recognize the
tion cartridge but cannot read the production data from an ECOCart.
EC-Contingent 1003 Indicates how many ECOCarts can be mixed as a special produc-
tion
Emergency-EC 1004 Allows the production when the left coupling with the magnet is
not detected. Together with the “special production” option, the
reading of both couplings can be circumvented.
IMSERVICE 112 Time limited administration mode (not listed in the menu)
Turn off all op- 1337 Resets all options (not listed in menu)
tions

To authorize use of an option, the specified number is entered in the upper field and a request is
sent. The data displayed then must be sent to Intermedt (info@intermedt.de). Until an answer has
been received and entered, the menu must not be left and the system must not be switched off.


If the menu for requesting the release code is exited before a code has been entered,
the generated code that has not yet been entered is no longer valid and must be
requested again.

4.9.2 EC region
The EC-Region option is used to ensure that ECOCarts, which are produced in production facilities
other than the main factory, cannot be produced on facilities in areas for which these cartridges have
not been registered.

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Figure 4.11: Menu “Authorisation”

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. It is also important to ensure that correct density values are stored. You can access the
values when reading in an ECOCart in the production menu or you can ask your local support for
this data.

Figure 4.12: Entering the production data in the tank menu

The special production can be switched on and off again in the General settings menu by ticking
the box.
To start a special production, select “Produce” from the main menu and then select an appropriate
tank programmed for the concentrate.
A special production must always be transferred manually. In all other respects the process is the
same as in a regular production.
The batch is uniquely identified in the batch history via the production date and the consecutive
batch number in the ECOMix. The batch is marked with SM in the batch history.
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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

Figure 4.13: Start of the special production procedure

4.9.4 EC-Contingent
In order to be able to use the special production option, an EC contingent is required. This is
increased by 20 with each request and reduced by 1 with each special production. A batch counts
as used up as soon as the pump starts up during mixing.


While the special production option is active, the technicians’ menus for mixing is
unavailable.

4.9.5 Emergency-EC
In the event that the left or right coupling is not recognized by an ECOCart, the left and right
coupling can be ignored with the emergency EC option.
In order to ignore only the left coupling with the magnetic sensor, only the emergency EC option
is authorized.
In order for the ECOMix to ignore both couplings, the special production option must be ac-
tivated additionally. In order to mix an ECOCart under these conditions, the corresponding tank
configuration must be fully stored (see section 4.9.3).


The option for an Emergency EC will be reset after the next production.


If the ECOMix can be remotely controlled, the production can be started by an
Intermedt technician without this option through the remote control.

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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.

Figure 4.14: Menu Settings

4.10.2 General Settings

In this menu the bicarbonate concentration, the filling of canisters and the self calibration can be
configured. Options in gray are only available for technicians when they are logged.

Figure 4.15: Menu ’General Settings’

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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. Ident. ECOMix starts production 2 min after connecting an ECOCart.
Auto. transfer ECOMix starts transfer process automatically
Auto. rinse ECOMix will start the Smartclean process (Rinse with connected ECOCart)
after the end of the transfer
Special production Only when turned on as an option: Switch between regular and special
production mode
Batch mix Bulk tank configuration: Batches of different ECOCarts can be mixed.
Cleaning Scheduled Cleaning will be activated
Canister filling Filling of canisters is activated
Autocalib.* Automatic self calibration of the ECOMix prior to each production process
Transfer – dura- Scheduled transfer time
tion*
Transfer – buffer* Additional transfer time to determine the time point, when the filter needs
to be changed
* Configurable for technicians only

4.10.3 Tank configuration

Concentrate types need to be programmed for the different ECOTanks. You can change the displayed
tanks by clicking on the numbered buttons. For every tank fill out the composition. You can access
the values in the identification menu or ask the support.

Figure 4.16: Menu configuration tanks

As of V1.7, additional data is requested when the “Special production” option is activated (see
section 4.9.3).

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 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.

Figure 4.17: Display batch history

The person responsible for decanting is entered at the bottom left:

EM2: Automatic process
ECOMix: Successfully measured by ECOMix
Other value: User input

4.11 Technicians’ programs

These programs are intended for authorised technicians. They allow the usage of isolated processes
(e.g. the drainage of the mixing tank) and after logging in the configuration of the DTF sensor. The
state of sensors and actors can be accessed through the I/O menu.

Figure 4.18: Tech. menu

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 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” to start or stop the mixing process. The machine will work continuously until the
function is switched off again.
The “Phase 2” option is only available if a technician has logged in, as the ECOCart is also
emptied during this mixing process.

Figure 4.19: Menu: Manual mixing

4.11.2 Manual evacuation

Press “Start” to evacuate an ECOCart.

Figure 4.20: Menu: Manual evacuation

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 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.” option is only available to logged-in technicians.

Figure 4.21: Menu: Manual measurement

4.11.4 Manual Transfer

To transfer the concentrates, the ECOCart must still be connected. If it has been removed in
between, it must be read in once via “Produce” from the main menu. The target density on the
display should also be noted. This density will be needed to be entered into the first field in the
“Transfer” program. Without this, the final validation is not possible.


As of V1.7, the target density can no longer be queried via the Production menu
after mixing. It must be looked up in the batch history.
For safety reasons, the concentrate cannot be transferred without any checks. There are three
options that can be used for approval:
• Measure the density in this menu and with a deviation of ≤ 0.30%; the density deviation is
displayed
• Enter an external density measurement (laborotary or a handheld device). Please also enter
a name and the measuring temperature. The density deviation is calculated by the ECOMix
and must be ≤ 0.30%.
As “name” enter a short form of your institution or company.
• Confirm that a laboratory check of the components has been carried out successfully . Please
enter “Labor” as the name, 20.00 as the temperature and the target density as the measured
density.
If one of these conditions is met, the “Continue” button allows to go to the next menu. To transfer
the concentrate, press the “Transfer” button and select a tank. Only tanks that are programmed for
a concentrate that matches the ECOCart are offered.


Rinse the ECOMix after manual transfer.

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 Operating instructions ECOMix Revolution

Figure 4.22: Menu: Manual transfer

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.

4.12.1 Protection of the ECOMix during hot water treatment

A hot water treatment can be performed on the ECOMix Revolution. It does not possess its own
heating device, but it can be rinsed during hot water treatment of the permeate loop line.
The production process during hot water treatment is not recommended. Therefore the inflow of
permeate during the production process is interrupted until the water has cooled down to 35°C.

" In case of recognisable technical failures or external damage inform the technical
service and do not take the unit into operation.
Service-Hotline: see chapter 11

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 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.

Error Error message Cause Explanation / Instruction

ID
273 High fluid temperature Temperature in the DTF sensor is Most likely, water was taken in the
above 40 °C midst of a hot water treatment
procedure. Wait for water to cool
down.
274 Low fluid temperature Temperature in the DTF sensor is The water is too cold to start pro-
below 10 °C duction
289 Error density measurement Measured Density ≤ 0 Inform service
290 Error level measurement Determined fluid level ≤ 0 Inform service
1025 Error during transfer No fillable tank was found, but it One tank was removed. Recon-
has been detected earlier nect tank or inform service
1026 Overflow mixing tank! Overflow sensor of the mixing The mixing tank was overfilled. In-
4097 tank is triggered for 15 seconds form service
4098 Pump is overheating The over-temperature sensor of Inform service
the pump has been triggered for
5 seconds
293 Density out of range (+/- See message Remix or take and analyse lab sam-
0.3 %) after final measure- ple
ment. Laboratory test!
292 Density out of range (+/- 4 See message Remix or inform service
%) after mixing phase 1
1028 Maximum transfer time ex- Maximum transfer time of 60 The transfer filter may be clogged
ceeded! minutes is exceeded and must be replaced. If no con-
centrate has been transferred: In-
form service
1029 Mixing tank not empty af- Overflow sensor of ECOTank is Manually select another storage
ter refilling! triggered, but mixing tank is not tank
empty
— DTF sensor not empty! Weight in DTF sensor during Abort, remove ECOCart from
ECOCart detection is over 60 g ECOMix and rinse through tech-
nicians’ menu
— Left coupling on EC not Error left magnetic sensor Repeat connecting the left cou-
connected pling; Production via remote dis-
play or Emergency-EC
— Right coupling not con- Sensor in right coupling does not Repeat connection of the right
nected recognize valid tag coupling; Production via remote
display or Emergency-EC

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 Operating instructions ECOMix Revolution

Error Error message Cause Explanation / Instruction

ID
257 ECOCart not connected Couplings not connected to Repeat the connection of both
515 ECOCart couplings
— ECOCart has already been ECOCart batch is already in the This ECOCart has already been
used batch history used. Use another ECOCart.
— No matching tank avail- No storage tanks that has been Adjust tank configuration (only if a
able! Continue? configured for the suitable type is concentrate change is to be done);
available otherwise either canisters should
be filled or the wrong ECOCart
was delivered (check composition)
— Please change filter. After Maximum transfer time exceeded Change filter
that “continue” or filter counter is > 50
— No suitable storage tanks No suitable ECOTank available Wait for fluid levels to sink
identified on which the overflow sensor is
not triggered
— Residual capacity of stor- Volume in the mixing tank does Concentrate may need to be split
age tank insufficient! Con- not fit completely into the se- manually into several tanks
tinue? lected storage tank
— Waiting. Power failure Power failure. ECOMix waits Please wait. If the display does not
1:40 min until the communication change: contact service
with the tank module is restored
294 Error: auto calibration Error during autocalibration Inform Service or disconnect
516 Error: pre-cleaning ECOCart, empty and rinse
296 Error: correction of weight ECOMix, then connect the same
measurement auto calibra- ECOCart.
tion
297 Error: max level measure-
ment auto calibration

5.1 Complaints
In the event of complaints, the following data must always be collected and transmitted with the
complaint:
• Serial number of the ECOMix (see nameplate)
• LOT no. of the ECOCart
• Detailed description of the error including the measures already taken
• In case of a density deviation: Measured density in kg/l (or g/cm3 ) or density deviation in %
and the laboratory result. Please also note section 6.4. If the concentrate is discarded without
consulting an authorized technician, a subsequent investigation is often no longer possible.
ECOCarts Revolution that are the subject of a complaint may only be returned after the complaint
has been submitted, otherwise they cannot be separated and tested for the described error upon arrival
at the factory.
ECOCarts ToGo that are the subject of a complaint must be withheld until the complaint has
been closed; otherwise arising questions cannot be investigated.

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 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 +/−0.30 %. Concentrates with a higher
deviation from the target value must never be used without a laboratory test.
Before a concentrate is discarded due to a density error or a faulty laboratory sample, you must
always contact the technical service. If the concentrate is discarded without this query, the error can
often no longer be determined.


Regardless of the repeatability of the batches, the concentrate must not be used
without laboratory testing for deviations of +/ − 0.30 % from the target value.

6.2 Validation of density measurement during the installation

The system is calibrated to a density deviation of +/ − 0.30 % from the target value. The validation
phase comprises the first 5 batches after the installation has started:
• The technicians authorized by Intermedt will submit the concentrates produced during instal-
lation to a suitable laboratory for analysis. However, based on their knowledge of the system
and the production process, the technician can authorize the use of these concentrates before
the results arrive, if they have a density deviation of max. +/ − 0.30 %. The technician is
responsible for forwarding the result of these samples to Intermedt.
• As part of the validation phase, of the five batches since the beginning of the installation,
the batches not produced and sampled by the technician must be sampled by the treatment
facility. These batches may only be released after the laboratory results have been received and
evaluated. Compliance with the tolerances listed in section 6.6 for the individual components
is decisive for the authorisation.
• For all of the following batches, the laboratory control is only needed if requested by the
ECOMix. This is no longer part of the validation.

6.2.1 Deviation from the validation scheme

If the dialysis facility wishes to deviate from these specifications for validation, this is only permitted
after consultation with Intermedt as the manufacturer.

6.3 Implementation of the laboratory analysis

The taking of samples is described in section 4.3.4.
The analysis must be carried out in a suitable laboratory. The laboratory should have been checked
before the first analysis (e.g. by sending in a sample with liquid concentrate prior to installation).

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 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). However, suitable laboratories that
can carry out this analysis in the concentrate with appropriate accuracy are not available everywhere.
Therefore, the analysis of the concentrations of Na, K, Ca, Mg, and Chloride is defined as the
standard.
If no suitable laboratory is available that can analyse all of these ions, as many ions as possible must
be measured, whereby at least two other components in addition to sodium must be included. If these
restriction occurs during the validation phase, samples with 50 ml each of 2 of the 5 concentrates
produced in the validation phase must be sent to Intermedt with a corresponding note for testing.

6.3.2 Identification of samples for analysis

Samples for laboratory analysis should always be marked with the batch identifier of the associ-
ated ECOCart for identification (e.g. A98765ML-EC767). If the sample is labelled differently for
the analysis (e.g. batch number of the dialysis), the batch identification must also be stated in
correspondence with Intermedt.
When sending samples or results for evaluating results to Intermedt, the following data is required:
• Batch ID
• Dialysis facility with location or serial numbers of ECOMix
• Date of production
• Density or density deviation according to ECOMix
• In the event of complaints:
– Copy of the completed production protocol
– Description of the complaint

6.3.3 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.
In addition, laboratories require at least the following information for each sample:
• A visible indication that it is dialysis concentrate
• Clear identification of the sample (ideally batch identification)
• Client with contact details
• Scope of the analysis
• Expected composition
• Dilution to be carried out by the laboratory (1:35 or 1:45)

6.4 Dealing with density deviations

After the validation phase, the ECOMix only displays the request for laboratory control, if the limits
for the density deviation are exceeded (see above).

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 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. In addition to the current batch ID and the displayed density
deviation, it is necessary to report the density deviations of the last 5 batches.
This procedure can also be used if a laboratory control contains implausible values.

6.4.2 Discarding of concentrates

If the concentrate could not be produced in the required quality, it must not be discarded or trans-
ferred without consulting an authorized technician. In most cases the batch can still be completed
successfully.
However, if the concentrate was discarded or the ECOCart was sent back without corresponding
consultation, it is often no longer possible to determine the circumstance that led to the faulty
process.
This does not apply to significant leaks at the ECOCart or ECOMix.

6.5 Transfer of a concentrate after release through the laboratory

values
Should the DTF sensor be defective or require recalibration and the quality of the concentrate has
been established either through another method of density measurement or through a laboratory
analysis, the concentrate needs to be transferred manually.
For safety reasons, this process can only be implemented via the technician programs. Please let
the local service know, so the ECOMix will be checked afterwards.
The ECOCart must still be connected to the ECOMix Revolution at this time.
For manual transfer without automatic density release, the following steps are performed:
1. From the error message about the density, select the button “Discard”
2. Confirm discard again
3. Do not start discarding, but exit via “Abort”
4. The ECOMix Revolution displays the main menu again
5. Go to the transfer program through choosing “Preferences” > “Techn. Menu” > “Transfer”
6. Follow the instructions in section 4.11.4 for manual tranfer
7. The ECOMix returns to the main menu
8. Remove the ECOCart and go to the rinsing program through “Settings” > “Techn. menu”
> “Rinse”
9. Press the button “Rinse” to start a rinsing process
10. The ECOMix automatically returns to the main program after rinsing

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 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.
Sodium +/ − 2.5% of the target value
Magnesium +/ − 0.05 mmol/l of the target value
All other components +/ − 5.0% of the target value
If all measured values are within these permissible tolerances, the concentrate can be used. The
laboratory result is to be filed together with the production protocol.
If Chloride is measured, too, the measurement has an internal control: The sum of the concen-
trations (in mmol/l) of Sodium, Potassium, Calcium and Magnesium needs to be the same as the
concentration of Chloride.
Conc(Na+ ) + Conc(K+ ) + 2 * Conc(Ca2+ ) + 2 * Conc(Mg2+ ) = Conc(Cl- )
A distinctive deviation in this calculation is indicative of a faulty measurement.
A critical deviation in a lab result that is higher than the allowed range must always be
discussed with the service, who will also discuss this with the manufacturer. In any case,
this must be done prior to discarding the concentrate, as it might not be possible to resolve
the issue afterwards (see section 6.4.2).

6.7 Values on the ECOCart label

Figure 6.1: Label ECOCart

The composition of the concentrate can be found in the upper area of the label, whereby the
target values are always given. When specifying the concentration in g/l, the water molecules given
in the left column were taken into account. Therefore, in the label printed here, the value for glucose
* 1 H2 O, for example, is 38.4 g/l and not 35 g/l.
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 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. Later in the process and in the batch history, only the lower value is shown.
If you need to derive the sodium value from the ECOCart label, divide the mmol/l value for sodium
chloride (NaCl) reported on the label by the dilution factor (35 or 45): e.g. 3,605 / 35 = 103.

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 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
manager
• Service technicians of cooperating partners who are trained for the installation and maintenance
of the ECOMix system
• Dialysis personnel who are authorized to instruct others

7.2 Execution of an instruction

The instructions will be performed at the end of an installation and when needed. The ideal group
contains 5 people at maximum. The instructions should not be interrupted by breaks or other tasks.
The system must be empty and in the main menu. ECOCarts must be available as all future
operators must connect an ECOCart to the ECOMix during the training. All of the topics in the
forms must be discussed, and the participants must get the chance to ask questions.
The topics to be taught can be found in the form “Form user training ECOMix Revolution”.

7.3 Documentation
The successful completion of thus training course must be documented through the signature of the
participant and the instructor in the designated form. The discussed topics on the form must be
ticked off. The form remains in the device book of the system.
The training is considered “successful”, if the participants took part in the whole training and the
instructor does not have reasonable doubts that parts have not been understood. In case of doubts
he/she should pose questions or discuss these parts again to remove any doubts.

7.4 Authorisation of future instructors

The instructions can performed in a way that the participant may instruct further operators. The
differences to a “basic training course” are:
• 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 “Density deviation” and
“Production log” must always be explained.

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 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” training. A renewal of an
authorisation for instructors can be performed in the way that the person, whose authorisation must
be renewed, performs an instruction training and the authorizing person corrects possible mistakes,
changes or omissions.

7.5 Forms for the instruction training

The forms for the training course can be obtained on request at support@intermedt.de.
The signed forms need to be archived in the machine log.

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 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. rel. < 80 % at 20°C, not condensing

Electrical safety

Protection class Class I

Over voltage category Class II
Contamination 3
Supply voltage 400 VAC / 50Hz or 230 VAC / 50 Hz
Power consumption 1,75 KW

Communication

Output RJ45 Ethercat/Ethernet

Output 24-VDC-Supply ECOTank max. 50 m 3 x 0,75 mm2
Standard: 10 m 2x 0,75 mm2

Additional Data
• Mixing tank capacity: up to 800 litres
• Transfer 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
• Required water RO water quality/free of floating particles

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 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)
– Ceramics – Polyethylene (PE)
– Polypropylene (PP) – Polyethersulfone (PES)
– Polyether ether ketone (PEEK) – Stainless steel
– Polyhexamethylene adipamide

The ECOMix Revolution does not contain any materials that have any pharmaceutical properties or
are of human or animal origin.

The ECOCart contains no materials of human or animal origin. The ingredients listed in the ECOCart
label can have pharmacological effects if they enter the human body.

8.3 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 Regulation (EU)2017/745 – DIN EN ISO 15223-1
– EU guideline 2014/30/EU – EN 1041
– EU directive 2011/65/EU – EN 62366
– DIN EN 14971 – EN ISO 10993
– DIN EN 60601-1 – EN ISO 14155-1, -2
– DIN EN 60601-1-2 – EN ISO 14971
– DIN EN 60601-1-6

8.4 Name plate

Figure 8.1: Name plate ECOMix Revolution

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 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.
• Flat floor
• Store equipment in an upright position.
• Humidity < 80 %, non condensing.
• Ambient temperature 10–40°C.
• Protect from falling or moving during transport.

9.3 Setting up the system

• Place components on a flat floor.
• Please check the floor load capacity
• Provide RO water connection (heat-resistant if required) at the inlet of the ECOMix Revolution
production system.
• Use a 19x25 mm fabric tube (customer-specific) to establish the connection between the output
connection of the filtration module (lateral screw connection) and the storage tank to be filled.
• Connect a HT 50 piping to the floor drain.
• Establish power connection
• Establish network connection
• Insert filter into the filter housing of the production system.
• The maximum cable length of the ECOMix to the master module/ECOTankmodul Rev is 10
m.

9.4 Safety instructions

• Use maximum care and cleanliness.
• Never operate the production system without filters.
• Do not introduce dirt or solids into the mixing tank.
• Only use operating media approved by Intermedt
• Flush the production system after preparing each batch.
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 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. 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.

9.5 Storage and shelf life of devices and chemicals/fluids

Downtime Permeate in mixing tank of the ECOMix: max. 24 hours

Storage concentrate ECOTank 24 month after production
Maximum durability ECOCart 12 month

The ECOMix Revolution was designed for a minimal life expectancy of 8 years. A maximum life
expectancy has not been defined. Disposal therefore should only occur, if –for any reason– the
customer decides not to use the system any more, or if local regulations or law change in a way that
do not allow the usage of the devices.
ECOCarts Revolution that have been used and full ECOCarts Revolution that have expired must
be returned to Intermedt. If ECOCarts Revolution are not returned, a fee will be charged by
Intermedt. ECOCarts ToGo that have been used and full ECOCarts ToGo that have expired can be
returned to Intermedt or can be disposed locally.
In case of returning ECOCarts that are still full, a fee for the disposal of the chemicals may be
charged by Intermedt. To avoid these and higher transport costs, the customer can dissolve the
ECOCarts on site and dispose of the resulting concentrate separately.

9.6 Disposal
In case of disposal of ECOMix or ECOCart, observe the local regulations and laws. The electronic
components of the ECOMix should be disposed of separately from the plastic material.
If a full ECOCart has to be disposed of, follow the rules for the local regulations and laws of the
disposal of chemicals.
Other than the acid, ECOMix and ECOCart do not contain hazardous substances. As both
medical devices do not come into contact with patients when used as intended, no special protocols
for the disposal of contaminated materials have to be observed.

" Dispose of ECOMix and disposable ECOCarts according to local regulations and
laws.

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 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.

9.8 Disposables
ECOCarts
The current list of available ECOCarts for your countries is available through Intermedt.

Filter types
Intermedt 0.5 µm media filters
Intermedt minifilter

All other interchangeable components will be replaced by authorized technicians as part of mainte-
nance if required.

9.9 Accessories
The products listed below are not medical devices:
• Storage tanks: ECOTank 860 l, ECOTank 1650 l, special sizes available on request
• Master module for controlling 4 storage tanks
• ECOTankmodule Rev for controlling 8 storage tanks
• Lifting pump for elevated drainage pipes
• Fuel nozzle for canister filling

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 10 Declaration of conformity

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 11 Contact adresses

Country Distributor Service contact

Austria B. Braun Austria GmbH Intermedt Medizin & Technik GmbH
Otto Braun-Straße 3-5 Gewerbestraße-Süd 13
2344 Maria Enzersdorf 26842 Ostrhauderfehn
Österreich Deutschland
+49 495282691-288
support@intermedt.de
Belgium B. Braun Medical N.V. B. Braun Medical N.V.
Lambroekstraat 5b Lambroekstraat 5b
BE-1831 Diegem BE-1831 Diegem
Tel. +32 2 712 86 50 Tel. +32 2 712 86 50
Fax. +32 2 725 96 05 technicalservices.bnl@bbraun.com
customercare.be@bbraun.com
Bosnia & Inel-med d.o.o. Inel-med d.o.o.
Herzegowina Rudarska 20b (Objekat1, Centar II) Rudarska 20b (Objekat1, Centar II)
BA-88000 Mostar BA-88000 Mostar
Tel: + 387 36 348 539 Tel: + 387 63 349 950
Dragana.Dzeba@inel-med.ba nenad.gvozdenovic@inel-med.ba
China B.Braun China B.Braun China
23F,Sunyoung Center 398 Jiangsu Road 23F,Sunyoung Center 398 Jiangsu Road
Shanghai 200050, P.R.China Shanghai 200050, P.R.China
_ops.bbmprc_service@bbraun.com _ops.bbmprc_service@bbraun.com
4008851698 4008851698
Croatia Medilab d.o.o. Medilab d.o.o.
Hondlova 2/9 Hondlova 2/9
10 000 Zagreb 10 000 Zagreb
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
lic V Parku 2335/20 Okružní ulice 781 (areál Olymptoy)
148 00 Praha 4 25081 Nehvizdy
Tel: +420 271 091 111 Tel: +420 271 091 333
Fax: +420 271 091 112 Fax: +420 271 091 552
info@bbraun.cz servis.cz@bbraun.com
Denmark Vibeke Møller Jakobsen Flemming Cederbo
Business Unit Manager Technical Manager
Hospital Care Division Hospital Care Division
B. Braun Medical A/S B. Braun Medical A/S
Dirch Passers Allé 27, 3. sal Dirch Passers Allé 27, 3. sal
2000 Frederiksberg 2000 Frederiksberg

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Country Distributor Service contact

Estonia B. Braun Medical OÜ B. Braun Medical OÜ
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
+358 40 4875 271
France B. Braun Medical B. Braun Medical
Service Marketing Service Technique
26 rue Armengaud 26 rue Armengaud
92210 Saint-Cloud 92210 Saint-Cloud
+ 33 1 41 10 73 48 + 33 821 230 016
Germany B. Braun Melsungen AG B. Braun Melsungen AG
Carl-Braun-Straße 1 Carl-Braun-Straße 1
34212 Melsungen 34212 Melsungen
+49-5661-710 Tel. +49 800 5890328
Hungary B.Braun Avitum Hungary CPLC B.Braun SSC Hungary Ltd.
1023 Budapest 1023 Budapest
Felhévizi u. 5. Felhévizi u. 5.
Tel. +36 1 346 9700 Tel. +36 1 346 9701
Iraq Karmel International Trading Co. Karmel International Trading Co.
3rd Floor Al Yarmouk Plaza 3rd Floor Al Yarmouk Plaza
Al Kiswah St. - Al Rabia Al Kiswah St. - Al Rabia
P.O.Box 17135 Amman 11195 Jordan P.O.Box 17135 Amman 11195 Jordan
Tel: +962 6 55 30 681 Tel: +962 6 55 30 681
Fax:+962 6 55 30 682 Fax:+962 6 55 30 682
Ireland Fiona Duggan Mark Power
Hospital Business Unit Manager Business Unit Manager Technical Ser-
BBraun Medical Limited vices
3 Naas Road Industrial Park B. Braun Medical Limited
Dublin, D12H5TF 3 Naas Road Industrial Park
Mobile +353(0) 86 0480332 Dublin, D12H5TF
Services Line: (01) 7091850 Mobile: +353(0)86 0480 368
Fax: (01) 7091888 Office: +353(0)1 709 1850
fiona.duggan@bbraun.com Mark.power@bbraun.com
Israel Lapidot Lapidot
8 Hashita Street P.O. Box 3552 8 Hashita Street P.O. Box 3552
Southern Caesarea Industrial Park Southern Caesarea Industrial Park
Israel, 3088900 Israel, 3088900
www.lapidot.com www.lapidot.com

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Country Distributor Service contact

Italy B. Braun Avitum Italy S.p.A. B. Braun Avitum Italy S.p.A..
Via XXV Luglio, 11. Via XXV Luglio, 11.
41037 Mirandola MO. 41037 Mirandola MO.
Phone: + 39 0535 616711 Phone: + 39 0535 616711
Fax: + 39 0535 610809 Fax: + 39 0535 610809
E-mail:avitum.italy@bbraun.com. E-mail:avitum.italy@bbraun.com
Lithuania B. Braun Avitum UAB B. Braun Avitum UAB
Miškiniu˛ 6A Miškiniu˛ 6A
04132, Vilnius 04132, Vilnius
Lithuania Lithuania
Netherlands B. Braun Medical B.V. B. Braun Medical B.V.
Postbus 659 Euterpehof 10
5340 AR Oss 5342 CW Oss
Tel. +31 (0)412 67 24 11 Tel. +31 (0)412 67 25 79
customercare.nl@bbraun.com technicalservices.bnl@bbraun.com
Norway B. Braun Medical AS B. Braun Medical AS
Kjernåsveien 13 B Kjernåsveien 13 B
3142 Vestskogen 3142 Vestskogen
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 64-300 Nowy Tomysl
Phone +48614427188 Phone +48614427188
Portugal B.Braun Medical, Lda B.Braun Medical, Lda
Estrada Consiglieri Pedroso nº80 Estrada Consiglieri Pedroso nº80
Queluz de Baixo Queluz de Baixo
2730-063 Barcarena 2730-063 Barcarena
Tel: 214 368 200 Tel: 214 368 200
Fax: 214 368 280 Fax: 214 368 280
technicalservices.pt@bbraun.com
Romania S.C. B. Braun Avitum S.R.L. Calin Nistor
Remetea Mare no. 636 Head Technician
RO-307350, Timis S.C. Avitum S.R.L.
Str. Soarelui nr.1
547530 Sângeorgiu de Mureş
Tel: +40 265 318 102
Mobile: +40 728 911 108
calin.nistor@bbraun.com
Russia Á.Áðàóí Àâèòóì Ðóññëàíä Á.Áðàóí Àâèòóì Ðóññëàíä

18-àÿ ëèíèÿ Â.Î., ä.29, îô. À511 18-àÿ ëèíèÿ Â.Î., ä.29, îô. À511

199178 Ñàíêò-Ïåòåðáóðã 199178 Ñàíêò-Ïåòåðáóðã

Òåëåôîí: (812) 334-06-86 Òåëåôîí: (812) 334-06-86

officeavitum.ru@bbraun.com officeavitum.ru@bbraun.com

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Country Distributor Service contact

Saudi Arabia Medical Supplies and Services Co.Ltd Medical Supplies and Services Co.Ltd
Mediserv Mediserv
Al Malaz District, Al Ahsa Street, Al Malaz District, Al Ahsa Street,
Mediserv Bld. 1 Floor Mediserv Bld. 1 Floor
P.O.Box 17750 Riyadh 11494 P.O.Box 17750 Riyadh 11494
Tel: +966114780555 Tel: +966114780555
Senegal ACD. Afrique Conception Distribution ACD. Afrique Conception Distribution
Sacré coeur 2, rue SC160 numéro Sacré coeur 2, rue SC160 numéro
8632/G – 1er étage – Dakar 8632/G – 1er étage – Dakar
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 #15-05 Parkview Square
Singapore 188778 Singapore 188778
Slovakia B. Braun Medical s.r.o. Servisní centrum B. Braun Medical
Hlučínska 3 Okružní ulice 781 (areál Olymptoy)
831 03 Bratislava 25081 Nehvizdy
Slovensko Česká republika
Tel: +421 2/638 389 20 Tel: +420 271 091 333
Fax: +421 2/446 380 67 Fax: +420 271 091 552
info.sk@bbraun.com servis.cz@bbraun.com
Slovenia Medis d.o.o. 1-servis
Brnčičeva ulica 1 Brnčičeva ulica 13
1000 Ljubljana 1231 Ljubljana-Crnuce
Tel: +386 1 589 69 66 Tel: +386 1 563 4069
Misa.Kobal@medis.si Ales.Marinko@1-servis.si
Spain B. Braun España B. Braun España
Carretera de Terrasa, 121 Carretera de Terrasa, 121
08191 Rubí, Barcelona 08191 Rubí, Barcelona
Telf.. +34 935 86 62 00 Telf.. +34 935 86 62 00
Fax. +34 935 88 10 96 Fax. +34 935 88 10 96
Sweden B Braun Medical AB B Braun Medical AB
Svärdvägen 21 Svärdvägen 21
Box 110 Box 110
182 12 Danderyd 182 12 Danderyd
Tel+468 634 34 00 Tel+468 634 34 00
info.sverige@bbraun.com service.sverige@bbraun.com
Switzerland B. Braun Medical AG B. Braun Medical AG
Seesatz 17 Seesatz 17
6204 Sempach 6204 Sempach
Tel. +41 58 258 50 00 Tel. +41 58 258 50 00
Fax +41 58 258 60 00 Fax +41 58 258 60 00
info.bbmch@bbraun.com info.bbmch@bbraun.com

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Country Distributor Service contact

United King- B|Braun Avitum UK Ltd B|Braun Avitum UK Ltd
dom 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.
Thanh Oai Industrial Area, Bich Hoa Sales Office Hanoi: 170 De La Thanh
Commune, Thanh Oai District Street, Dong Da District, Ha Noi City
Ha Noi City Sales Office Ho Chi Minh: 9th Floor,
Vinamilk Tower, 10 Tan Trao St., Dist.
7, Ho Chi Minh City
Phone: (+84) 24 3357 1616

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