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Operating instructions ECOM

ix

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

[email protected]

Contact data for your country

www.intermedt.de

can be found in chapter 11

0044

State: April 2021

4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021

Содержание Intermedt ECOMix

Страница 1: ...gen AG Gewerbestra e S d 13 Carl Braun Stra e 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...

Страница 2: ...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 sta...

Страница 3: ...s demonstrated by the following certificates Certificate of 15 02 2019 Reg No 44 232 130544 certifying compliance with Appendix II Section 3 2 of the directive 93 42 EEC on medical products of 05 09 2...

Страница 4: ...463 GW 800 35 ToGo IM3694 ECOCart DSK 0472 GW 585 45 IM3782 ECOCart DSK 0472 GW 622 45 Rev IM3742 ECOCart DSK 0472 GW 622 45 ToGo IM3743 ECOCart DSK 0472 GW 750 35 IM3779 ECOCart DSK 0472 GW 800 35 Re...

Страница 5: ...W Cit 622 45 ToGo IM4097 ECOCart DSK 3252 GW 585 45 IM3772 ECOCart DSK 3252 GW 622 45 Rev IM3655 ECOCart DSK 3252 GW 622 45 ToGo IM3723 ECOCart DSK 3252 GW 750 35 IM2218 ECOCart DSK 3252 GW 800 35 Rev...

Страница 6: ...Cit 750 35 IM3872 ECOCart DSK 3464 GW 585 45 IM2370 ECOCart DSK 3464 GW 750 35 IM1568 ECOCart DSK 3472 GW 585 45 IM3275 ECOCart DSK 3472 GW 622 45 Rev IM3952 ECOCart DSK 3472 GW 622 45 ToGo IM3954 EC...

Страница 7: ...M3823 ECOCart DSK 3672 GW Cit 750 35 IM3806 ECOCart DSK 3672 GW Cit 800 35 Rev IM3816 ECOCart DSK 3672 GW Cit 800 35 ToGo IM3817 ECOCart DSK 3673 GW 622 45 Rev IM4032 ECOCart DSK 3673 GW 622 45 ToGo I...

Страница 8: ...COCart DSK 3872 GW 800 35 ToGo IM3971 ECOCart DSK 3873 GW 585 45 IM4053 ECOCart DSK 3873 GW 622 45 Rev IM4042 ECOCart DSK 3873 GW 622 45 ToGo IM4043 ECOCart DSK 3873 GW 800 35 Rev IM4044 ECOCart DSK 3...

Страница 9: ...1 11 Instructions of Users 18 1 12 Failure 18 1 13 Using the operating instructions 18 2 System Description 19 2 1 Description of Components 20 2 2 Optional components 20 3 Safety 21 3 1 Overall Haza...

Страница 10: ...atory results 57 7 6 Values on the ECOCart label 57 8 Instructions of Users 59 8 1 Authorization for Instructions 59 8 2 Execution of an instruction 59 8 3 Documentation 59 8 4 Authorisation of future...

Страница 11: ...uctions ECOMix 10 10Disposal 66 10 11Regular cleaning 66 10 12Disposables 67 10 13Accessories 67 11 Contact Adresses 68 List of Figures 69 State April 2021 11 4 9 1 I Manual ECOMix Original EN 7 F M L...

Страница 12: ...4 9 1 I Manual ECOMix Original EN 7 F M Lorek 06 04 2021...

Страница 13: ...erious 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...

Страница 14: ...t Clinic Density deviation Date Lab test necessary Observe the manual Sample taken Batch number Transfered to tank no Person responsible Authorization Performed filter change Signature Yes No 14 State...

Страница 15: ...horised 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 allow...

Страница 16: ...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...

Страница 17: ...lt a physician 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...

Страница 18: ...ctions 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 au...

Страница 19: ...sts of two functional modules 1 Microprocessor controlled mixing system 2 Salt cartridge ECOCart on rollable base The production system may also contain optional tanks ECOTanks for storing the prepare...

Страница 20: ...omatic functions for automated production Automatic distribution of concentrates produced to connected storage tanks with fill level monitoring Salt cartridge ECOCart on a rollable base ECOCart with q...

Страница 21: ...tely Specifications Acetic acid 100 high purity Ph Eur USP General Formula C2H4O2 Chemical formula CH3COOH Warning In case of contact with eyes rinse immediately with plenty of water Remove any existi...

Страница 22: ...onic components of the system are protected from disturbances such as the following 1 Pulse type transients on supply lines 2 Interference pulses and high frequency fields 3 Electrostatic discharges T...

Страница 23: ...ush 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 st...

Страница 24: ...urement system 8 Main switch 3 Flow sensor 9 bar code scanner 4 Permeate connection 10 Concentrate outlet 5 Pump under cover 11 Coarse filter left fine filter right 6 Drain connection 12 Mixing tank b...

Страница 25: ...acters and is used for eight line display in this system In addition each function key has an LED Figure 4 2 Flashing LEDs show the next operation that can be selected 4 3 User Interface By pressing t...

Страница 26: ...ns on changing the filter see section 4 6 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 pr...

Страница 27: ...take them off 5 For an ECOMix without rinsing bridge Disconnect the hoses With both hoses consecutively Pull the hose to the ECOCart take of the corresponding coupling and immediately place the hose i...

Страница 28: ...art Please note that there is a seal below the couplings Use only original sealed ECOCarts from Intermedt 4 4 3 Scanning the bar code Figure 4 7 Request to scan the bar code Use the bar code scanner o...

Страница 29: ...the bar code the bar code scanner should be kept about 10 20 cm away from the bar code The optimal reading distance can be determined by varying the distance between the bar code scanner and the bar...

Страница 30: ...that it has already been opened but not produced The couplings must be closed again to prevent contami nation The ECOCart must be used as soon as possible in any case The user is responsible for the c...

Страница 31: ...erefore not be used for transfer the user is warned The user must confirm the production with F1 It also checks if the system is configured for this concentrate In order to prevent a wrong concen trat...

Страница 32: ...ent which is protected by a pressure reducer downstream of the flow sensor If there is no water in the water inlet of the ECOMix e g because the system was just installed one needs to contact an autho...

Страница 33: ...ommand stop after filling has been issued the system will enter standby mode and wait for further commands The osmosis water must not stay in the mixing tank for more than 24 hours 4 4 7 Stopping afte...

Страница 34: ...stem monitors the relevant parameters and stops the mixing operation in case of an error An error description is displayed After acknowledging an error message automatic production can be restarted Li...

Страница 35: ...ring evacuation of the ECOCart While emptying the tank the ECOMix production system automatically drains the liquid from the connected ECOCart until it is empty The ECOMix production system then moves...

Страница 36: ...with a maximum of 0 04 from the mean value of the last 5 concentrates produced In all other cases a lab control will be asked of the user If the ECOMix is switched off after mixing and before the tra...

Страница 37: ...lternative to transferring the user can also use Home Enter to get various other options F1 release Returns to the menu described above F2 new mixing Starts a new mixing phase This option is especiall...

Страница 38: ...rates have a shelf life of 24 months 4 4 13 Taking samples Laboratory samples are required in the validation phase and in case of deviations of the measured density To take samples the sampling valve...

Страница 39: ...Operating instructions ECOMix Figure 4 23 Production protocol State April 2021 39 4 9 1 I Manual ECOMix Original EN 7 F M Lorek 06 04 2021...

Страница 40: ...n the composition scanned before starting production to prevent any risk of a mixup Filling level indicators ensure that no storage tank is used that is still filled with a concentrate The system chec...

Страница 41: ...The LCD display will indicate that Press the Home Enter key to return to the last program step The production system requires approx 25 30 minutes to transfer 750 litres of concentrate After transfer...

Страница 42: ...e disconnected from the ECOCart and then short circuited see figure 4 27 Figure 4 27 Connected hoses of the ECOMix Confirm the connection by pressing the F1 key The device then switches to rinsing mod...

Страница 43: ...e rinsing bridge Confirm the connection by pressing the F1 key The device then switches to rinsing mode and approx 60 l of osmosis water begins to flow in see 4 5 3 4 5 3 Rinsing process After the spe...

Страница 44: ...emove residual water only for systems without rinsing bridge Lift the connected hoses to the highest point so the water can flow into the mixing tank Press the F1 key after the water has been removed...

Страница 45: ...the ECOMix are intended for the filtration of 4 or 8 ECOCarts Before starting an automatic production the ECOMix checks if the filter capacity has been reached If necessary a request to change the fi...

Страница 46: ...ot to confuse coarse and fine filters Confirm the operation with F1 4 7 Settings This menu gives the user access to the tank configuration and batch history 4 7 1 Tank configuration From the main menu...

Страница 47: ...peratures of up to approx 90 C 3 The temperature measurement of the density sensor is used to detect a temperature increase The permeate fed into the system always flows past the density sensor as a s...

Страница 48: ...from the permeate ring conduit The message Disconnect water supply is displayed The current inflow rate and excess quantity will be displayed Press the Info key to return to the previous step You can...

Страница 49: ...Operating instructions ECOMix Figure 4 37 Display Draining if too much water was collected State April 2021 49 4 9 1 I Manual ECOMix Original EN 7 F M Lorek 06 04 2021...

Страница 50: ...5 Short user instructions 50 State April 2021 4 9 1 I Manual ECOMix Original EN 7 F M Lorek 06 04 2021...

Страница 51: ...ed Error message bar code invalid bar code is already in the batch memory User error bar code has already been used request a new bar code Fill system Error message Water supply stopped current water...

Страница 52: ...Mixing process Error message Error barrel cock in the 2nd mix ing process System not set to flushing bridge Call service Configuration via config file Mixing process Error message Error tank cock Sen...

Страница 53: ...menu Transfer menu tanks cannot be selected Display fill canisters Configuration of tanks was not changed prior to concen trate change Configure the tanks and transfer manually Transfer menu pump sta...

Страница 54: ...concentrates produced In all other cases a laboratory check is required Regardless of the repeatability of the batches the concentrate must not be used without laboratory testing for deviations of 0...

Страница 55: ...ion of the concentrates 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...

Страница 56: ...tside 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 technicia...

Страница 57: ...d 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 reso...

Страница 58: ...Operating instructions ECOMix Figure 7 1 Label ECOCart 58 State April 2021 4 9 1 I Manual ECOMix Original EN 7 F M Lorek 06 04 2021...

Страница 59: ...re 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 taugh...

Страница 60: ...ctor 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...

Страница 61: ...et CEE 400V 16A 6h Supply voltage 400VAC 50Hz Power consumption 1 KW Electrical protection 3 x K16 circuit breakers FI Fuses device side Electrical protection 4A slow blow microfuse 3 pcs 1F5 Electric...

Страница 62: ...measurement 0 1 C 9 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 t...

Страница 63: ...EU guideline 93 42 EEC EU guideline 2014 30 EU EU directive 2011 65 EU DIN EN 14971 DIN EN 60601 1 DIN EN 60601 1 2 DIN EN 60601 1 6 ISO 23500 1 2 3 4 5 DIN EN ISO 15223 1 EN 1041 EN 62366 EN ISO 1099...

Страница 64: ...he ECOMix 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 tan...

Страница 65: ...ention The content of the first canister about 5 l has to be discarded as there may be another type of concentrate in the concentrate feed to the ECOTanks The facility is responsible for ensuring that...

Страница 66: ...may charge a fee to dispose of the chemicals In order to avoid these and higher transport costs the customer can dissolve the ECOCarts on site and dispose of the resulting concentrate separately 10 1...

Страница 67: ...terchangeable components will be replaced by authorized technicians as part of mainte nance if required 10 13 Accessories The products listed below are not medical devices Storage tanks ECOTank 860 l...

Страница 68: ...edizin Technik GmbH Gewerbestra e S d 13 26842 Ostrhauderfehn 49 495282691 288 support intermedt de Switzerland B Braun Medical AG Seesatz 17 6204 Sempach Tel 41 58 258 50 00 Fax 41 58 258 60 00 info...

Страница 69: ...icate the end of the filling process 33 4 17 Display during mixing process 34 4 18 Work flow of the program step Automatic production Mixing 35 4 19 Display during evacuation of the ECOCart 35 4 20 Di...

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