Operating instructions ECOMix Revolution - INTERMEDT ...
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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 10
0044
State: April 2021
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021
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.
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021
Operating instructions ECOMix Revolution
Declaration of conformity (EC)
Class IIb medical product: Valid until: 20.02.2022
Intermedt Medizin & Technik GmbH
Gewerbestraße-Süd 13
26842 Ostrhauderfehn
Germany
We hereby declare in our sole responsibility that
ECOMix, ECOMix Revolution and ECOCart
Dialysis-Concentrate-Production System
complies with all the applicable requirements of the Directive 93/42/EEC (last revised by
Directive 2007/47/EC).
Compliance of the designated products with the fundamental requirements of the directive is demon-
strated by the technical documentation and its full conformance with the standards specified.
Compliance with the requirements of Appendix II is 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 05.09.2007
Report Nr.: 3523 4287
Valid until: 20.02.2024
Notified body:
TÜV Nord Cert GmbH
Langemarckstr. 20
45141 Essen
Germany
ID number: 0044
DIMDI Code: DE/00 000 43487, Form number: 00227304 bigskip
Plus:
Certificate of the quality management system referred to DIN EN ISO 13485:2016 of 15.02.2019,
valid until: 20.02.2022
Reg.-No. 44 221 130544
Report No. 3523 4286
We also declare that these products comply with all the applicable requirements of the Directive
2011/65/EU (RoHS 2). Compliance is demonstrated by the technical documentation.
Ostrhauderfehn, 11.01.2021
Place, Date Christoph Dumschat,
. Managing Director
State: April 2021 3
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021
Operating instructions ECOMix Revolution
List of ECOCarts:
ECOCart DSK-0252-GW-585-45 (IM3773), ECOCart DSK-0252-GW-622-45-Rev (IM3724),
ECOCart DSK-0252-GW-622-45-ToGo (IM3725), ECOCart DSK-0252-GW-750-35 (IM3774),
ECOCart DSK-0252-GW-800-35-Rev (IM3681), ECOCart DSK-0252-GW-800-35-ToGo (IM3682),
ECOCart DSK-0262-GW-585-45 (IM3776), ECOCart DSK-0262-GW-622-45-Rev (IM3728),
ECOCart DSK-0262-GW-622-45-ToGo (IM3729), ECOCart DSK-0262-GW-750-35 (IM3775),
ECOCart DSK-0262-GW-800-35-Rev (IM3685), ECOCart DSK-0262-GW-800-35-ToGo (IM3686),
ECOCart DSK-0442-GW-B8-585-45 (IM3949), ECOCart DSK-0452-GW-622-45-Rev (IM3461),
ECOCart DSK-0452-GW-B9-585-45 (IM3803), ECOCart DSK-0452-GW-B9-622-45-Rev (IM3734),
ECOCart DSK-0452-GW-B9-622-45-ToGo (IM3733), ECOCart DSK-0452-GW-B9-750-35
(IM3802), ECOCart DSK-0452-GW-B9-800-35-Rev (IM3690), ECOCart DSK-0452-GW-B9-800-
35-ToGo (IM3691), ECOCart DSK-0453-GW-585-45 (IM1966), ECOCart DSK-0453-GW-622-45-
Rev (IM3735), ECOCart DSK-0453-GW-622-45-ToGo (IM3736), ECOCart DSK-0453-GW-750-35
(IM2211), ECOCart DSK-0453-GW-800-35-Rev (IM3598), ECOCart DSK-0453-GW-800-35-ToGo
(IM3693), ECOCart DSK-0453-GW-Cit-B9-622-45-Rev (IM3898), ECOCart DSK-0462-GW-585-45
(IM3287), ECOCart DSK-0462-GW-622-45-Rev (IM3738), ECOCart DSK-0462-GW-622-45-ToGo
(IM3739), ECOCart DSK-0462-GW-750-35 (IM3777), ECOCart DSK-0462-GW-800-35-Rev
(IM3695), ECOCart DSK-0462-GW-800-35-ToGo (IM3696), ECOCart DSK-0463-GW-585-45
(IM3781), ECOCart DSK-0463-GW-622-45-Rev (IM3740), ECOCart DSK-0463-GW-622-45-ToGo
(IM3741), ECOCart DSK-0463-GW-750-35 (IM3778), ECOCart DSK-0463-GW-800-35-Rev
(IM3692), ECOCart DSK-0463-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-Rev
(IM3442), ECOCart DSK-0472-GW-800-35-ToGo (IM3699), ECOCart DSK-0473-GW-585-45
(IM3783), ECOCart DSK-0473-GW-622-45-Rev (IM3744), ECOCart DSK-0473-GW-622-45-ToGo
(IM3745), ECOCart DSK-0473-GW-750-35 (IM3780), ECOCart DSK-0473-GW-800-35-Rev
(IM3700), ECOCart DSK-0473-GW-800-35-ToGo (IM3701), ECOCart DSK-0652-GW-622-45-Rev
(IM3460), ECOCart DSK-0652-GW-B9-585-45 (IM3792), ECOCart DSK-0652-GW-B9-622-45-Rev
(IM3867), ECOCart DSK-0652-GW-B9-622-45-ToGo (IM3747), ECOCart DSK-0652-GW-B9-
750-35 (IM3791), ECOCart DSK-0652-GW-B9-800-35-Rev (IM3703), ECOCart DSK-0652-GW-
B9-800-35-ToGo (IM3704), ECOCart DSK-0653-GW-585-45 (IM1970), ECOCart DSK-0653-
GW-622-45-Rev (IM3938), ECOCart DSK-0653-GW-750-35 (IM2213), ECOCart DSK-0653-GW-
800-35-Rev (IM3597), ECOCart DSK-0653-GW-Cit-B9-622-45-Rev (IM5007), ECOCart DSK-
0653-GW-Cit-B9-622-45-ToGo (IM3899), ECOCart DSK-0662-GW-585-45 (IM3288), ECOCart
DSK-0662-GW-622-45-Rev (IM3752), ECOCart DSK-0662-GW-622-45-ToGo (IM3753), ECOCart
DSK-0662-GW-750-35 (IM3790), ECOCart DSK-0662-GW-800-35-Rev (IM3709), ECOCart
DSK-0662-GW-800-35-ToGo (IM3710), ECOCart DSK-0663-G15W-500-45 (IM3105), ECOCart
DSK-0672-GW-585-45 (IM3784), ECOCart DSK-0672-GW-622-45-Rev (IM3754), ECOCart
DSK-0672-GW-622-45-ToGo (IM3755), ECOCart DSK-0672-GW-750-35 (IM3787), ECOCart
DSK-0672-GW-800-35-Rev (IM3711), ECOCart DSK-0672-GW-800-35-ToGo (IM3712), ECOCart
DSK-0673-GW-585-45 (IM3785), ECOCart DSK-0673-GW-622-45-Rev (IM3756), ECOCart
DSK-0673-GW-622-45-ToGo (IM3757), ECOCart DSK-0673-GW-750-35 (IM3788), ECOCart
DSK-0673-GW-800-35-Rev (IM3713), ECOCart DSK-0673-GW-800-35-ToGo (IM3714), ECOCart
DSK-0852-GW-585-45 (IM3793), ECOCart DSK-0852-GW-622-45-Rev (IM3758), ECOCart
DSK-0852-GW-622-45-ToGo (IM3759), ECOCart DSK-0852-GW-750-35 (IM3795), ECOCart
DSK-0852-GW-800-35-Rev (IM3715), ECOCart DSK-0852-GW-800-35-ToGo (IM3716), ECOCart
4 State: April 2021
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021
Operating instructions ECOMix Revolution
DSK-0853-GW-585-45 (IM2215), ECOCart DSK-0853-GW-622-45-Rev (IM3939), ECOCart
DSK-0862-GW-585-45 (IM3794), ECOCart DSK-0862-GW-622-45-Rev (IM3760), ECOCart
DSK-0862-GW-622-45-ToGo (IM3761), ECOCart DSK-0862-GW-750-35 (IM3796), ECOCart
DSK-0862-GW-800-35-Rev (IM3717), ECOCart DSK-0862-GW-800-35-ToGo (IM3718), ECOCart
DSK-0863-GW-585-45 (IM3106), ECOCart DSK-0863-GW-622-45-Rev (IM3762), ECOCart
DSK-0863-GW-622-45-ToGo (IM3763), ECOCart DSK-0863-GW-750-35 (IM3797), ECOCart
DSK-0863-GW-800-35-Rev (IM3719), ECOCart DSK-0863-GW-800-35-ToGo (IM3720), ECOCart
DSK-0872-GW-585-45 (IM3786), ECOCart DSK-0872-GW-622-45-Rev (IM3764), ECOCart
DSK-0872-GW-622-45-ToGo (IM3765), ECOCart DSK-0872-GW-750-35 (IM3789), ECOCart
DSK-0872-GW-800-35-Rev (IM3721), ECOCart DSK-0872-GW-800-35-ToGo (IM3722), ECOCart
DSK-2052-GW-622-45-Rev (IM3991), ECOCart DSK-2052-GW-622-45-ToGo (IM3985), ECOCart
DSK-2052-GW-Cit-622-45-ToGo (IM4094), ECOCart DSK-2062-GW-622-45-Rev (IM3993),
ECOCart DSK-2062-GW-622-45-ToGo (IM3987), ECOCart DSK-2062-GW-Cit-622-45-ToGo
(IM4096), ECOCart DSK-2452-GW-622-45-Rev (IM3992), ECOCart DSK-2452-GW-622-45-ToGo
(IM3986), ECOCart DSK-2452-GW-Cit-622-45-ToGo (IM4095), ECOCart DSK-2462-GW-622-45-
Rev (IM3994), ECOCart DSK-2462-GW-622-45-ToGo (IM3988), ECOCart DSK-2462-GW-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 (IM3679), ECOCart DSK-3252-GW-800-35-ToGo
(IM3680), ECOCart DSK-3253-GW-585-45 (IM4046), ECOCart DSK-3253-GW-622-45-Rev
(IM4005), ECOCart DSK-3253-GW-622-45-ToGo (IM4006), ECOCart DSK-3253-GW-750-35
(IM4047), ECOCart DSK-3253-GW-800-35-Rev (IM4007), ECOCart DSK-3253-GW-800-35-
ToGo (IM4008), ECOCart DSK-325V-GW-750-35 (IM2291), ECOCart DSK-3262-GW-585-45
(IM2464), ECOCart DSK-3262-GW-622-45-Rev (IM3726), ECOCart DSK-3262-GW-622-45-ToGo
(IM3727), ECOCart DSK-3262-GW-750-35 (IM1802), ECOCart DSK-3262-GW-800-35-Rev
(IM3683), ECOCart DSK-3262-GW-800-35-ToGo (IM3684), ECOCart DSK-3262-GW-Cit-585-
45 (IM5061), ECOCart DSK-3263-GW-585-45 (IM4048), ECOCart DSK-3263-GW-622-45-Rev
(IM4009), ECOCart DSK-3263-GW-622-45-ToGo (IM4010), ECOCart DSK-3263-GW-750-35
(IM1694), ECOCart DSK-3263-GW-800-35-Rev (IM4011), ECOCart DSK-3263-GW-800-35-ToGo
(IM4012), ECOCart DSK-3272-GW-585-45 (IM3801), ECOCart DSK-3272-GW-622-45-Rev
(IM3730), ECOCart DSK-3272-GW-622-45-ToGo (IM3731), ECOCart DSK-3272-GW-750-35
(IM3800), ECOCart DSK-3272-GW-800-35-Rev (IM3687), ECOCart DSK-3272-GW-800-35-ToGo
(IM3688), ECOCart DSK-3273-GW-585-45 (IM4049), ECOCart DSK-3273-GW-622-45-Rev
(IM4013), ECOCart DSK-3273-GW-622-45-ToGo (IM4014), ECOCart DSK-3273-GW-750-35
(IM4050), ECOCart DSK-3273-GW-800-35-Rev (IM4015), ECOCart DSK-3273-GW-800-35-ToGo
(IM4016), ECOCart DSK-3352-GW-800-35-Rev (IM3439), ECOCart DSK-3352-GW-B29-800-
35-ToGo (IM4062), ECOCart DSK-3353-GW-750-35 (IM2875), ECOCart DSK-33A4-GW-750-
35 (IM2828), ECOCart DSK-33S4-GW-750-35 (IM1544), ECOCart DSK-3442-GW-750-35
(IM3877), ECOCart DSK-3452-G15W-2-650-35 (IM2600), ECOCart DSK-3452-G2W-600-35-
Rev (IM3640), ECOCart DSK-3452-GW-585-45 (IM3799), ECOCart DSK-3452-GW-622-45-Rev
(IM3452), ECOCart DSK-3452-GW-622-45-ToGo (IM3732), ECOCart DSK-3452-GW-750-35
(IM1912), ECOCart DSK-3452-GW-800-35-Rev (IM3450), ECOCart DSK-3452-GW-800-35-ToGo
(IM3689), ECOCart DSK-3452-GW-B6-622-45-Rev (IM3671), ECOCart DSK-3453-G2W-600-35-
Rev (IM3848), ECOCart DSK-3453-GW-585-45 (IM2347), ECOCart DSK-3453-GW-622-45-Rev
(IM4017), ECOCart DSK-3453-GW-622-45-ToGo (IM4018), ECOCart DSK-3453-GW-750-35
(IM1690), ECOCart DSK-3453-GW-800-35-Rev (IM3864), ECOCart DSK-3453-GW-800-35-ToGo
State: April 2021 5
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021Operating instructions ECOMix Revolution
(IM4019), ECOCart DSK-3454-GW-750-35 (IM2035), ECOCart DSK-3456-GW-750-35 (IM4063),
ECOCart DSK-345V-GW-750-35 (IM2292), ECOCart DSK-3462-800-35-Rev (IM3619), ECOCart
DSK-3462-800-35-ToGo (IM4084), ECOCart DSK-3462-GW-585-45 (IM1843), ECOCart DSK-
3462-GW-622-45-Rev (IM3453), ECOCart DSK-3462-GW-622-45-ToGo (IM3737), ECOCart
DSK-3462-GW-750-35 (IM1561), ECOCart DSK-3462-GW-800-35-Rev (IM3451), ECOCart
DSK-3462-GW-800-35-ToGo (IM3697), ECOCart DSK-3462-GW-Cit-585-45 (IM3771), ECOCart
DSK-3462-GW-Cit-622-45-Rev (IM3768), ECOCart DSK-3462-GW-Cit-622-45-ToGo (IM3769),
ECOCart DSK-3462-GW-Cit-750-35 (IM3770), ECOCart DSK-3462-GW-Cit-800-35-Rev (IM3766),
ECOCart DSK-3462-GW-Cit-800-35-ToGo (IM3767), ECOCart DSK-3463-GW-585-45 (IM2348),
ECOCart DSK-3463-GW-622-45-Rev (IM4020), ECOCart DSK-3463-GW-622-45-ToGo (IM4021),
ECOCart DSK-3463-GW-750-35 (IM1691), ECOCart DSK-3463-GW-800-35-Rev (IM4022),
ECOCart DSK-3463-GW-800-35-ToGo (IM4023), ECOCart DSK-3463-GW-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), ECOCart DSK-3472-GW-750-35 (IM1569), ECOCart
DSK-3472-GW-800-35-Rev (IM3953), ECOCart DSK-3472-GW-800-35-ToGo (IM3955), ECOCart
DSK-3472-GW-Cit-585-45 (IM3808), ECOCart DSK-3472-GW-Cit-622-45-Rev (IM3820), ECOCart
DSK-3472-GW-Cit-622-45-ToGo (IM3821), ECOCart DSK-3472-GW-Cit-750-35 (IM3804),
ECOCart DSK-3472-GW-Cit-800-35-Rev (IM3812), ECOCart DSK-3472-GW-Cit-800-35-ToGo
(IM3813), ECOCart DSK-3473-GW-585-45 (IM3017), ECOCart DSK-3473-GW-622-45-Rev
(IM4024), ECOCart DSK-3473-GW-622-45-ToGo (IM4025), ECOCart DSK-3473-GW-750-35
(IM2022), ECOCart DSK-3473-GW-800-35-Rev (IM4026), ECOCart DSK-3473-GW-800-35-
ToGo (IM4027), ECOCart DSK-34A4-GW-750-35 (IM3107), ECOCart DSK-34C2-GW-750-35
(IM3875), ECOCart DSK-34C2-GW-Cit-585-45 (IM3260), ECOCart DSK-34M2-GW-622-45-
Rev (IM4057), ECOCart DSK-3552-GW-585-45 (IM3241), ECOCart DSK-3552-GW-750-35
(IM2353), ECOCart DSK-3553-GW-750-35 (IM1497), ECOCart DSK-3554-GW-750-35 (IM1540),
ECOCart DSK-3562-GW-750-35 (IM2216), ECOCart DSK-3572-GW-750-35 (IM1632), ECOCart
DSK-35A4-GW-750-35 (IM2829), ECOCart DSK-3652-G15W-650-35 (IM3291), ECOCart
DSK-3652-G2W-600-35-Rev (IM3641), ECOCart DSK-3652-GW-585-45 (IM2867), ECOCart
DSK-3652-GW-622-45-Rev (IM3635), ECOCart DSK-3652-GW-622-45-ToGo (IM3746), ECOCart
DSK-3652-GW-750-35 (IM1573), ECOCart DSK-3652-GW-800-35-Rev (IM3595), ECOCart
DSK-3652-GW-800-35-ToGo (IM3702), ECOCart DSK-3652-GW-B6-622-45-Rev (IM3672),
ECOCart DSK-3653-G2W-600-35-Rev (IM3849), ECOCart DSK-3653-GW-2-750-35 (IM1995),
ECOCart DSK-3653-GW-585-45 (IM3798), ECOCart DSK-3653-GW-622-45-Rev (IM3748),
ECOCart DSK-3653-GW-622-45-ToGo (IM3749), ECOCart DSK-3653-GW-750-35 (IM2036),
ECOCart DSK-3653-GW-800-35-Rev (IM3705), ECOCart DSK-3653-GW-800-35-ToGo (IM3706),
ECOCart DSK-3654-GW-585-45 (IM2371), ECOCart DSK-3654-GW-750-35 (IM2652), ECOCart
DSK-365V-GW-750-35 (IM2293), ECOCart DSK-3662-GW-3,5-750-35 (IM1571), ECOCart
DSK-3662-GW-585-45 (IM1850), ECOCart DSK-3662-GW-622-45-Rev (IM3750), ECOCart
DSK-3662-GW-622-45-ToGo (IM3751), ECOCart DSK-3662-GW-750-35 (IM1560), ECOCart
DSK-3662-GW-800-35-Rev (IM3707), ECOCart DSK-3662-GW-800-35-ToGo (IM3708), ECOCart
DSK-3662-GW-Cit-585-45 (IM3809), ECOCart DSK-3662-GW-Cit-622-45-Rev (IM3827), ECOCart
DSK-3662-GW-Cit-622-45-ToGo (IM3824), ECOCart DSK-3662-GW-Cit-750-35 (IM3805),
ECOCart DSK-3662-GW-Cit-800-35-Rev (IM3814), ECOCart DSK-3662-GW-Cit-800-35-ToGo
(IM3815), ECOCart DSK-3663-GW-585-45 (IM2349), ECOCart DSK-3663-GW-622-45-Rev
(IM4028), ECOCart DSK-3663-GW-622-45-ToGo (IM4029), ECOCart DSK-3663-GW-750-35
6 State: April 2021
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021Operating instructions ECOMix Revolution
(IM1366), ECOCart DSK-3663-GW-800-35-Rev (IM4030), ECOCart DSK-3663-GW-800-35-ToGo
(IM4031), ECOCart DSK-3663-GW-Cit-750-35 (IM3873), ECOCart DSK-3664-G15W-500-
45 (IM2374), ECOCart DSK-3664-GW-585-45 (IM2426), ECOCart DSK-3664-GW-750-35
(IM1839), ECOCart DSK-3672-GW-585-45 (IM3956), ECOCart DSK-3672-GW-585-45 (IM4051),
ECOCart DSK-3672-GW-622-45-Rev (IM3957), ECOCart DSK-3672-GW-622-45-ToGo (IM3959),
ECOCart DSK-3672-GW-750-35 (IM1575), ECOCart DSK-3672-GW-800-35-Rev (IM3958),
ECOCart DSK-3672-GW-800-35-ToGo (IM3960), ECOCart DSK-3672-GW-Cit-585-45 (IM3810),
ECOCart DSK-3672-GW-Cit-622-45-Rev (IM3822), ECOCart DSK-3672-GW-Cit-622-45-ToGo
(IM3823), 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 (IM4033), ECOCart DSK-3673-GW-750-35
(IM2001), ECOCart DSK-3673-GW-800-35-Rev (IM4034), ECOCart DSK-3673-GW-800-35-ToGo
(IM4035), ECOCart DSK-36A3-GW-750-35 (IM2276), ECOCart DSK-36C2-GW-750-35 (IM2838),
ECOCart DSK-36C2-GW-Cit-585-45 (IM3261), ECOCart DSK-36C2-GW-Cit-750-35 (IM5004),
ECOCart DSK-36K3-GW-750-35 (IM2355), ECOCart DSK-36K4-GW-750-35 (IM2985), ECOCart
DSK-36L2-GW-750-35 (IM1799), ECOCart DSK-36M2-GW-622-45-Rev (IM4058), ECOCart DSK-
3752-GW-585-45 (IM3242), ECOCart DSK-3752-GW-750-35 (IM2354), ECOCart DSK-37A4-GW-
750-35 (IM2830), ECOCart DSK-37S3-GW-750-35 (IM1496), ECOCart DSK-37S4-GW-750-35
(IM1542), ECOCart DSK-3852-G15W-650-35 (IM3292), ECOCart DSK-3852-G2W-600-35-Rev
(IM3642), ECOCart DSK-3852-GW-585-45 (IM2868), ECOCart DSK-3852-GW-622-45-Rev
(IM3962), ECOCart DSK-3852-GW-622-45-ToGo (IM3963), ECOCart DSK-3852-GW-750-35
(IM2168), ECOCart DSK-3852-GW-800-35-Rev (IM3596), ECOCart DSK-3852-GW-800-35-ToGo
(IM3961), ECOCart DSK-3853-G2W-600-35-Rev (IM3850), ECOCart DSK-3853-GW-2-750-35
(IM1996), ECOCart DSK-3853-GW-622-45-Rev (IM3995), ECOCart DSK-3853-GW-622-45-ToGo
(IM4036), ECOCart DSK-3853-GW-750-35 (IM2037), ECOCart DSK-3853-GW-800-35-Rev
(IM3865), ECOCart DSK-3853-GW-800-35-ToGo (IM4037), ECOCart DSK-3854-GW-575-45
(IM2372), ECOCart DSK-3854-GW-750-35 (IM2719), ECOCart DSK-3856-GW-750-35 (IM4064),
ECOCart DSK-385V-GW-750-35 (IM2294), ECOCart DSK-3862-GW-3,5-750-35 (IM1577),
ECOCart DSK-3862-GW-585-45 (IM2351), ECOCart DSK-3862-GW-622-45-Rev (IM3937),
ECOCart DSK-3862-GW-622-45-ToGo (IM3964), ECOCart DSK-3862-GW-750-35 (IM1562),
ECOCart DSK-3862-GW-800-35-Rev (IM3965), ECOCart DSK-3862-GW-800-35-ToGo (IM3966),
ECOCart DSK-3862-GW-Cit-585-45 (IM3811), ECOCart DSK-3862-GW-Cit-622-45-Rev (IM3826),
ECOCart DSK-3862-GW-Cit-622-45-ToGo (IM3825), ECOCart DSK-3862-GW-Cit-750-35
(IM3807), ECOCart DSK-3862-GW-Cit-800-35-Rev (IM3818), ECOCart DSK-3862-GW-Cit-800-
35-ToGo (IM3819), ECOCart DSK-3863-GW-585-45 (IM4052), ECOCart DSK-3863-GW-622-45-
Rev (IM4038), ECOCart DSK-3863-GW-622-45-ToGo (IM4039), ECOCart DSK-3863-GW-750-35
(IM1792), ECOCart DSK-3863-GW-800-35-Rev (IM4040), ECOCart DSK-3863-GW-800-35-
ToGo (IM4041), ECOCart DSK-3863-GW-Cit-750-35 (IM3874), ECOCart DSK-3864-GW-575-45
(IM2372), ECOCart DSK-3864-GW-750-35 (IM3386), ECOCart DSK-3872-GW-3,5-750-35
(IM1576), ECOCart DSK-3872-GW-585-45 (IM3967), ECOCart DSK-3872-GW-622-45-Rev
(IM3968), ECOCart DSK-3872-GW-622-45-ToGo (IM3969), ECOCart DSK-3872-GW-750-35
(IM1633), ECOCart DSK-3872-GW-800-35-Rev (IM3970), ECOCart 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-3873-GW-800-35-ToGo (IM4045), ECOCart DSK-38A4-GW-750-35
(IM3108), ECOCart DSK-38C2-GW-750-35 (IM3876), ECOCart DSK-38L2-GW-750-35 (IM1603),
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ECOCart DSK-5264-GW-2,5-575-45 (IM1815), ECOCart DSK-5454-GW-2,5-575-45 (IM2961),
ECOCart DSK-5462-GW-2-750-35 (IM3438), ECOCart DSK-5463-GW-750-35 (IM2466), ECOCart
DSK-5463-GW-800-35-Rev (IM5103), ECOCart DSK-5564-GW-2,5-575-45 (IM1816), ECOCart
DSK-5654-GW-2,5-575-45 (IM2963), ECOCart DSK-5663-G2W-575-35 (IM2713), ECOCart
DSK-5663-GW-750-35 (IM2465), ECOCart DSK-5663-GW-800-35-Rev (IM5104), ECOCart
DSK-5664-G2W-575-35 (IM3387), ECOCart DSK-5764-GW-2,5-575-45 (IM1814), ECOCart
DSK-5854-GW-2,5-575-45 (IM3856), ECOCart DSK-5856-GW-2,5-575-45 (IM2964), ECOCart
DSK-5862-GW-750-35 (IM3246), ECOCart DSK-5864-GW-2,5-575-45 (IM2030), ECOCart
DSK-5866-GW-2,5-575-45 (IM2004), ECOCart DSK-74V4-4-800-35-Rev (IM3443), ECOCart
DSK-V4V2-4-800-35-Rev (IM3440)
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13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021Contents
Markings 11
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Symbols: type plate and labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Symbols: Production protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1 General Information 13
1.1 Manufacturer’s Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.2 Operator Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.3 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.4 Designated Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.5 Improper Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.6 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.8 Service and repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.9 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.10 Sterilization and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.11 Instructions of Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.12 Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.13 Using the operating instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2 System Description 17
2.1 Description of Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.2 Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3 Safety 20
3.1 Overall Hazards Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.2 Chemicals Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.3 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.4 Protection from electrical hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.5 Emissions/EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7 Modifications of the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.8 Safe handling of ECOCarts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4 Operation and Functionality of the ECOMix Revolution 23
4.1 Main menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.2 Starting the production process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.3 Fully automatic production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.4 Production protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.5 Rinsing process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
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4.6 Filling of canisters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.7 Routine Hot Water Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.8 Changing the filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.9 Replacing the internal filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.10 Removing of filters in the coupling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.11 Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.12 Technicians’ programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.13 Protective functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5 Error Messages 40
6 Density deviation and laboratory analysis 42
6.1 Interpretation of density deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.2 Validation of density measurement during the installation . . . . . . . . . . . . . . . . . 42
6.3 Implementation of the laboratory analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.4 Dealing with density deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.5 Transfer of a concentrate after release through the laboratory values . . . . . . . . . . 44
6.6 Interpretation of laboratory results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
6.7 Values on the ECOCart label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
7 Instructions of Users 47
7.1 Authorization for Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
7.2 Execution of an instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
7.3 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
7.4 Authorisation of future instructors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
7.5 Forms for the instruction training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
8 Technical data/materials 49
8.1 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
8.2 Materials used for the fluids system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8.3 Used guidelines and standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
8.4 Name plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
9 Annex 51
9.1 Environmental conditions required for operation . . . . . . . . . . . . . . . . . . . . . . . 51
9.2 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
9.3 Setting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
9.4 Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
9.5 Storage and shelf life of devices and chemicals/fluids . . . . . . . . . . . . . . . . . . . . 52
9.6 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
9.7 Regular cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
9.8 Disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
9.9 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
10 Contact adresses 54
List of figures 58
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13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.2021Markings
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
Do not freeze Protect from heat
1-time-use only Corrosive
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Symbols: Production protocol
Center/Unit/Clinic Density deviation
Date Lab test necessary
Observe the manual Sample taken
Batch number Transfered to tank no.
Person responsible Authorization
Performed filter change Signature
Yes No
12 State: April 2021
13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.20211 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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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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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.
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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1.9 Calibration
Calibration of the ECOMix Revolution system must exclusively be performed by technicians autho-
rized by Intermedt. Calibration is done during installation and maintenance and is described in the
corresponding manuals. The calibration data is password protected 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 10 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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13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.20212 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)
At the moment, there are three different options available for ECOCarts:
• ECOCart Revolution on rollable base (ECOCart has a central screw cap)
• ECOCart ToGo on rollable base (ECOCart has no central screw cap)
• ECOCart ToGo on mini pallet (ECOCart has no central screw 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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2.2 Optional components
• ECOTanks to store the produced concentrates
• Master module for the administration and monitoring of up to 4 ECOTanks
• Sewage pump for elevated drainage connections
• Fuel nozzle for canister filling
Without ECOTanks and the master module it is not possible to transfer concentrates
automatically and in a safe way.
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13.18.1., I Manual ECOMix Revolution (EN), 14, F: M. Lorek, 06.04.20213 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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"
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 10
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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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.
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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.
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)
3. Take off the caps of the couplings on top of the ECOCart
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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 On top of the reusable ECOCart Revolution, there is a black screw cap
between the coupling connectors 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 20.
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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" 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 30 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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" 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 labo-
ratory 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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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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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.
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Figure 4.4: Production protocol ECOCart
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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.
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).
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