Braun Intermedt ECOMix User manual

Operating instructions ECOMix
Fully Automated Dialysis Concentrate Production System
Intermedt Medizin & Technik GmbH B. Braun Melsungen AG
Gewerbestraße-Süd 13 Carl-Braun-Straße 1
26842 Ostrhauderfehn 34212 Melsungen
Germany Germany
Tel.: [phone] www.bbraun.com
Fax: [phone]
suppo[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

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
D-26842 Ostrhauderfehn
Germany
Tel. [phone]
E-Mail: suppo[email protected]
Download of the manual: www.intermedt.de
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021

Operating instructions ECOMix
Declaration of conformity (EC)
Class IIb medical product: Valid until: 20.02.2022
Intermedt Medizin & Technik GmbH
Gewerbestraße-Süd 13
26842 Ostrhauderfehn
Germany
We hereby declare in our sole responsibility that
ECOMix, ECOMix Revolution and ECOCart
Dialysis-Concentrate-Production System
complies with all the applicable requirements of the Directive 93/42/EEC (last revised by
Directive 2007/47/EC).
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
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
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021

Operating instructions ECOMix
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
4 State: April 2021
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021

Operating instructions ECOMix
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
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
State: April 2021 5
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Operating instructions ECOMix
(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
(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),
6 State: April 2021
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Operating instructions ECOMix
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
(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),
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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),
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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Contents
Markings 13
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Symbols: type plate and labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Symbols: Production protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1 General Information 15
1.1 Manufacturer’s Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.2 Operator Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.3 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.4 Designated Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.5 Improper Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.6 Installation ............................................. 17
1.7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.8 Service and repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.9 Calibration ............................................. 18
1.10 Sterilization and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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 Hazards Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2 Chemicals Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.3 General Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.4 Protection from electrical hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.5 Emissions/EMC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.7 Modifications of the equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.8 Safe handling of ECOCarts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4 Operation and Functionality of the ECOMix 24
4.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
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4.2 Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.3 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.4 Automatic Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.5 Rinsing the ECOMix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.6 Filter change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.7 Settings ............................................... 46
4.8 Protection of the system with simultaneous hot cleaning of the permeate line . . . . . 47
4.9 Uncontrolled water inflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5 Short user instructions 50
6 Error messages 51
7 Density deviation and laboratory analysis 54
7.1 Interpretation of density deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
7.2 Validation of density measurement during the installation . . . . . . . . . . . . . . . . . 54
7.3 Implementation of the laboratory analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7.4 Dealing with density deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
7.5 Interpretation of laboratory 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 instructors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
8.5 Forms for the instruction training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
9 Technical data/materials 61
9.1 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
9.2 Materials used for the fluids system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
9.3 Used guidelines and standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
9.4 Name plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
10 Annex 64
10.1 Environmental conditions required for operation . . . . . . . . . . . . . . . . . . . . . . . 64
10.2 Storage and transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
10.3 Setting up the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
10.4 Preparing the mixing system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
10.5 Transferring the concentrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.6 Filling of canisters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.7 Practical advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.8 Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
10.9 Storage and shelf life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
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10.10Disposal ............................................... 66
10.11Regular cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
10.12Disposables ............................................. 67
10.13Accessories ............................................. 67
11 Contact Adresses 68
List of Figures 69
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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
Do not freeze Protect from heat
1-time-use only Corrosive
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Operating instructions ECOMix
Symbols: Production protocol
Center/Unit/Clinic Density deviation
Date Lab test necessary
Observe the manual Sample taken
Batch number Transfered to tank no.
Person responsible Authorization
Performed filter change Signature
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.
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1.4 Designated Use
The ECOMix/ECOCart system is used for the fully automated preparation of an acid dialysis con-
centrate: In a closed, validated and verified process dry concentrate process is converted into a liquid
state. This treatment process, referred to herein for convenience as production, is the designated
application of this certified medical device.
The ECOMix production system may only be used for the production of acidic dialysis concentrates
using the original ECOCart supplied by Intermedt. 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 are suitable for hemodialysis and hemodiafil-
tration. 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 ma-
chine. 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
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•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
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 are only operational when the
system is turned on.
1.6 Installation
Assembly and installation of the ECOMix system must exclusively be planned and performed 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 system must exclusively be performed by technicians authorized by
Intermedt. For maintenance, there is a separate manual which is issued exclusively to authorized
technicians. Maintenance is required every 12 months.
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Operating instructions ECOMix
1.8 Service and repairs
Service and repairs must exclusively performed by technicians authorized by Intermedt. The tasks
are described in the maintenance manual.
1.9 Calibration
Calibration of the ECOMix system must exclusively be performed by technicians authorized by Inter-
medt. 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 nor the ECOCart requires sterilisation. Disinfections of the ECOMix are only
necessary when the ECOMix has been in supplied with contaminated 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 8.
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 6.
1.13 Using the operating instructions
These instructions describe the proper and safe use of the ECOMix 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 production system is designed for producing sodium chloride based concentrates,
named concentrate in the following.
The ECOMix production system consists of two functional modules:
1. Microprocessor-controlled mixing system
2. Salt cartridge (ECOCart) on rollable base
The production system may also contain optional tanks (ECOTanks) for storing the prepared
concentrates.
Figure 2.1: ECOMix production system with salt cartridge (ECOCart) and storage tank (ECOTank)
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Operating instructions ECOMix
2.1 Description of Components
Microprocessor-controlled mixing system:
•With an integrated pump for mixing and decanting the concentrate to be produced
•Sensor system for dry run and overload protection
•Mixing tank capacity: up to 750 l of concentrate
•Production and decanting process controller
•Quick couplings for connecting the ECOCart
•Multi-level filtration of the finished solution while decanting into storage tanks or canisters
•Outlet for connecting to storage tanks or nozzle filling canisters
•Automatic 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 quick connect couplings for connecting to the production system
•Integrated fine filter for salt retention
2.2 Optional components
•ECOTanks to store the produced concentrates
•CANBus module for the administration and monitoring of up to 8 ECOTanks
•Sewage pump for elevated drainage connections
•Fuel nozzle for canister filling
•Remote display
Without ECOTanks and the CANBus module it is not possible to transfer concen-
trates automatically and in a safe way.
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