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CW II-OM-rev1.0

Angewandte gemeinsame technischen Spezifikationen,
harmonisierte Normen, nationale Normen oder andere normative
Dokumente

Applied common technical specifications, harmonised standards,
national standards or other normative documents

Spécifications techniques communes, normes harmonisées, normes
nationales et autres documents normatifs appliqués

Specifiche tecniche comuni, norme Armonizzate o nazionali
applicate, altri Documenti normativi applicati

EN 61010-1

EN 61010-2-020

EN 61326-1

Risikobewertungsverfahren

Risk assessment procedure

Procédure

d’évaluation du risique

Procedimento di valutazione del rischio

EN ISO 14971

Konformitätsbewertungsverfahren

Conformity assessment procedure

Procédure

d’évaluation da la conformité

Procedimento di valutazione della conformità

98/79/EG Anhang III (ohne Sektion 6)

98/79/EC Appendix III (without section 6)

98/79/CE Annexe III (sans section 6)

98/79/CE Allegato del III (senza parte 6)

Zertifiziertes Qualitätsmanagement-System gemäss

Certified quality management system in accordance with

Système de management de la qualité certifié d'après

Sistema di gestione della qualità certificato conforme a

ISO 13485:2012

Baech, 17.8.2016

Doris Friedlos

Geschäftsleiterin / Manager /

Directrice / Gerente

Ort, Datum / Place, date /
Lieu, date / Luogo, data

Name und Funktion / Name and function /
Nom et fonction / Nome e funzione

Содержание 1008-00

Страница 1: ...2017 by Hettich AG page 1 CW II OM rev1 0 Waschzentrifuge Helmer UltraCW II Waschzentrifuge Hettich Rotolavit II Operating Instructions...

Страница 2: ...Centrifugeuse lave cellule Helmer UCW II 0000020 num ro de serie Dichiariamo sotto la nostra unica responsabilit che il dispositivo medico diagnostico in vitro Centrifuge per lavaggio Hettich Rotolav...

Страница 3: ...d valuation du risique Procedimento di valutazione del rischio EN ISO 14971 Konformit tsbewertungsverfahren Conformity assessment procedure Proc dure d valuation da la conformit Procedimento di valut...

Страница 4: ...AG Seestrasse 204a CH 8806 Baech Switzerland phone 41 0 44 786 80 20 info hettich ch www hettich ch 2017 by Hettich AG All rights reserved No part of this publication may be reproduced without the pri...

Страница 5: ...e of malfunctions and irregularities 11 4 1 Remaining risks 11 4 2 Switching off the device in an emergency 11 4 3 Emergency release 11 5 Technical specifications 12 6 Unpacking the centrifuge 13 6 1...

Страница 6: ...ss 25 9 4 7 AGIT process 25 9 4 8 LOOP process 26 9 4 9 CHECK process 26 9 5 Add a new program 27 10 Adjusting 29 10 1 Entering the rotor type 29 10 2 Calibrating the filling volume 29 10 3 Audible si...

Страница 7: ...2017 by Hettich AG page 7 CW II OM rev1 0 Hettich AG Laborapparate phone 41 44 786 80 20 Seestrasse 204a e mail info hettich ch CH 8806 Baech internet www hettich ch 16 1 Rotors and accessories 37...

Страница 8: ...al damage and injury to personal Symbol in this document This symbol refers to important circumstances Symbol on the device and in this document Beware of biohazard Symbol on the device and in this do...

Страница 9: ...less condition of the device and for its proper operation in accordance to the specifications is responsible for ensuring that persons who are to operate or service the device are qualified to do this...

Страница 10: ...and the legal regulations on accident prevention you should also follow the recognised professional regulations for working in a safe and professional manner These operating instructions should be re...

Страница 11: ...ions or damage immediately take the device out of work and inform your superior You can find on correcting malfunctions in chapter 13 4 1 Remaining risks The device is built according to the state of...

Страница 12: ...yes no yes optional car battery DC input no no 11V 30VDC width mm inch 330mm 13inch depth mm inch 480mm 18 9inch height mm closed 280mm 11inch height mm open 580mm 22 9inch weight kg lb 24 4 53 8 24...

Страница 13: ...nce for damage If you notice deviations from the delivery note damage or irregularities do not put the appliance into operation but inform the haulage company and your supplier If it is possible keep...

Страница 14: ...7 1 Connections 1 mounting bracket for the Power supply 2 ON OFF main switch 3 Ethernet interface 4 DC power input 1 A 5 fuse fuse holder 6 inlet 1 Saline 7 inlet 2 solution 2 1 8 outlet Drain A solut...

Страница 15: ...on fig 7 1 pos 6 and dip the other side with the metal part into the container with the saline solution If the fill hose is to short for your installation and it is not possible to move closer the ca...

Страница 16: ...creen occurs push the lid open button and open the lid chapter 8 2 pos 5 remove the transportation safety device from the top of the rotor and keep it on a save place 8 Operation settings 8 1 Overview...

Страница 17: ...process of the program x 2 edit process x 3 back without saving to select a program x 4 add process x 5 navigate through the existing process of the program x 6 rename the program x 8 5 System Setting...

Страница 18: ...em settings 2 last or next month the day with a yellow background has some saved datas runs 8 5 2 Time settings Description Login wheel adjuster for date and time 1 accept changes 2 discard changes an...

Страница 19: ...lid x 2 fill in solution refill undefined x 3 start calibration x 4 back to service menu without saving x 5 select pump x 6 select target for measurement x 7 indicate filling level x 8 target measure...

Страница 20: ...w hettich ch 8 6 3 Device settings Description Login 1 save changes x 2 back to service menu without saving x 3 change device name x 4 activate deactivate pumps x 5 adjust motor speed limit x 6 add ne...

Страница 21: ...utton Select a program To add a new program see chapter 0 Each program must be validated by the user with the custom tube If the tube will be changed then the program must be revalidated After select...

Страница 22: ...pin 30sec 3500 susp 3ml spin 30sec wash and anti 9 3 1 flush 1 This preinstalled system program is especially to flush the external and also the internal tubing system for that the first FILL process...

Страница 23: ...3500RPM DECANT 300RPM AGIT 19x LOOP 2x 9 3 4 agit and spin The process values are AGIT 19x SPIN 30sec 3500RPM 9 3 5 decant The process values are DECANT 300RPM 9 3 6 spin 30sec 3500 The process value...

Страница 24: ...ological saline solution is injected directly into the tubes in order to receive a good resuspension of the cells The best results are with a speed of 900RPM for both kind of rotor types The device wi...

Страница 25: ...number of revolutions per minute is adjustable from 0RPM to 2500RPM The excess is decanted at the selectable rotation speed During decanting the rotor turns in the opposite direction of the normal ro...

Страница 26: ...n add every other process except a LOOP Process that means you can program to wash out cells with two cycles unstead of tree with a DECANT process with a speed of a e 320RPM so that some small amount...

Страница 27: ...t the name push at the top In this example the first process is FILL 1 push to choose the FILL 1 symbol Below with the bar you can choose the filling capacity and the rotation speed at which it should...

Страница 28: ...add more process push By selecting a process you can switch the process to the previous process position To switch to left push Or after the next process position to right To edit a process select it...

Страница 29: ...underneath the injection tube inside from the lid and push the button start calibration cha 8 6 1 pos 3 Adjust the reading from the cylinder at the target measure cha 8 6 1 pos 8 with the buttons or...

Страница 30: ...rying operating hours Go into the system settings start screen cha 8 2 pos 2 Go into the service menu system settings cha 8 5 pos 2 11 Centrifugation of materials or mixtures of materials with a densi...

Страница 31: ...pter Removal of the drain gutter Check the filling volume of the saline solution see the Adjusting the filling volume chapter The system must be rinsed through with distilled water to avoid formation...

Страница 32: ...After removing the radioactive contaminants remove agent residue by rinsing with water only outside of the centrifuge or wipe off with a damp cloth The rotors and accessories must be dried directly a...

Страница 33: ...olume ml and speed from the FILL process in the used program Clean the injection nozzles Pellet does not form on the base of used tube The revolutions per minute during the centrifugation run for the...

Страница 34: ...cked Open or check button was pressed but the lid could not be opened Lid mechanically blocked 31 Unlocking failed Open or check button was pressed but the lock could not be unlocked Motor was still r...

Страница 35: ...incurred for cleaning and disinfection are to be charged to the customer We ask for your understanding in this matter 15 Storage Before storage the device it should be decontaminated and cleaned to p...

Страница 36: ...W II OM rev1 1 Hettich AG Laborapparate phone 41 44 786 80 20 Seestrasse 204a e mail info hettich ch CH 8806 Baech internet www hettich ch Log serialnumber ______________ inventorynumber _____________...

Страница 37: ...tube Kapazit t capacity ml 3 5 Ma e dimensions x L mm 10 x 75 12 x 75 Anzahl p Rotor number p rotor 12 12 Drehzahl speed RPM 3500 2 RZB RCF 1438 Radius radius mm 105 CW 1024 A E2197 Dekantierrotor 24...

Страница 38: ...ml 3 5 Ma e dimensions x L mm 10 x 75 12 x 75 Anzahl p Rotor number p rotor 12 12 Drehzahl speed RPM 3500 2 RZB RCF 1438 Radius radius mm 105 1018 A E2197 Dekantierrotor 24 fach Decant rotor 24 times...

Страница 39: ...Seestrasse 204a e mail info hettich ch CH 8806 Baech internet www hettich ch 16 1 3 Document History rev date supersession Revision description 1 0 23 May 2017 01 06 Contents desc of preloaded progra...

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