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Hettich AG, Seestrasse 204a, 8806 Baech, Switzerland

Operator_Manual_Rotolavit II_und_Rotolavit II-S_en_rev2.5

Seite 57

2.5

2.4

Revision status corrected in footer, typing
error fixed (all chapters), layout adapted
(entire document), all images and tables
inserted in EN and updated according to
the latest software 421, image captions
and descriptions, image references
adjusted (entire document) chap. 5
Technical data, sound pressure level
changed from 49 to 62dB, chap. 16.2
inserted (from service manual), Fig.7.6
(rotor) inserted, chap. 8.1 Overview menu
navigation new picture inserted in DE,
chap. 8.6.3 Lid option explained and
extra picture inserted, 9.4.6 DECANT
new wording, 10.2 Calibration changed
from monthly to weekly, sentence
positions and spellings changed (all
chapters) Chap. 15 Remove storage
battery inserted, chap. 16.1 Added
information regarding glass tubes,
removed operator-manual from list in
Cha. 6.3

09.06.2020 LH

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Содержание Rotolavit II

Страница 1: ...ettich AG Seestrasse 204a 8806 Baech Switzerland Operator_Manual_Rotolavit II_und_Rotolavit II S_en_rev2 5 Seite 1 Operating Instructions Cell Washer Centrifuge Hettich Rotolavit II and Rotolavit II S...

Страница 2: ...2 5 Seite 2 manufactured by Hettich AG Seestrasse 204a CH 8806 Baech Switzerland phone 41 0 44 786 80 20 info hettich ch www hettich ch 2020 by Hettich AG All rights reserved No part of this publicati...

Страница 3: ...ra uso diagn stico in vitro Declaramos sob a nossa inteira responsabilidade que o dispositivo m dico para diagn sticos in vitro Rotolavit II Rotolavit II S und and et e y e UltraCW II ab Seriennummer...

Страница 4: ...diagn stico in vitro 98 79 CE anexo III aplic veis Baech 30 September 2019 Doris Friedlos Gesch ftsleiterin CEO Directrice g n ral Gerente Ort Datum Place date Lieu date Luogo data Lugar fecha Local d...

Страница 5: ...f malfunctions and irregularities 13 4 1 Remaining risks 13 4 2 Switching off the device in an emergency 13 4 3 Emergency release 13 5 Technical specifications 14 6 Unpacking the centrifuge 15 6 1 Sto...

Страница 6: ...2 9 3 5 decant 32 9 3 6 spin 20sec 3500rpm 32 9 3 7 susp 3 5ml spin 20sec centrifuge 3 5ml suspension for 20sec 32 9 3 8 wash 3 5ml 3x and anti wash 3 5 ml 3 x plus antihuman globulin test 33 9 3 9 wa...

Страница 7: ...or 44 12 3 Autoclaving 44 12 4 Removal of the splash guard receiver and cap 45 12 5 Flushing the system with deionized or distilled water 45 12 6 Cleaning the system with cleaning solution 45 12 7 Gla...

Страница 8: ...e device Attention general hazard area Before using the device make sure you read the operating instructions and observe the safety information Symbol in this document Attention general hazard area Th...

Страница 9: ...re centrifuged the supernatant decanted and then each sample tube is filled with a physiological saline solution and mixed The device should only be used by trained medical personnel in clinical labor...

Страница 10: ...cations are released the IQ Installation Qualification the OQ Operational Qualification and PQ Process Qualification is responsible for periodic routine to flush clean and disinfect the device as well...

Страница 11: ...tors suspensions and accessories that possess traces of corrosion or mechanical damage or if their term of use has expired may not be used any longer The centrifuge may no longer be put into operation...

Страница 12: ...ity of the materials or the material mixtures may not exceed 1 2 kg dm3 The centrifuge may only be operated when the balance is within the bounds of acceptability 5g pass and 10g stop If users centrif...

Страница 13: ...only when it is in safe working condition Malfunctions which could affect safety must be corrected immediately 4 2 Switching off the device in an emergency Push the on off switch on the rear panel to...

Страница 14: ...80 mm 18 9inch Height closed lid 280 mm 11inch Height open lid 580 mm 22 9inch Weight kg lb 24 4 53 8 24 7 54 5 24 4 53 8 Capacity standard 12 x 5 ml Capacity optional 24 x 5 ml Speed Radius 3500 RPM...

Страница 15: ...ge can be removed with the help of the enclosed hexagon L key wrench Carefully place the centrifuge back on its feet connect the power correctly and operate the centrifuge and open the lid so that the...

Страница 16: ...the quantity ordered 1 would be delivered only for devices with the optional secondary pump p n 1008 02 and 1008 04 2 would be delivered only for devices with the optional car battery DC input p n 100...

Страница 17: ...umber from your device tab 1 0 3 4 5 6 7 8 9 9 Emergency release hole Refer to chapter 4 3 If you use the device connected to a car or truck battery without the option then the device could become dam...

Страница 18: ...lug release pin anschluss input 1 hex L Key E4258 weight for suction tube separate Fig 7 2 1 Fig 7 2 2 E4374 drain hose complete E4259 plug for waste tube Fig 7 2 3 E4251 E4502 power supply Fig 7 2 4...

Страница 19: ...t parts e g ovens or torches Plug the connector from the fill hose to the inlet 1 on the rear side Fig 7 1 Pos 7 and dip the other side with the suction tube into the container with the saline solutio...

Страница 20: ...l_Rotolavit II_und_Rotolavit II S_en_rev2 5 Seite 20 fig 7 4 fig 7 3 seal splash guard receiver splash guard cap centrifugation area bowl inscription just on fig in red lid lock access hole fig 7 5 ha...

Страница 21: ...in the Rotolavit II and Rotolavit II S Both rotors can hold either 10 mm x 75 mm tubes or 12 mm x 75 mm tubes glass or plastic types A rotor must be installed and the setup must be correctly to opera...

Страница 22: ...tor_Manual_Rotolavit II_und_Rotolavit II S_en_rev2 5 Seite 22 8 Operation settings 8 1 Overview Operation settings for the Rotolavit II can be viewed and changed through the system settings menu Softw...

Страница 23: ...n delivery the password for the Advanced User is 1008 name can be changed see also the following table If you have to be logged in for an action with a password it is specified in this manual with Log...

Страница 24: ...rol 5 beep volume control 6 save changes 7 service menu Login 8 History 9 edit password Login 10 back without saving 8 3 Select program The individual programs must be matched or validated by the oper...

Страница 25: ...nsert old password Login 2 insert new password Login 3 repeat new password to confirm Login 4 show hide passwords verbergen Login 5 accept changes Login 6 discard changes and return to settings Login...

Страница 26: ...target measure Login 6 open lid Login 7 fill in solution 8 start calibration 9 back to service menu without calibration 1 calibration Login 2 user settings Login 3 device settings Login 4 network set...

Страница 27: ...Login 8 6 2 User settings Only the service user can generate a new advanced user and restrict or change the rights of the normal user account without a login e g change the green tick to a red X so t...

Страница 28: ...ve chganges Login 3 back to service menu without saving Login Start screen decant is the actual loaded program Push Start program to start 1 Push this button to select a different program Screen 2 Fac...

Страница 29: ...program see chapter 8 4 Each program must be validated by the user with the custom tube If the tube is changed then the program must be revalidated After selecting the program each process is displaye...

Страница 30: ..._Rotolavit II_und_Rotolavit II S_en_rev2 5 Seite 30 The program starts and the ongoing process is highlighted Push CHECK and the lid will open as soon as the ongoing process is finished 9 2 Stop a run...

Страница 31: ...program is designed to flush clean the external and the internal tubing system with deionized or demineralized water after the routine so no salt crystals are built Before the routine the tube system...

Страница 32: ...ns LOOP 3x two more runs a total of three wash cycles 9 3 4 agit and spin The process values are AGIT 15x 15 agitations SPIN 20sec 3500rpm acceleration 800rpm s braking 1000rpm s 9 3 5 decant The proc...

Страница 33: ...ILL 2 5ml 900rpm fill 2 5ml by 900rpm SPIN 7min 2260rpm acceleration 800rpm s braking 1000rpm s DECANT 370rpm decant by 370rpm AGIT 100x 100 agitations LOOP 2x only one more run 9 3 10 cell recovery o...

Страница 34: ...2500 rpm is available The fill volume to be set per tube is between 0 1 ml and 10 ml The default value is 3 5 ml at 1100 rpm 9 4 Process descriptions 9 4 1 Principle A program can have a maximum of 2...

Страница 35: ...0 01 to 2 00 00 The default value is 3500 rpm and 30 seconds 0 00 30 The erythrocytes are sedimented by a selectable rotation speed The time only begins to count after the set rotation speed is reache...

Страница 36: ...lt value is 15x The pellet is loosened again for the subsequent wash cycle by a fast brief movement of the rotor and the tube holders 9 4 6 DECANT process The correct speed must be validated with the...

Страница 37: ...am will continue 9 4 8 LOOP process If the foregone process is a spin process with a duration time of 2 hours and the loop process is adjusted to 2x then the program will repeat the spin process once...

Страница 38: ...program push To add a new program push To add the first process push To edit the name push at the top In this example the first process is FILL Push the FILL 1 symbol Below the symbol you can choose...

Страница 39: ...ccept the SPIN process push To add more process push By selecting a process you can switch the process to the previous process position To switch left push Or after the next process position to the ri...

Страница 40: ...stem settings cha 8 5 pos 7 Go into calibration service menu cha 8 6 pos 1 Open the lid cha 8 6 1 pos 6 Check that the 36ml target is green for the use of a 50ml graduated measuring cylinder conform t...

Страница 41: ...or one hour o Confirm it with the button save changes cha 8 5 pos 6 If an alarm or the program end beep is running then the standby mode will activate till after 60 minutes instead of the normal 10 mi...

Страница 42: ...sk when cleaning the equipment used for blood processing Before any other cleaning or decontamination process other than that recommended by the manufacturer is applied the user has to check with the...

Страница 43: ...nd a damp cloth if required This serves as hygiene protection and prevents corrosion caused by impurities Ingredients of suitable detergents soap anionic tensides non ionic tensides After using deterg...

Страница 44: ...tors or accessories they must be appropriately disinfected o Ingredients of suitable disinfectants glutaraldehyde propanol ethyl hexanol anionic tenside corrosion inhibitors o After using disinfectant...

Страница 45: ...the provided flask with deionized or distilled water Start the system program flush Take off the saline tube from the flask and dip it back into the saline solution container Open the lid and dry the...

Страница 46: ...t call your local distributor The tube holder where a tube was broken must be replaced the rotor and its tube holders must be checked for scratches and the rotor must be checked for correct function i...

Страница 47: ...er X Clean and dry the interior after normal usage to prevent corrosion and contamination X Flush the system with cleaning solution X Clean the fill ports on the rotor X Check the saline volume settin...

Страница 48: ...ging in the decantation position Check the spin process from the used program Check the rotor functions Wrong tube type Check if the used tube is the same as during the program validation No pellet pe...

Страница 49: ...es not work as intended Motor speed reading failure 14 Motor speed error Motor could not hold the desired speed motor was too fast Motor speed control does not work as intended Motor speed reading fai...

Страница 50: ...identified Unexpected behavior 51 Program interrupted A running program was interrupted Power interrupted during a running program 52 Program aborted by user The program was aborted by the user User...

Страница 51: ...to provide protection for people the environment and materials it must be decontaminated and cleaned before being shipped a declaration should to be apply to the device and respectively to the parts...

Страница 52: ...13 2005 may not be disposed as part of domestic household or industrial waste The device belongs to group 8 medical devices and is categorized in the business to business field The icon of the crossed...

Страница 53: ...x L mm 10 x 75 12 x 75 Number p rotor 12 12 Speed RPM U min 3500 2 RZB RCF 1438 Radius mm 105 1 1019 Set with 12 pieces 2 max speed 3500 rpm 1438RCF recheck with the supplier distributor manufacturer...

Страница 54: ...10 x 75 12 x 75 Number p rotor 24 24 Speed RPM U min 3500 2 RZB RCF 1438 Radius mm 105 1 1019 Set with 12 pieces 2 max speed 3500rpm 1438RCF recheck with the supplier distributor manufacturer of the t...

Страница 55: ...its E4259 plug waste for waste tube X E4261 plug Input 1 for saline tube X E4260 Push in plug for emergency release hole X E4258 weight for suction tube INOX X E4394 elbow nozzle for drain hose X E437...

Страница 56: ...lled programs DECANT max value error 15 16 08 2018 DK DF 16 08 2018 2 0 1 9 tech data Noise chapter password protection inserted CE declaration renewed 08 01 2019 DK DF 08 01 2019 2 1 2 0 Edit chapter...

Страница 57: ...nces adjusted entire document chap 5 Technical data sound pressure level changed from 49 to 62dB chap 16 2 inserted from service manual Fig 7 6 rotor inserted chap 8 1 Overview menu navigation new pic...

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