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Refrigerated Centrifuge Sigma 1-16K 

Refrigerated Centrifuge Sigma 1-16K IVD 

11 Appendix 

 

 

 

Version 10/2013, Rev. 2.21 of 08/05/2020 

• sb 

65 / 70 

Translation of the original operating manual, part no. 0700302 

 

11.6  Declaration of conformity 

– China RoHS 2 

 

 

 

Содержание 1-16K

Страница 1: ...sb 10 2013 Rev 2 21 of 08 05 2020 Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD Refrigerated Centrifuge part no 0700302 Sigma 1 16K Sigma 1 16K IVD From serial no 145758 Refrigerated Centrifuge...

Страница 2: ...Refrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 2 70 Version 10 2013 Rev 2 21 of 08 05 2020 sb Translation of the original operating manual part no 0700302...

Страница 3: ...Rev 2 21 of 08 05 2020 sb 3 70 Translation of the original operating manual part no 0700302 Copyright by Sigma Laborzentrifugen GmbH An der Unteren S se 50 37520 Osterode am Harz Germany Tel 49 0 5522...

Страница 4: ...Refrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 4 70 Version 10 2013 Rev 2 21 of 08 05 2020 sb Translation of the original operating manual part no 0700302...

Страница 5: ...2 2 2 1 Speed radius and relative centrifugal force 14 2 2 2 2 Density 14 3 Safety 15 3 1 Marking of the unit 15 3 2 Explanation of the symbols and notes 16 3 3 Responsibility of the operator 17 3 4 O...

Страница 6: ...essories 28 6 2 2 1 Installation of a rotor 28 6 2 2 2 Installation of a microhaematocrit rotor 29 6 2 2 3 Installation of accessories 30 6 2 2 4 Vessels 30 6 3 Control System Spincontrol Basic 31 6 3...

Страница 7: ...sories 43 8 1 2 1 Plastic accessories 44 8 1 3 Rotors 44 8 1 4 Microhaematocrit rotor 44 8 1 5 Glass breakage 45 8 2 Sterilisation and disinfection of the rotor chamber and accessories 45 8 2 1 Autocl...

Страница 8: ...efrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD Table of contents 8 70 Version 10 2013 Rev 2 21 of 08 05 2020 sb Translation of the original operating manual part no 0700302...

Страница 9: ...res with a maximum density of 1 2 g cm3 The laboratory centrifuge that is marked with IVD is intended for human biological samples including donated blood and tissue in conjunction with diagnostic in...

Страница 10: ...formation that must not be duplicated distributed or communicated in any other way Non compliance may be prosecuted under criminal law 1 5 Standards and regulations EC declaration of conformity see ch...

Страница 11: ...he original operating manual part no 0700302 2 Layout and mode of operation 2 1 Layout of the centrifuge 2 1 1 Functional and operating elements 1 Lid 2 Display 3 User interface see chapter 6 3 1 User...

Страница 12: ...700302 2 1 2 Name plate 1 Manufacturer 2 Power consumption 3 Max speed 4 Max kinetic energy 5 Serial number 6 Part number 7 Type 8 Nominal voltage 9 CE mark in compliance with the directive 2006 42 EC...

Страница 13: ...atically as a function of the angular velocity The bigger the radius in the rotor chamber is and the higher the speed is the higher the centripetal acceleration is However the forces acting on the rot...

Страница 14: ...y of the stated formula If afterwards the speed or the radius is changed the resulting relative centrifugal force will be recalculated automatically by the control unit If the RCF is changed the speed...

Страница 15: ...see chapter 2 1 2 Name plate Protective earth ground CE mark in compliance with the directive 2006 42 EC Earth ground Do not dispose as part of domestic waste Unplug the mains plug Do not dispose as...

Страница 16: ...ds for a direct hazard to the life and health of persons Non observance of these symbols causes serious health problems up to life endangering injuries DANGER This symbol stands for a direct hazard to...

Страница 17: ...entrifuges The operator must perform a risk assessment concerning potential accidents in connection with the centrifuge and take design related countermeasures if necessary The centrifuge has to be ma...

Страница 18: ...and specialised personnel must perform final inspection and testing in compliance with the relevant standards 3 6 2 Mechanical safety In order to ensure the safe operation of the centrifuge observe th...

Страница 19: ...when it is not in use so that moisture can evaporate 3 6 3 Fire prevention DANGER Do not spin explosive or inflammable substances Do not use the centrifuge within hazardous locations 3 6 4 Chemical a...

Страница 20: ...explicitly warn against the use of equipment of poor quality Breaking glass or bursting vessels can cause dangerous imbalances at high speeds Ensure that rotor and buckets are correctly fitted see cha...

Страница 21: ...es and a rotor with the engraving Exp date 01 27 must be scrapped in January 2027 at the latest see figure If a specification concerning the maximum number of cycles and a specification concerning the...

Страница 22: ...e measuring instrument Please contact the Sigma service department see chapter 7 3 Service contact 3 7 5 Temperature monitoring system If the temperature inside the rotor chamber rises above 50 C the...

Страница 23: ...orage conditions The centrifuge can be stored in its original packaging for up to a year Store the centrifuge only in dry rooms The permissible storage temperature is between 20 C and 60 C If you woul...

Страница 24: ...is packaged in a cardboard box Open the box Take out the box containing the accessories Lift the centrifuge with both foam cushions out of the cardboard box When lifting the centrifuge always reach un...

Страница 25: ...ar heat generators Avoid direct sunlight UV radiation The table must be stable and have a solid even surface Attention During transport from cold to warmer places condensational water will collect ins...

Страница 26: ...ation of the original operating manual part no 0700302 5 2 2 Customer provided fuses Typically the centrifuge must be protected with 16 Amp L or B fuses that are to be provided by the customer NOTE To...

Страница 27: ...nstalled see chapter 5 Set up and connection 6 2 Switching the centrifuge on Press the mains power switch The display then illuminates The centrifuge is ready for operation 6 2 1 Opening and closing t...

Страница 28: ...ght down onto the motor shaft Tighten the rotor tie down screw clockwise with the supplied rotor wrench with 3 Nm In doing so hold the rotor at its outer rim Follow the safety instructions and hazard...

Страница 29: ...hapter 3 Safety Operation Fill the capillary tubes with blood and seal them at one end with putty or by fusion Place the capillary tubes into the recesses of the rotor with the sealed end against the...

Страница 30: ...oid imbalance Centrifugation with low capacity Install the tubes axial symmetrically so that the rotor is loaded evenly It is not permissible to load angle rotors on only one axis correct incorrect Fi...

Страница 31: ...ram key 4 Arrow keys 5 Lid key 6 Start Stop key 7 Precool key Fig 7 User interface The centrifuge is started directly via the user interface When the centrifuge is switched on all segments will be ill...

Страница 32: ...CF The RCF value is determined by the rotor geometry and speed The RCF and speed values therefore depend on each other If one of the two values is entered the other value will be set automatically To...

Страница 33: ...is pressed within this time period 6 3 7 1 Changing the runtime during centrifugation The preselected runtime can be changed during centrifugation Press the set key repeatedly until the time unit flas...

Страница 34: ...lected Press the set key until the temperature unit flashes on the display Select the desired temperature by pressing the arrow keys Confirm the selection by pressing the start stop key The data will...

Страница 35: ...will not be saved in the program 6 3 9 Softstart and softstop function The softstart function is used to extend the acceleration time whereas the softstop function is used to extend the deceleration...

Страница 36: ...nfiguration must be changed so that the allowed maximum speed of the rotor can be reached To select another rotor press the set key and hold it for approx 2 seconds Choose the number of the installed...

Страница 37: ...The display Prog will now flash Select the correct rotor Press the set key repeatedly until the corresponding unit flashes on the display Select the desired parameters In order to save the data start...

Страница 38: ...lay No power in the mains supply Check fuse in the mains supply Power cord is not plugged in Plug in power cord correctly Mains power switch off Switch mains power switch on Lid is not closed correctl...

Страница 39: ...move the plug see figure item 1 from the opening on the left side of the control panel e g with a screwdriver Fig 9 Position of the opening for the emergency lid release Insert the supplied hexagon so...

Страница 40: ...ff Allow to cool down Provide better ventilation only air cooled centrifuges Provide sufficient water throughput only water cooled centrifuges 46 49 Imbalance error only for centrifuges with imbalance...

Страница 41: ...he event of queries malfunctions or spare part enquiries From Germany Contact Sigma Laborzentrifugen GmbH An der Unteren S se 50 37520 Osterode Germany Tel 49 0 55 22 50 07 44 44 E mail support lab si...

Страница 42: ...aggressive substances Do not use solvents Do not use agents with abrasive particles Do not expose the centrifuge and rotors to intensive UV radiation or thermal stress e g by heat generators 8 1 Main...

Страница 43: ...f the accessories special safety measures must be considered as these are measures that will ensure operational safety at the same time Immediately rinse off the rotor buckets or accessories under run...

Страница 44: ...ithstand the permanent high stress from high gravitational fields Chemical reactions as well as stress corrosion combination of oscillating pressure and chemical reaction can affect or destroy the met...

Страница 45: ...and rotor chamber In order to completely remove the glass particles and metal dust from the rotor chamber Grease the upper third of the rotor chamber with e g Vaseline Then let the rotor rotate for a...

Страница 46: ...in Max time min Max cycles Aluminium buckets 134 138 3 5 Aluminium rotors 134 138 3 5 Glass tubes 134 138 3 40 Polyallomer polycarbonate rectangular carriers 115 118 30 40 Polyallomer polycarbonate ro...

Страница 47: ...ss high quality components were used during the production of the centrifuge Nevertheless wear cannot be excluded and it may not be visible from the outside Especially the rubber parts that are among...

Страница 48: ...his purpose we require a declaration of decontamination The form must be filled in completely and signed by authorised and specialised personnel only Affix the original form in a clearly visible manne...

Страница 49: ...g manual part no 0700302 NOTE The defective part unit must be packaged in a transport safe manner Please use the original packaging for the unit if at all possible If the product is dispatched to us i...

Страница 50: ...eans that it is not permissible to dispose of the unit among household waste You can return these centrifuges free of cost to Sigma Laborzentrifugen GmbH Ensure that the unit is decontaminated Fill in...

Страница 51: ...plate I 20 Power consumption kW Input fuse AT 0 42 at 220 240 V 50 60 Hz 0 46 at 120 V 60 Hz 0 55 at 100 V 50 60 Hz 4 0 at 220 240 V 50 60 Hz 10 0 at 120 V 60 Hz 10 0 at 100 V 50 60 Hz Performance dat...

Страница 52: ...0 Power consumption kW Input fuse AT 0 54 at 220 240 V 50 60 Hz 0 54 at 120 V 60 Hz 0 54 at 100 V 50 60 Hz 10 0 at 220 240 V 50 60 Hz 10 0 at 120 V 60 Hz 10 0 at 100 V 50 60 Hz Performance data Max sp...

Страница 53: ...At a nominal voltage of 100V or 200V a tolerance of 10 5 applies For indoor use only Allowable ambient temperature 5 C to 35 C Max allowable relative humidity of air 80 from 5 C up to 31 C with a lin...

Страница 54: ...of accessories The complete list of accessories can be downloaded from www sigma zentrifugen de 11 1 1 Rotor radii The information in the accessories table concerning the radius refers to the values...

Страница 55: ...frigerated Centrifuge Sigma 1 16K IVD 11 Appendix Version 10 2013 Rev 2 21 of 08 05 2020 sb 55 70 Translation of the original operating manual part no 0700302 11 2 Speed gravitational field diagram Fi...

Страница 56: ...14 1 14K 12083 7 years 1 14 1 14K 12084 7 years 1 14 1 14K 12085 7 years 1 14 1 14K 12092 5 years 20x 1 14 1 14K 12093 5 years 20x 1 14 1 14K 12094 5 years 20x 1 14 1 14K 12096 5 years 20x 1 14 1 14K...

Страница 57: ...C3H3N 100 1 1 4 3 3 4 4 4 1 4 1 Allyl alcohol C3H6O 96 1 3 3 2 2 2 2 4 1 1 1 Aluminium chloride AlCl3 saturated 1 3 2 4 1 1 1 1 4 Aluminium sulfate Al2 SO4 3 10 1 1 1 3 1 1 1 1 1 1 1 Ammonium chlorid...

Страница 58: ...3 1 2 1 Diaminoethane C2H8N2 100 1 1 3 1 1 3 4 1 1 1 Diesel fuel 100 1 1 3 1 1 1 3 1 1 1 Dimethyl formamide DMF C3D7NO 100 1 1 4 1 1 4 3 1 3 1 Dimethyl sulfoxide DMSO C2H6SO 100 1 2 4 1 1 4 4 1 1 Dime...

Страница 59: ...4O 100 1 2 4 1 1 3 1 3 1 2 1 Methyl benzene C7H8 100 3 1 4 1 3 4 4 4 1 4 1 Methyl ethyl ketone MEK C4H8O 100 1 1 4 1 1 4 4 4 1 4 1 Methylene chloride CH2Cl2 100 4 3 4 3 3 4 4 4 1 1 Mineral oil 100 1 1...

Страница 60: ...30 1 1 1 1 1 1 1 1 1 1 3 Sodium hydroxide NaOH 30 1 1 4 1 1 1 1 1 1 2 4 Sodium hydroxide NaOH 50 1 1 4 1 1 1 1 1 2 4 Sodium sulfate Na2SO4 10 1 1 1 1 1 1 1 1 1 1 1 Spirits C2H6O 96 1 1 1 1 1 1 1 3 1 1...

Страница 61: ...ntrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 11 Appendix Version 10 2013 Rev 2 21 of 08 05 2020 sb 61 70 Translation of the original operating manual part no 0700302 11 5 EC declaratio...

Страница 62: ...Refrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 11 Appendix 62 70 Version 10 2013 Rev 2 21 of 08 05 2020 sb Translation of the original operating manual part no 0700302...

Страница 63: ...Refrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 11 Appendix Version 10 2013 Rev 2 21 of 08 05 2020 sb 63 70 Translation of the original operating manual part no 0700302...

Страница 64: ...Refrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 11 Appendix 64 70 Version 10 2013 Rev 2 21 of 08 05 2020 sb Translation of the original operating manual part no 0700302...

Страница 65: ...uge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 11 Appendix Version 10 2013 Rev 2 21 of 08 05 2020 sb 65 70 Translation of the original operating manual part no 0700302 11 6 Declaration of con...

Страница 66: ...Refrigerated Centrifuge Sigma 1 16K Refrigerated Centrifuge Sigma 1 16K IVD 11 Appendix 66 70 Version 10 2013 Rev 2 21 of 08 05 2020 sb Translation of the original operating manual part no 0700302...

Страница 67: ...ety 19 Chemical resistance of plastic 44 China RoHS 2 Declaration of conformity 65 Cleaning agents 45 Cleaning the bores of angle rotors 43 Cleaning the centrifuge 42 Closing the lid 18 27 CO2 equival...

Страница 68: ...crohaematocrit rotor 29 Installation of a rotor 28 Installation of accessories 30 Installation of rotors and accessories 28 Installation site 25 Intended use 9 Interrupting a centrifugation run 32 Int...

Страница 69: ...al shock 18 Rotor chamber 42 Rotor radii 54 Rotor wrench 28 Rotors and accessories with a different service life 21 56 Rotors cleaning and care 44 Runtime 33 S Safety area 20 Safety devices 21 Safety...

Страница 70: ...52 Technical documentation 53 Temperature 34 Temperature error 40 Temperature inside the rotor chamber 22 Temperature monitoring system 22 Temperature range 51 52 Temperature value cannot be reached 3...

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