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ROTOFIX 32 A Inhalt des Dokuments / content of the document Operating instructions (EN) Rotoren und Zubehör / Rotors and accessories AB1206en_SA Rev.: 06 / 11.2023...
Safety Intended use Intended use The centrifuge ROTOFIX 32 A is an in vitro diagnostic medical device in accordance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. The device is used for centrifugation as well as enrichment of sample material of human origin for subsequent further processing for diag- nostic purposes.
Safety Operator's responsibility Follow the instructions in this document for proper and safe use of the device. Keep the user manual for future reference. ■ Provide information Following the instructions in this document will help: – To avoid dangerous situations. –...
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Safety WARNING Dangers due to insufficient maintenance or maintenance not carried out on time. − Follow maintenance intervals. − Check the device for visible damage or defects. If any visible damage or defects are present, take the device out of service and inform a service technician. WARNING Risk of electric shock due to ingress of water or other liq- uids.
Do not trigger the emergency release on the device while the program is running. − Do not pull out the mains plug while the program is running. Device overview Technical data Manufacturer Andreas Hettich GmbH & Co. KG, D-78532 Tuttlingen Model ROTOFIX 32 A Type 1206 1206-01 1206-34 1206-33 Mains voltage (±10%)
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Device overview Obligation to perform checks (DGUV Rules 100-500) (valid only in Germany) Ambient conditions (EN / IEC 61010-1): Installation site indoors only Altitude up to 2000 m above sea level Ambient temperature 2 °C to 40 °C Humidity maximum relative humidity 80% for temperatures up to 31 °C, decreasing linearly to 50% relative humidity at 40 °C.
Device overview Rating plate Fig. 1: Rating plate Item number Serial number Revision Equipment number Data matrix code any labelling indicating whether medical device or in vitro diagnostic medical device Global Trade Item Number (GTIN) Date of manufacture Serial number 10 any EAC mark, CE mark 11 Country of manufacture 12 Date of manufacture...
Device overview Basic-UDI-DI Basic-UDI-DI Device assignment 040506740100129P ROTOFIX 32 A (in vitro diagnostic medical device) Important labels on the packaging This is the correct upright position of the shipping container for transport and/or storage. FRAGILE GOODS The contents of the shipping container are fragile, so it must be handled with care.
Device overview Attention, general danger area. Ensure you read the instructions for commissioning and operation and observe the safety instruc- tions before using the device. Biohazard warning. Direction of rotation of the rotor. The orientation of the arrow indicates the rotor's direction of rotation. Symbol for the separate collection of electrical and electronic equipment, in accordance with Directive 2012/19/EU (WEEE).
Device overview 3.5.3 Controls ■ Switch the device on and off. Fig. 6: [Mains switch] ■ Short-term centrifugation. The centrifugation run takes place as long as the button is being pressed. ■ Display the brake level and centrifuging radius. Fig. 7: [IMPULSE] button ■...
Transport and storage ■ 1 power cable ■ 2 Fuse links ■ 1 user manual ■ 1 instruction sheet, transport lock Rotors and the corresponding accessories are supplied depending on the order. Returns An original Return Material Authorisation (RMA) form from the manufacturer must always be requested for a return.
Transport and storage ■ When transporting using a transport aid (e.g., a pallet truck), the trans- port aid must be able to carry at least 1.6 times the transport weight of the device. ■ Secure the device to prevent it tipping over and falling down during transport.
Commissioning Commissioning Unpacking the centrifuge CAUTION Danger of crushing due to parts falling out of the transport packaging. − Keep the device balanced during the unpacking process. − Only open the packaging at the points provided for this purpose. CAUTION Risk of injury from lifting heavy loads.
Commissioning Fig. 14: Transport lock Transport lock Spacer sleeves Screws Tilt the device on the back of the device. 3 ) with spacer sleeves ( 2 ). Unscrew 3 screws ( 1 ) and store them safely. Remove 3 transport locks ( Keep the screws, spacer sleeves and transport lock in a safe place.
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Commissioning NOTICE Damage to the samples and the device if the ambient temperature exceeds or falls below the respective max- imum/minimum permissible ambient temperature. − Comply with the maximum and minimum permissible ambient temperatures for installation of the device. − Do not place the device next to a heat source.
Operation Switching the centrifuge on and off. Switching the centrifuge on Personnel: ■ Trained user [I] . Set the mains switch to The buttons flash, depending on the centrifuge type. The last centrifugation data used is displayed. Switching off the centrifuge The rotor is stationary.
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Operation Open the lid. Loosen the rotor clamping nut using the supplied spanner. After passing the working point for lifting the rotor, the rotor 2 ). detaches from the cone of the motor shaft ( Turn the clamping nut until the rotor can be lifted off the motor shaft. Remove the rotor.
Operation Removing the hub Open the lid. Unscrew the clamping nut. 1 ) After passing the working point for lifting the rotor, the hub ( 2 ). detaches from the cone of the motor ( Remove the hub. Fig. 17: Hub installation and removal Motor shaft Driver...
Operation Check that the rotor is firmly seated. Grease the trunnions (3). Insert the bucket (1) into the rotor from above. The trunnions (3) must be in the grooves (2). Push the bucket (1) down as far as it will go. Removing the bucket Pull the bucket (1) vertically upwards out of the rotor.
Operation 1 ) vertically upwards out of the bucket. removing Remove the adapter ( Loading Filling centrifuge tubes WARNING Risk of injury from contaminated sample material. Contaminated sample material escapes from the sample tube during centrifugation. − Use centrifuge tubes with special screw caps for haz- ardous substances.
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Operation Check that the rotor is firmly seated. The centrifuge tubes must be distributed symmetrically across all rotor locations. The weight of the permissible filling capacity is indicated on each rotor. The weight must not be exceeded. No liquid must be allowed to enter the buckets and the centrifuging chamber when loading the buckets and swinging them out during the centrifugation run.
Operation Opening and closing the biosafety system 6.6.1 Explanation The user must take appropriate actions when centrifuging hazardous sub- stances or mixtures of substances that are toxic, radioactive or contami- nated with pathogenic microorganisms. Centrifuge tubes with special screw caps for hazardous substances must always be used.
Operation [START] button. Press the The centrifugation run is started. ‘Rotation’ indicator light rotates while the rotor is turning. Timing starts at 0. The first minute is counted up in seconds, then the time is displayed in minutes. A dot flashes next to the number if the time is displayed in minutes.
Software operation Software operation Centrifugation parameters 7.1.1 Set the brake level Switch off the mains switch. [RPM/RCF x 100] button and the Press and hold down the ▲ [IMPULSE] button simultaneously. Switch on the mains switch and release the buttons. [RPM/RCF x 100] button repeatedly until the speed ...
Software operation For example: Maximum speed 4000 RPM, density 1.6 kg/dm³ If, in exceptional cases, the maximum load indicated on the bucket is exceeded, the speed must also be reduced. The permissible speed can be calculated using the following formula: For example: Maximum speed 4000 RPM, maximum load 300 g, actual load 350 g Please contact the manufacturer if you are not sure.
Cleaning and care 7.3.1.2 Setting an audible signal Switch off the mains switch. Press and hold down the ▲ [RPM/RCF x 100] button and the [IMPULSE] button simultaneously. Switch on the mains switch and release the buttons. [RPM/RCF x 100] button repeatedly until ‘BEL 1’ or ‘BEL Press the ▲...
Cleaning and care Chap. Task to execute Replacing centrifuge tubes Cleaning and disinfection instructions DANGER Risk of contamination for the user due to inadequate cleaning or failure to observe the cleaning instructions. − Observe cleaning instructions. − Wear personal protective equipment when cleaning the device.
Cleaning and care Dry the accessories immediately after cleaning using a lint-free cloth and oil-free compressed air. Dry all cavities completely using oil-free compressed air. Cleaning the accessories Clean the accessories using the detergent and a damp cloth. Remove any detergent residues with a damp cloth after using deter- gents.
Clean the trunnions. Remove any detergent residues with a damp cloth after using deter- gents. Grease the trunnions and suspension with Hettich Tubenfett 4051. Excess grease in the centrifuging chamber must be removed. Checking the accessories The accessories are to be checked for wear and corrosion damage.
Troubleshooting ■ The maximum permissible number of run cycles or the expiry date can be seen marked on the accessories. Replacing centrifuge tubes CAUTION Risk of injury from broken glass. Broken glass may cause glass splinters and contaminated liquids to be found inside the centrifuge. −...
Troubleshooting Fault description Cause Remedy ■ Overvoltage. Mains voltage Perform a MAINS RESET. outside tolerances. ■ Check the mains voltage. ■ Overspeed. Error in the power Perform a MAINS RESET. section. ■ Undervoltage. Mains voltage Perform a MAINS RESET. outside tolerances. ■...
Troubleshooting WARNING Risk of electric shock due to maintenance and servicing work on live device. − Disconnect the device from the mains before carrying out repairs and maintenance. WARNING Danger of cutting and crushing due to moving rotor. − Do not open the lid until the rotor has stopped. Personnel: ■...
The device can be disposed of via the manufacturer. A Return Material Authorisation (RMA) form must always be requested for a return. If necessary, contact the Technical Service Department of the manufacturer. − Andreas Hettich GmbH & Co. KG − Föhrenstrasse 12 − 78532 Tuttlingen, Germany −...
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Disposal The crossed-out wheelie bin symbol indicates that the device must not be disposed of with household waste. Regulations governing disposal of such devices may differ in individual countries. If necessary, contact the supplier. Fig. 22: Household waste ban 38 / 39 Rev.: 06 / 11.2023 AB1206en_SA...