Hettich EBA 270 Small Centrifuge User Manual

EBA 270 Small Centrifuge
User Manual

EBA 270 Small Centrifuge

Andreas Hettich GmbH & Co. KG
Germany
SRN: DE-MF-000010680
We hereby declare under our responsibility without involvement of a notified body that the designated device:
Type of device Small centrifuges Name EBA 270
Basic UDI-DI 4050674010007QC GMDN 36465
Classification in vitro diagnostic, class A  (Annex VIII, Rule 5) according to Regulation (EU) 2017/746 Annex IX and its accessories, which are listed in the related technical  documentation and whose conformity has been assessed together with the device, complies with the relevant provisions of the Regulation (EU) 2017/746 on in vitro  diagnostic devices.

Intended use
The centrifuge EBA 270 is an in vitro diagnostic medical device according to the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
The device is used for centrifuging and enriching sample material of human origin for subsequent further processing for diagnostic purposes. The user can set each of the variable physical parameters within the limits set by the device.
The centrifuge may only be used by qualified personnel in closed laboratories. The centrifuge is only intended for the use referred to above. Intended use also includes observing all instructions in the Operating Manual and compliance with the required inspection and maintenance work.

Any other use or use beyond this is considered improper. Andreas Hettich GmbH & Co. KG shall not be liable for any damage arising from this.
The device also complies to the applicable provisions of the following European directives, ordinances and standards
– 2006/42/EC “Directive on machinery”
– 2014/30/EU “EMC Directive”
– 2014/35/EU Low Voltage Directive”
– 2011/65/EC “RoHS Directive” (without involvement of a notified body)
– (EC) 1907/2006 Regulation on REACH” (without involvement of a notified body)
Applied relevant standards
DIN EN ISO 13485:2016; DIN EN ISO 14971:2020;
DIN EN 61010-1:2011-07; DIN EN 61010-2-020:2017;
DIN EN 61010-2-101:2002; DIN EN 61010-2-011:2017

Intended use

The centrifuge EBA 270 is an in vitro diagnostic medical device according to the ln Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
The device is used for centrifuging and enriching sample material of human origin for subsequent further processing for diagnostic purposes. The user can set each of the  variable physical parameters within the limits set by the device.
The centrifuge may only be used by qualified personnel in closed laboratories. The centrifuge is only intended for the use referred to above. Intended use also includes  observing all instructions in the Operating Manual and compliance with the required inspection and maintenance work.
Any other use or use beyond this is considered improper. Andreas Hettich GmbH & Co. KG shall not be liable for any damage arising from this.

Remaining risks

The device is built according to the state-of-the-art and the recognized safety regulations. If used and handled improperly, there could be life- threatening danger to the user or  third parties, or the device could be impaired or there could be other property damage. The device is only to be used for its intended purpose and only when it is in safe working condition.
Malfunctions which could affect safety must be corrected immediately.

Technical specifications

Manufacturer| Andreas Hettich GmbH & Co. KG
D-78532 Tuttlingen
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Model| EBA 270
Basic-UDI-01| 40506740100070C
Type| 2300| 2300-01
Mains voltage (± 10%)| 200 – 240 V 1-| 100 – 127 V 1-
Mains frequency| 50 – 60 Hz| 50 – 60 Hz
Connected load| 130 VA| 125 VA
Current consumption| 0.7 A| 1.25 A
Max. capacity| 6 x 15 ml
Allowed density| 1.2 kg/dm3
Speed (RPM)| 4000
Force (RCF)| 2254
Kinetic energy| 250 Nm
Obligatory inspection (DGUV Regel 100 – 500)| no
Ambient conditions (EN / IEC 61010-1) – Set-up site
– Altitude
– Ambient temperature
– Humidity
– Excess-voltage category (IEC 60364-4-443)
– Pollution degree| Indoors only
Up to 2000 m above sea level
2°C to 40°C
Maximum relative humidity 80% for temperatures up to 31°C. linearly
decreasing to 50% relative humidity at 40°C.
II
2
Device protection class|
Not suitable for use in ex| losion-endangered areas
EMC
– Emitted interference. Interference immunity| EN / IEC 61326-1.
Class B| FCC Class B
Noise level (dependent on rotor)| S 51 dB(A)
Dimensions
– Width
– Depth – Height| 326 mm
389 mm
239 mm
Weight| approx. 13.5 kg

Notes on safety

No claim of warranty will be considered by the manufacturer unless ALL instructions in this manual have been followed.
Reports of serious incidents involving the device
Report any serious incidents involving the device to the manufacturer and, if necessary, to the competent authority.

• The centrifuge should be installed on a good, stable base.

• Before using the centrifuge absolutely check the rotor for firm placement.

• When the centrifuge is running, according to EN / IEC 61010-2-020, no persons, dangerous substances or objects may be within the safety margin of 300 mm around  the centrifuge.

• Rotors, 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 when the centrifuging chamber has safetyrelated damages.

• For centrifuges without temperature control, when the room temperature is increased and/or if the device is frequently used, the centrifuging chamber could be heated  up. Therefore, it can’t be ruled out that the sample material might be changed due to the temperature.

• Before the initial operation of your centrifuge you should read and pay attention to the operating instructions. Only personnel that has read and understood the operating instructions are allowed tooperate the device.

• Along with the operating instructions 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 read in conjunction with any other instructions concerning accident prevention and environmental protection based on the national regulations of the country where the device is to be used.

• This centrifuge is a state-of-the-art piece of equipment which is extremely safe to operate. However, it can lead to danger for users or others if used by untrained staff, in  an inappropriate way or for a purpose other than that it was designed for.

• The centrifuge must not be moved or knocked during operation.

• In case of fault or emergency release, never touch the rotor before it has stopped turning.

• To avoid damage due to condensate, when changing from a cold to a warm room the centrifuge must either heat up for at least 3 hours in the warm room before being  connected to the mains, or run hot for 30 minutes in the cold room.

• Only the rotor approved by the manufacturer for this device and the approved accessories may be used (see chapter “Anhang/Appendix, Rotoren und Zubehör/Rotors  and accessories”). Before centrifuge vessels are used which are not listed in the chapter “Appendix, Rotors and accessories”, the user must make sure they can be used by  asking the manufacturer.

• The centrifuge rotor may only be loaded in accordance with the chapter “Loading the rotor”.

• When centrifuging with maxim revolutions per minute the density 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.

• The centrifuge may not be operated in explosion-endangered areas.

• The centrifuge must not be used with:
  − inflammable or explosive materials
  − materials that react with one another producing a lot of energy.

• If users have to centrifuge hazardous materials or compounds contaminated with toxic, radioactive or pathogenic micro-organisms, they must take appropriate measures.

For hazardous substances centrifuge containers with special screw caps must strictly be used. In addition to the screw cap centrifuge containers, for materials in hazard  category 3 and 4 a biosafety system must be used (see the World Health Organisation’s “Laboratory Biosafety Manual”).
No biosafety systems are available for this centrifuge.

• The centrifuge must not be operated with highly corrosive substances which could impair the mechanical integrity of rotors, hangers and accessories.

• Repairs must only be carried out by personnel authorised to do so by the manufacturer.

• Only original spare parts and original accessories licensed by the Andreas Hettich GmbH & Co. KG company are allowed to be utilised.

• The following safety regulations apply:
  EN / IEC 61010-1 EN / IEC 61010-2-020 as well as their national deviations.

• The safe operation and reliability of the centrifuge can only be guaranteed if:
  − the centrifuge is operated in accordance with the operating instructions,
  − the electrical installation on the site where the centrifuge is installed conforms to the demands of EN / IEC stipulations.

• Meeting the country-specific requirements concerning occupational safety with regard to the use of laboratory centrifuges at the workplaces provided for this purpose by the user is the responsibility of the user.

• The unlocking pin made of plastic included in delivery may only be used for emergency unlocking (see the chapter “Emergency unlocking”).
  The unlocking pin is to be kept in a safe place so that it is protected from unauthorized access.

Transport and storage

5.1 Transport
Before transporting the device, the transport securing device must be installed.
When the device and accessories are transported, the following ambient conditions must be complied with:

• Ambient temperature: -20°C to +60°C
• Relative humidity: 10% to 80%, non-condensing

5.2 Storage
The device and the accessories may only be stored in closed and dry rooms.
When the device and accessories are stored, the following ambient conditions must be complied with:

• Ambient temperature: -20°C to +60°C
• Relative humidity: 10% to 80%, non-condensing

Symbol meanings

| Symbol on the device:
Attention, general hazard area.
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| Symbol on the device:
Observe operating instructions.
This symbol indicates that the user must observe the operating instructions provided.
| Symbol in this document:
Attention, general hazard area.
This symbol refers to safety relevant warnings and indicates possibly dangerous situations.
The non-adherence to these warnings can lead to material damage and injury to personal.
****| Symbol in this document:
This symbol refers to important circumstances.
| Symbol on the device and in this document:
Symbol for the separate collection of electric and electronic devices according to the guideline 2012/19/EU.
Applies in the countries of the European Union, as well as in Norway and Switzerland.
| Symbol on the shipping carton label:
This way up.
| Symbol on the shipping carton label:
The shipping packaging must be transported and handled within the indicated humidity range (10% – 80%).
| Symbol on the shipping carton label:
The shipping packaging must be stored, transported and
handled within the temperature range shown (-20°C – +60°C).
| Symbol on the shipping carton label:
The shipping packaging must be kept away from rain and
kept in a dry environment.
| Symbol on the shipping carton label:
Fragile, handle with care.
| Symbol on the shipping carton label:
Stack limit. Maximum number of identical packages which may be stacked on the bottom package, whereby “n“ stands for the number of permissible packages. The bottom package is not included in “n”.

Delivery checklist

The following items and accessories are delivered with the centrifuge:

1 Connecting cable
2 Fuses
1 Release pin
1 One-opend-end wrench
1 Hex. pin driver for transport protection| 1 Rotor
6 Hanger 10 ml
6 Hanger 5 ml
1 Notes on moving the equipment safely
1 Operating instructions
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Initial operation

• Position the centrifuge in a stable and level manner in a suitable place. During set-up, the required safety margin of 300 mm around the centrifuge is to be kept according to EN / IEC 61010-2-020.
  When the centrifuge is running, according to EN / IEC 61010-2-020, no persons, dangerous substances or objects may be within the safety margin of 300 mm around the centrifuge.
  Substances can be discharged through the ventilation opening on the rear side of the centrifuge. The device is to be placed in such a way that the air stream is not  directed towards people.

• Ventilation openings may not be blocked.
  A distance of 300 mm must be maintained from the ventilation slots and openings of the centrifuge.

• Check whether the mains voltage tallies with the statement on the type plate.

• Connect the centrifuge with the power cord to a standard mains socket. For connection ratings refer to Chapter “Technical specifications”.

• Turn on the mains switch. Switch position “Ι”.
  The last used centrifuge data will be displayed.

• Open the lid.

• Remove the transportation safety device in the centrifuge, see sheet ”Transportation safety device”.

Opening and closing the lid

9.1 Opening the lid
The lid can only be opened when the centrifuge is switched on and the rotor is at rest. If it cannot be opened under these circumstances, see the section on “Emergency release”.

• Press the key OPEN and open the lid. The symbol ” ” (lid open) illuminates in the rotation indicator .

9.2 Closing the lid
Do not bang the lid shut.

• Place the lid and lightly press down the front edge of the lid. The symbol “-” (lid closed) illuminates in the rotation indicator.

Installation and removal of the rotor

After every fifth removal of the rotor or when installing a new rotor, the fastening nut must be exchanged.

• Clean the motor shaft (C) and the rotor drilling (A), and lightly grease the motor shaft afterwards. Dirt particles between the motor shaft and the rotor hinder a perfect  seating of the rotor and cause an irregular operation.

• Place the rotor vertically on the motor shaft. The driver areas (D) of the motor shaft must be located in the groove (B) of the rotor.

• Tighten the fastening nut of the rotor by turning it in the clockwise direction with the wrench included in delivery.

• Check the rotor for firm seating.
  To ensure a tight fit of the rotor, the nut of the rotor must be handtightened.

• Removing the rotor: Screw the fastening nut off by turning it in the counterclockwise direction.
  Lift the rotor off of the motor shaft.

Loading the rotor

Standard centrifuge containers of glass will not stand RCF values exceeding 4000 (DIN 58970, pg. 2).

• Check the rotor for firm seating.

• With swing-out rotors all rotor positions must be lined with identical hangers.

• The rotors and hangers may only be loaded symmetrically. The centrifuge containers have to be distributed evenly on all rotor positions. For authorised combinations see Chapter “Anhang/Appendix, Rotoren und Zubehör/Rotors and accessories”.
  

• The centrifuge containers may only be filled outside of the centrifuge.

• The maximum filling quantity for the centrifuge containers specified by the manufacturer must not be exceeded.

• When loading the hangers and when the hangers are swivelling out while the centrifuge is running, no liquid may enter the hangers or the centrifuging chamber.

• In order to maintain the weight differences within the centrifuge container as marginal as possible, a consistent fill level in the containers is to be heeded.

• The weight of the permissible filling quantity is specified on each rotor. This weight may not be exceeded.

WARNING
Risk of pollution and contamination for people and the environment.
When disposing of the centrifuge, people and the environment may be polluted or contaminated by incorrect or improper disposal.

• Removal and disposal may be carried out only by a trained and authorized service personnel.

The device is intended for the commercial sector (“Business to Business” – B2B).
According to Directive 2012/19/EU, the devices may no longer be disposed of with household waste.
The appliances are assigned to the following groups according to the Stiftung Elektro-Altgeräte Register (EAR (German foundation under civil law):

12.2 Keys and setting options

| • Speed
A numeric value of 500 RPM up to the maximum rotor speed can be set. For maximum rotor speed, see chapter “Anhang/Appendix, Rotor und Zubehör/Rotor and accessories”. Preset in steps of 100 (RPM = displayed value x 100).
If the key  or  is kept pressed, the value changes with increasing speed.
• Display the brake step.
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| • Running time
– Preset from 1 – 99 minutes, in 1 minute steps
– Continuous operation “–”
• Braking steps 0 or 1. Step 1 = short run-down time, Step 0 = long run-down time.
If the key  or  is kept pressed, the value changes with increasing speed.
| • Start centrifugation run.
| • Short-time centrifugation.
The centrifugation run occurs while the key PULSE  is kept pressed.
• Display the brake step.
| • Unlock the lid.

Setting the brake step

• Switch off the mains switch.

• Keep the key beneath the speed indicator and the key PULSE pressed simultaneously.

• Switch on the mains switch and release the keys again.
  The speed indicator shows the machine version and the time indicator shows the set brake step: e.g.:
  If the machine version and brake step are not displayed, press the key under the speed indicator until they are displayed.
  The machine version is set by the manufacturer and cannot be changed.

• Set the desired brake step with the keys beneath the time indicator.
  Step 1 = short run-down time, Step 0 = long run-down time.
  For run-down times, see chapter “Anhang/Appendix, Rotor und Zubehör/Rotor and accessories”.

• Press the key STOP to save the setting.

Group 5 (small appliances)
The crossed-out 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.

References

• Hettich | Centrifuges and Incubators

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