Ortho BioVue System Centrifuge Operators Manual Oct 2013

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Ortho BioVue® System Centrifuge EN

Operator’s Manual

953052

5mm size (minimum)

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REP

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Ortho-Clinical Diagnostics 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4DP United Kingdom

 rtho-Clinical Diagnostics, Inc. O 1001 U.S. Highway 202 Raritan, NJ 08869 USA

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Ortho BioVue® System Centrifuge

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  WARNING: CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED IN THIS MANUAL BEFORE OPERATING THE INSTRUMENT

EN Customer – For Future Reference: In the box below, please transcribe the serial number as it appears on the centrifuge.

Ortho BioVue® System Centrifuge SN:

Manufacturer’s Name:

Ortho-Clinical Diagnostics, Inc.

Manufacturer’s Address:

1001 US Highway 202, Raritan, NJ 08869 USA

Product Name:

Ortho BioVue® System Centrifuge

Proprietary Notice No part of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, for any purpose without the express written permission of Ortho-Clinical Diagnostics, Inc.

BioVue is a registered trademark of Ortho-Clinical Diagnostics, Inc.

Copyright © by Ortho-Clinical Diagnostics, Inc. 2002 Raritan NJ 08869 All rights reserved.

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Ortho BioVue® System Centrifuge

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Table of Contents Topic Page Section 1 Description... EN-5 Intended Use... EN-5 Overview... EN-5 Section 2 Specifications... EN-6 Section 3 Installation... EN-7 Unpacking Procedure... EN-7 Site Specifications... EN-7 Electrical Requirements... EN-7 Ventilation Requirements... EN-7 Section 4 Quality Assurance... EN-8 General... EN-8 Speed Verification... EN-8 Timing Verification... EN-8 Section 5 Operation... EN-9 Procedure – Spin Cassettes... EN-9 Operating Guidelines... EN-10 Section 6 Maintenance... EN-11 General... EN-11 Fuse Replacement... EN-11 Section 7 Troubleshooting... EN-12 Potential Problems... EN-12 Section 8 Instrument Disinfection... EN-13 Disinfection... EN-13 Disinfection Procedure... EN-13 Disinfection Certificate... EN-14 Section 9 Environmental Directives... EN-15 Disposal... EN-15 Chinese Environmental Regulations on Hazardous Substances (China RoHS)... EN-15 Section 10 Warranty... EN-16 Warranty Time Period... EN-16 Warranty Repair Coverage... EN-16 Limitations... EN-16 Revision History... EN-17 Key to Symbols... EN-19

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Section 1 – Description Intended Use The Ortho BioVue® System Centrifuge performs the required centrifugation step for processing Ortho BioVue® System cassettes. No other manufacturer’s centrifuge may be used in place of the Ortho BioVue® System Centrifuge. No other manufacturer’s cassettes may be used in the Ortho BioVue® System Centrifuge. T he Ortho BioVue® System column agglutination technology standardizes blood typing and compatibility testing in a 6-microcolumn cassette preloaded with diluent and/or reagent and glass beads. Test red cells, with or without serum, are placed in the chamber above the column. Upon centrifugation, red cells are forced through the bead column where agglutinated cells are trapped, while unagglutinated red cells travel to the bottom of the column, forming a discrete pellet. Overview  The centrifuge consists of the elements described below. Refer to Figure 1. • Power Cord and Fuse Assembly: Located on the right side of the unit toward the back. • ON/OFF Switch: Located on the right side of the unit toward the back. • Time/Speed LED Display: When the unit is idle with the power switch ON, the LED displays 5 00. When spinning, the LED displays the countdown time (or rpm if the START/RPM button is depressed and held). The centrifuge is preset at the factory to spin the cassettes at a slow speed of 794 rpm (55 g) for two minutes then will automatically increase to a higher speed of 1510 rpm (199 g) for three minutes. The LED display counts down from five minutes, which is the duration of the process. Verification procedures of speed and timing are provided in Section 4 - Quality Assurance. • Stop Button: Stops a cycle in progress (and renders the sample results invalid) or unlocks the lid. • Start/RPM Button: Starts a cycle, or changes the LED display when pressed and held to check the rpm. • Lid: Lid must be closed to begin a cycle. An autolock feature prevents opening the lid during a cycle. • Lid Lock: Consists of a mating pin and an internal solenoid switch. • Rotor: Holds the cassettes. (There are twelve cassette holders.) Use only rotors supplied by Ortho Clinical Diagnostics. • Rotor Handle: Pulling up on this handle locks the cassette holders for easier cassette insertion and removal. The cassette holders must be UNLOCKED to begin centrifugation. Closing the lid automatically unlocks the cassette holders. Figure 1: Centrifuge

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Section 2 – Specifications

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Specifications Dimensions:

Height – 9.45 inches (240 mm) Width – 12.6 inches (320 mm) Depth – 14.0 inches (355 mm)

Weight:

27.5 lb (12.5 kg)

Power Requirements:

100 – 240 V~, 50/60 Hz, single phase, 25 W (auto-sensing power input)

Fuses:

2 x 2 amp, 250 V, T (Slow-Blow) 5 x 20 mm

Speed:

• Phase 1 – 794 rpm ± 2% (55 x g) • Phase 2 – 1510 rpm ± 2% (199 x g)

Speed Indicator:

4 digits

Timing Indicator: 3 digits • Phase 1 – two minutes ± 5 sec. (including ramp-up time) • Phase 2 – three minutes ± 5 sec. (including ramp-up time) Cassette Capacity:

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12 cassettes

Ortho BioVue® System Centrifuge

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Section 3 – Installation Unpacking Procedure

1. Visually inspect the container for damage and ensure it is in an upright position before it is opened.

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Report any damage immediately to the freight carrier. 2. Remove the unit from the box and remove the foam block and corrugated insert from the rotor area. 3.

Visually inspect the instrument for loose, bent or broken parts.

 Report any damage immediately by contacting the hotline number provided by your local Ortho Clinical Diagnostics (OCD) company or distributor. If the Unit is Received Damaged If you have received a unit with obvious shipping damage, DO NOT connect power to the unit. Contact the hotline number provided by your local Ortho Clinical Diagnostics company or distributor for assistance.

Site Specifications Select a location for the Ortho BioVue® System Centrifuge that is convenient for laboratory personnel to perform testing. The surface must be stable, level and have an electrical outlet close enough to the unit to permit power access without an extension cord.

 WARNING: As with any electrical appliance, place the unit AWAY from any source of water, such as a laboratory sink. An electrical hazard may exist when improperly using the centrifuge near water.

WARNING: Do not block access to the power cord or STOP button during centrifuge operation.

Electrical Requirements The Ortho BioVue® System Centrifuge is equipped with automatic sensing of input voltage within the range of 100 – 240 V~, 50/60 Hz, single phase. Connect the unit to the power outlet with the power cord provided. Ensure that the centrifuge is grounded properly. An integrated fuse assembly is located where the power cord connects to the unit. The fuse must be a 2 x 2 amp, 250 V, T (Slow-Blow) 5 x 20 mm.

Ventilation Requirements There are no special ventilation requirements for this instrument.

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Section 4 – Quality Assurance General  Upon receipt of the Ortho BioVue® System Centrifuge, steps must be taken to ensure that no damage has occurred during transit to your site.

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NOTE: After installation, a quality control program must be followed through the life of the centrifuge to provide assurance of accurate test results. The speed and time of the centrifuge should be checked on a regular basis. Verify accuracy of the centrifuge according to standard operating procedures. Speed Verification An optical or electronic device (e.g., phototachometer) is acceptable to check the speed. Since the speed can be displayed during operation, a routine daily check can be made to ensure the centrifuge is spinning at the correct speed. Any fluctuations outside the specifications should be documented, along with what caused the fluctuation and how it was remedied. NOTE: The centrifuge must not be used if speed is outside of specification. The speed of the centrifuge can vary depending on rotor load (the number of cassettes inserted). OCD recommends that all calibration checks be performed with 2, 6 and 12 cassettes. Check both speeds with 2, 6 and 12 cassette configurations. • Phase 1: 794 rpm ± 2% (778 – 810 rpm) • Phase 2: 1510 rpm ± 2% (1480 – 1540 rpm) Timing Verification

A calibrated stopwatch or equivalent is acceptable to check the timer. • Phase 1: two minutes ± 5 sec. (including ramp-up time) • Phase 2: three minutes ± 5 sec. (including ramp-up time) NOTE: The centrifuge must not be used if the timer is out of specification.

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Section 5 – Operation Procedure – NOTE: No special training is required to operate this instrument. All test Spin Cassettes specimens and materials they contact should be handled using established good laboratory practices. 1. Turn unit ON. 2. The LED display will read 5 00. 3.  Open the lid of the centrifuge. If the lid is locked, press the STOP button to unlock the lid. NOTE: Ensure that the lid is fully opened. 4.  Lock the cassette holders by gently pulling up on the centrifuge rotor handle. (Locking the cassette holders makes it easier to insert and remove the cassettes.) See Figure 2. Figure 2: Locking the Cassette Holder

5. Insert cassettes into holders. Ensure that the centrifuge rotor is balanced. “Blank” cassettes may be required to balance the rotor.  NOTE: If the rotor is not properly balanced, excessive vibration after five to ten seconds will cause the unit to stop. An incomplete cycle VOIDS all results. 6.  Close the lid. Closing the lid unlocks the cassette holders. The centrifuge will not spin with the lid opened. 7. Press the START/RPM button. The lid will lock and the centrifuge rotor will accelerate to the first of two speeds.  NOTE: The ramp-up time is monitored for both speeds. If the unit cannot reach either speed due to a malfunction, a continuous alarm will sound. Press the STOP button to silence the alarm. An incomplete cycle VOIDS all results. Contact the hotline number provided by your local Ortho Clinical Diagnostics company or distributor for assistance.

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Section 5 – Operation, continued

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Procedure – Spin Phase 1 centrifugation will last for two minutes at 794 rpm. For Cassettes, continued Phase 2 centrifugation, the rotor speed will automatically increase to 1510 rpm for the final three minutes of the cycle. You may check the rpm any time during the centrifugation cycle by pressing and holding the START/RPM button. The LED timing display will change to display the rotor rpm. The rpm display updates every five seconds. NOTE: In an emergency, you can stop a cycle in progress by pressing the STOP button. An incomplete cycle VOIDS all results. At the conclusion of the five-minute spin (Phase 1 and 2 centrifugation), the unit will signal a completed cycle with three short beeps. 8. Open the lid within twenty seconds after the three beeps, or the lid will automatically relock. Press the STOP button to unlock the lid. 9.  Lock the cassette holders by gently pulling up on the rotor handle for easier removal of the cassettes. See Figure 3. Figure 3: Locking the Cassette Holders

10. Remove the cassettes.

Operating Guidelines Keep the following guidelines in mind when operating the Ortho BioVue® System Centrifuge. • Incomplete, interrupted or multiple cycles may produce erroneous results. When in doubt, discard the cassettes and repeat the test. • Always balance the rotor. • The lid must be closed for operation of the centrifuge. • Improper removal of the cassette foil can cause improper spinning of the cassettes and produce erroneous results.

 WARNING: If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.

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Section 6 – Maintenance General In normal use, the Ortho BioVue® System Centrifuge requires minimal maintenance. The reagents and samples are completely contained in the cassettes, so the centrifuge should not be exposed to the samples or reagents. If cleaning is required, use the following procedure.

WARNING: Turn OFF the centrifuge. Disconnect the power cord from BOTH the power source and the centrifuge before cleaning the unit.

To clean the centrifuge: 1. Use a clean cloth or paper towel dampened with a mild detergent solution to wipe the exterior surfaces and inside the rotor well. 2. Remove any remaining moisture with a clean, dry paper towel. 3. Connect the power cord to the centrifuge and the power source. WARNING: If other chemicals are used that are not specified for cleaning by the manufacturer, the protection provided by the equipment may be impaired.

Fuse Replacement In normal operation, the fuse should not fail. Only certain conditions (such as an internal short circuit) can produce enough current to cause the fuse to fail. If, after replacing the fuse, the fuse fails a second time, contact the hotline number provided by your local Ortho Clinical Diagnostics company or distributor for assistance.

W  ARNING: Turn the power switch to the OFF position on the centrifuge. Disconnect the power cord from BOTH the power source and the centrifuge before replacing the fuse.

1. 2. 3. 4. 5. 6.

Locate the fuse holder. Refer to Figure 1. Pry open the fuse holder with a small screwdriver. Remove the old fuse. Insert a new fuse (2 x 2 amp, 250 V, T [Slow-Blow] 5 x 20 mm). Place the fuse holder back into the instrument. Connect the power cord to the centrifuge and the power source.

W  ARNING: Do not open the instrument housing and attempt repairs. If the troubleshooting table suggestions do not correct the problem, contact the hotline number provided by your local Ortho Clinical Diagnostics company or distributor for assistance.

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Section 7 – Troubleshooting

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Potential Problems Use the following table to help correct problems with the centrifuge. Look for the symptoms of the problem you are experiencing in the left column, and try the suggestions in the right column.

Troubleshooting Symptom No display

Possible Cause

Suggested Remedy

Power cord pulled from the instrument or from the outlet

Ensure the power cord is connected to a working receptacle and to the unit, and that the unit is turned ON. Check the fuse.

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Unit will not spin

Lid is open or not closed properly

Ensure lid is closed.

Unit stops with continuous alarm signal

Centrifuge rotor is unbalanced

Refer to Section 5 – Operation, item 5.

Improper speed

Internal malfunction or external line voltage

Contact the hotline number provided by your local Ortho Clinical Diagnostics company or distributor for assistance.

Improper timing

Internal malfunction or external line voltage

Contact the hotline number provided by your local Ortho Clinical Diagnostics company or distributor for assistance.

Cannot open lid

The lid is locked

Press STOP button and retry. Turn unit OFF for one minute; turn unit ON and retry.

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Section 8 – Instrument Disinfection Disinfection

 ll parts of the instrument that come into contact with the test specimen or control A samples must be treated as potentially infectious areas. Follow instructions in the Ortho BioVue® System cassette instructions for use regarding disposal of cassettes. It is advisable to wear disposable gloves when performing the washing procedure and also when making adjustments to the instrument. It is very important that the instrument is thoroughly disinfected before it is removed from the laboratory or any servicing is performed on it. Before the instrument is returned to your local Ortho Clinical Diagnostics company or distributor for servicing, it must be disinfected and a disinfection certificate must be completed and attached. If a disinfection certificate is not supplied, the servicing center may not accept the instrument or it may be held by the customs authorities. W  ARNING: Turn OFF the centrifuge. Disconnect the power cord from BOTH the power source and the centrifuge before disinfecting the unit. Use appropriate laboratory safety equipment when working with cleaning agents.

Disinfection Procedure NOTE: If the laboratory has its own disinfection procedure, please contact your local Ortho Clinical Diagnostics company or distributor to ensure that the procedure will not damage the instrument. If the laboratory has no specific disinfection procedure, the following procedure should be used to disinfect the instrument. 1. Prepare a 1% iodine solution. 2. Use a clean cloth or paper towel dampened with the solution to wipe the exterior surfaces and inside the rotor well. 3. Remove any remaining moisture with a clean, dry paper towel. 4. Connect the power cord to the centrifuge and the power source.

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Section 8 – Instrument Disinfection, continued

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Disinfection Certificate This Disinfection Certificate must be completed before the instrument is returned to your local Ortho Clinical Diagnostics company or distributor for servicing. The certificate must be included at the top of the package in which the instrument is returned.

DISINFECTION CERTIFICATE For Ortho BioVue® System Centrifuge

I declare that the instrument SN in this package has never been exposed to any hazardous biological material or that it has been decontaminated or disinfected to remove or inactivate any biological material which could be dangerous to the service personnel.

Name: ____________________________________________________________________________________________ Firm: _____________________________________________________________________________________________ Address: __________________________________________________________________________________________ ___________________________________________________________________________________________ ___________________________________________________________________________________________ ___________________________________________________________________________________________ Country:

_________________________________________________________________________________________

Signature: ____________________________________________________

Date: _________________________

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Section 9 – Environmental Directives Disposal  In compliance with European Directive 2002/96/EC on waste electrical and electronic equipment (WEEE), this device must not be disposed of as unsorted municipal waste. Instead, this device must be collected separately in accordance with local recycling regulations. Presence of this symbol indicates that compliance must be adhered to for this device on waste electrical and electronic equipment (WEEE).

Chinese Environmental This label appears on the Ortho BioVue® System Centrifuge to comply with Chinese Regulations on regulations on Management Methods of the Control of Pollution from Electronic Hazardous Substances Information Products (EIP) – Ministry of Information Industry, February 28, 2006, (China RoHS) Order No. 39 (China RoHS). The labeling applies to the Chinese market; however, customers outside of China will also see this labeling on their equipment. China RoHS requires that all EIP be labeled with an appropriate symbol to indicate if the EIP contains one or more hazardous substances and the Environmental Protection use Period (EPUP). The label appears on the instrument and on the packaging for the instrument. The number in the symbol indicates the Environmental Protection Use Period (EPUP). The EPUP is the period of time (in years) during which, with normal use, no hazardous substances or elements will leach from the EIP or mutate into other forms that could result in severe environmental pollution, bodily damage or material damage.

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Section 10 – Warranty

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Warranty Time Period OCD warrants the Ortho BioVue® System Centrifuge to function properly for one year from date of shipment (from manufacturer storehouse). This warranty covers the purchaser of this instrument and anyone else who owns it during the warranty period.

Warranty Repair If this equipment does not function properly during the warranty period, please Coverage  contact the technical assistance hotline number provided by your local Ortho Clinical Diagnostics company or distributor to arrange for repair. The equipment will be repaired without charge. Such repair service will include any adjustments and/or replacement of parts required to maintain the equipment in good working order. Supply items are billed as required.

Limitations  OCD will not be responsible for any consequential or incidental damages resulting from the sale, use or improper functioning of this equipment.

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Revision History

Effective Date

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Description

09/29/95

Original manual

06/30/03

Revision to entire manual for application of IVD Directive and EN-591-2001.

2006-03-23

Manual updated for compliance to the WEEE directive and to update authorized representative address.

2007-03-31

Updated the manual date. Section 8, Instrument Disinfection, corrected a typographical error. Changed former Section 9, Warranty, to Section 10. Added a new Section 9, Environmental Directives. Added information pertaining to new Chinese environmental legislation. Also moved the Disposal labeling information from the Warranty section to the Environmental Directives section.

Ortho BioVue® System Centrifuge Operator’s Manual

2008-06-16

Updated the manual date. Initial release of Polish translation. Initial release of Norwegian translation. Added Manufacturer symbol and Date of Manufacture symbol to Key to Symbols.

2010-06-30

Addition of Russian language.

2012-10-10

Updated the manual date, trademarks, and logo. Updated Intended Use information. Added ventilation requirements. Added warning regarding blocking power cord and STOP button access. Added guidance to use manufacturer-specified cleaning chemicals and rotors. Added guidance to use equipment as specified by the manufacturer.

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Revision History, continued

2013-10-07

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Updated the manual date and revision history. Added Chinese manufacturer information to last page of the Chinese manual.

Ortho BioVue® System Centrifuge Operator’s Manual

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Ortho BioVue® System Centrifuge

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KEY TO SYMBOLS The following symbols may have been used in the labeling of this product.

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For In Vitro Diagnostic Use Authorized Representative

Product Code

Biological Risk

This End Up

Keep Dry

Fragile, handle with care

Attention

Do not use if damaged

Manufacturer

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OG-822

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Date of Manufacture

Ortho BioVue® System Centrifuge

EN-19OCD Raritan

06/23/08