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Pub. No.: J55700ENna

2013-09-04

ORTHO

™

Workstation for ID-MTS

™

Gel Cards Reference Guide

Contents

Section 1 - Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Section 2 - Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Section 3 - Installation & Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Unpacking Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Site Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Ventilation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Safety Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

EMC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Section 4 - Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Operational Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Procedure- Spin Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Centrifuge Card Holder Replacement . . . . . . . . . . . . . . . . . . . . . . . . 12

Section 5 - Incubator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Operational Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Procedure- Incubate ID-MTS

™

Gel Cards. . . . . . . . . . . . . . . . . . . . . 13

Section 6 - Troubleshooting and Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Section 7 - Qualification Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

When to Perform Qualification Procedures . . . . . . . . . . . . . . . . . . . . 17

Daily Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

As Needed Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Section 8 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Cleaning Under the Incubator (As Needed) . . . . . . . . . . . . . . . . . . . 20

Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Section 9 - Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Section 10 - Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Section 11 - Key to Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Содержание ID-MTS

Страница 1: ...TRANSFUSION MEDICINE J55700ENna ID MTS Gel Cards Reference Guide ...

Страница 2: ...ay 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 MTS is a trademark of Ortho Clinical Diagnostics Inc Copyright by Ortho Clinical Diagnostics Inc 2013 All rights reserved WARNING CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED IN THIS...

Страница 3: ... 10 Section 4 Centrifuge 11 Operational Guidelines 11 Procedure Spin Cards 11 Centrifuge Card Holder Replacement 12 Section 5 Incubator 13 Operational Guidelines 13 Procedure Incubate ID MTS Gel Cards 13 Section 6 Troubleshooting and Error Codes 14 Troubleshooting 14 Error Codes 14 Section 7 Qualification Procedures 17 When to Perform Qualification Procedures 17 Daily Procedures 17 As Needed Proce...

Страница 4: ...4 Pub No J55700ENna 2013 09 04 ...

Страница 5: ...igure 1 Figure 1 ORTHO Workstation Materials provided Materials required but not provided ORTHO Workstation Reference Guide Power Cord Balance card Photo calibrated tachometer Calibrated thin wire temperature meter ID MTS Gel card and reagents listed in corresponding IFU A calibrated stopwatch or equivalent Phillips screwdriver Centrifuge Rotor Centrifuge Lid Incubator Lid Balance Card Holder Cent...

Страница 6: ...lid as soon as operator is finished loading cards Operator may place additional cards in the heated block at any time After placing additional cards close lid immediately If an error occurs in the ORTHO Workstation hardware for which corrective action is not provided or assistance is needed or if you have any doubts about the safety of the equipment please contact OCD Customer Technical Services F...

Страница 7: ...n must be followed All areas of the instrument must be considered potentially biohazardous and handled with the appropriate care as per the laboratory s Standard Operating Procedure MTS Gel card handling When preparing ID MTS Gel cards refer to the corresponding IFU Ensure regular cleaning and maintenance The ORTHO Workstation is a precision instrument and requires regular cleaning and maintenance...

Страница 8: ...ument with the serial number in the packing slip If the Instrument is Received Damaged If you have received an instrument with obvious shipping damage do not connect power to the instrument Contact the OCD Customer Technical Services number provided by Ortho Clinical Diagnostics or your distributor for assistance After installation a quality control program should be followed through the life of t...

Страница 9: ...ange of 100 240 V 50 60 Hz single phase Connect the instrument to the power outlet with the grounded three prong power cord provided Ventilation Requirements There are no special ventilation requirements for this instrument Fuses 2 required T4AH250V 4 Amp 250V ceramic time delay 5x20mm Cycle Speed 1032 rpm 10 rpm Speed Indicator 4 digits Timing Indicator 4 digits Cycle Timing 10 minutes 10 sec inc...

Страница 10: ...ticular Requirements for Laboratory Equipment for the Heating of Materials IEC 61010 2 020 2nd Edition 2006 05 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 020 Particular Requirements for Laboratory Centrifuges IEC 61010 2 101 First Edition 2002 01 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 101 Pa...

Страница 11: ... the centrifuge rotor is balanced The balance card may be required to balance the rotor Balance card storage is located in the balance card holder on the top of the instrument Your lab will need to provide an ID MTS Gel card for use To avoid imbalance of the centrifuge please follow Balance Card Configurations as shown below in Figure 2 Figure 2 Balance Card Configurations 5 Close the lid The cent...

Страница 12: ...there are signs of damage or if the speed or timer is out of specification Centrifuge Card Holder Replacement 1 Open the centrifuge lid 2 Pinch the center of the damaged card holder and remove it from the centrifuge rotor 3 Place the new card holder in the centrifuge rotor and pinch the center of the card holder so that it sits in place in the centrifuge rotor 4 Ensure that the card holder swings ...

Страница 13: ...ll flash red and the incubator should not be used 3 Open the lid and load the cards When loading cards into the incubator block make sure the card is seated fully in the slot Ensure that the incubator lid is closed completely at all times during incubation except when loading and unloading cards 4 To select a desired incubation time other than the factory set default 15 minutes press the Up or Dow...

Страница 14: ...lled from the instrument or from the outlet Ensure the power cord is connected to a working receptacle and to the instrument and that the instrument is turned on Check the fuse Power cycle the instrument turn off the instrument for 10 seconds and power back on Centrifuge will not spin Lid is open or not closed properly Lid may not have been opened after previous cycle Latch is pressed Malfunction ...

Страница 15: ...s error is automatically cleared when the centrifuge lid is opened 3 Aborted Error The centrifuge Stop button was pressed the latch was pressed or the lid was opened during a centrifuge cycle 5 Latch Open Error The centrifuge lid latch was open while attempting to start the centrifuge Ensure that the lid is fully closed This error is automatically cleared when the centrifuge lid is opened 50 Still...

Страница 16: ...lculated High Error The calculated temperature setpoint is higher than the acceptable maximum This could be caused by lab environmental temperature Let the system stabilize for one hour then turn the instrument off then on 205 Temperature Sensor 1 Low Error The temperature sensor value read from the temperature controller was lower than expected 206 Temperature Sensor 1 High Error The temperature ...

Страница 17: ...Procedures Speed Verification The centrifuge is fully calibrated at the factory Additional calibration is not necessary However an additional speed verification may be performed with an optical or electronic device e g photo calibrated tachometer as needed Refer to your local laboratory practices for frequency of speed verification OCD recommends that calibration checks be performed with 10 cards ...

Страница 18: ...nt reaction chamber Figure 4 Sensor Wire Placement 4 Place card into any slot in the incubator and route the sensor wire out under the lid through the small slot in the right side Ensure the card is still seated completely in incubator slot after closing the lid 5 Incubate the card for 15 minutes and record the temperature Incubation Temperature 37 C 2 C Incubator Timing Verification A calibrated ...

Страница 19: ...eating blocks with a cloth moistened with mild detergent Avoid excessive use of water Remove detergent residue with a cloth moistened with clean water 3 Clean the system lids with distilled water 4 Clean any potentially contaminated areas of the system with mild detergent and then with 70 isopropyl alcohol Do not scrub excessively 5 Allow the surfaces to air dry completely 6 Plug in the power cord...

Страница 20: ...ock down 7 Install the three screws 8 Close the incubator lid Replacing Fuses 1 Turn off the instrument 2 Unplug the power cord 3 Pull out and flip fuse lid upwards on rear panel to open 4 Replace the broken fuse with another one of the same type and value See Section 3 Installation Specifications 5 Flip down and push in fuse lid to close 6 Plug in the power cord and turn on the instrument If the ...

Страница 21: ...aser of this instrument and anyone else who owns it during the warranty period Warranty Repair Coverage If this equipment does not function properly during the warranty period please contact the technical assistance OCD Customer Technical Services number provided by Ortho Clinical Diagnostics or your distributor to arrange for service The equipment will be replaced Limitations OCD will not be resp...

Страница 22: ...ry ORTHO Workstation for ID MTS Gel Cards Reference Guide 22 Pub No J55700ENna 2013 09 04 Section 10 Revision History ORTHO Workstation for ID MTS Gel Cards Reference Guide Effective Date Description 2013 09 04 Original Manual ...

Страница 23: ...rning Direct or indirect danger to personal safety or instrument Refer to Reference Guide Important or Caution Lot Number Manufacturer s Serial Number Catalog Number or Product Code Manufacturer Date of Manufacture For In Vitro Diagnostic Use Fragile Handle with Care Keep Dry This End Up Fuse Label Handle with Care ETL Intertek Certification Mark indicating compliance to US and Canadian standards ...

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Страница 26: ...Ortho Clinical Diagnostics Inc 1001 US Highway 202 Raritan NJ 08869 USA IVD ...

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