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ID-MTS™ Gel Cards
Reference Guide
TRANSFUSION MEDICINE
J55700ENna
WARNING: CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED IN THIS MANUAL BEFORE OPERATING THE INSTRUMENT
Customer – For Future Reference:
In the box below, please transcribe the serial number as it appears on the ORTHO™ Workstation.
ORTHO™ Workstation Serial Number:
6904630
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.
MTS is a trademark of Ortho-Clinical Diagnostics, Inc.
Copyright © by Ortho-Clinical Diagnostics, Inc. 2013
All rights reserved
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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 ProcedureSpin Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Centrifuge Card Holder Replacement . . . . . . . . . . . . . . . . . . . . . . . . 12 Section 5 - Incubator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Operational Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ProcedureIncubate 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
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ORTHO™ Workstation for ID-MTS™ Gel Cards Reference Guide |
Section 1 - Description |
Section 1 - Description
Intended Use
The ORTHO™ Workstation is intended to support the in vitro immunohematology testing of human blood through the incubation and centrifugation of ID-MTS™ Gel cards.
Overview
The ORTHO™ Workstation is a combined bench top workstation providing incubation and centrifugation, utilizing ID-MTS™Gel card Column Agglutination Technology. The ORTHO™ Workstation includes (refer to Figure 1):
Figure 1: ORTHO™ Workstation
Centrifuge Lid
Incubator Lid
Centrifuge Rotor
Balance Card
Holder
Centrifuge
Card Holder
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Incubator Block |
Centrifuge |
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Lid Latch |
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Incubator Time |
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LED Display |
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Power Cord and |
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Fuse Assembly |
Centrifuge Time |
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LED Display |
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Incubator Temperature |
Centrifuge RPM |
Centrifuge |
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Status Display |
LED Display |
Start Button |
Incubator Timer |
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Incubator |
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Centrifuge |
Up/Down Buttons |
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Start/Stop Button |
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Stop Button |
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Materials provided: |
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• ORTHO™ Workstation |
• Reference Guide |
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• Power Cord |
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Materials required but not provided: |
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• Balance card |
• Photo calibrated tachometer |
• Calibrated thin wire |
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• ID-MTS™ Gel card and reagents |
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temperature meter |
• A calibrated stopwatch or |
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• Phillips screwdriver |
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listed in corresponding IFU |
equivalent |
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Section 2 - Warnings and Precautions |
ORTHO™ Workstation for ID-MTS™ Gel Cards Reference Guide |
Section 2 - Warnings and Precautions
This section contains warnings and safety precautions applicable to the ORTHO™ Workstation. These warnings and safety precautions must be observed in order to avoid possible harm to personnel and the instrument, and to avoid false test interpretations.
Refer to the Instructions For Use for each product used with the ORTHO™ Workstation for important information, including proper storage temperature. Do not attempt to operate this instrument before thoroughly reading the instructions.
General precautions regarding use
•This equipment must only be operated by operators who are trained laboratory technicians and have a knowledge of immunohematology.
•Use of the instrument in a different way than specified in this reference guide may damage the instrument and system parts.
•Do not repeatedly turn on and turn off the power switch. This could cause damage to the electronics of the instrument.
•Incomplete, interrupted or multiple cycles may produce erroneous results. When in doubt, discard the cards and repeat the test.
•To avoid temperature loss and potentially impacting test results, close the incubator 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.
•Flashing "0000" on all displays indicates that power has been applied or that a power interruption has occurred. If an unexpected power interruption occurs during a test then the test results are no longer valid. Press any button to reset the system and continue normal use.
Electrical safety precautions
•The electrical plug is a three-prong type for safe grounding. If the wall outlet is not the grounded type, the outlet must be changed or another outlet must be used.
•In order to totally disconnect the instrument from the power supply, the instrument must be unplugged (the On/Off switch is insufficient).
•For continued protection against electrical hazard, use only voltages and fuses of the same type and rating as stated in Section 3 - Installation & Specifications and Section 8 - Maintenance.
•Although the instrument is completely isolated and grounded, it is important that all operators realize the danger of using liquids near a power supply. In the case of a large liquid spill, the instrument should be immediately disconnected from the power supply and cleaned.
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ORTHO™ Workstation for ID-MTS™ Gel Cards Reference Guide |
Section 2 - Warnings and Precautions |
• Due to the risk of electromagnetic interference, the instrument should not be used adjacent to, or stacked with, other equipment. The instrument should be observed to verify normal operation in the configuration in which it will be used.
Biohazardous materials
•Use universal precautions when working with the ORTHO™ Workstation. Use only materials and substances for which the ORTHO™ Workstation was designed. All materials and substances are outlined in this reference guide or laboratory procedures. Follow the laboratory’s Standard Operating Procedures when working with these materials and substances.
•Universal precautions and good laboratory working practices must be observed, and laboratory procedures regarding personal protective equipment (lab coats, gloves, and eye protection) 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 to ensure accurate operation and positioning of its movable parts. Care must be taken to ensure the maintenance schedule and procedures in this reference guide are followed.
•Failure to perform the appropriate cleaning, maintenance or quality control procedure at the necessary time can result in damaged parts, operating inaccuracy and/or compromised sample results.
•When cleaning the ORTHO™ Workstation, do not use cleaning solutions past their expiration date.
•Be sure to use 70% isopropyl alcohol or mild detergent. Do not use bleach.
General warning symbols used in this guide
Symbol |
Description |
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Important or Caution
General Warning
(Direct or indirect danger to personal safety or instrument)
Biohazard
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2013-09-04 |
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Section 3 - Installation & Specifications |
ORTHO™ Workstation for ID-MTS™ Gel Cards Reference Guide |
Section 3 - Installation & Specifications
Unpacking Procedure
1.Visually inspect the container for damage and ensure it is in an upright position before it is opened.
2.Remove power cord from box.
3.Remove the instrument from the box and protective bag.
4.Remove the foam block from the rotor area.
5.Visually inspect the instrument for loose, bent, or broken parts.
Report any damage immediately by contacting the OCD Customer Technical Services number provided by Ortho Clinical Diagnostics or your distributor.
6. Compare the serial number on the rear panel of the instrument with the serial number in the packing slip.
CAUTION: Operator is advised to read all instructions before plugging the instrument in.
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 the ORTHO™ Workstation to provide assurance of accurate test results. Never use if the equipment does not operate properly or is damaged.
Specifications
Dimensions: |
Height – 220 mm (8.66 inches) |
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Width – 575 mm (22.64 inches) |
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Depth – 325 mm (12.80 inches) |
Weight: |
10.89 kg (24 lb) |
Power Requirements: |
100 – 240 V~, 50/60 Hz, single phase |
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(Input auto-senses voltage/current, no |
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manual selection required) |
Power Consumption: |
150 VA |
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2013-09-04 |
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