ORTHO ID-MTS User manual

TRANSFUSION MEDICINE

J55700ENna

ID-MTS™ Gel Cards

Reference Guide

Customer – For Future Reference:

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

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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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

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

™

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

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

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ORTHO™ Workstation for ID-MTS™ Gel Cards Reference Guide

Centrifuge Rotor

Centrifuge Lid

Incubator Lid

Balance Card

Holder

Centrifuge

Card Holder

Centrifuge

Start Button

Centrifuge

Stop Button

Incubator Timer

Up/Down Buttons

Incubator

Start/Stop Button

Incubator Temperature

Status Display

Incubator Block

Centrifuge

Lid Latch

Centrifuge Time

LED Display

Centrifuge RPM

LED Display

Power Cord and

Fuse Assembly

Incubator Time

LED Display

Section 1 - Description

Intended Use

Section 1 - Description

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
Workstation includes (refer to Figure 1):

Figure 1: ORTHO

™

Workstation

™

Gel card Column Agglutination Technology. The ORTHO™

Materials provided:

• ORTHO™ Workstation • Reference Guide

• Power Cord

temperature meter

• Phillips screwdriver

Materials required but not provided:

• Balance card • Photo calibrated tachometer • Calibrated thin wire

•

ID-MTS™ Gel card and reagents

listed in corresponding IFU

• A calibrated stopwatch or
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
important information, including proper storage temperature. Do not attempt to operate this
instrument before thoroughly reading the instructions.

™

Workstation for

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
provided or assistance is needed, or if you have any doubts about the safety of the equipment,
please contact OCD Customer Technical Services.

™

Workstation hardware for which corrective action is not

• 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

• 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

Section 2 - Warnings and Precautions

• Use universal precautions when working with the ORTHO™ Workstation. Use only materials and
substances for which the ORTHO
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.

™

Workstation was designed. All materials and substances are

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
date.

• Be sure to use 70% isopropyl alcohol or mild detergent. Do not use bleach.

™

Workstation, do not use cleaning solutions past their expiration

General warning symbols used in this guide

Symbol Description

Important or Caution

General Warning
(Direct or indirect danger to personal safety or instrument)

Biohazard

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Section 3 - Installation & Specifications ORTHO™ Workstation for ID-MTS™ Gel Cards Reference Guide

CAUTION: Operator is advised to read all instructions before plugging the
instrument in.

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.

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)

Width – 575 mm (22.64 inches)
Depth – 325 mm (12.80 inches)

Weight: 10.89 kg (24 lb)

Power Requirements: 100 – 240 V~, 50/60 Hz, single phase

(Input auto-senses voltage/current, no
manual selection required)

Power Consumption: 150 VA

™

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