BD MicroProbe Processor (Affirm VP111 Microbial ID Test) Instrument Users Manual Rev D Oct 2010

BD MicroProbe Processor Instrument User’s Manual

System Software Notice This manual includes instructions for installing and operating the BD MicroProbe™ Processor as it is used with the BD Affirm™ VPIII Microbial Identification Test kits. Each Affirm Microbial Identification Test requires specific system software to be installed in the Processor. Please refer to the test kit package insert for the correct software version and the specific test procedures.

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Preface

Change History REVISION

DATE

PAGES

REASON

New

1/99

All

New Product Release

A

4/99

All

CE Marking

B

7/99

1, 2, 50, 52

Codification

C

1003

All

CE Marking

All

Update Format, Photos and AR Address Change. Update ambient operating temperature in Section 2.2.1. Update unpacking instructions in Section 2.3.1.

D

2010/10

BD, BD Logo, MicroProbe and Affirm are trademarks of Becton, Dickinson and Company. © Copyright Becton, Dickinson and Company, 2010. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated into any language or computer language, in any form or by any means, electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior written permission of BD, 7 Loveton Circle, Sparks, Maryland, 21152, United States of America.

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BD MicroProbe Processor Instrument User’s Manual

Table of Contents Introduction 1.1 General ... 1-1 1.2 Intended Use of the Processor... 1-1 1.3 Description and Principles of Operation ... 1-3 1.4 System Components ... 1-4 1.4.1 BD MicroProbe Processor ... 1-4 1.4.2 Program Card ... 1-4 1.4.3 Affirm Microbial Identification Test Kits ... 1-4 1.4.4 Affirm Sample Collection Kits... 1-4 1.4.5 Lysis Block... 1-4 1.5 Use of this Manual... 1-4 1.6 Notes, Cautions and Warnings ... 1-5 1.7 Summary of Cautions and Warnings... 1-6 Installation 2.1 General ... 2-1 2.2 Instrument Specifications... 2-1 2.2.1 Operating Specifications... 2-1 2.2.2 Calibration... 2-2 2.3 Instrument Installation... 2-2 2.3.1 Unpacking the Processor... 2-2 2.3.2 Setting Up the Processor... 2-5 2.3.3 Installing the Transformer... 2-6 2.3.4 Installing the Program Card ... 2-7 2.4 Powering On and Off the Instrument ... 2-8 2.4.1 Power On... 2-8 2.4.2 Power Standby... 2-9 2.4.3 Shut-down Procedure (Preparation for Storage or Shipping)... 2-9 2.5 Repacking the Processor... 2-10

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Preface Operation 3.1 General ... 3-1 3.2 Processor Components and Functions ... 3-1 3.2.1 Processor Base Unit... 3-1 3.2.2 Robotic Arm and PAC Arms ... 3-1 3.2.3 Cassette Caddy... 3-2 3.2.4 Program Card ... .3-2 3.2.5 Program Card Port ... 3-2 3.2.5 User Control Panel ... 3-3 3.3 User Control Panel Functions ... 3-3 3.3.1

[ON/STANDBY] Key ... 3-3

3.3.2 [RUN] Key... 3-3 3.3.3 [HELP] Key ... 3-3 3.3.4 Power Indicator ... 3-4 3.3.5 Display... 3-4 3.4 User Prompts and Responses ... 3-4 3.5 Setting Up and Processing Samples... 3-6 3.5.1 Using the Cassette Caddy ... 3-6 3.5.2 Positioning the Cassettes for Processing ... 3-6 3.5.3 Cassette Positions... 3-7 3.5.4 Turning the Processor Off... 3-7 Maintenance 4.1 General ... 4-1 4.2 Cleaning and Maintenance ... 4-2 4.3 General Cleaning... 4-2 4.4 Disinfection/Decontamination... 4-3 4.4.1 BD MicroProbe Processor Base Unit ... 4-3 4.4.2 Cassette Caddy... 4-4 4.4.3 Program Card ... 4-4

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BD MicroProbe Processor Instrument User’s Manual Troubleshooting 5.1 General ... 5-1 Warranty Replacement Parts International Contacts

List of Illustrations Figure 1-1 2-1 2-2 2-3 2-4 2-5 3-1 3-2

Title Page The BD MicroProbe Processor ... 1-2 Unpacking the Processor... 2-4 Setting Up the Processor... 2-5 Installing the Transformer... 2-6 Installing the Program Card ... 2-8 Power On and Standby ... 2-9 User Control Panel Controls and Indicators ... 3-4 Cassette Positions... 3-7

Bibliography Disinfecting Agents recommended in CLSI document M29-A3, 2005; Approved Guideline: Protection of Laboratory Workers from Occupationally Acquired Infections.

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Introduction 1.1 General This section provides introductory information on the BD MicroProbe Processor. The following major topics are included: Intended Use of the Processor ... Section 1.2 Description and Principles of Operation... Section 1.3 System Components... Section 1.4 Use of this Manual ... Section 1.5 Notes, Cautions and Warnings... Section 1.6 Summary of Cautions and Warnings ... Section 1.7

1.2 Intended Use of the Processor The BD MicroProbe Processor is used in the Automated Processing portion of the Affirm Microbial Identification Test procedure. The BD MicroProbe Processor is required for ALL Affirm tests and, together, they work as a SYSTEM. This User’s Manual describes the installation and operation of the Processor only. Refer to your Affirm Test kit package insert to perform the test. If the processor is used in a manner not specified, the protection afforded by the processor may be impaired.

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BD MicroProbe Processor Instrument User’s Manual The BD MicroProbe Processor is pictured below. Individual components are listed below. 6 1

5 3

4 2 7

Figure 1-1 The BD MicroProbe Processor

The BD MicroProbe Processor Components 1. 2. 3. 4. 5. 6. 7.

1-2

BD MicroProbe Processor Base Unit Cassette Caddy Probe Analysis Cards (PACs) Reagent Cassettes Robotic Arm PAC Arms Program Card

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Introduction

1.3 Description and Principles of Operation The BD MicroProbe Processor is a compact, robotic unit that automatically controls the reagent and sample mixing, and incubation timing of the Affirm Microbial Identification Tests. The Affirm tests use specialized beads coated with microbe-specific DNA probes to qualitatively identify the presence of selected target microorganisms in clinical samples. Each test consists of a panel of organism-specific probe beads, plus a specificity control (negative) bead and a procedural control (positive) bead. The beads are all located on a single test card called a Probe Analysis Card (PAC). The identification reaction takes place on the beads as the processor moves the PACs through a series of incubations with sample and reagent, resulting in a blue-colored bead if the test is positive. The BD MicroProbe Processor consists of a base unit with removable tray, called the cassette caddy, which holds from one to six reagent cassettes. The PAC arms on the robotic arm pick up the PACs and move them through a series of reagents in reaction wells in the reagent cassettes. The precise timing of incubations in the reaction wells is under software control as the PACs are automatically cycled, first into the sample well, then through the reagent wells. Depending on the test, the reaction is complete in approximately 30 minutes. The BD MicroProbe Processor is very simple to operate. Once started, the system automatically completes the test procedures without any further operator attention. A [HELP] mode is available to assist new or infrequent users. The system software is on a program card selected to match the specific test.

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BD MicroProbe Processor Instrument User’s Manual

1.4 System Components 1.4.1 BD MicroProbe Processor BD MicroProbe Processor Base Unit Cassette Caddy Power Transformer (selectable for voltage) User’s Manual

1.4.2 Program Card The test-specific program card must be matched to the test. Your Processor will initially arrive with a program card included. Please confirm that you have the correct software for the test you wish to run.

1.4.3 Affirm Microbial Identification Test Kits Each Kit contains: • • • •

Reagent Cassettes PACs (Probe Analysis Cards) Reagent Bottles Miscellaneous sample collection and processing supplies for the particular assay

1.4.4 Affirm Sample Collection Kits Specimen collection materials, such as swabs or aspiration tubes, are packaged for user convenience in the test kits or in separate sample collection kits.

1.4.5 Lysis Block A heating block (Lysis Block) with thermometer is supplied.

1.5 Use of this Manual This user’s manual is designed as a reference tool for technologists, supervisors and other personnel who operate and maintain the BD MicroProbe Processor on a regular basis.

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Introduction Every attempt has been made to include information which would be required during normal use and maintenance of the instrument. Should a question arise which is not answered in this manual, please contact the following parties (USA): For assistance in North America: Technical Services 1-800-638-8663 International contacts are listed in Appendix C, or contact your local BD representative.

1.6 Notes, Cautions and Warnings Throughout this manual, important information is presented in boxes offset from the regular text, and is labeled as either a NOTE, CAUTION or WARNING. These messages are formatted as shown below and bear the following significance: NOTE Important information about instrument use worthy of special attention is presented as a NOTE. CAUTION Information on an activity which potentially could cause damage to the instrument is presented as a CAUTION. WARNING INFORMATION ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE INJURY TO THE USER IS PRESENTED AS A WARNING.

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BD MicroProbe Processor Instrument User’s Manual

1.7 Summary of Cautions and Warnings

1-6

•

Do not use the robotic arm as a handle to lift or move the processor. Always lift from the bottom of the base unit.

•

To raise the robotic arm, grasp it near the PAC arms and move it upward using even but firm pressure. Do not use the PAC arms to raise the robotic arm.

•

The power plug on the transformer must be connected to a grounded power source. Do NOT use an adapter to connect the power plug to an outlet for which it is not designed.

•

Position the instrument in a place where the program card port on the front of the instrument is protected from dirt or liquids. If spillage occurs, contact your Technical Services representative before using the processor or installing the program card.

•

Handle the program cards carefully to prevent damage. Store the card in the plastic case when not installed in the instrument.

•

The robotic arm automatically rises when the power is turned ON and drops when the power is set to STANDBY. Keep hands and other objects clear of the arms when turning power ON or setting to STANDBY.

•

Do not add or remove reagent cassettes, or attempt to install or remove the cassette caddy when the processor is in operation ("homing" or processing PACs).

•

The BD MicroProbe Processor contains no user serviceable parts. All maintenance and repair other than the procedures described in Section 4 – Maintenance must be performed by BD qualified service personnel.

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Introduction •

Always set the Processor to STANDBY and disconnect the power supply before performing cleaning, disinfection or maintenance procedures.

•

Do not use organic solvents such as acetone or petroleum based products to clean the painted plastic instrument case. Do not use bleach on or near metal components.

•

Do not store reagents on the instrument. Wipe all reagent spills immediately.

•

Do not immerse the BD MicroProbe Processor or power transformer in liquid.

•

Make certain the 10 percent bleach solution does not come into contact with the program card.

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Installation 2.1 General This section provides specifications for installation and setup of the BD MicroProbe Processor. The following major topics are included: Instrument Specifications ... Section 2.2 Instrument Installation... Section 2.3 Powering On and Off the Instrument ... Section 2.4 Repacking ... Section 2.5

2.2 Instrument Specifications 2.2.1 Operating Specifications Dimensions Height:

6 in/16 cm

Width:

10 in/26 cm

Depth:

9 in/24 cm

Weight:

18 lbs/8 kg

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BD MicroProbe Processor Instrument User’s Manual

Power Voltage: Selectable by Transformer 120 VAC ± 10%; 220/240 VAC; 100 VAC ± 10% 50/60 Hz (± 10%) Maximum Input Current: <1 A

Environmental Indoor Use Ambient Temperature:

22 – 28°C

Ambient Humidity:

10 – 85%

Altitude:

2000 m maximum

Installation Category II, Pollution Degree 2 as per IEC 664

Regulatory Compliance Designed to meet UL, CSA and IEC standards.

2.2.2 Calibration The BD MicroProbe Processor is factory calibrated. No further calibration or alignment is required under conditions of normal use.

2.3 Instrument Installation 2.3.1 Unpacking the Processor 1. Place the shipping container in the upright position. Open the top of the container and remove the product literature and the top foam packing block. 2. Remove the accessories: The power transformer (120 V or 220/240 V or 100 V), lysis block, thermometer, program card and cassette caddy.

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Installation 3. Carefully lift the processor in the protective bag out of the box and place it on a level surface. 4. Remove the clear plastic bag, then remove the protective foam insert covering the robotic arm. CAUTION Do not use the robotic arm as a handle to lift or move the processor. Always lift from the bottom of the base unit. 5. Remove the power transformer, program card and cassette caddy and make certain the program card matches the Affirm test you intend to use. NOTE Retain the BD MicroProbe Processor shipping container and all packing materials for later transport or shipment. 6. To complete the installation, verify that all parts are present (see steps 1 – 5 above and Figure 2-1) and inspect for any damage. If any parts are missing or damaged contact BD: Technical Services 1-800-638-8663 or your local BD representative.

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BD MicroProbe Processor Instrument User’s Manual

Figure 2-1 Unpacking the Processor NOTE The plastic bag that covers the instrument is not pictured here.

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Installation

2.3.2 Setting Up the Processor CAUTION To raise the robotic arm, grasp it near the PAC arms and move it upward using even but firm pressure. Do not use the PAC arms to raise the robotic arm. 1. Place the processor on a clean, level surface away from liquids or mechanical equipment that may interfere with the operation of the instrument. 2. Gently raise the robotic arm to install the cassette caddy.=Rest the caddy on the locator pins on each side of the instrument, level with the surface of the base unit.

Locator Pins

Figure 2-2 Setting up the Processor

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BD MicroProbe Processor Instrument User’s Manual

2.3.3 Installing the Transformer WARNING THE POWER PLUG ON THE TRANSFORMER MUST BE CONNECTED TO A GROUNDED POWER SOURCE. DO NOT USE AN ADAPTER TO CONNECT THE POWER PLUG TO AN OUTLET FOR WHICH IT IS NOT DESIGNED. DO NOT, UNDER ANY CIRCUMSTANCES, OPERATE THE SYSTEM UNTIL AN ELECTRICAL GROUND IS PROVIDED, AND THE POWER CORD IS PROPERLY CONNECTED TO GROUND. Insert the transformer pin connector into the keyed port on the back of the processor, aligning the notch on the connector to the key at the top of the port. Then insert the end of the power cord into an outlet of appropriate voltage.

Transformer pin in keyed port

Transformer

Figure 2-3 Installing the Transformer (Rear View of the Processor)

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Installation

Installing the Program Card CAUTION Position the instrument in a place where the program card port on the front of the instrument is protected from dirt or liquids. If spillage occurs, contact your Technical Services representative before using the processor or installing the program card. CAUTION Handle the program cards carefully to prevent damage. Store the card in the plastic case when not installed in the instrument. The program card contains the specific processor operating software for a particular Affirm test. Confirm that the description on the card matches that on the Affirm test kit package insert. 1. Make sure the system is set to STANDBY (the green LED is NOT lit). If ON, press the [ON/STANDBY] key to set the Processor to STANDBY. NOTE Do not insert or remove the program card while the processor is turned ON or in operation. 2. With the label up, insert the card in the direction of the arrows into the program card port on the lower right front of the instrument. You will feel the card seat firmly in the port when it is properly installed.

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