Cardinal Health CHB-AGS Instructions For Use Manual

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AMS1800062
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CHB-AGS

Cardinal Health™
Single Slide Automated Gram Stainer

Instructions for Use Manual

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Table of Contents

Specifications ..................................................................................................................................................................5

1.0 INTRODUCTION ..........................................................................................................................................................6

2.0 WORK AREA REQUIREMENTS .....................................................................................................................................7

3.0 RECEIVING AND UNPACKING ......................................................................................................................................7

4.0 MATERIALS REQUIRED BUT NOT PROVIDED ...............................................................................................................7

5.0 GRAM STAIN KITS ......................................................................................................................................................7

5.1 General Information ..................................................................................................................................................7

5.2 Ordering Information ................................................................................................................................................7

5.3 Reagent Kit Installation ............................................................................................................................................7

6.0 OPERATIONS INSTRUCTIONS ......................................................................................................................................8

6.1 Instrument Anatomy .................................................................................................................................................8

6.2 Specimen Slide Preparation ......................................................................................................................................8

6.3 Instrument Preparation ............................................................................................................................................9

6.4 Stain Operation .........................................................................................................................................................10

7.0 QUALITY CONTROL .....................................................................................................................................................12

7.1 Quality Control Checks ..............................................................................................................................................12

7.2 Self Calibration Errors ................................................................................................................................................12

8.0 CONSUMABLES ..........................................................................................................................................................12

8.1 Gram Stain Kit Registration .......................................................................................................................................12

8.2 Pump Replacement Tube Procedure .........................................................................................................................13

8.3 Register New Pump Replacement Tube Kit ...............................................................................................................14

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9.0 MAINTENANCE ..........................................................................................................................................................14

9.1 Wash Cycle ................................................................................................................................................................14

9.2 Bleach Cycle ..............................................................................................................................................................15

9.3 Scrub Cycle ................................................................................................................................................................16

9.4 Cuvette Swabbing .....................................................................................................................................................17

9.5 Deionized Water Disinfectant ....................................................................................................................................17

9.6 Refilling the Water Supply ........................................................................................................................................18

9.7 Maintenance Summary .............................................................................................................................................18

10.0 IDLE DELAYS ............................................................................................................................................................18

10.1 Setting the Sleep Delay ...........................................................................................................................................19

11.0 UNIT SHUT DOWN....................................................................................................................................................19

11.1 Unit Shut Down Instructions ...................................................................................................................................19

12.0 SERVICES AND SUPPLIES ..........................................................................................................................................20

13.0 SAFETY DATA SHEETS ..............................................................................................................................................20

14.0 REFERENCES ............................................................................................................................................................21

15.0 Single Slide Automated Gram Stainer Warranty .....................................................................................................21

16.0 Maintenance Logs ...................................................................................................................................................22

Single Slide Automated Gram Stainer Training Checklist ................................................................................................23

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Single Slide Automated Gram Stainer User Manual

4

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AMS1800062
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Congratulations!

You have made an excellent choice for your Lab. Cardinal Health™ thanks you for the trust you have placed in our
products and services.

This operating manual has been designed to help you gain an understanding of the operation and application of our
Single Slide Automated Gram Stainer. For optimal utilization of all functions, we recommend that you thoroughly study
this manual prior to beginning operation.

This manual has been prepared as an aid for all operations and maintenance, which can be carried out in your facility.

The Cardinal Health™ Quality Management System

This product is manufactured by Hardy Diagnostics for Cardinal Health in accordance with its quality management
system, which complies with the U.S. Food and Drug Administration’s (FDA’s) Quality Systems Regulation (QSR) and
current Good Manufacturing Practices (cGMP) contained in Title 21 Part 820 of the Code of Federal Regulations (CFR).
The company’s manufacturing establishments are registered, and its medical devices are listed with the FDA.
In addition, Hardy Diagnostics’ quality management system is certified to ISO 13485 for medical devices

Unpacking and Inspecting

Carefully unpack the Single Slide Automated Gram Stainer and accessories. Check for damage incurred during transit.
Keep all packing material until you are sure the unit operates properly. Any damage to the shipping box should be
reported to the responsible carrier. These instructions must be followed for us to guarantee our full support of your
claim for protecting against loss from concealed damage. The form required for filing such a claim will be provided by
the carrier.

Important: Keep this operating manual for future use.

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Single Slide Automated Gram Stainer User Manual

5

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AMS1800062
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SPECIFICATIONS

Dimensions/Weight Width 30.5 cm (12.0 in.)

Height 40.6 cm (16.0 in.)
Depth 33.0 cm (13.0 in.)
Weight 12.24 Kg (27.0 lbs.)

Power Requirements Input: 100-240 VAC, 8-4A, 47-63Hz

Temperature, Ambient Operation 15-30C

Humidity 0 to 95%, without condensation

Operator Adjustments Individual adjustable stain times on both short and long cycles

Adjustable sleep mode
Adjustable audible sound volume control

Operator Entry Moisture proof, touch screen

Standards IEC-61010-1:2010 (Third Edition)

EN55022; CISPR 22:2005/A1: 2005: Class A
CFR 47, Part 15, Subpart B, Class A, 2008
ICES-003 Issue 4, 2004 CAN/CSA-CEI/IEC CISPR 22;02, Class A
EN55024: 2010
EN 61326-1: 2006

Warranty One Year Standard

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Single Slide Automated Gram Stainer User Manual

6

Art specications:

IFU/Manual - 8"Wx10"H

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AMS1800062
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1.0 INTRODUCTION

This Operation Manual is provided to guide the user in all aspects of unit set-up, operational use, and user-level maintenance of the Cardinal Health™ Single Slide
Automated Gram Stainer unit.

The Single Slide Automated Gram Stainer is a microscope slide stainer capable of automatically performing a Gram stain sequence on a slide containing biological
specimen for in vitro diagnostic use. An on-board computer, running software specially designed to accomplish correct Gram stain results for any type of sample,
controls the entire staining process.

The Single Slide Automated Gram Stainer software provides a series of menus for operator control of the unit. By pressing a key corresponding to a menu item,
the operator directs program flow to the various logic paths of the software. All program functions are accessed in this manner.

Operator Responsibility – Safety Instructions

The Single Slide Automated Gram Stainer ensures safe operation when installed, operated, and maintained according to common safety regulations.
This section describes the potential dangers that may arise when operating the Single Slide Automated Gram Stainer.

It is the operator’s responsibility to be properly qualified to operate the Single Slide Automated Gram Stainer. The operator and personnel are also advised to
refer to this Operating Manual and the set-up letter that is packaged with the unit. If you require additional assistance, please call [phone] (ext. 2) to be
connected with Cardinal Health™ Technical Support serviced by QuickSlide™.

In addition, the operator is to be familiar with good laboratory practices and safety precautions.

Explanation of Symbols

I - Power On
O - Power Off

- Caution: Refer to marked paragraphs

- Not Made with Natural Rubber Latex

- In Vitro Diagnostic Medical Device

Background – Gram’s Staining Technique

The Gram staining method, named after Hans Christian Gram, the Danish bacteriologist who originally devised it in 1882, is one of the most important
staining techniques in microbiology. It is usually the first test performed for the presumptive identification of bacteria. The primary stain of the Gram’s method
consists of staining with crystal violet which is then fixed with iodine. The microorganisms that retain the crystal violet-iodine complex appear purple under
microscopic examination and are commonly classified as Gram positive. Others that are not stained by crystal violet, due to a decolorization, step are referred to
as Gram negative, and appear red as a result of counter-staining with safranin.

Gram staining is based on the ability of the bacteria cell wall to retain the crystal violet dye during treatment with acetone-alcohol. The cell wall for Gram positive
microorganisms have a higher peptidoglycan and lower lipid content than Gram negative bacteria. Bacteria cell walls are stained by the crystal violet. Iodine is then
added as a mordant to form the crystal violet-iodine complex so that the dye cannot be removed easily. Subsequent treatment with an acetone-alcohol decolorizer,
which is a solvent, dissolves the lipid layer from the Gram negative cells. The removal of the lipid layer enhances the leaching of the primary crystal violet stain
from the cells into the surrounding solvent. In contrast, the solvent dehydrates the thicker Gram positive cell walls, closing the pores as the cell wall shrinks during
dehydration. As a result, the diffusion of the violet-iodine complex is blocked, and the bacteria remain stained purple. The length of the decolorization step is
critical in differentiating the Gram positive bacteria from the Gram negative bacteria. A prolonged exposure to the decolorizing agent will remove all the stain
from both types of bacteria. Some Gram positive bacteria may lose the stain easily and, therefore, appear as a mixture of Gram positive and Gram negative bacteria
(Gram variable). Finally, a counter-stain of safranin is applied to the smear to give decolorized Gram negative bacteria a red or pink color.

The decolorization step is especially critical and must be timed correctly; the crystal violet stain is removed from both Gram positive and negative cells if the
decolorizing agent is left on too long. This can be particularly problematic for smears of varying thickness – thicker smears require longer exposure for proper
decolorization than thinner smears. This is the most sensitive and variable step of the procedure, and requires experience to know just how much to decolorize
manually. Many labs performing manual Gram stains have considerable quality control problems for this reason.

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Single Slide Automated Gram Stainer User Manual

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AMS1800062
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2.0 WORK AREA REQUIREMENTS

IMPORTANT!

The Single Slide Automated Gram Stainer unit requires a level counter top surface of a minimum of 12 inches wide by 13 inches deep with a height clearance of 16
inches. The Gram Stain Kit (Cat. No. CHB-AGS-SK) and a container filled with deionized water should be positioned at the same level as the instrument immediately
on the left side connected by the tubing coming out of the machine. Do not place reagents below the instrument.

The Single Slide Automated Gram Stainer has one tube that drains all of the waste fluids. The Single Slide Automated Gram Stainer unit drain line can be placed
down a drain or into another disposal container to accommodate the waste fluids according to your facility and local regulations.

The Single Slide Automated Gram Stainer consumes less than 400 watts of power and uses an external power supply module that is supplied with 47- 63 Hz,
100-240V, 8-4A line power. The unit requires power from a grounded outlet. The Single Slide Automated Gram Stainer overvoltage category is II, the transient
overvoltage is 1440 volts, and the pollution category is 2. The IP protection is IP20.

The Single Slide Automated Gram Stainer is installed with tubing sets to connect the instrument to the reagents. The reagent supply line is equipped with
a cannula (rigid tube) to immerse in the reagent supply container. Labels attached to those lines indicate which reagent is to be used with each line.
The line labeled as DI Water needs to be immersed in the water supply container to supply the machine with available water.

3.0 RECEIVING AND UNPACKING

Unpacking and set-up assistance for the Single Slide Automated Gram Stainer may be obtained by calling the Cardinal Health™ Technical Support Department
serviced by QuickSlide™ at [phone] (ext. 2) during the hours of 8a.m. – 5p.m, Pacific Time, Monday through Friday.

The external power supply is a Class I supply that must be connected to an earthed (grounded) main power outlet. Failure to connect the Single Slide Automated
Gram Stainer as specified will prevent the electrical safety protection features to function as designed.

The power supply is equipped with one attached power cord and one removable power cord. The attached power cord is equipped with a connector that
plugs into the Single Slide Automated Gram Stainer rear panel receptacle near the power switch. The removable power cord adapts the IEC style connector
on the power supply to the local standard AC outlet. The cord supplied by Cardinal Health™ is appropriate for the country of operation.

4.0 MATERIALS REQUIRED BUT NOT PROVIDED

Standard microbiological supplies, such as Gram’s Iodine, Stabilized Dropper Bottle (Cat. No. CHB-GS-DI), Microscope Slide Charged Adhesion Frosted 25mmX75mm
1mm (Cat. No. M6143), Cuvette Swabs (Cat. No. CHB-GS-CS), and Gram Stain QC Slides (Cat. No. CHB-GS-QC), Gram Stain Kit (Cat. No. CHB-AGS-SK),
System Cleaner (Cat. No. CHB-AGS-SC), and Replacement Tubing (Cat. No. CHB-AGS-RT)

5.0 GRAM STAIN KITS

5.1 General Information

The Single Slide Automated Gram Stainer accomplishes automatic Gram staining by a systematically staining, rinsing, decolorizing, and counter-staining the
provided biological specimen. It is critical for the success of this automated process that the unit utilizes the Gram Stain Kit (Cat. No. CHB-AGS-SK)
from Cardinal Health™.

NOTE: For quality control purposes, Gram Stain Kits are labeled with a Kit Number, Lot Number, and Expiration Date. These values are used to track and identify the
Gram Stain Kit used in the unit, and are entered into the system as part of the Gram Stain Kit Registration procedure as explained in section 8.1.

5.2 Ordering Information

The Single Slide Automated Gram Stainer software monitors consumption of the Gram Stain Kit. When starting each Stain Cycle, the system displays a count of
the remaining number of stain cycles available in the current kit. This remaining count should be carefully monitored so that fresh reagents may be ordered and
available when needed.

5.3 Gram Stain Kit Installation

The Single Slide Automated Gram Stainer reagents are supplied to the unit through tubes connected to the individual reagent containers. Each tube is clearly
labeled with a color coded tag, and the tube cannula must be inserted into the correct reagent container. Tubes are also provided for connection to a deionized
water container and to a waste fluid drain. Use care to ensure that these lines are properly connected before use of the Single Slide Automated Gram Stain unit.

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Single Slide Automated Gram Stainer User Manual

8

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AMS1800062
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6.0 OPERATION INSTRUCTIONS

6.1 Instrument Anatomy

The basic anatomy of the Single Slide Automated Gram Stainer consists of four parts as described below:

Display screen – the screen that prompts which buttons to select for procedure steps.
Key Pad – the twelve button key pad used to select process options on the instrument.
Cuvette – holds the slide during the staining process.
Front panel – covers the reagent supply pumps and waste drain pumps.

6.2 Specimen Slide Preparation

6.2.1 If the culture is to be taken from a Petri dish or a slant culture tube, first add a drop or a few loops full of water on the slide and aseptically transfer a

minute amount of a colony on the Petri dish. Transfer a drop of the suspended culture to be examined on a slide with an inoculation loop. Note that only a
very small amount of culture is needed; a visual detection of the culture on an inoculation loop already indicates that too much is taken. If staining a clinical
specimen, smear a very thin layer onto the slide, using a wooden stick. Do not use a cotton swab as the cotton fibers may appear as artifacts. The smear should
be thin enough to dry completely within a few seconds. The stains will not penetrate thickly applied specimens, making interpretation very difficult.

6.2.2 Spread the culture with an inoculation loop to an even thin film over a circle of 1.5 cm in diameter, approximately the size of a dime.
Position the smear at least 3/4” below the frosted area. Labels should not extend below the frosted area.

6.2.3 Fixing the specimen causes the cells to adhere to the glass slide to make possible the subsequent rinsing of the smear with water without a significant loss
of cells. This can be accomplished by methanol fixation. For best results, it is required that the methanol method be used, rather than heat, since it
is superior in preventing lysis, distortion, or damage to the cells in clinical material. Red and white cells will not be harmed, whereas heat will distort

or disrupt the cells. Passing the slide over a flame is also not recommended.

Methanol fixed slides have been shown to retain two to ten times as many cells than with heat fixation.(1) In addition, Gram positive bacteria are much less
likely to become over-decolorized when fixed with methanol rather than heat.(2)

Methanol Fixation Procedure: Air-dry the specimen. If a heat block must be used, do not set the temperature above 40°C, and do not leave the slides on the
block for over an hour. It is extremely important that the specimen does not get damaged by excessive heat. Once fully dried, fix by submerging the slide into a
Coplin jar filled with methanol. Please ensure that the methanol covers the whole smear. Drain off remaining methanol without rinsing by tapping the bottom
edge of the slide to paper towel and allow slide to air dry. Do not apply heat after the methanol dries.

NOTE: Because the slide preparation technique can vary from institution to institution and technique is not always controllable (i.e., differences in smear
thickness, fixation techniques, drying time, specimen adherence to different types and brands of slides, etc.) rare instances of carryover from slide to slide have
been reported. The chance of this can be minimized by carefully following the instructions in this manual.

NOTE: For best results with this instrument use glass slides that are positively charged such as Cardinal Health™ Microscope Slide Charged Adhesion Frosted
25mm x 75mm 1mm (Cat. No. M6143) to increase specimen adhesion to the glass slide. The adhesion of the specimen can be variable, depending on the
specimen type, volume and its thickness. Lack of adhesion is most notable in blood or bloody culture smears, so it is mandatory to use chemically treated slides
that produce a positive electrical charge in order to enhance the specimen’s attachment to the slide. Excessively thick smears can lead to a sloughing off of cells
from the slide. So it is important to prepare smears that are relatively thin with some transparency. Software and fluid flow design have been engineered to
minimize the occurrence, but rare occasions of carryover may still be possible depending on the differences in the user’s slide and slide preparation techniques.
It is recommended to reconfirm the presence of low numbers of bacteria in traditionally sterile specimens (such as spinal or joint fluid) with manual staining and
culture results.

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