SMILE
Johns Hopkins University
Baltimore, MD USA
Rotator/Shaker Maintenance and Calibration- Guidelines
Digene Hybrid Capture System Rotary Shaker
Maintenance and Calibration
Guideline Number
Equ10-14-G
Effective Date
23 July 2010
Page
1 of 1
Rotator/Shaker Maintenance and CalibrationGuidelines
Supersedes
New
Review by
Review date
9-Feb-12
Subject
Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact your SMILE representative.
Audit:
Questions pertaining to Rotator/Shaker maintenance and calibration can be found in section
Equipment.
CAP Accreditation Checklist:
Questions pertaining to Rotator/Shaker maintenance and calibration can be found in the
Immunology CAP Accreditation Checklist.
Background Information:
The Hybrid Capture System Rotary Shaker I has been designed for shaking microplates, tube,
and microtube racks and other sample container. The shaker can be used in environment from
4°C to 65°C, which allows for cold room use as well as incubated applications.
The Hybrid Capture System Rotary Shaker I is compromised of the rotary shaker base and the
shaker platform. The shaker platform will hold from one to four standard microplates (96-wells),
one tube rack or two microtube racks. The shaker platform has a spring bar allowing it to hold
either microplates or tube racks. It also has a non-skid rubber surface to provide stability to
sample contains while shaking. Four flat head screws are used to attach the platform to the
shaker base and it can hold up to 2 kg of weights.
The speed of the shaker is variable, from 200 to 1200 rpm and it operates in a circular motion
with an orbit of 3mm. the Hybrid Capture System Rotary Shaker I features a timer with an
operating time range from 30 seconds to 30 minutes or continuous shaking when placed on the
“hold” positions.
Resources
1. College of American Pathologists (CAP) 2006. Commission on Laboratory
Accreditation, Laboratory Accreditation Program; Laboratory General Checklist Revised
4/6/2006.
2. Good Clinical Laboratory Practice (GCLP) 2008.
3. Digene Hybrid Capture System Rotary Shaker I Operator’s Manual. Digene Corporation
1999.
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SMILE
Johns Hopkins University
Baltimore, MD USA
Rotator/Shaker Maintenance and Calibration - Policy
Rotator/Shaker Maintenance and Calibration
Policy
Policy Number
Equ10-14-P
Effective Date
23 July 2010
Approval Signature: Laboratory Director
Review Cycle
1 year
Supercedes
New
Policy
The laboratory has processes and procedures to effectively ensure that
general maintenance and calibration performed on Hybrid Capture System
Rotary Shaker I instrument meets the correct standards for laboratory
testing.
Purpose
This policy provides direction for the processes and procedures to
effectively ensure that the maintenance and calibration performed on Hybrid
Capture System Rotary Shaker I instrument meets the correct standards.
Responsibility
The Laboratory Medical Director is responsible for (to be determined by
Laboratory).
The Laboratory Manager is responsible for (to be determined by
Laboratory).
The Lead Technologists are responsible for (to be determined by
Laboratory).
Additional Information
as required
NA
Supporting
Documents
The following processes support this policy:
81910032

Digene DML 2000 instrument plate reader

Digene DML 2000 instrument plate washer

Maintenance and calibration logs

Safety SOP
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SMILE
Johns Hopkins University
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Rotator/Shaker Maintenance and Calibration - Process
Rotator/Shaker Maintenance and calibration
process
Policy Number
Equ10-14-Pro
Effective Date
23 July 2010
Approval Signature e: Laboratory Director
Review Cycle
1 year
Supercedes
New
Process for Rotator/Shaker Maintenance and Calibration
Who’s Responsible
What Happens
Instructions
General maintenance and
calibration of shaker
instrument are determined

To be determined by the
Laboratory
Technical SOPs that require
the use of shaker
General maintenance and
calibration is performed on
shaker instrument

QA Technologist

Technicians/Technologists
Digene Hybrid Capture
System Rotary Shaker I
maintenance and calibration
SOP
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SMILE
Johns Hopkins University
Baltimore, MD USA
Rotator/Shaker Maintenance and Calibration - SOP
Mandana Godard
Author(s), Name &
Title
Document
Number
Penny Stevens
International QA/QC Coordinators
Equ10-14-SOP
Effective
Date
23 July 2010
SMILE Comments: This document is provided as an example only. It must be revised to accurately
reflect your lab’s specific processes and/or specific protocol requirements.
Name, Title
Signature
Date
Name, Title
Signature
Date
Approved
By
SOP
Annual
Review
Version # [0.0]
Revision Date
[dd/mm/yy]
Description (notes)
Revision
History
Name (or location)
# of copies
Name (or location)
# of copies
Distributed
Copies to
Associated Forms:
81910032
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SMILE
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I acknowledge that I have read, understand and agree to follow this SOP.
Name (print)
81910032
Signature
Version#: 1.0
Date
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SMILE
Johns Hopkins University
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Purpose
The purpose of this SOP is to describe and ensure the accurate operation, maintenance and
calibration of shaker used for variety of laboratory testing. Manufacturers’ recommended
instructions are followed for cleaning and disinfecting procedures.
Pre-analytic Procedure
Refer to the following procedures:



Safety SOP
Timer Calibration
Speed (RPM) calibration
The exceptions to these procedures are listed below:

NA
Definitions:
CAP- College of American Pathologists
RPM- Revolutions Per Minute
SOP- Standard Operating procedure
Analytic Procedure

All Shaker instruments must be inventoried and uniquely identified. This documentation
should at least include: manufacturer, model, serial number, date placed in service,
location and current service contact, if any.

Equipment and instruments must have written records of service and maintenance for
the life of the instrument.
Specimen Information:

NA
Reagents/Media:

NA
Supplies:

Tools

Lubricating grease

Reflective tape

Tachometer
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SMILE
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Calibration intervals:
It is recommended by the manufacture that the speed (RPM) of the hybrid Capture System
Rotary Shaker I be verified every three months.
For CAP Accredited labs note that the CAP guidelines state the following:
Most serologic centrifuges and timers do not require frequent recalibration. Accuracy of speed
and timing must be checked initially, after adjustments/repairs or implementation of new
techniques, and periodically thereafter. The frequency of periodic checks should be based on
the historical stability of the centrifuge, but at least every 6 months.
Equipment Maintenance:
Daily maintenance
Step
Action
1
Clean the shaker with a soft, dry cloth following each use. Any Spills should be
cleaned immediately, as stated below. The unit should not be immersed in water
or liquid poured over the unit as electrical shock may occur.
If
Then
A spill has occurred.
In order to clean the platform it has to be first
detached from the Shaker Base using following
steps:
1. Remove the center circular cutout in the
rubber mat platform, which covers the mounting
screws and remove the four flat head screws.
2. Lift Shaker platform up off the base mount.
2

Clean the platform with a cloth damped in
a dilute detergent solution.

Make sure the platform is completely dry
before reinstalling on the shaker base.
Prior to use, check that the Shaker is level and on a firm surface.
Quarterly Maintenance
Step
1
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Action
The four plastic bushings supporting the platform should be lubricated with a
small drop of the supplied lubricating grease every three months.
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Shaker Speed (RPM) Calibration
Step
Action
1
Calibrate speed using standard tachometer (Follow the steps bellow a-i).
If
Then
Measured speed is
within the designated
speed +/- 100 RPM.
No adjustment is necessary.
If the measured speed is
outside of these limit.
a. Adjust the shaker speed control
knob/dial to desired speed (e.g. 1000
RPM).
b. Turn the power to the “ON” position
and set the timer to the hold position.
c. Apply a 1/16-inch strip of reflective
tape to the platform.
d. Turn on the shaker by depressing the
Start/Stop switch and allow to reach
full speed (-5 sec.).
e. Set the tachometer for RPM. Start and
aim the tachometer beam at the center
of the tape strip. (The tachometer must
be securely held in place).
f.
Focus the light by raising or lowering
the tachometer until the beam comes
into focus.
g. Hold the tachometer steady for at least
ten seconds. Ensure that the light
beam on the tape crosses the beam
once every revolution.
h. Record RPM and turn off the shaker by
depressing the Start/Stop switch.
i.
After following steps a-h
the measured speed is
not within the limits.
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Measured speed is within +/- 100 RPM
from the shaker speed control setting,
speed calibration is verified and no
further action required.
Remove the speed knob cover by prying off
the knob center cap piece with a small
screwdriver. Loosen the revealed screw and
position the knob to agree with the measured
speed. Tighten the screw in this position.
Repeat the above steps f-h to confirm that the
adjustment made correct. Replace the speed
knob center cap piece.
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After following all steps
above the measured
speed is not within the
limits.
2
Take the shaker out of service and contact the
manufacture for service.
Record all of the results in the log (Appendix C).
Quality Control: NA
Test Method Instructions:
A. Follow the steps in the table below to operate the instrument.
Step
Action
1
Always make certain that the platform and any hardware are secure before
operating the shaker.
2
Turn the power switch to the “ON” position the power indicator will light at this
time.
3
Adjust the speed to the desired level using the shaker speed control.
4
Set the desired time interval or turn the knob to the “Hold” position for
continuous operation. An audible click is heard when enabling/disabling the
“Hold” function.
5
Load microplates(s) onto platform by pulling back on platform tension bar,
inserting plate flatly, and slowly releasing tension bar to secure plate (tension
bar should be even and tight).
6
Load the shaker symmetrically. If only shaking one microplate, place the
microplate in the center of the shaker.
7
To begin shaking, press the Start/Stop button.
8
If
Then
Microplates, micro tube
or tube rack is not being
held securely.
Set the tension of the bar by adjusting the two
screws at each end of the bar.
Difficulty pulling the roter
bar when loading the
microplates, micro tube
or tube rack.
Set the tension on the bar by adjusting the two
screws at each end of the bar.
Entire unit is vibrating
because of certain load
and speed ratios
The speed and/or load should be increased or
decreased as necessary to eliminate such
vibration.
Unit vibrates excessively
because;
a. Unit is placed on
81910032
a. Relocate the unit to a flat even surface.
b. Secure each suction feet on the
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an uneven
surface.
b. Suction feet are
loose.
c. Shaker platform
is loose.
d. The four plastic
bushings are dry.
Power switch not lit
when power is placed in
the “ON” position.
Because;
a. Power cord is not
plugged in
properly.
tabletop.
c. Securely attach the platform to the
base mount by tightening the four
screws under the platform center
circular cutout.
d. Check that the four plastic bushings
feet supporting the platform are
lubricated.
a. Check that the power cord is plugged
in properly.
b. Check that the power cord is plugged
into a known working power surface.
c. Check the fuse and replace by the
following steps:
b. Power source is
not functioning.
c. Blown out fuse.

Remove power cord from power
source.

Pry open the fuse drawer at the
rear of the shaker base unit.

Replace only with the same fuse.
SMILE recommends that you also include instructions for turning the shaker on and off as
established by your lab.
References:
1. Clinical Laboratory Standards Institute (CLSI). Clinical Laboratory Technical Procedure
Manuals; Fourth Edition. CLSI Document GP2-A4 (ISBN 1-56238-458-9). Clinical and
Laboratory Standards Institute, Wayne, PA.
2. Digene Hybrid Capture System Rotary Shaker I Operator’s Manual (1999).
Appendices: (Create as needed at your site.)
Appendix A: Rotary Shaker: Daily Maintenance Form
Appendix B: Rotary Shaker: Quarterly Maintenance Form
Appendix C: Rotary Shaker: Quarterly Speed (RPM) Calibration
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