Hologic Compass ASY-05576 User manual

Compass
™
Stainer
Operator’s Manual
For Use With Version 1.x.y Software US English AW-18006-001
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 USA
Tel: [phone]
1-508-263-2900
Fax: [phone]
Web: www.hologic.com

Caution: Federal law restricts this device to sale by or on the order of a physician, or any other
practitioner licensed by the law of the State in which the practitioner practices to use or order the use
of the device and are trained and experienced in the use of the Compass™ Stainer.
© Hologic, Inc., 2020. All rights reserved. No part of this publication may be reproduced,
transmitted, transcribed, stored in a retrieval system, 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 Hologic, 250 Campus Drive, Marlborough,
Massachusetts, 01752, United States of America.
Although this guide has been prepared with every precaution to ensure accuracy, Hologic assumes no
liability for any errors or omissions, nor for any damages resulting from the application or use of this
information.
This product may be covered by one or more U.S. patents identified at
http://hologic.com/patentinformation
Hologic and Compass are trademarks and/or registered trademarks of Hologic, Inc. or its
subsidiaries in the United States and/or other countries. All other trademarks are the property of
their respective owners.
Changes or modifications to this unit not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Document Number: AW-18006-001 Rev. 002
1-2020

Compass
™
Stainer Operator’s Manual page 1
TABLE OF CONTENTS
OVERVIEW OF THE COMPASS
™
STAINER. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Materials Provided . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
TECHNICAL SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Electrical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Power Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Fuse Rating. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
USB Flash Drive Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Operating Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Storage/Transportation Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Functional Capabilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Installation Category. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pollution Degree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety, EMI and EMC Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Compass Stainer System Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Symbols Used On the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Location of Labels on the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Important Safety and Operational Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposal of the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposal of Waste Electrical and Electronic Equipment (WEEE). . . . . . . . . . . . . 10
Your Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Symbol Used on the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Reclamation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Action Upon Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

page 2 Compass
™
Stainer Operator’s Manual
Preparation Prior to Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Moving the Compass Stainer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Storage and Handling Post Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Power on the Compass Stainer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Shutdown Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
System overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Description of Various Functional Areas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Fume Shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Transport Arm Mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
USB Data Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Operating Procedure Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Run a Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Start a Run - Single Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Pause or Stop a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Completion of a Run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Running Multiple Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Pause or Stop a Run of Multiple Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Completion of Multiple Racks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Create, Review and Edit Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Parameter Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Parameter Entry/Selection Scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Create a New Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Review and Edit a Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Insert a Step . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Delete a Step. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Utility Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Compass
™
Stainer Operator’s Manual page 3
Contrast. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Agitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Import . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Password Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Routine Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Cleaning Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Charcoal Filter Replacement (Once every 3 months, or as needed) . . . . . . . . . . 39
Changing the Fuses (as needed) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
SERVICE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Corporate Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Business Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Customer Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Protocol for Returned Goods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
ORDERING INFORMATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Mailing Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Remittance Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Business Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Customer Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Protocol for Returned Goods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
OPTIONAL ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
TROUBLESHOOTING GUIDE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
STAINING PROTOCOL, 95% Reagent Alcohol Fixed ThinPrep® Slides
for use with ThinPrep Imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Stain Protocol Worksheet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

page 4 Compass
™
Stainer Operator’s Manual
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Compass
™
Stainer Operator’s Manual page 5
OVERVIEW OF THE COMPASS™ STAINER
The Compass Stainer is an automated stainer designed for use in cytology/anatomical pathology
laboratories as a stand-alone, bench top unit for staining histologic and cytologic samples on slides.
The system must be operated only according to the instructions contained in this manual and only
for its intended use as defined above.
Any other use of the system is considered improper and
voids the warranty!
These instructions are for use in the United States. If you are in another country, follow the
instructions in the file called “English” with the part number AW-19788-001. The instructions for
using the Compass Stainer are the same regardless of the instrument color.
The Compass Stainer must be operated only by trained laboratory personnel. As with all laboratory
procedures, universal precautions should be followed.
The Compass Stainer offers flexibility and programmability for routine and special stains of samples
mounted on glass slides. This bench top unit contains 24 stations. Specific functions of some of these
stations are as follows.
The stations are organized in a circular fashion and are numbered in clockwise direction on the
platform. LOAD and UNLOAD Stations are located in the front of the unit. The station numbers for
the reagent stations (1 – 22) are clearly laser etched on the platform.
This manual covers information about initial set up, programming test protocols, and slide staining
operations only.
Materials Provided
The following items are included when the Compass Stainer is delivered for installation. (These
items may vary according to your order.)
Station Number/Name How Many Function
LOAD 1 Load Station
UNLOAD 1 Unload Station
1 - 22 22 Reagent Stations
Part Number Description Quantity
ASY-05576 Compass Stainer 1
OEM-01078 Reagent Containers with Lids 24
51873-001 Sakura 20-Slide Rack 4
OEM-01100 Adapter (Hanger) for Sakura or Leica Slide Rack 4
50077-013 Fuse (pack of 2 fuses) 1 spare set (1 set installed in the
unit)
5008∗-001 Line Cord (* country specific) 1
MAN-06370-001 Operator’s Manual, English Text and CD with translations 1
OEM-01081 Charcoal filter 2

page 6 Compass
™
Stainer Operator’s Manual
TECHNICAL SPECIFICATIONS
Electrical Characteristics
Power Input
Voltage: 100–230 VAC, 50/60 Hz
Power: 1.0 Amp max
Fuse Rating
1 Amp x 250 volts Slo-Blo (Time Delayed) fuse
Display
5 volts dc, max 0.5 amp, 8 lines x 20 characters per line presentation, LCD with white LED
back light.
Keyboard
Membrane keypad with 20 keys
USB Flash Drive Interface
USB 2.0 (low power) Flash Drive interface to exchange Programs
Physical Characteristics
Dimensions:
Width: 32" (81 cm) Additional required clearance 6” (15 cm)
Depth: 31" (79 cm) Additional required clearance 6” (15 cm)
Height: 16" (41 cm) Additional required clearance 12” (30 cm)
Weight:
Actual Weight: 55 lbs (25 kg) Max – without reagents in the container
Shipping Weight: 110 lbs (52 kg)
Operating Environmental Conditions
All Compass Stainer products are laboratory systems and should be used ONLY in laboratories with
the following conditions:
Indoor use Only
Ambient Temperature 15
o
C to 35
o
C (59
o
F to 95
o
F)
Relative Humidity 20-80% non-condensing
Ambient Pressure 29”-31” (740-790 mm) of Hg
Altitude Less than 6500 feet (Less than 2000 Meters)
OEM-01084 Fume Shield 1

Compass
™
Stainer Operator’s Manual page 7
Storage/Transportation Conditions
Temperature 10-40°C (50 to 102
o
F)
Humidity 15-80% non-condensing
Pressure 28”-32” (70-80 mm) of Hg
Functional Capabilities
Number of Stations 24
Dedicated Stations 2: one Load Station and one Unload Station
Reagent Stations 22
Reagent Volume 350 - 360 ml
Number of Programs Up to 15
Steps in a Program Up to 35
Step Duration 10 seconds up to 99 Minutes 59 Seconds per step
(programmable in 1 second increments)
Simultaneous Processing Up to 4 reagent racks at a time
Installation Category
In reference to Installation category as defined in UL 61010-1 standard, the Compass Stainer products
are categorized as Category II systems.
Pollution Degree
In reference to Pollution Degree as defined in UL 61010-1 standard, the Compass Stainer products are
categorized as Pollution Degree 2
SAFETY, EMI AND EMC STANDARDS
This system has been built and tested in accordance with the following safety regulations on
electrical measuring, control, regulating and laboratory devices: IEC 61010 – 1, 2nd Edition.

page 8 Compass
™
Stainer Operator’s Manual
Compass Stainer System Hazards
Symbols Used On the Instrument
Symbol Title Description Standard Information
Caution
To indicate that caution is nec-
essary when operating the
device or control close to where
the symbol is placed, or to indi-
cate that the current situation
needs operator awareness or
operator action in order to avoid
undesirable consequences
ISO 7000 Graphical symbols for
use on equipment, symbol
0434B
Caution, risk of electric
shock
To identify equipment that has
risk of electric shock
IEC 60417 Graphical symbols
for use on equipment, symbol
5042
Fuse To identify fuse boxes or their
location.
IEC 60417 Graphical symbols
for use on equipment, symbol
5016
Serial number
Indicates the manufacturer’s
serial number so that a specific
medical device can be identi-
fied.
ISO 15223-1 Medical devices—
Symbols to be used with medi-
cal device labeling and informa-
tion to be supplied, Section
5.1.7
In vitro diagnostic medi-
cal device
Indicates a medical device that
is intended to used as an in vitro
diagnostic medical device
ISO 15223-1 Medical devices—
Symbols to be used with medi-
cal device labeling and informa-
tion to be supplied, Section
5.5.1
Manufacturer
Indicates the medical device
manufacturer, as defined in the
EU Directives 90/385/EEC, 93/
42/EEC and 98/79/EC
ISO 15223-1 Medical devices—
Symbols to be used with medi-
cal device labeling and informa-
tion to be supplied, Section
5.1.1
Date of manufacture
Indicates the date when the
medical device was manufac-
tured
ISO 15223-1 Medical devices—
Symbols to be used with medi-
cal device labeling and informa-
tion to be supplied, Section
5.1.3