General Data Healthcare RTPH-360 User manual

®
A Division of General Data Healthcare
Histology Innovation for a NEW Generation
Operator’s Manual
Product Name
Here
RTP™/RTPH™-360
Rapid Tissue Processor
Catalog #s
RTP-360; RTPH-360
Pub No.: OM RTP360-1
May 2014
RTP-360

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General Data Healthcare, Inc.
Copyright©2009 General Data Company. All rights reserved
This document may not be copied in whole or in part or reproduced in any other media without the express
written permission of TBS-A Division of General Data Healthcare, or General Data Healthcare. Please note that
under copyright law, copying includes translation into another language.
General Data Healthcare TBS-A Division of General Data Healthcare
Corporate Headquarters 3014 Croasdaile Road
4354 Ferguson Drive Durham, NC 27705
Cincinnati, Ohio 45245 tel. [phone]
Tel. [phone] Fax. [phone]
Fax.[phone]
User Resources and Customer Support
Contact your TBS representative for customer support. For the latest information on TBS products and
services, please visit the TBS website at: www.trianglebiomedical.com.
Scope
This document contains basic information on the use and operation of the RTP™-360 Tissue processor, and
assumes you have received basic training on the instrument. Please contact your TBS representative for
information not provided in this manual.
Intended Use
This instrument has been designed to be solely used in a Histology laboratory, by trained technicians, for
processing specimen, provided that is used accordinglywith the instructions contained in this manual.
The RTP™-360 is a tissue processor designed for the following laboratoryapplications:
• fixation
• dehydration
• Paraffin wax infiltration of histological tissue samples. Anyother usage is expresslyprohibited.
Failure to follow to these instructions may result in accidents, damages to the instrument and accessory
equipment, personal injury.
Installation Procedure
The RTP™-360 Tissue Processor must be installed, and instrument performance is to be verified, at the
customer site by trained TBS representatives.
Disclaimers
This manual is not a substitute for the detailed operator training provided by TBS, or for other advanced
instruction. A TBS representative should be contacted immediately for assistance in the event of any
instrument malfunction.

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Operator Controls and Components
Back Panel

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General Data Healthcare, Inc.
Table of Contents
Copyright©2009 General Data Company. All rights reserved ................................................................................. 3
Operator Controls and Components .......................................................................................................................... 4
Declaration of Conformity............................................................................................................................................ 7
Instrument Compliance................................................................................................................................................ 8
Section 1 | Safety Instructions .................................................................................................................................... 9
Safety Devices................................................................................................................................................. 10
Protection against overheating.................................................................................................................... 10
Protection against over-pressures............................................................................................................... 10
Fuse replacement........................................................................................................................................ 10
Remote Alarm.............................................................................................................................................. 10
Runtime Test................................................................................................................................................ 10
SPC (Sample Processing Chamber) lid heating............................................................................................ 11
Section 2 | Performance and Specifications............................................................................................................ 12
Technical Specifications .................................................................................................................................. 12
Section 3 | Preparation/Installation........................................................................................................................... 14
Unpacking, transporting and handling............................................................................................................. 14
Unpacking........................................................................................................................................................ 14
Packaging and/or preparation for transport ..................................................................................................... 15
Transportation.................................................................................................................................................. 15
Installation and start-up.................................................................................................................................... 15
Initial stage set-up ....................................................................................................................................... 16
Before starting a process............................................................................................................................. 16
At the end of a process................................................................................................................................ 16
Section 4 | Operation.................................................................................................................................................. 17
Introduction to the RTP™-360 Tissue Processor.............................................................................................. 17
User interface and keyboard........................................................................................................................ 17
Monitor......................................................................................................................................................... 17
Screen Saver............................................................................................................................................... 17
Rear panel ................................................................................................................................................... 19
The RHE device........................................................................................................................................... 19
Reagents.......................................................................................................................................................... 20
Reagent tanks arrangement........................................................................................................................ 20
Compatible reagents.................................................................................................................................... 20
Disposable factory pre-filled bottles............................................................................................................. 20
RFD – Remote Fill and Drain system .......................................................................................................... 21
EWD/PWD - External or ProtectedWax Dumping..................................................................................... 23
Filling Paraffin Cylinders .............................................................................................................................. 24
Wax Cleaning Cycle (WCC) ........................................................................................................................ 24
Processing capacity..................................................................................................................................... 24
Level Sensors.............................................................................................................................................. 24
Half-Load function........................................................................................................................................ 25
SETUP............................................................................................................................................................. 27
PARAMS SETUP............................................................................................................................................. 27
RHE Set Point.............................................................................................................................................. 29
RMS SETUP.................................................................................................................................................... 29
HOUR and DATE............................................................................................................................................. 29
PASSWORD SETUP....................................................................................................................................... 29
ReagentLabels ............................................................................................................................................ 30

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SERVICE......................................................................................................................................................... 30
EXT. SERVICE................................................................................................................................................ 30
START MENU ................................................................................................................................................. 31
Programming process protocols.................................................................................................................. 31
Reagent Names........................................................................................................................................... 31
Time............................................................................................................................................................. 31
Reagent Management System (RMS)............................................................................................................. 33
RMS basic concepts.................................................................................................................................... 33
The DAF (Decreasing Aging Factor)............................................................................................................ 34
RMS setup................................................................................................................................................... 35
RMS Define Reagents................................................................................................................................. 35
RMS Define Limits....................................................................................................................................... 35
RMS Counters Total Reset.......................................................................................................................... 36
RMS Single Counter Reset ......................................................................................................................... 36
RMS Enable/Disable.................................................................................................................................... 36
Purge Agents Setting................................................................................................................................... 36
Print RMS Status & Print RMS Setup.......................................................................................................... 37
Using the RMS............................................................................................................................................. 37
Checks and Procedures before operating................................................................................................... 38
Delay setting................................................................................................................................................ 39
Process END-TIME memory ....................................................................................................................... 39
Start from step different from the first.......................................................................................................... 40
Starting a process program ......................................................................................................................... 40
Interrupting/suspending the process............................................................................................................ 40
Opening the SPC lid during a process......................................................................................................... 40
Process completion ..................................................................................................................................... 41
Purging the SPC.......................................................................................................................................... 41
Purge Steps................................................................................................................................................. 41
Timing.......................................................................................................................................................... 42
Vacuum and Pressure................................................................................................................................. 42
Heating ........................................................................................................................................................ 42
Circulation/Agitation..................................................................................................................................... 42
RHE ............................................................................................................................................................. 42
Reagents warm-up by the RHE................................................................................................................... 45
Examples of fast protocols (with RHE......................................................................................................... 45
Fixation........................................................................................................................................................ 47
Graphs of the last 30 processes executed .................................................................................................. 47
Section 5 | Service...................................................................................................................................................... 48
Periodic Maintenance ...................................................................................................................................... 49
Section 6 | Troubleshooting ...................................................................................................................................... 50
Alerts and Alarms............................................................................................................................................. 50
Managing alarms......................................................................................................................................... 50
NON BLOCKING ALERTS:............................................................................................................................. 50
BLOCKING ALARMS:...................................................................................................................................... 50
Procedure for the instrument reset .............................................................................................................. 50
NON-BLOCKING ALERT CODE..................................................................................................................... 51
BLOCKING ALARM CODES........................................................................................................................... 56
Appendix 1 | Accessories.......................................................................................................................................... 59
Printers ........................................................................................................................................................ 59
UPS (Uninterruptible Power Source............................................................................................................ 59
Appendix 2 | Glossary of Abbreviations .................................................................................................................. 61

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General Data Healthcare, Inc.
Konformitätserklärung
Déclaration de conformité
Declaración de Confomidad
Verklaring de overeenstemming
Dichiarazione di conformità
We/Wir/ Nous/WIJ/Noi
TBS-A Division of General Data Healthcare
Declare under our sole responsibility that the product,
erklären, in alleniniger Verantwortung,daß dieses Produkt,
déclarons sous notre seule responsabilité que le produit,
declaramos, bajo nuestra sola responsabilidad, que el producto,
verklaren onder onze verantwoordelijkheid, dat het product,
dichiariamo sotto nostra unica responsabilità, che il prodotto,
RTP™/RTPH™-360 Tissue Processor
to which this declaration relates is in conformity with the following standard(s) or other normative documents.
auf das sich diese Erklärung bezieht, mit der/den folgenden Norm(en) oder Richtlinie(n) übereinstimmt.
auquel se réfère cette déclaration est conforme à la (aux) norme(s) ou au(x) document(s) normatif(s).
al que se refiere esta declaración es conforme a la(s) norma(s) u otro(s) documento(s) normativo(s).
waarnaar deze verklaring verwijst, aan de volende norm(en) of richtlijn(en) beantwoordt.
a cui si riferisce questa dichiarazione è conforme alla/e seguente/i norma/o documento/i normativo/i
Declaration of Conformity

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Instrument Compliance
TBS-A division of General Data Healthcare, hereby declares the equipment specified conforms to the
Classification(s), Directive(s) and Standard(s) set forth in this document.
Certifications:
CE, TUV CSA UL
EMC Immunity
IEC 61010-1:2001 (Second Edition) / EN 61010-1: 2001
CAN/CSA C22.2 No. 61010-1 +GI1 (2nd Edition, R2009);
UL 61010-1 (2nd Edition, R10.08)
IEC 61010-2-010: 2003 (2nd Ed) for use with IEC 61010-1: 2001
EN 61010-2-010: 2003, CAN/CSA 22.2 No.61010-2-010-4 (R9)
IEC 61010-2-101: 2002 (ed.1) for use with IEC 61010-1: 2001 (ed.2)
EN 61010-2-101: 2002 (ed.1) for use with IEC 61010-1: 2001 (ed.2)
CSA C22.2 61010.2.101-04-2004

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General Data Healthcare, Inc.
Section 1 | Safety Instructions
Severe damage can result if the instrument is connected to a power supply different from the
rating stated in the identification tag placed on the rear of the instrument.
The instrument must NEVER be used without being connected to an appropriate and fully
efficient ground connection.
If damages due to transport occur, DO NOT use and DO NOT connect the instrument to a
power source. Contact our technical service.
This instrument has been designed to work 24/7; for this reason and for operative precautions,
the power switch is placed on the rear of the instrument.
Access to the instrument’s internal components is reserved only to specialists trained in the
service of the instrument.
Always disconnect the processor from the electrical main source before accessing the
electronics and internal parts.
BEFORE replacing fuses, disconnect the instrument from the power source.
Always make certain to correctlyengage the reagent bottles.
DO NOT open the processing chamber lid when the instrument is working without following the
instructions contained in this manual
Use specific precautions in handling flammable reagents such as ethanol (wear protective
gloves and eyeglasses).
Use specific precautions in handling liquid paraffin’s as they can cause burns
The emptying and filling of reagent bottles must only be done only by qualified technicians
Due to the presence of flammable substances inside reagents bottles, it is recommendedto:
Avoid smoking near the instrument
Avoid using open flames near the instrument.
DO NOT wear clothes that can create electrostatic charges while handling reagents.
Contaminated reagent waste must be disposed of in accordance with all applicable local
laws, ordinances and safety standards.
Use only original spare parts supplied by the manufacturer or by authorized dealers
DO NOT extract bottles, replace reagents or do other maintenance operations when the
instrument is operating.
To complete the knowledge on the instrument safety please read also the chapter SAFETY
DEVICES near the end pages of this manual.

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Safety Devices
Protection against overheating
The thermostat controls include a thermal overtemp switch to prevent overheating of WWC and SPC.
These devices do not prevent alarms, but prevent overheating when primary control devices fail. DO NOT use
the instrument when an alarm indicates an abnormal temperature status.
In the event of an overheating, it is advisable to switch off the instrument and disconnect the power cord.
Protection against over-pressures
In the RTP™-360 and RTPH™-360, there is no danger of excessive pressures. The pressure levels
developed in the SPC are small and do not present any hazard. Sometimes a slight pressure can be
present in the SPC at the end of a process. The lid must be opened with care to avoid the possibility of
eye injury by reagent vapors and splashing. Always wear safety glasses when handling reagents.
Fuse replacement
Fuse replacement should be done only by qualified personnel. Please note: Always disconnect
the instrument from the main power line! Never use fuses of a different rating and never try to repair damaged
fuses.
The RTP™-360 and RTPH™-360, is equipped with two line voltage fuses.
Fuses are placed into fuse holders located on the rear panel. Rating:
100V = 20A / 110V = 16A / 125V = 13A / 225V = 8A / 240V = 8A / (6.3x32mm) (T)
After the instrument is powered, if a fuse blows again, do not try to substitute it another time! A possible main
electrical failure is undergoing in the instrument.
Call our service department for technical assistance.
Remote Alarm
The socket of the Remote Alarm connector has 3 contacts with the following disposition:
- No alarm = contacts 1-2 closed, contacts 1-3 open.
- Alarm active = contacts 1-2 open, contacts 1-3 closed.
For the location of the Remote Alarm connector please refer to the paragraph “The Rear Panel” at the
beginning of the manual. There are no electrical signals on the remote alarm contacts. They are isolated from
the rest of the instrument and can be used to activate an external device such as an Auto-Dialer to call a pre-
selected phone number and relay the message that an alarm occurred.
Rating of the remote alarm connector and its associated electronics:
- Maximum voltage: 48V ac/dc.
- Maximum current: 1A
Runtime Test
Before starting a function (process or purge), the instrument executes a series of tests to verify the
conditions are correct foroperating.
If the test fails, the requested action is aborted and an alarm is issued. The tests include:
•Temperatures of all the heated components, those temperatures must be compatible with their
correct operational ranges.
•SPC lid:, Monitors the position of the SPC lid, if the lid is open, an alarm is issued.
•Pressure Transducer: Monitors pressure in the SPC
•VR Position: VR position Sensor Monitors the position of the Rotary Valve.
•The content of the starting process program, if the program is incomplete or part of
the data is lost or inconsistent the process cannot be started
•Various memory variables to make sure that a process is not started with the SPC empty or
dirty.
•Active alarms: no active alarm can be present at the starting of a process or purge.
•The UPS: if a UPS is installed and active, and there is a power failure, even if the
instrument is working, no process can be started because the UPS autonomy is limited to
30 or 60 minutes depending on the charge status of the batteries.