Johnson & Johnson ASP STERRAD 100S User manual

STERRAD®100S Sterilizer
Installation Guide
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STERRAD®100S Installation Guide
2
STERRAD®100S Sterilizer
Installation Guide
1-888-STERRAD
1-888-783-7723
www.sterrad.com
ASP USA Customer Support (001.949.581.5799)
©2003 Advanced Sterilization Products. All rights reserved. Products mentioned in this
publication are trademarked by their respective corporations. Reproduction, adaptation, or
translation of this publication without prior written permission is prohibited. Printed in the USA.
08-51917-0-00X TS-51756-0-001
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STERRAD®100S Installation Guide 3
Contents
Chapter 1. Installation Overview..............................................................................5
Introduction........................................................................................................6
Installation Forms ......................................................................................................6
Physical Specifications ......................................................................................7
Environmental Conditions..................................................................................8
Electrical Requirements.....................................................................................9
Heater Impedance .............................................................................................9
Thermocouples..................................................................................................10
Standards ..........................................................................................................10
System Configuration ........................................................................................11
STERRAD100S Sterilizer Configuration Kit – USA.............................................11
STERRAD100S Sterilizer Configuration Kit - International .................................11
Tools and Test Equipment.................................................................................13
Chapter 2. For Your Safety.......................................................................................15
Overview............................................................................................................16
Personal Safety and First Aid ............................................................................ 16
Safe Maintenance..............................................................................................17
Cassette Handling .............................................................................................18
Device Safety.....................................................................................................19
Chapter 3. Installation...............................................................................................21
Pre-Installation...................................................................................................22
Uncrating the System ........................................................................................24
Installing the Seismic Restraints........................................................................27
Pre-Installation Procedure-To Be Done by the Customer .........................................28
Installing the Brackets ...............................................................................................30
Vacuum Subsystem Assembly ..........................................................................31
System Configurations.......................................................................................33
Attach Machine Label................................................................................................33
Thermal Overload Relay............................................................................................34
Power Plug.................................................................................................................35
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STERRAD®100S Installation Guide
4
Control Panel Bezel ...................................................................................................35
Software Installation ..........................................................................................36
System Reset ....................................................................................................37
Set System Parameters.....................................................................................37
Verify Voltages..........................................................................................................37
Install Printer Ribbon and Paper........................................................................38
Power Connection .............................................................................................38
Phase Rotation ..................................................................................................39
Preparing The System For Use .........................................................................39
Initialization...............................................................................................................39
Replace the Panels............................................................................................43
Perform BI Validation......................................................................................... 43
Final Procedures................................................................................................44
Certification Statement Instructions ..........................................................................44
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STERRAD®100S Installation Guide 5
Chapter 1.
Installation
Overview
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide
6
Introduction
This section describes how to uncrate, assemble, set up and initialize a
new STERRAD®100S Sterilization System. Following initialization, the
system performance must be verified using the product certification
procedures. This installation procedure is for the Block 2 systems as 1.8
systems are no longer available for new installation. If you have an
unusual circumstance where you are installing a system version that is
not a STERRAD 100S Block 2.0 System, please contact ASP Technical
Support for further information.
Installation Forms
A number of forms are required by ASP Customer Support to complete
the installation process. ASP Field Service Engineers can obtain these
forms from the ASP Knowledge Center or by contacting ASP Customer
Support. Full-sized installation drawings are available on request by
contacting ASP Customer Support. As of this publication, these are the
current forms; please be sure you have the latest revision of each form
prior to proceeding with your installation.
Name Form Number
Functional Test Record Sheet 1010X 15-01578-001 rev C
STERRAD 100S Sterilizer Check List 15-09743-001 rev B
Installation Validation Report LC-2023X-003 rev B
Installation Requirement (drawing) 09-00909-1-XXX rev F
IMPORTANT! The STERRAD®100S Sterilization
System must only be installed by
ASP-trained technicians. Installation
by any other group or persons without
the permission of ADVANCED
STERILIZATION PRODUCTS, a
Johnson & Johnson company, may
void the sterilizer warranty.
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide 7
Physical Specifications
System Dimensions
Dimensions 765 mm W x 1660 mm H x 1020 mm D
(30² W x 65.5² H x 40² D)
Appearance FED color specification #26408 Block 2 has a custom color
Weight Approximately 325 Kg (700 lbs)
Shipping Weight Approximately 350 Kg (750 lbs)
Chamber
Volume 173 liter (6.1 cubic feet)
Usable Volume 100 liter (3.5 cubic feet)
Inside Length 810 mm (32 inches)
Inside Diameter 510 mm (20 inches)
Shelving
Upper Shelf Dimension 700 x 425 mm (28² x 17²)700 x 426 mm ( 28² x 16.7²) Block 2
Lower Shelf Dimension 760 x 425 mm (30² x 17²)760 x 325 mm (30² x 12.8²) Block 2
Shelving Strength 25 kgs (55 lbs) uniformly distributed per shelf
Shelving Materials Passivated stainless steel and polyethylene
Top Shelf Adjustment Removable. Shelf slides out of chamber to one half of its length.
Bottom Shelf Adjustment Fixed
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide
8
Environmental Conditions
Transport and Storage
Ambient Temperature -40 to +70° C (50 to 104° F)
Relative Humidity 10 to 100% including condensation
Atmospheric Pressure 500 hPa to 1060 hPa
Operation
Ambient Temperature +10 to 40° C (50 to 104° F)
Altitude -100 to 3000 m above msl (-330 to 10,000 ft above msl)
Relative Humidity 0 to 95% RH, non-condensing
Atmospheric Pressure 700 hPa to 1060 hPa
Surface The floor at the installation is flat and level to + 5 mm/M.
Installation Space Requirements In operation, the system shall not be placed closer than 50
mm (2 in) to a wall at the rear and/or sides of the system.
The system should be installed in a space of sufficient size
to permit access to all four sides of the system when the
system is rolled away from the rear and/or side walls a
distance of 3 meters (10 ft), the extent of the power cord.
Service access should allow for a minimum clearance of
one meter (3 ft) on all sides of the system.
Mobility The sterilizer is designed to be free standing and self
contained with no required connections other than the
electrical power cord. The sterilizer is equipped with
wheels that allow it to be rolled easily from one location to
another. The unit is also equipped with adjustable feet at
the front of the unit if leveling is required.
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide 9
Electrical Requirements
Voltage Specification
IMPORTANT WARNING! Prior to relocating the sterilizer to a new power source,
electrical phase rotation should be checked by a qualified
technician. Failure to verify phase rotation may cause
damage to the system and void the warranty.
208V 60 Hz Power
200V and 208V (Block 2)
For versions employing 208V, 60 Hz power, the sterilizer
requires a NEMA L21-20 five wire grounding twist lock
outlet attached to a dedicated 20 Amp 3 phase 208 Volt
circuit with separate neutral and ground conductors.
380 - 415V 50 Hz Power
380V, 398V and 415V (Block 2)
The sterilizer requires a five wire grounding outlet attached
to a dedicated 10 AMP, 3 phase, 380V circuit with separate
neutral and ground conductors.
Phase Rotation The system requires CBA phase rotation. The phase
rotation is adjusted to match the system requirements at
installation.
Power Calculation Phase A 228 W-hours per cycle
Phase B 158 W-hours per cycle
Phase C 177 W-hours per cycle
Total 563 W-hours per cycle
Heat Generation 1919 Btu per cycle
Heater Impedance
Heater Location Impedance
Door 190 Ohms
Chamber 100 Ohms
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide
10
Thermocouples
Thermocouples Measurement Location
TC1 42°-50° C Top of chamber behind injector valve
TC2 42°-50° C Bottom of chamber near door
TC3 42°-50° C Middle of door
TC4 42°-50° C Edge of door
Standards
Agency Description
EPA/OSHA Maximum hydrogen peroxide ambient concentration: less than 1 PPM (8
hour weighted average). Tested average was 0.014 PPM.
NEC The system meets all applicable National Electrical Code (US) standards.
VDE VDE 871 certification. Report Number 91287V.
FCC The system meets all FCC Class A, IEC CISPR requirements.
CSA All electrical components are CSA approved. Block 2 meets CSA
requirement certificate number LR-103178-1
IEC IEC 601-1 Medical Equipment Safety Certification. File Number 112 MT
14880.
LA City of Los Angeles Electrical Testing Lab Approval. Application
Number 330300
TUV Meets TUV requirements.
NSTA The shipping container includes an integral pallet which meets US and
International standards. The package provides protection for the machine
to pass NSTA tests ASTM D-999 and FED-STD-101.
NRTL/C Block 2 meets UL standard 1262-Laboratory Equipment
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