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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Chapter 1. Installation Overview
STERRAD®100S Installation Guide 11
System Configuration
STERRAD®100S Sterilization systems are generic until the
configuration kit is installed. Configuration kits contain language
specific software, membrane panel, a power label, and a language-
specific user’s guide. It also contains voltage specific parts; thermal
overload relay and one of the Configuration PWAs
STERRAD100S Sterilizer Configuration Kit – USA
Domestic product configurations require that you order sterilizer part
number 10101 and the following configuration kit.
Country Language Voltage Configuration Kit
USA English 208V 05-09786-X-001
STERRAD100S Sterilizer Configuration Kit - International
International product configurations require that you order sterilizer part
number 00-10101-X-001 and the specific configuration kit from the
following table:
Country Language Voltage Configuration Kit
Argentina Spanish 380V 05-06421-X-003
Australia English 415V 05-06420-X-005
Austria German 380V 05-06424-X-003
Benelux English 380V 05-06428-X-003
Benelux French 380V 05-06423-X-003
Benelux German 380V 05-06424-X-003
Brazil English 208V 05-06427-X-002
Canada English 208V 05-06420-X-002
Canada French 208V 05-06423-X-002
Chile Spanish 380V 05-06421-X-003
Colombia Spanish 208V 05-06421-X-002
Czech Republic English 380V 05-06420-X-003
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide
12
Country Language Voltage Configuration Kit
Ecuador Spanish 208V 05-06421-X-002
Finland Finnish 380V 05-06426-X-003
France French 380V 05-06423-X-003
Germany German 380V 05-06424-X-003
Greece Greek 380V 05-51269-X-003
Hong Kong English 380V 05-06420-X-003
Hungary English 398V 05-06430-X-004
Indonesia English 415V 05-06420-X-005
Ireland English 380V 05-06420-X-003
Italy Italian 380V 05-06422-X-003
Japan English 200V 05-06429-X-001
Korea English 380V 05-06420-X-003
Malaysia English 415V 05-06420-X-005
Mexico Spanish 208V 05-06421-X-002
Middle East English 208V 05-06420-X-002
Middle East English 415V 05-06420-X-005
Panama Spanish 208V 05-06421-X-002
Peru Spanish 208V 05-06421-X-002
Philippines English 208V 05-06420-X-002
Poland English 380V 05-06420-X-003
Portugal English 380V 05-06427-X-003
Puerto Rico English 208V 05-06420-X-002
Puerto Rico Spanish 208V 05-06421-X-002
Singapore English 415V 05-06420-X-005
South Africa English 380V 05-06420-X-003
Spain Spanish 380V 05-06421-X-003
Sweden Swedish 380V 05-06425-X-003
Switzerland French 380V 05-06423-X-003
Switzerland German 380V 05-06424-X-003
Switzerland Italian 380V 05-06422-X-003
Taiwan English 208V 05-06420-X-002
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Chapter 1. Installation Overview
STERRAD®100S Installation Guide 13
Country Language Voltage Configuration Kit
Thailand English 380V 05-06420-X-003
United Kingdom English 415V 05-06420-X-005
Uruguay Spanish 380V 05-06421-X-003
Venezuela Spanish 208V 05-06421-X-002
Generic (200V) English 200V 05-06420-X-001
Generic (208V) English 208V 05-06420-X-002
Generic (380V) English 380V 05-06420-X-003
Generic (398V) English 398V 05-06420-X-004
Generic (415V) English 415V 05-06420-X-005
Tools and Test Equipment
The following items may be needed to perform the service procedures
for the STERRAD 100 Sterilizer. Included are parts needed for chamber
heater and feedthrough replacement.
Manufacturer Model or ASP Part
Number
Where Used
Metric Tool kit Local Supplier All maintenance
Digital multimeter (DMM)
accurate to 3 decimal places
Fluke 87 or equivalent Certification and calibration
Temp. Probe -50°C to +150°C Fluke 80T-150U Certification and calibration
Service Access Key 04-09071-0-001 Repairs, certification and
calibration
LFPS Power Tester 35-50384-0-001 Certification
Adjustment Tool Baratron 35-02211-001 Certification and calibration
Vaporizer spanner wrench 35-03000-001 Repairs
Omega Thermometer with J-
type thermocouple cable
Omega HH-81 or
equivalent.
Certification and calibration
Cassette Alignment Tool 35-50494-1-001 Injector pump calibration.
Baratron Zero Shift Test Kit
(Vacuum Gauge Kit)
35-04264-001 Capacitance manometer testing
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STERRAD®100S Installation Guide 15
Chapter 2.
For Your Safety
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Chapter 2. For Your Safety
STERRAD®100S Installation Guide
16
Overview
Your safety is of primary concern to ASP. This section provides
information on safely using the sterilizer. You must read, understand,
and use the information in this section before operating the unit. Also,
always pay attention to the warnings, cautions, and notes throughout this
guide. This information is for your safety and to ensure that you receive
the most benefit from the safe installation, operation, and maintenance of
the STERRAD 100S Sterilization System. Only trained, experienced
technicians, who are fully acquainted with the unit, should install, repair,
or adjust the STERRAD System.
Personal Safety and First Aid
• Installation procedure should be performed with the SYSTEM
TURNED OFF AND THE POWER CORD DISCONNECTED until
you are ready to verify system function.
• IT IS REQUIREMENT OF ASP TECHNICAL SERVICES, INC.
THAT ALL ASP FIELD SERVICE ENGINEERS WEAR SAFETY
GOGGLES WHEN SERVICING ASP PRODUCTS.
• For canceled cycles WEAR LATEX OR VINYL GLOVES WHILE
REMOVING ITEMS FROM THE STERILIZER.
CONCENTRATED HYDROGEN PEROXIDE IS CORROSIVE TO
SKIN, EYES, NOSE, THROAT, LUNGS, AND
GASTROINTESTINAL TRACT. If a cycle cancels and the items in
the load have any visible moisture or liquid, hydrogen peroxide may
be present.
• Direct hydrogen peroxide contact with the skin can cause severe
irritation. If skin contact occurs, immediately flush with large
amounts of water. If symptoms are severe or persist, consult a
physician immediately.
• Direct hydrogen peroxide contact with eyes can cause irreversible
tissue damage. If eye contact occurs, immediately flush with large
amounts of water and immediately consult a physician.
• Inhalation of mist can cause severe irritation of lungs, throat, and
nose. If inhalation occurs, move to fresh air and consult a physician
immediately.
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Chapter 2. For Your Safety
STERRAD®100S Installation Guide 17
• Ingestion can produce injury that may be life threatening. If
swallowed, drink plenty of water immediately to dilute. Do not
induce vomiting. Consult a physician.
• If hydrogen peroxide comes into contact with organic material (such
as greasy surfaces) it can be a fire hazard.
Safe Maintenance
• Repairs and adjustments should only be attempted by experienced
technicians who are fully trained to maintain and repair the
STERRAD 100S Sterilizers.
• Use of unauthorized parts for maintenance or repair could cause
personal injury, result in costly damage or unit malfunction, and void
the warranty.
• Do not clean the chamber door area with abrasives. The sterilization
chamber uses an O-ring vacuum seal to maintain a vacuum in the
chamber. Never use rough cleaning tools, such as a wire brush or
steel wool, on the door housing or chamber assembly. This could
damage the seal.
• Do not change the power source without checking the electrical
phase rotation. Prior to relocating the sterilizer to a new power
source, electrical phase rotation should be checked. Failure to verify
and match phase rotation may cause damage to the sterilizer.
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Chapter 2. For Your Safety
STERRAD®100S Installation Guide
18
Cassette Handling
• STERRAD CASSETTES CONTAIN CONCENTRATED
HYDROGEN PEROXIDE, A STRONG OXIDIZER.
CONCENTRATED HYDROGEN PEROXIDE IS CORROSIVE TO
SKIN, EYES, NOSE, THROAT, LUNGS, AND
GASTROINTESTINAL TRACT. Direct contact with the skin can
cause severe irritation. If skin contact occurs, immediately flush with
large amounts of water. If symptoms are severe or persist, consult a
physician immediately. Direct contact with eyes can cause
irreversible tissue damage. If eye contact occurs, immediately flush
with large amounts of water and immediately consult a physician.
Inhalation of mist can cause severe irritation of lungs, throat, and
nose. If inhalation occurs, move to fresh air and consult a physician
immediately. Ingestion can produce corrosion that may be life
threatening. If swallowed, drink plenty of water immediately to
dilute. Do not induce vomiting. Consult a physician.
• Do not remove the plastic wrapper from the cassette package if the
indicator strip is red. Red indicates that the cassette might have been
damaged.
• Do not remove used cassettes from the protective cardboard sleeve.
Dispose of the cassette inside the protective sleeve in normal waste
or follow the facility’s procedures. Empty or expired cassettes must
be replaced prior to starting the cycle.
• If it is necessary to handle a used cassette that is not in the cardboard
sleeve, wear latex or vinyl gloves. Do not touch your gloved hands to
your face or eyes.
• FOR ROUTINE HANDLING, MINIMUM PPE REQUIREMENTS
INCLUDE APPROVED; (e.g., ANSI Z87.1), CHEMICAL SPLASH
GOGGLES, NITRILE OR LATEX GLOVES, AND A CHEMICAL
RESISTANT; (e.g., polyolefin fiber), LAB COAT. WHERE THERE
IS A RISK OF PRODUCT CONTACT WITH SHOES, CHEMICAL
RESISTANT SHOE COVERINGS ARE RECOMMENDED.
WHERE THERE IS RISK OF PRODUCT SPLASHING INTO
EYES, AN INDEPENDENT FACE SHIELD MUST BE WORN IN
ADDITION TO CHEMICAL SPLASH GOGGLES as authorized in
29 CFR 1910.133, applicable U.S. State regulations, or the
appropriate standards of Canada and its Provinces or EC Member
States (per European Standard EN 166).
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Chapter 2. For Your Safety
STERRAD®100S Installation Guide 19
Device Safety
• The chapter on Preparing Items To Be Sterilized in the STERRAD
100S User's Guide contains information about materials and devices
that can be processed by the sterilizer. Make sure your customer is
familiar with that section prior to using the sterilizer.
• Metal objects must not come into contact with the chamber walls, the
door, or the electrode. Contact with the walls, door, or electrode
could damage the sterilizer or the instruments.
• Warn the customer that they must not change the power source
without checking the electrical phase rotation. Also, prior to
relocating the sterilizer to a new power source, electrical phase
rotation should be checked. Failure to verify and match phase
rotation may cause damage to the sterilizer.
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