Johnson & Johnson ASP STERRAD 100S Installation Manual Download Page 6 | Manualshive

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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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Summary of Contents for ASP STERRAD 100S

Page 1: ...STERRAD 100S Sterilizer Installation Guide ...

Page 2: ...ustomer 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 ...

Page 3: ...D 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...

Page 4: ...tem 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 ...

Page 5: ...STERRAD 100S Installation Guide 5 Chapter 1 Installation Overview ...

Page 6: ...ete 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 For...

Page 7: ...olume 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 28 x 17 700 x 426 mm 28 x 16 7 Block 2 Lower Shelf Dimension 760 x 425 mm 30 x 17 760 x 325 mm 30 x 12 8 Block 2 Shelving Strength 25 kgs 55 lbs uniformly distributed per shelf Shelving Materials Passivated stainless steel...

Page 8: ...ystem 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 o...

Page 9: ...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 mat...

Page 10: ...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 Meet...

Page 11: ...ntry 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...

Page 12: ...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 Span...

Page 13: ...eeded 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...

Page 14: ......

Page 15: ...STERRAD 100S Installation Guide 15 Chapter 2 For Your Safety ...

Page 16: ...dy 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 hav...

Page 17: ...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 assemb...

Page 18: ...t 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 necessa...

Page 19: ... 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 rota...

Page 20: ......

Page 21: ...STERRAD 100S Installation Guide 21 Chapter 3 Installation ...

Page 22: ...mic restraint is being installed the hospital must have identified the location of the restraints and have pre drilled the proper holes 1 Prior to your arrival verify the number of cartons and items shipped to the customer 2 Confirm that a proper location exists for correct installation the location should be the correct size for the unit with the needed amount of clearance in front and on the cas...

Page 23: ...Chapter 3 Installation STERRAD 100S Installation Guide 23 Figure 1 Installation Diagram ...

Page 24: ...rotation 4 Make sure that the route from the delivery area to the installation area is large enough to accommodate the system and is not blocked by other equipment 5 At the customer site verify that the system and all necessary operating supplies have arrived Uncrating the System The Accessory Installation Kit consists of two boxes One is on top of the unit the other is inside the cassette chute T...

Page 25: ...the nose ramp under the end of the main ramp Note The middle support and the E block support are angled to fit the angle of the ramp 7 Position the middle support under the center of the ramp and place the E block support at the top of the ramp near the crate 8 Remove the remaining clips the top and the other three sides Remove the foam protectors 9 Remove the box on top of the unit 10 Remove the ...

Page 26: ...present 16 Remove the four 4 mm hex bolts securing the door in the closed position 17 Remove the two 6 mm hex bolts securing the counterweight Note The screws are behind neoprene and fit through the chamber flange into the door 18 Manually open the door by pushing down on the top of the door The door should open with ease Remove the boxes from inside the system Note The boxes shipped with the syst...

Page 27: ...c restraint procedure and is required for units installed in California Customers in other states or countries or ships at sea may need to have seismic restraints installed The Seismic Restraint installation kit contains two brackets attachment hardware drilling template The kit should be ordered from Customer Service and the installation coordinated by ASP Technical Services ...

Page 28: ...r installation procedures Figure 3 Optional Mounting Plan Note There is a drilling template included in the kit It has the proper dimensions and drilling positions 1 Position the rear bracket on the floor about 2 inches away from the wall 1 1 16 inches minimum and mark the location of the holes for drilling If there is an outlet in the wall at the desired installation location add at least 3 inche...

Page 29: ...hor bolts shown in the table S standard steel SS stainless steel Concrete Type Min fc psi 3 8 Anchor Type ICBO Report Min Embedment inches Test Loads Hardrock 2000 Hilti Kwikbolt II S SS 4627 1 5 8 Direct Pull Tension 1100 lbs Torque 25 ft lbs Rawl Stud S SS 4514 1 5 8 ITW Ramset Trubolt S SS 1372 1 1 2 Wej It Anchor Bolt S 1821 1 1 2 Lightweight 3000 Hilti Kwik Bolt II S SS 4627 1 5 8 Direct Pull...

Page 30: ...wheel guides 7 Pull the sterilizer away from the rear locating pins Ensure that unit pulls out easily The level of the floor may affect the locating pins tightness into the channel 8 Attach the front bracket to the anchor bolts using the 3 8 wide flat washers and the nuts supplied with anchor bolts 9 Adjust the rubber tipped bumpers to stop the unit when the anchor pins line up with the front brac...

Page 31: ...tened more than finger tight Do not use tools to tighten Change the oil in the vacuum pump CAUTION REMOVE the exhaust port blanking flange prior to operating the pump Operating the vacuum pump with the exhaust port blanking flange installed can cause permanent internal damage to the pump 1 Locate the installation parts box attached to the frame member This box used to contain the throttle valve as...

Page 32: ... the control enclosure 7 Connect the tubing from the pneumatic solenoid T fitting to the On Off valve See Figure 5 Figure 5 Tubing Connection from Solenoid to On Off Valve 8 Remove the drain plugs and install the oil return fitting Use the existing drain plug washer with the new fitting 9 Attach the oil return line that connects the oil return solenoid and the exhaust filter 10 Verify that the vac...

Page 33: ...hes the system and returns the completion notification to ASP The instructions for this configuration are as follows Attach Machine Label 1 Remove side panels and rear panels 2 Locate the label that is in the correct language for the country receiving the unit 3 Remove the rear cover of the AC enclosure 4 Clean the lower left rear corner of the AC cover with 3M natural cleaner or equivalent and at...

Page 34: ...DISCONNECTED FROM THE SYSTEM 1 Attach the thermal overload relay to the AC interface enclosure 2 Switch the mounting pins so that the two movable pins are set to outboard widest location 3 Lift the clear plastic cover and set the overload to 3 6 amps for the low voltage units 200 VAC 208 VAC and 1 8 amps for high voltage units 308 VAC 398 VAC 415 VAC 4 Replace the clear plastic cover Note Terminat...

Page 35: ...he connectors into the PWA Power Plug 1 If not already installed install a plug to the power cord for the correct voltage for your country Connect as shown in the table below Wire Number Color and Number P80 Connect 1 Black 1 P80 X 2 Black 2 P80 Y 3 Black 3 P80 Z 4 Black 4 P80 W 5 Green Yellow P80 Ground Control Panel Bezel 1 Remove the plastic cover from the INSIDE of the clear plastic window DO ...

Page 36: ...ve the microprocessor PWA remove the EPROM and replace it with the appropriate language EPROM Note the check sum listed on the EPROM Place the removed EPROM in a static safe area CAUTION Pay particular attention to the orientation of the EPROM during insertion into its IC socket Additionally exercise care to ensure that the EPROM pins are not bent broken or otherwise damaged during insertion 4 Rem...

Page 37: ... Measure AC voltages for chamber and door heaters control enclosure LFPS vaporizer and compressor Refer to chart for version main line voltage and nominal voltages expected 10 for each circuit Main Line Voltage Version 200 VAC 208 VAC 380 VAC 398 VAC 415 VAC Feature Measure Input Voltage At 208V 60 380V 50 380V 50 380V 50 LFPS CB7 A B 200 220 220 220 220 Chamber Heaters CB6 A B 200 208 220 220 220...

Page 38: ...e 3 Check all circuit breakers located on the AC enclosure The circuit breakers are on the side of the unit and accessible with the panels in place Verify that all circuit breakers are ON Movement during shipping may cause the circuit breakers to trip Figure 8 Circuit Breakers 4 Check that all of the connectors throughout the entire machine are in place and correctly mated Some of the connectors m...

Page 39: ...the vacuum pump Preparing The System For Use 1 Open the accessories boxes shipped with the system Remove all materials 2 Install all the accessories in their proper locations Make sure to wipe off any fingerprints or packaging material that may be present 3 Set the cycle type according to the customer s needs Initialization The system must be initialized prior to use The Master Reset procedures mu...

Page 40: ...um Enter the Edit Mode 1 To enter the EDIT mode press CANCEL 2 Press and hold CANCEL and simultaneously press START This opens the Date Time menu DATE DAT MM DD YY OPEN chng CLOSE accept TOTAL MACHINE CYCLES 0 3 Press CANCEL to move sequentially through the available menus System Variables Reset 1 Enter the edit mode Simultaneously press and hold START and OPEN DOOR for 5 seconds After 5 seconds t...

Page 41: ...itches to the edit date time display Then simultaneously press START and CANCEL to return to the active display Cassette Collector Box Reset 1 Remove the cassette collector box from the box base assembly 2 Reinstall the collector box after the system has signaled reset by a single beep tone approximately 10 seconds Date and Time Reset 1 Enter the edit mode by pressing START and CANCEL at the same ...

Page 42: ...ired date and time settings have been obtained simultaneously press START and CANCEL to exit the month time program and continue to the PM Log Rest PM Log Reset 1 Press OPEN DOOR and START to enter the edit mode The system displays the total machine cycles Press CANCEL to display the PM warning Press CANCEL again to display PM 1500 L1 The display looks like the following example P M Y NEXT PM 1500...

Page 43: ...nstallation STERRAD 100S Installation Guide 43 Replace the Panels 1 Replace the system panels 2 Perform a complete system certification Perform BI Validation 1 Perform a complete BI validation and keep the records ...

Page 44: ... it is correctly packed and secured Certification Statement Instructions Complete the certification statement and fax it back after the configuration has been done The system serial number configuration kit number LC number and country of origin MUST be included on the form for proper certification 1 Enter the complete system serial number 2 Enter the configuration kit number 3 Fill in your name A...

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