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Technical Data

STERRAD

Sterilization System Routine Maintenance Guide

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.

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

Содержание STERRAD 100S

Страница 1: ...STERRAD 100S Sterilization System Routine Maintenance Guide ...

Страница 2: ...cts All rights reserved STERRAD is a registered trademark of Advanced Sterilization Products Other 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 50571 0 001 Rev D TS 53237 0 001 Rev A ...

Страница 3: ... Drain the Pressure Regulator Moisture Trap 15 Replace the Vacuum Pump Oil Filter 15 Replace the Catalytic Converter Exhaust Filter 16 Clean Air Filters Panel Assemblies 16 Vacuum Pump Flush 17 PM Main Menu 18 PM Level 2 21 Baratron Zero Shift Test 21 Replace the HEPA Filter 22 Door and Chamber Procedures 22 Clean Injector Pump Platen Surface 23 PM Main Menu 23 As Needed Maintenance 26 Changing th...

Страница 4: ...Chapter 4 Technical Data 41 Physical Specifications 41 Environmental Conditions 42 Electrical Requirements 43 Heater Impedance 43 Thermocouples 44 Standards 44 ...

Страница 5: ... the safety information presented in Chapter 2 and throughout this guide The safety information is provided for your benefit and for the benefit of your instruments and equipment Operation Information This section provides a brief description of the operation of the STERRAD 100S Sterilizer More detailed information is found in the STERRAD 100S Sterilization System User s Guide and in the STERRAD 1...

Страница 6: ... different in appearance Briefly the sterilizer operates as follows Ready to Use is displayed indicating that a sterilization cycle can be started Place the items to be sterilized in the chamber Insert a cassette if needed Press START The door automatically closes and the sterilization process begins When the process is complete the load can then be used immediately or stored according to your pro...

Страница 7: ...ld perform maintenance repair or adjust the STERRAD 100S System Personal Safety and First Aid WEAR LATEX PVC VINYL OR NITRILE GLOVES WHILE REMOVING ITEMS FROM THE STERILIZER AFTER A CYCLE HAS CANCELED 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 peroxid...

Страница 8: ...n item can be sterilized in this unit Information may also be obtained from the device manufacturer The chapter on Preparing Items To Be Sterilized in the STERRAD 100S Sterilization System User s Guide contains infor mation about recommended materials it lists items that can be sterilized in the STERRAD 100S Sterilizer and gives important details on cleaning packaging load preparation etc Do not c...

Страница 9: ...nty of water 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 Call the ASP Customer Care Center at 1 888 STERRAD for credit Do not remove used cassettes from the cassette collection box Dispose of cassettes inside the closed box in normal waste or fo...

Страница 10: ...is chapter is repeated where appropriate throughout this guide for your safety and use This information is subsequently labeled WARNINGS Cautions or Notes as appropriate WARNINGS are shown in the text in all bold upper case letters They indicate events or conditions that can result in serious injury or death Cautions are shown in the text in bold letters and they indicate events or conditions that...

Страница 11: ...omes first In addition there are a number of as needed maintenance activities to be performed These are presented near the end of this chapter WARNING ONLY EXPERIENCED ASP TRAINED TECHNICIANS SHOULD REPAIR OR ADJUST THIS UNIT REPAIRS AND ADJUSTMENTS SHOULD ONLY BE ATTEMPTED BY EXPERIENCED TECHNICIANS WHO ARE FULLY TRAINED TO MAINTAIN AND REPAIR THE STERRAD STERILIZER USE OF UNAUTHORIZED PARTS FOR ...

Страница 12: ... Yes Yes Replace Vacuum Pump Oil Filter Leybold D16A only Yes Yes Clean Air Filters Panel Assemblies No Yes Baratron Zero Shift Test No Yes Replace the Catalytic Converter No Yes Replace HEPA Filter Yes Yes Replace Exhaust Filters Yes Yes Clean Door and Inside Chamber Assembly No Yes Clean Platen Surface No Yes Clean Door Seal and Replace Door Seal O ring No Yes Inspect throttle valve and O ring C...

Страница 13: ...using not done on Block 2 0 Replace Vacuum Pump Oil Filter Leybold D16A only Replace Exhaust Filters Clean Air Filters Panel Assemblies Clean Door and Inside Chamber Assembly Product Certification Update PM Log Seismic Restraint Inspection 1 Disengage the system from the brackets then move it out of the way 2 Make sure the bolts are tight the brackets are in good shape and the flooring has not cra...

Страница 14: ...ossible Place the bottle on the cloth Open the drain valve place the hose in the bottle and drain the oil 3 When draining oil from a Leybold D16A pump insert the funnel in the empty bottle and place it on an oil absorbent cloth under the valve at the rear of the pump Open the valve to drain the oil 4 After the flow has stopped close the drain valve Make sure the main circuit breaker is off before ...

Страница 15: ...empty it and replace it Drain the Pressure Regulator Moisture Trap 1 Place a towel below the pressure regulator trap prior to draining 2 Press upwards through the towel on the button at the bottom of the trap and permit water to escape Replace the Vacuum Pump Oil Filter This procedure is for the Leybold D16A vacuum pump only You should complete this procedure before proceeding on to the next one I...

Страница 16: ...cedures permitting in normal customer trash 5 Using a lint free cloth wipe all oil from the interior of the housing and the mating faces of the housing Be careful not to unseat the mating surface O ring seal 6 Insert a new filter element and replace the filter cap making sure the core is correctly oriented Be sure that the O ring seal on the bottom of the filter element is correctly seated 7 Seat ...

Страница 17: ...e pump oil again as described in the Replace Vacuum Pump Oil procedure If the pump oil used for flushing is still dirty repeat steps 1 3 until the oil is clean 5 Reconnect the vacuum line to the intake tube and close the drain valve 6 Open a new bottle of pump oil and replace the cap with the oil filler cap red tipped Remove the red tip and cut about 1 6 to 1 4 inch off the cap tip so the oil flow...

Страница 18: ... the Serial Number Edit Menu The PM warning is set to ON by default whenever a loss of battery power occurs or the number of total machine cycle is reset to zero PM Level 1 2 Edit Menu The following is displayed PM Y or N NEXT PM XXXX L X OPEN reset CANCEL next Y is yes PM was done N is no PM has not been done XXXX is the number of cycles before the PM is due or the month in which the PM is due an...

Страница 19: ...enters the new record in the 10th position The system prints the PM service history when it is updated 2 Press CANCEL to transfer to the PM Level 1 Cycles Interval menu PM Level 1 Cycles Interval The following is displayed PM 1 CYCLES XXXX OPEN chng CLOSE accept XXXX is the current Level 1 PM cycles service interval 1 Press CLOSE DOOR to move the cursor to each digit in turn starting at the rightm...

Страница 20: ...h digit in turn Press OPEN DOOR to increment the digit by 1 ranging from 0 to 9 The interval type months can be programmed to a value between 4 and 12 months with a default value of 6 months 2 Press CANCEL to transfer to the PM Level 2 Months Interval menu PM Level 2 Months Interval The following is displayed PM 2 MONTHS XX OPEN chng CLOSE accept XX is the default PM level 2 months service interva...

Страница 21: ...e manometer Baratron from the chamber and attach it to one side of the T piece 2 Connect the T piece to the chamber 3 Using an extension harness connect the one end to the Baratron harness and the other end to the Baratron Figure 2 Baratron Zero Shift Test Set Up 4 Install the vacuum gauge head to the center of the T piece Let the vacuum gauge warm up for about 15 minutes prior to use 5 Turn on th...

Страница 22: ...ospital procedures Door and Chamber Procedures Cleaning the door and process chamber requires a number of steps including the removal of the electrode The rear of the door should be cleaned during PM 1 and the chamber and electrode examined and cleaned if necessary during that PM PM2 procedures require that the electrode be removed and it and the chamber thoroughly cleaned During PM2 the door seal...

Страница 23: ... If the warning feature is ON pressing CANCEL gives different options for selecting the PM interval If this feature is OFF Press CANCEL to transfer to the Serial Number Edit Menu The PM warning is set to ON by default whenever a loss of battery power occurs or the number of total machine cycles is reset to zero PM Level 1 2 Edit Menu The following is displayed PM Y or N NEXT PM XXXX L X OPEN reset...

Страница 24: ...he new record in the 10th position The system prints the PM service history when it is updated 3 Press CANCEL to transfer to the PM Level 1 Cycles Interval menu PM Level 1 Cycles Interval The following is displayed PM 1 CYCLES XXXX OPEN chng CLOSE accept XXXX is the current Level 1 PM cycles service interval 1 Press CLOSE DOOR to move the cursor to each digit in turn starting at the rightmost digi...

Страница 25: ...h digit in turn Pressing OPEN DOOR increments the digit by 1 ranging from 0 to 9 The interval type months can be programmed to a value between 4 and 12 months with a default value of 6 months 2 Press CANCEL to transfer to the PM Level 2 Months Interval menu PM Level 2 Months Interval The following is displayed PM 2 MONTHS XX OPEN chng CLOSE accept XX is the default PM level 2 months service interv...

Страница 26: ...re units Use the history menus Clean the sterilizer Master Reset Changing the Cassette Collection Box The cassette collection box can hold 30 used cassettes The cassette box must be changed after 145 cycles The customer is instructed to change the vaporizer plate every time a new cassette collection box is needed If the cassette collection box is not replaced at the proper cycle intervals the ster...

Страница 27: ...ot remove used cassettes from the collection box To replace the cassette collection box do the following 1 Unlock and open the door on the right side panel Figure 4 Open the door and remove the cassette collection box 2 Remove the filled box and close it Secure both ends with tape Figure 5 Close the cassette collection box and seal it with tape 3 Inspect the chute from which the used cassettes sli...

Страница 28: ...At least 10 seconds must pass before the microprocessor accepts that a new box has been loaded A single beep sounds at 10 seconds Replacing the Vaporizer Plate A vaporizer plate is installed in all STERRAD 100S Sterilizers This vaporizer plate minimizes the risk of liquid hydrogen peroxide coming into contact with the load in the chamber It also helps keep the load and the chamber clean Operation ...

Страница 29: ...spital policy Installing a New Vaporizer Plate CAUTION Please make sure you follow the steps below and hold the vaporizer plate as shown in the illustration It is very important that the vaporizer plate be correctly installed so that it functions properly WARNING YOU MUST WEAR EYE PROTECTION AND GLOVES WHILE PERFORMING THIS PROCEDURE 1 Remove the vaporizer plate from its packaging Hold the plate a...

Страница 30: ...ollowing 1 Open the printer drawer on the control panel Figure 10 Opening the printer drawer 2 Hold back the left and right security clips and pull carefully to remove the old ribbon rolls Discard Figure 11 Holding back the security clip to remove the old ribbon roll 3 Remove the new ribbon rolls from the packaging Unroll the ribbon about 150 mm 6 inches Hold back the left security clips and inser...

Страница 31: ...e printer paper exits the printer paper slot To replace a printer ribbon cartridge do the following 1 Open the printer drawer on the control panel 2 Remove the used cartridge by firmly but carefully pulling on the right side as indicated by the arrow on the cartridge Figure 13 Removing the used printer cartridge 3 Discard the used cartridge 4 Insert a new cartridge by aligning the left side of the...

Страница 32: ...ing care to ensure that the printer paper exits the printer paper slot Figure 16 Closing the printer drawer Replacing the Printer Paper To replace the single roll printer paper do the following 1 Open the printer drawer on the control panel Figure 17 Opening the printer drawer Early version of STERRAD System shown 2 Remove the metal rod from the empty paper core and discard the core 3 Insert the r...

Страница 33: ...anism begins to pull the paper Continue pressing PAPER ADVANCE until about 70 to 80 mm 3 inches of paper exits the slot above Figure 19 Feeding the paper into the mechanism 7 Close the printer drawer taking care to ensure the paper exits the printer paper slot To replace the double roll printer paper do the following Note Do not pull the remaining paper out of the printer mechanism Instead cut or ...

Страница 34: ...pull off the metal side of the reel Figure 21 Removing the metal side of the take up reel 3 Remove the roll of yellow backup copies and save per hospital policies procedures 4 Snap the metal side back onto the reel and replace the reel into the holder 5 Remove the empty paper core and discard the core Figure 22 Removing the empty paper core 6 Place a new paper roll into position so that the paper ...

Страница 35: ...ind the paper roll 8 Feed the edges of both the white and yellow papers into the slot behind the printer Figure 24 Feeding the paper into the slot leading to the printer cartridge 9 Push up gently on the paper and press PAPER ADVANCE until the mechanism begins to pull the paper Continue pressing PAPER ADVANCE until about 150 to 160 mm 6 inches of paper exits the printer cartridge Figure 25 Advanci...

Страница 36: ...e white printer paper through the slot in the printer drawer and close the drawer Figure 27 Feeding the white paper through the slot in the printer drawer Note To use a single white paper only roll follow the steps above but ignore all references to yellow paper and the take up reel Resetting the Date and Time The STERRAD 100S Sterilizer is set up at installation by a Field Service Engineer to dis...

Страница 37: ...y The cursor moves to the next field 9 Press OPEN DOOR to change the display 10 Press CLOSE DOOR to accept the information The display changes to the time editing mode Note If you are also going to change the time skip step 10 below and step 1 in the following section 11 At the same time press START and CANCEL to exit the date and time editor To change the time do the following 1 Press START and C...

Страница 38: ...select the clock mode 3 Press CLOSE DOOR or CANCEL in Clock Mode to go to the Pressure Units menu CLOCK MODE XX OPEN chng CLOSE accept Setting Pressure Units The Pressure Units menu displays the units select for pressure The selected units are also printed at cycle completion The units can either be in Torr or Pascals PRESSURE UNITS TORR OPEN chng CANCEL next 1 Press OPEN DOOR to switch the pressu...

Страница 39: ...o display the following HISTORY CANCELLATION OPEN Select CLOSE Prnt 3 Press CLOSE DOOR to print the last 10 cycle cancellations report Press OPEN DOOR to display the following HISTORY CASSETTE OPEN Select CLOSE Prnt 4 Press CLOSE DOOR to print the last 10 barcode read failures report Press OPEN DOOR to display the following HISTORY PRINT RF REFL OPEN chng CLOSE accept 5 Press CLOSE DOOR to print t...

Страница 40: ...ing Chapter or by an ASP Customer Care Representative The master reset is best accomplished by two people There is NO danger to the operator or the system when performing this operation To perform a master reset do the following 1 One person remains at the front of the system the second person moves to the rear of the system 2 The person at the rear of the system turns the system main power circui...

Страница 41: ...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 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 stainl...

Страница 42: ...he 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 ...

Страница 43: ...h 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 22...

Страница 44: ...al 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 M...

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