STERRAD 100S Sterilization System Routine Maintenance Guide

STERRAD® 100S Sterilization System Routine Maintenance Guide

1-888-STERRAD (1.888.783.7723) 949.581.5799 www.sterrad.com

©2005 Advanced Sterilization Products. 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

Contents Chapter 1. Introduction

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Operation Information ...5 Chapter 2. For Your Safety

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Overview ...7 Personal Safety and First Aid ...7 Device Safety ...8 Cassette Handling ...9 Safe Maintenance...9 Additional Information ...10 Chapter 3. Routine Maintenance

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Maintenance Schedule ...12 PM Level 1 ...13 Seismic Restraint Inspection ...13 Vaporizer Plate/Vaporizer Maintenance ...14 Replace Vacuum Pump Oil...14 Drain the Air Storage Tank ...15 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 the Cassette Collection Box...26 Replacing the Vaporizer Plate...28 Replacing the Printer Ribbon Rolls or Cartridge ...30 Replacing the Printer Paper...32 Resetting the Date and Time ...36 Setting Pressure Units ...38 Using the History Menu...39 Cleaning the Sterilizer...40 Master Reset...40

STERRAD® Sterilization System Routine Maintenance Guide

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Chapter 4. Technical Data

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Physical Specifications ... 41 Environmental Conditions ... 42 Electrical Requirements ... 43 Heater Impedance ... 43 Thermocouples... 44 Standards... 44

Chapter 1.

Introduction The STERRAD® 100S Sterilization System is a general purpose, low temperature sterilizer using the STERRAD Process to inactivate microorganisms on a broad range of reprocessable medical devices and surgical instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method. A variety of routine maintenance procedures are performed on the STERRAD 100S Sterilizer both at scheduled intervals and as needed. These procedures are detailed in Chapter 3 of this guide. You must read, understand, and follow 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 100S FSE Troubleshooting Guide. The User’s Guide is shipped with the system and is available by contacting the Customer Care Center. The FSE Troubleshooting Guide is only available to those persons who are trained to service STERRAD equipment by ASP Technical Training. Please contact the ASP Customer Care Center for more information: 1-888-STERRAD. Note:

This following section presents a simplified overview of the sterilizer components.

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1

Introduction

The main sterilizer components are shown in the following illustration:

Figure 1. STERRAD® 100S Sterilizer. Your sterilizer may be slightly 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 procedures.

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STERRAD® Sterilization System Routine Maintenance Guide

Chapter 2.

For Your Safety 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 chapter 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 safely using and maintaining your STERRAD® 100S Sterilization System. Only trained, experienced technicians, who are fully acquainted with the unit, should 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 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.

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2

For Your Safety

•

Inhalation of vapor or 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 ATTEMPT TO STERILIZE ITEMS OR MATERIALS THAT DO NOT COMPLY WITH THE DIRECTIONS SPECIFIED IN CHAPTER 3 OF THE STERRAD 100S STERILIZATION SYSTEM USER’S GUIDE. In addition, you should read the medical device manufacturer's instructions, or call the ASP Customer Care Center to determine whether an 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 information 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 change the power source without checking the electrical phase rotation. Prior to relocating the STERRAD 100S Sterilizer to a new power source, electrical phase rotation should be checked by a qualified technician. Failure to verify and match phase rotation may cause damage to the sterilizer and voids the warranty.

•

Do not leave the sterilizer unplugged or turned off for longer than 24 hours. If you plan to disconnect the sterilizer for any lengthy of time, call the ASP Customer Care Center for instructions.

Device Safety

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STERRAD® Sterilization System Routine Maintenance Guide

For Your Safety

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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, immediately drink plenty 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 follow your specific site procedures.

•

If it is necessary to handle a used cassette, wear latex, PVC (vinyl), or nitrile gloves. Do not touch your gloved hands to face or eyes.

•

Empty or expired cassettes must be replaced prior to starting the cycle as directed by a message on the sterilizer display.

Safe Maintenance •

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 MAINTENANCE OR REPAIR COULD CAUSE PERSONAL INJURY, RESULT IN COSTLY DAMAGE OR UNIT MALFUNCTION, AND VOIDS THE WARRANTY.

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2

For Your Safety

•

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.

Additional Information The information in this chapter is repeated where appropriate throughout this guide for your safety and use. This information is subsequently labeled: WARNINGS, Cautions, or Notes as appropriate.

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•

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 can result in damage to equipment.

•

Notes are shown in the text with the word Note in bold. They highlight specific information about the proper use and maintenance of the STERRAD 100S Sterilizer.

STERRAD® Sterilization System Routine Maintenance Guide

Chapter 3.

Routine Maintenance This chapter presents the routine maintenance, or PM (planned maintenance) procedures that are performed on the STERRAD® 100S Sterilizer. There are two maintenance intervals: PM Level 1 and PM Level 2. These intervals are tracked by the system and the user is notified when the PM is due. The PM Level 1 is performed every 1500 cycles or 6 months whichever comes first. PM Level 2 is performed every 3000 cycles or 1 year, whichever comes 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 MAINTENANCE OR REPAIR COULD CAUSE PERSONAL INJURY, RESULT IN COSTLY DAMAGE OR UNIT MALFUNCTION, AND VOIDS THE WARRANTY. Caution: Do not leave the sterilizer unplugged or turned off for longer than 24 hours. If the sterilizer must be turned off for longer than 24 hours, call the ASP Customer Care Center for instructions.

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Routine Maintenance

Maintenance Schedule PM1

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PM2

Task Description

Yes

Yes

Inspect Seismic Restraints

Yes

Yes

Replace Vacuum Pump Oil

Yes

Yes

Vaporizer Plate and Vaporizer Maintenance

Yes

Yes

Drain Water From Air Storage Tank

Yes

Yes

Drain Pressure Regulator Moisture Trap

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. Clean if needed.

No

Yes

Replace Upper Shelf Stops

No

Yes

Replace Electrode Spacers

Yes

Yes

Product Certification

Yes

Yes

Update PM Log

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Routine Maintenance

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PM Level 1 The PM Level 1 is performed every 1500 cycles or 6 months whichever comes first. When performing PM Level 2, the PM Level 1 procedures should be done first. Following are the items serviced during this PM. ♦ Inspect Seismic Restraints ♦ Replace Vacuum Pump Oil ♦ Vaporizer Plate/Vaporizer Maintenance ♦ Drain Water From Air Storage Tank ♦ Drain Pressure Regulator Moisture Trap ♦ Drain Oil From Vacuum Pump Exhaust Filter Housing (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 cracked or crumbled around the bolts. 3. If there is any problem, even if the brackets are only slightly loose, contact the proper facilities maintenance personnel at the customer site and make sure the brackets are properly tightened. CAUTION: DO NOT replace the system back on the brackets if they are loose.

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Routine Maintenance

Vaporizer Plate/Vaporizer Maintenance The injector valve vaporizer plate is normally replaced by the customer when the cassette collection box is replaced. If the vaporizer plate needs to be changed at planned maintenance, this procedure should be performed for the customer. See the section on “As Needed Maintenance” in this chapter for detailed removal and replacement procedures. The vaporizer bowl should be wiped with a clean, damp cloth.

Replace Vacuum Pump Oil Note:

Always change the pump oil while the pump is warm to prevent condensation in the pump.

1. Using an 8 mm Allen wrench, unscrew and remove the oil fill plug located at the top of the pump. 2. Remove the cap from the empty bottle in the kit. Place an oil absorbing cloth on the floor inside the machine as close to the drain valve hose as possible. 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 proceeding. Note:

If the used pump oil is excessively dirty, flush out the pump using clean oil.

5. 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 flows freely. 6. Pour new pump oil (slightly less than one quart) into the oil fill port until oil reaches the raised line at the top of the sight glass (the MAX line on the Leybold D16A). DO NOT OVERFILL or attempt to empty the oil bottle. Some oil may remain in the bottle when the pump oil is at the specified fill level. 7. Re-cap and dispose of the drained oil and the oil absorbent cloth following standard hospital procedures.

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Routine Maintenance

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Drain the Air Storage Tank The air storage tank is different on Block 2.0 machines. See the following section for details. 1. Using a towel, cover the drain of the air storage tank, and then slowly open the drain cock. On Block 2 systems, press the trigger or turn the valve to fill the bottle. Then empty the bottle and replace it. 2. When no further water flows from the drain, close the drain cock. Repeat steps 1 and 2 after 10 seconds. Clean up any areas splashed with water.

Drain the Air Storage Tank (Block 2.0) 1. Locate the water collection bottle. 2. Press the air trigger or turn the valve and water flows from the tank into the collection bottle. 3. Remove the bottle, 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. If you are servicing a Block 2.0 device, proceed to “Drain the Pressure Regulator Moisture Trap.” If you are servicing a pump without the oil return feature, go to “Drain the Exhaust Filter.” 1. Remove the screws and washers attaching the gas ballast valve to the oil casing. Remove the gas ballast valve. 2. Remove the oil filter from the gas ballast hole in the oil casing. Remove any dirt or corrosion found on the gas ballast valve prior to reassembly. 3. Install a new oil filter in the gas ballast hole in the oil casing. Reinstall the gas ballast valve.

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Routine Maintenance

Replace the Catalytic Converter/Exhaust Filter The converter filter core is disposable according to standard facility procedures. 1. Unscrew the converter element from the top of the housing and discard it. 2. Loosen the wing nut on the clamp holding the exhaust filter assembly on the vacuum pump, then open the clamp and remove the filter assembly. Be careful not to damage the O-ring seal. 3. Use a 4 mm Allen wrench to remove the four screws holding the upper and lower sections of the filter housing, then remove the upper section. Be sure the O-ring seal remains in the groove in the lower section. 4. Remove the filter cap from the filter core and dispose of the filter core according to hospital procedures, or, procedures 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 the upper housing section on the lower section and tighten the screws. 8. Install a new converter onto the housing.

Clean Air Filters/Panel Assemblies 1. Lift out the filter over the fan. Gently clean with soap and water. Replace the filter with a new one if necessary. 2. Clean the fan (Block 1.8 only). 3. Thoroughly dry the filter and snap it back in place. 4. Vacuum the screen on the outside of the plasma generator. Carefully vacuum inside the sterilizer. 5. Vacuum the air filter on the rear panel on Block 2 systems. 6. Using a soft cloth dampened with soap and water, clean the exterior panel surfaces.

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Routine Maintenance

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Vacuum Pump Flush This procedure should be used ONLY if the drained pump oil was very dirty. It is not a regular PM procedure. 1. Turn OFF the pump and reference the “Replace Vacuum Pump Oil” procedure to drain the used pump oil. 2. Disconnect the vacuum line from the intake tube, turn the main circuit breaker and vacuum pump ON, and pour clean pump oil into the intake tube while the pump is running. CAUTION: When flushing the pump, fill it to capacity with pump oil. 3. Allow the pump to run for at least 10 minutes, then turn the main circuit breaker OFF. 4. Drain the 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 flows freely. 7. Pour new pump oil (slightly less than one quart) into the oil fill port until oil reaches the raised line at the top of the sight glass (the MAX line on the Leybold D16A). DO NOT OVERFILL or attempt to empty the oil bottle. Some oil may remain in the bottle when the pump oil is at the specified fill level. Replace the oil fill plug on the pump. 8. Dispose of the drained oil following standard customer procedures for lubrication oils.

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Routine Maintenance

PM Main Menu Enter the deep edit mode as shown in Module 6. PM WARNING = ON (or) OFF OPEN(chng)CANCEL(next) ON or OFF indicates the state of the Planned Maintenance warning feature. When this feature has been turned OFF, no messages related to performing planned maintenance are generated. Press OPEN DOOR to toggle the warning between ON and OFF. Press CANCEL to accept the choice displayed. If the warning feature is ON, pressing CANCEL gives different options for selecting the PM interval. If this feature is OFF, pressing CANCEL transfers you 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 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 and L(X) is level 1 or level 2. If PM is not due on the basis of either months or cycles, XXXX is in cycles. If both months and cycles are due, or both are past due, XXXX is also in cycles. XXXX is displayed in months, if months are due, and cycles are not due. Months are also displayed if months are past due, while cycles are less than past due. If the number shown is a negative number, then it is the number of cycles past due.

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The Y changes to N automatically when a PM is due. The level of PM due is indicated on the printout after a cycle has been completed, and on the display in the idle state. You can reset the N to Y by pressing OPEN DOOR; XXXX automatically changes to the level 1 or 2 PM service interval in cycles. If no PM is due, then the number of cycles until the next level 1 or 2 PM is displayed. 1. Press OPEN DOOR to store the data, the total machine cycles, and print the information while exiting the Edit mode. The maximum storage capacity is 10 PM service records. When the 11th PM service record is entered, the system deletes the oldest record, re-sequences the existing records and 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 rightmost digit, moving left, and wrapping back to the rightmost digit. 2. Press OPEN DOOR to increment the digit by 1 ranging from 0 to 9. The Level 1 PM cycles can be programmed to a value between 500 and 2000 cycles, with a default value of 1500 cycles. 3. Press CANCEL to transfer to the PM Level 2 Cycles Interval menu.

PM Level 2 Cycles Interval The following is displayed: PM 2 CYCLES = XXXX OPEN(chng)-CLOSE(accept) XXXX is the default PM level 2 cycles service interval. The default PM level 2 cycles interval is 2 times that of the PM level 1 cycles interval.

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Routine Maintenance

1. Press OPEN DOOR to change the displayed interval to the next available option, based on the PM Level 1 duration. The PM Level 2 interval can be only 1, 2 or 3 times the PM Level 1 duration, with a range of 500 to 4000 cycles. A duration outside the valid range reverts to the default values. 2. Press CANCEL to transfer to the PM Level 1 Months Interval menu.

PM Level 1 Months Interval The following is displayed: PM 1 MONTHS = XX OPEN(chng)-CLOSE(accept) XX is the current PM Level 1 service interval in months. 1. Press CLOSE DOOR to move the cursor to each 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 interval. The default PM level 2 months interval is twice that of the PM level 1 months interval. 1. Press OPEN DOOR to change the displayed interval to the next available option, based on the PM level 1 duration. The PM level 2 interval can be only 1, 2, or 3 times the PM level 1 duration, within a range of 4 to 24 months. A duration outside the valid range reverts to the default values. 2. Press CANCEL to transfer to the Cassette Log Menu.

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STERRAD® Sterilization System Routine Maintenance Guide