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Section

 

3.5

   

Operational

 

Situations

 

and

 

Responses

 

 

SMU

 

–

 

Testing

 

Related

 

Situations

 

What

 

do

 

you

 

do

 

if

 

…

 

Response

 

A

 

biological

 

indicator

 

fails

 

but

 

the

 

cycle

 

ran

 

successfully

 

with

 

no

 

alarms?

 

Reprocess

 

per

 

latest

 

edition

 

of

 

ANSI/AAMI

 

ST79.

 

The

 

Bowie

‐

Dick

 

Test

 

fails?

 

Reprocess

 

per

 

latest

 

edition

 

of

 

ANSI/AAMI

 

ST79.

 

 

Was

 

a

 

warm

‐

up

 

cycle

 

(IUSS)

 

run

 

to

 

ensure

 

that

 

the

 

chamber

 

was

 

heated

 

up?

  

If

 

NO,

 

then

 

run

 

the

 

Bowie

‐

Dick

 

test

 

again.

  

If

 

YES,

 

then

 

call

 

a

 

qualified

 

maintenance

 

technician

 

to

 

troubleshoot.

 

The

 

Vacuum

 

Leak

 

Test

 

fails?

 

Take

 

the

 

sterilizer

 

out

 

of

 

service

 

and

 

contact

 

a

 

qualified

 

maintenance

 

technician

 

who

 

will

 

use

 

the

 

Vacuum

 

Leak

 

Test

 

troubleshooting

 

guide

 

in

 

Section

 

4.3.14.

 

 

SMU

 

–

 

Cycle

 

and

 

PLC

 

Related

 

Situations

 

What

 

do

 

you

 

do

 

if

 

…

 

Response

 

The

 

unit

 

shuts

 

off

 

and

 

emits

 

a

 

sustained

 

alarm

 

tone?

 

Turn

 

the

 

SMU

 

OFF

 

and

 

disconnect

 

power.

 

Contact

 

a

 

qualified

 

maintenance

 

technician

 

to

 

troubleshoot

 

the

 

system.

  

You

 

experience

 

a

 

power

 

failure

 

during

 

operation?

 

Flip

 

the

 

control

 

power

 

switch

 

to

 

the

 

OFF

 

position.

  

When

 

the

 

power

 

returns,

 

flip

 

the

 

control

 

power

 

switch

 

ON.

  

If

 

the

 

power

 

outage

 

was

 

short,

 

there

 

will

 

still

 

be

 

pressure

 

in

 

the

 

jacket

 

and

 

pressure

 

or

 

vacuum

 

in

 

the

 

chamber.

 

Press

 

“CONFIRM”

 

on

 

the

 

“SETUP”

 

screen,

 

then

 

press

 

“VENT.”

  

This

 

will

 

vent

 

the

 

pressure

 

or

 

vacuum

 

in

 

the

 

chamber.

  

After

 

venting,

 

open

 

the

 

door

 

and

 

reprocess

 

the

 

load

 

per

 

AAMI

 

ST79

 

standards.

 

You

 

want

 

to

 

stop

 

a

 

cycle?

 

Press

 

“ABORT.”

 

The

 

touch

 

screen

 

will

 

not

 

accept

 

a

 

command

 

or

 

seems

 

to

 

be

 

“lost”

 

and

 

not

 

functioning

 

correctly?

 

Flip

 

the

 

control

 

power

 

switch

 

to

 

OFF,

 

wait

 

5

 

seconds,

 

and

 

then

 

flip

 

it

 

back

 

ON.

  

Restart

 

the

 

cycle.

 

The

 

cycles

 

are

 

taking

 

a

 

lot

 

longer

 

than

 

usual?

 

Allow

 

the

 

WRS

 

water

 

to

 

cool.

  

In

 

a

 

hot

 

environment

 

the

 

cycles

 

may

 

take

 

longer

 

because

 

the

 

WRS

 

water

 

may

 

be

 

hot

 

which

 

effects

 

the

 

eductor

 

performance.

 

You

 

forgot

 

to

 

record

 

a

 

previous

 

cycle?

 

From

 

the

 

“Main

 

Menu”,

 

press

 

“Log.”

  

On

 

the

 

“Log”

 

screen

 

you

 

can

 

view

 

previous

 

results

 

by

 

using

 

the

 

left

‐

arrow

 

button.

 

You

 

turn

 

ON

 

the

 

sterilizer

 

and

 

get

 

a

 

low

 

battery

 

error

 

while

 

the

 

PLC

 

is

 

booting

 

up.

 

Contact

 

a

 

qualified

 

maintenance

 

technician

 

to

 

have

 

the

 

battery

 

replaced

 

according

 

to

 

the

 

Battery

 

Replacement

 

Procedure

 

found

 

in

 

Section

 

4.3.16.

 

The

 

PLC

 

screen

 

responds

 

slowly

 

when

 

the

 

screen

 

is

 

pressed.

 

Contact

 

a

 

qualified

 

maintenance

 

technician

 

to

 

have

 

the

 

battery

 

replaced

 

according

 

to

 

the

 

Battery

 

Replacement

 

Procedure

 

found

 

in

 

Section

 

4.3.16.

 

 

57

Summary of Contents for P2131

Page 1: ... 8001 Rev 17 P2131 AUTOMATED FIELD STEAM STERILIZER NSN 6530 01 641 4641 TECHNICAL MANUAL Fort Defiance Industries LLC FDI 2411 Maremont Pkwy Loudon TN 37774 Phone 865 408 0100 techsupport fortdefianceind com ...

Page 2: ...ment for measurement control and laboratory use Part 2 040 Particular requirements for sterilizers and washer disinfectors used to treat medical materials ASME Boiler and Pressure Vessel Code Section VIII Division I Current Edition Rules for Construction of Pressure Vessels U Fort Defiance Industries FDI is ISO 13485 2016 certified and FDA compliant for the design and manufacture of medical device...

Page 3: ... imperative that these notices be read in full and followed FEEDBACK FOR IMPROVEMENT AND GENERAL QUESTIONS Fort Defiance Industries LLC 2411 Maremont Pkwy Loudon TN 37774 techsupport fortdefianceind com 865 408 0100 phone fortdefianceind com Operational and Maintenance Videos Please visit the FDI video channel for helpful and informative videos on the operation and maintenance of the P2131 Automat...

Page 4: ...ric Pressure Setup 41 3 3 3 Running a Normal Sterilization Cycle 41 3 3 4 Running a Performance Test Vacuum Leak or Bowie Dick Test 44 3 3 5 Alarms 46 3 3 6 Maintenance Reminder 47 3 3 7 Status 47 3 3 8 Programmable Cycles 48 3 4 Operational Checklists 50 3 4 1 Testing Total Dissolved Solids TDS 55 3 4 2 SWS Deionized Water Cartridge Capacity 55 3 4 3 Testing Free Chlorine Level 56 3 5 Operational...

Page 5: ...ts 89 4 3 11 Replacing the PLC 90 4 3 12 PLC Software Update 92 4 3 13 PLC Firmware Update 92 4 3 14 Vacuum Leak Test Troubleshooting 95 4 3 15 Door Switch Reprogramming 96 4 3 16 Replacing the PLC Battery 97 4 3 17 Removing Back Lower Panel and Heater Assembly Cover 99 4 4 Replacement Parts List 101 4 5 Interior Components Diagrams 105 4 6 Theory of Operation 116 4 6 1 Process Flow Description 11...

Page 6: ...cal Engineers BI Biological indicator B PV Boiler and Pressure Vessel CI Chemical integrator DI Deionized FDA Food and Drug Administration FDI Fort Defiance Industries LLC IFU Instructions for Use HTS High Temperature Limit Switch IQ OQ PQ Installation Operational and Performance Qualification IUSS Immediate Use Steam Sterilization MAWP Maximum Allowable Working Pressure MTTR Mean time to repair P...

Page 7: ... in the P2131 sterilizer and should be sourced from FDI Use of unauthorized parts could compromise the safety and or efficacy of the sterilizer and will void the warranty Burn hazard Chamber door and rack shelves will be hot after a cycle Always wear protective gloves and apron when loading and unloading the chamber Hot water can remain in the chamber after a cycle Always wear protective gloves Be...

Page 8: ...to conduct routine biological monitoring to verify the sterilization performance Refer to the instrument device manufacturer s Instructions for Use IFU before selecting the appropriate cycle including exposure and dry times The P2131 sterilizer is designed to sterilize loads using only the FDA cleared cycles as specified in this manual If you have any question or concern about a specific material ...

Page 9: ... water from a Jerry can or bucket if a pressurized water system is not available The P2131 sterilizer is an automated microprocessor controlled pre vacuum autoclave A visual alert indicator LED light and an audible alarm notify the operator of any abnormal condition during operation It has a fully jacketed horizontal type pressure vessel and is designed as a transportable sterilization unit The P2...

Page 10: ...ssure vacuum pulses Maximum working pressure vacuum 40 psig full vacuum Electrical receptacle MIL C 22992 cord connecting class L Length endcaps closed for transport 46 00 Length endcaps open for operation 38 00 Width 26 75 Height endcaps closed for transport 31 00 Height endcaps open for operation 62 00 Chamber size 16 diam x 36 long 4 2 ft3 SMU weight dry 306 lbs SAB weight 17 lbs Jacket boiler ...

Page 11: ...est NA NA Test time 20 0 1 The AAMI minimum temperature is 270 F 132 C for all cycles except Bowie Dick which is 273 F 134 C The P2131 sterilizer setpoint temperature is 273 F 134 C for all cycles except Bowie Dick which is 274 F 2 AAMI standard 16 towel pack 9 x9 x6 3 Dry times are pre set to established standard conditions but can be manually increased 4 The FDA cleared Process Challenge Device ...

Page 12: ...m Pulse 1 A medium vacuum is pulled on the chamber to remove more air c Steam Pulse 1 Steam is released into the chamber to increase pressure and temperature to heat up the load d Vacuum Pulse 2 A slightly deeper vacuum is pulled on the chamber to remove even more air e Steam Pulse 2 Steam is released into the chamber again to increase pressure and to continue heating up the load f Vacuum Pulse 3 ...

Page 13: ...WRS must be drained and refilled every 14 days or 100 cycles whichever comes first Reference Section 3 4 CAUTION It is critical to use and maintain the SWS Reference Sections 3 4 and 4 3 4 If a pressurized potable water system is available a hose can be connected directly to the inlet of the SWS As water flows through the SWS calcium magnesium and other contaminants are removed from the water prev...

Page 14: ...mical Integrator P N P2131 1 9011 1292 Biological Indicator P N P2131 1 9012 10 Minute Exposure Reusable Process Challenge Device P N P2131 1 9003 Extended Cycle Tube P N P2131 1 9005 1292 Biological Indicator P N P2131 1 9012 NOTE There are currently no other FDA Cleared PCDs for a 10 minute pre vacuum cycle Bowie Dick Test Reusable Process Challenge Device P N P2131 1 9003 Bowie Dick Test Strip ...

Page 15: ...ilizer system includes the following 1 One SMU P N P2131 1 2 One WRS P N P2131 2 3 One SWS P N P2131 3 4 One SAB P N P2131 4 Sterilizer Main Unit SMU Water Recovery System WRS Sterilizer Water Softener SWS Sterilizer Accessory Bag SAB 9 ...

Page 16: ...P N P2131 1 4012 and three spare 750 milliamp fuses P N P2131 1 4013 in rigid plastic container 10 One setup multi tool for S N s AFS 0001 through AFS 0215 P N P2131 1 2020 For S N s after AFS 0215 the multi tool is stored in the rear endcap 11 One Technical Manual with a digital version on CD P N P2131 1 8001 12 One MicroSD w adapter P N P2131 1 4020 and Micro SD extender P N P2131 1 4028 13 Five...

Page 17: ...2131 sterilizer is designed to be carried by 6 people 2 Place the SMU on one of its ends WARNING To prevent potential injuries during transport installation and setup FDI recommends a six person team lift for the SMU and a four person team lift for the WRS 11 ...

Page 18: ...hite washer in between the knob and the spring does not spin Do not overtighten WARNING A potential pinch point exists near the hinge area of the endcap It is very important to keep hands positioned on the SIDES of the endcap and away from the pinch point Proper hand placement is on the side of the end cap away from the pinch point This will help avoid injury when opening the endcap Placing your h...

Page 19: ...d end of the unit pivoting on the endcap that is already opened and secured As the SMU is raised into position rest the weight of the unit on your thigh allowing you to unlock the two latches holding the endcap against the main frame If a third person is available to help they should be positioned at the end of the SMU to help unlock the latches 13 ...

Page 20: ...en 10 Remove the SAB from the chamber of the SMU The SAB contains items necessary to complete the assembly of the unit Refer to Section 3 2 1 Chamber Door Operation for instructions on operating the chamber door The multi tool is stored in the rear endcap and will also be used for S N s AFS 0001 through AFS 0215 the multi tool is in the SAB WARNING A potential pinch point exists near the hinge are...

Page 21: ... fuses are in place and not damaged CAUTION Hold panel firmly in place when loosening the panel latches 13 Remove top panel and front back panels of the WRS to ensure that a There are no loose or disconnected wires b There are no damaged or loose components 14 Clean and wipe down the unit as needed and reinstall all panels 15 Place the WRS next to the SMU orienting the unit such that the side of t...

Page 22: ...he SMU is an access hole for the condensate hose red tagged Push the hose through this hole and unscrew the cap on the left side of the drain manifold Ensure the O ring on the manifold fitting is in place and then connect the hose to the condensate outlet on the chamber drain manifold Hand tighten the nut and then tighten 45 max using the multi tool NOTE If the fitting O ring is missing spare O ri...

Page 23: ...en 45 max using the multi tool NOTE If the fitting O ring is missing spare O rings are provided in the SAB 20 On the back of the SMU unscrew the Vacuum Exhaust to WRS OUT bulkhead cap and verify that the O ring on the bulkhead fitting is in place Attach the white tagged vacuum exhaust hose The connection has a white bulkhead retainer to match the white tag on the hose Hand tighten the nut and then...

Page 24: ... the SAB 22 On the back of the SMU unscrew the Recovered Water from WRS IN bulkhead cap and verify that the bulkhead fitting O ring is in place Attach the blue tagged recovered water hose On the WRS unscrew the Recovered Water to Sterilizer OUT bulkhead cap and verify that the bulkhead fitting O ring is in place Attach the blue tagged recovered water hose These connections both have blue bulkhead ...

Page 25: ... holder and set to the side CAUTION Do not connect this receptacle to a power source yet SMU Electrical Power Cord Connecting Receptacle P N P2131 1 4027 Red tagged Condensate Hose P N P2131 1 3103 White tagged Vacuum Exhaust Hose P N P2131 1 3102 Blue tagged Recovered Water Hose P N P2131 1 3101 19 ...

Page 26: ...d connect the receptacle into the WRS Main Power Plug P N P2131 1 4010 on the WRS 26 Ensure all three manual valves on the back of the SMU are closed firmly Chamber Vent Jacket Vent Jacket Drain WRS Power Cord Receptacle P N P2131 1 0014 WRS Main Power Plug P N P2131 2 4010 20 ...

Page 27: ...S N s AFS 0001 through AFS 0236 first remove Back Lower Panel and black Heater Assembly Cover Reinstall the two Heater Flange Drain Caps at the rear of the unit by removing the caps from Tee Cap Retainers and tightening them to the Heater Flange Tees finger tight then only one quarter turn with wrench Reinstall Back Lower Panel and Heater Assembly Cover 29 Connect the high temperature drain hose t...

Page 28: ...4 shims or 1 under the rear endcap The target angle is 1 5 31 To test for proper angle pour a cup of water in the back of the chamber and ensure that it flows to the chamber drain 32 Clean the chamber and then install the trays found in the SAB CAUTION Do not allow sand chemicals or other debris to flow down the chamber drain into the WRS This could contaminate the water or damage components in th...

Page 29: ...egularly 36 For S N s AFS 0001 through AFS 0236 with the yellow valve handle as shown below connect the clear Outlet Hose from the SWS to the Fill Connection on the bottom of the WRS This is a cam style connection Ensure WRS drain valve is closed then open the yellow valve on the end of the SWS outlet hose pictured below to allow water to flow into the tank Once the HIGH mark is reached close the ...

Page 30: ...es Connect the Suction Line and drop strainer into a Jerry can or bucket Hook hand pump Discharge Line to Inlet of SWS Push pull the white handle back and forth to pump water into the WRS Once the HIGH mark is reached close the yellow valve at the end of the SWS outlet hose and the blue valve on the Water Fill Connection Suction Strainer P N P2131 3 3009 Manual Hand Pump P N P2131 3 0003 Handle La...

Page 31: ...n the Low Water position The alarm will prevent the heater elements from energizing but will allow operation of the WRS to fill the jacket with water The Low Water alarm will be reset in a later step WARNING If this Low Water alarm does not occur turn the sterilizer OFF immediately to prevent damage to the heater elements Contact a qualified maintenance technician to troubleshoot the liquid level ...

Page 32: ...o the jacket during a cycle This will cause the jacket to cool lose pressure and alarm 41 Firmly close the jacket vent valve on the back of the SMU 42 Refill the WRS back to its HIGH mark and disconnect the SWS hose 43 Reset the 02 LOW WATER LEVEL alarm If the alarm clears the liquid level switch is functioning correctly in the Water OK position CAUTION If this Low Water alarm does not reset conta...

Page 33: ...the PLC to zero NOTE The sterilizer control system uses absolute pressure transmitters for cycle operation By pressing ZERO the controller knows the exact atmospheric pressure so that the chamber can be vented consistently to 0 psig equal to atmospheric pressure This allows the chamber door to be opened easily and not be locked with a vacuum a From the CONFIRM SETUP screen press the BAROMETRIC PRE...

Page 34: ...c phase is working correctly Reference Section 3 3 4 for procedure 51 Perform Performance Qualification using PCDs per AAMI ST79 standards Reference Section 2 6 for information on recommended sterility assurance products 52 After all of these tests are successful the P2131 sterilizer is ready for OPERATION If any of these tests fail the sterilizer cannot be placed into service Call a qualified mai...

Page 35: ...1 1 1021 8 Locking Arm Lever P N P2131 1 1023 7 Door Handles P N P2131 1 1020 6 Audible Alarm ALM 1 behind panel P N P2131 1 4008 5 Controller P N P2131 1 4000 4 Indicator Light LAMP 1 P N P2131 1 4018 3 Pressure Gauges P N P2131 1 3406 2 Control Power Switch SW 1 P N P2131 1 4017 1 Warnings 29 ...

Page 36: ...these handles tightens and seals the door into place These handles may become warm during operation 8 Locking Arm Lever Pivots the radial arms to lock the door into place as well as activating the door switch 9 Radial Arms Engages with the door frame to lock the door closed When retracted the door can be opened 3 2 1 CHAMBER DOOR OPERATION WARNING Steam and or hot water can remain in the chamber a...

Page 37: ...9 7 Jacket and Chamber Manual Vent Valve Outlets P N P2131 1 9008 10a Heater Flange Drain Cap Fill P N P2131 1 3015 6 Vacuum Exhaust Hose Connection White Tagged P N P2131 1 9007 11 Multi tool P N P2131 1 2020 12a Tee Cap Retainer 10b Heater Flange Drain Cap Water Level P N P2131 1 3016 12b Tee Cap Retainer Rear View of SMU for S N S AFS 0001 though AFS 0236 Note Back Lower Panel P N P2131 1 0139 ...

Page 38: ...afety Valve P N P2131 1 3403 8 Jacket Drain Hose Connection P N P2131 1 9009 7 Jacket and Chamber Manual Vent Valve Outlets P N P2131 1 9008 6 Vacuum Exhaust Hose Connection White Tagged P N P2131 1 9007 11 Multi tool P N P2131 1 2020 3 Jacket Vent Valve P N P2131 1 0035 Rear View of SMU for S N S after AFS 0236 13 Back Lower Panel P N P2131 1 0139 14 Heater Assembly Cover P N P2131 1 9041 32 ...

Page 39: ...sterilizer operation 7 Jacket and Chamber Manual Vent Valve Outlets Outlet points for the Jacket and Chamber vent valves WARNING A small amount of hot condensate will collect above these valves during operation Slowly crack the valve to allow any hot condensate to empty out and keep hands away from this outlet point 8 Jacket Drain Hose Connection Hose connection draining hot water from jacket ONLY...

Page 40: ...ob Located on each corner of the SMU these are used to secure endcap in down position during setup When breaking down the sterilizer for storage or transport the endcap knobs should be turned counter clockwise When the knobs disengage from the endcap a spring will pop them upwards indicating they are free 3 Carry Handle Recessed spring loaded handle used for transporting the SMU 2 Endcap Knob P N ...

Page 41: ... also provides an easy push button method to refill the SMU jacket NOTE The Power Switch on the WRS should always be in the ON position during operation Right Side of WRS 6 Tank Drain Connection P N P2131 2 0045 7 Water Fill Connection P N P2131 2 0046 3 Water Return Switch SW 2 P N P2131 2 4009 1 LOW Water Line 2 HIGH Water Line 4 Power Switch SW 3 P N P2131 2 4008 5 Power Connection P N P2131 2 ...

Page 42: ... the WRS with water above the HIGH mark when the jacket is at the HIGH mark may result in water burping out of the relief vent or breather on top of the WRS water tank 3 Water Return Switch SW 2 A push button that turns ON the pump to flow water into the sterilizer when pressed Releasing the switch will stop the flow of water 4 Power Switch SW 3 A two position switch that turns electricity ON and ...

Page 43: ...e SMU chamber and connects to a water eductor inside the WRS which generates the vacuum needed for the pre vac and post vac stages of sterilization 3 Condensate Hose Connection Red Tagged This hose carries hot condensate from the SMU chamber to the WRS A steam trap inside the WRS controls the flow of condensate 3 Condensate Hose Connection Red Tagged P N P2131 2 0009 1 Recovered Water Hose Connect...

Page 44: ... supply hose to this connection If not available connect the outlet hose from the manual hand pump 2 Top Cap Remove this cap to replace the deionized water cartridge Reference cartridge replacement procedure in Section 4 3 4 3 Outlet Hose Connection Discharge of deionized water to WRS 4 Outlet Hose to WRS This hose is connected to the SWS outlet as well as to the WRS fill connection The cam and gr...

Page 45: ... to 8 gpm Turn handle inwards for transport to prevent breakage 3 Discharge Line to Inlet of SWS Carries water from hand pump to SWS inlet connection 4 Suction Strainer Used when hand pump is in service Strains out any potential debris from Jerry can or bucket from water before entering SWS 5 Spanner Wrench Used to remove Top Cap from blue housing and replace the DI Cartridge 1 Suction Line to Man...

Page 46: ...PLC 3 3 1 TURNING THE STERILIZER ON 1 Flip up the Control Power Switch on the front panel to turn the sterilizer ON 2 On the CONFIRM SETUP screen make any necessary updates to the TIME DATE or UNIT ID To do so touch the box to the right of the metric that needs to be updated A new screen will appear where you can make necessary updates NOTE This screen will appear every time the Control Power is t...

Page 47: ...een press the BAROMETRIC PRESSURE SETUP button 2 Open the chamber door completely so that the chamber and pressure transmitters are exposed to atmospheric pressure 3 Once the door is wide open press the ZERO button on the BAROMETRIC SETUP screen 4 Press the BACK button to return to the CONFIRM SETUP screen 5 Press CONFIRM to proceed 3 3 3 RUNNING A NORMAL STERILIZATION CYCLE 1 Assemble the items t...

Page 48: ...un 4 For the TEXTILES or WRAPPED INSTRUMENTS cycles use the arrow buttons to select the desired dry time For the WRAPPED INSTRUMENTS cycle select the 4 minute or 10 minute exposure Press the ACCEPT button CAUTION For a 10 minutes sterilization cycle the VERIFY 10 minute PCD must be used Reference Section 2 6 for information on sterility assurance products Textiles Cycle Screen Wrapped Instruments ...

Page 49: ...will begin automatically During the cycle the run screen will display the total cycle time type of cycle phase within the cycle the time remaining for exposure drying or vacuum testing only the chamber temperature and the chamber pressure A cycle can be aborted at any time by choosing the ABORT button This will stop the cycle and vent the chamber 6 At the end of the cycle the buzzer will sound and...

Page 50: ...TEST or VACUUM LEAK TEST For a BOWIE DICK TEST Place a U S Food and Drug Administration FDA approved BOWIE DICK test pack on the bottom rack near the drain in the chamber Follow all test pack manufacturer s recommended procedures For example a warmup cycle e g IUSS 4 0 should always be run prior to the BOWIE DICK test WARNING A BOWIE DICK test should be performed each day to ensure air removal is ...

Page 51: ...dd water from the WRS If you need to add water to the WRS do so with the SWS 5 Verify that the two vent valves on the back of the unit are closed 6 Verify that the door is closed and tightened then choose START to initiate the sterilization cycle If the jacket is not up to setpoint pressure the START screen will display Warming Up instead of Ready If you choose START before the jacket is ready the...

Page 52: ... a situation in which the door may not open due to vacuum in the chamber If this happens lock the door and press VENT from the Log screen The Log screen will be displayed at the end of the test displaying the results of the test Previous Log entries can be viewed using the LEFT and RIGHT arrows NOTE If the VACUUM LEAK TEST fails contact a qualified maintenance technician and follow the troubleshoo...

Page 53: ... every 100 cycles a Maintenance Reminder screen is shown to remind the operator that the water in the SMU jacket the WRS and the SWS must be drained and replenished with fresh potable water If needed flush the SWS until clear 2 minute flush This reminder also serves to help encourage maintenance technicians to check and follow the recommended maintenance schedule Reference Section 4 3 3 7 STATUS T...

Page 54: ... from the Main Menu 2 After carefully reading the WARNING press Accept to continue 3 Press the arrow keys to select the desired exposure and dry times and then press ACCEPT WARNING Only the standard AAMI cycles listed in Section 2 3 have been cleared by the FDA Programmable cycles have not been validated The FDA highly recommends that programmable cycles be used for research purposes The user acce...

Page 55: ...ng the door which actuates the door switch before the chamber reaches 0 psig will stop the venting and may create a situation in which the door may not open due to vacuum in the chamber If this happens lock the door and press VENT from the Log screen The Log screen will be displayed at the end of the cycle showing the results of the cycle A total of 40 previous Log entries can be viewed using the ...

Page 56: ... water cartridge as needed Reference Section 3 4 1 Testing Total Dissolved Solids and Section 4 3 4 SWS Cartridge Replacement 4 Follow every step of Section 3 7 Checklist for Transport and or Storage to prevent storage related issues upon startup Why the SWS is Important Preventing scale buildup buildup of mineral deposits is critical for ensuring that the P2131 sterilizer continues to operate rel...

Page 57: ... alarm 5 Ensure the water level in the WRS is at or near the HIGH mark If not add water using the SWS 6 Run an IUSS cycle to warm up the chamber NOTE It is critical to run this warmup cycle to ensure successful completion of the Bowie Dick test 7 Run a Bowie Dick test per AAMI standards to ensure that air removal during the preconditioning phase is functioning properly 8 Proceed with a normal ster...

Page 58: ...ch DO NOT open the jacket vent valve NOTE As the SMU cools down the steam in the jacket will condense resulting in a deep vacuum This condition is not a problem and will not cause any damage to the SMU In fact this is a recommended practice since relieving the vacuum by opening the jacket vent valve will allow air to enter the jacket Keeping air out of the jacket will enable the next cycle to oper...

Page 59: ...sten for possible water and steam leaks 4 Verify that the cooling fans in the SMU qty 1 and the WRS qty 2 are running NOTE On S N s after AFS 0236 there is only 1 cooling fan mounted to the Back Panel of the WRS 5 Monitor water levels in the SMU jacket and WRS NOTE When the SMU jacket is at the HIGH mark the WRS water level should be at or near the HIGH mark also REMEMBER Always use the SWS when a...

Page 60: ...2 WARNING To avoid a potential burn hazard ensure the high temperature drain hose is used 3 Drain the WRS by attaching the drain hose and opening the drain valve 4 SWS maintenance a Test the TDS level of the water coming out of SWS and replace the deionized water cartridge as needed Reference Section 3 4 1 Testing Total Dissolved Solids and Section 4 3 4 SWS Cartridge Replacement b Test the chlori...

Page 61: ...ads 5 ppm either the distilled water could be contaminated or TDS Meter is out of calibration and should be replaced Taking a TDS Measurement 1 Remove the protective cap 2 Turn the TDS Meter ON 3 Collect a sample of SWS outlet water in a clean container 4 Immerse the Meter into the sample up to the Water Level Limit 5 Lightly stir the Meter in the water to dislodge any air bubbles 6 Wait until the...

Page 62: ...ine Level Test the supply water and outlet water stream as shown below FDI s recommended Free Chlorine Levels Free Chlorine Level Range Supply Water ppm 0 5 2 6 SWS Outlet Water Stream ppm 0 2 1 If the SWS outlet water stream reads 0 2 ppm flush the SWS for another 2 minutes If the test strip still reads 0 2 ppm this is an indication that the supplied water may not contain enough free chlorine 2 I...

Page 63: ... was short there will still be pressure in the jacket and pressure or vacuum in the chamber Press CONFIRM on the SETUP screen then press VENT This will vent the pressure or vacuum in the chamber After venting open the door and reprocess the load per AAMI ST79 standards You want to stop a cycle Press ABORT The touch screen will not accept a command or seems to be lost and not functioning correctly ...

Page 64: ...is and repair on the WRS pump The jacket does not refill when switch on WRS depressed Verify the water level in the WRS adding water through the SWS if necessary Ensure that the power cord is plugged into the WRS and that the power switch is in the ON position If the problem continues contact a qualified maintenance technician for further diagnosis and repair The water level in jacket drops when s...

Page 65: ...uges are different One of the gauges is likely malfunctioning Contact a qualified maintenance technician The chamber is failing to pull vacuum during pre vac or drying Contact a qualified maintenance technician WRS and SWS General Situations What do you do if Response You hear the WRS pump start and stop intermittently or completely shut down The low water level switch may be activated With the ja...

Page 66: ...umbing that leads to switch including the heater flange tees the hoses and any other fittings Remove blockage and flush hoses Re qualify the switch per Operational Qualification OQ of the Liquid Level Switch before placing the unit back into service See Section 3 1 Remove right side panel Inspect HTS 1 INPUT LED and STATUS SCREEN to determine if there is an input failure INPUT LED will turn red an...

Page 67: ... steam trap Resistance Temperature Detector RTD or RTD transmitter failure Multiple Heater element failure Inspect door gasket and chamber fittings for steam leaks Ensure trap is working properly If steam trap is failed closed condensate will pool in chamber If steam trap fails open steam will flow to the WRS water tank and make a loud popping noise or use more water than normal Replace as needed ...

Page 68: ... open steam will flow to WRS water tank and make a loud popping noise or use more water than normal Replace as needed Contact a qualified maintenance technician to inspect RTD and RTD transmitter for physical damage loose wires broken communication cable to PLC Compare temperature versus pressure on STATUS screen Replace as needed Remove and clean screen Verify correct tilt Condensate should drain...

Page 69: ...mp is ON Ensure water level is at least 1 2 full Too little water will tend to overheat and cause low eductor performance Contact a qualified maintenance technician to inspect eductor for leak or worn broken nozzle inside eductor Replace if needed Contact a qualified maintenance technician to inspect solenoid valve and replace if needed NOTE Reference Appendix A 5 Vacuum Leak Test Troubleshooting ...

Page 70: ...ed maintenance technician to inspect vent valve and replace as needed Ensure trap is working properly If steam trap is failed closed condensate will pool in chamber If steam trap fails open steam will flow to WRS water tank and make loud popping noise or use more water than normal Replace as needed Contact a qualified maintenance technician to inspect outlet of valve for leaking Contact a qualifie...

Page 71: ...ve and clean screen Replace after cleaning Contact a qualified maintenance technician to test relay for leakage and replace as needed Open Chamber Door and compare digital pressure readout on STATUS screen on PLC to analog gauge on front panel Jacket Pressure reading 28 psig and Chamber Pressure Reading 0 psig 10 Long Vent Time Barometric Pressure Not Zeroed Door not tightened during manual VENT V...

Page 72: ...ks Repair as needed NOTE Reference Appendix A 5 Vacuum Leak Test troubleshooting guide for more help on troubleshooting a potential leak in the system 13 Fuse F3 Inputs Overcurrent Faulty fuse Contact a qualified maintenance technician to correct cause of overcurrent and replace fuse F3 Contact a qualified maintenance technician inspect and replace fuse F3 14 Fuse F5 Outputs Overcurrent Faulty fus...

Page 73: ...ain easily to front chamber drain Contact a qualified maintenance technician to test relay for leakage and replace as needed 17 Chamber Sensor RTD or RTD transmitter failure Chamber pressure transmitter failure Contact a qualified maintenance technician to inspect RTD and RTD transmitter for physical damage loose wires broken communication cable to PLC Compare temperature versus pressure on STATUS...

Page 74: ...e technician to inspect RTD and RTD transmitter for physical damage loose wires broken communication cable to PLC Compare temperature versus pressure on STATUS SCREEN Replace as needed Ensure trap is working properly If steam trap is failed closed condensate will pool in chamber If steam trap fails open steam will flow to WRS water tank and make loud popping noise or use more water than normal Rep...

Page 75: ...Blowdown Procedure in Section 4 1 to remove any contaminants that may have accumulated in the jacket Allow the SMU to cool to ambient temperature Remove the drain hose WARNING Do not blow out with compressed air 6 Confirm the SMU power switch and the WRS power switch are in the OFF position 7 Disconnect the WRS power cord and store in SMU endcap 8 Disconnect the SMU power cord and store in endcap ...

Page 76: ...Water Fill Valve for storage WARNING Water remaining in pump could freeze and crack the pump or cause it to seize 17 For S N s AFS 0001 through AFS 0236 remove Back Lower Panel and the black Heater Assembly Cover reference Section 4 3 17 and then drain the Heater Flange Tees by removing the two Tee Caps on the back of the SMU reference Section 3 2 Controls and Indicators Rear View of SMU for locat...

Page 77: ...ng the water Replace cartridge as needed See Section 3 4 1 24 Remove the inlet and outlet hoses on SWS Remove the blue housing and turn upside down to allow the water to drain completely from the inlet outlet Place back into frame connect outlet hose and ensure manual valve is closed Connect manual pump outlet hose to inlet of SWS Wrap and secure all hoses for transport NOTE On S N s after AFS 025...

Page 78: ...ENDED CYCLE TUBE 50 BOX P2131 1 9005 4 VERIFY BOWIE DICK TEST STRIP 100 BAG P2131 1 9006 5 3M 1296 BIOLOGICAL PROCESS CHALLENGE DEVICE 25 BOX P2131 1 9010 6 3M 1243 CLASS 5 CHEMICAL INTEGRATOR 100 BAG P2131 1 9011 7 3M 1292 BIOLOGICAL INDICATOR 50 BOX P2131 1 9012 8 3M 1233L BOWIE DICK TEST PACK 30 BOX P2131 1 9013 9 TEST STRIPS WATER CHLORINE LEVEL PACKS OF 50 P2131 3 9007 10 CARTRIDGE SWS DEIONI...

Page 79: ... SMU or WRS back and forth Do not use compressed air to blow out water WARNING The P2131 sterilizer has a pressure vessel that has been ASME B PV code stamped It is a violation of federal code to replace the main door plate or make any repairs to the pressure vessel All repairs to the pressure vessel including the door plate must be made BY FDI WARNING Replacement parts should be sourced from FDI ...

Page 80: ...al Wiring 8 Ensure Jam Nuts are tight 9 Ensure adequate replacement parts 10 Retorque Doorpost Screws 11 Retorque Heater Plate Nuts 12 Check calibration of Handheld TDS Meter 4 1 3 3 4 1 12 Months 1 WRS Disinfecting Clean 2 Heater Flange Tee Inspection and Cleanout NOTE For S N s after AFS 0236 this procedure is no longer required 3 High Temperature Limit Switch Check 4 WRS K4 Relay and Liquid Lev...

Page 81: ...alve and attach remove the drain hose CAUTION To avoid a potential burn hazard ensure the high temperature drain hose is used to perform the jacket blowdown 2 Relocate the shims to the front of the sterilizer to tilt the unit towards the jacket drain valve 3 Ensure the outlet of the drain hose is positioned at a safe location Securely anchor the drain hose outlet to prevent any hose whip that migh...

Page 82: ... mounted on the heat exchanger mounted on the Back Panel Operation of this fan can be observed by checking for air flow during operation of the Sterilizer 7 Inspect wiring in SMU and WRS electrical boxes for loose wires corrosion or other concerns 8 Ensure jam nuts on the two front chamber mounts are tight Also ensure the rear chamber mounting bolts are tight 9 Ensure adequate replacement parts ar...

Page 83: ...ns as the bleach port and can be removed and replaced for this procedure CAUTION Do not pump water into the SMU until bleach has been rinsed from the WRS 4 Run a Textile 4 5 cycle The 4 5 cycle has a total cycle time of over 20 minutes providing continuous turbulent water circulation in the WRS to ensure complete contact and effective disinfection 5 After completion of this cycle drain the WRS com...

Page 84: ...d Back Lower Panel High Temperature Limit Switch Check CAUTION High Voltage contacts exposed with the right side panel removed Electrical shock hazard when observing the HTS display while the SMU is ON CHECK TASK 1 Ensure the SMU is full of water With the sterilizer OFF and at room temperature remove the right side panel of the SMU 2 Locate the High Temperature Limit Switch HTS display 3 Turn the ...

Page 85: ...multi meter to check terminal 10 on S N s AFS 0001 0236 and terminal 14 on S N s after AFS 0236 for 0 to 40 VAC 6 With the WRS filled use a multimeter to check for continuity across terminal 1 and 5 on K4 Relay Inspect SMU Fill Check Valve WRS Fill Valve CAUTION Burn Hazard Hot water and or steam can remain in the hose that will be removed below when it is disconnected CHECK TASK 1 Ensure the Ster...

Page 86: ... into the SMU WRS Breather PSV Inspection CHECK TASK 1 Ensure the WRS is disconnected from the SMU and is accessible from all sides 2 Remove the Top Panel 3 Remove the Bleach Fill Port and Breather Plug See Section 4 5 Interior Components Diagrams for location and inspect that air can freely pass through the breather and that the breather is not clogged with debris 4 If necessary clean the breathe...

Page 87: ... both at the HIGH marks 7 The jacket vent valve chamber vent valve and both drain valves are closed firmly 8 The WRS is turned ON 9 All accessories are accounted for in the SAB and the SAB is properly stored 10 All shelves are in place 11 All alarms repairs and cycle count found in STATUS screen are documented 12 During a cycle there are no steam leaks or water leaks 13 Cycle times are normal 14 C...

Page 88: ...ipment that may be less readily available These unique items are listed below 1 Wrench Torque 3 8 Square Drive capable up to 150 inch lbs P N P2131 1 9015 2 Grease High Temperature 275 F NLGI 2 P N P2131 1 9016 3 Bleach Chlorine 3 6 Solution P N P2131 2 9004 4 Mallet Soft P N P2131 1 9020 5 Gloves Heat Resistant P N P2131 1 9017 6 Brush Long Thin Bottle type P N P2131 1 9018 7 Wrench 11 16 Flare N...

Page 89: ...Replacing the HTS 1 RTD Sensors 4 3 2 Disinfecting Clean for WRS 4 3 3 Cleaning the Sight Glass 4 3 4 Replacing the SWS Cartridge 4 3 5 Replacing the HEPA Filter 4 3 6 Replacing the Steam Trap 4 3 7 Replacing the RTD Sensor 4 3 8 Replacing the Chamber Door Gasket 4 3 9 Replacing the Chamber Doorpost O Ring 4 3 10 Replacing Electric Immersion Heating Elements 4 3 11 Replacing the PLC 4 3 12 PLC Sof...

Page 90: ...s the springs and slide the springs off the end of both RTD s 10 Remove both RTD s by loosening Swagelok nut and sliding out Discard old RTD s 11 Install new RTD s by inserting into Swagelok fitting and tightening nut finger tight then 1 4 turn The long RTD is installed in the right fitting on right leg of center heater element The short RTD is installed in the center fitting on left leg of center...

Page 91: ...that are in the sterilizer pressure vessel 1 With the sterilizer OFF de energized and depressurized open the jacket vent valve to completely vent the jacket 2 Connect the high temperature drain hose to the drain connection Then open the jacket drain valve to drain the water from the jacket Close this valve once all water has drained from the jacket 3 Unscrew the 2 hex head fasteners on the front o...

Page 92: ...he opening of the housing 6 Verify large Blue Housing O ring is in place and is lubricated with silicone grease 7 Follow steps 1 3 in reverse order to return the SWS to operation 4 3 5 Replacing the HEPA Filter 1 Turn OFF the SMU disconnect power and ensure pressure in the chamber and jacket is at 0 psig 2 Remove the left side panel of the SMU 3 Using an 11 16 wrench to counter torque the fitting ...

Page 93: ...psig 2 Remove the front bottom panel on the SMU 3 Remove the right side panel on the SMU 4 Disconnect the RTD Connector This connector is located on the frame cross bar 5 Carefully slide the insulation sleeve down away from the RTD wiring 6 Use a 13 16 wrench to counter torque the fitting while using a 9 16 wrench to loosen the 1 4 fitting nut located at the top right 7 Carefully slide the RTD sen...

Page 94: ...icone doorpost O rings due to inferior resistance to steam Contact FDI for replacement parts Reference Section 4 4 Recommended Replacement Parts 1 Turn OFF the SMU disconnect power and ensure pressure in the chamber and jacket is at 0 psig 2 Open the chamber door and remove the handwheel retainer large washer on the outboard end of the doorpost 3 Remove the six radial arm wire retainers 4 Rotate t...

Page 95: ...studs and pull the heater plate from the jacket The gasket should be removed and discarded 4 If the middle heater is being replaced remove the RTD s and set aside to protect them Transfer the springs to the new heater element by unwinding winding them on the element 5 Loosen the 2 nuts on the compression fitting for the heater to be replaced Slide the heating element from the plate and discard the...

Page 96: ...12 Slide a new heater block gasket over the stud bolts on the heater block 13 Insert the heater assembly into the jacket opening and over the stud bolts Ensure the white Teflon isolation bushings are reused and are flush 14 Place isolation washers up against heater plate large stainless washers lock washers and nuts onto the stud bolts and tighten using a circular type pattern to slowly and evenly...

Page 97: ...in the PLC case One clip should be installed on each corner 14 Lightly tighten each screw so the clip is held in place 15 Tighten the screws on the clips such that the gasket is compressed against the panel 16 Reinstall the incoming power connector bottom side 17 Reinstall the black J2 connector far side and the orange J1 connector near side 18 Reinstall the MJ2 connector RJ45 connector near side ...

Page 98: ...een 7 The UPDATE SOFTWARE screen will display and the PLC will initialize the Micro SD card This may take a few minutes after which a list of files will appear 8 Use the up and down arrow keys on the right hand side of the screen to select the new software file Example V1285 OR V1043 9 Choose OK when you are asked if you are sure you want to load the application 10 A moving clock and progress bars...

Page 99: ...e following window enter the COM port number that you are using for communication and choose FINISH 6 Within Cscape select FILE and then NEW to create a new blank program This blank program is only used to access the firmware update wizard 7 Start the firmware update by selecting FILE and then FIRMWARE UPDATE WIZARD 8 In the Firmware Update Wizard select XLT for the Product Type and CsCAN NETWORK ...

Page 100: ...initialize the Micro SD card This may take a few minutes after which a list of files will appear 6 Use the up and down arrow keys on the right hand side of the screen to select the software file that matches the firmware version number For example if the firmware version is 12 85 then choose software file 1285 pgm Press RETURN 7 Choose OK when you are asked if you are sure you want to load the app...

Page 101: ...acuum leak The source of the vacuum is the water eductor that is located inside the WRS Water flowing through an internal tapered nozzle uses the Venturi effect to create a drop in pressure at the tip of the nozzle This pressure drop creates the source of vacuum for the SMU chamber The green highlighted areas of the Process Flow Diagram in Section 4 6 show the parts of the system that experience v...

Page 102: ...side panel to expose the electrical enclosure Locate the yellow door switch in the upper left portion of the enclosure 2 Press the black TEACH button on the side of the door switch sensor until the green LED turns to yellow or blinks red 3 Present the ON condition which is the door closed and the Locking Arm Lever rotated clockwise until the radial arms are fully extended Press the TEACH button an...

Page 103: ... the 4 screws on the back of the PLC and remove the back cover e Remove the I O board by carefully lifting it straight up f Remove the old battery It may require a small flat blade screwdriver to lift it from the holder Be careful not to permanently deform the battery holder tab g Dispose of the battery properly per the above note on disposal regulations h Slide the new battery into the holder Mak...

Page 104: ...eens and finally a screen that says No User Screens to Display 3 Updating the Screen Update Time a Press the SYSTEM button b Arrow down to SET SCREEN and choose ENTER c Arrow down to UPDATE TIME mS and choose ENTER d Change the time to 47 and choose ENTER e Choose ESC 4 Loading the Program a Arrow down to REMOVABLE MEDIA and choose ENTER b Arrow down to the program examples 1285 PGM V1043 PGM and ...

Page 105: ...ve the Back Lower Panel b Follow Step 1a in reverse order to install the Back Lower Panel 2 Removing the Heater Assembly Cover a Carefully position your hands to grab underneath the black Heater Assembly Cover b First pull down and then away from the Heater Block Enclosure c Carefully remove the Heater Assembly Cover Bottom View Green Recommended areas to grab and pull Red Not recommended areas to...

Page 106: ...r over the Heater Block Enclosure Note The two bottom tabs are designed to secure the black Heater Cover to the bottom flange of the Heater Block Enclosure c Tap the center of black Heater Assembly Cover with a Dead Blow Hammer or the bottom of the fist until it clips into place d Check the fit of the black Heater Assembly Cover It is designed for a close fit and should not be able to be removed e...

Page 107: ...ROGRAMMABLE LOGIC P2131 1 4000 13 COVER HEATER ASSEMBLY P2131 1 9040 14 ELEMENT ELECTRIC HEATING H1 H2 H3 P2131 1 4001 15 FAN ELECTRICAL BOX COOLING F1 P2131 1 4011 16 FILTER ELECTRICAL BOX AIR INLET P2131 1 5001 17 FILTER HEPA P2131 1 0028 18 FUSE 30A TIME DELAY FB1 A THROUGH FB1 C PKG OF 3 P2131 1 4012 19 FUSE 750mA SLOW BLOW FB2 1 THROUGH FB2 6 PKG OF 6 P2131 1 4013 20 GASKET CHAMBER DOOR POST ...

Page 108: ...6 O RING CHAMBER DRAIN SCREEN P2131 1 1150 47 O RING LEVEL SIGHT GAUGE PKG OF 50 P2131 1 9019 48 O RING SMU TO WRS HOSES WHITE TAGGED HOSES PKG OF 25 P2131 1 3408 49 OUTLET CHAMBER VENT VALVE P2131 1 9008 50 OUTLET JACKET VENT VALVE P2131 1 9008 51 POWER SUPPLY DC PS 1 P2131 1 4003 52 RECEPTACLE MAIN POWER CORD CONNECTING P2131 1 4027 53 RELAY SOLID STATE FOR HEATERS SSR 6 SSR 7 SSR 8 P2131 1 4004...

Page 109: ...TION CONDENSATE RED TAGGED P2131 2 0009 83 CONNECTION RECOVERED WATER BLUE TAGGED P2131 2 0009 84 CONNECTION VACUUM EXHAUST WHITE TAGGED P2131 2 0009 85 COOLER HEAT EXCHANGER S N S AFS 0001 THROUGH 0236 P2131 2 3000 86 COOLER HEAT EXCHANGER S N S AFTER AFS 0333 P2131 2 9009 87 COOLER HEAT EXCHANGER UPGRADE KIT S N S AFS 0237 THROUGH AFS 0333 P2131 2 9010 88 EDUCTOR VACUUM P2131 2 3402 89 FAN WRS H...

Page 110: ... VALVE SOLENOID WRS FILL SV 5 P2131 2 0004 116 VALVE TANK PRESSURE RELIEF S N S AFTER AFS 0236 P2131 2 9010 SWS Replacement Parts Item Description Part Number 117 CARTRIDGE DEIONIZED WATER PACK OF 6 P2131 3 9008 118 CONNECTION INLET HOSE P2131 3 3004 119 CONNECTION OUTLET HOSE P2131 3 3005 120 GASKET CAM AND GROOVE FITTING PKG OF 10 P2131 3 9004 121 GASKET GARDEN HOSE FITTING PKG OF 10 P2131 3 900...

Page 111: ...SMU Top of SMU from Left Side Back of SMU from Left Side Chamber Pressure Transmitter PT 2 P N P2131 1 4014 Jacket Pressure Transmitter PT 1 P N P2131 1 4014 Small fire sleeve insulation NOTE Pressure transmitters are factory calibrated and cannot be adjusted Sterilize Valve SV 1 P N P2131 1 0024 Vacuum Break Valve SV 4 P N P2131 1 0027 HEPA Filter P N P2131 1 0028 Vacuum Break Valve SV 3 P N P213...

Page 112: ...o the rear bulkhead remain the same Left Side of SMU Vacuum Exhaust Valve SV 2 P N P2131 1 0025 Hose Chamber Vent In P N P2131 1 3117 Hose Vent Break Valve P N P2131 1 3111 Hose Chamber Vent Out P N P2131 1 3118 Hose Jacket Vent Out P N P2131 1 3115 Hose Jacket Fill Not Shown P N P2131 1 3107 Hose Jacket Vent In P N P2131 1 3116 Hose Level Switch P N P2131 1 3106 HEPA Filter P N P2131 1 0028 Vacuu...

Page 113: ...de of SMU for S N s AFS 0001 through AFS 0236 After AFS 0236 Dual RTD RTD 1 RTD 2 Inside insulation and tubing P N P2131 1 0023 Chamber Drain Manifold P N P2131 1 0022 Connections for Dual RTD Condensate Hose Red tagged and Vacuum Exhaust Hose Large fire sleeve insulation Liquid Level Switch FS 1 P N P2131 1 4016 RTD Connector P N P2131 1 4021 RTD Connector P N P2131 1 4021 107 ...

Page 114: ...1 1 4011 Cable from Incoming Power Cable to WRS Cable to Heater Elements Cable from RTDs Front High Temperature Limit Switch HTS 1 P N P2131 1 4033 Back RTD Transmitter RTD 1 RTD 2 P N P2131 1 4006 Terminal Block 2 TB2 P N P2131 1 4026 Fuse Block 2 FB2 P N P2131 1 4025 DC Power Supply PS 1 P N P2131 1 4003 Buzzer Alarm ALM 1 P N P2131 1 4008 Terminal Block 1 TB1 P N P2131 1 4022 PLC P N P2131 1 40...

Page 115: ...e of WRS Left Side of WRS Eductor Behind Bracket P N P2131 2 3402 Water Fill Valve SV 5 P N P2131 2 0004 Water Circulation Valve SV 6 P N P2131 2 0005 Eductor Check Valve P N P2131 1 3402 Drain Check Valve P N P2131 2 3405 Fill Check Valve Behind Panel P N P2131 2 3407 109 ...

Page 116: ...2 4001 Pump P N P2131 2 3403 Water Fill Valve SV 5 P N P2131 2 0004 Steam Trap P N P2131 2 3401 Steam Trap Check Valve P N P2131 1 3402 Cooler Heat Exchanger S N S AFS 0001 0236 P N P2131 2 3000 Heat Exchanger Fan F2 P N P2131 2 4004 NOTE Not pictured S N s AFS 0001 0027 Pressure Safety Valve P N P2131 2 3404 110 ...

Page 117: ...ws Bleach Port Plug P N P2131 2 9003 Relay K2 P N P2131 2 4006 Relay K3 P N P2131 2 4006 Relay K4 P N P2131 2 4007 Vacuum Relief Check Valve P N P2131 2 3406 Pressure Relief Check Valve P N P2131 2 3406 Relay K1 P N P2131 2 4006 111 ...

Page 118: ... s after AFS 0236 Right Side of WRS Left Side of WRS Cooler Heat Exchanger S N S After AFS 0236 P N P2131 2 9009 Eductor Behind Bracket P N P2131 2 3402 Eductor Check Valve P N P2131 1 3402 Liquid Level Switch LS 1 P N P2131 2 4003 112 ...

Page 119: ...lation Valve SV 6 P N P2131 2 0005 Pump Water including Motor P N P2131 2 9008 Steam Trap P N P2131 2 3401 Water Tank P N P2131 2 0008 Steam Trap Check Valve P N P2131 1 3402 Tank Pressure Relief Valve P N P2131 2 9010 Pump Head Bolts Water Fill Valve SV 5 P N P2131 2 0004 113 ...

Page 120: ...Top of WRS Bleach Fill Port Breather Plug P N P2131 2 3019 Relay K2 P N P2131 2 4006 Relay K3 P N P2131 2 4006 Relay K4 P N P2131 2 4007 Relay K1 P N P2131 2 4006 114 ...

Page 121: ... THIS PAGE INTENTIONALLY LEFT BLANK 115 ...

Page 122: ...ss the door is closed and latched When a cycle is started and steam is required in the Chamber the Sterilize Valve SV 1 is opened by the PLC to allow steam from the Jacket to flow into the Chamber During the conditioning phase of a cycle the Chamber Pressure Transmitter PT 2 supplies pressure data to the PLC to allow it to pressurize or pull a vacuum in the Chamber to specific set points When stea...

Page 123: ...tener SWS P2131 3 Chamber Vent Valve IN Steam Trap Check Valve Vacuum Relief Valve Pressure Relief Valve Liquid Level Switch LS 1 Drain Check Valve Drain Valve Drain Drain Sight Glass Fill Valve Fill Check Valve Recovered Water From WRS Blue Note These two valves are installed with directional arrows facing each other Vacuum Exhaust From SMU White Condensate From SMU Red Green color indicates area...

Page 124: ...WHU 6 VWHP 1 287 Sterilizer Water Softener SWS P2131 3 KDPEHU 9HQW 9DOYH 1 6WHDP 7UDS KHFN 9DOYH LTXLG HYHO 6ZLWFK 6 UDLQ 9DOYH UDLQ UDLQ 6LJKW ODVV LOO 9DOYH 5HFRYHUHG DWHU URP 56 OXH 1RWH 7KHVH WZR YDOYHV DUH LQVWDOOHG ZLWK GLUHFWLRQDO DUURZV IDFLQJ HDFK RWKHU 9DFXXP KDXVW URP 608 KLWH RQGHQVDWH URP 608 5HG ϰ ϲ Ϯ WϮϭϯϭ WƌŽĐĞƐƐ ůŽǁ ŝĂŐƌĂŵ EΖƐ ĂĨƚĞƌ ͲϬϮϯϲͿ UHHQ FRORU LQGLFDWHV DUHDV WKDW H SHULHQF...

Page 125: ... TB2 8 WRS Control 2 8 FB2 2 L3 2 L3 1 L2 2 PS 1 DC DC RET DC 1 TB1 8 A BLACK D GREEN C RED E ORANGE B WHITE A BLACK JUMPER D GREEN YELLOW C WIRE 6 E WIRE 5 B WIRE 1 SNUBBER SN 1 10 2 1 SSR 6 2 1 SSR 7 2 1 SSR 8 2 1 2 Wire 2 Wire 4 Wire 3 7 3 2 Wire 2 Wire 1 Omega Connector Omega Connector RED BLUE BLUE BLUE RED ORANGE WHITE WHITE 2 1 RED RED BLUE 2 1 RED RED WHITE BLACK 2 1 BLACK BLACK 2 1 BLACK ...

Page 126: ...1 3 TB1 1 TB1 5 Door Switch N O DS 1 DC 1 DC 1 DC 5 DC 2 DC 2 TB1 1 DC 3 TB2 8 TB1 12 TB1 4 DC 4 Output Fuse Status TB1 2 PT 1 PT 2 NC BROWN WHITE BLUE RTD Transmitter 2 CHANNEL CONTROL AND MONITOR S N s AFS 0075 3 4 SSR 8 LAMP 1 TB1 10 Spare Spare 2 of 2 09 11 2018 REV 10 Fort Defiance Industries 79 78 TB1 8 MJ2 J3 FB2 6 FB2 5 FB2 3 3 9 750 mA Slow Blow 750 mA Slow Blow TB1 12 BLUE BROWN WHITE GR...

Page 127: ...8 7 K4 C1 C1 Continued on Pg 2 4 7 P2131 Electrical Wiring Diagram S N s after AFS 0236 T1 012 B10 013 B10 016 B10 022 R10 023 R10 015 10 035 10 025 10 032 O10 033 O10 036 O10 042 W10 054 G10 053 G10 101 B10 044 W 071 O J J J J J 074 O 084 O 092 R 111 BL 112 W B J J J J J J 161 V 162 W TB2 4 180 B A1 A2 F1 J TB2 6 1 of 2 12 31 2018 REV 11 Fort Defiance Industries 1 of 2 12 31 2018 REV 11 Fort Defi...

Page 128: ... DS 1 DC 1 DC 1 DC 5 DC 2 DC 2 TB1 1 DC 3 TB2 8 TB1 12 TB1 4 DC 4 Output Fuse Status TB1 2 PT 1 PT 2 NC BROWN WHITE BLUE RTD Transmitter 2 CHANNEL CONTROL AND MONITOR S N s after AFS 0074 3 4 SSR 8 3 4 SSR 8 LAMP 1 TB1 10 Spare Spare 2 of 2 12 31 2018 REV 11 Fort Defiance Industries 2 of 2 12 31 2018 REV 11 Fort Defiance Industries 79 78 TB1 8 MJ2 J3 FB2 6 FB2 5 FB2 3 3 9 750 mA Slow Blow 750 mA S...

Page 129: ...G SENSE EXC W R R BTX BRX GND ATX ARX N C RS485 V 0V J2 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 70 71 72 73 74 75 76 77 Q9 Q10 Q11 Q12 Q13 Programmable Logic Controller PLC TB1 3 TB1 12 GRAY BROWN WHITE BLUE BLACK RTD Module 2 MONITOR 2 of 2 7 14 2016 Fort Defiance Industries 79 78 MJ2 J 701 O TB2 7 703 G 702 W B GRAY BROWN WHITE BLUE BLACK WϮϭϯϭ ůĞĐƚƌŝĐĂů tŝƌŝŶŐ ŝĂŐƌĂŵ ůĂĐŬ Zd dƌĂŶƐŵŝƚƚĞƌ EΖƐ ͲϬϬϬϭ ƚŚƌŽƵŐŚ ͲϬϬϳϰ...

Page 130: ...SECTION A APPENDIX 124 ...

Page 131: ...A 1 Swagelok Fitting Installation Instructions 125 ...

Page 132: ...ody and turn nut Avoid unnecessary disassembly of unused fittings Use only long reducers in female Swagelok end connections See the instructions starting below for installation of Swagelok tube fittings O seal male connectors caps and plugs port connectors tube adapters positionable elbows and tees weld fittings depth marking tool and preswaging tool 10 10 INSTALLATION INSTRUCTIONS While holding t...

Page 133: ...ng the tightness of a tube fitting connection If the gauge will enter the gap additional tightening is required If the gauge will not enter the gap the fitting is sufficiently tightened 12 12 INSTALLATION INSTRUCTIONS Reassembly All Sizes You may disassemble and reassemble Swagelok tube fittings many times Always depressurize the system before disassembling a Swagelok tube fitting While holding the fi...

Page 134: ...g is accomplished with a captive O ring in the body component O Assemblies can be used from high pressure to critical vacuum within a wide range of temperatures Test ports at two locations for easy leak testing Female nut threads silver plated for easy assembly O ring contained completely for maximum efficiency Smooth finish on gland face ensures positive seal VCO Body VCO Gland VCO Nut VCO Fittin...

Page 135: ...A 2 PLC Data Sheet 129 ...

Page 136: ...Programming only CAN 1xCANPort Isolated1KV CAN Protocols CsCAN CANopen DeviceNet J1939 Ethernet Ethernet versions only Ethernet Protocols TCP IP Modbus TCP FTP SRTP EGD ICMP ASCII Remote I O SmartRail SmartStix SmartBlock SmartMod Removable Memory MicroSD SDHC SDXC IN FAT32 format support for 32GB max Application Updates Datalogging more Audio XLt only Beeper System or Software Controlled 1 1 Gene...

Page 137: ... ON to OFF Response 1 mS PWM Out 10 kHz Output Characteristics Current Sourcing Pos Logic See I O info below for detail regarding HSC and PWM Wiring Details Solid Stranded wire 12 24 awg 2 5 0 2mm2 Strip length 0 28 7mm Torque rating 4 5 7 lb in 0 50 0 78 N m technical specifications continued 1 8 Analog Outputs Number of Channels 2 Input Ranges Safe Input Range Input Impedance Clamped 0 5 VDC to ...

Page 138: ...0 50 N m V pin is not internally connected the SHLD pin is connected to Earth ground via a 1 Mȍ resistor and 10 nF capacitor MJ1 PINS PIN SIGNAL DIRECTION 8 TXD OUT 7 RXD IN 6 0V GROUND 5 5V at 60mA OUT 4 RTS OUT 3 CTS IN 2 RX TX IN OUT 1 RX TX IN OUT 3 2 Serial Communications MJ1 RS 232 w full handshaking or RS 485 half duplex RS 485 termination via switches biasing via software MJ2 PINS PIN SIGN...

Page 139: ...tion ON Terminated OFF 2 MJ2RS 485 Termination ON Terminated OFF 3 Bootload Always Off OFF 1 2 3 The DIP switches are used to provide a built in termination to both the MJ1 port and MJ2 port if needed The termination for these ports should only be used if this device is located at either end of the multidrop daisy chained RS 485 network Panel Cut Out 3 62 92mm 3 62 92mm 5 1 Installation Procedure ...

Page 140: ...kers 3 Do NOT make connection to live power lines 4 Make connections to the module first then connect to the circuit to be monitored 5 Route power wires in a save manner in accordance with good practice and local codes 6 Wear proper personal protective equipment including safety glasses and insulted gloves when making connections to power circuits 7 Ensure hands shoes and floor are dry before maki...

Page 141: ...A 3 VERIFY Product Information 135 ...

Page 142: ...ntegrating indicator as defined in ANSI AAMI ISO 11140 1 2 Product Device Description The VERIFY All In One STEAM Reusable Test Pack consists of a hollow tube shaped process challenge device PCD for steam sterilization A biological indicator chemical indicator or both a biological and chemical indicator are placed within the hollow center of the metal tube The PCD creates a challenge for air remov...

Page 143: ...ycle the steam sensitive chemical located within the strip will wick across the viewing window The dark color will completely fill the window if all air was removed from the reusable test pack and replaced by steam The VERIFY Reusable test pack comprises three models 1 Standard Test Pack 2 Test Pack with Step Counter 3 Test Pack with Tracker Tag VERIFY All In One STEAM Reusable Test Pack Standard ...

Page 144: ...tor is used on its own or in conjunction with a biological indicator for routine monitoring and release of steam sterilized loads INTEGRATING INDICATOR i5 VERIFY STEAM REJECT NO ACCEPT OK DARK BAR MUST ENTER ACCEPT WINDOW LOT 615 A EXP 20200601 During the test cycle the steam sensitive chemical located within the strip will wick across the REJECT viewing window and enter into the ACCEPT viewing wi...

Page 145: ...e specifically designed and approved by the FDA for testing an extended 10 minute cycle U S Patent Nos 7 740 802 7 718 125 and 7 790 105 Other patents pending nding Patented Plastic Sleeve Technology when used with the SteriScan Reusable Test Pack provides an accurate test of an extended 10 minute pre vac cycle 7 3 5 YUFOEFE ZDMF 5VCF 139 ...

Page 146: ...ositive Biological Indicators survival 7 3 5 Reusable Extended Cycle Test Pack Other BI Test Packs Time Elapsed 74 100 100 0 0 Challenges Extended Pre Vac Cycles Test Pack Resistance 270 F Pre Vacuum Cycle Percentage of Positive Biological Indicators survival 140 ...

Page 147: ...A 4 WRS Pump Information 141 ...

Page 148: ...mbing has been removed from the intake and discharge ports the pump can be readily disassembled 1 Remove the four 3 8 diameter bolts Ref No 3 that attach to front cover Ref No 9 of the body Then remove the cover and o ring gasket Ref No 8 Care should be taken not to pinch or shave the o ring gasket Ref No 8 between the adapter and the casing 2 The impeller Ref No 7 floats on the pump shaft sleeve ...

Page 149: ...ntil it bottoms This loca tion provides the proper seal tension for good surface contact between the seal and seat If the key is assem bled in the pump shaft before the shaft is threaded on it will provide a better grip for tightening Tighten setscrew Ref No 11 on sleeve See Figure 7 NOTE A short run in period may be necessary to provide completely leak proof seal operation NOTE It will be necessa...

Page 150: ...ler Installation Figure 6 Seal Seat Installation Seal Assembly Removal and Installation Figures 4 thru 7 Bronze and Cast Iron Models Close Coupled Turbine Pumps Bronze and Cast Iron Models Form L 4069 4 06 S N s AFS 0001 through AFS 0236 Shertech Operating Instructions Performance Specifications and Parts Manual 144 ...

Page 151: ...edestal Base Form L 4069 4 06 Please provide following information Model number Serial number if any Part description and number as shown in parts list Contact a Shertech Distributor Distributors can be found at www shertech com or www hyproindustrial com The factory only sells pumps and parts to distributors S N s AFS 0001 through AFS 0236 145 ...

Page 152: ...eeks depending on the duty cycle During this period KORGNNGTU CTG ſPFKPI VJGKT J FTCWNKECNN balanced position 3E Adjustments No adjustments are required or advis able on new pumps Because of the ENQUG ſVU KP TGIGPGTCVKXG VWTDKPG RWORU it is not uncommon for the pump to be FKHſEWNV VQ VWTP QXGT D JCPF CHVGT VJG have been allowed to dry out inside New pumps from the factory are tested using rust inh...

Page 153: ...y load after approximately ſHVGGP OKPWVGU QH QRGTCVKQP 3I Stopping It is best to stop the pump with the least discharge head possible both for minimizing strain on components and to be in low power mode in anticipation of T31 SERIES 4 Maintenance CLOSE COUPLED PUMPS A Seals B Cooling Water C Lubrication 4A Seals Mechanical seals are used in MTH Pumps to eliminate the maintenance that is normally a...

Page 154: ...CP ƀCV UWTHCEG Look into the opening in the center of the motor bracket and you will see a portion of the seat Insert the 11 16 dowel and very gently tap the seat until it drops out Care must be taken with the seat It is often a brittle material and is prone to breakage It is recommended that a new re placement seat be installed during reassembly 5C Inspection of Components Thoroughly clean all pa...

Page 155: ...G ő1Œ TKPI KPVQ VJG QWVUKFG ő1Œ TKPI ITQQXG KP VJG OQVQT bracket Place the two 2 smaller O rings 8 into the smaller O ring grooves 9 Place the cover 2 over the motor bracket and install the four 4 M6 1 X 80mm bolts 19 Tighten the bolts systematically alternating diagonally across the cover DO NOT exceed 7 11 ft lbs of torque or damage to the motor C face may occur 5E Testing and Final Adjustment T...

Page 156: ...all the bearings on the shaft prior to install ing the shaft into the pedestal A UVGGN őFQPWVŒ YKVJ VJG RTQRGT KPUKFG diameter and outside diameter Refer to Chart 1 should be used between the arbor face plate and the lower bearing to insure proper installation and to prevent bearing damage The bearings must seat against the shoulder for proper alignment Refer to Figure 5 7 Also refer to Alternate ...

Page 157: ... installed on the shaft WUKPI VJG HQNNQYKPI RTQEGFWTG This procedure is not recommended and should only be used in an emergency situation 5E Testing and Final Adjustments 1 Check to be sure that the rotating assembly turns freely Turn the shaft by hand If it is tight or rough spots are encountered it is likely that at least one of the bearings was damaged during disassembly assembly operations and...

Page 158: ...A 5 Vacuum Leak Test Troubleshooting Guide 152 ...

Page 159: ...GASKET ARE THE THREE DOOR POST BOLTS TIGHT E G 90 IN LBS IS THE DOOR POST O RING IN GOOD CONDITION WHEN JACKET IS AT PRESSURE AND DOOR OPEN IS THERE A SOUND OF CONDENSATION SIZZLING BEHIND BACK CHAMBER BAFFLE REPLACE VACUUM EXHAUST CHECK VALVE IN WRS REPLACE CONDENSATE CHECK VALVE IN WRS NO END YES CONTACT FDI techsupport fortdefianceind com 865 408 0100 REPLACE STERILIZE VALVE YES NO NO NO NO NO ...

Page 160: ...rance Colorless clean without sediment Hardness 10 mg L Total Dissolved Solids TDS 50 ppm NOTE 1 Reference Section 2 5 Water Supply Quality It is the responsibility of the user to supply feedwater that meets FDA bottled water criteria 2 Reference Section 3 4 Operational Checklists Testing Total Dissolved Solids TDS FDA Required Water Changeout and Testing Free Chlorine Level It is the responsibili...

Page 161: ...ly cleaned and maintained as required in the P2131 Technical Manual 3 Components considered to be of a consumable nature e g O rings water test strips filters or components that will require replacement per the maintenance schedule 4 Parts and accessories not purchased through FDI nor product failure or damage associated with parts not purchased through FDI 5 Charges by anyone for adjustments repa...

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