On this page
Asset Type
Manufacturer
Model
What This Guide Helps With
Troubleshoots process temperature or pressure conditions that prevent cycle progression because of utilities, loading, leakage, environmental, or service-level causes.
Step-by-Step Troubleshooting
1. Protect the Load and Stop Questionable Processing
Do not consider a load successfully processed when the reprocessor cannot achieve or maintain required process conditions. Move processing to another validated workflow.
Expected outcome: No potentially underprocessed device is released for clinical use, and troubleshooting occurs without compromising patient care.
2. Confirm the Exact Condition
Determine whether temperature or pressure rises slowly, never reaches the required process value, reaches it and then falls, or produces an abort. Record any displayed message and the point in the cycle where the problem occurs.
Expected outcome: The failure pattern is clearly documented. If normal conditions are later achieved, a full verification cycle is still required before return to service.
3. Check for Visible Leakage or Door-Sealing Problems
Inspect the door area, chamber exterior, hoses, fittings, and surrounding floor for visible leakage. Verify the door closes and seals normally without obstruction.
Expected outcome: No external leak or door problem explains the inability to maintain process conditions. If correcting a loading or sealing obstruction restores normal operation, verify a full cycle and stop.
4. Verify Required Facility Utilities
Confirm required water, electrical power, and any other facility service supporting the process is available and stable. Ask whether utility maintenance or outages recently occurred.
Expected outcome: External utilities are available. If restoration of a facility utility corrects the condition, verify complete cycle performance before stopping.
5. Verify Load and Accessory Configuration
Confirm that the load, processing tray, tubing, adapters, and accessories are correctly positioned. An incorrectly configured load can interfere with normal circulation or process sensing.
Expected outcome: The processing setup is correct. If correcting load configuration restores normal conditions, complete final verification.
6. Check Environmental Conditions
Look for obvious environmental factors such as unusually cold incoming water conditions, excessive room temperature, blocked external ventilation, or recent relocation that could affect operation. Do not obstruct ventilation openings.
Expected outcome: The equipment is operating in a normal environment without obvious external thermal restrictions.
7. Observe the Process Trend
Run an approved test cycle while observing displayed temperature, pressure, cycle progression, and alarms. Do not compare values against invented limits; use the system's own normal cycle behavior and approved documentation.
Expected outcome: Temperature and pressure progress normally and remain sufficient for cycle completion. If they do after correcting an external cause, troubleshooting can stop after verification.
8. Compare Repeated Behavior
If permitted, repeat the test with an approved standard load or setup to determine whether the condition follows a particular load arrangement or occurs regardless of load.
Expected outcome: A load-related cause is either identified or ruled out. Persistent failure independent of load indicates the need for service escalation.
9. Perform Final Functional Verification
After correction, complete a full approved cycle and verify normal process progression, absence of leaks or alarms, successful completion indication, and proper cycle record.
Expected outcome: The unit reliably reaches and maintains required process conditions. Troubleshooting can stop.
10. Escalate an Unresolved Process-Control Problem
If utilities, door sealing, load configuration, and environmental conditions are acceptable but the unit still cannot achieve or maintain its process conditions, discontinue use.
Expected outcome: The SYSTEM 1E is removed from service for qualified evaluation.
If the Problem Persists
External utility, environmental, door, leakage, and loading causes have been ruled out. The remaining condition may involve internal heating, fluid control, pressure sensing, temperature sensing, circulation, sealing, or process-control components.
Remove the system from service, label it Out of Service, and arrange repair or bench evaluation. Qualified personnel should use appropriate STERIS documentation and approved test equipment for diagnosis, repair, calibration, or configuration.
Return-to-service testing must demonstrate reliable process control and completion of required functional testing before clinical use.
Knowing when to stop rather than repeatedly attempting failed cycles is proper troubleshooting.
Clinical Use Tip
If required process conditions were not achieved, the load should remain segregated and be reprocessed using an approved validated method.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Sterile Processing reported the SYSTEM 1E repeatedly aborted because the process conditions would not stabilize."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found the door sealing area obstructed by an incorrectly positioned processing accessory."
Resolution
What action was taken.
Example:
"Corrected accessory placement, verified proper door sealing, and completed a full functional cycle with normal process progression and no alarms."
Helpful Details to Include (If Known)
- Whether temperature, pressure, or both were affected
- Exact displayed message
- Cycle phase
- Door and sealing condition
- Water and power availability
- Recent utility work
- Load configuration
- Environmental conditions
- Presence of visible leakage
- Results of repeated test cycle
- Final device status
Final Thought
Treat process-condition failures as potential sterilization or reprocessing failures, verify external utilities and setup first, confirm correction with a complete cycle, and escalate persistent control problems appropriately.
That is successful troubleshooting.