EPS20 Cardiac Stimulator Safety

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EPS20 Cardiac Stimulator Safety

• Installation issues
• Safety Warnings and Notes
• Configuration
• Stimulator Safety Features
• Safety in demonstrating system
• Safety in routine application

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1. Installation Issues

• Isolation transformer
• RF filtered Patient Connection Box
• In-line RF Filter
• Stim extension cable
• Good External ECG channel setup
• Demonstration of safety features
• IEC60601-1 test before patient

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2. Safety Warnings

• Go through User Manual Warnings Section with
  customer
• Explain RF Filtering
• Explain, determine and set safety limits
• Stimulator is not Life Support Device

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Causes of Failure to Pace
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Mitigations for Failure to Pace
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3. Stimulator Configuration

• Lower limits for S1
• Pace
• Burst Pace
• Auto-decremented
• QRS sync timeout
• Idle safety timeout

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4. Stimulator Safety Features

• Lower limit S1 interlocks
• Data entry validation
• Lead High Impedance warning
• Emergency Pace - F12
• Backup Pace BACKUP ENABLE
• Emergency Fixed Rate Pacing
• Warning Messages e.g Defib

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5. Safety in demonstrating EPS320

• What harm can you cause patient ?
• How can you bring about this harm ?

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5. Safety in demonstrating EPS320

• Potential Patient harms
• Asystole
• VF induction
• VT acceleration
• VT failure to Burst Overdrive
• inadvertent VT termination

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AsystoleCauses of Failure to Pace in Asystole

• Asystole may not be noticed
• Not select PACE protocol - in panic
• Pace into A instead of V
• Current too low
• Leads / Stim Channel not connected
• EP Recorder Stim setting wrong
• Failed EP Recorder Stim Relays

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Asystole Failure to pace -Remedies
Remedies All solved with F12 function

• Not select PACE protocol -in panic
• Pace into A instead of V
• Pace at to low a current
• EP Recorder stim setting wrong
• Leads disconnected
• Failed EP Recorder Stim relays

1. High impedance warning 2. Use EP Recorder
Bypass
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Ventricular Fibrillation Induction - User Fault

• Accidental Burst Pace S1lt200ms
• Unsynchronised Stimulation - R on T
• Burst Pacing into VT
• Pace with S2-S7 too short
• Excessive stimulation current
• Remedy Use PACE for all non-burst
• Remedy Set safety limits /vigilance

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Ventricular Fibrillation Induction - Equipment
fault

• DC current Stimulation - Stimulator fault or
  external source - e.g. RF Ablation energy
• Remedy Note alarm and disconnect patient
• Micro-electrocution - Exposed catheter pins /
  attached equipment non-isolated
• Remedy check and remove

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VT Acceleration

• Accidental Pacing into VT
• Remedy ready to stop pacing in VT induction
• Remedy Use StopOnTachy feature
• Load ATP protocol with S1 too low
• Remedy ensure good QRS sensing

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Inadvertent VT termination

• Continuation of pacing once VT induced
• Remedy be ready to stop pacing when VT induced
• Remedy Use StopOnTachy feature, ensuring good
  ECG sensing during sinus arrhythmia