BodyGuard Series Performance Verification Procedure Check List Issue 19

Performance Verification Procedure BodyGuard Classic and Color Vision 323 (BodyGuard) / 545 (BodyGuard Epidural) / 575 / 595 (BodyGuard Pain Manager) Volumetric Pumps Model / Serial Number:

Service Order / Inventory Number:

Hospital Name / Reference:

Software Version:

Physical Inspection and Clean. Replace damaged labels. ¨ Perform Test Verification Workflow. Enter Technician Code 21377 for BodyGuard 323 Color Vision™, 911 for BodyGuard 545 / 575 / 595 Color Vision™. Keypad Test All keys must operate without failure ¨ Display Test Verify operation of all display pixels ¨ Alarm sounds Alarm Test ¨ Door Position Verify smooth movement ¨ Door Test / Pressure Plate Trigger Door Open Alarm Test ¨ Air Sensor Test Air Sensor (with primed set) Verify Liquid and >320mV ¨ Motor Test ¨ 50±4 without set. Connect to manometer and check actual pressure Pressure Sensor Test on pump versus manometer. Pump should stop pumping when the ¨ actual pressure reaches the occlusion setting +200/−100mmHg. 14PSI +4/−2 at 125ml/h OR ____PSI Occlusion Alarm 10PSI +4/−2 at 125ml/h for BodyGuard 575 ColorVision™ Voltage Test Only DC power is relevant (when pump is connected to main power) ¨ Primary Battery Run Time Test ¨ 3V Li Back-up Battery Test ¨ Air Sensor Distance Test Use Go / No Go tool 2.2–2.3mm (P/N: 111-003X) ¨ RS232 Communication Test ¨ DC Extension Cable Verify DC extension cable connector operation ¨ Bolus Delivery Verify Bolus Delivery operation ¨ Check Pump Continuity ≤0.8 ohm ¨ Set / Confirm Time and Date Info/set up/more/901/set Time and Date ¨ Set Service Date / Hours Tech Mode/911 or 21377/Hours Counter ¨ Volume Accuracy

Zero Rates, Clear Logs

Charger

Electrical Safety Tests

Electrical Safety Tests (Class II Type CF)

Verification Performed By

Delivery of 25ml±5% at 125ml/hr in Continuous Mode. For 545/575/595 access Technician Menu and perform delivery in Volume Test.

_____ml

Set rate to zero (or lowest value possible) ¨ Clear Volume Infused and VTBI. ¨ Clear Error / Alarm / Battery logs (as required) ¨ Customer Charger Available? Yes ¨ / No ¨ If No, Test Charger to be used. Physical Inspection and Clean. ¨ Replace damaged labels on Customer Charger. ¨ Charger Voltage Output 9.0 ± 0.5V ¨ Class II Type CF Test results are stored: Test in accordance with Electronically ¨ EN 60601-1 standard Print-out ¨ PASS / FAIL and test equipment Other ¨ operation manual. _____________________________ Normal condition, polarity normal, reverse powerline OK ≤500µA _______ Earth Leakage Single fault condition, polarity normal and reverse powerline CUT ≤1000µA _______ Normal condition, polarity normal and ¨ Patient Leakage reverse powerline OK, earth OK ≤100µA (Standard leakage Single Fault Condition, polarity normal and equipment and ¨ reverse powerline CUT, earth OK ≤500µA procedures. Patient Single Fault Condition, polarity normal and access is pump door.) ¨ reverse powerline OK, earth OK ≤500µA __________________ Sign

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