INFINITI PM Data Sheet
INFINITI PM Data Sheet
NOTE: Throughout this checklist, fill in the requested data or indicate completed. Explain N/A’s in notes section of this document.
Equipment Calibration Number Calibration Due Date
Equipment
Test
2.1.1 Inspect and clean front panel touchscreen. 2.1.8 Check Fluidic Module Hub Rollers
2.1.2 Verify Front Panel Display movement 2.1.9 System Cooling
2.1.3 Inspect and clean internal console 2.1.10 IV Pole test
2.1.4 Check ground resistance 2.1.11 CPC Connector
2.1.5 Inspect system hardware 2.1.12 Inspect Pneumatic Air and Moisture Filters
2.1.6 Visually inspect all cables, connectors, PCB’s, etc 2.1.13 Replace system covers
2.1.7 Check and tighten casters. 2.1.14 Video Output Test (see step 2.2.13)
2.2.2. REMOTE CONTROL TEST 2.2.2.3 Verify system changes between selected steps
2.2.3.1 FMS AUTO LOAD 2.2.4.1 Verify footswitch icon indicates position 0.
2.2.3.1.3 Verify FMS Latch Mechanism pulls/holds FMS 2.2.4.3.1 Observe change from position 0 to 1 and to 2.
2.2.3.1.4. Record REL from the About Screen 2.2.4.3.2 Coag power increases from 0-100% as pedal depressed
2.2.3.2 ASPIRATION SENSOR CALIBRATION 2.2.4.4 No intermittent response: COAG Power or FTSW icon.
2.2.3.2.1. Verify FMS calibration passed 2.2.4.6 Verify footswitch detects vibration.
2.2.3.3 IRRIGATION FAILSAFE 2.2.4.7 Verify footswitch vertical, horizontal, and treadle
2.2.3.3.4. Verify list of faults displayed switches (left and right for each).
Form ITCDOC-000360, Version 4.0, Page 1 of 2 Parent Document: ITCSOP-000637 Supercedes: S0637-01
Data Sheet for Infiniti Vision System
2.2.5.3. OCCLUSION TEST
2.2.5.3.1 Measurements:
VACUUM LIMIT ASPIRATE RATE SPECIFICATION Reading on Display
6 12 0 to -16 mmHg - mmHg
26 15 -16 to -36 mmHg - mmHg
65 25 -55 to -75 mmHg - mmHg
400 40 -360 to -440 mmHg - mmHg
600 60 -540 to -660 mmHg - mmHg
2.2.5.4 RESIDUAL PRESSURE 2.2.5.5 ASPIRATION FLOW RATE – Indicate test method used to verify flow rates:
2.2.5.4.3 Three readings ≤ 15mmHg at 100mmHg FLOWMETER or BEAKER
2.2.5.4.4 Three readings ≤ 15mmHg at 400mmHg 2.2.5.5.1 ( cc/min) FLOW RATE at 35cc/min (30-40cc/min)
2.2.5.5.2 ( cc/min) FLOW RATE at 25cc/min (21-29cc/min)
2.2.5.4.5 Three readings ≤ 15mmHg at 600mmHg
2.2.6. PNEUMATICS TEST 2.2.7. CAUTERY TEST
2.2.6.1 Method: DPM III/Scopemeter N/A 2.2.7.1 ( ohms) Cautery Test Load (75.0 ± 4.0 ohms)
2.2.6.1.4 ( mVp) ≥+231.84 mV at 50cpm 2.2.7.4 ( MHz) Coag frequency (from 1.43 to 1.67 MHz)
2.2.6.1.5 ≥+231.84mV for each cut rate 100-800 2.2.7.5 ( VRMS) Coag voltage at 100% (24.4 to 30.4 VRMS)
2.2.6.2 Method: Probe Drive Test Box/Scopemeter N/A 2.2.7.6 ( VRMS) Coag voltage at 50% actual (17.4 to 21.4 VRMS)
2.2.6.2.5 Peak output > 23psi (1.15Vpp or 2.3 div) 2.2.7.7 ( VRMS) Coag voltage at 25% actual (12.2 to 15.2 VRMS)
2.2.8 PHACO AND NEOSONIX DRIVE TEST 2.2.8.3. NEOSONIX DRIVE TEST
2.2.8.1. NeoSonix Load Box Verification. 2.2.8.3.5.1. ( VRMS) 1.785 to 3.775 VRMS
Unable to use NeoSonix Loadbox, go to Step 2.2.9 2.2.8.3.5.2. ( %) 57% to 63% of Duty Cycle
2.2.8.1.1 ( Kohms) Connector pin 9 and GND (2.37-2.62 kΩ) 2.2.9 CUSTOMER HANDPIECE CHECK: (perform these tests if customer will
2.2.8.1.2 ( ohms) MOTOR OUTPUT and GND (9.5-10.5Ω) provide the use of their handpieces or unable to use Loadbox Check here if
handpieces not available )
2.2.8.1.3 ( ohms) MOTOR OUTPUT and MOTOR 1 (9.5-10.5Ω)
2.2.9.1. Customers handpiece(s) operated properly per procedure
2.2.8.1.4 ( ohms) MOTOR OUTPUT and MOTOR 2 (9.5-10.5Ω)
Record Customer Handpiece Serial Number(s) (Any additional Handpiece put in
2.2.8.2 PHACO DRIVE TEST Notes Field): (T= Torsional/P=Phaco/N=NeoSonix):
2.2.8.2.5.1 ( VRMS) 4.62 to 6.93 VRMS (S/N T P N )
2.2.8.2.5.2 ( kHz ) 33.5 to 37.5kHz (S/N T P N )
2.2.10 AQUALASE DRIVE AND PNEUMATIC TEST 2.2.11 CUSTOMER AQUALASE HANDPIECE CHECK
2.2.10.1.1 Aqualase™ Load Box Verification. ( ohms) (perform these tests if customer will provide the use of their handpieces or unable to
(23.0-27.0Ω) use Loadbox.. Check here if handpieces not available )
Unable to use Aqualase Load box, go to Step 2.2.11 Record Customer Handpiece Serial Number(s) (Any additional Handpiece put in Notes
Field): (S/N )
2.2.10.1.4 Verify Setup screen states “Aqualase™ Test Tuned”
(S/N )
2.2.10.2. AQUALASE LOAD BOX USAGE
2.2.11.2 AQUALASE HANDPIECE TUNING
2.2.10.2.6 In Magnitude Linear, Limit 100, Pulse, 50pps and
Burst Linear, Limit 100, press F/S to pos. 3: verify: 2.2.11.2.2 Verify H/P passes tune status displayed on LCD Display
• MAGNITUDE varies 0 to 100, PULSE displays 50pps, 2.2.11.3 AQUALASE HANDPIECE USAGE
BURST varies 0 to 100 2.2.11.3.4 In Magnitude Linear, Limit 100, Pulse, 50pps and Burst Linear, Limit
2.2.10.2.7 ScopeMeter above 280vpp, DPM reading above 5psi 100, press F/S to pos. 3; verify:
• MAGNITUDE varies 0 to 100, PULSE displays 50pps, BURST varies 0 to 100,
Aqualase H/P buzzing sound, Pneumatic Pump occasionally on
2.2.11.3.8 In Magnitude Fixed, Limit 100, Pulse displays 50pps and Burst Fixed,
Limit 100, press F/S to pos. 3; verify:
• MAGNITUDE indicates 100, PULSE displays 50pps, BURST displays 100,
Aqualase H/P buzzing sound, Pump occasionally on
______________________________________ __________________
Test Performed By (PRINT) Date
Notes:
Form ITCDOC-000360, Version 4.0, Page 2 of 2 Parent Document: ITCSOP-000637 Supercedes: S0637-01