IRADIMED 3880 Preventive Maintenance Procedure Rev B

2.0

3.0

4.0

Battery Indicator Verification 2.1

Install 1133 battery. Connect the AC mains powered 1120 DC Charger and 1122 cable to the rear of the unit and verify front panel ON/CHARGE LED is lit Orange as the 1133 charges. This LED glows green when the 1133 is fully charged.

2.2

Turn Rotary switch to MONITOR ON position. Verify A/C plug & battery indicator icons are shown on the upper right portion of the display.

2.3

Remove 1133 battery, verify front panel ON/CHARGE LED is lit Green and Monitor is on.

2.4

Verify battery indicator show “X” in the upper right portion of the display.

2.5

With no PODs inserted into both Charger holsters; verify that the Yellow/Orange and Green LEDs alternately flash on the rear of the Monitor, indicating no PODs are present.

2.6

Insert a POD into the Left Charger holster and verify that the LEFT POD Yellow/ Orange (while charging) or Green LED is constantly lit (not flashing) when fully charged.

2.7

Insert a POD into the Right Charger holster and verify that the RIGHT POD Yellow/ Orange (while charging) or Green LED is constantly lit (not flashing) when fully charged.

Display Verification 3.1

Inspect for damage or scratches on the display window area.

3.2

Touch the upper-left portion of the display screen. Verify that the Channel selection dropdown box is shown. Touch the same part to close the box.

3.3

Touch the Adult/Pediatric/Neonatal box on the top middle portion of the display screen. Verify that the Adult/Pediatric/Neonatal drop-down box is shown. Touch the same part to close the box.

3.4

Touch the upper-right portion of the display screen. Verify that the ECG menu is displayed. Press BACK to close menu.

3.5

Touch the lower-right portion of the display screen. Verify that the NIBP menu is displayed.

3.6

Touch the Diastolic Low Limit UP/DOWN arrow. Verify the slide bar changes up/down.

Pressure Sensor Verification & Calibration 4.1

Press SETTINGS key on the keypad. On the display, touch Service Mode, Enter Password: 1025, ENTER, then NIBP Service.

4.2

Verify AN00: NIBP-DC is 0.060V +/- 0.010V. If value is out of spec, remove the left side panel and adjust ‘DC Offset’ Pot R145 (middle pot) accordingly.

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4.3

Verify AN01: NIBP-AC is 1.1900V +/- 0.015V. If value is out of spec, remove the left side panel and adjust ‘AC Offset’ Pot R287 (bottom pot) accordingly.

4.4

Connect airline from AMETEK PK11 Dead Weight Tester (or equivalent) to NIBP input port. Set Valve & DValve to CLOSE. Apply 150mmHg pressure on Dead-Weight Tester and verify proper pressure reading of 150mmHg +/- 1mmHg as shown in the AN00: NIBP-DC box on the display. Disconnect Dead Weight Tester from NIBP input port and verify 0.00 mmHg pressure reading. Repeat several times to verify accuracy of reading. 4.4.1

4.5

5.0

6.0

If pressure reading is out of spec, remove the left side panel and adjust ‘DC Gain’ Pot R152 (top pot) for proper pressure reading of 150mmHg +/- 1mmHg as shown in the AN00: NIBP-DC box on the display. If necessary, readjust ‘DC Offset’ Pot R145 (middle pot) to = 0.060V +/- 0.010V). Repeat step 3.4 above several times to achieve accurate pressure sensor calibration.

Apply 250mmHg pressure on Dead-Weight Tester and verify reading of 250mmHg +/- 2mmHg as shown on the display. Disconnect Dead-Weight Tester from NIBP input port and exit menus.

3881 ECG POD Interface Verification 5.1

Press the Power ON (I) button on the 3881 ePOD. With Channel selection option on the upper left of the Monitor display, select desired Channel then set the ePOD to the same Channel. Verify CONNECTED LED is illuminated on the ePOD.

5.2

Verify “e” battery indicator is shown on the upper right portion of the display. The “e” indicates proper radio link is established. Verify link margin of the RF link remains solid as the ePOD distance is increased to approximately 10 meters in an unobstructed ‘open field’.

5.3

Connect ePOD to a Fluke ProSim 8 Simulator (or equivalent) using the 1811 or 1811E ECG Lead Set (follow color code for wires used). Power ON the Fluke ProSim 8 simulator and select ECG. Verify ECG waveform is displayed on the Monitor screen.

5.4

Remove the RA/R lead on the Fluke ProSim 8 Simulator and verify “ECG Lead Fail” message is displayed on the screen, no waveform, HR, and audible alarm sound every 10 seconds.

5.5

Reconnect the RA/R lead on the Fluke ProSim 8 Simulator and verify waveform and HR is present, no message, and no alarm.

5.6

Touch the upper left portion of the display for leads III, aVR, aVL, aVF, V, and I and verify a waveform is detected for each lead.

5.7

Touch the ECG Vital Signs box. Exercise the HR Limit bar-line by pressing the up and down arrows on each end and by dragging the H and L left to right. Set L=30 & H=250. Press Back to exit ECG Menu. Press ePOD Power OFF. Cycle the Monitor Power OFF/ON.

3882 SpO2 POD Interface Verification 6.1

Press the Power ON (I) button on the 3882 oPOD. Set the oPOD channel to the same Channel as what is set on the Monitor. Verify CONNECTED LED is illuminated on oPOD and “SpO2 Probe Off” message is on the Monitor display. PM005 Rev. B

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7.0

6.2

Verify “o” battery indicator is shown on the upper right portion of the display. The “o” indicates proper radio link is established. Verify link margin of the RF link remains solid as the oPOD distance is increased to approximately 10 meters in an unobstructed ‘open field’.

6.3

Attach finger grip to Fiber Optic Cable of oPOD (white button with IR goes to #2). Connect SpO2 cable with IR side as labeled to the ProSim SPOT SpO2 Test Module. Verify momentary message “SpO2 Searching” then goes away when waveform is detected.

6.4

Press SpO2 on the Fluke ProSim 8 Simulator and change the Test Value: 70% and Heart Rate: 30bpm. Verify Monitor readings match the simulator settings (+/-10%).

6.5

Change the Test Value: 85% and Heart Rate: 150bpm. Verify Monitor readings match the simulator settings (+/- 10%).

6.6

Change the Test Value: 100% and Heart Rate: 240bpm. Verify Monitor readings match the simulator settings (+/-10%). Press oPOD Power OFF. Cycle the Monitor Power OFF/ON.

3883 Invasive Pressure POD Interface Verification (if equipped) NOTE: The 3883 ipPOD uses a 2.5V reference voltage, the accuracy produced by commercial Invasive Pressure simulators has been found to be poor. Expect errors of approximately +/- 7mmHg as normal and within ‘spec’ of such simulators using the low (2.5V) excitation of the 3883. Alternate IBP Test using a Simulator (step 7.5) can be performed instead of step 7.4. 7.1

Install 1887 Dual Radio Module to the rear of the Monitor. Turn Rotary switch to MONITOR ON. Press SETTINGS key on the keypad. On the display, touch Parameter Setup to turn ON the IBP1 & IBP2 options.

7.2

Press the Power ON (I) button on the 3883 ipPOD. Set the ipPOD channel to the same Channel as what is set on the Monitor. Verify CONNECTED LED is illuminated on ipPOD.

7.3

Verify “ip” battery indicator is shown on the upper right portion of the display. The “ip” indicates proper radio link is established. Verify link margin of the RF link remains solid as the ipPOD distance is increased to approximately 10 meters in an unobstructed ‘open field’.

7.4

IBP Test Using a Pressure Transducer and Pressure Source: 7.4.1

Verify IBP1 Disconnect and IBP 2 Disconnect (no connection to ipPOD input cables) messages are shown on the display.

7.4.2

Attach a “known good/accurate” pressure transducer and accurate pressure source to the ipPOD P1 and P2 connectors; verify Disconnect message clears.

7.4.3

In the 3880 IBP1 Menu, set the scale range for 300mmHg. Ensure pressure transducer and accurate pressure source is set to “0” then press Cal Zero; verify IBP1 displayed numbers 0/0 (0) +/- 2 mmHg.

7.4.4

Connect pressure transducer and accurate pressure source set to 300mmHg; verify IBP1 displayed numbers 300mmHg +/- 12mmHg.

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7.5

8.0

7.4.5

In the 3880 IBP2 Menu, set the scale range for 300mmHg. Ensure pressure transducer and accurate pressure source is set to “0” then press Cal Zero; verify IBP2 displayed numbers 0/0 (0) +/- 2 mmHg.

7.4.6

Connect pressure transducer and accurate pressure source set to 300mmHg; verify IBP2 displayed numbers 300mmHg +/- 12mmHg.

Alternate IBP Test Using a Simulator: 7.5.1

Connect IBP1 and IBP2 cables to Fluke ProSim8 Simulator with IBP test cables. Press Zero Channel 1 and Zero Channel 2 on the simulator. On the Monitor press Cal Zero on both IBP1 and IBP2 Menu.

7.5.2

Set both IBP1 and IBP2 channels of the Simulator for ‘Arterial’ and verify simulation pressure of 120/80 +/- 6mmHg.

7.5.3

View 3880 display of IBP1 waveform and IBP2 waveform. Verify both channels waveforms are the same.

NIBP Verification 8.1

Leak Test Connect a 200mL Fixed Volume Chamber to the NIBP Cuff port. Press SETTINGS key on the keypad. Touch Service Mode, Enter Password: 1025, ENTER, NIBP Service, Leak Test; this will close the Valve and DValve then start the automated leak test which will apply a High (250mmHg), Medium (150mmHg), and Low (50mmHg) pressure to the fixed volume chamber. Allow the leak test to run for a minimum of Cycle ≥ 9 as indicated on the screen. Verify no gross leaks. Verify Fail ≤ 2% of the number of run cycles as indicated on the screen. Press Leak Test again to stop the automated test. Touch Back on the display to exit menu. Disconnect fixed volume chamber from the NIBP Cuff port.

8.2

NIBP Flow Check Connect Flow Meter (TE#248 or equivalent) to NIBP port. Press NIBP on the keypad and verify a flow rate of about 1 LPM on the Flow Meter.

8.3

Neonatal Over-Pressure Verification Connect tubing to Monitor NIBP CUFF port and Fluke ProSim 8 Simulator. Connect a Neonatal Cuff to the tubing. On simulator, set NIBP settings Pressure: 100/65, Heart Rate: 75bpm, and Wave: Neonatal. Select Neonatal Mode on the top right of the Monitor display. Press NIBP key on the keypad and allow the cuff to inflate to above 100 (as shown on the bottom right of the NIBP Vital Sign box) then squeeze the cuff to create an over-pressure. Verify an “NIBP Over Press” message on the display, audible alarm tone and LEDs on top of the Monitor. Touch “NIBP Over Press” message to clear error message.

8.4

Neonatal Cuff Inflation Time Verification Tighten the Neonatal Cuff to the Mandrel. On Fluke ProSim 8 Simulator, set NIBP settings to Pressure: 100/80, Heart Rate: 60bpm. Using a stopwatch, measure the time it takes for the cuff to inflate to >100 (as shown on the bottom right of the NIBP Vital Sign box) after the NIBP key on the keypad is pressed. Verify time is <15 seconds. Cycle the Monitor Power OFF then ON. PM005 Rev. B

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8.5

Neonatal NIBP Range and Accuracy On the Fluke ProSim 8 Simulator, set NIBP to Pressure: 100/65, Heart Rate: 240bpm, Pulse Volume: 0.30mL, Envelope Shift: -10%. Press NIBP key on the keypad and allow the cuff to inflate. Verify the Monitor displays 100/65/240 +/- 10 on the NIBP Vital Sign box. Repeat the above step with the following settings on the simulator and verify the Monitor readings are within +/- tolerance: SETTINGS Pressure: 80/50, Heart Rate: 240bpm Pressure: 60/30, Heart Rate: 240bpm

8.6

READING +/- 10 +/- 5

Remove Neonatal Cuff and Mandrel from the tubing. Adult/Pediatric Over-Pressure Verification Loosely fit an Adult Cuff to the Mandrel then connect it to the tubing. On Fluke ProSim 8 Simulator, set NIBP and verify settings of Pressure: 120/80, Heart Rate: 60bpm, Wave: Adult, Envelope Shift: 0%. Select Adult Mode on the top right of the Monitor display. Press NIBP key on the keypad and allow the cuff to inflate to above 150 (as shown on the bottom right of the NIBP Vital Sign box) then squeeze the cuff to create an over-pressure. Verify an “NIBP Over Press” message on the display, audible alarm tone and LEDs on top of the Monitor. Touch “NIBP Over Press” message on the display to clear error message.

8.7

Adult Cuff Inflation Time Verification Tighten the Adult Cuff to the Mandrel. On the Fluke ProSim 8 Simulator set NIBP settings to Pressure: 165/80, Heart Rate: 60bpm. Using a stopwatch, measure the time it takes for the cuff to inflate to >165 (as shown on the bottom right of the NIBP Vital Sign box) after the NIBP key on the keypad is pressed. Verify time is <60 seconds. Cycle the Monitor Power OFF then ON.

8.8

Adult NIBP Range and Accuracy On the Fluke ProSim 8 Simulator set NIBP settings to Pressure: 150/100, Heart Rate: 120bpm, Pulse Volume: 0.30mL. Press NIBP key on the keypad and allow the cuff to inflate. Verify the Monitor displays a reading of 150/100/120 +/-10 on the NIBP Vital Sign box. Repeat the above step with the following settings on the simulator and verify the Monitor readings are within +/- tolerance: SETTINGS Pressure: 100/65, Heart Rate: 120bpm Pressure: 60/30, Heart Rate: 120bpm

8.9

9.0

READING +/- 10 +/- 5

‘Dead Man’ Test Cycle the Monitor Power OFF then ON. Remove Adult Cuff and Mandrel from simulator connection and connect to 1831 NIBP hose assembly. Press NIBP key on the keypad and allow the cuff to inflate. Verify the Monitor displays a reading of 0/0/0 on the NIBP Vital Sign box. Cycle the Simulator and Monitor Power OFF/ON.

CO2 Verification (if equipped) The optional CO2 Module has a range of 0 - 76 mmHg. 9.1

Connect AALBORG Mass Flow Meter (or equivalent) test equipment with filter to CO2 ONLY input port. On the display, touch Parameter Setup then CO2 OFF button. Verify CO2 pump PM005 Rev. B

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turns on and CO2 ON is displayed on the screen. Touch Back twice to exit menus and verify CO2 Vital Signs box is now shown on the display. Verify for suction flow of 0.095 LPM +/0.015 LPM as indicated by the Mass Flow Meter.

10.0

9.2

Remove Mass Flow Meter and connect 1842A Adult CO2 Nasal Cannula with filter to CO2 ONLY input port. Breathe into Nasal Cannula and verify CO2 and Respiration activity on the Monitor and Tablet display. Remove Nasal Cannula from CO2 ONLY port.

9.3

Connect M0127 CO2 Calibration Gas [4% CO2, 16% O2, Balance N2] (or equivalent) to CO2 ONLY input port. On the Monitor, touch the CO2 Vital Sign Box and verify EtCO2/Resp menu comes up. Press Unit and change to “%”. Press Back to exit menu. OPEN and CLOSE the valve on the M0127 Gas every 2 seconds to simulate breathing for about 30 seconds. Verify CO2 reading is 4.0% +/- 0.75%.

9.4

Verify Resp. is 15bpm +/- 1bpm. Turn Monitor Power to OFF position.

9.5

Cap-off the EXHAUST ONLY port on the right-side panel of the Monitor. Connect a pressure gauge and hand bulb onto the CO2 ONLY input port. Use the hand bulb to pressurize the system to 4.0 +/- 0.5 PSI; verify no pressure loss ≥ 0.5 PSI for 10 seconds.

Temperature Verification (if equipped) 10.1

Turn Monitor Power to ON position. Connect 1851 Fiber Optic Temperature Sensor into the Temp Port. Press SETTINGS key on the keypad. On the display, touch Parameter Setup then Temp OFF button. Verify Temp ON is displayed on the screen. Touch Back twice to exit menus and verify Temp Vital Signs box is now shown on the display.

10.2

Turn ON the Fluke 9102S Dry Well Temperature Calibrator (or equivalent). Insert TF079 Temp Sensor into the hole labeled in front of the 9102S. Press SET then or to select 37°C (or desired set temperature). Press SET then press EXIT 6 times (or until 37.0C is shown). Allow a few minutes for stabilization once the 9102S reaches the desired set point. Verify temperature accuracy 37°C (98.6°F) +/-0.3°C in both °C and °F (touch Temp Vital Sign box to change from °C to °F) on the Monitor.

10.3

Remove Temp Sensor from Monitor and verify Temp Probe Fail message. Turn Monitor Power to OFF (0).

Verify the following performance while connected to optional TABLET (3885T) and BASE STATION (3885B). Verify that the TABLET matches the Monitor where applicable. Ensure BASE and TABLET is set to the same channel as the MONITOR. 11.0

Base, Monitor & Tablet Communication Verification 11.1

Turn 3880 Monitor Rotary switch to ON position. Move Base Station A/C Power switch to ON position. Press 3885T Tablet Power ON (I) button. Press the RF SELECT button on the front panel of the Base Station to set the same channel as set on the Monitor and Tablet. Verify communication between the Tablet, Base, and Monitor is present as shown by the Green signal-strength bars on the top-left of the Tablet and Monitor. Verify no message, alarm sound, or flashing LEDs on the Tablet.

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12.0

11.2

Change the Base Station channel setting different from the Tablet by pressing the RF SELECT button on the front panel. Verify “Comm Loss” message, alarm sound, and flashing LEDs on the Tablet.

11.3

Press the RF SELECT button on the front panel to set the same channel that is set on the Tablet. Verify communication between the Tablet, Base, and Monitor is restored as shown by the Green signal-strength bars on the top-left of the Tablet and no message, alarm sound, or flashing LEDs.

Date & Time and Keypad Verification 12.1

Verify time on the top row of the display reflects current time (refer to 1200 Operation Manual section 2.1.4.1.1. item 5). NOTE: If no time is displayed on the top row, replacement of the internal coin cell battery (p/n: HB02, 3V Lithium Non-Magnetic) is required. To adjust Time and Date: press SETTINGS key on the keypad, touch Service Mode, Enter Password: 1025, ENTER, Configuration, Language and Time. Set Date and Time accordingly; press ENTER after each data entry. Verify time on the top row of the display has changed to what was just set. Press Back several times to exit all menus.

13.0

12.2

Press ALARM OFF / STANDBY key; verify “STANDBY, All Alarms OFF” the display. Press STANDBY key again to exit mode.

message on

12.3

Press TREND key on the keypad; verify Trend History log comes on the display. Press TREND key again and verify log closes.

12.4

Remove paper from the Base Station printer. Press RECORD key on the Tablet; verify “Out of Paper” message.

12.5

Install a roll of printer paper inside the Base Station printer. Press RECORD key on the Monitor; verify printout on the printer.

12.6

Press NIBP key on the keypad; verify pump starts. Press NIBP key again and verify pump stops.

Heart Rate (HR) Tone and Alarm Function Verification 13.1

Press the Power ON (I) button on SpO2 Pod and allow it to communicate with the Monitor. Insert the operator’s finger into the SpO2 grip. Verify waveform on the Monitor. In the ECG Menu, set HR Source SpO2, then press HR Tone and verify selections of 100%, 75%, 50%, 25%, and 0% of audible Heart Rate tone independent of the Tablet. Set Monitor HR Tone to the desired setting.

13.2

On the Tablet, press HR Tone and verify selections of 100%, 75%, 50%, 25%, and 0% of audible Heart Rate tone independent of the Monitor. Set Tablet HR Tone to the desired setting. Touch Back on the Tablet display to exit menu.

13.3

Open SpO2 Vital Sign box and increase/decrease SpO2 Pulse Rate Limit to create an alarm condition. On the Monitor, press SETTINGS, Alarms Function and Alarm Volume; verify selections of 100%, 75%, 50%, 25%, and 0% of audible Alarm tone independent of the Tablet. Set Monitor Alarm Volume to the desired setting. PM005 Rev. B

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14.0

13.4

On the Tablet, press Alarm Volume and verify selections of 100%, 75%, 50%, 25%, and 0% of audible tone independent of the Monitor. Set Tablet Alarm Volume to the desired setting.

13.5

Press the AUDIO ALARM OFF / SILENCE key on the keypad and verify the alarm sound has been silenced but the flashing LEDs continue. Turn Monitor Power to OFF position.

3886 Multigas Unit Verification (if equipped) 14.1

Install 1887 Dual Radio Module to the rear of the Monitor. Turn Rotary switch to MONITOR ON. Press SETTINGS key on the keypad, touch Parameter Setup then Agents ON. Press Back twice to exit menu.

15.0

14.2

Switch the 3886 Power to ON (I) and verify “CO2 Zeroing” message is displayed on the Monitor screen. Verify “CO2 Zeroing” message goes away after 20 seconds.

14.3

Verify wireless LED on the front of the 3886 unit is lit White and CONN AGENTS LED on the 1887 Dual Radio Module is also lit White.

14.4

Connect 1849 CO2/Agents Sample Line to Nomoline input port in front of 3886 unit. Verify input port lights up Green and “No Sample Line” message goes away.

14.5

Breathe into the end of the 1849 Sample Line and verify CO2 activity on the Monitor display.

14.6

Breath into the Sample Line and quickly connect to the exhaust port at the rear of the Multigas unit. This will circulate the sample gas in a closed loop fashion. The reading may initially drop due to air mixing. However, the readings should level off in less than 30 seconds, and then hold at this level for 2 minutes without falling more than an additional 0.5%.

Gas Verification / Calibration (if equipped) 15.1

Cal Zero Verification On the Monitor, press SETTINGS key on the keypad. Touch Service Mode, Enter Password: 1025, ENTER, Agents Maintenance. Press the Cal Zero “Start” button; verify Nomoline input port Green light begins to flash then stops when Zeroing is finished.

15.2

Connect 1849 Sample Line to 1848 Verification Check Gas [5% CO2, 42% N2O, 2% Desflurane, 51% O2] (or equivalent). Deliver Gas (2 seconds on / 2 seconds off) and verify Nomoline input port is lit Blue. Verify Gas readings: CO2 N2O DES (AA1) O2

5.0 +/- 0.83. 42.0 +/- 2.84. 2.0 +/- 0.25. 51.0 +/- 2.02.

15.3

If any of the above Gas readings are out of spec; select the Cal Gas type (CO2, N2O, DES, or O2 100%). Press the Cal Zero “Start” button and wait for it to complete Cal Zero. Begin flowing the 1848 Cal Gas until stable Gas levels appear on the display, then press Calibration START and continue to deliver Gas (approx. 35 seconds) until the calibration has finished. Repeat as needed for each Gas type calibration. Repeat step 15.2 to verify Gas readings.

15.4

Switch 3886 Power OFF (O) and disconnect Sample line. PM005 Rev. B

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