D00064969 - Cryo Console Preventive Maintenance - RevB

Number: Revision: Page:
D00064969 B 1 of 16
CORONARY AND STRUCTURAL HEART
Title: Work Instruction, Preventive Maintenance, CryoFlex Console
1.0 PURPOSE
The purpose of this work instruction is to provide a detailed method for the Preventive
Maintenance and Performance check of the CryoFlex Consoles by Service technicians in-
field or at the Service Depot. See Appendix A – Component Identification for a list of
components. See Appendix B – Flow Chart for a complete overview of the PM. See
Appendix C – Checklist for a complete list of all the checks and measurements in the
PM.
2.0 RESPONSIBILITY
Cardiovascular Service is responsible for the content and maintenance of this work
instruction.
3.0 PRELIMINARY
3.1 Initiate a Service Record.
3.2 Clean console per procedure 29472.
3.3 Verify the console operates in all modes and all necessary repairs have been made.
3.4 Repair or replace parts during this procedure when needed.
3.5 All mechanical inspections must be completed before beginning electrical
inspections.
3.6 This procedure should be performed annually.
3.7 All equipment requiring calibration must have calibration date checked prior to use.
If calibration date has expired, equipment must be tagged and recalibrated prior to
use.
3.8 Work area must be kept neat and clean.
3.9 This Assembly contains Static-sensitive components. Always handle the parts at an
approved Static-controlled work area and be certain you are properly grounded
through an approved Wrist Strap (per 40415).
3.10 WARNING - Use extreme caution when working around CryoProbes while
refrigerant is being applied. Do not touch any exposed leads. Risk of tissue ablation
exists during non-clinical setups.
4.0 EQUIPMENT NEEDED

Equipment ID Description
NA Hand tool kit
53993 Electrical Safety Analyzer
51214
DMM – Fluke 87 or equivalent
52409
53029 Temperature Calibrator
60002-336 Temp. Calibrator adaptor
60002-335 Pressure Transducer Simulator
Medtronic Confidential
Printed copy is not controlled
D00064969 B 2 of 16
67H08-005 High Pressure Line

NA Argon Gas supply
M996728A001 Pressure gauge 0-5000 PSI
DP01-0105-003 Plugged QD
3841-000 Tool, Inlet Pressure Adjustment
M996615A001 Leak Test Fixture
CryoFlex Disposable (Such as
Test Probe
60SF7, 60SF3, 60SF2, 60CM1)
M996642A001 Tool Regulator Adjustment
5.0 APPLICABLE DOCUMENTS

Document Description
M950761A001 Operator’s Manual, CryoFlex Console
MP_10000-04 MP, Assembly, Cryo Console
10167107DOC Service Process Work Instruction
29472 SOP, Decontamination of Hardware
Handling of Electrostatic Sensitive Components,
40145
Sub-Assemblies and Assemblies
SOP, Service Depot Nonconforming Material
21071
Process
29494 SOP, Cardiovascular Service Workflow
Work Instruction, Omega Temperature Calibrator
D00188289
Setup
6.0 PARTS REQUIRED

Part Number Description
75108 Silicone, 732
7.0 INSTRUMENT CLEANING

All instruments must be clean and free of blood. Refer to 29472 - SOP, Decontamination
of Hardware.
8.0 BACK PANEL - VISUAL INSPECTION

Ensure no power is applied. Anti-static safeguard measures must be followed during
internal inspections. Remove dust from unit as seen during the visual inspections.
8.1 Remove the nine screws from around the outer edge of the back panel. Tilt Back
Panel down and support to protect the gas inlet port from damage.
D00064969 B 3 of 16
8.2 Inspect the Gas inlet port.

8.2.1 Ensure it is securely mounted and is not damaged.
8.2.2 Check hose is connected properly and is not damaged.
8.3 Inspect the pressure sensor connector.

8.3.1 Ensure the connector is securely mounted and is not damaged.
8.3.2 Check cabling and connectors are secure and are not damaged.
8.4 Inspect the power supply.

8.4.1 Check it is securely mounted.
8.4.2 Check the wire connections are secure and are not damaged.
8.5 Inspect the fan.

8.6 Inspect the transformer.

8.7 Inspect the Main PCBA module.

8.7.1 Check the mounting hardware.
8.7.2 Check all cabling and connectors are secure and are not damaged.
8.7.3 Ensure there is silicone on the J13 and J15 ribbon cable connections to
keep them securely attached. See picture below for reference.
8.8 Inspect the Terminal Block.

9.0 FRONT PANEL – VISUAL INSPECTION
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9.1 Inspect the display panel overlays.

9.1.1 Ensure the display panel overlays are not damaged.
9.2 Inspect the Blue Connector Assembly.

9.2.1 Ensure the connector is securely mounted to the quick disconnect and is
not damaged.
9.2.2 Inspect the quick disconnect, ensure it is not damaged.
9.2.3 Inspect isolator for cracks or damage.
9.3 Inspect the power entry module.

9.3.2 Check all cabling and connectors are secure.
9.3.3 Ensure there are two 2 amp fuses in the fuse holder.
9.4 Inspect the Equipotential Ground Lug.

9.4.1 Ensure the connector is securely attached and is not damaged.
9.4.2 Check all cabling and connector are secure.
9.5 Inspect the Solid State Relay.

9.5.1 Ensure the relay is securely attached and is not damaged.
9.5.2 Check all cabling and connector are secure.
9.6 Inspect the Display PCBA module.

9.6.3 Ensure there is silicone on the VFD power cable connection to keep it
securely attached. See picture below for reference
9.7 Inspect the LED PCBA module.

9.8 Inspect the Pneumatic Assembly.
D00064969 B 5 of 16

9.8.2 Check all hoses and connectors are secure and are not damaged.
9.9 Inspect the Enclosure.

9.9.1 Check the enclosure for structural damage. Cosmetic scratches are
acceptable.
9.9.2 Inspect the RFI strips on the back flange of the enclosure.
10.0 SYSTEM START UP

10.1 Plug the power cord into the CryoConsole and appropriate AC outlet.
10.2 Turn power switch to the “on” position.
10.3 Check the console starts up successfully.
10.3.1 Verify the displays show the message:
NOTE: See Operators Manual for language options and DIP switch settings.
10.3.2 Verify the red LED display reads 1:00 for the target freeze duration and “-
“ for the target temperature.
10.3.3 Verify the red light above the warning symbol is on while the rest of them
are off.
10.3.4 Verify fan is running and there are no unusual noises.
11.0 TEMPERATURE CHECKS

11.1 Connect the pressure transducer simulator tool (60002-335) to the console.
11.2 Wait for the self-test to complete.
11.3 Switch on the temperature calibrator (53029), and ensure it is set up as follows
(see picture below for reference):
• Thermocouple Type: T
• Scale: Celsius (C)
• Resolution: 0.0 (one zero after the decimal)
• Mode: Calibrator
D00064969 B 6 of 16
11.4 Set the temperature on the calibrator to -150 C. Connect the Temperature
Calibrator adaptor (60002-336) to theT1 connection port of the Temperature
Calibrator (53029) and to the console probe connector. Remove pin on left side of
the probe connector. See pictures below for reference.
11.5 Calibrator and console need to be turned on for 10-15 min before testing to
stabilize its temperature.
11.6 Ensure the console display reads -150C +/- 1C.
11.7 Set the temperature on the calibrator to 25C, ensure the console display reads 25C
+/- 1C.
11.8 If either of the temperatures are out of limits, adjust the potentiometer (R22) on the
main PC board so the temperature on the display equals calibrator settings +/-1C.
Observe the temperature for a period of 2 minutes to ensure the temperature still
reads within limits. Let stabilize after each adjustment. See picture below for
reference.
D00064969 B 7 of 16
11.9 If temperature was adjusted, recheck at both settings (-150C and 25C) to ensure
they are both within limits.
11.10 Reinstall pin into blue connector. Disconnect the Temperature Calibrator adaptor
(60002-336) from the system.
11.11 Turn off the system.
11.12 If the temperature was adjusted, apply silicone to the potentiometer (R22) on the
main PC board. See picture below for reference.
12.0 RELIEF VALVE SETTING

NOTE: All gas quick disconnects / connections need to be made with tank valve closed
(no pressure applied) and all QDs need to be connected or plugged prior to being
pressurized.
NOTE: Regulator does not self-vent, you must bleed excess pressure by opening the
bleed valve on regulator if trying to reduce output of regulator.
12.1 Ensure Argon tank valve is closed.

12.2 Ensure customer regulator is attached to Argon tank.
12.3 Attach leak test fixture (M996615A001) onto regulator.
12.3.1 Attach pressure gauge (M996728A001) to test fixture.
12.3.2 Attach high pressure hose to test fixture.
12.3.3 Attach high pressure hose to CryoConsole.
12.3.4 Ensure the bleed valve on test fixture is closed.
12.4 Install Regulator Adjustment Tool (M996642A001) onto regulator.

12.4.1 Loosen nut on regulator.
12.4.2 Turn regulator adjustment CCW, ½ - 1 turn.
12.5 Relief Valve Setting

12.5.1 Turn on the pressure meter.
12.5.2 Open the valve on the Argon tank.
12.5.3 Adjust pressure from Regulator CW, bring pressure up to 3000 psi and
slowly adjust up further. Go very slow and listen for the relief valve inside
console to open. This must happen between 3500 and 3700 psi. Adjust relief
D00064969 B 8 of 16
valve, if necessary. If relief valve setting is OK, skip to next section.

12.5.3.1 Remove rigid metal strap from relief valve.
12.5.3.2 Remove the lock wire.
12.5.3.3 Loosen locking nut.
12.5.3.4 To increase setting turn clockwise, to decrease turn counter-
clockwise.
12.5.3.5 Tighten locking nut, reattach locking wire, and reinstall metal
strap.
12.5.3.6 Repeat relief valve test.
12.5.4 Close valve on the Argon tank.
12.5.5 Open bleed valve on Regulator to vent system.
12.5.6 Turn regulator adjustment CCW, 3-4 turns.
12.5.7 Close bleed valve.
13.0 GAS LEAK TEST

13.1 Install test fixture 3841-000 onto blue connector of Console. Remove plugged QD
stem (DP01-0105-003) from QD body of test fixture 3841-000 if it is installed.
13.2 Open the valve on the Argon tank.
13.3 Adjust pressure from regulator to 1500 +/- 100 psi and let stabilize for 5 minutes.
13.4 Install plugged (DP01-0105-003) QD stem in QD body of test fixture 3841-000.
If plug cannot be installed easily, V1 is leaking – remove pneumatic system,
troubleshoot, repair and retest
13.5 Remove plugged stem (DP01-0105-003) from QD body of test fixture 3841-000.
13.6 Power on console. Console should go through self-test. Let stabilize for 2
minutes.
13.7 Install plugged QD stem (DP01-0105-003) in QD body of test fixture 3841-000.
If plug cannot be installed easily, V1 is leaking – remove pneumatic system,
troubleshoot, repair and retest. (there may be some low residual pressure at
connector, but if plug installs with ease, V1 is OK).
13.8 Increase pressure from regulator to 3000 +/- 100 psi and let stabilize.
13.9 Close valve on Argon tank.
13.10 Monitor pressure gauge (M996728A001) for 2 minutes. A pressure drop indicates
a leak between the gas inlet port up to and including V1. If a leak is noted -
remove pneumatic system, troubleshoot, repair and retest.
13.11 Open valve on Argon tank.
13.12 Pull probe pin from test fixture 3841-000. Console should display ambient
temperature.
13.13 Press the start freeze button. Let pressure meter reading stabilize. Listen for
solenoid hum, this would indicate V1 needs to have spring washer adjusted.
13.14 Close valve on Argon tank and monitor pressure for 2 minutes. A pressure drop
indicates a leak between V1 and V2. If a leak is noted - remove pneumatic
system, troubleshoot, repair and retest.
D00064969 B 9 of 16
13.15 Press the stop freeze button on the console. Listen for solenoid hum, this would
indicate V2 needs to have spring washer adjusted.
13.16 Bleed off the pressure by pressing the vent button (2x) or use the bleed knob of
the regulator.
13.17 If no leaks were found, reinsert probe pin into test fixture 3841-000 and remove
fixture, high pressure hose, and Pressure Simulator from the console.
13.18 Turn console power off and remove power cord.
14.0 ASSEMBLY
14.1 Close back panel while ensuring cables and tubing do not get pinched.
14.2 Install the 9 screws around back panel and tighten. All edges of back panel should
be inside front panel.
15.0 LABEL INSPECTION

15.1 Verify the following labels are present and legible.
Equipotential
Fuse Label Go Label Connector Label
Symbol
16000-049 M951758A001 16001-001 PL35-0085-001
16.0 REGULATOR OUTPUT SETTING

16.1 Install plugged QD Stem (DP01-0105-003) into High pressure hose.
16.3 Adjust the regulator pressure to 3200 psi +/- 100 psi.
16.4 Tighten nut on regulator and remove Regulator Adjustment Tool
(M996642A001).
16.6 Open bleed valve on regulator.
16.7 Close bleed valve on regulator.
D00064969 B 10 of 16
16.9 Verify regulator output is 3200 psi +/-100 psi. If not within spec, reinstall
Regulator Adjustment tool, loosen nut, and repeat steps above.
16.11 Open bleed valve on regulator.
16.12 Remove plugged QD Stem from high pressure hose.
16.13 Close bleed valve on regulator.
16.14 Disconnect the leak test fixture (M996615A001) from regulator.
16.15 Disconnect high pressure hose from test fixture.
17.0 FUNCTIONAL TEST

17.1 Connect High pressure hose from the regulator to the CryoConsole.
17.2 Connect the pressure sensor cable from the regulator to the CryoConsole
17.3 Plug the power cord into the CryoConsole and appropriate AC outlet.
17.4 Turn power switch to the “on” position.
17.5 Verify the display is not garbled and the red LED display reads 1:00 for the target
freeze and “–“ for the target temperature.
17.6 Verify the screen reads “TURN GAS ON TO BEGIN SELF TEST” and “GAS
REMAINING 0 MINUTES”.
17.7 Open valve on Argon tank. The CryoFlex console will perform a self-test. Verify
the console passes the self-test and the “minutes remaining” is now properly
displayed.
17.8 Probe connection:
17.8.1 Push the test probe connector into the console connector until the grips
snap into place. Do not press the top and bottom grips. If too much force
is required, vent the system manually and try connecting again.
17.8.2 Gently tug on the probe connector to ensure it is securely connected.
17.8.3 Pull out the pin on the left side of the probe connector. Do not dispose of
the pin as it will need to be re-inserted into the test probe for future
testing.
17.9 The control panel displays:
17.10 Press the up and down arrows, verify the time and temperature increase and
decrease in the LED displays.
Note: If the temperature indicator displays a dashed line the system is set to full
power.
D00064969 B 11 of 16
17.11 With the probe in the air press the START FREEZE button on the control panel
for at least 2 seconds to start the injection of refrigerant. The green light above the
button lights up to indicate refrigerant is flowing.
17.11.1 The temp should drop to -110°C within 20 seconds. The injection should
stop after 60 seconds and the temperature should rise.
NOTE: The clock on the control panel does not start until the temperature
reaches -40°C.
Warnings: If an unanticipated event occurs, the injection of refrigerant can be

stopped at any time by pressing the STOP FREEZE button on the console
control panel.
If you are unable to stop the injection, immediately turn the system off, by using
the power switch located on the side of the control panel or by disconnecting the
power cord.
Do not attempt to disconnect the probe or pressure sensor cable during operation
in the freeze mode as the sudden release of pressure may cause the probe or
pressure sensor cable to recoil, which may injure the operator. The system must
be vented prior to disconnecting the probe and pressure sensor cable.
17.12 Set the timer to 20 seconds and press the START FREEZE button on the control
panel for at least 2 seconds. Ensure freezing stops after 20 seconds.
17.13 Close the valve on Argon tank and vent the system by pressing the VENT button
on the display. Press VENT again once you are sure the gas tank is closed as
prompted on the screen.
NOTE: You will hear a loud hissing noise as the gas is vented from the gas line
between the tank and the regulator. This is normal.
17.14 Turn the power switch “off”.
17.15 Disconnect the high pressure hose and pressure sensor cable.
NOTE: Leave test probe connected for use during Electrical Safety Patient
Leakage tests.
18.0 ELECTRICAL SAFETY

18.1 Enclosure Leakage Test – Connect test lead of leakage tester to Equipotential
ground lug of Console and test under the following test conditions. Test should
D00064969 B 12 of 16
read no more than 300 µAmp with closed ground and 1000 µAmp with open
ground. Inputs of 230 VAC and 120 VAC should be tested at those voltages on
the Safety Analyzer.
Failure
DUT Power Polarity Neutral Ground
Threshold
On Reversed Closed Closed 300 µA
On Reversed Closed Open 1000 µA
On Normal Closed Closed 300 µA
On Normal Closed Open 1000 µA
18.2 Patient Leakage Test – Tests should read no more than 10 µAmp maximum.
Inputs of 230 VAC and 120 VAC should be tested at those voltages on the Safety
Analyzer.
18.2.1 Perform the test with the test lead of the Safety Analyzer connected to
bellows end of the probe and test under the following test conditions.
Failure
Threshold
On Reversed Closed Closed 10 µA
On Reversed Closed Open 10 µA
D00064969 B 13 of 16
Failure
Threshold
On Normal Closed Closed 10 µA
On Normal Closed Open 10 µA
18.3 Mains on A.P. (MAP)

18.3.1 Perform the MAP test under the following: All tests should be less than
20 µAmp for 110V. 50 µAmp for 220V.
USE CAUTION – HAZARDOUS VOLTAGE PRESENT ON TEST

LEAD DURING MAP TEST.
110V 220V
DUT Power Polarity Failure Failure
Threshold Threshold
On Normal 20 µA 50 µA
19.0 FINALIZE
19.1 Re-insert black single-use pin into CryoFlex Probe connector by angling it
forward as it is pushed into hole.
19.2 Disconnect the test probe from the CryoFlex Console.
19.3 Complete all paper work. Indicate the Preventive Maintenance has been
completed.
19.4 Install warranty seal over upper middle screw of back panel.
D00064969 B 14 of 16
Attachment A: Flowchart of work instruction identifying section headers and decision points.
Instrument cleaning
Back panel
Front panel
System start up
Temperature checks
Relief valve setting
Gas leak checks
Assembly
Label inspection
Regulator setting
Functional test
Electrical Safety Analyzer
Enclosure Leakage Current –

DUT power ON
Patient Leakage –
DUT power ON
Mains on A.P. – Power ON
Finalize
D00064969 B 15 of 16
Attachment B: Checklist
This checklist (form) is available upon request for any customer. The data is electronically
maintained in the Service database.
Upper Lower
Section Header Test Elements Data Type Unit
Limit Limit
Instrument Cleaning Device is clean and free of blood per 29472 P/F NA NA NA
Inspect gas inlet port P/F NA NA NA
Inspect pressure sensor connector P/F NA NA NA
Inspect power supply P/F NA NA NA
Back Panel – Visual
Inspect fan P/F NA NA NA
Inspection
Inspect transformer P/F NA NA NA
Inspect Main PCBA Module P/F NA NA NA
Inspect terminal block P/F NA NA NA
Inspect display panel overlays P/F NA NA NA
Inspect blue connector assembly P/F NA NA NA
Inspect the power entry module P/F NA NA NA
Inspect equipotential ground lug P/F NA NA NA
Front Panel – Visual
Inspect solid state relay P/F NA NA NA
Inspection
Inspect display PCBA P/F NA NA NA
Inspect LED PCBA P/F NA NA NA
Inspect pneumatic assembly P/F NA NA NA
Inspect enclosure P/F NA NA NA
Verify system starts up successfully P/F NA NA NA
Verify displayed message P/F NA NA NA
System start up Verify LED values P/F NA NA NA
Verify red light P/F NA NA NA
Verify fan function P/F NA NA NA
Verify temperature -150 C +/-1C Measurement C -149 -151
Temperature Checks
Verify temperature 25 C +/- 1C Measurement C 24 26
Relief valve setting Relief Valve setting (3500-3700 psi) Measurement PSI 3500 3700
Power off leak test 1500 psi P/F NA NA NA
Power on leak test 1500 psi P/F NA NA NA
Gas leak checks
Power on leak test 3000 psi P/F NA NA NA
Freeze leak test P/F NA NA NA
D00064969 B 16 of 16
Upper Lower
Section Header Test Elements Data Type Unit
Limit Limit
Stop freeze / vent P/F NA NA NA
Verify Screws present P/F NA NA NA
Assembly / label inspection
Verify labels present P/F NA NA NA
Adjust regulator output (3100-3300 psi) Measurement PSI 3300 3100
Regulator output setting
Verify regulator output (3100-3300 psi) Measurement PSI 3300 3100
Connect Regulator, Gas hose, & Pressure sensor P/F NA NA NA
cable
Verify display and LED displays P/F NA NA NA
Verify self-test passes with 2 purge cycles P/F NA NA NA
Verify probe connection P/F NA NA NA
Verify probe recognition P/F NA NA NA
Verify up and down buttons function P/F NA NA NA
Setup / Functional test
Verify temp. drops below -110 within 20 seconds P/F NA NA NA
Verify freeze stops after 60 seconds P/F NA NA NA
Verify freeze stops after 20 seconds P/F NA NA NA
Verify system vents properly P/F NA NA NA
Electrical Analyzer Type Using a Fluke ESA612 analyzer Y/N NA NA NA

Power On, Normal, Closed, Closed < 300 µA Measurement µA 300 0
Enclosure Leakage – Power On, Normal, Closed, Open < 1000 µA Measurement µA 1000 0
Power ON Power On, Reversed, Closed, Closed < 300 µA Measurement µA 300 0
Power On, Reversed, Closed, Open < 1000 µA Measurement µA 1000 0
Power On, Normal, Closed, Closed < 10 µA Measurement µA 10 0
Patient Leakage – Power Power On, Normal, Closed, Open < 10 µA Measurement µA 10 0
ON Power On, Reversed, Closed, Closed < 10 µA Measurement µA 10 0
Power On, Reversed, Closed, Open < 10 µA Measurement µA 10 0
Mains on A.P. – Power ON MAP – Normal < 20 µA Measurement µA 20 0

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4.0 EQUIPMENT NEEDED

67H08-005 High Pressure Line

5.0 APPLICABLE DOCUMENTS

6.0 PARTS REQUIRED

7.0 INSTRUMENT CLEANING

8.0 BACK PANEL - VISUAL INSPECTION

8.2 Inspect the Gas inlet port.

8.3 Inspect the pressure sensor connector.

8.4 Inspect the power supply.

8.5 Inspect the fan.

8.6 Inspect the transformer.

8.7 Inspect the Main PCBA module.

8.8 Inspect the Terminal Block.

9.0 FRONT PANEL – VISUAL INSPECTION

9.1 Inspect the display panel overlays.

9.2 Inspect the Blue Connector Assembly.

9.3 Inspect the power entry module.

9.4 Inspect the Equipotential Ground Lug.

9.5 Inspect the Solid State Relay.

9.6 Inspect the Display PCBA module.

9.7 Inspect the LED PCBA module.

9.8 Inspect the Pneumatic Assembly.

9.8.1 Check the mounting hardware.

9.9 Inspect the Enclosure.

10.0 SYSTEM START UP

11.0 TEMPERATURE CHECKS

12.0 RELIEF VALVE SETTING

12.1 Ensure Argon tank valve is closed.

12.4 Install Regulator Adjustment Tool (M996642A001) onto regulator.

12.5 Relief Valve Setting

valve, if necessary. If relief valve setting is OK, skip to next section.

13.0 GAS LEAK TEST

15.0 LABEL INSPECTION

16.0 REGULATOR OUTPUT SETTING

17.0 FUNCTIONAL TEST

Warnings: If an unanticipated event occurs, the injection of refrigerant can be

17.14 Turn the power switch “off”.

18.0 ELECTRICAL SAFETY

18.3 Mains on A.P. (MAP)

USE CAUTION – HAZARDOUS VOLTAGE PRESENT ON TEST

Relief valve setting

Gas leak checks

Electrical Safety Analyzer

Enclosure Leakage Current –

Mains on A.P. – Power ON

Electrical Analyzer Type Using a Fluke ESA612 analyzer Y/N NA NA NA

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