Frigitronics CCS-200 Operation & Maintenance Manual Rev CE Sept 2006

The CCS-200 Cardiac Cryosurgical System 1

4

10

5

11

6

12

7

13

2

3

8

14

9 15 16 19 17 18 20 21 (not shown)

22

Front View

Rear View 23

1. 2. 3. 4. 5. 6. 7. 8.

Probe Socket - Exhaust (2) Probe Socket - Supply (2) Digital TTI Socket (2) Digital Probe Temperature Meter (2) Line Pressure Gauge (2) Digital Timer (2) Temperature Control Valve (2) Feeze/Defrost Control Valve (2)

Specifications

9. 10. 11. 12. 13. 14. 15. 16.

Battery Compartment (2) Digital Tissue Temperature Indicator Exhaust Pressure Gauge (2) Digital Temperature Indicator Switch Maximum Freeze Control Valve (2) ON/OFF Control Valve (2) Main Meter Power Switch Exhaust Nipple

CCS-200 System 47” High (119.4cm), 19” Wide (48.25cm) 24” Deep (70cm) Weight: 74lbs (35.8kg) without cylinders

17. 18. 19. 20. 21. 22. 23.

Filter Assembly - Pressure Gauge Filter Assembly - Canister Cylinder Valve (2) Cylinder Yoke Assembly (2) Cylinder Bracket (2) Cylinder Strap (2) Mobile Carrier - Casters (4)

Two 20lb. Nitrous Oxide Cylinders required Digital Meters use Four 9 Volt Alkaline Batteries

Note: To convert psi to kg/sq cm multiply by 0.07. CAUTION: U.S. Federal law restrcts this device to sale by or on the order of a physician.

CCS-200 Operation & Maintenance Manual

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Introduction Introduction

The system provides the surgeon the capability to:

The Frigitronics® Model CCS-200 is a dual probe, independently controlled, fully-exhausted, non-AC powered (1), selfcontained Cardiac Cryosurgical System. This system uses readily available medical grade nitrous oxide gas.

• Select either maximum or preset controlled freeze temperatures

This state-of-the-art instrument was primarily designed for treatment of cardiac arrythmias and can be used for other procedures requiring controlled temperatures down to -500 to -600 C depending on the probe used. The system was designed to provide the surgeon with precise temperature control enabling him to perform reversible freezing (2). The system operates on the Joule-Thomson principal where pressurized gas expands through a fine orifice producing a rapid drop in temperature.

Unpacking and Set-Up Unpacking The CCS-200 System includes the following: • Console with integrated mobile carrier The console is supplied with: • Four 9 volt batteries • Replacement “O” rings • Filter and gauge assembly w/cartridge • Filter bracket and wrench • Indicator Bands (6 each) The carrier is supplied with:

• Quickly defrost the probe(s) • Monitor the probe tip temperature • Track actual tissue temperature using thermocouple needles • Time any aspect of the operation, such as the freeze duration • Use two probes consecutively or simultaneously. They can be identical or of different sizes and shapes • Select from a wide range of probe configurations

Refer to your packing list then check all packing material for accessories and components. Please read this operation manual carefully before using the system.

Set-Up 1. Install filter bracket and filter assembly (17,18) per the instruction sheet supplied. 2. Install filter cartridge (see To Install Filter Cartridge, Page 7) 3. Install two 9 volt batteries, for the digital display in each of the two battery compartments (9) (Four total). Confirm proper orientation of + and - on 9V battery inside holder. Improper orientation of battery will damage temperature meters.

• Two 20 lb cylinders (empty) • Four locking casters (23) 1. System does not require any external AC power source. Batteries used for Temperature and Timer Displays only. 2. Reversible freezing-to cause temporary blockage of the signal when frozen-does not cause tissue necrosis or permanent damage-effect is reversed upon thawing.

CCS-200 Operation & Maintenance Manual

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Unpacking & Set Up

Installation of Cylinders Medical grade nitrous oxide cylinders are locally available worldwide. Consult your yellow pages under Gas Medical or Welding Supplies. Be sure to specify MEDICAL GRADE nitrous oxide gas. The CCS-200 System is designed for nitrous oxide gas only.

Note: Cylinders must be at room temperature for maximum pressure and optimum performance. Nitrous Oxide at room temperature is approximately 740 psi. 2. Place cylinder yoke nipples (20) into cylinder valves. Hand tighten yoke nut. DO NOT OPEN CYLINDER AT THIS TIME.

1. Place a full nitrous oxide cylinder against bracket (21) and secure in place by fastening buckle and tightening the straps (22). Repeat procedure for second cylinder. Remove end of cylinder tags to show cylinders are now in use.

3. Two reserve cylinders are recommended. They can be purchased from CooperSurgical or your local gas supplier.

Checking The System

Caution:

Gas Exhaust

1. Only use the exhaust hose provided by Coopersurgical. No substitutes allowed.

The National Institute for Occupational Safety and Health (NIOSH) current recommended exposure limit for nitrous oxide (N2O) gas is 25 parts per million (ppm) averaged over the period of administration. 1. Connect the exhaust hose supplied by CooperSurgical to the console exhaust nipple (16) located on the bottom of the console. 2. Safely vent the other end of the hose in one of the following manners:

2. Do not restrict or kink the exhaust hose in any way.

Leaks 1. Turn both console On/Off knobs (14) “off ”. 2. Turn one cylinder (19) “on” by turning one cylinder valve counterclockwise (Gas Gauge (17) should show pressure). Check all exterior connections for leaks.

a. Directly to the outside. b. Directly to a Non-Recirculated room exhaust ventilation system. c. Directly to a dedicated system for venting anesthetic gases. The flow capacity of the system shall not be less than 40 liters/min.

CCS-200 Operation & Maintenance Manual

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Checking the System

Installation of Probes

• Do Not block exhaust holes at the end of probe lines where the probe plugs into the console.

1. Plug desired probe into respective probe sockets (1,2) on front of console. To engage exhaust plug (1), slide retainer ring back on quick disconnect while inserting plug, then release. To engage input plug (2), depress latch while inserting then release. Tug at probe connections to ensure both connectors are latched. Repeat procedure for second probe if required.

• Do Not autoclave or submerge probe in solutions. If autoclaved-Do Not Use, Return to CooperSurgical for servicing.

2. Turn the Main Meter Switch (15) “on”. The digital probe temperature meters (4) will now display the probe tip temperature.

• Do Not remove or install probes unless the line (5) and exhaust pressure gauges (11) read “0” psi. • Do Not restrict, kink, bend, clamp or otherwise damage or restrict probe lines.

• Do Not attempt to insert or remove probe from console when it is pressurized.

Digital Probe Temperature Meters The temperature meters (4) are calibrated in degrees Celsius. There is no calibration required. To check if the system is functioning correctly, place the tip (with pressure gauges reading zero) in ice water. The tip temperature display should read approximately 0O C. The temperature meter is for reference only.

CCS-200 Operation & Maintenance Manual

Battery Information The CCS-200 is equipped with three (3) Digital Temperature Meters. These meters are powered by the four 9 volt batteries located in the battery compartment (9) at the rear of the console. Two of the batteries (one each) power the probe meters of System I and System II. The battery clips are marked “Sys I” and “Sys II” respectively.

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Operational Summary

Operational Summary The operation of System I and System II can be done individually or simultaneously. The controls labeled in blue are for System I and those in green are for System II. Switch controls slowly to minimize gas surge. The sequence of operation can be changed as required. A flow of gas can be heard in the probe during the operation-this is normal in a functioning probe.

Operational Set-up 1. With the two probes plugged into the front of the CCS-200 console, open both cylinder valves (19) fully. Check line pressure gauge (5) to insure adequate line pressure. CAUTION: It is not recommended to use the system when the pressure is below 650 psi. Use of the system when in the yellow zone will result in reduced performance. WARNING: DO NOT OPERATE SYSTEM IN RED ZONE. 2. Turn the Freeze/Defrost Control knobs (8) to the “defrost” position. 3. Close the Temperature Control valves (7) by turning fully clockwise. Do not overtighten. 4. Turn the Maximum Freeze Control knobs (13) to the “temperature control” position. 5. Turn the On/Off control knob (14) to the “on” position. You are now ready to start freezing.

CCS-200 Operation & Maintenance Manual

For controlled Temperature Freezing a. Turn the Maximum Freeze Control knob to “temperature control”. b. Slowly turn the Freeze/Defrost Control knob to the “freeze position”. c. Turn the Temperature Control knob counterclockwise to decrease temperature (colder), clockwise to increase temperature (warmer)-monitor the probe temperature meter until the desired tip temperature is obtained. It may be necessary to wait momentarily for the temperature to stabilize before making final adjustments.

For Maximum Freeze Slowly turn the Maximum Freeze Control knob to the “maximum freeze” position.

To Defrost The probe can be defrosted or warmed above 0O C at any time. Slowly turn the red Freeze/Defrost Control knob to the “defrost” position.

Dual Probe Operation Indicator bands are supplied with the console. When two probes are used, place one sterile band on the probe handle connected to System I. This will allow the surgeon to distinguish between the two. Sterilize band with probe.

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Timers Timers Your system is equipped with two manual digital timers (6). Timers are constantly “on”. They operate on Lithium batteries, with a life expectancy of 5 years. They may be used to time any portion of the operation, i.e. freeze duration. They are capable of timing up, elapsed time, or timing down from a preset limit. The timer reads in minutes and seconds. The first two digits are minutes and the second two digits are seconds. The timer can time up to 60 minutes. Read the following instructions carefully then practice using it a few times.

To Use Your Timer A. Minute Mark B. Second Mark C. LCD Digital Display D. Number Keys E. Start Button

When Timing Period is Completed When the Timer counts down to 00 minutes 00 seconds, an electronic tone will sound. This tone will continue to sound for one minute or until Timer is turned off. (The tone automatically turns off after one minute to extend battery life.) To turn off the tone, simply press any one of the buttons on the Timer: Start, Stop/Reset, or 0 through 9.

Elapsed Timing To Set Timer for Count-Up 1. Press the Stop/Reset button to set Timer to zero. 2. Press Start button once. Timer will immediately begin to count up at 1 second intervals. It will count up to 60 minutes and then automatically recycle itself to zero and start counting up again. 3. To stop the count-up, simply press Stop/Reset twice.

F. Stop/Reset Button

Preset Timing To Set Time for Countdown 1. Press the Stop/Reset button to set Timer to zero. 2. Press number keys 0 through 9 to set desired minutes and seconds. Example: To set 12 minutes 38 seconds, press 1,2,3,8. The first and second keys pressed are the minutes. The third and fourth keys are the seconds. NOTE: If you are timing in seconds only, press just two number keys 0 through 9. Example: To set 15 seconds, press 1,5. 3. If the wrong time has been set, simply press the Stop/Reset button to reset time to zero and begin again. 4. When accurate time is set press Start button. The seconds will immediately begin counting down.

CCS-200 Operation & Maintenance Manual

To Stop the Timer During Countdown or Count-Up If it is necessary to stop Timer while it is counting down or up, press Stop/Reset button once and Timer will stop. To start countdown or count-up where you left off, press the Start button once. Or, if you want to clear Timer to zero, press Stop/Reset button a second time. To replace the battery in your electronic Timer/Stopwatch, first remove filter assembly from console, then remove bottom cover. Carefully remove Timer backup plate and remove Timer from console. Use a standard Phillips screwdriver to turn the screw on the Timer backside in the direction of the arrow. Remove the Timer back cover and exhausted battery. Insert a new G-13 size button cell battery making sure the positive (+) side is facing up and replace the Timer back cover. Reverse procedure for installation of Timer.

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Exchanging Components

Exchanging Components

To Exchange Filter Cartridge

To Exchange Probes

1. Turn both Cylinder Valves (19) “off” (clockwise). Turn the system On/Off knobs “on” and “off” repeatedly. This will relieve the pressure in the system while safely venting the gas.

1. Turn the On/Off control knobs (14) of System I and/or II “off”, depending on which probe is to be changed. 2. Do Not remove probe(s) until the system line and exhaust pressure gauge needles touch the silver stop. 3. Remove the probe and exchange. Tug at probe connections to ensure both probe connectors are latched.

To Exchange Cylinders 1. Turn both Cylinder Valves (19) “off” (clockwise). Turn the system On/Off knobs “on” and “off” repeatedly. This will relieve the pressure in the system while safely venting the gas. 2. When the cylinder pressure gauge (17) on the filter assembly reads “0” psi, remove cylinder yokes. 3. Exchange Cylinders-Place On/Off valves (14) in the “off” position. 4. It is recommended that the filter cartridge be replaced with each change of cylinders. This will help insure clean, trouble-free performance. WARNING: USE MEDICAL GRADE NITROUS OXIDE GAS ONLY.

2. When the cylinder pressure gauge reads “0” psi, unscrew the filter canister (18) and remove. 3. Unscrew the filter cartridge and replace with a new cartridge. 4. Inspect filter “O” ring for swelling, nicks, cuts, abrasions, or other physical damage. Replace as necessary. 5. Replace filter canister and tighten securely. CAUTION: There should be no gap between canister and housing when tightened. 6. Turn one Cylinder Valve “on” (counterclockwise). Inspect for leaks.

To Shut Down 1. Turn Cylinder Valves “off” (clockwise). Turn the system On/Off valves “on” and “off” repeatedly until line pressure gauges read “0” psi and the Exhaust pressure gauge needles touch the silver stop. 2. Turn system On/Off knobs “off”. 3. Remove probes. 4. Turn Main Meter switch “off”. Place D.T.T.I. switch (10) in the center position. 5. Exhaust hose can be disconnected from console for storage.

CCS-200 Operation & Maintenance Manual

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Care & Maintenance Care and Maintenance The CCS-200 should be handled with the care appropriate to any precision medical instrument. Avoid banging, dropping or mishandling the system and probes. Periodically inspect the hoses, fittings and probes for any damage or wear. Other than maintaining an adequate supply of medical grade nitrous oxide, the system is essentially maintenance free.

CCS-200 Cleaning The control console with mobile carrier may be washed with any mild soap solution that is commonly used to clean equipment in the operating room. Care should be exercised to use only a lightly dampened sponge when wiping down the timers and temperature meters. They should be wiped dry after cleaning. Under no circumstances should solution be allowed to enter internally.

CooperSurgical suggests the following process limitations: Precondition 60 minutes ± 10 minutes Prevacuum 24” Hg ± 2” Hg Pressure/Gas 6-8 psig/550-660 Exposure 4 hours minimum 140O F Maximum Temperature 12-15 Hour Forced Aeration Cycle @ 120O F Minimum Temperature 50O F to get tanks with enough pressure DO NOT AUTOCLAVE PROBES. DO NOT IMMERSE PROBE AND LINES IN ANY SOLUTION. If probe is accidentally autoclaved or immersed-DO NOT USE-Return to CooperSurgical for servicing.

Storage Recommended CCS-200 Probe Cleaning and Sterilization

Store nitrous oxide cylinders, CCS-200 System, and probes at room temperature.

The CCS-200 Probes can ONLY be ethylene oxide gas sterilized.

Cautions

Initial Cleaning: Follow standard procedure for cleaning instruments as per use practice. It is recommended that the CCS-200 probes be wiped clean with 70% Isopropyl Alcohol (IPA) to remove blood, body fluids, tissue, and saline. To prevent coagulation of protein on the device, rinse immediately in luke warm water (not hot). Personal protection equipment should be worn during these steps. Ethylene Oxide Sterilization: Probes must be thoroughly cleaned prior to sterilization. Always follow the instructions supplied by the manufacturer of the EO Sterilizer. Use only valid parameters, conditions, and equipment to assure sterility.

CCS-200 Operation & Maintenance Manual

1. Nitrous oxide gas must be safely exhausted. Do not restrict or limit the gas flow in any way. 2. Always ensure that the safety latch is engaged when inserting the probe plug into the probe jack on the front of the system. 3. Use CooperSurgical part no. 32873 exhaust tube only. 4. Do not use the system below 650 psi. Low pressure will reduce performance. 5. Do not autoclave probes or use a probe if it has been autoclaved. 6. Do not remove or install probe unless the line and the exhaust pressure gauge needle touches the silver stop.

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Troubleshooting Troubleshooting CCS-200 Cryosurgical System Probe Does Not Freeze Properly: Cause

Remedy

1.

On/Off valve off.

1.

Turn valve “on”.

2.

Cylinder valves closed.

2.

Open cylinders.

3.

Cylinder pressure below 650 psi.

3.

Replace cylinders or refer to 4.

4.

Cylinders are cold.

4.

Warm cylinders to room temperature.

5.

Crimped probe or exhaust line.

5.

Check line for restrictions.

6.

Dirty filter in probe plug.

6.

Remove surface contaminants with nylon brush and retest probe.

7.

Probe not properly engaged.

7.

Insure probe is properly engaged and locked in position.

8.

Probe tip temperature not recording on display.

8.

Refer to Digital Display, Section.

9.

Leaks in serviceable area.

9.

Tighten fittings. Replace nipple on cylinder yoke or replace damaged “O” rings.

10. Controls not in proper position.

10. Properly set controls.

11. Contaminated Nitrous Oxide Gas.

11. Replace cylinders.

12. Console or probe malfunction.

12. Connect a second probe and test.

13. Clogged filter or contamination.

13. Replace filter, part no. 21720.

Probe Does Not Defrost Properly: Cause

Remedy

1.

Controls not set properly.

1.

Properly set controls.

2.

Exhaust line not connected.

2.

Ensure probe plugs are properly connected.

3.

Probe does not defrost during operation.

3.

Immediately shut console off and flood tip area with sterile saline.

Digital Temperature Display Malfunction: Cause

Remedy

1.

Meter not “on”.

1.

Turn main meter switch “on”.

2.

Open circuit in thermocouple.

2.

Connect a second thermocoupled probe to console and test.

3.

Display out of calibration.

3.

Check digital meter calibration with probe connected and system off. Submerge probe tip in ice water. Reading should be approximately 0OC. No calibration required.

4.

Batteries low.

4.

Replace four 9 volt batteries.

CCS-200 Operation & Maintenance Manual

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Troubleshooting Control Valves Do Not Operate Properly: Cause

Remedy

1.

Knob is loose on shaft.

1.

Tighten knob with allen wrench.

2.

Valve freezing tip.

2.

Remove knob and tighten packing nut. Do Not Over Tighten. Tighten only until leak stops.

Difficult to Insert Probe Plugs into Probe sockets or Leaks: Cause

Remedy

1.

No lubricant.

1.

Apply a small amount of lubricant, e.g. syringe lubricant, to the probe shank; then insert shank into the console. Twist the plug while inserting to lubricate “O” ring. Do not place lubricant on filter or in probe opening.

2.

“O” rings damaged.

2.

Replace with new “O” ring. Refer to user information for part number.

Exhaust Hose Slips Off Console: Cause

Remedy

1.

Exhaust line restricted.

1.

Check exhaust line for restrictions and correct.

2.

External exhaust source restricted or not adjusted correctly.

2.

Check venting for restrictions and correct adjustments.

Digital Timer Display Malfunction: Cause

Remedy

1.

Batteries low.

1.

Replace batteries (Refer to timer section).

2.

Controls not set properly.

2.

Properly set controls (Refer to timer section).

CCS-200 Operation & Maintenance Manual

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Replacement Parts

Replacement Parts for CCS-200 Console, Cat. No. 3050 Catalog Number

Description

32873... Exhaust Tube, 20 ft. 10313... Batteries, 9 volt 20808... “O” Ring - Upper Probe Socket 20440... “O” Ring - Lower Probe Socket 21720... Filter Cartridge - Replacement 10924... Filter “O” Ring - Replacement 51875... Pressure Gauge - Filter Assembly 20370-3... 30” Pressure Hose 21837... Yoke Tip Replacement 21910... Caster - Braking 52329-202... Base, Legs 30740... Mold Trim 21913... Wrench 686... 20 lb. N2O Cylinders (empty)

Note: The only user serviceable parts contained in the CCS-200 console are the timer batteries and the temperature display meter batteries.

CCS-200 Operation & Maintenance Manual

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Symbol Legend/Certifications

CCS-200 Operation & Maintenance Manual

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EMC Compliance Information

CCS-200 Operation & Maintenance Manual

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EMC Compliance Information

CCS-200 Operation & Maintenance Manual

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EMC Compliance Information

NOTE 1: NOTE 2:

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

CCS-200 Operation & Maintenance Manual

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EMC Compliance Information

CCS-200 Operation & Maintenance Manual

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