AtriCure Cryo Module (ACM)
Contents
1. 9 3 1 Tools and Parts e 3 32 inch Allen Wrench e Snap Ring Pliers e 1 0 inch Socket e Socket Wrench e Filter Swagelok 157 4TF K6 9 3 2 Procedure NOTE ACM unit should be powered off and unplugged before continuing with the fuse replacement procedure 1 Turn over the ACM unit so that the bottom side is up 2 Remove the 4 screws holding the filter service cover in its place using the 3 32 inch Allen wrench az EEEE TTE e a 3 Using the 1 inch 25 mm Socket loosen the filter bonnet nut 47 4 Remove the old filter and replace with new one Breakdown of each component is shown below for reference 1 SnapRing 2 Filter Bonnet Nut 3 Filter 5 Reassemble the filter housing 6 Replace the filter service cover Confirm operational status by plugging in the ACM and powering it up Check to see that the self test is completed without errors 9 4 Replacement of Gas Line Desiccant Filter 9 4 1 Tools and Parts e 9 16 Open end wrench e Replacement parts Supplied By Part Number Filter Cartridge F021720 Filter O ring F010924 Pressure Gauge Assembly F051875 Tip Washer F021837 Teflon Tape 48 A Desiccant Filter Cartridge B Filter Housing C Tip Washer 9 4 2 Procedure 1 Unscrew the filter cartridge housing by rotating it counter clockwise Refer to the figure below 2 Remove the desiccant filter cartridge by rotating it counter clockwise2. Atricure ma COZSROWO EOEJ B O O Oo 6 I gt gt w A eo Atri ure AtriCure Cryo Module ACM USER S MANUAL Model ACM1 115 VAC Model ACM2 230 VAC AtriCure Inc 6217 Centre Park Drive West Chester Ohio 45069 USA P000669 Rev D European Representative Herbert Kontges Kontges SPRL Avenue Hellevelt 35 B 1180 Brussels Belgium Tel 32 2 375 51 63 FAX 32 2 375 89 06 email herbert kontges skynet be C 0086 Table of Contents I GETTING STARTE Dia nee euere Tee 4 Moths SYSIEMDeSCHDUONa ico aa nen 5 1 2 UNDACKING ansehen 6 1 3 Warnings and Precautions eGP EWA AEO A ee ee 6 1 4 EMC Guidance and Manufacturer s Declaration 2 002202200220 aaa aaa nenn 7 1 5 Responsibility of the Manufacturer ccccccceccceecseeceeeceeeceeeseeeeeeseeeseeeeeeeaees 11 2 THE ATRICURE CRYO MODULE ACM ossa eeemosaaneeeoaaanaeaoezaanawaczannnecce 12 2 14 DEVICE DESCHPIUON ZA GR ARA Beek ae 12 2 2 ACM Front Panel Illustration and Nomenclature e aaeaaa aaa aaa seen 13 2 3 ACM Rear Panel Illustration and Nomenclature 202200200220020 22020 19 3 INSTALLING THE ACN 2 ann 22 Oks LIANSDONNNA OLAEMI atak ERSCHIEN zada a taaa aaa 22 3 2 Preparing the ACM For Use eeaaa aaa aaa aaa a aaa aaa aaa aaa zaa aaa zak aaaazaaa zana 22 2 5 Installing POWer CONG sos
3. Timer Decrement Timer Increment Probe Temperature Gas Inlet Gas Outlet Temperature Adjust Gas Exhaust Maintenance Needed Low Gas Pressure 40 Cylinder Heater Band Footswitch 41 7 2 1 3 7 4 7 5 7 6 Technical Specifications Mechanical Specifications e Size 17 5 in W x 27 0 in D x 4 5 in H maximum 44 5 cm W x 68 6 cm D x 11 4 cm H maximum e Weight 50 Ib 23 kg absolute maximum Environmental Specifications e Operational temperature 10 C to 40 C e Storage and Transit temperature 35 C to 54 C e Humidity 15 to 90 relative humidity Electrical Specifications e ACM1 100 120VAC 115 VAC nominal 50 60 Hz e ACM2 220 240VAC 230 VAC nominal 50 60 Hz Fuses e 100 120VAC 50 60 Hz Replace fuses as marked 4 0A 250V T lag 5 x 20 mm UL Recognized IEC Approved e 220 240VAC 50 60 Hz Replace fuses as marked 2 0A 250V T lag 5 x 20 mm UL Recognized IEC Approved Footswitch Specifications e Moisture protection rating IPX8 Equipment Type Classification e Class 1 Equipment 42 Preventive Maintenance and Cleaning of ACM Preventive Maintenance Perform annual preventative maintenance procedures to ensure all ACM components are functioning as defined within this manual Pay particular attention to operational and safety features including but not limited to e Electrical power cords for fraying damage and proper grounding
4. As a result the displayed value many decrement quicker than anticipated This time value should not be taken as an absolute measurement but only as a reference in gauging the amount of gas remaining in the cylinder The display value will start to blink when there is approximately 10 minutes or less of anticipated useable gas left in the cylinder NOTE Replacement of the N20 cylinder at this point is highly recommended NOTE Along with the blinking gas gauge the Low Cylinder Pressure indicator LED may also be blinking indicative of empty or near empty N20 cylinder Typical usage time for a new cylinder is between 30 to 40 minutes depending on the type and size of the cylinder when used with the ACM cylinder heater band The gas gauge value can be reset upon replacement of the N20 cylinder by pressing down on the Timer Increment and Timer Decrement key simultaneously and releasing Secondary function of the gas gauge is to display the N2O cylinder gas pressure during the ablation cycle This provides the user with additional real time information regarding the gas status within the cylinder during system operation in psi x10 18 2 2 4 2 Ablation Timer e This display indicates the desired ablation duration in units of seconds e The default duration time is 120 seconds per ablation run e his timer value can be adjusted prior to or during the ablation cycle by using either the Timer Increment or Timer Decrement key p
5. Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 5 Responsibility of the Manufacturer AtriCure is responsible for safety reliability and performance of the equipment only if e Installation procedures in this manual are followed e Persons authorized by AtriCure carry out modifications or repairs e The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI e The equipment is used in accordance with the AtriCure Users Manual 11 2 1 The AtriCure Cryo Module ACM This section provides a detailed description of the ACM including its function and operating features Device Description The AtriCure Cryo Module ACM unit is an electro mechanical and pneumatic cryogenic surgical system that delivers a cryogenic source Nitrous Oxide to create lines of ablation through cardiac tissue The ACM is part of a system which includes the nitrous oxide gas and its cylinder N20 gas line hose N O exhaust hose cylinder heater band a footswitch system power cord and single use cryo handpiece with integrated electronics cable gas hoses The system provides a controlled lesion forming temperature that is below 40 C with typical operating ranges between 50 C to 70 C for the treatment of cardiac arrhythmias creating an inflammatory response cryonecrosis that blocks the cardiac electrical conductio
6. Figure 3 ACM Ablation Status Indicators READY Green LED 1 This status indicates the ACM is in stand by mode and is ready to start the cryo ablation cycle FREEZE Blue LED This status indicates the ACM is in cryo freeze state and the N2O gas is allowed to flow through the Handpiece causing drop in probe temperature DEFROST Amber LED This status indicates the ACM is in defrost state N20 gas flow is ceased Handpiece is back pressurized and the Handpiece probe is warming back up to the ambient temperature 14 2 2 2 System Status Indicators There are six system status indicators on the front panel ofthe ACM SYSTEM POWER SYSTEM FAULT MAINTENANCE NEEDED LOW CYLINDER PRESSURE CYLINDER HEATER BAND ACTIVE and FOOTSWITCH ACTIVE These indicators are described below SYSTEM POWER Green LED This status indicates system logic power for the ACM is available SYSTEM FAULT Red LED This status indicates ACM has encountered a system fault condition and has halted all operation The ACM unit will not operate until the fault condition has been addressed MAINTENANCE NEEDED Amber LED This status indicates the ACM system is still in normal functional and safe operating mode However maintenance is being requested to address such items as replacing in line N20 gas filter to optimize system performance LOW CYLINDER PRESSURE Amber LED This status indicates the N20 cylinder
7. Refer to the figure below 49 9 5 3 Replace the desiccant filter cartridge with a new one 4 Replace the filter housing Other Replacement Components 9 5 1 USA Only C000262 9 5 2 International C002090 9 5 3 Electromagnetic Compatibility Use of accessories other than identified in Section 9 5 1 and 9 5 2 may result in increased EMISSIONS or decreased IMMUNITY of the AtriCure Cryo Module 50 10 10 1 10 2 10 3 11 Accessories CMH15 Cryo Module Cylinder Heater Band Cylinder heater band with dimensions of 12 inch x 15 inch 30 5 cm x 38 1 cm CMH22 Cryo Module Cylinder Heater Band Cylinder heater band with dimensions of 12 inch x 22 inch 30 5 cm x 55 9 cm CMF1 Cryo Module Footswitch Momentary contact pedal switch with 15 feet signal cord which can be used in place of the Ablation Activation Switch at the ACM front panel Disposal Follow local governing ordinances and recycling plans regarding disposal or recycling of device components 51 Warranties Limitation on Liability This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Ohio U S A AtriCure Inc warrants this product to be free from defects in material and workmanship under normal use and preventive maintenance for the respective warranty period shown below AtriCures obligation under this warranty is limited to the repair or replacemen
8. System 24V out of range Replace Fuse or System Controller Board Fuse F2 blown Contact AtriCure Customer Service for support N20 cylinder temperature high Wait for N20 gas cylinder to cool down or N20 gas cylinder likely empty Replace with new N20 gas cylinder Contact AtriCure Customer Service for support Cold junction temperature out of range System Controller Board requires service Contact AtriCure Customer Service for support In line N20 gas filter clogged Replace In line N20 gas filter or P3 36 9 3 ACM Error Codes If an error condition should occur the N20 Gas Gauge display on the front panel will display the following error code while the ACM unit is in the READY Mode System Maintenance Needed indicator LED will also be lit Use the table below to attempt to resolve the following application errors DISPLAY DESCRIPTION SOLUTION MESSAGE No 230VAC to the cylinder heater band Replace Fuse or System Controller Board Fuse F1 blown Contact AtriCure Customer Service for support No cylinder heater band voltage System Controller Board requires service System Controller Board Triac inoperative Contact AtriCure Customer Service for support Handpiece pressure regulator out of Handpiece Pressure Regulator range requires service Contact AtriCure Customer Service for support In line NO gas filter dirty Replace In line NO Gas Filter or E4 Contact AtriCure Customer Service for
9. contact AtriCure Inc at 6217 Centre Park Drive West Chester Ohio 45069 USA Telephone 513 755 4100 866 349 2342 Toll Free 43 8 2 Cleaning and Disinfecting 8 2 1 ACM Cleaning and Disinfection Instructions Use a mild detergent and damp cloth to clean the ACM enclosure front and rear panel N20 exhaust tube N20 gas line hose and power cable The ACM and associated accessories cannot be sterilized Do not allow fluids to enter the enclosure The ACM and associated accessories may be disinfected using a standard hospital alcohol solution applied with a cloth NOTE Do not spray or pour liquids directly on the unit 8 2 2 8 2 3 Footswitch Cleaning and Disinfection Instructions Use a mild detergent prepared to its specifications and a damp cloth to clean the exterior of the Footswitch and cord Do not allow fluids to enter the chassis Take care not to wet the electrical connector on the cable Do not use caustic corrosive or abrasive cleaning materials The Footswitch cannot be sterilized The Footswitch may be disinfected using a standard hospital alcohol solution applied with a cloth Cylinder Heater Band Cleaning and Disinfecting Instructions Use a mild detergent prepared to its specifications and a damp cloth to clean the exterior of the Cylinder Heater Band and its device cord Take care not to wet the electrical connector on the cable Do not use caustic corrosive or abrasive cleaning materials Th
10. Year Grounded Electrical Cord srira anaia aaa aa aaa aaraa Mia Aa EEEREN One 1 Year THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING THE WARRANTIES OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF ATRICURE INC AND IS A PURCHASER S EXCLUSIVE REMEDY IN NO EVENT SHALL ATRICURE INC BE LIABLE FOR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION DAMAGES RESULTING FROM LOSS OF USE PROFITS BUSINESS OR GOODWILL AtriCure Inc neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of AtriCure Inc products There are no warranties that extend beyond the terms presented unless an extended warranty is purchased before the original warranty expires No agent employee or representative of AtriCure has any authority to change any of the foregoing or assume or bind AtriCure to any additional liability or responsibility AtriCure Inc reserves the right to make changes to products built and or sold by them at any time without incurring any obligation to make the same or similar changes on products previously built and or sold by them 52
11. also resets to the target ablation time value Once the Handpiece has been depressurized it is ready for the next ablation run which may take place immediately thereafter NOTE The transition from Defrost to either Freeze Mode or Ready Mode will not occur until the probe temperature has reached above 10 C Actuation of the Ablation Activation Switch or the Footswitch when the probe temperature is below 10 C is simply ignored by the ACM unit NOTE The Defrost status LED will start to blink indicating to the operator when the ACM unit is ready to transition back to either the Freeze Mode or the Ready Mode NOTE Handpiece probe temperature may drop temporarily during depressurization phase transition from Defrost to either Freeze Mode or Ready Mode 4 3 4 Powering down the ACM Upon completion of the procedure the ACM unit can be powered down NOTE Verify that the ACM unit is in the Ready Mode prior to powering down the unit If the unit is not in the Ready Mode cycle the ACM by continuously pressing the Ablation Activation Switch or depressing the Footswitch until the unit returns to the Ready Mode CAUTION Do not remove cryo handpiece from the the ACM unit if the ACM has been powered down prior to the system being in the Ready Mode as N O gas may be trapped within the cryo handpiece interface and the handpiece couplers may still be under pressure 33 To remove any trapped N20 gas turn the ACM unit back ON As the
12. cable and connector If physical damage is found or the Cylinder Heater Band does not perform within specification contact AtriCure for replacement 3 5 2 Wrapping the Cylinder Heater Band Place the Cylinder Heater Band around the N20 cylinder and secure all 6 tensioning spring retainers as shown in Figure 6 Start with the top and bottom spring retainers NOTE Cylinder Heater Band should be positioned approximately 2 0 inch 5 0 cm from the cylinder bottom for optimal performance Figure 6 Cylinder Heater Band Installation 23 3 5 3 Connecting and Disconnecting the Cylinder Heater Band With the connector alignment arrow in the 12 o clock position push the Cylinder Heater Band Connector into the Cylinder Heater Band Receptacle on the rear panel of the ACM as shown in Figure 7 To disconnect firmly grasp the connector body push down on the locking latch and pull out from the Cylinder Heater Band Receptacle NOTE Cylinder Heater Band must be connected to the ACM prior to powering up the unit However the ACM unit can operate without the Cylinder Heater Band in place but the system performance will not be optimal NOTE It is highly recommended that the ACM unit and the cylinder heater band be activated at least 15 minutes prior to first use to allow for the cylinder pressure to reach optimal operating level Figure 7 Connecting the Footswitch Cylinder Heater Band and Power Cord to ACM 3 6 Inst
13. can also affect ACM performance and care should be taken to minimize such interference However there is no guarantee that interference will not occur in a particular installation 1 4 1 4 If the ACM does cause harmful interference to other devices which can be determined by turning the ACM off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving device e Increase the separation between the ACM and the other devices e Connect the ACM into an outlet on a circuit different from that to which the other device s are connected e Contact the AtriCure service representative for help 1 4 2 Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emissions The AtriCure Cryo Module ACM is intended for use in the electromagnetic environment specified below The customer or the user of the ACM unit should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance The ACM unit uses RF energy only for its internal ak function Therefore its RF emissions are very low and RE emissions CISPR TI Group 1 are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The ACM unit is suitable for use in all establishments other than domestic and those directly connected to DE EEE RO itt the public low voltage power supply
14. fails the system transitions to the FAULT mode NOTE Refer to Section 4 2 below for a full description of the READY and FAULT modes as well as all the other operating modes It is highly recommended that the ACM system be prepared and powered up well in advance of start of the procedure to verify its operational readiness as well as preheating of N20 cylinder gas pressure to raise it to its optimal performance level NOTE N20 cylinder valve must be open for the system to detect its presence and to start the preheating cycle 28 4 2 Operating Modes The ACM operates in one of five modes READY FREEZE DEFROST ERROR and FAULT modes These modes are identified by the system status indicator LEDs and the ablation status indicator LEDs located on the front of the ACM unit See Figure 11 below 4 2 1 READY Mode This mode is entered automatically upon successful execution of Power On Self Test when the unit is first turned on or following DEFROST Mode upon venting of the Handpiece by depressing the Ablation Activation Switch or the Footswitch This indicates that the system is ready for the next cryo ablation run 4 2 2 FREEZE Mode This Mode is entered from the READY Mode when the user initiates the cryo ablation cycle by pressing the Ablation Activation Switch or depressing and releasing the Footswitch In this mode the N20 gas is allowed to cycle through the handpiece causing a temperature drop to take place at the h
15. message when in READY Mode and may halt operation temporarily upon detection of the error condition These are non fatal self remedying errors and does not impact continue use ofthe system System Maintenance LED will be active to alert the user that an error condition has occurred To reset the Maintenance LED hold down both the Timer Increment and Timer Decrement button and power cycling the unit The system will undergo power on self test for system functionality confirmation and return to the operating state if appropriate FAULT Mode This Mode is entered upon detection of any unrecoverable error condition during any Mode The system is inoperable in this Mode until the power is cycled off then on and only if the fault condition no longer exists or has been remedied To reset the Fault LED hold down both the Timer Increment and Timer Decrement button and power cycling the unit The system will undergo power on self test for system functionality confirmation and return to the operating state if appropriate 30 4 3 Delivering Cryo Energy 4 3 1 Connect the Handpiece Pneumatics Cylinder Heater Band and Footswitch Connect the Handpiece N20 Gas Line Hose N20 Exhaust Hose Cylinder Heater Band and Footswitch as described in Sections 3 4 through 3 8 and note no errors are indicated by the ACM unit The ACM should indicate that the system is in the READY mode and the display showing ablation parameters See Figure 11 If
16. not use extension cords or three prong to two prong adapters The Power Cord assembly should be periodically checked for damaged insulation or connectors Installing the Footswitch 3 4 1 Inspect the Footswitch Inspect the Footswitch for any signs of physical damage to the cable and connector If physical damage is found or the Footswitch does not perform within specification contact AtriCure for replacement 22 3 4 2 Connecting and Disconnecting the Footswitch With the connector alignment arrow in the 12 o clock position push the Footswitch Connector into the Footswitch Receptacle on the rear panel of the ACM as shown in Figure 7 To disconnect firmly grasp the connector body and pull out from the Footswitch Receptacle NOTE Typically you will connect the Footswitch to the ACM prior to powering up the unit However the Footswitch may be connected to the ACM when the unit is powered up and is in READY operating mode see Section 4 regarding the READY mode 3 4 3 Preparing the Footswitch for Use The Footswitch should be placed on a flat floor It is recommended that the area near the Footswitch be kept dry to reduce the risk of slippage Appropriate precautions should be taken to ensure that the cable connecting the Footswitch to the ACM does not create a hazard in the operating room Installing Cylinder Heater Band 3 5 1 Inspect the Cylinder Heater Band Inspect the Cylinder Heater Band for any signs of physical damage to the
17. operator e Ablation Timer Duration Freeze duration value in seconds e Probe Temperature Threshold Temperature value at which the ablation timer Starts its countdown sequence Ablation Timer Duration Adjustment e Using the Timer Increment and the Timer Decrement key pad adjust the timer value until the desired time value is shown The displayed value corresponds to the desired length of freeze time in units of seconds Valid range is from 010 to 300 seconds in 10 second increments e Once the desired time value is displayed press the Ablation Activation Switch to accept the value 34 The system will now start blinking the display of the probe temperature threshold parameter 6 Probe Temperature Threshold This value is used by the system to start the ablation timer countdown when the probe temperature has dropped below the set threshold value Using the Timer Increment and the Timer Decrement key pad adjust the probe temperature threshold value until the desired temperature value is shown The displayed value corresponds to the desired probe temperature threshold value in units of degrees Celsius Valid range is from 10 C down to 0 C in 5 C increments Once the desired temperature value is displayed press the Ablation Activation Switch to accept the value 7 The entry of the parameter value is now complete and the system exits the parameter entry mode and returns to the operating mode with the new set of parame
18. the ACM unit FOOTSWITCH ACTIVE Blue LED This status indicates the ACM footswitch pedal is depressed and is in activate state The indicator LED will extinguish when the footswitch pedal is released 2 2 3 Front Panel Functions Description HANDPIECE THERMOCOUPLE Receptacle This 2 pin receptacle accepts the AtriCure Handpiece thermocouple connectors This connection is patient isolated HANDPIECE ELECTRONIC INTERFACE Receptacle This 14 pin receptacle is reserved for future release of AtriCure Handpiece This connection is patient isolated HANDPIECE PNEUMATIC Receptacle This 2 port pneumatic receptacle provides the N20 interface with the AtriCure Handpiece The ports are polarized to prevent cross coupling of the nozzles Description HANDPIECE PROBE TEMPERATURE ADJUST Knob This control knob provides the operator with the ability to adjust the terminal temperature of the handpiece probe Turning the knob in the counter clockwise rotation lowers the probe temperature while turning the knob in clockwise rotation raises the probe temperature In normal operation the knob will be adjusted to provide maximum negative temperature 2 2 4 Front Panel Displays 2 2 4 1 N20 Gas Gauge This display indicates in minutes the approximate amount of useable N20 gas remaining in the cylinder As the gas is being consumed this value will adjust based on the actual gas flow time and the cylinder pressure
19. transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz Yms d 1 2 VP d 1 2 VP 80 MHz to 800 MHz Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ACM is used exceeds the applicable RF compliance level above the ACM should be ob
20. unit cycles through the Power On Self Test POST it will purge any trapped N2O gas within the cryo handpiece interface Upon completion of POST and the ACM unit enters the Ready Mode the unit may now be powered down and the cryo handpiece removed from the ACM unit safely 1 Close the N20 gas cylinder valve 2 Depressurize the ACM unit by pulling on the Pressure Relief Valve Knob located in the rear of the unit This will remove any excess N20 that may be trapped within the ACM pneumatic system 3 Unplug the power cord from the hospital mains outlet and disconnect from the ACM unit 4 Disconnect cryo handpiece from the ACM unit and dispose properly 5 Disconnect N20 gas line hose from the ACM unit and N20 cylinder 6 Loosen all 6 cylinder heater band tensioning springs and remove from the N20 cylinder Disconnect the cylinder heater band connector from the ACM unit 7 Disconnect the footswitch from the ACM unit 8 Return ACM unit its accessories and N O cylinder back to proper storage 4 4 Parameter Entry Mode Adjusting the System Default Parameter Values 1 Power up the ACM unit The system will go through its Power On Self Test POST routine Upon completion of POST press and hold down the Ablation Activation Switch for approximately three seconds and release The User Display will start to blink indicating entry into the parameter entry mode 4 There are two parameters that can be modified by the
21. ACM Model Number or the ACM Rating Label 2 Using the needle nose pliers carefully extract the fuse box from the power entry module by squeezing down on the fuse box tabs in the slots as shown 45 3 Replace the 2 two fuses located in the fuse box Make sure the fuses are lined up straight 4 Line up the fuse cartridge so the guide tab is towards the power entry side as shown 5 Slide the fuse box back into the power entry module and seat it firmly 6 Confirm operational status by plugging in the ACM and powering it up Check to see that the self test is completed without errors 9 2 Replacement of System Controller Board Fuses 9 2 1 Tools and Parts e Fuse Extractor e 3 32 inch Allen Wrench e Fuses System Controller Fuse Type Part Number T 1 6A 250V Littlefuse 021801 6HXP T 1 6A 250V Littlefuse 021801 6HXP T 1 6A 250V Littlefuse 021801 6HXP 9 2 2 Procedure NOTE ACM unit should be powered off and unplugged before continuing with the fuse replacement procedure 1 Turn over the ACM unit so that the bottom side is up 2 Remove the 6 screws holding the bottom cover in its place using the 3 32 inch Allen wrench 3 Using the fuse extracting tool remove the appropriate fuse and replace 4 Re secure the bottom cover 5 Confirm operational status by plugging in the ACM and powering it up Check to see that the self test is completed without errors 46 9 3 Replacement of In Line N20 Filter
22. REVENTIVE MAINTENANCE AND CLEANING OF ACM 2 112 43 8 1 PIEYENIMOMaIMENANCCZa GG weap ORGA AAA a 43 82 Cleaning ahd DISINIECHNO wk AREA KARA AA AAA OE 44 9 SERVICING OF ACM UNIT 2 aaas raaa aaae a Soc L 45 9 1 Replacement of AC Line FUSES sua aaa aaa aaa aaa aaa aaa anna aaa aaa aaa aaa naa aE Gi 45 9 2 Replacement of System Controller Board FUSES eaaaaa aaa aaa aaaaaaiaa 46 9 3 Replacement of In Line NoO Filter uueoa aaa aaa aaa aaa aaa aaa aaa aaa aaa aaa aaa aaa aa 47 9 4 Replacement of Gas Line Desiccant Filter aeaaa aaa aaa aaa aaa aa nana aiaa 48 9 5 Other Replacement Components ssae aaa aaa a aaa aaa a aaa aaa aaa aaa aaa aaa aaa aaa aaa a 50 10 ACCESSORIE Ser u 2 see eo ae ger OS R 51 10 1 CMH15 Cryo Module Cylinder Heater Band esaaeaaa aaa aaa aaa aaaaaancaa 51 10 2 CMH22 Cryo Module Cylinder Heater Band esaaeaaa aaa aaa aaa nennen 51 10 3 CMF1 Cryo Module Footswitch e aeaaae aaa a aaa Rene nnnnnnnennnennn nenn nene nenn nennen 51 11 DISPOSAL osc ooo ZA ROR AANA AA wi AGGA ee 51 Getting Started This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed Caution Federal USA law restricts t
23. UT for5s Uris the a c mains voltage prior to application of the test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the ACM unit requires continued operation during power mains interruptions it is recommended that the ACM unit be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 1 4 4 EMC Guidance and Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic immunity The AtriCure Cryo Module ACM is intended for use in the electromagnetic environment specified below The customer or the user of the ACM should assure that it is used in such an environment IMMUNITY IEC 60601 TEST Compliance Electromagnetic environment quidance test LEVEL level g g Portable and mobile RF communications equipment should be used no closer to any part of the ACM including cables than the recommended separation distance calculated from the equation applicable to the frequency of the
24. a Handpiece or the Handpiece thermocouple is not connected the ACM unit will indicate such by displaying an error message in the probe temperature display window with E H See Figures 12A and 12B Figure 11 ACM Indicating READY Mode Figure 12A ACM Indicating Missing Handpiece Thermocouple 31 Figure 12B ACM Indicating Missing Handpiece 4 3 2 Position the Handpiece To position the Handpiece follow the Instructions for Use provided with the Handpiece 4 3 3 Delivery of Cryo Energy 1 To start the cryo ablation cycle simply press the Ablation Activation Switch or depress and release the Footswitch The ACM unit s Ablation Status Indicator LED will transition from Ready to Freeze 2 N20 starts to flow through the ACM pneumatics and into the cryo ablation handpiece and the probe temperature starts to drop 3 Upon probe temperature dropping below the set threshold value is programmable with default value of 40 C the ablation timer starts its decrement from a preset value this value is also programmable with default value of 120 s NOTE The Freeze Mode can be manually terminated at any moment by pressing the Ablation Activation Switch or depressing and releasing the Footswitch causing the ACM unit to transition into Defrost Mode NOTE The Ablation Timer value can be manually adjusted from its start value either prior to the start of the ablation cycle or during the freeze cycle using t
25. ad e Each key press of the Timer Increment or Timer Decrement will modify the target ablation time value by 10 seconds either adding or subtracting from its present value e At the termination of the freeze cycle Defrost mode the display will show total time in freeze state A full 120 second run will result in the display showing 120 as an example An aborted freeze cycle will show the number of seconds the system operated in the Freeze mode 2 2 4 3 Handpiece Probe Temperature This display indicates the current handpiece probe temperature in Celsius and is continuously updated each second 2 3 ACM Rear Panel Illustration and Nomenclature An illustration of the ACM rear panel is shown in Figure 5 below Figure 5 ACM Rear Panel 1 N20 Exhaust Port 5 Equipotential Terminal 2 System Pressure Relief Knob 6 Cylinder Heater Band Receptacle 3 N20 Inlet Port 7 AC Power Entry Module 4 Footswitch Receptacle 8 Input Voltage Selector Switch Note Input Voltage Level Switch is factory set and is covered by unit model label The switch and the label should not be tampered with or changed except by an authorized AtriCure personnel 2 3 1 Rear Panel Functions em Description Power Entry Module This module contains both the ON OFF switch and the fuses Fuse Box The Fuse Box contains fuses selected for the input voltage See Technical Specifications in Section 7 of this manual Cylinder Heater Ba
26. alling N20 Gas Line Hose 3 6 1 Inspect the N O Gas Line Hose Inspect the N20 Gas Line Hose for any signs of physical damage to the hose and pneumatic connectors on both ends including pressure gauge and the desiccant filter assembly If physical damage is found do not use the N20 Gas Line Hose and contact AtriCure for replacement 3 6 2 Connecting and Disconnecting the N20 Gas Line Hose with ACM unit e Align the quick connect gas connector from the gas hose line with the ACM N20 inlet port e Insert and push in the connector until you hear it click in place and the connection is fully seated and secured from unlatching e To disconnect the N20 gas line connector from the ACM slide back on the N20 inlet port connector sleeve and remove See Figure 8 24 NOTE The N20 cylinder valve should be in the CLOSED position during connection and disconnection from the ACM unit Figure 8 Aligning the N20 gas line quick connect to the ACM N2O inlet port 3 6 3 Connecting and Disconnecting the N20 Gas Line Hose with Gas Cylinder e Align the CGA326 hand knob or equivalent coupler from the gas hose line with the gas cylinder s threaded connection port and screw in place by turning the hand knob in clockwise rotation NOTE The desiccant filter should be positioned vertically in line with the N2O gas cylinder as shown below Hand tighten the connection and verify there is no leak when cylinder valve is opened 25 e fa l
27. andpiece probe 4 2 3 DEFROST Mode This Mode is entered automatically from FREEZE Mode upon expiration of the ablation timer or manually by the operator when the Ablation Activation Switch or the Footswitch is depressed while in the FREEZE Mode In this mode the handpiece probe temperature is actively forced towards the ambient temperature Once the handpiece temperature has reached 10 C or higher the DEFROST status LED start to blink to indicate to the user the ACM unit is ready to transition back to the READY Mode or return to the FREEZE Mode to start the next ablation cycle The ACM unit can be returned to the FREEZE Mode by pressing and releasing the Ablation Activation Switch or depressing and releasing the Footswitch which causes the handpiece to vent and start the freeze cycle again The ACM unit can be returned to the READY Mode by pressing the Ablation Activation Switch or depressing the Footswitch and holding it in place for 2 seconds or longer The ACM unit will automatically vent and depressurize the handpiece Once depressurized the Ablation Activation Switch or the Footswitch can be released NOTE Handpiece probe temperature may drop temporarily during depressurization phase transition from Defrost to Ready state 29 4 2 4 4 2 5 ERROR Mode This Mode is entered upon detection of any recoverable error conditions during any Mode excluding the FAULT Mode The ACM unit will display the corresponding error
28. e AC power switch e Indicator damage Power On Fault Maintenance Needed Low Cylinder Pressure Cylinder Heater Band Active Footswitch Active Ready Freeze Defrost e NO Gas Gauge display damage or loss of information e Ablation Timer display damage or loss of information e Temperature display damage or loss of information e Handpiece electronic interface connector damage cracking or inability to insert and latch Handpiece connector e Handpiece pneumatic interface connector damage or inability to insert and latch Handpiece pneumatic connector e Carrying handle damage or inability to fold e Rubber feet damage cracking or inability for the ACM to remain stable on a flat surface e Rubber alignment cup damage cracking or inability for the ASB ASU to remain stable atop ACM and within the alignment cup e Footswitch cord fraying or damage e Footswitch connector damage cracking or inability to insert and latch footswitch plug e Footswitch pedal damage check activation by pressing and releasing the pedal Other medical equipment that may be used simultaneously with the ACM should also be inspected for damage Specifically check for insulation damage of electrical cables and associated connectors Visually inspect the footswitch for fluids or other infectious hazards Clean as necessary using the instructions in Section 8 2 The ACM does not have any customer serviceable parts aside from fuses and gas filter For servicing issues
29. e AtriCure Cryo Module will be referred to in this User s Manual as the ACM The AtriCure Cryo Handpiece will be referred in this Users Manual as the Handpiece This Users Manual provides a description of the ACM its controls displays indicators and a sequence for its operation with the Handpiece This User s Manual also supplies other information of importance to the user This manual is intended as a Users Manual only Do not operate the ACM before thoroughly reading this manual 1 1 System Description As shown in Figure 1 the system is comprised of the following A AC moO w AtriCure Cryo Module Cylinder Heater Band CMH15 or CMH22 AtriCure Cryo Footswitch ACM N20 Exhaust Hose ACM N20 Gas Line Hose AtriCure Cryo Module ACM Power Cord not shown AtriCure Cryo Handpiece with integral cable not shown Accessory devices are described in Section 10 Figure 1 ACM Footswitch N O Gas Line Hose N O Exhaust Hose and Cylinder Heater Band 1 2 Unpacking 1 2 1 ACM Unit Lift the ACM unit from the box and remove the protective wrapping and side caps Note The ACM unit is packed upside down for transit purpose Note Take precautions when lifting the unit as it weighs approx 45 Ibs 20 kg 1 2 2 Accessories ACM accessories are shipped separately from the ACM unit The accessory box contains the following items e ACM Power Cord e NO Gas Line Hose e N20 Exhaust Hose e ACM Cyli
30. e Cylinder Heater Band and its device cable cannot be sterilized The Cylinder Heater Band may be disinfected using a standard hospital alcohol solution applied with a cloth 44 Servicing of ACM Unit The ACM unit does not have any customer serviceable parts aside from fuses and gas filter The manufacturer does not require or recommend routine calibration output verification As stated in Section 4 the ACM performs its own maintenance check every time it is powered ON The check is called the Power On Self Test POST No calibration is needed for the system and the unit will generate an error if further maintenance is required Following identifies servicing that can be performed on the ACM unit based on Section 5 Troubleshooting guide Replacement of AC Line Fuses 9 1 1 Tools and Parts e Needle Nose Pliers e Fuses ACM Model Fuse Type Part Number ACM1 T 4A L 250V 0034 5049 ACM2 T 2A L 250V Schurter 0034 5046 9 1 2 Procedure The ACM unit has been pre set at the factory to either 110V 120V ACM1 or 220V 240V ACM2 The Rating Label below the Power Entry Module on the back panel of the ACM indicates the selected Input Voltage for this unit This setting should only be adjusted by the manufacturer or by an authorized AtriCure technical service representative NOTE ACM unit should be powered off and unplugged before continuing with the fuse replacement procedure 1 Determine the fuse type by looking at the
31. eak is detected tighten the hand knob connection further A wrench may be needed to tighten the connection e fthe leak cannot be eliminated either the N2O gas line hose or the N20 gas cylinder may need to be replaced e o disconnect from the gas cylinder turn the hand knob in a counter clockwise rotation until the connection is disengaged 3 7 Installing N20 Exhaust Hose Align the 50 ft 15m exhaust hose with the N2O Exhaust port of the ACM and push in place Run the exhaust hose to an appropriate venting mechanism that meets the hospital and local regulation To remove the exhaust hose from the ACM unit simply pull back on the tubing until it releases See Figure 9 NOTE It is not necessary or required for the N20 Exhaust Hose to be removed from the ACM unit at the end of the procedure The hose may be left in place Figure 9 Connecting the N20 gas line hose and N2O exhaust hose to the ACM 3 8 Connecting and Disconnecting the Handpiece Connect the Handpiece directly to the ACM Insert the Handpiece pneumatic interface connectors into the pneumatic receptacles on the front panel of the ACM ensuring that each pneumatic inlet and exhaust connection is fully seated and secured Insert the thermocouple connectors into their respective color coded connection ports on the front panel of the ACM See Figure 10 26 NOTE NOTE NOTE NOTE Typically you will connect the Handpiece to the ACM when the ACM ha
32. en cO eure 22 54 I stalimg ine FOOIEWICH aa ar ee 22 3 5 Installing Cylinder Heater Band ae aaa e aaa aaa aaa aaa aaa aaa nnnennnnnn ernennen 23 30 lAStallinG NsoO Gas LING Hose ung 24 3 7 Installing N20 Exhaust OSS nun sea aaa 26 3 8 Connecting and Disconnecting the Handpiece esa aaa aaa aaa aaa aaa nennen 26 4 INSTRUCTIONS FOR USE re EEEE 28 AA iPOWErNG Up De ACM essen 28 4 2 O 6 lt CZ UILG TOBI 80 O 29 4 3 DEIWENNACIO ENCIJV aS a i a do az oaz dz 31 4 4 Parameter Entry Mode Adjusting the System Default Parameter Values 34 5 TROJBLESNOOMNOGa nee 36 5 1 No ACM Power Display Function esaae aaa aaa aa aaa aaa Bene anne nnnennnnnnn nennen 36 Dees ACM Faul COdGS ea 36 Side ACM EMO CODES ee R 37 5 4 Handpiece Error CoOdes cccceccseccseceeceeeceeceeeseeteesneceeeeeeteeseessesseeeeeneeeeenaes 38 6 SYMBOLS USED inaari Gi O hdi A GEE 39 7 TECHNICAL SPECIFICATIONS zei 42 Tats MECHaNICAESBECHCANONS EO AEO 42 7 2 Environmental Specifications eaaa aaa aaa aaa aaa aaa aaa aaa aaa aaa aaa a zakazana wina ai aaa 42 1 3 EIECMICALODECIICANONS asearen henni a AA A 42 IA PUSE Gaia RA RO od B R O O AGR ARG 42 7 5 IFOOIEWIEN SDECIICGANO S srasni n ndatadaudsacacaunearareunaueatvansawers 42 7 6 Equipment Type Classification cccccccceccseeceeeeeeseeceeeseeseeeeeeneeeeeeaeeeeeeseenees 42 8 P
33. gas pressure into the ACM unit is below initial system power up or is dropping below during usage the optimal operating level Two LED indication modes are available Initial Power Up Constant Indicates the cylinder pressure is still below the optimal operating level Blinking Indicates cylinder valve is closed or if the valve is open the cylinder pressure is well below the operating level or is empty of N20 gas In both of these cases the cylinder heater band will be active to raise the cylinder pressure to its recommended operating level as long as the cylinder valve is in the open position The cylinder heater band will not be active if the cylinder valve is in the CLOSED position The indicator LED will extinguish when the cylinder pressure has reached its optimal operating level During Usage Constant Indicates the cylinder pressure has dropped below the optimal operating level and the cylinder heater band will be activated The indicator LED will extinguish when the cylinder pressure has risen back to the optimal operating level Blinking Indicates the cylinder pressure is well below the recommended operating level and the cylinder has less than 10 minutes of functional gas left 16 CYLINDER HEATER BAND ACTIVE Amber LED This status indicates ACM unit has energized the N20 cylinder heater band and itis active The indicator LED will extinguish when the cylinder heater band is turned off by
34. he Timer Increment and Timer Decrement key pad Each key press increments or decrements the timer value by 10 seconds NOTE The factory default values of 120 seconds for ablation duration and 40 C for the probe temperature threshold value can be altered by the operator and set as a site default values following the parameter entry procedure as defined in Section 4 4 4 When the ablation timer reaches zero the ACM unit automatically transitions into Defrost Mode As it transitions into the Defrost Mode the Ablation Timer display will now show the actual total ablation run time The ACM unit s Ablation Status Indicator LED will transition from Freeze to Defrost 32 5 Atthis point the ACM unit can be made to transition into one of two modes Freeze Mode or Ready Mode Defrost to Freeze Press and release the Ablation Activation Switch or depress and release the Footswitch The ACM units Ablation Status Indicator LED will transition from Defrost back to Freeze and the ablation cycle starts again As it transitions back to the Freeze Mode the Ablation Timer display also resets to the target ablation time value Defrost to Ready Press and hold the Ablation Activation Switch or depress and hold the Footswitch until the ACM unit vents and depressurizes the handpiece The ACM unit s Ablation Status Indicator LED will transition from Defrost back to Ready As it transitions back to the Ready Mode the Ablation Timer display
35. he generator AN Electric Shock Hazard Ensure that the Handpiece is correctly connected to the ACM and that no thermocouple wires are exposed from the cable connector or the Handpiece 1 3 2 PRECAUTIONS e Use only with the AtriCure Handpieces intended for use with the ACM e Donotactivate the ACM unit until the Handpiece is properly positioned at the ablation site e he system status indicators and displays are important safety features Do not obstruct either the ablation or the system status indicators Do not remove the ACM cover except for the in line gas filter access port as there is a potential for electrical shock Refer to authorized personnel for service e Use only the Footswitch provided with the ACM e The Power Cord of the ACM must be connected to a properly grounded receptacle Extension cords and or adapter plugs must not be used 1 4 EMC Guidance and Manufacturer s Declaration 1 4 1 Electromagnetic Requirements 1 4 1 1 The AtriCure Cryo Module ACM has been tested and found to comply with the limits for medical devices in IEC 60601 1 2 2007 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation 1 4 1 2 The ACM can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity 1 4 1 3 Portable and mobile RF communications equipment
36. his device to sale by or on the order of a physician Please read all information carefully Failure to properly follow the instructions may lead to serious surgical consequences Important This manual is designed to provide instructions for use of the AtriCure Cryo Module ACM with the AtriCure Cryo Handpiece CRYO1 and cryolCE and AtriCure Accessory Devices CMF1 CMH15 CMH22 This manual is not a reference to surgical technique The AtriCure Cryo Module ACM unit is an electro mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source namely Nitrous Oxide to create lines of ablation through cardiac tissue The ACM is part of a system which includes the nitrous oxide gas N20 gas line hose N O exhaust hose cylinder heater band a footswitch and single use cryo handpiece with integrated electronics cable gas hoses The system provides controlled lesion forming temperature that is below 40 C with typical operating ranges between 50 C to 70 C The system is also equipped with the ability to tune or set the terminal handpiece temperature The ACM is designed to operate only with AtriCure designed and developed handpieces Along with the Ablation Activation Switch on the front panel of the ACM a footswitch can also be used to activate the ablation cycle Refer to the handpiece Instruction for Use for a complete description of the indications and uses of these devices For the users convenience th
37. n pathway The system is also equipped with the ability to tune or set the terminal handpiece temperature Along with the Ablation Activation Switch on the front panel of the ACM the ACM Footswitch can also be used as the input device to activate and terminate the cryo ablation cycle The presence of the ACM Footswitch is not a requirement for the ACM unit to operate and is made available as a secondary means of interfacing with the ACM unit and to provide control of the ablation cycle to the surgeon The ACM is designed to operate only with AtriCure designed and developed handpieces Refer to the Handpiece Instruction for Use for complete description of the indications and uses of these devices 12 2 2 ACM Front Panel Illustration and Nomenclature An illustration of the ACM front panel is shown in Figure 2 below 12 3 5 B 10 Figure 2 ACM Front Panel 1 Ablation Activation Switch 7 Ablation Timer Increment 2 Ablation Status Indicator 8 Handpiece Probe Temperature 3 N2O Gas Gauge Display 9 Handpiece Thermocouple Port 4 System Status Indicator 10 Handpiece Electronic Interface Port 5 Ablation Timer Decrement 11 Handpiece Gas Connection Port 6 Ablation Timer Display 12 Handpiece Probe Temperature Control 2 2 1 Ablation Status Indicators There are three indicators on the front panel of the ACM READY FREEZE and DEFROST These indicators are described below Atri ure O 1 lt gt M 2 3
38. nd Receptacle This receptacle accepts the ACM Cylinder Heater Band connector It provides power for the heating element embedded in the heater band as well as transmitting back to the ACM unit the N20 cylinder wall temperature Footswitch Receptacle This receptacle accepts the ACM Footswitch connector The single momentary actuation pedal provides for the activation and termination of the cryo ablation cycle N20 Inlet Receptacle This receptacle accepts the N20 gas line hose with the quick connect disconnect interface used to transfer gas from the N gt O gas cylinder to the ACM unit to be utilized by the Handpiece 20 em Description 0000 N20 Exhaust Receptacle This inch 1 25cm receptacle accepts the 50 ft 15 m flexible tubing to direct the expelled N2O gas in a manner appropriate with local and hospital regulation System Pressure Relief Knob This knob when pulled will depressurize and expel any trapped N20 gas within the ACM unit at any time Be sure the N20 cylinder valve is CLOSED prior to performing this task Equipotential Terminal This terminal provides a means of securely linking the earth ground of the AtriCure ACM unit to other grounded equipment 21 3 1 3 2 3 3 3 4 Installing the ACM Inspect the ACM system for any signs of physical damage to the front and rear panel N2O gas couplers connector receptacles chassis or cover NOTE If a
39. nder Heater Band e ACM Footswitch e ACM Users Manual It is recommended that the original shipping box and protective wrapping be saved for future storing and or transporting of the device 1 3 Warnings and Precautions The safe and effective use of the cryo device and equipment is highly dependent upon factors under the control of the operator There is no substitute for a properly trained operating room staff It is important that the operating instructions supplied with the ACM unit be read understood and followed before use 1 3 1 WARNINGS e Do not operate the ACM unit before thoroughly reading this manual e Do not use cryo surgical equipment unless properly trained in the specific procedure being undertaken This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed Fire Hazard Do not use extension cords Trip Hazard Standard care should be used to reduce the risk of tripping on the Footswitch cable as well as the N2O exhaust hose The voltage selector is factory set and should not be changed by the user The voltage setting and the fuse rating must be appropriate as identified to prevent ACM malfunction and potential instrument damage Electric Shock Hazard Connect the ACM Power Cord to a properly grounded receptacle Do not use power plug adapters AN Electric Shock Hazard Do not connect wet accessories to t
40. network that Class A supplies buildings used for domestic purposes 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Complies 1 4 3 Electromagnetic Immunity Guidance and manufacturer s declaration electromagnetic immunity The AtriCure Cryo Module ACM is intended for use in the electromagnetic environment specified below The customer or the user of the ACM unit should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance level AG een Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 Ur gt 95 dip in UT for 0 5 cycle 40 Ur 60 dip in UT for 5 cycles 70 Ur 30 dip in UT for 25 cycles lt 5 Ur gt 95 dip in UT for5s 6 kV contact 8 kV air 2 kV for power supply Lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in UT for 0 5 cycle 40 Ur 60 dip in UT for 5 cycles 70 Ur 30 dip in UT for 25 cycles lt 5 Ur gt 95 dip in
41. ny physical damage is found DO NOT USE THE UNIT Contact AtriCure for a replacement All returns must be approved by AtriCure Transporting of ACM The use of handles is highly recommended in lifting carrying or moving of the ACM unit The ACM weighs approximately 45 Ibs 20 kg so care should be taken when transporting the ACM unit Preparing the ACM For Use 3 2 1 The ACM unit may be placed on a cart or on any sturdy table or platform It is recommended that carts have conductive wheels Refer to hospital procedures or local codes for detailed information 3 2 2 The ACM unit may be placed together or stacked with other AtriCure capital equipment such as the ASU ASB and the ORLab However care must be taken when stacking or placing the ACM unit adjacent to other medical equipment and unit performance should be observed to verify normal operation in the configuration in which it will be used 3 2 3 Provide at least four to six inches of space around the sides of the ACM for convection cooling Under continuous use for extended periods of time it is normal for the top panel to be warm to the touch Installing Power Cord The ACM unit is shipped with an approved hospital grade power cord Insert the power cord into the power entry module of the ACM unit as shown in Figure 7 and then into a grounded hospital AC power receptacle NOTE ACM power cord is shipped with the accessories and found in the accessory package NOTE Do
42. s been powered up and is in READY operating mode see Section 4 2 regarding the READY mode However the Handpiece may be connected when powered up or prior to powering up the ACM Once the Handpiece has been connected it cannot be disconnected from the ACM by pulling on the cable To disconnect the Handpiece slide back on the pneumatic connector sleeve and remove it from the ACM pneumatic receptacle Connection and disconnection of the Handpiece with the ACM unit should take place with the ACM unit in the READY state and the N20 cylinder valve in the CLOSED position Refer to the Handpiece instruction sheet for more detailed information about connecting the Handpiece to the ACM in a sterile environment Figure 10 Connecting the Handpiece to the ACM 2 4 4 1 Instructions For Use Powering Up the ACM 1 Ensure that the ACM has been plugged into a proper hospital power receptacle NOTE Do not use extension cords or three prong to two prong adapters where applicable The power cord assembly should be periodically checked for damaged insulation or connectors 2 Apply power to the ACM unit by flipping the ON OFF power switch located on the power entry module at the rear panel The GREEN LED on the power switch should energize if power is being applied to the system The ACM unit will go through a system Power On Self Test POST IfPOST passes the system transitions to the READY mode If any portion of the POST
43. served to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ACM Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 10 1 4 5 Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the AtriCure Cryo Module The AtriCure Cryo Module ACM is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ACM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ACM as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHZ the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations
44. support No cylinder heater band current Verify Cylinder Heater Band is wrapped around the NO gas cylinder or ANASI nealen pane Replace Cylinder Heater Band if e Heating element malfunction or defective heating element is Thermal cutoff switch was activated determined or heater band reached 65 C Contact AtriCure Customer Service for support Caution cylinder heater band may be hot to the touch 3 5 4 Handpiece Error Codes If Handpiece related error condition should occur the Probe Temperature display on the front panel will display the following error code Use the table below to attempt to resolve the following application errors DISPLAY DESCRIPTION SOLUTION MESSAGE READY Mode Only Handpiece Not Connected READY Mode Only Defective Thermocouple READY Mode Only Defective Thermocouple DEFROST Mode Only Probe temperature has risen above the operating limit FREEZE Mode Only Probe temperature has dropped below operating limit Connect Handpiece Thermocouple Connection Replace Handpiece Replace Handpiece Replace Handpiece If Problem Repeats Contact AtriCure Customer Service Replace Handpiece If Problem Repeats Contact AtriCure Customer Service 38 6 Symbols Used Attention consult accompanying documents Dangerous Voltage Power OFF Alternating Current Equipotential Terminal Type CF Applied Part Gas Gauge Time Remaining 39
45. t at its option of any product or part thereof which has been returned to AtriCure Inc or its Distributor within the applicable time period shown below and which examination disclosed to AtriCure s satisfaction to be defective This warranty does not apply to any product or part thereof that has been 1 adversely affected due to use with devices manufactured or distributed by parties not authorized by AtriCure Inc 2 repaired or altered outside AtriCure s factory in a way so as to in AtriCure s judgment affect its stability or reliability 3 subjected to improper use negligence or accident or 4 used other than in accordance with the design and use parameters instructions and guidelines for the product or with functional operational or environmental standards for similar products generally accepted in the industry AtriCure has no control over the operation inspection maintenance or use of its products after sale lease or transfer and has no control of the selection of Customer s patients AtriCure s products are warranted for the following periods after shipment to the original purchaser AtriCure Cryo Module Unit aan ana ae ea tut One 1 Year AtriCure Cylinder Heater Band u022222000000000000000nnnnnnennnnnn en nennnn nn One 1 Year AtICUle Gas LING Hose ss ea nee u One 1 Year AtriCure Cryo Footswitch eeesaaaee aaa aa aaa aaa aaa wazna nennen nnnnnnennennne nennen One 1
46. ters 8 Factory Default The ACM unit can have its parameter values reset to its factory default setting at any time To restore the factory default parameter values power down the ACM unit Hold down the Ablation Activation Switch and power up the ACM unit A letter P will be displayed in the N20 Gas Gauge display Release the Ablation Activation Switch and the system will now go through its Power On Self Test POST routine Upon completion of system POST the unit returns to its normal operational state and the system has restored all of the parameters back to the original factory default values 9 Factory default values are Ablation Timer Duration 120 seconds Probe Temperature Threshold 40 C 35 9 Troubleshooting Use the following sections to help troubleshoot possible problems with the ACM 5 1 No ACM Power Display Function If there is no ACM power or display function attempt to correct this problem using the following checklist Possible Cause Sollen O O lt o ACM not plugged in Confirm electrical connections and then turn power on Replace fuse confirm electrical connections and turn power on Internal ACM failure Contact AtriCure Customer Service 5 2 ACM Fault Codes If a fault condition should occur the N20 Gas Gauge display on the front panel will display the following fault code Use the table below to attempt to resolve the errors DISPLAY DESCRIPTION SOLUTION MESSAGE
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