AtriCure cryoICE BOX1 User Manual Download Page 4 | Manualshive

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AtriCure cryoICE BOX1 User Manual Download Page 4

Change Ablation Time during Ablation.......................................................................................14
Emergency Stop............................................................................................................................14
Set Default Ablation Time............................................................................................................14
Operate without temperature reading............................................................................................14

SYSTEM DISASSEMBLY AFTER USE..............................................................................15

Disconnecting the cryoICE Probe.................................................................................................15
N

O Cylinder Removal.................................................................................................................15

PREVENTIVE MAINTENANCE AND CLEANING OF THE CRYOICE BOX..............16

Cleaning and Disinfecting Instructions.........................................................................................16
Preventive Maintenance................................................................................................................16
Replacement of AC Line Fuses....................................................................................................17
Tank Hose Accessory – Alternate (Replacement of Gas Line Desiccant Filter)..........................20
Other Replacement Components..................................................................................................22
Disposal.........................................................................................................................................22

TROUBLESHOOTING..........................................................................................................23

cryoICE BOX Error Codes...........................................................................................................27

10. ELECTROMAGNETIC COMPATABILITY TABLES......................................................27

Electromagnetic Emissions...........................................................................................................27
Electromagnetic Immunity............................................................................................................28
EMC Guidance and Manufacturer’s Declaration.........................................................................29
Recommended Separation Distance.............................................................................................30

WARRANTIES...............................................................................................................................31

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Summary of Contents for cryoICE BOX1

Page 1: ...cryoICE BOX Version 6 USER S MANUAL Model cryoICE BOX1 115 VAC Model cryoICE BOX2 230 VAC ...

Page 2: ...AtriCure Inc 7555 Innovation Way Mason Ohio 45040 USA P001207 Rev A ii ...

Page 3: ...3 2 TECHNICAL SPECIFICATIONS 4 Mechanical Specifications 4 Environmental Specifications 4 Electrical Specifications 4 Mains Fuses 4 Footswitch Specifications 4 Equipment Type Classification 4 3 CRYOICE BOX AND ACCESSORIES 5 4 CRYOICE BOX SET UP AND PREPARATION 6 N2O Cylinder Installation 6 Exhaust tubing 8 Heater Band Installation 8 Turning On the cryoICE BOX 9 Resetting the N2O Gas Gauge 10 Meani...

Page 4: ... BOX 16 Cleaning and Disinfecting Instructions 16 Preventive Maintenance 16 Replacement of AC Line Fuses 17 Tank Hose Accessory Alternate Replacement of Gas Line Desiccant Filter 20 Other Replacement Components 22 Disposal 22 9 TROUBLESHOOTING 23 cryoICE BOX Error Codes 27 10 ELECTROMAGNETIC COMPATABILITY TABLES 27 Electromagnetic Emissions 27 Electromagnetic Immunity 28 EMC Guidance and Manufactu...

Page 5: ...at delivers a cryogenic Nitrous Oxide N2O energy source to a cryoICE Probe to create lines of ablation through tissue The cryoICE BOX is part of a system which includes the N2O gas cylinder N2O gas line hose N2O exhaust hose cylinder heater band an optional footswitch and single use cryoICE Probe The system provides controlled lesion forming temperatures below 40 C with typical operating ranges be...

Page 6: ...ICE BOX malfunction and potential instrument damage Electric Shock Hazard Connect the cryoICE BOX Power Cord to a properly grounded receptacle Do not use power plug adapters Electric Shock Hazard Do not connect wet accessories to the generator Electric Shock Hazard Ensure that the cryoICE PROBE is correctly connected to the cryoICE BOX and that no thermocouple wires are exposed from the cable conn...

Page 7: ...ols on cryoICE BOX Attention consult accompanying documents Dangerous Voltage Power OFF Alternating Current Equipotential Terminal Type CF Applied Part READY FREEZE DEFROST N2O Gas Gauge Timer Timer Increase Button vii ...

Page 8: ...Timer Decrease Button cryoICE Probe Temperature Thermocouple Probe Cylinder Valve On Off N2O Gas Gauge Reset Gas Exhaust Maintenance Needed Cylinder Heater Band viii ...

Page 9: ...essure Gas Inlet Gas Outlet Humidity and Temperature Storage Limits located on corrugated cardboard packaging Meanings of Symbols on cryoICE Probe Classification in accordance with EN 60601 1 Safety CSA Mark Information ix ...

Page 10: ...er transportable rated 115 230Vac 4 2A 50 60Hz 1 Type of protection against electric shock Class I 2 Degree of protection against electric shock Type CF 3 Degree of protection against ingress of water IPX0 4 Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide 5 Mode of operation Continuous Environmental Conditions Normal 10 40 C...

Page 11: ... band an optional footswitch and single use cryoICE Probe The system provides controlled lesion forming temperature that is below 40 C with typical operating ranges between 50 C to 70 C Along with the Activation Button on the front panel of the cryoICE BOX an optional Footswitch can also be used to activate and terminate the cryo ablation cycle The cryoICE BOX is designed to operate only with Atri...

Page 12: ... Ablation Timer Display 18 N2O Manual Exhaust Knob 5 Ablation Timer Decrement 19 N2O Inlet Port 6 Ablation Timer Increment 20 N2O Exhaust Switch 7 cryoICE Probe Temperature 21 Activation Footswitch Connection Port 8 Future Probe Connection 22 Heater Band Cord Receptacle 9 cryoICE Probe Gas Outlet Port 23 Power Plug Receptacle 10 cryoICE Probe Gas Inlet Port 24 Power Switch 11 Ablation Status Indic...

Page 13: ...ng a temperature drop to take place at the cryoICE Probe DEFROST Mode This Mode is entered automatically from FREEZE Mode upon expiration of the ablation timer or manually by the operator when the Activation Switch or the Footswitch is actuated while in the FREEZE Mode In this mode the cryoICE Probe temperature is actively forced towards the ambient temperature Once the cryoICE Probe temperature i...

Page 14: ...umidity 980mb to 1050mb Transit 35 C to 54 C 15 to 90 relative humidity 980mb to 1050mb Electrical Specifications cryoICE BOX1 100 120VAC 115 VAC nominal 50 60 Hz cryoICE BOX2 220 240VAC 230 VAC nominal 50 60 Hz Mains Fuses cryoICE BOX1 100 120VAC 50 60 Hz Replace fuses as marked 4 0A 250V T lag 5 20 mm UL Recognized IEC Approved cryoICE BOX2 220 240VAC 50 60 Hz Replace fuses as marked 2 0A 250V T...

Page 15: ...2 B cryoICE BOX N2O Gas Line Hose Module standard C cryoICE BOX N2O Exhaust Hose D cryoICE BOX N2O Gas Line Hose Module with filter canister set Optional E cryoICE BOX F cryoICE BOX Footswitch Optional not shown G cryoICE BOX Power Cord not shown H AtriCure cryoICE Probe with integral tube set not shown Figure 3 cryoICE BOX Accessories xv A E D C B ...

Page 16: ...cylinders Always install a completely full cylinder so the cylinder volume can be indicated correctly To install a new N2O cylinder first find the N2O gas line receptacle on the rear panel and connect this end into the corresponding end of the N2O gas line Insert and push in the connector until you hear it click in place and the connection is fully seated and secured from unlatching as seen below ...

Page 17: ... leak is detected tighten the black knob with a wrench if needed If the Low Pressure indicator as seen in Figure 7 illuminate s amber this indicates that the cryoICE BOX is not detecting proper pressure Check to ensure that the gas cylinder valve is open fully and that the cylinder you have attached is not empty xvii ...

Page 18: ...2O gas cylinder Place heater band with the cord facing upward Secure all tensioning spring retainers around the gas cylinder starting with the very bottom and very top retainers and then proceed to secure the middle retainers as shown in Figure 8 The Heater band must be positioned less than 2 inches 5 cm from bottom of the cylinder to ensure that the N2O is heated efficiently Plug heater band cord...

Page 19: ...n the cryoICE BOX unit into an approved hospital outlet Turn on the cryoICE BOX unit with the switch located on the back as seen in Figure 10 After powering up the Activation Button on the front of the cryoICE BOX interface will be illuminated If no light is observed check for proper power cord connection and switch position xix ...

Page 20: ...he RESET button to the right of this display see Figure 11 Press and hold the RESET button for one second Caution Replace the N2O cylinder with a full cylinder only The N2O remaining volume is calculated from the expected cylinder full volume The gauge can only be reset to full after a system power cycle or following a cylinder swap out If Reset button is pressed following usage the gauge will res...

Page 21: ...ed or System Fault icons are illuminated 5 DEVICE USE Install cryoICE Probe 1 Ensure cryoICE BOX is properly connected to a N2O gas cylinder 2 The cryoICE Probe may be connected before the cryoICE BOX has been turned on while the cryoICE BOX is being turned on or when the cryoICE BOX unit is on and in READY mode 3 Insert the corresponding connections on the pneumatic connectors as shown below in F...

Page 22: ...15 Figure 14 Figure 15 6 The cryoICE Probe icon seen above in Figure 14 will extinguish if the cryoICE Probe is functioning properly and the approximate room temperature will be displayed on the temperature display typically 10 to 25 C An example of this is shown in Figure 16 Figure 16 Probe Temperature Display 7 A test run is advised to ensure the cryoICE Probe and system is working properly prio...

Page 23: ...that desired ablation time is displayed change if needed 3 Press and release the Activation Button at the left of the device to begin the ablation 4 The temperature display on the front panel displays the cryoICE Probe temperature A double beep will indicate that the therapeutic temperature has been reached typically 40 C and the ablation timer will begin to count down A short beep will sound ever...

Page 24: ...ICE BOX is powered on 2 Press and hold both up and down arrows simultaneously for one second to initiate the mode that allows a change to the default ablation time 3 The time display will flash and the default time can now be changed by using the up or down arrows The time will change in increments of 10 seconds The time cannot be set lower than 10 seconds nor higher than 300 seconds 4 To save the...

Page 25: ...ns for the thermocouples N2O Cylinder Removal 1 Turn off the N2O cylinder by turning the knob clockwise 2 Purge the N2O from the system by pressing and holding the N2O Exhaust Switch in the back of the unit Watch the pressure gage on the cylinder to see that all the pressure has been released If the cryoICE BOX is powered off pull and hold the N2O Manual Exhaust Knob until the pressure is relieved...

Page 26: ...uct annual preventative maintenance procedures to ensure all cryoICE BOX components are functioning as defined within this manual Pay particular attention to operational and safety features including but not limited to Electrical power cords for fraying damage and proper grounding AC power switch Any front panel display damage including switches numeric displays and indicator lights cryoICE Probe ...

Page 27: ...CE BOX 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 cryoICE BOX 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 cryoICE BOX unit should be powered off and unplugged be...

Page 28: ...in Figure 19 Figure 19 Guide Tab Location 4 Align the fuse cartridge so the guide tab is towards the power entry side 5 Return the fuse box to the power entry module and push in firmly 6 Confirm operational status by plugging in the cryoICE BOX and turning power on Ensure that the self test is completed without errors xxviii ...

Page 29: ... ACM Installation A001053 Packaged ACM Accessories Domestic Existing ACM Upgrade A001056 Packaged Tank Hose Assembly Domestic N2O Cylinder Interface ACM Tank Hose Accessory Replacement Part Component C Tip Washer AtriCure F021837 xxix ...

Page 30: ...Figure 20 Replacement Parts Item Supplied By Part Number Filter Cartridge AtriCure F021720 Filter O ring AtriCure F010924 Tip Washer AtriCure F021837 O Ring Lubricant AtriCure C002502 Figure 20 Gas Line Components A Filter Cartridge Desiccant B Filter Housing C Tip Washer D Filter O Ring Procedure 1 Unscrew the filter cartridge housing by rotating it counter clockwise Refer to Figure 21 below xxx ...

Page 31: ... from the top of the filter housing fixture 4 Slide the new O ring onto the filter housing fixture making sure that it is fully seated in the groove at the top 5 Apply a thin film of O Ring Lubricant around the new O Ring 6 Replace the desiccant filter cartridge with the new cartridge 7 Replace the filter housing by screwing on clockwise using hand force only 8 Remove the old Tip Washer and replac...

Page 32: ...Hose AtriCure C002051 C002051 Cylinder Heater Band CMH15 AtriCure A000728 A000728 Cylinder Heater Band CMH22 AtriCure A000727 A000727 AC Power Cord 10ft 3 3m AtriCure C000262 C002090 Disposal The cryoICE BOX does not contain hazardous substances Follow local governing ordinances and recycling plans regarding disposal or recycling of device components The used cryoICE probe is considered bio hazard...

Page 33: ...emely cold N2O cylinder Allow 15 minutes to warm up Heater not attached to N2O cylinder Attach Heater Band to cylinder Heater malfunctioning Call AtriCure Service Temperature Not Displayed cryoICE Probe not plugged in Ensure cryoICE Probe thermocouple leads are firmly seated within their receptacles Malfunctioning cryoICE Probe Replace cryoICE Probe cryoICE BOX malfunctioning Call AtriCure Service...

Page 34: ...nd red plugs are in correct receptacles Malfunctioning cryoICE Probe Replace cryoICE Probe cryoICE BOX malfunctioning Call AtriCure Service Bottom segment on N2O icon flasing N2O cylinder empty Replace with full cylinder N2O cylinder cold Make sure heater blanket is installed and working Allow time for the cylinder to warm up if it is cold Indicator not reset when cylinder was replaced Press Reset...

Page 35: ...ly clicks Lubricate the connector inside with silicon based O ring lubrication such as AtriCure Part No C002502 Wrench Icon flashing and clicking heard inside ACM may also include display flashing Heater band over temperature due to empty N2O Cylinder Heater band over temperature due to loose fit on N2O cylinder Unplug heater band if clicking stops and or display flashing stops check if tank is wa...

Page 36: ...ne to the tissue and probe area as necessary Replace the tank hose accessory which has canister set with tank hose accessory without canister set A001056 Domestic Accessory A001055 International Accessory Power On ACM within a few minutes of Cryo Probe use to minimize N2O condensing in system Medical grade nitrous oxide 3ppm water maximum is preferred for use with AtriCure cryogenic Devices Verify...

Page 37: ... TABLES Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emissions The cryoICE BOX is intended for use in the electromagnetic environment specified below The customer or the user of the cryoICE BOX unit should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The cryoICE BOX un...

Page 38: ...o line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5...

Page 39: ...s from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp...

Page 40: ... transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 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...

Page 41: ...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 One 1 Year AtriCure Cylinder Heater Band One 1 Year AtriCure Gas Line Hose Assembly One 1 Year Grounded Electrical Cord One 1 Year AtriCure Cryo Footswitch One 1 Year THIS WARR...

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