AtriCure cryoICE BOX User manual

cryoICE BOX
Version 6
INSTRUCTION FOR USE
AtriCure cryoICE BOX, model ACM2 – 230 (220-240)VAC, 2A, 50/60 Hz
AtriCure Europe B.V.
De entree 260
1101 EE Amsterdam
NL
[phone]
[e-mail]
AtriCure Inc.

Mason, Ohio 45040 USA
[phone]
[phone]
2023-04 | IFU-0093.A | en
MD

II

FOREWORD.............................................................................IV
WARNING ..............................................................................IV
IMPORTANT ............................................................................IV
INTENDED PURPOSE/INDICATIONS FOR USE ...............................................IV
INTENDED USER AND TARGET POPULATION................................................IV
PATENT INFORMATION ..................................................................IV
WARNINGS AND CAUTIONS ..............................................................IV
 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV
CAUTIONS ....................................................................V
  ...................................VI
  ....................VII
1. SYSTEM OVERVIEW ................................................................... 1
  .............................................................1
 .......................................1
 ........................................................2
  .....................................................3
  ..........3
  ..............................................................4
  ................................................................4
  ...............................................................4
  ..............................................................4
  .............................................................4
2. TECHNICAL SPECIFICATIONS ............................................................ 4
  .......................................................4
 .....................................................4
  .........................................................5
Mains Fuses...................................................................5
  .............................................5
  .....................................................5
  ........................................................5
 ...................................................5
3. ATRICURE CRYOICE SYSTEM, DETACHABLES, AND ACCESSORIES ............................... 5
N2 ....................................................5
N2 ........................................................5
  ................................................................7
 .........................................................7
  ............................................7
 2.....................................................8

III 2023-04 | IFU-0093.A | en
 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4. DEVICE USE.......................................................................... 9
  ....................................................9
  .............................................................10
  ................................................................10
5. SPECIAL CASES ...................................................................... 10
 .................................................................10
  ............................................10
  ..............................................................10
  ......................................................11
  ...........................................11
6. SYSTEM DISASSEMBLY AFTER USE ...................................................... 11
  .........................................11
N2..........................................................11
7. PREVENTIVE MAINTENANCE AND CLEANING OF THE ATRICURE CRYOICE SYSTEM.............. 11
  ............................................11
  ...................................................................11
  ................................................12
  .............................................................12
  .................................................12
  ...................................................12
  ............................................12
  ..................................13
  .....................................................................13
Expected Life Time ............................................................13
8. TROUBLESHOOTING ................................................................. 14
 ..............................................16
9. ELECTROMAGNETIC COMPATABILITY TABLES ............................................. 17
 ......................................................17
  .......................................17
  .................................18
  ...................20
 ..................................20
SERIOUS INCIDENT ..................................................................... 20
................................ 20
WARRANTIES .......................................................................... 21
DISCLAIMER ........................................................................... 21

IV
FOREWORD

cryoICE BOX


WARNING


IMPORTANT



INDICATIONS FOR USE
The AtriCure cryo

INTENDED PURPOSE







INTENDED USER AND TARGET POPULATION



PATENT INFORMATION

WARNINGS AND CAUTIONS



WARNINGS
• 

• 


performed.
• 

• 


V2023-04 | IFU-0093.A | en
• 

• 

• 
• 

• 


• 

• 


• 

• 

• 

CAUTIONS
• 
• 
improper device performance.
• 

• 
• equipment.
• 
• 
• 

• 

• 
• 
• damage.
• 



2

VI
Meanings of Symbols on AtriCure Cryo Module
 
 N2

~

 Maintenance Needed

 
 
 
 
N2 
Timer 
 Manufacturer
 
 Temperature 
 
Temperature Transit Limits
100°F
(37°C)
-20°F
(-28°C)
Conforms to the requirements of the


 
 

 
  PHT
 US


Importer

VII 2023-04 | IFU-0093.A | en

SAFETY INFORMATION
E509985
MEDICAL — GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA C22.2 No. 60601-1 (2014) E509985









1
1. SYSTEM OVERVIEW









• 
• 


• 
• 

Table 1: AtriCure Cryo Module
 


A001350-1 A001350-
2
A001350-
3
A001350-
4
A001350-
5
A001350-
6
A001350-
7
 A000836 1


S000543
-
aged individu-

1 1 1 1 1 1 1
N2 S000622 1 1 1 1 1 1 1

(CMH15) A000728-2 1 1 1 1 1 1

(CMH22) A000727-2 1

 S000628 1 1

 S000629 1

 S000630 1

 S000631 1

 S000632 1

 S000633 1
POWER CORD - EURO,
STRAIGHT 3.5 M, 10A,
250V
S000623 1 1 1 1 1 1

22023-04 | IFU-0093.A | en
 


A001350-1 A001350-
2
A001350-
3
A001350-
4
A001350-
5
A001350-
6
A001350-
7
POWER CORD - UK,
STRAIGHT 3.0 M, 10A,
250V
S000624 1
POWER CORD - ITALY,
STRAIGHT 3.0 M, 10A,
250V
S000625 1
POWER CORD - DEN-
MARK, STRAIGHT 3.0 M,
10A, 250V
S000626 1
POWER CORD -
SWITZERLAND, STRAIGHT
3.0 M, 10A, 250V
S000627 1




A001150-13 
A001150-14 
A001361 
See Table 2
Figure 1: Exhaust Hose Connector Assembly – A001150

3

 
• 2



• 

• 


ACM 3
Figure 2: AtriCure Cryo Module Front Panel
 
2. N2 
3. N2 
 
 13. Maintenance Needed Indicator
 
 
 
Figure 3: AtriCure Cryo Module System Rear Panel International
17. N2 
18. N2 
19. N2 
20. N2 26. ACM
 
 

42023-04 | IFU-0093.A | en

The ACM 
ACM 
READY Mode

°C  and
automatically
FREEZE Mode

2

DEFROST Mode



°
Mode.
 ACM

 




2. TECHNICAL SPECIFICATIONS

 17.5 in (44.5 cm) ×27.0 in (68.6 cm) ×4.5 in (11.4 cm) 
 (20.4 kg)
Environmental Specications
Temperature  Atmospheric pressure
 +10°C to +40°C

 

Storage -29°C to +37°C

 

Transit -29°C to +37°C



5




×





The ACM 





3.  SETUP AND PREPARATION
Figure 4: AtriCure Cryo Module
2


the N2
N2
2
• Connect the N2

N2
• 

• 
• 
• 22
2

seated and secured.

62023-04 | IFU-0093.A | en
Figure 5: N2O Inlet Connection
• 2
2
• 

2
• 
Figure 7.
Figure 6: Attach Black Knob to Threaded Connection Figure 7: Turn Valve Counter-Clockwise to Open
• 
• 


Figure 8: Low Pressure Indicator

7

2O exhaust port, see Figure 3 item 17.
• Be sure to route the N2
• 

• 
• 
• 

• 
N
• 

• 
Figure 9: Secure All Tensioning Spring Retainers Figure 10: Plug Heater Band Cord into Receptacle

• 
• -

• 

Figure 11: Turn-ON AtriCure Cryo Module with Switch

82023-04 | IFU-0093.A | en
2
• 
• Ensure ACM
• 
• ACM
see Figure 12.
• 
 Once the N2

• 

Figure 12: N2O Gas Gauge RESET Button
• Meaning of gas gauge indicators seen in Figure 13
Figure 13: N2O Gauge Indicators
20-40 minutes remaining
15-20 minutes remaining
5-10 minutes remaining
CHANGE TANK

• 

9
4. DEVICE USE
cryoICE
1. 
2. 

3. 

Figure 14: Color Coded Pneumatic Connectors
4. -

5. 
Figure 15 Figure 16
6. -
[50°F to 77°F]

Figure 17: Probe Temperature Display

10 2023-04 | IFU-0093.A | en
7. 
8. 

1. -

Figure 18: Ablation Time Display
2. -



1. 
2. 
3. 
4. 
[-40°F]


5. 


(32°F)
degrees.
5. SPECIAL CASES





increments.







11

1. Ensure ACM
2. 

3. 

4. 




-

6. SYSTEM DISASSEMBLY AFTER USE


cryoICE
1. 
2. 

3. 
N2O Cylinder Removal
1. Turn-OFF the N2
2. 22
-
2
3. 
4. Disconnect the hose from the N2
5. 
7. 



CAUTION

CAUTION



1. 
2. 

3. 

chassis.

12 2023-04 | IFU-0093.A | en
4. 

5. 
6. 
7. 
8. 
9. 







• 
• 
• 



 
 [email protected]

  
 AtriCure C002502



Fuses

 Model
 
ACM2 T 2A L 250V C002261



 The ACM

1. ACMACM
2. 


13
Figure 19: Fuse Box Tabs
3. 
Figure 20: Guide Tab Location
4. 
5. 
6. 




-







 

