AtriCure ACM1, ACM2 User Manual

AtriCure Cryo Module

(ACM)

USER’S MANUAL

Model ACM1 – 115 VAC
Model ACM2 – 230 VAC

AtriCure Incorporated
7555 Innovation Way
Mason, Ohio 45040 USA

Customer Service:
1-866-349-2342 (toll
free)
1-513-755-4100 (phone)

P000669 Rev. J

European Representative:
Herbert Köntges
Köntges SPRL
Avenue Hellevelt 35
B-1180 Brussels Belgium
Tel: [phone]
FAX: [phone]
email: [e-mail]

Table of Contents

1. GETTING STARTED .................................................................................................................... 4

1.1. System Description ......................................................................................................... 5

1.2. Unpacking ......................................................................................................................... 6

1.3. Warnings and Precautions ............................................................................................. 6

1.4. EMC Guidance and Manufacturer’s Declaration ........................................................ 7

1.5. Responsibility of the Manufacturer ............................................................................. 11

2. THE ATRICURE CRYO MODULE (ACM) ............................................................................. 12

2.1. Device Description ......................................................................................................... 12

2.2. ACM Front Panel – Il lustration and Nomenclatur e ................................................... 13

2.3. ACM Rear Panel – Il lustration and Nomenclatur e ................................................... 20

3. INSTALLING THE ACM ............................................................................................................ 23

3.1. Transporting of ACM ..................................................................................................... 23

3.2. Preparing the ACM For Use ......................................................................................... 23

3.3. Installing Power Cord .................................................................................................... 23

3.4. Installing the Footswitch ............................................................................................... 23

3.5. Installing Cylinder Heater Band ................................................................................... 24

3.6. Installing N2O Gas Line Hose ...................................................................................... 25

3.7. Installing N2O Exhaust Hose........................................................................................ 27

3.8. Connecting and Disconnecting the Handpiece ......................................................... 28

4. INSTRUCTIONS FOR USE ....................................................................................................... 30

4.1. Powering Up the ACM .................................................................................................. 30

4.2. Operating Modes ........................................................................................................... 31

4.3. Delivering Cryo Energy ................................................................................................. 33

4.4. Parameter Entry Mode / Adjusting the System Default Parameter Values .......... 37

5. TROUBLESHOOTING ............................................................................................................... 38

5.1. No ACM Power / Display Function ............................................................................. 38

5.2. ACM Fault Codes .......................................................................................................... 38

5.3. ACM Error Codes .......................................................................................................... 39

5.4. Handpiece Error Codes ................................................................................................ 41

6. SYMBOLS USED ........................................................................................................................ 42

7. TECHNICAL SPECIFICATIONS .............................................................................................. 45

7.1. Mechanical Specific ations ............................................................................................ 45

7.2. Environmental Specifications ....................................................................................... 45

7.3. Electrical Specifications ................................................................................................ 45

7.4. Mains Fuses ................................................................................................................... 45

7.5. Footswitch Specifications ............................................................................................. 45

7.6. Equipment Type / Classification .................................................................................. 45

8. PREVENTIVE MAINTENANCE AND CLEANING OF ACM .............................................. 46

8.1. Preventive Maintenance ............................................................................................... 46

8.2. Cleaning and Disinfecting ............................................................................................. 47

2

9. SERVICING OF ACM UNIT ...................................................................................................... 48

9.1. Replacement of AC Mains Fuses ............................................................................... 48

9.2. Inspection and Replaceme nt of In-Line N2O Filter ................................................... 49

9.3. Replacement of Gas Line Desiccant Filter and Tip Washer ................................... 51

9.4. Other Replacement Components ............................................................................... 53

10. ACCESSORIES ........................................................................................................................... 54

10.1. CMH15, Cryo Module Cylinder Heater Band ............................................................ 54

10.2. CMH22, Cryo Module Cylinder Heater Band ............................................................ 54

10.3. CMF1, Cryo Module Footswitch .................................................................................. 54

11. DISPOSAL .................................................................................................................................... 54

3

1. Getting Started

This manual a nd the equip ment it describes are for use onl y by qualified medical
professionals trained in the particular technique and surgical procedure to be performed.

Caution: F eder al (USA) law res tr icts thi s dev ic e to s ale by or o n the or der of a

physician.

Please rea d al l informati on carefully. F ailure to properly fol low the ins tructions may lead
to serious s ur g i cal consequ ences.

Important: This manual is designed to provide instructions for use of the AtriCure
Cryo Module (ACM) with the AtriCure Cryo Handpiece (CRYO1 and cryoICE) 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 d elivers a cryogenic ener gy source, namely Nit rous Oxide, t o c reate
lines of a blation thro ugh cardiac tissue. The ACM is part of a sys t e m which includes the
nitrous oxi de gas , N2O gas line h ose, N2O exhaust hos e, cy l inder hea ter ban d, a
footswitch, and single-use cryo ha ndpiece with integrated electronics cabl e / g as hos es.
The syste m pr ov i d es 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 t o tu ne 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 ca n
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 user’s conv e nienc e, t he AtriC ur e Cryo Module will be referred to in this User’s
Manual as the “ ACM”. The AtriCure Cryo Handpiece will b e r e f erred in this User’s
Manual as the “Hand pi ece” .

This User’s 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
User’s Manual only. Do not operate the ACM before thoroughly reading this manual.

4

A E D C B

1.1. System Description

As shown i n F i g ure 1, the s ystem is c o mpri sed of the following:

• A: AtriCure Cr yo Module C ylinder Heat er B and (CMH15 or C M H 2 2)

• B: AtriCure Cryo Footswitch (CMF-1)

• C: ACM N2O Exhaust Hos e

• D: ACM N2O Gas Line Hose Module

• E: AtriCure Cryo Module (ACM)

• ACM Power Cor d ( n o t shown)

• AtriCure Cr yo Handpiec e with integ ral c a ble (not shown)

Accessory d evices are de s cr i b e d in Section 10.

Figure 1 – ACM, Footswitch, N2O Gas Line Hos e Module, N2O

5

Exhaust Hose, and Cylinder Heater Ba nd

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 precaution s when lifting the unit as it weig hs approx 45 lbs (20 kg) .

1.2.2. Accessories

ACM accessor ies are ship ped sep ara tely fro m th e ACM uni t. Th e acc ess ory box
contains th e foll ow ing items:

• ACM Power Cord

• N2O Gas Line Hose

• N2O Exhaust Hose

• ACM Cylinder Heater Band

• ACM Footswitch

It is recomme nde d that th e ori gin al s hippi ng box and pr ote ctiv e w ra pping be sav e d for
future stori ng a nd/ or tr a nspor ti ng o f th e devi ce.

1.3. Warnings and Precautions

The safe and effective use of the cryo d ev ice an d equi p men t is highly dependent

upon factors und er th e co ntr ol o f the op era tor . Ther e is no su bsti tut e f or a pr op erly
trained operating room staff. It is important that t h e op erating instructions supplied
with the ACM unit be read, understood, and foll ow ed b efor e use.

1.3.1. WARNINGS

• Do not operat e the ACM unit before thoroug hl y rea ding thi s man ual .

• Do not use cryo surgical equipment unless pro perly tr ai ned i n the spe ci fic

procedure b eing und ert aken . Thi s man ual and the equip men t it desc ri bes are for
use only by quali fi ed m edi cal pro fessi o nal s trai ne d in t he par ti cul ar te c hniq ue and
surgical proc e dur e to be per for m ed.

• Fire Hazard: Do not use extension cords.

• Trip Hazard: Stan dar d care sho ul d be use d t o red uce th e ri sk o f tri ppi ng on the

Footswitc h cable, as well as t he N2O exhaust hose.

• No modificati on of t his eq ui pme nt is al low ed.
The voltage selec tor is fact ory set and sh oul d no t be chang ed by the us er. The

voltage setting and the fuse r ati ng m ust be ap propr i ate as id enti fi ed to prev ent ACM
malfunction and potential instrument damage.

Electric S ho c k Hazard: Connect the ACM Power C or d to a properl y grounded
receptacle. Do not use power plug adapters.

Electric S ho c k Hazard: Do not conn ec t wet accessories to the generator.

6

Electric S ho c k Hazard: Ensure that th e Handpiece is correc tl y connected t o the
ACM and that no thermocouple w ires are expo se d fro m the cabl e, conne ct or, or the
Handpiece.

1.3.2. PRECAUTIONS

• Use only with the Atri Cure Handpi ec es intended for use with t h e ACM.

• Do not activat e th e ACM unit until the Handpiece is properly positioned at the

ablation site.

• The system status indicators and di spl ays are importa nt safety features. Do n ot

obstruct either the ablation or the s ystem stat u s indicators.
Do not remove the ACM cover , ex cep t for th e in-line gas filter ac ces s por t, as

there is a p otential for electrical shock. Re fer to authoriz e d per sonnel for s er vice.

• Use only the Footswitch provided with the ACM.

• The Power Cord of the ACM must be connected to a properly grounded

receptacle . Exte nsi o n cord s an d/or ada pter pl ugs m ust not be use d.

• Do not contac t Atri C ure Ha ndpi ec es w ith a RF dev ic e.

• Compressed Air Hazard: Do not operate N2O tanks wit h a pr essure grea ter than

1000 PSIG (690 0 kP a).

1.4. EMC Guidance and M an ufacturer’s Declarat ion

1.4.1. Electromag n et ic Requirements

1.4.1.1. The AtriCure Cryo Module (ACM) has been tested and found to comply

with the limits for m e di c al devices in IEC 60601-1-2:2007. These limits are
designed to pr ovi de r eas ona ble prot ecti on against harmful interference in a
typical medic al ins tall at i on.

1.4.1.2. The AC M can radi at e radio frequency ener g y and, if not installed and used

in accorda nce with the instructions, may caus e harmful in terference t o
other devi ces in the vicinity.

1.4.1.3. Port abl e an d mobile RF communications equipment can also affect ACM

performanc e an d car e sh oul d be tak e n to mini miz e suc h inter fer e nce .
However, t h er e i s no guarantee that int erference will not occur in a
particular installation.

1.4.1.4. If th e ACM does c a use harmful i nter fer e nc e to ot her dev ices , w hic h can be

determined by turning t he A CM off and on, the us er is encouraged to try to
correct the int erf ere nce by on e or mor e of t he follow i ng m easur es :

• Reorient or rel oc at e the rec eiv ing devi ce .

• Increase the separation between the ACM and the other devices.

• Connect the ACM into an outlet on a ci r cuit different from t h at to which

the other devi ce( s) are conn ect ed.

• Contact t he A tr i C ure servic e representative for help.

7

Emissions test

Compliance

Electromagnetic environment – guidance

The ACM unit uses RF energy only for its internal

electronic equipment.

RF emissions

Class A

The ACM unit is suitable for use in all establishments

Voltage fluctuations/

1.4.2. Electromag net ic Em is sion s

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.

RF emissions CISPR 11 Group 1

CISPR 11
Harmonic emissi on s IEC

61000-3-2

flicker emissions IEC
61000-3-3

Class A

Complies

function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby

other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domesti c purposes.

8

± 6 kV contact

± 6 kV contact

Floors should be wood, concrete,

least 30 %.

Electrical fast

± 2 kV for power

± 2 kV for power

lines

Mains power quality should be that
± 1 kV differential

mode

Mains power quality should be that

Voltage dips, short

<5 % UT

for 5 s

<5 % UT

for 5 s

Mains power quality should be that

Power frequency

3 A/m

3 A/m

Power frequency magnetic fields

environment.

1.4.3. Electromag net ic I mmu nity

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

Electromagnetic environment –

guidance

Electrostatic
discharge (ESD)
IEC 61000-4-2

transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11

± 8 kV air

supply lines
± 1 kV for

input/output lines

± 1 kV line(s) to
line(s)

± 2 kV line(s) to earth

(>95 % dip in UT)
for 0,5 cycle

40 % U

T

(60 % dip in UT)
for 5 cycles

70 % U

T

(30 % dip in UT)
for 25 cycles

<5 % U

T

(>95 % dip in UT)

± 8 kV air

supply
Lines

± 1 kV for
input/output

mode
± 2 kV common

(>95 % dip in UT)
for 0,5 cycle

40 % U

T

(60 % dip in UT)
for 5 cycles

70 % U

T

(30 % dip in UT)
for 25 cycles

<5 % U

T

(>95 % dip in UT)

or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at

of a typical commercial or hospital
environment.

of a typical commercial or hospital
environment.

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.

(50/60 Hz)
magnetic field
IEC 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

9

should be at levels characteristic
of a typical location in a typical
commercial or hospital

Portable and mobile RF communications

d = 1.2 √P 80 MHz to 800 MHz

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

absorption and reflection from structures, objects, and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

1.4.4. EMC Guidan ce and Manuf act urer’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
test

Conducted RF
IEC 61000-4-6

IEC 60601 TEST
LEVEL

3 Vrms
150 kHz to 80 MHz

Compliance
level

3 Vrms

Electromagnetic environment – guidance

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 transmitter.

Recommended separation di st ance
d = 1.2 √P

Radiated RF
IEC 61000-4-3

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

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
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 observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the ACM.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

3 V/m
80 MHz to 2.5 GHz

3 V/m

d = 2.3 √P 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:

b

a

10

The AtriCure Cryo Module (ACM) is intended for use in an electromagnetic environment in which radiated

the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance

absorption and reflection from structures, objects, and people.

1.4.5. Recommended Separation Distance

Recommended separation distances between portable and mobile RF communications
equipment and the AtriCure Cryo Module

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 t he ACM as recommended below, according to the maximum output power of

Rated maximum

output power of

transmitter W

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

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. Electromagnetic propagation is affected by

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

1.5. Responsibility of the Manufacturer

AtriCure is responsibl e for safety , reliability, and per formance of the equip me n t only if:

• Installati on pr oce dur es in this m anual are followed.

• Persons aut horiz e d by A triC ur e car ry out mo di fic ati ons or re pai rs.

• The electri cal install ation of the relevant r o o m complies w i th local codes a n d

regulatory requi r eme nts such as IEC and BS I.

• The equipme nt is us ed in acc ord anc e w ith the Atr iC ure Us er’ s Manual.

11

2. The AtriCure Cryo Module (ACM)

This section prov id es a de tail e d desc rip ti on of t he ACM including its function and
operating f eatur es .

2.1. Device Description

• The AtriCure Cryo Module (ACM) unit is an electro-mechanical and pneu mati c

cryogenic surgical system that delivers a cr yogenic sour ce, Nitrous O xide, to
create lines of ablation through cardiac t issue.

• The ACM is part of a system which includes the nitrous oxide gas and its cylinder,

N2O gas line hose, N2O exhaust hos e, cy l inder heat er b an d, a footswitch, system
power cord, and single-use cryo handpiece with integrated electronics cable / gas
hoses.

• The system prov id es a co ntr oll ed l esi on for mi n g temperature that is below -40°C,

with typical operating ra ng es between -50°C to -70°C for the tr eat ment o f cardi ac
arrhythmias , cr eat ing a n infl am mator y r es pons e (cry o nec rosi s) that bloc ks the
cardiac el ec t r ical conduc ti o n p athway.

• 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

Footswitc h can al so be us ed as the i npu t dev ic e to ac tiv at e and t erminate the cryo
ablation cyc le.

• The presence of the ACM Footsw itch i s not a r equi re me nt for the A CM unit to

operate and is mad e avai la bl e as a se con dary mea ns of int er faci ng with th e ACM
unit, and to provide control of the ablation cycle to the surgeon.

• The ACM is desig ne d to op er at e only with AtriCure designed and developed

handpieces.

• Refer to the Handpiece Instruc ti on for Us e for co mple te des cri pt io n of t he

indications an d us es of t hes e dev ice s.

12

1. Ablation Activation Switch

7. Ablation Timer Increase Button

1

5

7

12

11

6

3

8

2

4

10

9

1

2

3

2.2. ACM Front Panel – Illustration and Nomencl ature

An illustration of the ACM front pa n el i s shown in Figure 2, below.

Figure 2 – ACM Fro nt Panel

2. Ablation Status Indicator 8. Handpiece Probe Te mper ature

3. N

O Gas Gauge Display 9. Handpiece Thermocouple Port

2

4. System Sta tu s Indicator 10. Handpiece Electronic Interface Port

5. Ablation Timer Decrease Button 11. Handpiece Gas Connection Port

6. Ablation Timer Display 12. Handpiece Probe Temperature Cont rol

2.2.1. Ablation Status Indicators

There are three indicators on the front panel of the ACM: READY, FREEZE,
and DEFROST. These indicators are descr ibed below.

13

Figure 3 – AC M Ablatio n Status Indic a tor s

Indicator Symbol Description

READY – Green LED

This status indicates the ACM is in

1

stand-by mode and is ready to start the
cryo ablation cycle.

2

3

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
Constant:

This status indicates th e ACM is in
defrost state, N2O gas flow is ceased,
Handpiece is bac k pr es suri zed , a nd the
Handpiece probe is warming back up to
the ambient temperature.

Blinking:
Indicates t he ACM is now ready to
transitio n to the nex t st ate. Upon
activation o f eit her th e Abl ati on Act iv ati on
Switch or the Foot sw itc h, the ACM unit
will transition into the next state
depending on the ACM model as
described bel ow .

International – ACM

• Transitions to Ready state only

US – ACM

• Press and rel eas e – Freeze stat e

• Press and h old – Ready state

14

1

2

3

4

6

5

2.2.2. System Status Indicators

There are six system status indicators on the front panel of the ACM: SYSTEM
POWER, SYSTEM FAULT, MAINTENANCE NEEDED, LOW CYLINDER
PRESSURE, CYLINDER HEATER BAND ACTIVE, and FOOTSWITCH
ACTIVE. These indicators are described below.

Figure 4 – ACM Status Indicators

15

Indicator Symbol Description

SYSTEM POWER – Green LED

1

2

3

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 condi ti on has
been addressed.

MAINTENANCE NEEDED – Amber LED
This status indicates th e ACM syst em is s till

in normal, fu ncti o nal, and saf e oper ati ng
mode. How ever, maintenance is being
requested to address such items as
replacing in-line N2O gas filter to opti mize
system perfor m anc e.

16

Indicator Symbol Description

4

LOW CYLINDER PRESSURE – Amber
LED

This status indicates the N2O cylinder 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 N2O 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 oper a ti ng
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.

17

HANDPIECE THERMOCOUPLE

HANDPIECE ELECTRONIC

HANDPIECE PNEUMATIC Receptacle

Indicator Symbol Description

5

6

2.2.3. Front Panel Functions

Item Description

CYLINDER HEATER BAND ACTIVE –

Amber LED
This status indicates ACM unit has

energized the N2O cylinder heater band
and it is active. The indicator LED will
extinguish when the cylinder heater band
is turned off by the ACM unit (when
optimal cylinder pressure is reached).

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.

Receptacle
This 2-pin receptacle accepts the AtriCure

Handpiece thermocouple connectors. This
connection is patient-isolated.

INTERFACE Receptacle
This 14-pin receptac le is reserv e d for

future releas e o f Atri C ur e Hand piec e . This
connection is patient-isolated.

This 2 port pneumatic receptacle provides
the N2O interfac e with the AtriCure
Handpiece. The ports are sized differ en tly
to prevent c ross-coupling of the
connections.

18

HANDPIECE PROBE TEMPERATURE

Item Description

ADJUST Knob

This control knob prov i des t he op er ator
with the a bil ity to adj us t the terminal
temperature of the ha ndpiece pro b e.
Turning the kn ob in th e coun ter-clockwise
rotation low er s th e prob e te mper at ur e,
while turn ing the knob in clockwise rotati on
raises the probe temperature. In normal
operation the knob wi ll be adjusted to
provide max imu m neg at iv e temp er atur e.

2.2.4. Front Panel Displays

2.2.4.1. N2O Gas Gauge

• This displ ay indicates, i n minutes, the approximate amount of useable
N2O gas remaining in the cylinder. As the gas is being c onsumed, this
value will adjust based on the actual gas flow tim e and the cylinder
pressure. As a resul t, the displ ayed value may decrease quicker than
anticipated.

• This time value should no t be tak e n as a n abs olu te me as urement, but
only as a r e f erence in gaug ing the amount of gas remaining in the
cylinder.

• The display value wil l start to blink when there is appr oximately 1 0
minutes or les s of a ntic i pate d us eabl e g as le ft in th e cy li nder.

NOTE: Replacement of the N2O cylinder at this po int i s high ly

recommended.

NOTE: Along with the blinking gas gauge , th e Lo w Cylinder

Pressure in dicator LED may also be blinking in dicative of
empty or near empty N2O cylinder.

• Typical usag e ti me for a new cyl in der is between 30 to 40 minutes
depending on the ty pe and si z e of the cyl in der w hen used with the ACM
cylinder he ater ban d. The usage time will be less when the cylinder
heater band is not us ed .

• The gas gauge value can be reset upon replacement of the N2O
cylinder by pressing down on th e Ti m er Increase and Timer Decrease
key simult aneously an d r eleasing.

• Secondary function of the gas gauge is to display the N2O cylinder gas
pressure dur ing the abl ati on cy cle . Thi s prov id es th e user wi th
additional r e al -time info r m ation regarding the gas status w i t hi n the
cylinder during system operation in psi x10.

19

1. N2O Exhaust Port

5. Equipotential Terminal

1
5 32 4 6 8 7

2.2.4.2. Ablation Timer

• This display indi cat es t he desir ed abl ati on dur ati on in uni ts o f sec ond s.

• The default dur at ion time is 120 s econds per ablation run.

• This timer v alue can be adjusted pr ior to, or d uring the ablation cycle,

by using either the Ti mer Increase or Timer Decrease Button.

• Each key press of th e Ti mer Increase Button or Timer Decrease Button
will modi fy the target ablation ti m e value by 1 0 s ec onds, either addi ng
or subtracting from its present value.

• At the termination o f the freeze c y c l e ( Defrost mod e) , the displ ay will
show total time in freeze state. A full 120 second run will resul t in the
display show ing 120 as an ex ampl e. An abor ted freez e cycle will show
the number of seconds the system operated in the Freeze mode.

2.2.4.3. Handpiece Probe T e m perature

This displ ay indicates the current handpiece probe temperature in Celsius,
and is cont inuously updated each second.

2.3. ACM Rear Panel – Illustration and Nomenclature

An illustration of the ACM rear pan el i s shown in Figure 5, bel ow .

Figure 5 – ACM Re ar P anel

2. System Pressure Relief Knob 6. Cylinder Heater Band Receptacle

3. N

O Inlet Port 7. AC Power Entry Module

2

4. Footswitch Receptacle 8. Input Voltage S el ec to r S witch

Note: Input Vol tag e Level Switch is factory set a nd i s covered by unit mod el label. The
switch and t he label should not be tampered with or changed ex cep t b y aut hori z ed
AtriCure personnel.

20

2.3.1. Rear Panel Functions

Item Description

Power Entry Module –

This module co nt ains bot h th e ON/OFF
switch and the w all receptacle mains fuses.

Fuse Box –
The Fuse Box conta ins fus es selec t ed for
the input voltage. S ee T echnical
Specificati ons in S ecti o n 7 of this manu al .

Cylinder Heater Band 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 N2O cylinder wall
temperature.

Footswitch Receptacle –
This receptacle accepts the ACM
Footswitch connector. The single
momentary actuation p edal pr ovides for
the activation and termination of the cryo
ablation cycle.

N2O Inlet Receptacle –
This receptacle accepts the N2O gas line
hose with the quick connect / disconnect
interface used to transfer gas from the
N2O gas cylinder to the ACM unit to be
utilized by the Handpiece.

21

protective earth connection.

Item Description

N2O Exhaust Receptacle –

This ½ inch (1.25cm) receptacle accepts
the 50 ft (15 m) flexible tubing to direc t 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 trapped N2O gas within the
ACM unit.

Be sure the N2O 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.

This terminal is accessible during any
position of normal use and mini mi zes risk
of accidental disconnecti on. Th e
conductor is detached without use of a
tool.

This terminal is not to be used for a

22

3. Installing the ACM

Inspect the ACM system for any signs of physical damage to the front and re ar panel,
N2O gas couplers, connector receptacles, chassis or cover.

NOTE: If any physical damag e is f oun d , DO NOT USE THE UNIT. Contact

AtriCure for a replacement .

All return s must be app r oved by AtriCure.

3.1. Transporting of ACM

The use of handles is highly recommended in lifting, carrying, or moving of the ACM unit.
The ACM wei g hs approximately 45 l bs ( 20 kg) so c are should be taken when
transporting the ACM unit.

3.2. Preparing the ACM For Use

3.2.1. The ACM unit may be placed on a cart or on any sturdy t a bl e or platform. It is
recommended that carts have cond uctive wheel s. Refer to hospital p r oce dures or
local codes f or det ail ed in for mati on.

3.2.2. The ACM unit may be pl a c e d together or stacked w it h o ther AtriCure capital
equipment s uch as the ASU , A SB, and t he ORLab. Howev er, car e m ust be tak en
when stacki ng or pl ac ing the AC M uni t adj ac en t to ot her medi cal equipment and
unit performance should be obs er ved to veri fy normal operation in th e
configuration in whic h it will be used.

3.2.3. Provide at le ast f our t o si x inc hes of space around the sides of the ACM for
convection cooling. U n der continuous use for extended peri ods of time, i t is
normal for t he top pane l t o be warm to the touch.

3.3. Installing Power Cord

The ACM unit is ship ped with an approved hospital grad e power cord.
Insert the pow er c ord i nto the pow er en try mod ule of the AC M u nit as shown in Fig ure 7,
and then into a grounded hospi tal AC power receptacle.

NOTE: ACM power cord is shipped wi th the accessories and found in the acc ess or y

package.

NOTE: Do not use extension c ords or thr ee-prong to two-prong adapters . T he Pow er

Cord assem bl y should be p er iodically c he c k ed for damaged insulatio n or
connectors.

3.4. Installing the F ootswitch

3.4.1. Inspect the Footswitch

Inspect t he Footswitc h for any signs o f p hysical damage to the cable and
connector. If physical damage is found or the Footswitch does not perform within
specification, contact AtriCure for replacement.

3.4.2. Connecting and Disconnecting the Fo otswitch

With the connector al i g n me nt arrow in the 12 o’cl ock position , push the Fo ots witch
Connector into the Footswitch Receptacle on the rear panel of the ACM as shown

23

in Figure 7. To disconnect, firmly grasp the connector body and pull out from the
Footswitc h 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 ( s ee Secti on 4 reg ar ding the
READY mode).

3.4.3. Preparing the Footswitch for Us e

The Footsw i tc h should be pl aced on a fl at floor. I t i s recommended that the area
near the Foot sw itch b e ke pt dry to red uc e the ri sk o f slip pag e.
Appropriat e precautio n s s hould be tak en to ensure t hat the cabl e connecting the
Footswitch to the ACM does not creat e a hazard in the operating room.

3.5. Installing Cylinder Heater Band

3.5.1. Inspect th e C y li nder Heat er Band

Inspect the Cylinder Heater Band for any s i g ns of physic al da m ag e to the ca ble
and connector . If phy si c al da mage is foun d or th e Cylinder Heater Band does not
perform w i thi n specificati o n, contact AtriCure for replacement.

3.5.2. Wrapping the Cylinder Heater B and

Place the Cyl ind er He at er Ba nd aro un d the bottom of the N2O cylinder, with the
cord at the top of the Heater Band, and s e c ure all 6 tensioning s pr ing retainers as
shown in Fi g ure 6. Sta r t with the top a nd bottom spr ing retain er s . Be sur e he at er
band is flat agai ns t the cy li nder (n o w rink les , no pu cker s ).

NOTE: Cylinder Heater Band should be positioned approximately 2.0 inch (5.0 cm)

from the cylinder bottom for optimal performance.

NOTE: If the nitrous oxide cylinder is too large or too small for the supplied ACM

Heater Band to fit securely, contact AtriCure Customer Supp or t for
replacement.

Figure 6 – Cyli nd er Heater Band Installation

24

3.5.3. Connecting and Disconnecting the Cylinder Heater Band

With the c onnector alig nment arrow i n t he 12 o’clock position, pu s h t he Cylinder
Heater Ba nd Connector into the Cylinder Heater Band R ec e p t acle on the r ear
panel of the ACM as shown in Figure 7. T o disconnect , fi rmly gr asp the connector
body, push dow n on the l ocki ng latc h, an d p ull out fr om th e Cy lin der Hea ter 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 fi rst use to all ow for t he cy lind er pr ess ur e to
reach opti m al o perating level.

Figure 7 – Connecting the Footswitch, Cylinder Heater Band, and Power Cord to ACM

3.6. Installing N2O Gas Line Hose

3.6.1. Inspect th e N2O Gas Line Hose Module

Inspect the N2O Gas Line Hose for any signs of phys ic al da mag e to th e hose and
pneumatic connectors on both ends, including pressure gauge, press ure rel i ef
vessel, and the d esic ca nt filt er as sem bly . If physical damage is found do not use
the N2O Gas Line Hose and contact AtriCure for replacement.

NOTE: Refer to the ACM Tank Hose Subassembly Cart Attachment Instruction

(P000862) for details on securing the N2O Gas Line Hose M o dul e to the
AtriCure System Cart.

3.6.2. Connecting and Disconnecting the N2O Gas Line Hose with ACM unit

25

• Align the quick-connec t gas co nnec t or from the gas hose line with the ACM

N2O inlet port.

• Insert and push in the conn ect or unt il you h ear it “cli ck ” in pl ac e and the

connection is fully seated and secured from unlatc hi ng.

• To disconnec t th e N2O gas line connector from the ACM, slide back on the

N2O inlet port connector sleeve and remove. See Figure 8.

NOTE: The N2O cylinder valve should be in the CLOSED position during

connection and discon nec ti o n fro m the ACM uni t.

Figure 8 – Aligning the N2O gas line quick connect to the ACM N2O inlet port

3.6.3. Connecting and Disconnecting the N2O Gas Line Hose with Gas

Cylinder

• Align the CGA326 hand knob (or equival e nt cylinder coupler) from the gas

hose line with the N2O gas cylinder’s threaded connection port , and screw i n
place by turning the hand knob in clockwise rotation.

26

• Hand tighten the connection and verify there is no leak when cylinder valve is

opened.

• If a leak is de tect e d, tig ht en the hand knob conne cti on f urt her . A wren ch m ay

be needed to tighten the connection.

• If the leak cannot be eliminated, either the N2O gas line hose or the N2O gas

cylinder may need to be repl ac ed.

• To disconnec t fr om the gas cy l in der , tur n the hand k nob in a counter-clockwise

rotation un til the connection is disengaged.

NOTE: Keep gas cylinder or gas line c anisters stan di ng vertically, in an up-right
position

NOTE: Only me di c al g rade N2O gas and an N2O gas cy l inder should be used in
the gas line connection.

3.7. Installing N2O Exhaust Hose

• Align the 50 ft (15m) exhaust hose with the N2O Exhaust por t of the AC M an d push

in place.

• Run the exhaus t hos e t o an ap pro pri at e vent in g mecha nis m tha t mee t s the hos pi tal

and local r egulation.

NOTE: The venting mechanism needs to vent at least 60L per minute.

• To remove the exhaust hose fr om th e ACM uni t , si mply pull bac k on th e tu bing unti l it

releases. See Figure 9.

NOTE: It is not necessary or required for the N2O Exhaust Hose to be removed from

the ACM unit at the end of the procedure. The hose may be left in place.

27

Figure 9 – Connecting the N2O 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.

NOTE: Typically, you will connect the Handpiece to the ACM when the ACM has

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.

NOTE: 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.

NOTE: Connection and disconnection of the Handpiece with the ACM unit should

ONLY take place with the ACM unit in the READY state, N2O cylinder valve in
the CLOSED position, and ACM unit fully depressurized by pulling on the
System Pressure Relie f Knob i f the unit has b een pr ess ur i z ed pri or .

NOTE: Refer to the Handpiece instruction sheet for more detailed information about

connecting the Handpiece to the ACM in a sterile environment.

28

Figure 10 – Connecting the Handpiece to the ACM

29

4. Instructions For Use

4.1. Powering Up the ACM

1. Ensure that the ACM has been plugged into a proper hospital pow er receptacle.

NOTE: Do not use extension c ords or thr ee-prong to two-prong adapt ers where

applicable. The power cord ass embly sho ul d be per i odic al ly check ed f or
damaged insulation or connectors .

2. Apply power t o the ACM unit by flipping the ON/OFF power swi tch located on the

power entry module at the rear panel. The GREEN LED on th e pow er switch should
energize i f p ower is being applied to the system.

3. The ACM unit will go through a system Power On Self Test (POST). If POST

passes, the system transitions to the READY mode. If any por tio n of the POS T fails,
the system transitions to the FAULT mode.

NOTE: Refer to Section 4.2 ., bel ow , for a full d escr i pti on of t he READY and FAULT

modes, as w el l as all the other op er a t ing modes.

4. It is highly recommended that the ACM system be prepare d a nd po w ered up w ell i n

advance of st art of the proc e dur e to verify its o perational readiness a s well as
preheating of N2O cylinder g as pressure to raise it to its optimal performance level.

NOTE: N2O cylinder val ve m us t be op en f or th e sy stem to de tect its pres enc e an d to

start the preh ea ti ng cy cle.

NOTE: Heating of the N2O cylinder is auto mat e d and cont rol le d by t he ACM uni t

only as needed and when appropriate. Operator intervention is no t required.

30

4.2. Operating Modes

The ACM operates in one of five modes: READY, FREEZE, DEFROST, ERROR and
FAULT modes. These mod es are i de n tified by the syste m s t a tu s indicator LEDs and the
ablation s ta tus indicat or LEDs located on th e front of the ACM unit. See Figure 11,
below.

4.2.1. READY Mode – This mode is en ter ed au to matic al ly upon successful

execution of Power On Self Test when the uni t i s firs t turned on, or
following DEFROST Mode u pon venting of the Handpiece by depressi ng
the Ablatio n Act iv ati on Sw it ch or t he Footswitch. This indicates that the
system is rea dy f or th e next c ry o abl ati on r un.

4.2.2. FREEZE Mode – This Mod e i s en ter ed from the READY Mode when the

user initi ates the cry o ablation cy c le by pressin g and relea s ing the Ablat ion
Activation Switch or the Footswitch. In this mode the N2O gas is allowed to
cycle thr oug h the handpiece causing a temperature drop to take place at
the handpiec e pr obe.

4.2.3. DEFROST Mode – This Mo de is enter ed automatically from FREEZE

Mode upon expi ra ti on of th e abl ati on ti mer , or man uall y by the op era t or
when the Ablat ion Acti v ati on Swi tc h or th e Footswitch is actuated while in
the FREEZE Mode. In this mode th e h an dpiece probe temperatur e i s
actively forc e d towards the ambient temperature.

Once the h a nd pi e c e temperature has reached 10°C or higher, the
DEFROST status LED will start to blink to indi cate to the us er the ACM unit
is ready to transition back to the READY Mode or retur n t o t he FREEZE
Mode to start the next ablation cycle.

International units:

The ACM unit returns t o the READY M ode by press i ng a nd releasing t h e
Ablation Activation Switch or the Footswitch. The ACM unit will
automatical ly vent and depr ess ur iz e the ha ndp iec e in preparati on for the
next freeze cy cl e.

US units:

The ACM unit can be returned to the FREEZE Mode by pre ssi ng and
releasing the Ablation Acti va tio n Switch or depressing and rel easi ng the
Footswitch, which causes the handpiece to vent and start the freeze cy cle
again.

The ACM unit can be r eturned to t he R EADY Mode by pressing t h e
Ablation Acti va tio n Sw itc h or depressing the Footswitch and holding it in
place for 2 sec onds or l ong er. The ACM unit will automatically vent and
depressurize the han dpiec e. Onc e d epr ess uriz ed , th e Abla tio n Ac tiv ati on
Switch or the Footswitch can be releas ed .

NOTE: ACM does allow e ar l y transition o ut from the DEFROST Mode into

either th e READY Mode or the FREEZE Mode upon user req ues t
and upon handp iec e t emper at ure reaching above 0°C.

31

NOTE: Handpiece probe temperature may drop temporarily during

depressurization phase (transition from Defrost to Ready state).

4.2.4. ERROR Mode – This Mode is ent ere d up on d etec ti on o f any recov er abl e

error conditi on s duri ng any Mod e exc ludi ng t h e FAUL T Mod e. The ACM
unit will display the correspondi ng error me ss a g e when in READ Y Mode,
and may halt operation temporarily upon detection of the error conditio n.
These are recoverable errors and do not impact continued use of the
system. The System Maintenance LED will be active to alert the user that
an error condition has occurred.

To reset t he Maintenance LED, hold down bot h th e Tim er Increase and
Timer Decrease button and power cycle the unit. The system will undergo
power-on self test for system functionality confirmation and return to the
operating state if appropriate.

4.2.5. FAULT Mode – This Mode is entered upon detection of any unrecoverable

error condi tion duri ng a ny Mod e. T he sy stem i s in opera ble i n thi s Mo de un til
the unit is first power cycled, and only if the fault condition no longer exists
or has been remedied.

32

4.3. Delivering Cryo Energy

4.3.1. Connect the Handpiece, Pneumatics, Cylinder Heater Band, and

Footswitch

Connect the Handpiece, N2O Gas Line Hose, N2O Exhaust Hos e, C ylinder H e at er
Band, and Footswitch as described in Sections 3.4. through 3.8., and note no
errors are i n di cated by t he AC M unit. The ACM should indicate that the system is
in the READY mo de, a nd the di spl ay s how ing abl ati o n par am eter s. S ee Figure

11.
If a Handpiece or the Handpiece thermocouple is not connected, the ACM unit will

indicate suc h by displ a y ing an error mess ag e i n the pr ob e tem per atur e di spl ay
window wi th “E-H”. See Figures 12A and 12B.

Figure 11 – ACM Indicating READY Mode

Figure 12A – ACM Indicating Missing Handpiece Thermocouple

33

Figure 12B – ACM Indicating Missing Handpiece

4.3.2. Position the Handpiece

To positio n the Handpi ece, follow the Instructions for Use provided with t he
Handpiece.

4.3.3. Delivery of Cryo Energy

1. To start the cryo ablation cycle, simply press and release the Ablation

Activation Switch or the Footswitch. The ACM unit’s Ablation Status
Indicator LED will transition from Ready to Freeze.

2. N2O 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 and releasing the Ablation Activ ati on Switch or 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 the Timer Increase and Timer Decrease key pad.
Each key press increases or decreases 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, follow i ng 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.

34

5. At this point, the ACM unit can be made to transition into one of two modes

depending on the ACM model: Freeze Mode or Ready Mode.

International – ACMs

Defrost to Ready:

Press and release the Ablation Activation Switch or the Footswitch.
The ACM unit vents and depressurizes the handpiece.
The ACM Ablation Status Indicator LED will transition from Defrost back

to Ready. As it transitions back to the Ready Mode, the Ablation Timer
display 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.

US – ACMs

Defrost to Freeze:

Press and release the Ablation Activation Switch or the Footswitch.
The ACM 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 Ac ti v at ion Switch or the Footswitch for three
seconds, until the ACM unit begins to vent and depressurize the
handpiece. Total depressurization requires 30 seconds to complete.

The ACM Ablation Status Indicator LED will transition from Defrost back
to Ready. As it transitions back to the Ready Mode, the Ablation Timer
display 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 is warmer than 0°C .
Actuation of the Ablation Activation Switch or the Footswitch when
the probe temperature i s colder than 0°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).

NOTE: Total Handpiece depressurization requires 30 seconds to complete.

35

4.3.4. Powering down the ACM

Upon completion of the procedure, the ACM uni t 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 the Footswitch until the unit
returns to the Ready Mode.

CAUTION: Do not remove cryo handpiece from the ACM unit if the ACM has

been powered down prior to the system being in the Ready Mode
as N2O gas may be trapped within the cryo handpiece interface
and the handpiece couplers may still be under pressure.

To remove any trapped N2O gas, turn the ACM unit back ON.
Depress the Ablation Activation Switch or the Footswitch to initiate
an ablation. After two seconds, stop the ablation by depressing
and releasing the Ablation Activation switch or the Footswitch.
Depress and hold the Ablation Activation Switch of the Footswitch
until depressurization is initiated, then release the Ablation
Activation Switch or the Footswitch. Wait 30 seconds for complete
depressurization, and then turn OFF the unit utilizing the ON/OFF
switch.

When the ACM enters the Ready Mode, the ACM may now be
powered down, and the cryo handpiece can removed from the
ACM safely and disposed of properly.

NOTE: When un plugging the handpiece, remove the large diameter tube first.

If a rush of gas is heard or felt, pause before unplugging the small
diameter tube until no gas is noticed.

1. Close the N2O gas cylinder valve.

2. Depressurize the ACM by pulling on the Pressure Relief Valve Knob located

in the rear of the ACM. This will remove excess N2O that may be trapped
within the ACM pneumatic system.

3. Unplug the power cord from the hospital mains outlet, and position on the

Cart.

4. Disconnect the cryo handpiece from the ACM unit and dispose of properly.

5. Position the footswitch from the ACM on the Cart.

6. Return ACM Cart back to proper storage.

36

4.4. Parameter Entry Mode / Adjusting t he S ystem Default Param et e r Values

1. Power up the ACM unit. The system will go through its Power On Self Test (POST)

routine.

2. Upon completion of POST, press and hold down the Ablation Activation Switch for

approximately three seconds and release.

3. 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 operator:

• Ablation Timer / Duration: Freeze duration value in seconds

• Probe Temperature Threshold: Temperature value at which the ablation timer

starts its countdown sequence

5. Ablation Timer / Duration Adjustment

• Using the Timer Increase and the Timer Decrease 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.

• Once the desired time value is displayed, press the Ablat ion Activation Switch
to accept the value.

• 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 Increase and the Timer Decrease 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 -70°C in 5°C
increments.

• Once the desired temperature value is displayed, press the Ablat ion 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
parameters.

8. Factory default values are:

• Ablation Timer / Duration = 120 seconds

• Probe Temperature Thr eshol d = -40°C

37

Possible Cause

Solution

DISPLAY

MESSAGE

DESCRIPTION

SOLUTION

Cold junction temperature out of range

System Controller Board

Service for support

5. Troubleshooting

Use the follow ing sec tio ns to hel p tro ubles h oot po ssi bl e pr obl ems with t he AC M.
To clear a faul t or error code from the ACM:

1. Power OFF the ACM

2. Depress and hold bot h th e increase (+) and decrease (-) buttons

3. Power ON the ACM. An “E” will b e di splayed in th e N2O gauge display

4. Release the increase(+) and decrease (-) buttons simultaneously

5. ACM will cycle thr o ugh its startup test an d c o nt i nu e into Ready Mode

6. If the Fault/Error Code returns, repeat ste ps 1-5, ensuring complete d epr essi o n of

the buttons

5.1. No ACM Power / Display Function

If there is no ACM power or display func ti on, attempt to correct this problem using the
following checklist.

ACM not turned on Turn power on
ACM not plugged in Confirm electrical connections and then turn power on
Blown fuse Replace fuse, confirm electrical connections and turn power on.
Internal ACM failure Contact AtriCure Customer Service

5.2. ACM Fault Codes

If a fault condi tio n shoul d occ ur , the N2O Gas Gaug e display on the front panel will
display the following fault code. Contact AtriCure Custo mer Service for support.

NOTE: The ACM will be unusable until the P-Error is resolved .

P1

P4

System Controller Board – Fuse F2 blown

Contact AtriCure Customer
Service for support

requires service.
Contact AtriCure Customer

38

DISPLAY

MESSAGE

DESCRIPTION

SOLUTION

System Controller Board Error – Fuse

Contact AtriCure Customer Service

System Controller Board Error – Triac

Contact AtriCure Customer Service

Handpiece pressure regulator out of

Contact AtriCure Customer Service

Internal pressure difference greater than

Wait for N2O Cylinder to cool down,

N2O Cylinder Temperature High

Reposition Heater Band, or

5.3. ACM Error Codes

If an error condition should occur, the N2O Gas Gaug e display on the front panel will
display th e following error code while the A CM unit is in the READ Y Mode. The System
Maintenance Needed indicator LED will also be lit. Use the table below to attempt to
resolve th e following application er rors.

NOTE: The ACM will remain usable while displaying an E-Error

E1

E2

E3

E4

E6

blown

inoperative

range

check value

• Cylinder over heated (pressure
gage over 900psi)

• In-line N

• N2O Gas Cylinder Empty, or

• Heater Band is not attached to

tank, or

• Heater Band secured improperly

o Bottom of Heater Band is not

o Some spring retainers are not

O gas filter dirty

2

approximately 2 inches from
the bottom of the cylinder

secured

for support

for support

for support

or
Replace cylinder with cool cylinder,

or
Pull Red Knob to vent pressure, or
Visually inspect In-line filter element

for debris (see section 9), or
Contact AtriCure Customer Service

for support

Secure all 6 tensioning spring
retainers, or

Wait for N
or

Replace with new N
or

Contact AtriCure Customer Service
for support

O Cylinder to cool down,

2

O gas cylinder,

2

39

DISPLAY

MESSAGE

DESCRIPTION

SOLUTION

Trapped N2O gas in the Inlet Line

For ACMs WITH an “L” on the

For ACMs WITHOUT an “L” label

No cylinder heater band current

Verify Cylinder Heater Band is

E7

-System

Maintenance

Light

illuminated (no

error code
displayed)

• Trying to enter Freeze Mode before
connecting the handpiece), or

• Powering down ACM before fully
depressurizing the handpiece, or

• Leaking Inlet Valve

Note: User may be unable to connect
handpiece to the ACM.

Cylinder heater band

• Heater Band is not secured to tank
(i.e. lying on floor, table, etc.), or

• Heating element malfunction, or

• Thermal cutoff switch was activated

(heater band reached 65°C –
cylinder will feel very warm to the
touch adjacent to the heater band)

Note: May notice hot rubber smell
Caution: cylinder heater band may be

hot to the touch.

top of the unit:

Turn off ACM for a minimum of 4
seconds and turn the ACM back on,
or

If problem persists, contact AtriCure
Customer Service for support.

on the top of the unit:

Close the N2O cylinder. Connect
the Handpiece Thermocouple
Connections. Enter into Freeze
Mode. Pull the red System
Pressure Relief knob in the back of
the unit until all gas has been
released. Depress Button to initiate
Defrost.Depress Button and hold 3­seconds for Ready state Connect
probe and re-open the N
cylinder, or

If problem persists, contact AtriCure
Customer Service for support.

wrapped around the N2O gas
cylinder, and all latches engaged,
or

Wait for Cylinder to cool down and
allow thermal cutoff switch to reset,
or

Replace Cylinder Heater Band if
defective heating element is
determined, or

Contact AtriCure Customer Service
for support

O

2

40

DISPLAY

MESSAGE

DESCRIPTION

SOLUTION

READY Mode Only

Connect Handpiece

READY Mode Only

Replace Handpiece.

READY Mode Only

Replace Handpiece.

FREEZE and DEFROST Mode Only

Replace Handpiece.

FREEZE and DEFROST Mode Only

Replace Handpiece.

5.4. Handpiece Error Codes

If Handpiece related error condition should occur, the Probe Temperature display on the
front panel will displ ay the following error code. Use the table below to attempt to r e s ol v e
the followi ng ap plic ati o n err ors .

E-H

E-L

HI

LO

Handpiece Not Connected.

Defective Thermocouple.

Defective Thermocouple.

Probe temperature has risen above the
operating limit.

Probe temperature has dropped below
operating limit.

Thermocouple Connection

If Problem Persists, Contact
AtriCure Customer Service.

If Problem Repeats, Contact
AtriCure Customer Service.

If Problem Repeats, Contact
AtriCure Customer Service.

If Problem Repeats, Contact
AtriCure Customer Service.

41

6. Symbols Used

Attention: consult accompanying
documents

Dangerous Voltage

Power OFF
Power ON
Alternating Current

Fuses

Equipotential Termi nal

Type CF Applied Part

Start

READY

FREEZE

DEFROST

Gas Gauge (Time Remaining)

Timer

42

Timer Decrease Button

Timer Increase Button

Probe Temperature

Connector

Gas Inlet

Gas Outlet

Temperature Adjust

Gas Exhaust

Power

Maintenance Needed

Low Gas Pressure

43

Cylinder Heater Band

Footswitch

Maximum Pressure

Follow instructions for use

44

7. Technical Specifications

7.1. Mechanical Specifications

• Size: 17.5 in (W) × 27.0 in (D) × 4.5 in ( H) maximum

44.5 cm (W) × 68.6 cm (D) × 11.4 cm (H) maximum

• Weight: 50 lb. (23 kg) absolute maximum.

7.2. Environmental Specifications

• Operational temperature: +10°C to +40°C

• Storage and Transit temperature: –35°C to +54°C

• Humidity: 15 to 90% relati ve h umi dit y

7.3. Elect ri cal Sp ec ifi cat io ns

• ACM1: 100-120VAC, (115 VAC nominal), 50/60 Hz

• ACM2: 220-240VAC, (230 VAC nominal), 50/60 Hz

7.4. Mains Fuses

• 100 -120VAC, 50 / 60 Hz,: Replace fus es as mark ed:

4.0A/250V, T-lag, 5 × 20 mm, UL Recog niz ed , IEC A ppr ov ed

• 220-240VAC, 50 / 60 Hz,: Replace fuses as marke d :

2.0A/250V , T-lag, 5 × 2 0 mm, UL Rec og niz ed, IEC A ppr oved

7.5. Footswitch Specifications

• Moisture protection rating: IPX8

7.6. Equipment Ty pe / Cla ssifi cation

• Class 1 Equipment

45

8. Preventive Main tenance and Clean ing of ACM

8.1. Preventive Maint enance

Perform annu al pr eve nt ativ e mai nt ena nc e proc edur es to ens ure all ACM components
are functioni ng as de fin ed withi n thi s ma nual . Pay par ti cul ar atten tio n to oper at io nal and
safety features, including but not limited to:

• Electrical pow er cor ds for fr ay ing, da mag e, an d pro per gro undi ng

• AC power swi tch

• Indicator da mag e (P ow er On, Fault, Maintenance Needed, Low Cylinder Pressure,

Cylinder Heater Band A c ti ve, Footsw it ch A c t ive, Ready, Freeze, Defrost)

• N2O Gas Gauge dis pl ay damage or loss of information

• Ablation Ti mer di spl ay damag e or los s of in for mati on

• Temperatur e display da mage or loss of information

• Handpiece elec tro nic i nter fac e co nnec t or da ma ge, cr ack ing or i nabi li ty to inser t an d

latch Hand piece connector

• Handpiece p ne u m ati c interfac e connector damage or i n abi l ity to ins er t and latch
Handpiece pneumatic connector

• Carrying handle damage or ina bili ty to fol d

• Rubber feet damag e, crac ki ng or ina bili ty f or t he AC M to remai n st abl e on a fla t

surface.

• Rubber align men t cu p dam age , cr acki ng or in abili ty for the AS B/ ASU to re mai n stabl e
atop ACM a n d within th e al ignment cup.

• Footswitch cord fr aying or damage

• Footswitch connector damage cracking or inability to insert and latch footswitch plug

• Footswitch pedal damage; check acti v ati on by pres sing and rele asi ng the pe dal

Other medical equipme nt that may be used sim ul t an eously with t h e ACM should als o be
inspected for da mag e. Sp eci fic all y , chec k for ins ula tio n d amage o f electrical cables and
associated connectors .

Visually ins pec t th e foo t sw itch for fl uid s or ot he r infec ti ous haz ar ds. Clean as nec ess ary
using the i n s tructions in Section 8.2.

The ACM does not hav e any customer serviceabl e part s aside from mains fuses, gas
line desiccant filter, and Inline gas filter element. For servi c ing issues, contact AtriC ure,
Inc. at:

7555 Innovation Way
Mason, Ohio 45 040
USA
Telephone: [phone]
866-349-2342 Toll Free

46

8.2. Cleaning and Disinfecting

NOTE: Do not spra y or po ur liq ui ds dir ec tly on t he unit .
NOTE: The unit and/or accessories cannot be sterilized.
WARNING: Ensure Isopropyl Alcohol (IPA) is completely dry before operating the unit.
CAUTION: Avoid caustic or abrasive cleaners

Guidelines
The following guideline s a re rec ommended f or cleaning the unit. It is the user ’ s respon sib ility to qualify

any deviations from these processing methods.

1. Disconnect the unit or ca rt from the o ut let be fore cleaning.

2. If the unit and/or ac ces sor ies are co ntam ina te d w ith blo od or ot he r body fluids, they shall be cleaned
before the contamination ca n dry (within two hours of con tami nation).

3. The outer surfaces of the unit and/or accessories shall be cleaned with 70% -90% I sopropyl alcohol
(IPA) wipes for a minimu m of two min utes. Do n ot allow f lui ds to en ter the c ha ssis.

4. Pay attention to all are a s whe re f lu ids or soi l may g a ther, such a s under / a ro und t he ha nd les or any tight
crevices/ grooves.

5. Dry the unit and/or ac c essorie s wi th a dry, white lint-free cloth.

6. Conduct a final confir ma tion of the c lea ning pr o ce ss by visually inspecting the white cloth for
remaining soil.

7. If soil remains o n the w hite c lot h, re pea t step s 3 t hroug h 6.

8. After cleaning is com ple te, tur n t he un it on to per f orm Pow er O n Self-Test (POST). If any errors are
received, contact Atri Cur e to beg in return process.

47

ACM Model

Fuse Type

Manufacturer

Part Number

AtriCure

P/N

ACM1

T 4A L 250V

Schurter

0034.5049

C002262

ACM2

T 2A L 250V

Schurter

0034.5046

C002261

9. Servicin g of ACM Unit

The ACM unit does not have any cust omer serv i ceable 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. T he che c k is cal le d th e Pow er On Sel f Tes t (PO S T). No calibrat ion 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,
Troublesho ot ing guide.

9.1. Repla cement of A C Mains Fuses

9.1.1. Tools and Parts

• Needle Nose Pliers

• Fuses:

9.1.2. Procedure

The ACM unit has be en pr e-s e t at t he fac tor y to eith er 1 10V – 120V (ACM1) or
220V – 240V (ACM2). The Rating La bel below the Power E n tr y Module on the
back panel of the ACM indica tes t he sel ect e d Inp ut Volt age for thi s uni t. This
setting sho uld only be adj ust ed by the m anu fac tur er or by an au t horiz e d Atri Cur e
technical service re pr es entative.

NOTE: ACM unit sh oul d be po w ered o ff a nd un plug ge d befor e c onti n uing wit h

the fuse replacement procedure.

1. Determine the fuse type by looking at the ACM Model Nu mb er or th e ACM Rati ng

Label.

2. Using needle nose pliers, car eful ly extra ct the f use box fr om th e pow er entry

module by sque ez ing d ow n on t he fus e box tabs in t he sl ots as sh ow n.

48

In-Line N2O

Filter

AtriCure

P/N

Type

Manufacturer

Part Number

Filter

C002458

TF Series

Swagelok

SS-4F-K4-60

Filter Bonnet

Nut

C002500

TF Series

Swagelok

SS-4TF-K5

Filter Gasket

C002501

TF Series

Swagelok

SS-4TF-K2

1

3. Replace the ( 2) two fuses located in t h e fuse box. Ma ke sure the fuses are lined

up straight.

4. Line up the fuse cartridge so the guide tab is tow ar ds the power entry side as

shown.

5. Slide the fuse box back into the power entr y mod ule and seat it firmly.

6. Confirm operati on al st a tus by plug ging in the ACM and p owering it u p. Check to

see that t he self-test is completed without er rors.

9.2. Inspection and R ep lace ment of I n-Line N2O Filter

9.2.1. Tools and Parts

• 3/32 inch Allen Wrench

• 1.0 inch hex Socket

• Socket Wrench

• Filter:

9.2.2. Procedure

NOTE: ACM unit sh oul d be totally depressuri z ed, in the ready state , then

powered off and unplugged before continuing with the In-Line N2O Filter
Inspectio n and/ or replacement procedure.

1. Turn over the A C M unit so that the botto m s ide is up.

2. Remove the 4 s crews holding the filter service cover in i ts place usi ng the 3/ 3 2

inch Allen wr ench .

49

1 2 3

3. Using the 1 i nch (25 mm) hex Socket, loo se n the fil ter bonnet nut (Note: s n a p r ing

does not n e ed to be removed).

4. Visually inspec t th e out er s ur fac e of th e fil ter el eme nt for an acc u mul ati on of

debris. If mor e tha n hal f o f the outer sur fa ce is c oat ed w ith d ebris pr ocee d to step
5 to replace the filt er el e ment , ot her w ise insert the Fil ter El eme nt in to th e ho usi ng,
verify the filter gas k et is in position and t hr e a d the Filter B onnet Nut ti g ht onto the
housing proc eed to st ep 7.

5. Remove the old filter element and filt er gask et and replace with new. Breakdown

of each compone n t i s shown below for reference.

50

1. Filter Bonnet Nut

2. Filter Element

3. Filter Gasket

Item

Supplied By

Part Number

Filter Cartridge

AtriCure

F021720

Filter O-ring

AtriCure

F010924

O-ring lubricant

AtriCure

C002502

US Tank Hose Assembly

AtriCure

A000837

International Tank Hose
Assembly

AtriCure

A000838
Tip Washer

AtriCure

F021837

1. Desiccant Filter Cartridge

2. Filter Housing

3. Tip Washer

1 2 3

6. Insert the filt er el em ent c ent ering it i n the filter housing. Insert the filter gasket into

the housing. Install the Filter Bonnet Nut finger tight and tighten to approximately

45.8 ft-lbs (62.2 N-m).

7. Replace the filt er servi c e cov er to the ACM bottom. Tighten the four cover

retaining screws without stripping them.

8. Confirm oper ational status by plugging in the ACM and pow er ing it up. Check to

see that t he self-test is completed without er rors.

9.3. Repla cement of Ga s L in e Desiccant F ilter and Tip Washer

9.3.1. Parts

• Replacement parts:

9.3.2. Procedure – Desiccant Filt er

1. Unscrew the filt er car tr i dge h ous ing by ro tati ng it counter-clockwise. Refer to the

figure bel ow.

51

Note: There are two fil ter car tr idg e housi ng . Make sur e s erv ici ng of th e fil te r

cartridge is per for med onl y on the uni t nex t to th e pre ss ure gaug e as
shown in t he figure below.

2. Remove the desiccant filter cartridge by rotating it counter-clockwise. Refer to the

figure bel ow.

3. Replace the desic ca nt filter car tr idg e with a new one.

4. Replace the filt er housi ng .

9.3.3. Procedure – Tip Washer (US Mode l)

1. Unscrew the w orn out Tip Washer by rotating i t counter-clockw ise and disc ard.

Refer to the figure below.

52

Item

Supplied By

Part Number

ACM Footswitch

AtriCure

A000708

N2O Gas Line Hose Assembly (2.5ft /

0.75m)

AtriCure

A000837
N2O Exhaust Hose

AtriCure

C002051

Cylinder Heater Band (CMH15)

AtriCure

A000728

Cylinder Heater Band (CMH22)

AtriCure

A000727

AC Power Cord – 10 ft (USA)

AtriCure

C000262

Item

Supplied By

Part Number

ACM Footswitch

AtriCure

A000708

N2O Gas Line Hose Assembly (2.5ft /

0.75m)

AtriCure

A000838
N2O Exhaust Hose

AtriCure

C002051

Cylinder Heater Band (CMH15)

AtriCure

A000728

Cylinder Heater Band (CMH22)

AtriCure

A000727

AC Power Cord – 3.5 m (Europe)

AtriCure

C002090

2. Replace with new tip was her.

9.4. Other Replacement Components

9.4.1. USA Only

NOTE: Standard cylinder size for the AtriCure Cart is 20lbs with a CGA326 valve.

9.4.2. International

NOTE: Nitrous Oxide cylinders and valves are country specific.

9.4.3. Electromag n et ic Compatib i l ity

Use of access orie s ot her than ide nti fie d in Sec tio n 9.5.1 and 9.5.2 may result in
increased EM ISS ION S or decr eas ed IMMUN I TY of the AtriCure Cryo Module.

53

10. Accessories

10.1. CMH15, Cryo Module Cylinder Heater Band

Cylinder heater band with dimensions of 12 inch x 15 inch (30.5 cm x 38.1 cm).

10.2. CMH22, Cryo Module Cylinder Heater Band

Cylinder heater band with dimensions of 12 inch x 22 inch (30.5 cm x 55.9 cm).
Spring Extension Kit is available for larger diameter cylinders – contact

AtriCure customer service

10.3. 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.

11. Disposal

Follow loc al g overning ordinances a n d recyclin g pl a ns regarding di sposal or rec y c l ing of
device components.

54

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 f ree from defects in material and workm anship under norm al use and
preventive maintenance for the respective warranty period shown below. AtriCure’s obligation under this warranty
is limited to the repair or replacem ent, at its option, of any product, or part thereof, wh ich has been retur ned 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 affec ted due t o us e with devices manufactured or dis tribut ed by parties not authorized b y Atri Cure,
Inc. (2) repaired or alt ered outsid e AtriCure ’s fac tory in a wa y so as to, in A triCur e’s judgm ent, affec t its stabilit y
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 sta ndards for sim ilar prod ucts g enera lly ac cepte d in t he industr y. 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 ................................................................................ One (1) Year

AtriCure Cylinder Heater Band ......................................................................... One (1) Year

AtriCure Gas Line Hose Assembly……………………………………………… .. One (1) Year

AtriCure Cryo Footswitch .................................................................................. One (1) Year

Grounded Electrical Cord .................................................................................. 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 LIABILI TIES ON T HE PART O F ATRICUR E, INC. AND IS A PURCH ASER’S EX CLUSIVE
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. neith er assum es nor authorizes a ny other pers on to assum e for it any other liability in con nection
with the sale or use of any of AtriCure Inc. pr oducts. There are no warranties that extend beyond the term s
presented unless an extended warranty is purchased before the original warranty expires. No agent, employee

or representative of AtriCure has any author ity to change any of the foregoing or assume or bind Atri Cure
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 b y them .

55