AtriCure Cryo Module (ACM) Module Users Manual Rev H

Table of Contents 1.

GETTING STARTED...4 1.1. 1.2. 1.3. 1.4. 1.5.

2.

THE ATRICURE CRYO MODULE (ACM) ... 12 2.1. 2.2. 2.3.

3.

Transporting of ACM ... 22 Preparing the ACM For Use... 22 Installing Power Cord ... 22 Installing the Footswitch ... 22 Installing Cylinder Heater Band ... 23 Installing N2O Gas Line Hose ... 24 Installing N2O Exhaust Hose... 26 Connecting and Disconnecting the Handpiece ... 27

INSTRUCTIONS FOR USE ... 29 4.1. 4.2. 4.3. 4.4.

5.

Device Description... 12 ACM Front Panel – Illustration and Nomenclature ... 13 ACM Rear Panel – Illustration and Nomenclature ... 19

INSTALLING THE ACM ... 22 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8.

4.

System Description ... 5 Unpacking ... 6 Warnings and Precautions ... 6 EMC Guidance and Manufacturer’s Declaration ... 7 Responsibility of the Manufacturer ... 11

Powering Up the ACM ... 29 Operating Modes ... 30 Delivering Cryo Energy ... 32 Parameter Entry Mode / Adjusting the System Default Parameter Values ... 36

TROUBLESHOOTING... 37 5.1. 5.2. 5.3. 5.4.

No ACM Power / Display Function ... 37 ACM Fault Codes ... 37 ACM Error Codes ... 38 Handpiece Error Codes ... 40

6.

SYMBOLS USED... 41

7.

TECHNICAL SPECIFICATIONS ... 44 7.1. 7.2. 7.3. 7.4. 7.5. 7.6.

8.

Mechanical Specifications ... 44 Environmental Specifications... 44 Electrical Specifications ... 44 Mains Fuses ... 44 Footswitch Specifications ... 44 Equipment Type / Classification ... 44

PREVENTIVE MAINTENANCE AND CLEANING OF ACM ... 45 8.1. 8.2.

Preventive Maintenance ... 45 Cleaning and Disinfecting... 46 2

9.

SERVICING OF ACM UNIT... 47 9.1. 9.2. 9.3. 9.4.

Replacement of AC Mains Fuses ... 47 Inspection and Replacement of In-Line N2O Filter ... 48 Replacement of Gas Line Desiccant Filter and Tip Washer ... 50 Other Replacement Components ... 52

10. ACCESSORIES... 53 10.1. CMH15, Cryo Module Cylinder Heater Band ... 53 10.2. CMH22, Cryo Module Cylinder Heater Band ... 53 10.3. CMF1, Cryo Module Footswitch ... 53 11. DISPOSAL ... 53

3

1.

Getting Started This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. Important: This manual is designed to provide instructions for use of the AtriCure Cryo Module (ACM) with the AtriCure Cryo Handpiece (CRYO1 and 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 delivers a cryogenic energy source, namely Nitrous Oxide, to create lines of ablation through cardiac tissue. The ACM is part of a system which includes the nitrous oxide gas, N2O gas line hose, N2O exhaust hose, cylinder heater band, a footswitch, and single-use cryo handpiece with integrated electronics cable / gas hoses. The system provides controlled lesion forming temperature that is below -40°C, with typical operating ranges between -50°C to -70°C. The system is also equipped with the ability to tune or set the terminal handpiece temperature. The ACM is designed to operate only with AtriCure designed and developed handpieces. Along with the Ablation Activation Switch on the front panel of the ACM, a footswitch can also be used to activate the ablation cycle. Refer to the handpiece Instruction for Use for a complete description of the indications and uses of these devices. For the user’s convenience, the AtriCure Cryo Module will be referred to in this User’s Manual as the “ACM”. The AtriCure Cryo Handpiece will be referred in this User’s Manual as the “Handpiece”. 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.

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1.1.

System Description As shown in Figure 1, the system is comprised of the following: 

A:

AtriCure Cryo Module Cylinder Heater Band (CMH15 or CMH22)



B:

AtriCure Cryo Footswitch (CMF-1)



C:

ACM N2O Exhaust Hose



D:

ACM N2O Gas Line Hose Module



E:

AtriCure Cryo Module (ACM)



ACM Power Cord (not shown)



AtriCure Cryo Handpiece with integral cable (not shown)

Accessory devices are described in Section 10. A

B

C

D

E

Figure 1 – ACM, Footswitch, N2O Gas Line Hose Module, N2O Exhaust Hose, and Cylinder Heater Band

5

1.2.

Unpacking 1.2.1. ACM Unit Lift the ACM unit from the box and remove the protective wrapping and side caps. Note: The ACM unit is packed upside down for transit purpose. Note: Take precautions when lifting the unit as it weighs approx 45 lbs (20 kg). 1.2.2. Accessories ACM accessories are shipped separately from the ACM unit. The accessory box contains the following items: 

ACM Power Cord



N2O Gas Line Hose



N2O Exhaust Hose



ACM Cylinder Heater Band



ACM Footswitch

It is recommended that the original shipping box and protective wrapping be saved for future storing and/or transporting of the device. 1.3.

Warnings and Precautions The safe and effective use of the cryo device and equipment is highly dependent upon factors under the control of the operator. There is no substitute for a properly trained operating room staff. It is important that the operating instructions supplied with the ACM unit be read, understood, and followed before use. 1.3.1. WARNINGS  Do not operate the ACM unit before thoroughly reading this manual.  Do not use cryo surgical equipment unless properly trained in the specific procedure being undertaken. This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed.  Fire Hazard: Do not use extension cords.  Trip Hazard: Standard care should be used to reduce the risk of tripping on the Footswitch cable, as well as the N2O exhaust hose.  No modification of this equipment is allowed. The voltage selector is factory set and should not be changed by the user. The voltage setting and the fuse rating must be appropriate as identified to prevent ACM malfunction and potential instrument damage. Electric Shock Hazard: Connect the ACM Power Cord to a properly grounded receptacle. Do not use power plug adapters. Electric Shock Hazard: Do not connect wet accessories to the generator. 6

Electric Shock Hazard: Ensure that the Handpiece is correctly connected to the ACM and that no thermocouple wires are exposed from the cable, connector, or the Handpiece. 1.3.2.   

   

1.4.

PRECAUTIONS Use only with the AtriCure Handpieces intended for use with the ACM. Do not activate the ACM unit until the Handpiece is properly positioned at the ablation site. The system status indicators and displays are important safety features. Do not obstruct either the ablation or the system status indicators. Do not remove the ACM cover, except for the in-line gas filter access port, as there is a potential for electrical shock. Refer to authorized personnel for service. Use only the Footswitch provided with the ACM. The Power Cord of the ACM must be connected to a properly grounded receptacle. Extension cords and/or adapter plugs must not be used. Do not contact AtriCure Handpieces with a RF device. Compressed Air Hazard: Do not operate N2O tanks with a pressure greater than 1000 PSIG (6900 kPa).

EMC Guidance and Manufacturer’s Declaration 1.4.1. Electromagnetic Requirements 1.4.1.1.

The AtriCure Cryo Module (ACM) has been tested and found to comply with the limits for medical devices in IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

1.4.1.2.

The ACM can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.

1.4.1.3.

Portable and mobile RF communications equipment can also affect ACM performance and care should be taken to minimize such interference. However, there is no guarantee that interference will not occur in a particular installation.

1.4.1.4. If the ACM does cause harmful interference to other devices, which can be determined by turning the ACM off and on, the user is encouraged to try to correct the interference by one or more of the following measures: 

Reorient or relocate the receiving device.



Increase the separation between the ACM and the other devices.



Connect the ACM into an outlet on a circuit different from that to which the other device(s) are connected.



Contact the AtriCure service representative for help. 7

1.4.2. Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The AtriCure Cryo Module (ACM) is intended for use in the electromagnetic environment specified below. The customer or the user of the ACM unit should assure that it is used in such an environment. Emissions test

Compliance

RF emissions CISPR 11

Group 1

Electromagnetic environment – guidance The ACM unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

The ACM unit is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

8

1.4.3.

Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity The AtriCure Cryo Module (ACM) is intended for use in the electromagnetic environment specified below. The customer or the user of the ACM unit should assure that it is used in such an environment. IMMUNITY test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4

IEC 60601 test level ± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

± 2 kV for power supply lines

± 2 kV for power supply Lines

± 1 kV for input/output lines

Surge IEC 61000-4-5

± 1 kV line(s) to line(s)

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE:

± 1 kV for input/output lines ± 1 kV differential mode

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

± 2 kV common mode <5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 s 3 A/m

<5 % UT (>95 % dip in UT) for 5 s 3 A/m

± 2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Compliance level

Electromagnetic environment – guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the ACM unit requires continued operation during power mains interruptions, it is recommended that the ACM unit be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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

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1.4.4. EMC Guidance and Manufacturer’s Declaration Guidance and manufacturer’s declaration – electromagnetic immunity The AtriCure Cryo Module (ACM) is intended for use in the electromagnetic environment specified below. The customer or the user of the ACM should assure that it is used in such an environment. IMMUNITY test

IEC 60601 TEST LEVEL

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the ACM, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

Recommended separation distance 3 Vrms d = 1.2 √P

d = 1.2 √P 80 MHz to 800 MHz 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 a determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1:

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

NOTE 2: a

b

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF 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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

10

1.4.5. Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the AtriCure Cryo Module The AtriCure Cryo Module (ACM) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ACM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ACM as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2 √P

80 MHz to 800 MHz d = 1.2 √P

800 MHz to 2.5 GHz d = 2.3 √P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

1.5.

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 absorption and reflection from structures, objects, and people.

Responsibility of the Manufacturer AtriCure is responsible for safety, reliability, and performance of the equipment only if:  Installation procedures in this manual are followed.  Persons authorized by AtriCure carry out modifications or repairs.  The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI.  The equipment is used in accordance with the AtriCure User’s Manual.

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2.

The AtriCure Cryo Module (ACM) This section provides a detailed description of the ACM including its function and operating features.

2.1.

Device Description  The AtriCure Cryo Module (ACM) unit is an electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic source, Nitrous Oxide, to create lines of ablation through cardiac tissue.  The ACM is part of a system which includes the nitrous oxide gas and its cylinder, N2O gas line hose, N2O exhaust hose, cylinder heater band, a footswitch, system power cord, and single-use cryo handpiece with integrated electronics cable / gas hoses.  The system provides a controlled lesion forming temperature that is below -40°C, with typical operating ranges between -50°C to -70°C for the treatment of cardiac arrhythmias, creating an inflammatory response (cryonecrosis) that blocks the cardiac electrical conduction pathway.  The system is also equipped with the ability to tune or set the terminal handpiece temperature.  Along with the Ablation Activation Switch on the front panel of the ACM, the ACM Footswitch can also be used as the input device to activate and terminate the cryo ablation cycle.  The presence of the ACM Footswitch is not a requirement for the ACM unit to operate and is made available as a secondary means of interfacing with the ACM unit, and to provide control of the ablation cycle to the surgeon.  The ACM is designed to operate only with AtriCure designed and developed handpieces.  Refer to the Handpiece Instruction for Use for complete description of the indications and uses of these devices.

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2.2.

ACM Front Panel – Illustration and Nomenclature An illustration of the ACM front panel is shown in Figure 2, below. 2

4

1

9

5

7

3

8

6

10

11

12

Figure 2 – ACM Front Panel 1.

Ablation Activation Switch

7.

Ablation Timer Increase Button

2.

Ablation Status Indicator

8.

Handpiece Probe Temperature

3.

N2O Gas Gauge Display

9.

Handpiece Thermocouple Port

4.

System Status Indicator

10. Handpiece Electronic Interface Port

5.

Ablation Timer Decrease Button

11. Handpiece Gas Connection Port

6.

Ablation Timer Display

12. Handpiece Probe Temperature Control

2.2.1.

Ablation Status Indicators There are three indicators on the front panel of the ACM: READY, FREEZE, and DEFROST. These indicators are described below.

1 2 3

Figure 3 – ACM Ablation Status Indicators 13

Indicator

Symbol

Description READY – Green LED

1

This status indicates the ACM is in stand-by mode and is ready to start the cryo ablation cycle. FREEZE – Blue LED

2

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 the ACM is in defrost state, N2O gas flow is ceased, Handpiece is back pressurized, and the Handpiece probe is warming back up to the ambient temperature.

3

Blinking: Indicates the ACM is now ready to transition to the next state. Upon activation of either the Ablation Activation Switch or the Footswitch, the ACM unit will transition into the next state depending on the ACM model as described below. International – ACM  Transitions to Ready state only US – ACM  Press and release – Freeze state  Press and hold – Ready state

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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. 2

1

3

4

5

6

Figure 4 – ACM Status Indicators Indicator

1

Symbol

Description SYSTEM POWER – Green LED This status indicates system logic power for the ACM is available. SYSTEM FAULT – Red LED

2

This status indicates ACM has encountered a system fault condition and has halted all operation. The ACM unit will not operate until the fault condition has been addressed. MAINTENANCE NEEDED – Amber LED

3

This status indicates the ACM system is still in normal, functional, and safe operating mode. However, maintenance is being requested to address such items as replacing in-line N2O gas filter to optimize system performance.

15

Indicator

Symbol

Description 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.

4

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 operating level, and the cylinder heater band will be activated. The indicator LED will extinguish when the cylinder pressure has risen back to the optimal operating level. Blinking: Indicates the cylinder pressure is well below the recommended operating level, and the cylinder has less than 10 minutes of functional gas left.

16

Indicator

Symbol

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).

5

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.

6

2.2.3.

Front Panel Functions Item

Description HANDPIECE THERMOCOUPLE Receptacle This 2-pin receptacle accepts the AtriCure Handpiece thermocouple connectors. This connection is patient-isolated. HANDPIECE ELECTRONIC INTERFACE Receptacle This 14-pin receptacle is reserved for future release of AtriCure Handpiece. This connection is patient-isolated.

HANDPIECE PNEUMATIC Receptacle This 2 port pneumatic receptacle provides the N2O interface with the AtriCure Handpiece. The ports are sized differently to prevent cross-coupling of the connections.

17

Item

Description HANDPIECE PROBE TEMPERATURE ADJUST Knob This control knob provides the operator with the ability to adjust the terminal temperature of the handpiece probe. Turning the knob in the counter-clockwise rotation lowers the probe temperature, while turning the knob in clockwise rotation raises the probe temperature. In normal operation the knob will be adjusted to provide maximum negative temperature.

2.2.4. 2.2.4.1.

Front Panel Displays N2O Gas Gauge 

This display indicates, in minutes, the approximate amount of useable N2O gas remaining in the cylinder. As the gas is being consumed, this value will adjust based on the actual gas flow time and the cylinder pressure. As a result, the displayed value may decrease quicker than anticipated.



This time value should not be taken as an absolute measurement, but only as a reference in gauging the amount of gas remaining in the cylinder.



The display value will start to blink when there is approximately 10 minutes or less of anticipated useable gas left in the cylinder.

NOTE:

Replacement of the N2O cylinder at this point is highly recommended.

NOTE:

Along with the blinking gas gauge, the Low Cylinder Pressure indicator LED may also be blinking indicative of empty or near empty N2O cylinder.



Typical usage time for a new cylinder is between 30 to 40 minutes depending on the type and size of the cylinder when used with the ACM cylinder heater band. The usage time will be less when the cylinder heater band is not used.



The gas gauge value can be reset upon replacement of the N2O cylinder by pressing down on the Timer Increase and Timer Decrease key simultaneously and releasing.



Secondary function of the gas gauge is to display the N2O cylinder gas pressure during the ablation cycle. This provides the user with additional real-time information regarding the gas status within the cylinder during system operation in psi x10. 18

2.2.4.2.

2.2.4.3.

2.3.

Ablation Timer 

This display indicates the desired ablation duration in units of seconds.



The default duration time is 120 seconds per ablation run.



This timer value can be adjusted prior to, or during the ablation cycle, by using either the Timer Increase or Timer Decrease Button.



Each key press of the Timer Increase Button or Timer Decrease Button will modify the target ablation time value by 10 seconds, either adding or subtracting from its present value.



At the termination of the freeze cycle (Defrost mode), the display will show total time in freeze state. A full 120 second run will result in the display showing 120 as an example. An aborted freeze cycle will show the number of seconds the system operated in the Freeze mode.

Handpiece Probe Temperature This display indicates the current handpiece probe temperature in Celsius, and is continuously updated each second.

ACM Rear Panel – Illustration and Nomenclature An illustration of the ACM rear panel is shown in Figure 5, below. 7

4

1

2

3

5

6

8

Figure 5 – ACM Rear Panel 1. N2O Exhaust Port

5. Equipotential Terminal

2. System Pressure Relief Knob

6. Cylinder Heater Band Receptacle

3. N2O Inlet Port

7. AC Power Entry Module

4. Footswitch Receptacle

8. Input Voltage Selector Switch

Note: Input Voltage Level Switch is factory set and is covered by unit model label. The switch and the label should not be tampered with or changed except by authorized AtriCure personnel.

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2.3.1.

Rear Panel Functions Item

Description Power Entry Module – This module contains both the ON/OFF switch and the wall receptacle mains fuses. Fuse Box – The Fuse Box contains fuses selected for the input voltage. See Technical Specifications in Section 7 of this manual. 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 pedal provides 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.

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