Steris Arc Smart Argon Coagulation Probe Operating instructions

Brand: Steris

Model: Arc Smart Argon Coagulation Probe

Type: Operating instructions

Reorder No. G1140001

G1140002

G1140003

ArC SmartTM Probe

INSTRUCTIONS FOR USE

Manufactured for US Endoscopy

5976 Heisley Road

Mentor, OH 44060

800-548-4873

www.steris.com

A subsidiary of STERIS Corporation

Explanation of symbols used on Labels and Instructions for Use

SDO (if applicable) Symbol and

Reference Number

Title of Symbol Meaning of Symbol

ISO 15223-1

Medical Devices –

Symbols to be used

with medical device

labels, labelling, and

information to be

supplied

5.1.1 Manufacturer Indicates the medical device manufacturer

5.1.4 Use By Indicates the date after which the medical device is

not to be used.

5.1.5 Batch Code Indicates the manufacturer’s batch code

5.1.6 Catalog Number Indicates the manufacturer’s catalogue number

5.2.3 Sterilized by Ethylene

Oxide

Indicates a medical device that has been sterilized

using ethylene oxide

5.3.7 Temperature Limitation Indicates the temperature limits to which the device

can be safely exposed.

5.3.8 Humidity Limitation Indicates the range of humidity to which the device

can be safely exposed during storage, operation,

and transport.

5.4.1 Biological Risks Indicates that there are potential biological risks

5.4.2 Do not reuse Indicates a medical device that is intended for a

single procedure

5.4.3 Consult instructions for

use

Indicates the need for the user to consult instruc-

tions for use

5.4.4 Caution Consult instructions for use for cautionary informa-

tion

21 CFR 801.109 (b) (1) N/A Caution: Federal law (U.S.A.) restricts this device to sale or on the order of a

physician.

N/A N/A Unique Device Identifier Indicates the unique device identifier

N/A N/A Contents Number of devices/kits within packaging

IEC 60417 Graphical

Symbols for Use

Equipment

5334 Defibrillation-Proof Type

CF Applied Part

Indicates a defibrillation-proof type CF applied part

complying with IEC 60601-1.

UDI

(U.S.A.)

12276023 Rev. A. Page 4 of 4

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Intended Use:

The ArC Smart™ Probe is indicated for argon enhanced coagulation of tissue.

This device is rated at 5400Vpeak

The device is not made with any natural rubber latex.

Operating Principal:

99.99% argon gas is advanced through a tube. Concurrently, RF energy is delivered by wire to an electrode at the distal tip of the tube. Gas passing over the

electrode is ionized. The ionized gas forms a noncontact pathway for the delivery of energy to the tissue surface to create therapeutic coagulation.

Argon coagulation probe for flexible endoscopy

SIGNAL WORDS:

Warnings: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Cautions: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against

unsafe practices or potential equipment damage.

Warnings:

• The use of flammable anesthetics or oxidizing gases should be avoided when using this device.

• Before using any electrosurgery, be sure that there are no endogenous explosive gases present in the lumen of the subject organ.

• Be aware of the danger of fire in the tracheobronchial system. The argon coagulation plasma beam may cause highly flammable, combustible materials

to burn. Examples of combustible materials are plastic insulation at the distal end of the bronchoscope and a tracheal tube. However, ignition can

only occur if there is also a fire supporting gas such as oxygen present. This particularly applies to bronchoscopic treatments in the presence of highly

concentrated or pure oxygen. For this reason, it is essential to follow these rules:

○Before and during the probe activation, never introduce oxygen to the trachea bronchial system. This also applies to other combustible

or fire supporting gases or liquids.

○If argon coagulation therapy is to be applied for more than a few seconds, apply the oxygen and activate the probe alternately.

• This device is intended for single use only. The product and the packaging have not been designed or tested for reuse. Attempts to clean and re-sterilize

this device and subsequently reuse may adversely affect the clinical performance, safety, and/or sterility of the device.

• These instructions for use are not a substitute for the operating instructions / user manual of the argon equipped electrosurgery generator being used

with this probe. Users must also read and understand the operating instructions provided with the argon equipped electrosurgery generator to be used.

• For patients with pacemakers or other implants, a potential hazard exists due to interference with or damage to the active implant. Follow facility

guidelines for patients with implanted devices and consult with cardiology and/or the manufacturer of the implanted device before using this device on

the patient.

• Never activate the argon probe when the open tip is in direct contact with the tissue as this may cause a mild emphysema or embolism and may increase

the risk of perforation.

• The distal end of the probe must always be within the field of view of the endoscope before and during activation. Never activate the probe without first

visualizing the target tissue.

• To avoid risk of electric shock, this device must only be connected to a supply main with protective earth.

• When in use, the temperature of the probe can exceed 41°C. There is a potential for unintended surgical site burns due to direct contact with the probe.

• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state

and federal laws and regulations.

Cautions:

• Argon coagulation therapy should be used only by endoscopists experienced in argon coagulation techniques and safety.

• Be sure to use care when using argon coagulation therapy near metal devices such as stents or clips.

• To reduce the potential of gas emphysema or embolism, use the minimum argon gas flow rate that will support the arc beam and achieve the

appropriate clinical effect.

• Do not touch the probe tip or touch it to the tissue immediately after it has been activated as the tip may be hot.

• Do not activate probe until it is at least 4mm forward from the tip of the endoscope and clearly visible.

• Do not exceed the maximum electrical capacity for the Arc Smart™ Probe.

• The use of high frequency electrosurgical units, with or without argon capability, may cause interference with other devices and video endoscopic

equipment.

• Do not insert or retract the probe in a duodenoscope with the elevator in the up position.

• Electrosurgical accessories constitute a potential electrical hazard to the patient or operator.

• Be sure that the proper path from the patient return electrode to the electrosurgery unit is maintained throughout the procedure.

• Be sure to use proper accessory passing technique, and short forward strokes, to avoid kinking while introducing the probe into the endoscope

accessory channel.

Pre-cautions:

• Inspect all devices prior to use.

• Do not use this device if there is detectable handling or shipping damage.

• Do not use any sterile device beyond its expiration date.

• Never modify the probe tip in anyway. Doing so will void all warranties and may be unsafe.

• Use this probe only with properly equipped argon capable electrosurgical generators that meet or exceed all appropriate IEC 60601-1 Standards.

Ex Vivo Argon Coagulation Zone Width Measurements in Two Tissue Types

(Average Measures at Two-Watt Settings)

Bovine liver Porcine kidney

45 watts 5.56 mm 4.88 mm

60 watts 5.99 mm 5.73 mm

Probe Configuration:

REF No. Outer Diameter Length Min. Scope Channel Maximum Watts

G1140001 2.3 mm 220 cm 2.7 mm 90 watts

G1140002 2.3 mm 330 cm 2.7 mm 90 watts

G1140003 3.2 mm 220 cm 2.7 mm 90 watts

The chart above shows the suggested gi4000 wattage maximum for each probe size. Follow all appropriate instructions for use provided with the gi4000. Use the

minimum wattage and flow rate for the desired tissue effect and the maintenance of an argon coagulation plasma beam sufficient to apply non-contact therapy.

The physician is responsible for choosing the appropriate settings to treat a patient. This determination is based upon the physician’s preference and technique

as well as the patient’s size, condition, age, etc. and the desired outcome of the planned treatment.

INSTRUCTIONS FOR USE

Before you begin:

1. Be sure to check the compatibility of the endoscope channel with the package label for the ArC Smart™ Probe.

2. Inspect the package for damage that may have occurred during transit or handling. If damaged, do not use.

3. Use aseptic or appropriate clean techniques when removing the device from the package and inspecting for damage.

4. Inspect the ArC Smart™ Probe, including the tip, and do not use if cracked, sharp or damaged in any way.

Connection to the gi4000 using the single use ArConnect®:

1. Inspect the ArConnect® for damage.

2. Inspect the Arc Smart™ Probe for damage.

3. First remove the ArConnect® from the package and insert the distal connector into the gi4000 per the generator Operation and Maintenance Manual and

the instructions for use provided with the ArConnect®. Ensure a complete connection.

4. Remove the Arc Smart™ Probe and connect the distal connector of the probe to the proximal end of the ArConnect®. Ensure a complete connection.

5. Be sure that the patient is properly connected to a return electrode (grounding pad).

6. Activate the purge button on the gi4000 to fill the connected devices with argon gas.

Insertion into the endoscope:

1. Insert the Arc Smart™ Probe into the endoscope instrument channel using short strokes until the distal tip appears in the field of view. A minimum

distance of 4mm protruding from the endoscope is recommended.

The device is ready for activation.

After use:

Discard both the ArConnect® and the ArC Smart™ probe using proper disposal technique.

WARNING: This product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local,

state, and federal laws and regulations.

Environmental Conditions:

Operating Environmental Conditions Storage Environmental Conditions Transport Environmental Conditions

Ambient Temp: +10°C to +40°C Ambient Temp: +10°C to +30°C Ambient Temp: -40°C to +70°C

Relative Humidity: 30% to 75%,

non-condensing

Relative Humidity: 10% to 75%,

non-condensing

Relative Humidity: 10% to 100%, including

condensation

Atmospheric Pressure: 70kPa to 106kPa Atmospheric Pressure: 50kPa to 106kPa Atmospheric Pressure: 50kPa to 106kPa

Product Disposal:

After use, this product may be a potential biohazard which presents a risk of cross-contamination. Handle and dispose of in accordance with accepted medical

practice and applicable local, state and federal laws and regulations.

Issued Date: January 2021

Warning: An issued or revision date for these instructions is included for the user’s information. In the event two years has elapsed between this date and

product use, the user should contact STERIS to determine if additional information is available.

Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark Office, or are trademarks owned by STERIS

Corporation.

Serious incidents that have occurred in relation to this medical device should be reported to STERIS Endoscopy.

US Endoscopy, a wholly owned subsidiary of STERIS Corporation.

This end attaches to the

ArConnect® Argon Probe

Connector,

see Instructions for Use

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