Steris Arconnect Argon Probe Connector Operating instructions

Brand: Steris

Model: Arconnect Argon Probe Connector

Type: Operating instructions

00732484 Rev. A Page 1 of 6

Manufactured for US Endoscopy

5976 Heisley Road

Mentor, OH 44060

800-548-4873

www.steris.com

A subsidiary of STERIS Corporation

ArConnect®

Reorder No.

G1120020

INSTRUCTIONS

FOR

USE

00732484 Rev. A Page 2 of 6

No latex is used in the manufacturing process.

ArConnect®

Single Use

Conducting Adapter for

Argon Coagulation Probe Attachment

Part number: G1120020

Intended Use:

The ArConnect® conducting adapter is intended for use with the gi4000

electrosurgery generator during argon assisted coagulation.

The ArConnect® can only be used with the gi4000 generator. In conjunction

with the gi4000, the ArConnect® can be used with standard disposable argon

coagulation probes such as the Erbe 20132-156.

NOTE: Based on test results, the ArConnect® meets all applicable requirements

of IEC 60601-2-2 to support a high-frequency rating of 4kVp.

CONSTRUCTION

Design: The single use ArConnect® has been designed to allow the delivery of

monopolar high frequency electrosurgical energy and argon gas to a single use

argon coagulation probe sold separately. Designed for use only with the gi4000

generator with positive pressure gas control to prevent fluid contamination of the

generator.

SIGNAL WORDS

The following signal words are used throughout this insert:

Warning:

Indicates a potentially hazardous situation which, if not

avoided, could result in death or serious injury.

Caution:

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.

00732484 Rev. A Page 3 of 6

Warnings:

• This device has been validated and is warranted for single use only.

Any re-use or reprocessing could destabilize the design structure

of the device, which could result in device failure, which in turn

could result in patient and/or injury, illness, or death. Also, any re-

use or reprocessing could create the risk of cross-contamination of

the device, which could result in patient infection or cross-infection.

• Potential adverse effects of argon coagulation therapy include, but

are not limited to: risk of perforation, hemorrhage, thermal burns

and explosion.

• The user must thoroughly understand the technical principles,

clinical techniques and risks associated with the use of high

frequency electrosurgical energy and argon coagulation in general

and the characteristics of the gi4000 and the chosen argon

coagulation probe before using this product.

Cautions:

• Only the user can evaluate the clinical factors involved with each

patient to determine if the use of this device is indicated. The user

must then decide on the specific technique and procedure that will

best accomplish the desired clinical effect. Do not use this device

for any purpose other than the stated indication for use.

CONTRAINDICATIONS:

Argon coagulation therapy, and therefore this device, must never be used in the

treatment of patients with the following:

• Massive active hemorrhage requiring open surgical intervention

• Esophageal or gastric varices

• Any indication of free peritoneal air

• Inadequately visualized bleeding sites

• Inadequate colon preparation

INSTRUCTIONS FOR USE

• Remove the device from the package and handle with clean technique.

• Save the product number for future reference.

• Inspect for any functional abnormality and ensure that insulation is intact. If

any irregularities are noted, call STERIS Endoscopy for a return

authorization number.

00732484 Rev. A Page 4 of 6

• Apply grounding pad to patient according to your facility’s protocol and

manufacturer’s recommendation and attach ArConnect® to the gi4000

electrosurgical generator at the picture matched compatible connector port.

• Attach a compatible single use argon coagulation probe of choice.

• Proceed with the argon coagulation procedure per facility protocol.

• When treatment is complete, carefully withdraw the argon coagulation probe

from the endoscope and disconnect the ArConnect® from the gi4000 by

depressing the thumb tab and pulling the device toward you.

• Dispose of both of the used devices according to your healthcare facility’s

disposable instrument protocol.

Product Disposal:

Consumables: 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 the manufacturer.

US Endoscopy, a wholly owned subsidiary of STERIS Corporation.

Made in Taiwan.

00732484 Rev. A Page 5 of 6

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

5.1.3

Date of

Manufacture

Indicates the date when the

medical device was

manufactured

5.1.5

Batch Code

Indicates the manufacturer’s

batch code

5.1.6

Catalog Number Indicates the manufacturer’s

catalogue number

5.2.7

Non-Sterile

Indicates a medical device that

has not been sterilized

5.2.8

Do not use if

package is

damaged

Do not use if the product sterile

barrier system or its packaging is

compromised.

5.3.4

Keep dry

Indicates a medical device that

needs to be protected from

moisture

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 instructions for use

00732484 Rev. A Page 6 of 6

5.4.4

Caution

Consult instructions for use for

cautionary information

21 CFR

801.109 (b)

(1)

N/A

Rx Only

(U.S.A.)

Caution: Federal law (U.S.A.) restricts this device to sale

or on the order of a physician.

N/A

Unique Device

Identifier

Indicates the unique device

identifier

N/A

Contents

Number of devices/kits within

packaging

Steris Arconnect Argon Probe Connector Operating instructions

Brand: Steris

Model: Arconnect Argon Probe Connector

Type: Operating instructions

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Steris Arconnect Argon Probe Connector Operating instructions

Steris Arconnect Argon Probe Connector Operating instructions

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