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UroSeal
®
adjustable endoscopic valve
Reorder No. 00913410
INSTRUCTIONS FOR USE
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This product is not made with natural rubber latex.
Intended use
:
The single use UroSeal adjustable endoscopic valve is intended to resist the backflow of fluid around an instrument inserted through the working
channel of a ureteroscope or cystoscope.
Device description:
The
UroSeal
®
Adjustable Endoscopic Valve is an endoscopic adapter designed to facilitate the passage of instruments sized up to 9
French in diameter during a procedure. It has a cap feature to allow instruments to be inserted and secured during a procedure. A
clicking mechanism is used to facilitate the open, semi-closed and closed position. The device also has a side arm y-port with a luer cap
to allow for irrigation if needed.
The device must accommodate the size of the instrument to be introduced through the valve. The adjustable size selection is limited to the size
of the internal working channel of the endoscope.
Warnings and Precautions:
•
Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic
techniques.
•
Consult the medical literature relative to techniques, complications and hazards prior to the performance of any endoscopic
procedure.
•
Exposure to body fluids may occur during connection or disconnection of these devices; adherence to body substance isolation
protocol is the responsibility of the user.
•
This device has been designed to work optimally with luer connector geometry. Other geometries may not have optimal performance
characteristics.
•
Do not attempt to reuse, reprocess, refurbish, remanufacture or resterilize this device. STERIS Endoscopy did not design this device,
nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this disposable
medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).
Prior to Use:
1. Prior to clinical use, inspect and familiarize yourself with the device and read the entire Instructions for use.
If there is
evidence
of damage (i.e. cracked, damaged packaging), or the device is not functioning properly, do not use this
product and contact your local Product Specialist.
Directions for Use:
1.
Use sterile technique to open the
UroSeal
®
adjustable endoscopic valve and place onto the sterile field.
2.
Securely place the
UroSeal
®
adjustable endoscopic valve onto the biopsy channel opening of the endoscope.
3.
Twist the
UroSeal
®
adjustable endoscopic valve at the biopsy port to make a secure attachment.
4.
Prior to removal of the valve, close the stopcock or roller clamp on the IV tubing to stop the flow of fluid.
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: June 2021
Warning:
An issued or revision date for these instructions is included for the user’s information. In the event that two years have 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 and competent authority in
the country where the incident occurred.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation.
Made in the U.S.A.
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Explanation of symbols used on Labels and Instructions for Use
Explication des symboles utilisés sur les étiquettes et dans le Mode d’emploi
Erläuterung der auf den Etiketten und in der Gebrauchsanleitung verwendeten Symbole
Spiegazione dei simboli usati sulle etichette e Istruzioni per l’uso
Explicación de los símbolos utilizados en las etiquetas y las instrucciones de uso
Explicação dos símbolos utilizados nas Etiquetas e Instruções de Utilização
Forklaring af symboler, der er anvendt på etiketter og brugsanvisning
Verklaring van de symbolen die in de gebruiksaanwijzing en op de etiketten worden gebruikt
Etiketlerde ve Kullanım Talimatlarında kullanılan sembollerin açıklaması
라벨과 사용 설명서의 기호 안내
Разъяснение символов, приведенных на этикетках и в инструкции по эксплуатации
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
5.1.4
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
5.2.6
Do Not Resterilize
Indicates a medical device that is not to be resterilized
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
5.3.1
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
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5.4.3
Consult instructions for use
Indicates the need for the user to consult instructions for use
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
N/A
Unique Device Identifier
Indicates the unique device identifier
N/A
N/A
Medical Device
Indicates the product is a medical device
N/A
N/A
Contents
Number of devices/kits within packaging
/
