Инструментарий и принадлежности хирургические: система глубокой ретракции мошонки SKW/SKW Deep Scrotal Retraction System

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

CooperSurgical Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

CooperSurgical Inc.

Дата Авторизация:

2020-11-11

Характеристики продукта

SKW RETRACTOR
SYSTEM
INSTRUCTIONS FOR USE
(ENGLISH)
NOTICE D’UTILISATION
(FRANÇAIS/FRENCH)
GEBRAUCHSANWEISUNG
(DEUTSCH/GERMAN)
ISTRUZIONI PER L’USO
(ITALIANO/ITALIAN)
INSTRUCCIONES DE USO
(ESPAÑOL/SPANISH)
INSTRUÇÕES DE UTILIZAÇÃO
(PORTUGUÊS/PORTUGUESE)
ИНСТРУКЦИЯ ПО ПРИМЕНЕНИЮ
(
РУССКИЙ, RUSSIAN)
WC 92515072 - Attachment 3 SKW DFU
Page 1 of 24
2
SKW RETRACTOR SYSTEM • INSTRUCTIONS FOR USE • ENGLISH
DEVICE DESCRIPTION/INTENDED USE
The SKW Retractor System is a single-use, disposable device that is
used to retract tissue from the surgical site. It is designed for use
with an
inflatable penile prosthesis (penoscrotal approach), or an artificial
urinary
sphincter (transverse scrotal approach).
SKW RETRACTOR SYSTEM COMPONENTS
•
1 Retractor Ring
•
1 Penile Strap
•
2 Baby Deavers
•
1 Catheter Clip
•
Set of Hooks:
- 7 Yellow, 12-mm Blunt Stay Hooks (3 Extra)
- 1 Green, 5-mm Sharp Stay Hook
- 2 Spira Three-Finger Hooks
INDICATIONS FOR USE
The SKW Retractor System is indicated for use to provide incision
retraction
and to aid in visualization during surgical procedures.
CONTRAINDICATIONS
There are no known contraindications associated with the use of this
device.
WARNINGS
•
Do not use if sterile barrier is damaged.
•
Do not use if the device has been opened or damaged.
•
For single use only. Do not reuse, reprocess or re-sterilize. Reuse,
reprocessing or re-sterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing
or re-sterilization may create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or
death of the patient.
•
Dispose of in accordance with all applicable Federal, State and local
Medical Hazardous waste practices.
R
X ONLY
WC 92490333 -