Набор инструментов для витреоретинальной хирургии: универсальный комплект управления вязкой жидкости / Universal Viscous Fluid Control Pack (BL7600)
国: ベラルーシ
言語: ロシア語
ソース: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
製品の特徴
(SPC)
16-02-2022
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から入手可能:
Synergetics, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
クラス:
изделия медицинского назначения
製:
Synergetics
承認日:
2022-02-18
製品の特徴
Page 1 of 15
BL7600
Universal Viscous Fluid Control Pack
EN
Pacchetto universale per fluido viscoso
IT
Universal Viscous Fluid Control Pack
DE
Pack de contrôle de liquide visqueux universel
FR
Pack Universal de Control de Fluidos Viscosos
ES
Pacote Universal de Controle de Fluido Viscoso
PT
Универсальный
комплект
управления
вязкой
жидкости
RU
Bausch & Lomb GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Germany
Synergetics, Inc., 3845 Corporate Centre Drive, O’Fallon, MO USA
63368-8678 Tel: (800) 338-2020
©2019 Synergetics, Inc.
55203983 rev D (07/2019)
Page 2 of 15
ENGLISH
The Synergetics
®
Universal Viscous Fluid Control Pack (BL7600) is to be used for
posterior segment sugery with the Bausch + Lomb
Stellaris
®
PC or Stellaris Elite™, Alcon CONSTELLATION
®
or DORC EVA
®
.
This device is for use by those trained in the use of ophthalmic
surgical instrument systems. This would include surgical
applications, appropriate surgical use, contraindications, etc.
INDICATIONS FOR USE:
The Synergetics
®
Universal Viscous Fluid Control Pack is indidcated for the controlled
injection or extraction of viscuous fluids during
vitreoretinal surgery.
CONTRAINDICATIONS:
•
Re-use and/or re-sterilization of this product by the customer. Re-use
and/or re-sterilization can lead to patient cross
contamination and significantly reduced device performance.
•
Repair of damaged product by the customer.
•
Use of this product if package integrity has been breached or
compromised.
KNOWN COMPLICATIONS:
•
Inflammation
•
Retinal Detachment
•
Proliferative Vitreoretinopathy
•
Infection
•
Cataract formation or progression
•
Glaucoma
•
Keratopathy
•
Ocular hypertension
•
Ocular hypotony
Appearance of these complications is statistically rare. It is assumed
that the user is adequately trained in the treatment of these
known complications, as well as methods of avoidance.
Synergetics, Inc. excludes all warranties, whether expressed, implied,
or otherwise, to matters bey
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