apollo endosurgery OverStitch ESS-G02-160 User Manual

SINGLE PATIENT USE
DISPOSABLE
Caution:
Please read all instructions prior to use
GRF-00002-00R20
OverStitch™ Endoscopic Suturing System ESS-G02-160
OverStitch™ 2-0 Polydioxanone Suture PDO-G02-020
OverStitch™ 2-0 Polypropylene Suture PLY-G02-020
OverStitch™ 2-0 Polypropylene Suture PLY-G02-020-A
OverStitch™ 2-0 Polypropylene Suture PLY-G02-020-APL
OverStitch™ Suture Cinch CNH-G01-000
Tissue Helix THX-165-028
Product Code:
Dening the Future
of Endoscopic Surgery
™
OverStitch™
English page 2
[Endoscopic Suturing System] (ESS)
INSTRUCTIONS FOR USE
Español página 8
[Sistema de sutura endoscópica]
INSTRUCCIONES DE USO
Deutsch Seite 14
[Endoskopisches Nahtsystem]
GEBRAUCHSANWEISUNG
Français page 20
[Système de suture endoscopique]
MODE D’EMPLOI
Italiano pagina 26
[Sistema di sutura endscopica]
ISTRUZIONI PER L’USO
Português página 32
[Sistema de sutura endoscópica]
INSTRUÇÕES DE UTILIZAÇÃO
Nederlands pagina 38
[Endoscopisch hechtsysteem]
GEBRUIKSAANWIJZING
Dansk
side 44
[Endoskopisk sutureringssystem]
BRUGSANVISNING
Norsk
side 50
[Endoskopisk sutureringssystem]
BRUKSANVISNING
Suomi sivu 56
[Endoskooppinen ommeljärjestelmä]
KÄYTTÖOHJEET
Svenska sidan 62
[Endoskopiskt sutureringssystem]
BRUKSANVISNING
Polski
strona 68
[System do wziernikowego zakładania szwów]
INSTRUKCJA UŻYCIA
Čeština
strana 74
[Endoskopický šicí systém]
NÁVOD K POUŽITÍ
Magyar
oldal 80
[Endoszkópos varrógéprendszer]
HASZNÁLATI ÚTMUTATÓ
български страница 86
[Ендоскопска система за хирургични шевове]
ИНСТРУКЦИИ ЗА УПОТРЕБА
Eesti
lk 92
[Endoskoopiline õmblussüsteem]
KASUTUSJUHEND
Srpski
strana 98
[Sistem za endoskopsko ušivanje]
UPUTSTVO ZA UPOTREBU
Slovenčina strana 104
[Endoskopický šijací systém]
NÁVOD NA POUŽITIE
Slovenščina stran 110
[Endoskopski sistem za šivanje]
NAVODILA ZA UPORABO
Română
pagina 116
[Sistem de sutură endoscopică] (SSE)
INSTRUCȚIUNI DE UTILIZARE
Українська сторінка 122
[Система накладання
ендоскопічного шва]
ІНСТРУКЦІЯ З ВИКОРИСТАННЯ
Ελληνικά σελίδα 128
[Σύστημα ενδοσκοπικής συρραφής]
ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
Türkçe
sayfa 134
[Endoskopik Sütür Sistemi]
KULLANMA TALİMATI
140  
[   ]
 
Bahasa Indonesia halaman 146
[Endoscopic Suture System]
(ESS/Sistem Jahitan Endoskopi)
PETUNJUK PENGGUNAAN

apollo endosurgery OverStitch ESS-G02-160 Specifications

General

Brand	apollo endosurgery
Model	OverStitch ESS-G02-160
Category	Medical Equipment
Language	English

Summary

Disclaimer of Warranty and Limitation of Remedy

Intended Use and Safety Information

Contraindications and Adverse Events

Lists conditions where the system should not be used and potential complications.

Warnings and Precautions

Highlights critical safety precautions, physician skill requirements, and usage advisories.

System Compatibility

Details compatible sutures and endoscope models for optimal system performance.

Packaged System Components

Device Nomenclature

Assembly and Preparation

Initial Setup and Anchor Loading

Steps for preparing the endoscope, Needle Driver, loading the anchor, and connecting to the Tower.

Procedural Steps

Navigating Anatomy and Tissue Management

Guidance on advancing the device, locating anatomy, and positioning tissue for suturing.

Tissue Helix Usage

Instructions for advancing the Helix, acquiring tissue, and positioning it for suturing.

Suturing and Securing Suture

Driving Needle, Retrieving Anchor, Releasing Tissue

Steps for driving the needle through tissue, retrieving, and releasing the anchor and tissue.

Securing and Cutting Suture

Instructions for deploying the cinch to secure the suture and cutting the excess.

Multiple Sutures

Using Multiple Anchors and Sutures

Guidance on reusing the anchor exchange and needle driver for additional sutures.

Device Removal

Endoscope and Accessory Removal

Steps for removing accessory devices, closing the Needle Body, and retracting the endoscope.

Safety and Information

MRI Safety and Hazardous Substances

Information on MRI safety compliance and hazardous substance content within the device.

Troubleshooting Common Issues

Needle Body and Anchor Exchange Problems

Solutions for issues related to the Needle Body not opening/closing and Anchor Exchange failures.