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apollo endosurgery THX-165-028 User Manual

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SINGLE PATIENT USE
DISPOSABLE
Caution:
Please read all instructions prior to use
GRF-00400-00R05
OverStitch Sx™ Endoscopic Suturing System ESS-G02-Sx1
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:
OverStitch Sx
English page 3
[Endoscopic Suturing System (ESS)]
INSTRUCTIONS FOR USE
Español página 11
[Sistema de sutura endoscópico (SSE)]
INSTRUCCIONES DE USO
Deutsch Seite 19
(Endoskopisches Nahtsystem [ENS])
GEBRAUCHSANWEISUNG
Français page 27
(Système de suture endoscopique [SSE])
MODE D’EMPLOI
Italiano pagina 35
[Sistema di sutura endoscopica (SSE)]
ISTRUZIONI PER L’USO
Português página 43
[Sistema de sutura endoscópica (SSE)]
INSTRUÇÕES DE UTILIZAÇÃO
Nederlands pagina 51
[Endoscopisch hechtsysteem (EHS)]
GEBRUIKSAANWIJZING
Dansk side 59
[Endoskopisk sutureringssystem (ESS)]
BRUGSANVISNING
Norsk side 67
[Endoskopisk sutureringssystem (ESS)]
BRUKSANVISNING
Suomi sivu 75
[Endoskooppinen ommeljärjestelmä (EO)]
YTTÖOHJEET
Svenska sida 83
[Endoskopiskt sutursystem (ESS)]
BRUKSANVISNING
Polski strona 91
[System wziernikowego zakładania szwów (SWZS)]
INSTRUKCJA UŻYTKOWANIA
Čeština strana 99
[Endoskopický šicí systém (ESS)]
VOD K POUŽITÍ
Magyar 107. oldal
[Endoszkópos varrógéprendszer (EVR)]
HASZNÁLATI ÚTMUTA
Български страница 115
[Ендоскопска система за хирургични шевове (ESS)]
ИНСТРУКЦИИ ЗА УПОТРЕБА
Eesti lk 123
[Endoskoopiline õmblussüsteem (EÕS)]
KASUTUSJUHISED
Srpski strana 131
[Sistem za endoskopsko ušivanje (SEU)]
UPUTSTVO ZA UPOTREBU
Slovenščina stran 147
[Endoskopski sistem za šivanje (ESŠ)]
NAVODILA ZA UPORABO
Slovenčina strana 139
[Endoskopický šijací systém (ESS)]
VOD NA POUŽITIE
Українська стор. 163
[Система накладання ендоскопічного шва (СЕШ)]
ІНСТРУКЦІЯ З ВИКОРИСТАННЯ
Ελληνικά σελίδα 171
[Σύστημα ενδοσκοπικής συρραφής (ΣΕΣ)]
ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
Türkçe sayfa 179
[Endoskopik Sütür Sistemi (ESS)]
KULLANMA TALİMATI
187  
[(ESS)
   ]
 
Română pagina 155
[Sistem endoscopic de suturare (ESS)]
INSTRUCȚIUNI DE UTILIZARE

Questions and Answers:

apollo endosurgery THX-165-028 Specifications

General IconGeneral
CategoryMedical Equipment
Model NumberTHX-165-028
ManufacturerApollo Endosurgery
Compatible Endoscope Channel Size2.8 mm
SterilitySterile
Single UseYes

Summary

Intended Use

Contraindications

Lists situations where the system should not be used.

Warnings

Details critical safety precautions and potential risks during use.

Precautions

Outlines important steps to take before and during use.

Adverse Events

Lists potential adverse events that may occur with system use.

Assembly

Prepare Endoscope

Instructions on preparing the endoscope before device installation.

Prepare Device

Steps for preparing the OverStitch Sx™™ device.

Fix Catheter Sheath to Endoscope

Instructions on securing the catheter sheath to the endoscope.

Load Anchor

Instructions for loading the anchor onto the anchor exchange.

Navigating to target anatomy

Steps for advancing the device to the target area.

Suturing

Open Needle Body

How to open the needle body of the device.

Drive Needle through tissue

Steps for driving the needle through the target tissue.

Securing and Cutting Suture

Pull the Suture and apply counter traction to the Cinch

Tightening the cinch to approximate tissue.

Firmly squeeze Cinch Handle to deploy Cinch and cut Suture

Deploying the cinch and cutting the suture.

Multiple Sutures

Removal of Device

Troubleshooting

Needle Body will not open

Resolutions for issues where the needle body fails to open.

Needle Body will not close

Resolutions for issues where the needle body fails to close.

Anchor Exchange will not exchange

Troubleshooting for anchor exchange installation or release failures.

Cinch does not cut the Suture when fired

Inadvertent drop of Anchor

Suture entanglement

Endcap detachment from endoscope

Helix does not unscrew

Endcap Strap end is not seated in Endcap prior to cutting Endcap Strap Tails

Difficulty passing installed device through overtube

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