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apollo endosurgery PLY-G02-020-APL - 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

  • E
    erin03Aug 12, 2025
    How to fix apollo endosurgery PLY-G02-020-APL Medical Equipment when the Needle Body will not open?
    • D
      Dylan McmahonAug 12, 2025
      If the Needle Body of your apollo endosurgery Medical Equipment won't open, here are a few things to check: * **Obstruction:** Make sure there's enough space to work, and straighten the endoscope. * **Suture Restriction:** If the Anchor is on the Needle Body, make sure the suture isn't held too close to the handle while opening. * **Sheath/Catheter Issues:** Check the Sheath and Actuation Catheter for any loops or kinks. * **Foreign Body:** If there's a foreign body obstruction, remove the Anchor Exchange.
  • M
    Marilyn PetersonAug 15, 2025
    What to do if apollo endosurgery PLY-G02-020-APL Needle Body will not close?
    • H
      Heather WeaverAug 15, 2025
      If the Needle Body of your apollo endosurgery Medical Equipment won't close, consider the following: * **General Obstruction:** Refer to the solutions for when the Needle Body won't open, as these may also apply. * **Needle Driver Cable Broken:** Deploy the Anchor and Cinch. Advance grasper through endoscope and secure Needle Driver.
  • A
    Amy CookAug 19, 2025
    How to resolve suture entanglement in apollo endosurgery PLY-G02-020-APL?
    • D
      David MorganAug 19, 2025
      If you're experiencing suture entanglement with your apollo endosurgery Medical Equipment: * **Suture out of view:** Close the Needle Driver Handle and move the endoscope back to release the suture. * **Suture behind Tissue Guard:** Slightly close the Needle Body while pulling back the endoscope. * **Suture twisted:** If the suture is twisted, reposition the endoscope and transfer the Anchor between the Needle Body and Anchor Exchange on the opposite side of the suture thread to untwist it.
  • A
    Angela KimAug 25, 2025
    Why won't the Anchor Exchange work on my apollo endosurgery PLY-G02-020-APL?
    • T
      Travis HoltAug 25, 2025
      If the Anchor Exchange isn't working on your apollo endosurgery Medical Equipment, it may be because: * **Anchor Exchange will not install Anchor onto the Needle Body:** Ensure there is sufficient Suture slack and the Suture outside the device is not entangled. * **Anchor Exchange will not release an Anchor:** Ensure there is sufficient Suture slack and the Suture outside the device is not entangled.
  • J
    Jose FrancisAug 27, 2025
    Why is it difficult to pass the installed apollo endosurgery Medical Equipment device through the overtube?
    • D
      Daniel BurgessAug 27, 2025
      If you're having difficulty passing the installed apollo endosurgery Medical Equipment device through the overtube, here are some possible reasons: 1. **Insufficient lubricant:** Make sure to fully lubricate both the device and the inside of the overtube. 2. **Incompatible sizing:** The endoscope and/or overtube sizes might not be compatible. Try exchanging the overtube for a larger size. 3. **Catheters not flat:** Ensure the catheters are lying flat against the scope by maneuvering the scope and device. 4. **Endcap Straps:** Remove endoscope from overtube. Trim Endcap Straps flush with Endcap per Step 4.18.
  • R
    Ryan GarciaAug 31, 2025
    What to do if the Anchor drops unexpectedly from apollo endosurgery PLY-G02-020-APL?
    • J
      jonesbarbaraAug 31, 2025
      If the Anchor drops unexpectedly from your apollo endosurgery Medical Equipment because the Anchor Exchange button was depressed out of sequence, you can either retrieve the Anchor as a foreign body, or follow the procedure to Cinch it in place.
  • R
    renee67Sep 4, 2025
    What if the Cinch doesn't cut the Suture when fired on my apollo endosurgery PLY-G02-020-APL Medical Equipment?
    • S
      Sandra CollierSep 4, 2025
      If the Cinch on your apollo endosurgery Medical Equipment fails to cut the Suture when fired, use a suitable accessory through the device secondary channel or endoscope working channel to cut the Suture and remove the Cinch.
  • P
    Paige MarshallSep 7, 2025
    How to troubleshoot when the Helix does not unscrew in apollo endosurgery Medical Equipment?
    • L
      lisa57Sep 7, 2025
      If the Helix on your apollo endosurgery Medical Equipment doesn't unscrew because it's stuck in tissue, use a suitable accessory through the device primary channel or endoscope working channel to apply counter traction to the tissue around the Helix, and pull the Helix free.

Summary

Intended Use and Warnings

Intended Use

Specifies the purpose of the Apollo Endosurgery OverStitch Sx™ Endoscopic Suture System for tissue approximation.

Warnings

Highlights critical safety considerations for device integrity, physician skill, and potential interactions with electrosurgical components.

Navigating and Operating the System

Suturing Process

Detailed steps for driving the needle, retrieving the anchor, and managing tissue during suturing.

Securing and Cutting Suture

Steps for approximating tissue, securing the suture with a cinch, and cutting the suture.

MRI Information and Troubleshooting

Troubleshooting: Needle Body Issues

Addresses problems with the Needle Body not opening or closing and provides resolutions.

Troubleshooting: Anchor Exchange

Solutions for issues related to the Anchor Exchange not installing or releasing anchors.

apollo endosurgery PLY-G02-020-APL Specifications

General IconGeneral
Model NumberPLY-G02-020-APL
Device TypeEndoscopic Suturing System
SterilitySterile
Single UseYes
ManufacturerApollo Endosurgery
CompatibilityCompatible with endoscopes having a working channel of 2.8mm or larger
Intended UseEndoscopic suturing for tissue approximation and fixation in the gastrointestinal tract

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