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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

  • D
    Daniel LoweAug 12, 2025
    How to fix apollo endosurgery THX-165-028 Medical Equipment when the Needle Body will not open?
    • G
      Gina BrownAug 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.
  • A
    Aaron LongAug 16, 2025
    What to do if apollo endosurgery THX-165-028 Medical Equipment Needle Body will not close?
    • A
      Alejandro RossAug 16, 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.
  • M
    Michael LeeAug 19, 2025
    How to resolve suture entanglement in apollo endosurgery THX-165-028?
    • K
      Kevin McguireAug 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.
  • F
    fcolemanAug 23, 2025
    Why won't the Anchor Exchange work on my apollo endosurgery THX-165-028?
    • W
      wbaileyAug 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.
  • L
    lucaswoodsAug 27, 2025
    Why is it difficult to pass the installed apollo endosurgery Medical Equipment device through the overtube?
    • S
      Scott JonesAug 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.
  • K
    katelynleeAug 30, 2025
    What to do if the Anchor drops unexpectedly from apollo endosurgery THX-165-028 Medical Equipment?
    • M
      Maria RichardsonAug 30, 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.
  • J
    James SmithSep 3, 2025
    What if the Cinch doesn't cut the Suture when fired on my apollo endosurgery THX-165-028?
    • L
      Lindsey PollardSep 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.
  • E
    erik89Sep 7, 2025
    How to troubleshoot when the Helix does not unscrew in apollo endosurgery THX-165-028?
    • P
      Patrick ClarkSep 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

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

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

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