apollo endosurgery OverStitch Sx User manual

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)]
KÄYTTÖOHJEET
Svenska sida 83
[Endoskopiskt sutursystem (ESS)]
BRUKSANVISNING
Polski strona 91
[System wziernikowego zakładania szwów (SWZS)]
INSTRUKCJA UŻYTKOWANIA
Čeština strana 99
[Endoskopický šicí systém (ESS)]
NÁVOD K POUŽITÍ
Magyar 107. oldal
[Endoszkópos varrógéprendszer (EVR)]
HASZNÁLATI ÚTMUTATÓ
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)]
NÁVOD 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

3
Table of Symbols
Single use only. Disposable. Do not resterilize. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Patent Pending.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, ON THE APOLLO ENDOSURGERY, INC. PRODUCT(S) DESCRIBED IN THIS PUBLICATION. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, APOLLO
ENDOSURGERY, INC. DISCLAIMS ALL LIABILITY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, REGARDLESS OF WHETHER SUCH LIABILITY
IS BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY OR OTHERWISE. THE SOLE AND ENTIRE MAXIMUM LIABILITY OF APOLLO
ENDOSURGERY, INC., FOR ANY REASON, AND BUYER’S SOLE AND EXCLUSIVE REMEDY FOR ANY CAUSE WHATSOEVER, SHALL BE LIMITEDTO THE AMOUNT PAID BY THE
CUSTOMER FOR THE PARTICULAR ITEMS PURCHASED. NO PERSON HASTHE AUTHORITYTO BIND APOLLO ENDOSURGERY, INC. TO ANY REPRESENTATION OR WARRANTY
EXCEPT AS SPECIFICALLY SET FORTH HEREIN. DESCRIPTIONS OR SPECIFICATIONS IN APOLLO ENDOSURGERY, INC PRINTED MATTER, INCLUDINGTHIS PUBLICATION, ARE
MEANT SOLELYTO GENERALLY DESCRIBETHE PRODUCT ATTHETIME OF MANUFACTURE AND DO NOT CONSTITUTE ANY EXPRESS WARRANTIES OR RECOMMENDATIONS
FOR USE OF THE PRODUCT IN SPECIFIC CIRCUMSTANCES. APOLLO ENDOSURGERY, INC. EXPRESSLY DISCLAIMS ANY AND ALL LIABILITY, INCLUDING ALL LIABILITY FOR
ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, RESULTING FROM REUSE OF THE PRODUCT.
1. Intended Use
The Apollo Endosurgery OverStitch Sx™ Endoscopic
Suture System (ESS) is intended for endoscopic
placement of suture(s) and approximation of soft
tissue.
1.1 Contraindications
Contraindications include those specific to use of
an endoscopic suturing system, and any endoscopic
procedure, which may include, but not limited to, the
following:
- This system is not for use where endoscopic
techniques are contraindicated.
- This system is not for use with malignant tissue.
1.2 Warnings
- Do not use a device where the integrity of the
sterile packaging has been compromised or if the
device appears damaged.
- Only physicians possessing sufficient skill and
experience in similar or the same techniques should
perform endoscopic procedures.
- Contact of electrosurgical components with other
components may result in injury to the patient and/
or operator as well as damage to the device and/or
endoscope.
- Verify compatibility of endoscope size, endoscopic
instruments and accessories and ensure
performance is not compromised.
- Ensure endoscope is clean, dry, and free of
lubricants prior to device installation.
- OverStitch Sx is recommended to be used in
combination with an overtube having an inner
diameter of at least 16.7 mm
- Ensure that there is sufficient space for the Needle
to open.
- Ensure that the Handle Grip of the Endoscopic
Suturing System is closed and locked, and Actuation
Catheter slack removed, during intubation and
extubation.
- Users should be familiar with surgical procedures
and techniques involving absorbable sutures before
employing Synthetic Absorbable Sutures for wound
closure, as the risk of wound dehiscence may vary
with the site of application and the suture material
used.
- In situations where the operative site poses a risk
of harm to adjacent anatomic structures, use of
endoscopic accessories such as the OverStitch
Tissue Helix is recommended to retract the tissue
intended to be sutured away from these unseen
structures.
- If used to oversew foreign objects, such as staples,
stents, clips or mesh, it is possible for the needle
to become trapped in the foreign body, requiring
surgical intervention.
- Reuse or reprocessing of the OverStitch system
could result in device malfunction or patient
consequences to include:
-Infection or the transmission of disease
-Failure of the handle mechanism causing the
device to become locked on tissue that may
require surgical intervention
-Reduced retention on the endoscope, causing
the device to detach during use that may require
surgical intervention to retrieve
-Reduced retention of the Anchor to the Needle
Body, resulting in an inadvertent Anchor drop
causing procedural delay or requiring subsequent
intervention
-Bending of the Needle Body, preventing the
physician from driving the Needle correctly or
performing the intended procedure
-Failure of the Helix to extend fully, limiting the
ability to acquire tissue and perform intended
procedure
1.3 Precautions
- The System may only be used if purchased from
Apollo Endosurgery, Inc. or one of its authorized
agents.
- With the Endoscopic Suturing System installed, the
endoscope’s effective outer diameter is increased
by approximately 5mm.
1.4 Adverse Events
Possible complications that may result from using the
Endoscopic Suturing System include, but may not be
limited to:
- Pharyngitis / Sore throat
- Nausea and / or Vomiting
- Abdominal pain and / or Bloating
- Hemorrhage
- Hematoma
- Conversion to laparoscopic or open procedure
- Stricture
- Infection / Sepsis
- Pharyngeal, colonic and/or esophageal perforation
- Esophageal, colonic and/or pharyngeal laceration
- Intra-abdominal (hollow or solid) visceral injury
- Aspiration
- Wound dehiscence
- Acute inflammatory tissue reaction
- Death
1.5 Compatibility
- The system is compatible with endoscopes having an
insertion tube and distal diameter between 8.8mm
and 9.8mm, a working length up to 110cm, and
using overtubes having an inner diameter of at least
16.7mm.
- The system is only compatible with the sutures listed
on the first page. The system is not compatible with
other sutures on the market.
Description Symbol
Consult Instructions for Use
Do Not Re-use
Sterilized Using Ethylene Oxide
Reference Number
Description Symbol
Manufacturer
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician
Date of manufacture
Do Not Resterilize
Description Symbol
Use By
Lot Number
Do not use if package is damaged
Authorized Representative in the
European Community

4
2. Packaged System
3. Nomenclature
Needle Driver & Anchor
Exchange
Package 1
Package 2
Package 3 Package 4
Polydioxanone (absorbable) -
VIOLET
Polypropylene (nonabsorbable) -
BLUE
Needle Driver
Endcap
Anchor Exchange
Anchor Release Button
Needle Driver Handle
Suture Assembly
Anchor Body
Suture
Helix Tip
Helix
Helix Handle
Cinch
Cinch Handle
Collar Plug
Suture Loading Loop
Helix
(AVAILABLE SEPARATELY)
Cinch
Suture Assembly
Anchor Receptacle

5
4. Assembly
Prepare Endoscope
WARNING: Endoscope distal end and
insertion tube must be dry and free of any
lubricants prior to device installation. Failure
to do so may cause the device to slip off
endoscope during use.
4.1. Connect endoscope to video processor and light
source to assist device installation.
4.2. Ensure endoscope is straight with wheels locked
prior to device installation.
Prepare Device
4.3. Remove Needle Driver from packaging.
CAUTION: Ensure Endcap is not dropped or
otherwise damaged.
4.4. Close Needle Body.
4.5. From the Actuation Catheter side of the device,
thread the endoscope between Actuation
Catheter and Catheter Sheath.
Secure Handle
4.6. Slide Needle Driver Handle Collar firmly onto
endoscope handle until the channel ports are
positioned near the endoscope channel port.
4.7. Secure by stretching the rubber Handle Strap
around the rear of endoscope and fitting end
back onto attachment peg.
Position Endcap
4.8. Fully insert endoscope distal end through
clear Endcap Strap loops until endoscope face
touches the Overhang Stop feature.
CAUTION: Ensure the Catheter Sheath is not
twisted along the length of the scope.
4.9. Use the monitor to orient the Endcap as desired.
NOTE: Final orientation on monitor may
shift clockwise during assembly and can be
compensated for here.
4.10. Confirm both ends of the Needle Body are
visible on the monitor.
Secure Endcap Straps
4.11. With left thumb placed on the Apollo logo of
Endcap clip, slowly pull Strap 1 until a watertight
seal is achieved.
NOTE:The strap appears clear in colour when
sufficiently tightened.
WARNING: Straps should not be stretched
beyond 3cm (1 inch) of travel as damage may
occur.
WARNING: Do not attempt to twist or re-
position Endcap. Doing so may damage
device or endoscope.
4.12. Repeat for Strap 2.
4.13. To lock the Straps, apply further stretching of
both Straps 1 and 2 to remove any slack and
firmly press the Apollo logo on Clip Hinge until
Hinge Step is fully recessed.
NOTE:The Hinge Step is easier to close whilst
a stretch is applied to both Straps.
Fix Catheter Sheath to Endoscope
CAUTION: Ensure endoscope is flat, straight
and with scope wheels locked.
4.14. Working from the distal end, remove protective
backing from each side of the Sheath Strap and
wrap Strap around endoscope, pressing back
onto itself.
4.15. Work along the length of the Catheter Sheath
and secure remaining 4 Straps.
CAUTION:The endoscope should fit within
the inner surface of the Catheter Sheath
along its length.
CAUTION: Do not overstretch any Sheath
Strap.
WARNING: Ensure the Catheters and Sheath
are flush along the length of the scope.
WARNING: Ensure all Sheath Straps are
adhered to themselves and not misaligned.
An exposed corner may unpeel if force is
applied.