TeDan Surgical Innovations
Phantom Series GS-1000 User Guide Rev 01 2022
User Guide
37 Pages
Preview
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TeDan Surgical Innovations, Inc. 12320 Cardinal Meadow Dr. Suite 150 Sugar Land, TX 77478 USA P: 713-726-0886 F: 713-726-0846 [email protected]
TeDan Surgical Innovations, B.V. Kantstraat 19 NL-5076 NP Haaren The Netherlands P: +31 (411) 623791 (EU) [email protected]
QNET CH-REP GmbH Im Büel 15, 8750 Glarus, Schweiz Postfach 1558, 8750 Glarus, Schweiz [email protected]
QNET LTD. Livingston House 309 Harrow Road Wembley, Middlesex HA9 6BD (UK) [email protected]
Refer to the accompanying TeDan Surgical Innovations (TSI) Surgical Access Systems Instructions for Use for TSI’s non-sterile, reusable and single-use surgical access instruments. Informationen zu den unsterilen, wiederverwendbaren Einweginstrumenten zum chirurgischen Zugang von TSI finden Sie in der beiliegenden Gebrauchsanweisung für chirurgische Zugangssysteme von TeDan Surgical Innovations (TSI). Raadpleeg de bijbehorende gebruiksaanwijzing voor chirurgische toegangssystemen van TeDan Surgical Innovations (TSI) voor de niet-steriele, herbruikbare en eenmalige chirurgische toegangsinstrumenten van TSI. Consulte as Instruções de Utilização dos Sistemas de Acesso Cirúrgico TeDan Surgical Innovations (TSI) para instrumentos de acesso cirúrgico não esterilizados, reutilizáveis e de utilização única da TSI. Consulte las Instrucciones de uso de los sistemas de acceso quirúrgico de TeDan Surgical Innovations (TSI) para los instrumentos de acceso quirúrgico sin esterilizar, reutilizables y de un solo uso de TSI. Fare riferimento alle istruzioni per l’uso dei sistemi di accesso chirurgico TeDan Surgical Innovations (TSI) allegate per gli strumenti di accesso chirurgico non sterili, riutilizzabili e monouso di TSI. Reportez-vous aux modes d’emploi des systèmes d’accès chirurgicaux TeDan Surgical Innovations (TSI) pour les instruments d’accès chirurgicaux non stériles, réutilisables et à usage unique de TSI.
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Phantom General Surgery Access System Setup Arm Assembly: •
Loosen knob of Rotating Table Clamp (ML-0021). Attach table clamp to the surgical rail over the sterile drape by the top and bottom jaws. Tighten knob to secure clamp at the desired location. Using the same method, attach the second rotating table clamp to the opposite side of the table. Note: Table clamps should be positioned so that one table clamp is positioned as far caudally while the other is positioned as far cranially as possible while still allowing the arm clamp to attach to the ring.
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Insert an Articulating Arm (AL0110) into each of the Rotating Table Clamps. Position the Articulating Arm and Table Clamp so that they are angled as low as possible and will not impede the surgeon’s movement (Figure One). Note: When loosening, do not force the knob of the articulating arm past the stop. Doing so could damage the ball joint and affect the rigidity of the articulating arm.
Figure One Rotating Table Clamp and Articulating Arms attached to operating table
Retractor Ring Assembly: •
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Clear enough space on a flat surface for assembly of the Retractor Ring (AL-0100). Each of the following Retractor Ring steps must be conducted on a flat surface to ensure that the screws and forks are properly aligned. The Retractor Ring consists of two ring segments. To loosen the screws, ENGLISH
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turn the screws counterclockwise no more than two times on each ring segment using the Hex Tool (ML-0505). Assemble the Retractor Ring by pushing the two segments together. Note: Connection points of the Retractor Ring should be brought to edge of flat surface to provide clearance for Hex Tool during assembly.
With the Hex Tool, tighten each screw on the Retractor Ring to secure the assembly (Figure Two & Figure Three).
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Note: To prevent damage to the screws and forks on the connection points of the Retractor Ring, pull rings directly apart. Do not cant or twist the rings.
Figure Two Hex Tool tightening Retractor Ring assembly Note: Do not force the screw past the stop. Excessive force may damage the assembly mechanism. SEN LOO P T STO
S TO PAS TIME CE N2 FOR TUR NOT DO
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ATTACH RIGID ARM HERE
TSI
A US L-0 A 100 MM
YY
Retractor Ring to Articulating Arms Assembly:
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US -010 A MM 0
ARM HERE
TSI AL
ATTACH RIGID
Note: If a larger frame is desired, Phantom Extension Bars (AL-0101) may be attached to the Ring Segments (AL-0100) to create an ovular retractor ring.
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EN LOOS STOP S TO 2 TIME E PAST TURN FORC NOT DO
Using the Hex Wrench (AL-0106), unscrew the ring attachment of both Articulating Arms. Insert the Retractor Ring into the clamps and tighten the clamps around the ring where marked “Attach Rigid Arm Here” (Figure Four). Adjust the Articulating Arms to position the Retractor Ring in accordance with the markings that indicate the Caudal and Cephalic direction. To prevent movement of the Retractor Ring, ensure that the knob of the Articulating Arms are completely tightened.
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Figure Three Retractor Ring Assembly
Figure Four Hex Wrench tightening the ring attachment around the Retractor Ring Note: Ensure the hex wrench and screw are aligned with the threaded hole. Attempting to insert the screw at an angle may cause cross-threading. ENGLISH
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Blade to Blade Holder Assembly: •
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Retractor blades have a “dual fixation” connection which allows the blade to remain fixed or to rotate. To attach the Retractor Blade to the Retractor Blade Holder (AL-0105), insert the blade through the blade holder connection so that the first pin in the connector can pass through the groove in the blade holder. When the first pin is engaged with the Blade Holder, the Retractor Blade is attached and able to rotate. 1st pin If a fixed connection is preferred, the 2nd pin second pin should be aligned with the groove, and the blade pushed upward. When the second pin is engaged in the Blade Holder, the Retractor Blade will remain fixed Figure Five Dual fixation connection (Figure Five).
Ring Clamp to Retractor Ring Assembly and Positioning: •
Ring clamps (AL-0103) attach to any point of the ring. To attach, loosen knob of the Ring Clamp and press the larger of the two openings onto the ring frame; the clamps will snap onto the ring. Press the shaft of the Blade Holder into the smaller opening of the Ring Clamp to attach the two components. The Ring Clamp/Blade Holder Assembly can be freely adjusted until the knob of the clamp is ENGLISH
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tightened. Additional Ring Clamps and Blade Holders may be added to the Retractor Ring as desired. (Figure Six). To angulate the Retractor Blades, use the Hex Wrench to loosen the swivel mechanism on the Blade Holder and manipulate the blade by hand to the desired position. To secure the blade, tighten the swivel mechanism with the Hex Wrench (Figure Seven).
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Figure Six Ring Clamp/Blade Holder Assembly attached to the Retractor Ring
Note: it is only necessary to rotate the mechanism counterclockwise until the swivel mechanism moves freely. To avoid damage to mechanism, do not force screw mechanism past stop.
Lighting System Assembly: Loosen the small blue knob of Light Cable Flex Arm (HS-0305) and position jaws around the segment of either Articulating Arm that is closest to the Retractor Ring. Tighten small blue knob to affix the Light Cable Flex Arm to the Articulating Arm. Insert the bifurcated tips of the Light Cable (ML-0058 or ML-0048) into the light ports located at proximal end of the Light Cable Flex Arm. Ensure that the Light Cable is connected to the LED Light Source (ML-0051) and that the light source is plugged into a power source. Insert the Light Cable into the LED Light Source. Turn on the light source to illuminate the operative site.
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Figure Seven Use Hex Wrench to loosen swivel mechanism
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The Light Cable Flex Arm may be positioned as desired and readjusted as needed. Tighten the large blue knob to lock the arm into position (Figure Eight).
Note: Attaching the light cable flex arm to the ring segment may obstruct the surgeon’s access. For optimal visualization, the Light Cable Flex Arm should be attached onto the Articulating Arm.
Disassembly: • • •
Completely loosen the Articulating Figure Eight Full setup with Light Cable Flex Arm Arm screws, do not over-loosen or force the screws past the stop. Disassemble the Retractor Ring by turning the screws counterclockwise twice with the Hex Tool. It is important that the Retractor Ring is disassembled by pulling the segments directly apart on a flat surface. Note: To prevent damage to the screws and forks on the connection points of the Retractor Ring, pull segments directly apart. Do not cant or twist the rings.
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