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Buffalo Filter PlumePen Elite Handbuch

Chirurgischer rauchabzugsstift

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BUFFALO FILTER
PlumePen
Surgical Smoke Evacuation Pencil
Figure 1.
Open product packaging and remove the
PlumePen
Elite Surgical Plume Evacuation
®
Pencil assembly. Connect the tubing provided
with the PlumePen
Elite to a smoke evacuation
®
system or other appropriate vacuum source;
example shown, (Figure 1). For connection and
operation to a specific smoke evacuation system,
please refer to the specific instructions for use for
appropriate setup and use.
Figure 4.
The PlumePen
Elite is equipped with several key features for the
®
surgeon's convenience. Above the electrode blade is a translucent
plastic tube that can be positioned at varying lengths, (Figure 4) to
most effectively capture surgical smoke plume as it is created.
With the electrosurgical generator off and the electrode blade
cool, position this tube as near the point of the tissue interaction
as possible without obstructing the view of the target tissue.
Keep the active electrodes clean. Build-up of eschar may reduce
the instrument's effectiveness. Do not activate the instrument
while cleaning. Injury to operating room personnel may result.
CAUTION:
Intended for use with a maximum voltage of 10kV P-P.
DO NOT USE in patients who have electronic implants such as cardiac
pacemakers without first consulting a qualified professional (e.g.,
cardiologist). A possible hazard exists because interference with the action
of the electronic implant may occur, or the implant may be damaged.
INSPECT instruments and cables for damage prior to each use, especially
the insulation of laparoscopic/endoscopic instruments. This may be done
visually under magnification or with a high voltage insulation testing device. Insulation
failures may result in burns or other injuries to the patient or operator.
Sterility unless packaging is damaged or any seal is broken. Do not use electrosurgery
in the presence of flammable anesthetics or other flammable gases, fluids, or objects,
or in the presence of oxidizing agents, as fire may result. Place active accessories in a
holster or in a clean, dry, non-conductive and highly visible area away from the patient
when not in use. Inadvertent contact with the patient may result in burns. Contact with
drapes or linens may cause a fire.
DO NOT activate the instrument when not in contact with target tissue, as this may cause
injuries due to capacitive coupling.
PlumePen
Elite is designed and intended only to be used with an electrosurgical
®
generator that has been tested to the IEC 60601 standard. Please refer to generator to
ensure compatibility. PlumePen
Elite is not a fluid removal device, therefore, it should
®
not be used for such application.
ASPIRATE fluid from the area before activating the instrument. Conductive fluids
Buffalo Filter LLC
5900 Genesee Street, Lancaster, NY 14086
U.S. toll-free 800.343.2324 . International: +1 716.835.7000 . Fax: +1 716.835.3414
Email: bf.smoke.info@filtrationgroup.com . www.buffalofilter.com
904162 RevE - 08/16/2017
Elite
®
Figure 2.
Prior to connecting the PlumePen
power cord to the electro-surgical generator,
ensure that the electrode blade (provided) is fully
inserted into the pencil by gently pressing it in
front of the PlumePen
Elite. Remove the plastic
®
shield from the blade and discard.
Figure 5.
The PlumePen
COAG buttons located on the top of the
electrosurgical pencil body. The YELLOW
button is for cutting and the BLUE button is
for coagulation, (Figure 5).
After use, turn off smoke evacuation unit and
electrosurgical generator. Discard the entire
PlumePen
Tubing, and Power Cord) per facility protocol
for contaminated items.
Intended Use: The PlumePen
Elite is designed for general
®
electrosurgical applications, including cutting and coagulation, and for removing
smoke generated by electrosurgery when used in conjunction with an effective
smoke evacuation system. The pencil enables the operator to remotely conduct
an electrosurgical current from the output connector of an electrosurgical unit to the
operative site for the desired surgical effect to remove tissues and control bleeding by
means of high-frequency electrical current.
Indications for Use for the PlumePen
include:
a. To remove smoke plume from the surgical site.
b. To remotely conduct an electrosurgical current from the output connector of an
electrosurgical unit to the target tissue for the desired surgical effect.
Figure 3.
Elite 3-prong
Plug the 3-prong power cord into the electrosurgical generator
®
of your choice, (Figure 3). Confirm that all power settings on the
generator are appropriate for the procedure being performed. The
electrosurgical generator's intensity should be set as low as is
necessary to achieve the desired effect. The PlumePen
monopolar electrode, the use of a dispersive electrode is required
to prevent burns/injury to patient. Please refer to electrosurgical
generator user manual and dispersive electrode instructions for
use for additional instructions.
Elite has CUT and
®
Elite assembly (Pencil, Blade,
®
(e.g., blood or saline) in direct contact with or in close proximity to an active electrode
may carry electrical current or heat away from target tissues, which may cause
unintended burns to the patient.
Buffalo Filter recommends that the original blade be utilized with the PlumePen Elite.
If original blade is removed, visually confirm new blade is completely inserted and
secured before activating the pencil. Never force the blade into the pencil. Rotate the
pencil if the smoke tube is obstructing view of the insertion point.
For procedures where visualization may be impaired, be alert of these potential hazards:
The electrode tip may remain hot enough to cause burns after the current has been
de-activated.
Inadvertent activation or movement of the activated electrode outside of the field of
vision may result in injury to the patient.
Localized burns to the patient or physician may result from electrical currents carried
through conductive objects. Current may be generated in conductive objects by direct
contact with the active electrode, or by the active accessory being in close proximity
to the conductive object.
For single use only. Do not reuse, reprocess, or re-sterilize. Reuse, reprocessing, or
re-sterilization may compromise the structural integrity of the device and/or lead to device
failure which in turn may result in patient injury, illness, or death.
This single-use product is not designed or validated to be reused. Reuse may cause a risk
of cross-contamination or cause a malfunction as a result of the product being physically
damaged due to cleaning, disinfection, re-sterilization, or reuse.
Not Made with
Natural Rubber Latex
Consult Regulatory Symbol Glossary at www.buffalofilter.com
Elite Integrated Smoke Evacuation Pencil
®
Figure 6.
To optimize the life of your smoke evacuation filter, it
is recommended that a Buffalo Filter Surgical Smoke
Plume Evacuator be used in conjunction with an
EZLink
Automatic Activation Device
®
(Model EZLink01), (Figure 6).
The EZLink
will automatically turn the Buffalo Filter
®
Surgical Smoke Evacuator on or turn it off when either
the CUT or COAG function is activated/de-activated on
the PlumePen
Elite. Contact Buffalo Filter
®
details on the EZLink
.
®
STERILE EO
0120
ONLY
Elite is a
®
for more
®
EC REP
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
PLP1001
PLP2001
PLP1501
PLP2501

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Inhaltszusammenfassung für Buffalo Filter PlumePen Elite

  • Seite 1 (e.g., Buffalo Filter recommends that the original blade be utilized with the PlumePen Elite. cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged.
  • Seite 2: Chirurgischer Rauchabzugsstift

    Patienten führen. NICHT an Patienten mit elektronischen Implantaten wie zum Beispiel Herzschrittmachern Buffalo Filter empfiehlt die Verwendung der Originalklinge mit dem PlumePen Elite. verwenden, ohne zuvor qualifiziertes Personal zu Rate zu ziehen (z.B. Kardiologen). Ein Falls die Originalklinge entfernt wird, bestätigen Sie visuell, dass die neue Klinge vollständig eingesetzt und mögliches Risiko besteht darin, dass es zu Interferenzen mit dem Betrieb des elektronischen...
  • Seite 3 PRECAUCIÓN: Buffalo Filter recomienda utilizar el bisturí original con el PlumePen Elite. Diseñado para utilizarse con una tensión máxima de 10 kV P-P. Si extrae la cuchilla original, compruebe visualmente que la cuchilla nueva está completamente NO LO UTILICE en pacientes que tengan implantes electrónicos, como marcapasos...
  • Seite 4 NE PAS UTILISER chez des patients équipés d’implants électroniques comme un stimulateur cardiaque sans avoir préalablement consulté un professionnel qualifié Buffalo Filter recommande l’utilisation de la lame d’origine avec le produit PlumePen Elite. (p. ex. cardiologue). Un risque éventuel d’endommagement de l’implant ou Si la lame d’origine est retirée, confirmer visuellement que la nouvelle lame est entièrement insérée...
  • Seite 5 NON UTILIZZARE su pazienti che hanno impiantati dispositivi elettronici, come Buffalo Filter raccomanda di utilizzare la lama originale con PlumePen Elite. pacemaker cardiaci, senza aver prima consultato un professionista qualificato (ad es. un cardiologo). Esiste un pericolo potenziale, poiché può verificarsi interferenza Nel caso venga rimossa la lama originale, verificare visivamente che la nuova lama sia completamente con l’azione del dispositivo elettronico impiantato oppure il dispositivo stesso potrebbe...
  • Seite 6 Buffalo Filter anbefaler, at det originale blad bruges med PlumePen Elite. (fx hjertespecialist). Der eksisterer en mulig fare, idet der kan forekomme interferens Hvis det originale blad fjernes, skal det kontrolleres, at det nye blad er sat helt ind og sikret, inden med det elektroniske implantats funktioner, eller implantatet kan blive beskadiget.
  • Seite 7 NIET GEBRUIKEN bij patiënten met elektronische implantaten zoals pacemakers zonder eerst een gekwalificeerd deskundige (bijv. een cardioloog) te raadplegen. Er Buffalo Filter adviseert om het originele snijblad te gebruiken met de PlumePen Elite. bestaat een mogelijk risico, omdat interferentie met de werking van het elektronische implantaat kan optreden of het implantaat kan beschadigd raken.
  • Seite 8 ÄLÄ KÄYTÄ potilailla, joilla on sähköisiä implantteja, kuten sydämentahdistin, kuulematta Buffalo Filter suosittelee, että PlumePen Elite kanssa käytetään alkuperäistä terää. ensin pätevää ammattilaista (esim. sydänlääkäriä). Tällaiseen käyttöön liittyy mahdollisia Jos alkuperäinen terä poistetaan, vahvista silmämääräisesti, että uusi terä on työnnetty kokonaan vaaroja, koska sähköisen implantin toiminta voi häiriintyä...
  • Seite 9 NÃO utilize em doentes com implantes electrónicos, como pacemakers cardíacos sem A Buffalo Filter recomenda que a lâmina original seja utilizada com o PlumePen Elite. consultar em primeiro lugar um profissional qualificado (por ex., cardiologista). Existe um possível perigo porque poderá...
  • Seite 10 SKAL IKKE BRUKES på pasienter som har elektroniske implantater som f.eks. Buffalo Filter anbefaler at det originale bladet brukes med PlumePen Elite. pacemakere uten først å rådføre deg med en kvalifisert profesjonell (f.eks. kardiolog).
  • Seite 11 VARNING: Buffalo Filter rekommenderar att originalkniven används med PlumePen Elite. Avsedd att användas med en högsta spänning på 10 kV P-P. Om originalkniven tas bort ska du visuellt kontrollera att den nya kniven är fullt införd och att den FÅR EJ ANVÄNDAS på...
  • Seite 12 UPOZORNĚNÍ: Buffalo Filter doporučuje, aby byla originální čepel používána společně s PlumePen Elite. Zamýšleno pro použití s maximálním napětím 10 kV P-P. Pokud je originální čepel odstraněna, vizuálně zkontrolujte, že je nová čepel zcela zasunuta a zajištěna NEPOUŽÍVEJTE u pacientů...
  • Seite 13 NIE STOSOWAĆ u pacjentów z wszczepionymi implantami elektronicznymi, Firma Buffalo Filter zaleca, aby wraz z PlumePen Elite utylizować również oryginalne takimi jak stymulator serca, bez konsultacji z wykwalifikowanym specjalistą...
  • Seite 14 ısıyı hedef dokunun uzağına taşıyabilir ve bu da istenmeyen yanıklara neden olabilir. Kalp pili gibi elektronik implantları olan hastalarda, önceden yetkili Buffalo Filtre, PlumePen Elite ile birlikte orijinal bıçağın kullanılmasını önerir. uzmanlara (örn. bir kardiyologa) danışmaksızın KULLANMAYIN. Elektronik implantın etkisiyle parazit meydana gelebileceğinden veya implant zarar Orijinal bıçak çıkarılmışsa, kalem aktive etmeden önce yeni bıçağın tam olarak yerine...
  • Seite 15 たりオフにしたりできます。EZLink ® の詳細について 器具の出力を行わないでください。手術室職員の傷害につながる は、Buffalo Filter ムに対する施設のプロトコルに従って廃棄し ® に問い合わせてください。 可能性があります。 てください。 注意: たは近接する導電性の液体 (例えば、血液や生理食塩水) は標的組織から離れた場所に電流や 最大電圧10kV P-P での使用が意図されています。 熱を伝える可能性があり、これは患者への意図しない熱傷の原因となる恐れがあります。 心臓ペースメーカーなどの電子インプラントが植込まれている患者には、最初に Buffalo Filterは、元のブレードがPlumePen Eliteと共に使用されることを推奨します。 有資格の専門家 (例えば、心臓専門医) に相談せずに使用しないでください。電 子インプラントの動作との干渉が発生する恐れや、インプラントが破損する可能 納品時に取り付けられているブレードを取り外した場合、ペンシルへの出力を行う前に新しい 性による潜在的な危険が存在します。 ブレードが完全に挿入されて固定されていることを視認してください。ブレードは、絶対にペ ンシルに押し込まないでください。煙チューブが挿入点の視覚をさえぎっている場合は、ペン 使用する前に、器具、ケーブルに損傷が無いか、特に腹腔鏡または内視鏡の器具 シルを回してください。 の絶縁を確認してください。これは、拡大された状態を視覚で確認するか、また は高圧絶縁試験装置を使うことによって行われます。絶縁の失敗は、患者または操作者に火傷 可視性が損なわれる手技では、以下の潜在的な危険に注意してください。 または怪我を負わせる可能性があります。 • 電流の出力を止めた後も、電極先端部は熱傷を引き起こすのに十分な熱さを保っている可能 パッケージが破損しているかシールが破れていない限り、滅菌状態になっています。火災につ...
  • Seite 16 固)功能被激活/停用时自动开启或关闭Buffalo Filter 在使用后,请关闭排烟单元和电外科发生器。 标组织。 ® 按照污染物设施协议丢弃整个 手术排烟器。有关EZLink 的更多详细信息,请联系 请保持活性电极的清洁。黑斑的堆积可能会降低本仪器的有效性。在 PlumePen Elite组装件(包括笔身、 Buffalo Filter ® ® 。 清洁过程中请勿启动本仪器, 否则可能会对手术室人员造成伤害。 电极片、管筒和电源线)。 小心: Buffalo Filter建议将原装电极片与PlumePen Elite配合使用。 最大工作电压:10kV P-P。 在拆下原装电极片之后,在开启本排烟笔之前请用肉眼确认新电极片已完全、牢固插入本排烟 在未事先咨询合格专业人士(如心脏病专家)的情况下,请勿将本排烟笔用于体内 笔。切勿将电极片强行插入本排烟笔。如果排烟管筒妨碍了查看插入点,请旋转排烟笔。 有心脏起搏器等电子植入物的患者。由于本排烟笔可能会对电子植入物的活动造成 干扰,这可能造成潜在的危险,也有可能损坏电子植入物。 对于无法进行肉眼检查的步骤,请注意这些潜在的危险: 在每次使用之前,检查仪器和电缆是否损坏,尤其是腹腔镜/内窥镜仪器的绝缘状 • 在断电之后,电极末端可能仍然很热,足以造成灼伤。 况。在放大镜下用肉眼执行此检查,或使用高压绝缘测试设备进行检查。绝缘故障 • 意外启动或移动视线之外的活性电极可能会对患者造成伤害。 可能给患者或手术人员造成灼伤或其他伤害。 • 导电物体携带的电流可能会对患者或医生造成局部灼伤。如果导电物体与活性电极直接接触,...