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Storz UH 801 - User Manual

Storz UH 801
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RFID-HF-Kabel
Modell UH 801
RFID HF Cable
Model UH 801
Cable de AF RFID
Modelo UH 801
D E ES
GEBRAUCHSANWEISUNG INSTRUCTION MANUAL MANUAL DE INSTRUCCIONES
1
KARL STORZ SE & Co. KG, Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen, Germany, Phone: +49 7461 708-0, Fax: +49 7461 708-105, E-Mail: info@karlstorz.com
V 2.0 – 10/2017
1 Zweckbestimmung
KARL STORZ Hochfrequenz (HF-)Kabel dienen der
Verbindung von endoskopisch verwendbarem Zubehör
zu HF-Geräten mit Hochfrequenzchirurgie-Generatoren.
Sie dürfen nur durch entsprechend ausgebildetes und
qualifiziertes Fachpersonal eingesetzt werden.
Es wird empfohlen, vor der Verwendung die Eignung
der Produkte für den geplanten Eingriff zu
überprüfen.
2 Codierungssystem
Das Codierungssystem mit Instrumentenerkennung und
Voreinstellung der Parameter steht nur für ausgewählte
Instrumente in Kombination mit dem HF-Gerät
AUTOCON
®
III 400 zur Verfügung. Die codierten
Kabel/Instrumente sind an der entsprechenden Punkt-
Markierung 3 erkennbar. Die Kompatibilität und die
notwendige Softwareversion des AUTOCON
®
III 400
entnehmen Sie bitte der den Instrumenten beiliegenden
Liste.
97000149
1
2
3
1 Kabelanschluss instrumentenseitig
2 Kabelanschluss geräteseitig
3 Markierung RFID-kompatibel
MN031-679-S2
Symbolerläuterungen
3
WARNUNG: Nichtbeachtung kann
Verletzungen oder Tod zur Folge
haben.
2
VORSICHT: Nichtbeachtung kann zur
Beschädigung oder Zerstörung des
Produktes führen.
1
HINWEIS: Spezielle Informationen zur
󰘵
Anleitung beachten
Hersteller
Trocken aufbewahren
Symbol description
3
WARNING: Failure to observe may result
in injury or even death.
2
CAUTION: Failure to observe may result
in damage to or even destruction of the
product.
1
NOTE: Special information on the
operation of the instrument.
Refer to instruction manual
Manufacturer
Keep dry
Explicación de los símbolos
3
CUIDADO: La inobservancia de este
aviso podría conllevar lesiones o incluso
la muerte.
2
ADVERTENCIA: La inobservancia de este
aviso podría conllevar deterioros o incluso
la destrucción del producto.
1
NOTA: Informaciones especiales para el
manejo del instrumento.
Siga las instrucciones
Fabricante
Manténgase seco
1 Uso previsto
Los cables de alta frecuencia (AF) de KARL STORZ
sirven para conectar accesorios para uso endoscópico
a aparatos de AF con generadores quirúrgicos de alta
frecuencia.
Estos solo deben ser utilizados por personal
especializado que cuente con la cualificación y
formación pertinentes.
Antes de su utilización, se recomienda comprobar
la idoneidad de los productos en cuanto a la
intervención planeada.
2 Sistema de codificación
El sistema de codificación con reconocimiento de
instrumentos y ajuste previo de los parámetros
está únicamente disponible para los instrumentos
seleccionados en combinación con el aparato de AF
AUTOCON
®
III 400. Los cables/instrumentos codificados
pueden identificarse por medio de las correspondientes
marcas en forma de punto 3. Podrá comprobar la
compatibilidad y la versión de software necesaria para
AUTOCON
®
III 400 en la lista adjunta a los instrumentos.
1 Conexión del cable, lado del instrumento
2 Conexión del cable, lado del aparato
3 Marca de compatibilidad con RFID
1 Intended use
KARL STORZ High Frequency (HF) cables are used to
connect endoscopically applicable accessories to HF
equipment with high frequency surgery generators.
They must only be used by suitably trained and qualified
technical staff.
It is recommended to check the suitability of the
products for the intended procedure prior to use.
2 Coding system
The coding system with instrument recognition and
presetting of the parameters is only available for
selected instruments in combination with the HF device
AUTOCON
®
III 400. The coded cables/instruments can
be recognised by the corresponding dot marking 3.
Please refer to the list included with the instruments for
information on compatibility and the necessary software
version of the AUTOCON
®
III 400.
1
Cable connection, instrument side
2 Cable connection, device side
3 Marking RFID-compatible
Gilt nicht für USA und Kanada!
Kunden aus den USA und Kanada bitte die separate
US-Anleitung verwenden!
Does not apply to USA and Canada!
US and Canadian customers, please use the
separate US instructions!
No es válido para los EE.UU. y Canadá.
Los clientes estadounidenses y canadienses deben
utilizar la Instrucción específica para los EE.UU.
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Overview

  1. Function Description
  2. Important Technical Specifications
  3. Usage Features
  4. Maintenance Features
  5. Compliance

The KARL STORZ RFID HF Cable, Model UH 801, is a medical device designed for use in endoscopic procedures. It serves as an accessory to high-frequency (HF) equipment, connecting compatible endoscopic accessories to HF surgical generators. The device is intended for use by appropriately trained and qualified technical personnel.

Function Description:

The RFID HF Cable facilitates the connection between endoscopic accessories and HF surgical generators, enabling the delivery of high-frequency energy for various surgical applications. The integrated RFID tag (③) allows for identification and parameter pre-setting when used with selected AUTOCON® III 400 HF devices. This coding system ensures compatibility and helps streamline the setup process for specific instrument combinations.

Important Technical Specifications:

  • Model: UH 801
  • Type: RFID HF Cable
  • Bipolar HF Cables: Intended for use with HF equipment having a recurring peak voltage of 1.5 kVp.
  • Operating Temperature: +10 °C to +40 °C (50°F to 104°F)
  • Storage Temperature: -20 °C to +50 °C (-4°F to 122°F)
  • Relative Humidity (Operating): 30% to 70%
  • Relative Humidity (Storage): 0% to 75%
  • Air Pressure: 700 hPa to 1060 hPa
  • Sterilization: Validated for steam sterilization using the fractionated prevacuum procedure at 132 °C (270 °F) for 4 minutes exposure time, followed by a 20-minute dry time. This method is suitable for thermostable instruments only.
  • Reusability: Guaranteed for a life cycle of 20 reprocessings/uses.

Usage Features:

  • Connection: The cable features two connectors: one for the HF treatment instrument (①) and one for the electrosurgical unit (②). Proper contact and secure locking are crucial to prevent voltage flashovers due to high voltage at the contacts, which could damage the contacts or the insulation.
  • Compatibility: The RFID tag allows for automatic identification and pre-setting of parameters with compatible AUTOCON® III 400 HF devices. Users should consult the provided list to verify compatibility and required software versions for the AUTOCON® III 400.
  • Safety Precautions:
    • Risk of Injury/Damage: Sparks may be produced when using HF devices and accessories, potentially igniting combustible or flammable liquids. Ensure all flammable agents have evaporated and no flammable gases are present before use.
    • Voltage Settings: Using device settings exceeding 1.5 kVp with bipolar HF cables can damage the instrument. Adhere to IEC 60601-2-2, 3rd Edition guidelines.
    • Infection Risk: The device is not supplied sterile. Reprocessing is mandatory before initial use and after every subsequent use to prevent infection. Visible contamination indicates improper reprocessing.
    • Instrument Integrity: Before and after each use, instruments and accessories must be checked for completeness, functionality, and absence of rough surfaces, sharp corners, burred edges, or projecting parts. Incorrectly assembled or damaged instruments can cause patient injury.
    • Handling: HF cables should be stored in loose loops, never tightly coiled or kinked. Avoid placing heavy objects on the cables.

Maintenance Features:

  • Reprocessing: Adhere strictly to the "Cleaning, Disinfection, Care and Sterilization of KARL STORZ Instruments" manual and accompanying documents.
  • Pre-cleaning: Immediately after use, remove gross soil, corrosive solutions, and medications by wiping and rinsing. Manual pre-cleaning under cold running water is generally recommended.
  • Manual Cleaning: Immerse the device completely in a cleaning solution. Disassemble, open, and fill lumens to ensure all surfaces, including hard-to-reach areas, are wetted without air bubbles. Mechanically clean with a brush or sponge after the required immersion time. Finish with a final rinse under cold water for neutralization.
  • Manual Disinfection: Immerse the device completely in a disinfectant solution. Ensure all surfaces are wetted. After the required exposure time, rinse multiple times with demineralized or microbiologically pure, sterile water to remove chemical residues. Completely dry all surfaces, articulations, openings, channels, and lumens with medical-grade compressed air. The cleaning pistol with accessories (Art. No. 27660) is recommended for this.
  • Machine Cleaning and Disinfection: Thermal disinfection is preferred, adhering to national regulations and A0 value. Select appropriate slide-in trays or instrument holders in consultation with the device manufacturer to ensure thorough rinsing. Manual drying may be necessary.
  • Assembly, Inspection, and Care: After cleaning and disinfection, visually inspect the device for cleanliness, completeness, damage, and dryness. If contamination persists, re-clean manually and repeat the full reprocessing cycle. Discard damaged or corroded devices. Perform a functional check. Use care products from the "Care, Sterilization and Storage Techniques" catalog.
  • Packaging: Use only standardized and approved packaging materials and systems (EN 868 Parts 2-10, ISO 11607 Parts 1 + 2, DIN 58953).
  • Disposal: No special measures are required for disposal of HF cables, but national laws and regulations must be observed.

Compliance:

This medical device bears the CE mark in accordance with the Medical Device Directive (MDD) 93/42/EEC. A code number after the CE mark indicates the responsible notified body. For customers in the USA and Canada, a separate US-specific instruction manual must be consulted.

Storz UH 801 Specifications

General IconGeneral
BrandStorz
ModelUH 801
CategoryCables and connectors
LanguageEnglish