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AS Medizintechnik 65-000-01 Instructions Of Use

Rigid autoclavable endoscopes

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Instruction of use
Rigid autoclavable endoscopes
65-000-01 - 65-145-05
Indications and use
AS Medizintechnik endoscopes are used for illumination and visualization for diagnostic and therapeutic endoscopic surgical procedures in the following
areas:
Arthroscopy; Bronchoscopy; Hysteroscopy; Laparoscopy; Laryngoscopy; Esophagoscopy; Otoscopy; Sinuscopy; Thoracoscopy; Urethroscopy; Uretero-
renoscopy; Ventriculoscopy; Cystoscopy; Spinal surgery.
The main goal of endoscopic diagnosis and endoscopic surgery lies in tissue saving and thereby an enhanced preservation of function. In this users
manual, no clinical applications are outlined or explained.
Side Effects / Contraindications
Infection Risk
In endoscopic studies, the risk of infection is of particular importance. The risk factor for an increased risk of infection are divided into two groups:
Process-related risks:
The nature and extend of tissue damage in therapeutic procedures.
Circumstances of the endoscopic surgery (emergency surgery or elective surgery).
Expertise and experience of the examiner / user.
Proper cleaning and desinfection of endoscopes and accessories.
Patient-related risks:
Reduced immune status of patients or immunosuppression (HIV, Leukemia, Lymphoma, Immunosuppressive therapy, advanced liver or kidney
desease, advanced age).
Existence of specific infections or anatomical characteristics.
Encouraging situations of body bacteria adhesion (heart valve defects, heart valve replacements, endoprostheses, an intravenous catheter).
In endoscopic procedures, there may be an endogenous movement of microorganisms with subsequent bacteraemia. In this regard, the national and
international recommendations for the prophylactic administration of antibiotics before certain procedures are to be followed (ESGE Guidelines 1998).
Safe handling
Prepare a brand-new endoscope before initial use (unsterilized in delivery condition).
Check the endoscope for sharp edges, bent, loose or broken components before each use.
Check the endoscope for correct function and for damage after each preparation.
Segregate damaged endoscopes immediately.
When using the endoscope in a trocar, avoid bending/pressure during insertion and withdrawal.
Semi-flexible endoscopes are designed for minor flexural loads. A deflection of the tubing is admissible up to max. 20°! Higher bending forces
cause permanent deformation and damage of the product.
Endoscopes may only be used by physicians or by medical personnel under the supervision of a physician. Adequate training, knowledge and
experience in the clinical application of endoscopic techniques is required.
Read the instructions for use carefully and follow them in detail.
Visual and functional inspection
Check for:
external damage (shaft deformed, dents or sharp edges)
cleaner or disinfectant residues
condition of the three optical surfaces – 1. objective window, 2. ocular window, 3. light cable connection – using reflected light or magnifying glass
(smooth, clean and undamaged)
optimal image quality (sharp, bright and clear)
loss-free light transmission from light cable connection to light output (compare with new device, if necessary)
unobstructed working channels
Revision status: C
File name:
GA_019_Starre Endoskope_EN_B
AS Medizintechnik GmbH
Tel: +49 / 74 61/ 9 66 32-6
Sattlerstraße 15
Fax: +49 / 74 61/ 9 66 32-88
78532 Tuttlingen
www.AS-Medizintechnik.de
Germany
info@AS-Medizintechnik.de
Issued at:
01.03.2012
Revised at:
14.01.2015
Issued from:
NS
Revised from: NS
Page 1 of 6

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Summary of Contents for AS Medizintechnik 65-000-01

  • Page 1 Germany info@AS-Medizintechnik.de Indications and use AS Medizintechnik endoscopes are used for illumination and visualization for diagnostic and therapeutic endoscopic surgical procedures in the following areas: Arthroscopy; Bronchoscopy; Hysteroscopy; Laparoscopy; Laryngoscopy; Esophagoscopy; Otoscopy; Sinuscopy; Thoracoscopy; Urethroscopy; Uretero- renoscopy; Ventriculoscopy; Cystoscopy; Spinal surgery.
  • Page 2 In the case of laser surgery, do not use reflective objects in the working area and do not direct the laser beam towards endoscope. Possible cause of burns! All AS Medizintechnik endoscopes must be prepared according to the instructions for each use and application. Possible cause of infection! Do not use damaged endoscopes (see section “Visual and functional inspection”)
  • Page 3 General requirements All AS Medizintechnik endoscopes must be cleaned, disinfected and sterilised before each application. This applies in particular to brand-new optics, as all endoscopes are unsterilised when delivered (cleaning and disinfection following removal of the transport packaging; sterilisation in suitable sterilisati- on packaging).
  • Page 4 Other methods for cleaning and disinfection AS Medizintechnik endoscopes were successfully tested for the basic stability of the used materials using per-acetic acid process (STERIS-System 1). However, utilisation is only permitted if this process is approved for your facility in your country and the effectiveness has been proven by the user wit- hin the scope of a product/geometry/material process and device specific qualification, taking account of EN ISO 15883 specifications (including basic suitability of device and process) and, if necessary, supplementation through additional effective processes has occurred.
  • Page 5 Observe cooling time. Accelerated cooling (e.g. with cold water) can result in the destruction of the endoscopes. Proof of the suitability of the AS Medizintechnik endoscopes fort the effective steam sterilisation was provided by an independent testing laboratory, using the Systec V-150 steam steriliser (Systec GmbH Labor- Systemtechnik, Wettenberg) and the fractionated vacuum process as well as the gravitati- on process.
  • Page 6 The use of damaged and/or contaminated endoscopes is the responsibility of the user. Disregarding these instructions for use will void the guarantee or warranty claims. We accept no liability in the case of improper handling, incorrect or inadequate preparation or unauthorized repairs. AS MEDIZINTECHNIK GMBH DOES NOT ACCEPT RESPONSIBILITY IF THIS CUSTOMER INFORMATION HAS BEEN VIOLATED PROVABLY. Revision status: C Issued at: 01.03.2012...

This manual is also suitable for:

65-145-05