Emc Instructions - bowa 605 Serie Gebrauchsanweisung

2.3 EMC instructions

Medical electrical devices are subject to special precautionary measures with regard to EMC. Observe the following instructions:
 The BOWA accessory is only intended to be connected to BOWA HF devices.
 Using the accessory with medical devices from other manufacturers can result in higher emission levels or reduced interference
immunity.
Note:
With combinations of medical devices, safety can only be assured if:
 The desired combination is allowed by the relevant operating manuals, or
 Using the devices in the desired combination complies with the intended use and the interface specification.
Strict attention must be given to the operating manuals and interface specifications of medical devices used in combination.
3 Preparation
Ensure that insulated parts do not come in contact with hard, pointed or heavy objects during preparation, as such objects may damage the
insulation and render the device unusable.
Non-stick forcep tips (REF 607-xxx) may not be cleaned with metallic brushes, abrasive substances, or other media or tools which may damage the
surface of the instrument. Damp swabs or similar should be used to clean the tip area.
Preparation cycles
75
Soak the instrument immediately after use, or no later than 2 hours after use. Use only aldehyde-free disinfectants
(recommended: Gigasept Instru AF) designed for the disinfection of instruments (e.g. with DGHM or FDA approval
or CE mark).
Soaking
Place the instrument in an ultrasonic bath for at least 5 minutes.
Use a cleaning solution to soften coagulation residues (encrustations), and remove them with a soft cleaning cloth.
Recommendation: Machine cleaning in a cleaning/disinfection machine and thermal disinfection.
Parameters: minimum 5 minutes at 90°C or A0 value > 3000
BOWA recommends the use of neutral to slightly alkaline (pH 9.5 – 11.5) cleaning agents or cleaning and
disinfection agents suitable for medical devices made from plastic and metal. Alcoholic and/or aldehydic ingredients
Cleaning/
may be permissible, depending on the concentration.
Disinfection
If necessary, blow off with filtered compressed air.
Only dry the devices with compressed air at pressures below 3 bar, to avoid possible damage.
The manual method is not suitable for these devices.
Machine cleaning (90°C, 5 minutes)
Effective cleaning
using an alkaline cleaning agent
verified by BOWA
with surfactant additive (Neodisher MediClean forte)
Fractionated vacuum method
Autoclaving
Retention time: 3-20 minutes; Sterilisation temperature: 134–137°C
The manufacturer accepts no responsibility if other types of cleaning and disinfection agents are used. Follow the recommendations of the
cleaning agent manufacturer.
4 Operation, storage and transport
Temperature: -20 to +50°C; Relative humidity: 0 - 75%, non-condensing; Air pressure: 500 - 1060 hPa.
All forceps must be handled with the greatest possible care during transportation. This applies in particular to fine tips and other vulnerable areas.
Protect sterilised devices from exposure to direct sunlight during storage. It is recommended to keep the devices in the original packaging until
use.
5 Disposal
The medical device, packaging material and accessories must be disposed of in accordance with any applicable country-specific regulations and
laws.
BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Str. 4-10
Tel. (+49) 7072-6002-0 Fax (+49) 7072-6002-33
72810 Gomaringen/Germany
info@bowa.de www.bowa-medical.com