Idiomas disponibles
Idiomas disponibles
The packing is to be marked with information about method and date of sterilization, expiration date and batch.
STERILIZATION
The individual user is responsible for the validation of the specified sterilization process. The following method must be used:
Steam sterilization with fractionated vacuum procedure with a temperature of 132°C/270°F for a minimum of 3 minutes /
a maximum of 5 minutes and a drying time of 20 minutes.
Specific sterilization parameters for a particular unit should be validated by the use of spore strips or inoculated products.
Any manufacturer's sterilization instructions for a particular unit should take precedence over recommendations given
here.
• Do not exceed 138°C/280°F
• Do not use hot air sterilization
• The FDA does not recognize sterilization methods that have not been 510(k)-cleared
joimax
recommendation regarding sterilization:
®
Proof of basic instrument suitability for effective steam sterilization was performed by an independent accredited testing
laboratory by using the steam sterilizer Getinge 400HC and 500HC (FDA clearance K103504) with the fractional vacuum
procedure. Typical conditions prevalent at a clinic or physician's practice as well as the above-mentioned procedure were
taken into consideration.
STORAGE
Temperature: -20° C to +50° C / -4° F to +122° F
Atmospheric pressure: 50 –106 kPa
Relative humidity: 0 – 75 %, non-condensing
CUSTOMER SERVICE
In case of questions or problems please contact the customer service of joimax
In the interest of rapid processing of enquiries please send us the product with the following information:
• Article number (REF)
• Serial number (SN or LOT)
• Description of the error as accurate as possible
Please notify us of any events according to MPG § 29 or § 2 of the Medical Devices Safety Plan Ordinance under the
following telephone number:
for the US 949-859-3472 (24-hour availability)
for all other countries +49 (0) 721 255 14-999 (24-hour availability).
The CE Mark confirms product compliance with the Medical Device Directive 93/42/EEC and the German Medical Devices
Act (MPG).
GmbH.
®
11
