Karl Storz AIDA WD 300 System Description page 177

1. 5 Information for users
• All of the actions described in this instruction manual must only be carried out by
trained specialist personnel who have been delegated to do so by the operator.
1. 5. 1 Training in the operation of the device
• Training must be conducted by KARL STORZ, a company authorized by
KARL STORZ, or a person delegated by the operator, and must provide direct,
practical experience of operating the device.
• When the training has been completed, the user's understanding of the special
actions required to operate the device in accordance with its intended use must be
documented.
1. 5. 2 Obligation of the user to check and inform
• Read this instruction manual carefully before using the device for the first time. This is
the best way to get the most out of the device and avoid potential injuries and material
damage.
• The user must inspect the device to ensure that it is in proper condition and
functioning correctly before every use or before handing it over for use by a third party.
• If particular problems arise which are not addressed in sufficient detail for you in this
instruction manual, please consult your supplier for your own safety.
1. 6 Intended use of the device
1. 6. 1 Labeling
The manufacturer declares the conformity of this device with the essential requirements
outlined in Annex I of the MDD and documents this by means of the CE mark.
Directive conformity
The WD 300 is a medical device in accordance to the Medical Device Directive 93/42/
EWG (MDD). Risk class: I
1. 6. 2 Standards and dirctives
The device complies with the safety requirements of the following standards an directives:
• Electrical safety according to IEC 60601-1
- Protection against electric shock: Class I ME Equipment
- IP Classification: IPX0
• Electromagnetic Compatibility according to IEC 60601-1-2
nOTE: Observe the information on electromagnetic compatibility in chapter 7.
1
• 2014/53/EU – Radio equipment Dirctive (RED)
- Frequency band: 5 GHz
- Maximum radio-frequency power transmitted in the frequency band: 250 mW
• 2012/19/EU – Waste electrical and electronic equipment directive (WEEE)
• 2011/65/EU –Restriction of the use of certain hazardous substances in electrical and
electronic equipment (RoHS2)
WD 300
KARL STORZ AIDA ®
CE-conformity marking: With this marking, the manufacturer declares the
compliance of the product with the applicable regulations and directives.
CSA certification mark for the USA and Canada: With this marking, the
manufacturer declares compliance with the certification requirements.
Important information for safe use
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