Instructions for use, ERGO 300 - BOWA- IFU-12930- ERG0300-S0-EN-20210701 9
3
Safety information
Your safety, the safety of your team, and of course that of your patients is very important to us. It is therefore essential to
bear the following information in mind:
Every use of the ERGO 300 - Morcellator different to the product description defined in chapter “Intended use and oper-
ation”, causes risks for patients and trained personnel. If physical examinations and therapies are carried out without use
of the devices then the devices must be removed from the place of treatment. Avoid any connection or close adjacency to
other devices.
3.1
EMC, Manufacturer’s Declaration of Conformity
The use of (RF) Radio Frequency emitting devices and equipment as well as the occurrence of negative environmental
factors in the close area of the ERGO 300 - Morcellator may cause unexpected or adverse operation. The connection or the
placing of other devices in close vicinity is not allowed.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class
A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
Use only accessories and cables as specified in the product description. Further observe the EMC manufacturers declara-
tion of conformity.
3.2
Modification and misuse
• Modification or manipulation of the ERGO 300 - Morcellator and its accessories is prohibited. The manufacturer is not
liable for any damages resulting from unauthorized modifications or manipulations. The warranty will be canceled.
• Use of the ERGO 300 - Morcellator outside the indications described in Section 1.1 is prohibited.
The user or operator is solely responsible for any such use.
3.3
In the event of a serious incident
Any serious incident or problem with the device must be reported to the device manufacturer immediately. An electronic
mail is an advantage and a corresponding form is essential, provided this has already been created.
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