Safety Information; Emc Manufacturer's Declaration Of Conformity; Modification And Misuse; Essential Requirements - Nouvag TCM3000BL Bedienungsanleitung

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Safety information

Your safety, the safety of your team, and of course that of your patients is very important to us. It is there-
fore essential to bear the following information in mind:
Every use of the TCM 3000 BL - Morcellator different to the product description defined in chapter "Intend-
ed use and operation", causes risks for patients and trained personnel. If physical examinations and thera-
pies are carried out without use of the devices then the devices must be removed from the place of treat-
ment. 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 envi-
ronmental factors in the close area of the TCM 3000 BL - Morcellator may cause unexpected or adverse op-
eration. Use only accessories and cables as specified in the product description. Further observe the EMC
manufacturers declaration of conformity.
3.2

Modification and misuse

• Modification or manipulation of the TCM 3000 BL - Morcellator and its accessories is prohibited.
The manufacturer is not liable for any damages resulting from unauthorized modifications or manipula-
tions. The warranty will be cancelled.
• Use of the TCM 3000 BL - Morcellator outside the indications described in Section 1.1 is prohibited.
The user or operator is solely responsible for any such use.
3.3

Essential requirements

Before use read this manual and the man-
uals for all other equipment used in the
procedure thoroughly.
For protection of the patient, the user and
third parties the products used must be
prepared as specified in the manual.
The use of third-party products is the
responsibility of the operator. Functionali-
ty and patient safety cannot be guaran-
teed with third-party accessories.
Repairs may only be performed by author-
ized NOUVAG service technicians.
Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fi-
broid surgery may spread cancer, and decrease the long-term survival of patients. This information should
be shared with patients when considering surgery with the use of these devices.
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The products described in this manual must be used
by trained and qualified medical personnel only in
accordance with the requirements and with refer-
ence to the manual.
Improper use or repair of the device, or failure to
observe these instructions, will relieve us from any
obligation arising from warranty provisions or other
claims.
Prior to using the device, before startup, and before
operation, the user must always ensure that the
device and accessories are in good working order
and are clean, sterile and operational.
Use Nou-Clean spray to care for the motor and gear
unit. Using other care products can result in mal-
functions and/or cause the warranty to be revoked.
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
TCM 3000 BL - Morcellator