Applicable regulations and standards

Medical Device Regulation

This product conforms with the requirements of the Medical Device Regulation 2017/745 when they bear the following CE Mark of conformity:

The year of CE marking is 2016.

Ukrainian mark of conformity

Authorized Representative in Ukraine

Regulatory Markings-UDI Label

Every medical device has a unique marking for identification. The UDI marking appears on the device labeling.

The following figures are only examples of a UDI marking. The device may have a linear barcode, or a DataMatrix code, or only alphanumeric identifiers with no barcode. Also the identifiers vary per product.

Manufacturer

GE HEALTHCARE (TIANJIN) COMPANY LIMITED

NO.266 JINGSAN ROAD, TIANJIN AIRPORT ECONOMIC AREA,

TIANJIN, P.R.CHINA 300308

Manufacturing Site 1

GE HEALTHCARE (TIANJIN) COMPANY LIMITED

NO.266 JINGSAN ROAD, TIANJIN AIRPORT ECONOMIC AREA,

TIANJIN, P.R.CHINA 300308

Manufacturing Site 2

GE Healthcare Manufacturing LLC

3001 West Radio Drive

Florence, SC 29501 USA

For the specific manufacturing site for your system, please refer to the rating plate attached on your system cabinet.

Legal notices

GE and the GE Monogram are trademarks of General Electric Company.

ASSET, VIBRANT, ReportCARD, INSITE and ILinq are trademarks of General Electric Company.

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information.

All other trademarks are the property of their respective owners.

Turkey importer details

GE Medical Systems Türkiye Ltd. Şti.

Esentepe Mah. Harman Sok. No: 8

34394 Şişli-İstanbul Türkiye

Authorized representative of the manufacturer to receive claims in the Republic of Belarus

Authorized representative of the manufacturer in Russian Federation

Authorized representative in Kazakhstan

Radio frequency energy

This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio frequency interference with other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, the:

GE MR Systems

comply with emissions limits for (Group 2, Class A) Medical Devices as stated in IEC 60601-1-2. However, there is no guarantee that interference will not occur in a particular installation.

If this equipment is found to cause interference (which may be determined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measures:

• reorient or relocated the affected devices;
• increase the separation between equipment and the affected device;
• power the equipment from a source different from that of the affected device; and/or
• consult the point of purchase or service representative for further suggestions.

The manufacturer is not responsible for any interference caused by using interconnect cables that are not recommended or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment.

Do not use devices that transmit RF Signals (cellular phones, transceivers, or radio controlled products) in the vicinity of this equipment as they may cause performance outside the published specifications. Keep the power to these types of devices turned off when near this equipment.

The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who may be around this equipment to fully comply with the above requirement.

Immunity/Emissions Exceptions: Note the exceptions from the EMC test results. Check with the business EMC engineer for this information.

In accordance with the international safety standard IEC 60601-1, this system is:

• a Class I device

  Warning
  	To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

• acceptable for Continuous Operation
• having ordinary protection against ingress of water (IPX0)
• type B and BF applied parts
• is not for use in the presence of flammable anesthetics.

Equipment disposal

A WEEE passport report is available from a GE representative upon request.

Indications for use

IEC 62366: 6

The SIGNA^TM Voyager system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the SIGNA^TM Voyager system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.