NDS VIMA User Manual - Terms and Conditions
Terms and Conditions | 75
Terms and Conditions
This device is only to be operated within secured and cybersecurity compliant environments. It is the
responsibility of the product integration entity/user to ensure local governing laws and regulations are followed
without limitations, such as HIPAA, GDPR, or other applicable cybersecurity rules, regulations, or laws.
Declarations of Conformity
FCC and Council Directives of European Standards
This device complies with Part 15 of FCC rules and 93/42/EEC and 2007/47/EC of the Council Directives of
European Standards. Operation is subject to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received, including interference that may cause
undesirable results.
1. Use the attached specified cables with the color monitor so as not to interfere with radio and television
reception. Use of other cable and adapters may cause interference with other electronic equipment.
2. This equipment has been tested and found to comply with the limits pursuant to FCC part 15 and CISPR 11.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications.
IEC
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
FCC, Council Directives of European Standards, and IEC:
There is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult your dealer or an experienced radio/TV technician for help.
Accessory equipment connected to this product must be certified according to the respective IEC Standards (i.e.,
IEC 60950-1) for data processing equipment and IEC 60601-1 for medical equipment. Furthermore, all
configurations shall comply with the system standard, IEC 60601-1-1. Anyone who connects additional
equipment to the signal input part or signal output part configures a medical system, and is therefore
responsible that the system complies with the requirements of system standard IEC 60601-1-1. Whoever is
responsible for securing the unit to a system needs to insure that the mounting equipment used with this
product complies to IEC standard 60601-1. If in doubt, consult the technical services department or your local
representative.
Legal Statement
NDS may sell its products through other medical device manufacturers, distributors and resellers and therefore,
purchasers of this NDS product should consult with the entity through which this product was originally
purchased regarding the terms of any applicable product warranties provided by such entity, if any.
NDS neither assumes nor authorizes any person to assume for it any other liabilities in conjunction with and/or
related to the sale and/or use of its products. To ensure proper use, handling and care of NDS products,
customers should consult the product specific literature, instruction manual, and/or labeling included with the
product or otherwise available.
Customers are cautioned that system configuration, software, the application, customer data and operator
control of the system, among other factors, affect the product’s performance. While NDS products are
considered to be compatible with many systems, specific functional implementation by customers may vary.
Therefore, suitability of a product for a specific purpose or application must be determined by the consumer and