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Important information
LINAK
®
products, within the scope of this manual, are not classified as medical electrical equipment or systems, nor do they fall within the scope of
the EU Medical Device Directive/Regulation or other similar national regulations. The products are components to be built into a piece of medical
electrical equipment by a manufacturer.
To support the assessment and certification task of the complete medical electrical equipment or system worldwide, LINAK provides certification,
on a component level, according to the IEC 60601-1, (Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance) as IEC-certificate and listed as recognised components by NRTL (Nationally Recognized Testing Laboratories).
Description of the various signs used in this manual:
Warning
Failure to comply with these instructions may result in accidents involving serious personal injury.
Recommendation
Failing to follow these instructions can result in product damage.
Please read the following safety information carefully:
It is important for everyone who is to connect, install or use the systems to have the necessary information and access to this User Manual.
Please be aware that LINAK has taken precautions to ensure the safety of the actuator system. The manufacturer/OEM is responsible for the overall
approval of the complete application.
LINAK recommends to use the actuators in push applications rather than pull applications.
LINAK actuators are not to be used for repeated dynamic push-to-pull movements.
For general pull applications or repeated dynamic push-to-pull movements in the application, please contact LINAK A/S if in doubt.
LINAK
®
actuators and electronics generally fall outside the IEC 60601-1 definition of applied parts and are not marked as such.
However, assessing the risk whether actuators and electronics can unintentionally come into contact with the patient, determines that they are
subject to the requirements for applied parts. All the relevant requirements and tests of the standard are carried out as part of the IEC CB-Scheme
assessment.
RF transmitter properties:
Some LINAK products emit RF-power by intention for communication purposes.
Frequency band of transmission: 2400 MHz – 2485 MHz.
Type: BLUETOOTH Low Energy BLE 4.2
Modulation: GFSK
Maximum Effective Radiated Power (ERP): 10 dBm
Output ratings:
Nominal values:
On LINAK control boxes, battery boxes and power supply marking plates, the nominal output voltage at a certain load for a certain product may be
stated.
Depending on product and load, this value may vary significantly due to construction.
The expected output voltage may for instance vary depending on product and load within a range from approximately 20 V DC to approximately 50 V
DC for a product with a nominal output voltage of 24 V DC due to the construction.
When combining LINAK control boxes, battery boxes and power supplies with other LINAK components, compatibility is ensured. When combining
LINAK control boxes, battery boxes or power supplies with third party products, special precautions may be taken. In this case, contact LINAK.
Classification:
The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
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