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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 / receiver properties:
Some LINAK products emit RF-power by intention for communication purposes.
Frequency band of transmission: 2402 MHz - 2480 MHz
Type: BLUETOOTH Low Energy BLE 4.2
Modulation: GFSK
Maximum Effective Radiated Power (ERP): 10 dBm
FCC and IC Statements
For RF-emitting products (e.g. BLUETOOTH
®
, Wi-Fi) intended to be used on the North American continent, the following applies:
FCC statement
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference in a residential 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 radio communications.
However, 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 the dealer or an experienced radio/TV technician for help
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
This device complies with Part 15 of the FCC Rules. 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 undesired operation.
IC statement
This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-
exempt RSS(s). Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause undesired operation of the device.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique
Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes :
(1) L’ appareil ne doit pas produire de brouillage;
(2) L’ appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’ en compromettre le fonctionnement.
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