Welch Allyn RetinaVue 100 Imager Directions For Use Manual page 56

52 General compliance and standards
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of 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. If not installed and
used in accordance with the instructions, it 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 and correct the interference by one or more of the following
measures:
• Reorient or relocate the receiving antenna
• Increase the distance between the equipment and the receiver
• Connect the equipment to 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
The user may find the following booklet prepared by the Federal Communications
Commission helpful:
The Interference Handbook
This booklet is available from the U.S. Government Printing Office, Washington, D.C.
20402. Stock No. 004-000-0034504.
Welch Allyn is not responsible for any radio or television interference caused by
unauthorized modification of the devices included with this Welch Allyn product, or the
substitution or attachment of connecting cables and equipment other than specified by
Welch Allyn.
The correction of interference caused by such unauthorized modification, substitution, or
attachment will be the responsibility of the user.
The device is designed and tested to meet the applicable limits for radio frequency (RF)
exposure established by the Federal Communications Commission (U.S.A.) Specific
Absorption Rate; (SAR) refers to the rate at which the body absorbs RF energy.
The maximum allowable SAR limit is 4.0 W/kg, averaged over 10 gram of tissue for the
device. The following SAR values were measured during product certification, 1.060 W/
kg with a (0mm gap) a value well below the maximum allowable limit of 4.0 W/kg.
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC EN 60601-1-2:2007.
• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The 901103 Imager complies with all applicable and required standards for
electromagnetic interference.
• It does not normally affect nearby equipment and devices.
• It is not normally affected by nearby equipment and devices.
Welch Allyn RetinaVue™ 100 Imager