ELECTROMAGNETIC COMPATIBILITY INFORMATION
If the device performance is lost or degraded due to electromagnetic disturbances, a visual and audible alarm indicates that the device is not meeting specification or a failure has been
detected.
WARNING
MR Unsafe
1. Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to the patient or damage to the iGo2 or MR
medical devices. The device and accessories have not been evaluated for safety in an MR environment.
2. Do not use the device or accessories in an environment with electromagnetic equipment such as CT scanners, Diathermy, RFID and electromagnetic security systems
(metal detectors) as it may cause unacceptable risk to the patient or damage to the iGo2. Some electromagnetic sources may not be apparent, if you notice any
unexplained changes in the performance of this device, if it is making unusual or harsh sounds, disconnect the power cord and discontinue use. Contact your home care
provider.
3. This device is suitable for use in home and healthcare environments except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM
for magnetic resonance imaging, where the intensity of Electromagnetic DISTURBANCES is high.
WARNING
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
CABLES AND MAXIMUM LENGTHS OF CABLES
• DC power cord (cigarette lighter adapter) #DV6X-619 maximum length = 2.2 meter (7.2 ft)
WARNING
Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
WARNING
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part
of the iGo2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
FCC AND INDUSTRY CANADA STATEMENT
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.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this
device must accept any interference, including interference that may cause undesired operation of the device.
The output power of this device is less than 20mW. The SAR test is not required. When using it, ensure that the antenna of the device is at least 20cm away from all persons.
This Class B digital apparatus complies with Canadian ICES-003.
NOTE– The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications or changes to this equipment. Such modifications or changes
could void the user's authority to operate the equipment.
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.
FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this 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.
FCC Radiation Exposure Statement: This product complies with the US portable RF exposure limit set forth for an uncontrolled environment and is safe for intended operation as
described in this manual. Further RF exposure reduction can be achieved if the product is kept as far as possible from the user body or is set to a lower output power if such function is
available.
This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.
This device complies with Industry Canada's license-exempt RSSs. Operation is subject to the following two conditions: (1) This device may not cause interference; and (2) This device
must accept any interference, including interference that may cause undesired operation of the device.
Radiation Exposure Statement: The product complies with the Canada portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as
described in this manual. The minimum separation distance for portable use is limited to 15mm assuming use of antenna with 2 dBi of gain. The further RF exposure reduction can be
achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available.
Bluetooth® Module Contains FCC ID: BL652, Contains IC: 3147A-BL652
EUROPEAN UNION STATEMENT
This device complies with the essential requirements of the 2014/53/EU – Radio Equipment Directive (RED). The following test methods have been applied in order to prove presumption
of conformity with the essential requirements of the 2014/53/EU – Radio Equipment Directive (RED):
• EN 62368-1:2014/A11:2017: Safety requirements for audio/video, information, and technology equipment
• EN 300 328 v2.2.2 (2019-07): Electromagnetic compatibility and Radio Spectrum Matters (ERM); Wideband Transmission systems; Data transmission equipment operating in the 2,4
GHz ISM band and using spread spectrum modulation techniques; Harmonized EN covering essential requirements under article 3.2 of the R&TTE Directive
A-125B
EN - 19