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Comftech HOWDY BABY - Applicable Norms; Packaging and Accessories

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Figura 4: Il simbolo dello standard Qi per la
ricarica ad induzione.
PACKAGING AND ACCESSORIES
HOWDY BABY Supply equipment
•1 textile unit
•1 electronic unit
•1 Use and Maintenance Manual
The packaging for transport consists of a cardboard
box.
Note:
To charge the electronic unit it is necessary to get an
induction battery charger (NOT supplied) Qi standard
compliant. The Qi standard identifying symbol must be
displayed as shown below.
Note: Is Bluetooth technology dangerous to human
health?
According to current research, the Specic Absorption
Rate (SAR) is the basic factor to measure possible
harm to our health caused by the exposure to high
frequency electromagnetic elds.
The Absorption Rate describes the amount of RF
energy (measured in Watt (W), 1 W= 1000 mW)
absorbed by the human body (Kg).
The maximum SAR allowed is 0,08 W/Kg for the whole
body and 2,00 W/Kg for body parts, for example for
the head.
APPLICABLE NORMS
HOWDY BABY is classied as a class IIb
medical device, in accordance with the
requirements of 93/42/CEE Directive on Medical
Devices amended by the 2007/47/CE Directive.
The Medical Device Comftech Howdy meets all
the requirements of the following regulations:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-47
• EN ISO 15223-1
• EN 1041
• EN ISO 14971
• EN ISO 10993-1
• EN 60601-1-6
• EN 62304
• EN 62366
• EN 60601-1-11
31
The devices connected via Bluetooth or WLAN, as
single components, remain far below this SAR limit.
The HOWDY BABY device has been tested for
electromagnetic compatibility and totally complies with
the SAR limit.
When the limit is respected, at the current state of
science, there is no evidence that high frequency
electromagnetic elds can be a risk to one’s health.

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