ANNEX 13: MEDICAL DATA ACQUISITION

Scope of annex
This annex covers frequency bands and regulatory as well as informative parameters recommended for medical data acquisition applications. They cover transmission of non-voice data to and from non-implantable medical devices for the purpose of monitoring, diagnosing and treating patients in healthcare facilities or patient's home, as prescribed by duly authorised healthcare professionals, including: - Ultra-Low Power Wireless Medical Capsule Endoscopy (ULP-WMCE) application designed for use in medical doctor-patient scenarios with the aim of acquiring images of human digestive tract; - Medical Body Area Network System (MBANS) for low-power wireless networking of a plurality of body-worn sensors and/or actuators as well as of a hub device placed on/around the human body. Active Medical Implants and their associated peripherals are included in Annex 12 of this Recommendation.

Frequency Band Power / Magnetic Field Spectrum access and mitigation requirements Modulation / maximum occupied bandwidth ECC/ERC Deliverable Notes
a 430MHz  -  440MHz
-50 dBm/100kHz max e.r.p. density but not exceeding a total power of -40 dBm/10MHz (both limits are intended for measurement outside of the patient's body) No requirement ≤ 10 MHz ULP-WMCE
b2 2483.5MHz  -  2500MHz
10 mW e.i.r.p. Adequate spectrum sharing mechanisms (e.g. Listen-Before-Talk and Adaptive Frequency Agility) shall be implemented by the equipment and ≤ 2% duty cycle ≤ 3 MHz MBANS, indoor only within the patient’s home. The frequency band is also identified in Annex 12
b1 2483.5MHz  -  2500MHz
1 mW e.i.r.p. Adequate spectrum sharing mechanisms (e.g. Listen-Before-Talk and Adaptive Frequency Agility) shall be implemented by the equipment and ≤ 10% duty cycle ≤ 3 MHz MBANS, indoor only within healthcare facilities. The frequency band is also identified in Annex 12


Additional Information

Harmonised Standards
EN 303 520 sub-band a) EN 303 203 sub-bands b1) and b2)

Technical parameters also referred to in the harmonised standard
No information

Frequency issues
Sub-bands b1) and b2): MBANS equipment shall implement a spectrum access mechanism as described in the applicable harmonised European standard EN 303 203 or an equivalent spectrum access mechanism. Based on the assumptions used in ECC Report 201, the modulation bandwidth for MBANS shall not exceed 3 MHz.