Title:
DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE
DCO#:
00271
Document#:
870-00001-01
Originating Author:
E Keate
Modifying Author:
R. Massie
Date Created:
9/04/2018
Date Modified:
05/28/2020
Revision:
AR
Page
158 of 175
22
Standards and Compliance
The IDM100 Medical Tablet adheres to the FDA Regulatory, IEC/AAMI, and ISO, and Federal
Communications Commission (FCC) requirements.
22.1 General Compliance
Safety, EMC, and Regulatory Compliance
Agency Compliance
Standard
IEC/AAMI
3
rd
Edition, Medical electrical equipment
— Part 1: General requirements for safety
60601-1
Medical electrical equipment
— Part 1-2: General requirements for safety
60601-1-2
Medical electrical equipment
– Part 1-6 General requirements Usability
60601-1-6
Medical electrical equipment
— Part 1-11 General requirements for basic safety and
essential performance in home healthcare environment.
60601-1-11
Medical electrical equipment
— Part 2-25: Particular requirements for the basic safety
and essential performance of electrocardiographs
60601-2-25
Medical electrical equipment
— Part 2-49: Particular requirements for the basic safety
and essential performance of multi-function patient monitoring equipment.
60601-2-49
ISO
Medical electrical equipment
— Part 2-30: particular requirements for the safety,
including essential performance, of auto-cycling NIBP monitoring equipment
80601-2-30
Medical electrical equipment
— Basic safety and essential performance of SpO2
equipment for medical use
80601-2-61
Non-invasive sphygmomanometers
— Part 2: Clinical validation of automated
measurement type
81060-2
FDA
Cyber Security Guidance Oct 2, 2014
22.2 General Radio Compliance
Federal Communications Commission (FCC)
FCC Wireless Specifications
Wi-Fi product code
SDIO Wireless Module Model: SX-SDMAN
FCC ID
N6C-SDMAN
IC ID
4908B-SDMAN
