Application Field - Omron M6 Comfort Information Sheet

Please note that the device is not intended to diagnose Afib. A diagnosis
of Afib can only be confirmed by an Electrocardiogram (ECG). If the Afib
symbol appears, consult with your physician
The manufacturer produces M6 Comfort / X6 Comfort with the applicable
accessories included, necessary for the application of its intended
purpose.
1. Monitor
2. Arm cuff (HEM-FL31)
3. 4 "AA" batteries
4. Instruction Manual 1 and 2
5. Setup instructions
6. Storage case
The complete set of the medical device is specified in the Instruction
Manual 1 in the Specifications section.
The device is intended for use in measuring blood pressure and pulse
rate in adult patient population. It detects the appearance of irregular
heartbeats during measurement and gives a warning signal with readings.
It is mainly designed for general household use.
This unit is intended to be operated by adults who can understand this
instruction manual.
Before using this device please refer to 'Important Safety Information"
section of the Instruction Manual 1 and 2.
This device shouldn't be used by people mentioned in these sections.
Packaging content
Purpose

Application field

Intended User
6
PM-1826-01-07/2019
.