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New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
RS2 (HEM-6161-E)
OMRON HEALTHCARE EUROPE B.V.
Scorpius 33 2132 LR Hoofddorp The Netherlands
P.O. Box 2050 2130 GL Hoofddorp The Netherlands
Phone: +31 (0)23 55 44 700 fax +31 (0)23 55 44 701
www.omron.healthcare.com
BANKERS JP Morgan Chase Bank NA ACC. NR.
PM-1769-E-01-03/2018
413.90.366
IBAN GB04CHAS60924241390366 SWIFT CHASGB2L
CHAMBER OF COMMERCE NR. 342.10306
BTW/VAT NR. NL8132.86.281.B01
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Table of Contents
Related Manuals for Omron HEM-6161-E
Summarization of Contents
General Description and Usage
Packaging Content
Lists the items included with the HEM-6161-E, such as monitor, storage case, batteries, and manual.
Purpose of the Device
Describes the device's intended use for measuring blood pressure and pulse rate in adults with specific wrist circumferences.
Application Field
Details the device's capability to detect irregular heartbeats and its primary design for general household use.
Intended User Profile
Specifies that the device is for legally certified medical experts or healthcare personnel under guidance.
Device Features and Operation
Indications for Use
States the device is a digital monitor for measuring blood pressure and pulse rate in adult patients.
Key Product Features
Highlights unique selling points like Intellisense Technology, cuff wrapping guide, irregular heartbeat detection, and memory.
Operating Principle Explanation
Explains the oscillometric method used for blood pressure measurement and how the sensor displays readings.
How to Use the Device
Outlines the main steps for using the blood pressure monitor, from wrapping the cuff to turning off.
Technical Specifications
Product Category and Description
Defines the product as an Electronic Sphygmomanometer and an Automatic Wrist Blood Pressure Monitor.
Measurement Ranges and Accuracy
Details ranges for cuff pressure, blood pressure (SYS/DIA), pulse, and accuracy for pressure and pulse.
Operational and Environmental Data
Covers operating mode, IP classification, power source, battery life, operating conditions, and storage/transport conditions.
Physical Characteristics and Contents
Provides weight, dimensions, wrist circumference range, memory capacity, and package contents.
Materials and Safety Information
Materials List
Lists materials used for the main device components like housing, LCD, cloth, and bladder.
Harmonized EN Standards
Lists applicable medical device directive standards and EN standards for the device.
Operation and Care Instructions
Provides guidance on cleaning the device using a dry cloth or mild soap.
General Warnings and Precautions
Highlights important safety warnings, including not using on infants and consulting physicians.
Usage Guidelines and Warnings
Medication and Usage Restrictions
Advises against adjusting medication based on readings and lists specific conditions/situations for not using the monitor.
Battery Handling and Safety
Details safe battery handling, including keeping them away from children and consulting a doctor for exposure.
User Discomfort and Medical Conditions
Instructs users to consult a physician for skin irritation, specific medical conditions, or post-mastectomy.
Measurement Precautions
Covers precautions like not taking measurements too often, inflating cuff correctly, and avoiding electromagnetic interference.
Operational Precautions and Battery Care
Environmental and Usage Restrictions
Lists restrictions on use in moving vehicles, high/low humidity, or with other medical equipment simultaneously.
Pre-Measurement Preparation
Advises on avoiding certain activities before measurement, resting, and removing restrictive clothing/accessories.
Temperature Acclimation
Recommends acclimating the monitor to room temperature before measurement to ensure accuracy.
Battery Usage and Management
Details correct battery insertion, type, mixing, and handling of battery fluid exposure.
Disposal, Storage, and Maintenance
Environmental Disposal Guidelines
Provides instructions on following local regulations for disposal or recycling of the equipment and batteries.
Transportation and Storage Conditions
Specifies conditions for storing the monitor, including temperature and humidity ranges, and avoiding adverse environments.
Warranty and Lifetime Information
States the warranty term for the blood pressure monitor is 3 years and the durable period is 5 years.
Repair and Servicing Recommendations
Advises against self-repair and recommends consulting the OMRON retail outlet or distributor for servicing.
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