Omron RS2 Handbuch

PM-1769-E-01-03/2018

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.

413.90.366

IBAN GB04CHAS60924241390366 SWIFT CHASGB2L

CHAMBER OF COMMERCE NR. 342.10306

BTW/VAT NR. NL8132.86.281.B01

New Product Information Sheet

Specifications subject to change

Model (code): RS2 (HEM-6161-E)

PM-1769-E-01-03/2018

Product description: Automatic Wrist Blood Pressure Monitor

Product category: Electronic Sphygmomanometers

Model (code): RS2 (HEM-6161-E)

LEGAL MANUFACTURER

OMRON HEALTHCARE Co., Ltd

53, Kunotsubo, Terado-cho, Muko, KYOTO,

617-0002 Japan

PRODUCION FACILITY

OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.

No.28 VSIP II, Street2, Vietnam-Singapore Industrial Park II,

Binh Duong Industry-Services Urban Complex, Hoa Phu Ward,

Thu Dau Mot City, Binh Duong Province, Vietnam

EU REPRESENTATIVE

OMRON HEALTHCARE EUROPE B.V.

Scorpius 33, 2132 LR Hoofddorp,

THE NETHERLANDS

PM-1769-E-01-03/2018

Included accessories / optional accessories

n/a

General description

The RS2 is an automatic wrist blood pressure monitor, operating on the oscillometric

principle. This blood pressure monitor is to be worn on your wrist. When the cuff

inflates, this monitor senses the pressure pulsations of the artery underneath the cuff.

Packaging content

The manufacturer produces the HEM-6161-E with the applicable accessories

included, necessary for the application of its intended purpose.

1. Monitor

2. Storage case

3. 2 “AAA” alkaline batteries

4. Instruction Manual

Purpose

This device is a digital monitor intended for use in measuring blood pressure and

pulse rate in adult patient population with wrist circumference ranging from 13.5 cm

to 21.5 cm.

Application field

This monitor detects the appearance of irregular heartbeats during measurement

and gives a warning signal with readings. It is mainly designed for general household

use.

Intended user

• Legally certified medical experts, such as doctor, nurse and therapist, or

healthcare personnel or patient under the guidance of qualified medical

experts.

PM-1769-E-01-03/2018

• The user should also be capable of understanding general operation of this

device and the content of instruction manual.

Indications for use

This device is a digital monitor intended for use in measuring blood pressure and

pulse rate in adult patient population.

Features (Particularities)

RS2 (HEM-6161-E) is an automatic wrist type blood pressure monitor that has the

unique selling points as noted:

• Intellisense Technology

• Cuff wrapping guide

• Irregular heartbeat detection

• Pre-formed easy to fit cuff

• 30 memories

Description of operating principle

How it works

This blood pressure monitor uses the oscillometric method of blood pressure

measurement. When the cuff inflates, this monitor senses the pressure pulsations of

the artery underneath the cuff. The pulses are called oscillometric pulses. The

electronic pressure sensor displays a digital reading of blood pressure.

How to use the device

Main steps:

1. Wrap the wrist cuff correctly on a bare arm.

2. Sit correctly

3. Press start

4. Remain still until the measurement process is completed

5. Press the stop button to turn off

Review the Instruction Manual for the full details on the application of this product.

PM-1769-E-01-03/2018

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.

413.90.366

IBAN GB04CHAS60924241390366 SWIFT CHASGB2L

CHAMBER OF COMMERCE NR. 342.10306

BTW/VAT NR. NL8132.86.281.B01

Technical data

Product category Electronic Sphygmomanometers

Product Description Automatic Wrist Blood Pressure Monitor

Model (code) RS2 (HEM-6161-E)

Display LCD Digital Display

Cuff pressure range 0 to 299 mmHg

Blood pressure

measurement range

SYS: 60 to 260 mmHg

DIA: 40 to 215 mmHg

Pulse measurement range 40 to 180 beats / min.

Accuracy Pressure: ±3 mmHg

Pulse: ±5% of display reading

Inflation Automatic by electric pump

Deflation Automatic rapid deflation

Measurement method Oscillometric method

Operattion mode Continuous operation

IP classification IP 22

Rating DC3 V 3.0 W

Power source 2 “AAA” alkaline batteries 1.5V

Battery life Approximately 300 measurements (using new alkaline batteries)

Durable period (Service life) 5 years

Operating conditions +10°C to +40°C / 15 to 90% RH (noncondensing) / 800 to 1060 hPa

Storage / Transport

conditions

-20°C to +60°C / 10 to 90% RH (noncondensing)

Weight Approximately 85 g not including batteries

Dimensions Approximately 84 mm (w) × 62 mm (h) × 21 mm (l) (not including the wrist

cuff

)

Measurable wrist

circumference 13.5 to 21.5 cm

Memory Stores up to 30 readings

Contents Monitor, storage case, 2 “AAA” alkaline batteries, instruction manual

Protection against electric

shock Internally powered ME equipment

Applied part Type BF (wrist cuff)

Maximum temperature of the

applied par

Lower than +48°C

EAN code 401567211111 0

Note

• These specifications are subject to change without notice.

• In the clinical validation study, K5 was used on 85 subjects for determination of diastolic blood

pressure.

• This monitor is clinically investigated according to the requirements of ISO 81060-2:2013.

PM-1769-E-01-03/2018

• IP classification is degrees of protection provided by enclosures in accordance with IEC 60529. This

monitor is protected against solid foreign objects of 12.5 mm diameter and greater such as a finger,

and against oblique falling water drops which may cause issues during a normal operation.

• This device has not been validated for use on pregnant patients.

Materials used in main device and all accessories

Parts Name Material

Front Housing Acrylonitrile butadiene styrene

Ground Housing Acrylonitrile butadiene styrene

Battery Cover Acrylonitrile butadiene styrene

LCD Glass

Front Panel Polyethylene terephthalate

Outer Cloth Polyester

Inner Cloth Nylon

Collar Polypropylene

Bladder Polyvinyl chloride

PM-1769-E-01-03/2018

Title page of Instruction Manual

PM-1769-E-01-03/2018

Unfolded package design of main device and accessories

Main device:

Accessories:

n/a

Packaging specifications from Explanation Diagram

Package Amount Approx. weight Approx. dimensions

W x D x H, mm

Main Unit 1 85

84 x 21 x 62 mm

Packa

e 1 320

109 x 94 x 115 mm

Master Carton 10 3.64k

492 x 236 x 144 mm

PM-1769-E-01-03/2018

List of Harmonized EN Standards

The device is classified as a medical device, Class IIa (MDD Annex IX Rule 10)

Applicable Medical Device Directive (93/42/EEC) standards:

EN ISO 15223-1:2016

EN 1041:2008

EN 1060ꞏ1:1995+A2:2009

EN 1060ꞏ3:1997+A2:2009

EN 60601-1:2006+A1:2013

EN 60601-1-2:2015

EN 60601-1-6:2010+A1:2015

EN 60601-1-11:2015

EN 80601-2-30:2010+A1:2015

EN 62304:2006+A1:2015

EN 62366:2008+A1:2015

EN ISO 10993-1:20091AC:2010

EN ISO 10993-5:2009

EN ISO 10993-10:2013

EN ISO 14971:2012

EN ISO 81060-2:2014

Operation and care

Cleaning of the device

The device should be cleaned with a soft dry cloth, or a soft cloth moistened with

neutral soap to clean on the monitor and the wrist cuff.

Warnings

Please read the Important Safety Information in this instruction manual before using

this monitor.

Please follow this instruction manual thoroughly for your safety.

Please keep for future reference. For specific information about your own blood

pressure, CONSULT WITH YOUR PHYSICIAN.

Warning: Indicates a potentially hazardous situation which, if not avoided, could

result in serious injury.

• DO NOT use this monitor on infants, toddlers, children or persons who cannot

express themselves.

PM-1769-E-01-03/2018

• DO NOT adjust medication based on readings from this blood pressure monitor.

Take medication as prescribed by your physician. ONLY a physician is qualified to

diagnose and treat high blood pressure.

• DO NOT use this monitor on an injured wrist or a wrist under medical treatment.

• DO NOT apply the wrist cuff on your wrist while on an intravenous drip or blood

transfusion.

• DO NOT use this monitor in areas containing high frequency (HF) surgical

equipment, magnetic resonance imaging (MRI) equipment, computerized

tomography (CT) scanners. This may result in incorrect operation of the monitor

and/or cause an inaccurate reading.

• DO NOT use this monitor in oxygen rich environments or near flammable gas.

• Consult with your physician before using this monitor if you have common

arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial

sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease.

NOTE that any of these conditions in addition to patient motion, trembling, or

shivering may affect the measurement reading.

• NEVER diagnose or treat yourself based on your readings. ALWAYS consult with

your physician.

• This product contains small parts that may cause a choking hazard if swallowed by

infants, toddlers or children.

Battery Handling and Usage

• Keep batteries out of the reach of infants, toddlers or children.

Caution: Indicates a potentially hazardous situation which, if not avoided, may result

in minor or moderate injury to the user or patient, or cause damage to the equipment

or other property.

• Stop using this monitor and consult with your physician if you experience skin

irritation or discomfort.

• Consult with your physician before using this monitor on a wrist where intravascular

access or therapy, or an arteriovenous (A-V) shunt, is present because of temporary

interference to blood flow which could result in injury.

• Consult with your physician before using this monitor if you have had a mastectomy.

• Consult with your physician before using this monitor if you have severe blood flow

problems or blood disorders as cuff inflation can cause bruising.

• DO NOT take measurements more often than necessary because bruising, due to

blood flow interference, may occur.

• ONLY inflate the wrist cuff when it is applied on your wrist.

• Remove the wrist cuff if it does not start deflating during a measurement.

• DO NOT use this monitor for any purpose other than measuring blood pressure.

• During measurement, make sure that no mobile device or any other electrical

device that emits electromagnetic fields is within 30 cm of this monitor. This may

result in incorrect operation of the monitor and/or cause an inaccurate reading.

• DO NOT disassemble or attempt to repair this monitor or other components. This

may cause an inaccurate reading.

• DO NOT use in a location where there is moisture or a risk of water splashing this

monitor. This may damage this monitor.

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