Omron RS7 Intelli IT Bedienungsanleitung

PM-1771-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):

RS7 Intelli IT (HEM-6232T-E)

PM-1771-E-01-03/2018

Product description: Automatic Wrist Blood Pressure Monitor

Product category: Electronic Sphygmomanometers

Model (code): RS7 Intelli IT (HEM-6232T-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-1771-E-01-03/2018

Included accessories / optional accessories

n/a

General description

The RS7 Intelli IT 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-6232T-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

5. Setup instructions

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.

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Intended user

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

healthcare personnel or patient under the guidance of qualified medical

experts.

• 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)

RS7 Intelli IT (HEM-6232T-E) is an automatic wrist type blood pressure monitor that

has the unique selling points as noted:

• Intellisense Technology

• OMRON connect mobile application for iPhone / AndroidTM

• Cuff wrapping guide

• Irregular heartbeat detection

• Pre-formed easy to fit cuff

• Stores up to 100 readings per user

• Average of 3 readings

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.

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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.

Technical data

Product category Electronic Sphygmomanometers

Product Description Automatic Wrist Blood Pressure Monitor

Model (code) RS7 Intelli IT (HEM-6232T-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

Transmission method Bluetooth® low energy technology

Wireless communication Frequency range: 2.4 GHz (2400 - 2483.5 MHz)

Modulation: GFSK

Effective radiated power: < 20 dBm

Operation 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)

PM-1771-E-01-03/2018

Weight Approximately 91 g not including batteries

Dimensions Approximately 91 mm (w) × 63 mm (h) × 13 mm* (l)

(

not includin

the wrist cuff

)

Measurable wrist

circumference 13.5 to 21.5 cm

Memory Stores up to 100 readings per user

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

instructions

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 401567211117 2

* thinnest part

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.

• 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.

PM-1771-E-01-03/2018

Materials used in main device and all accessories

Parts Name Material

Front Housing Acrylonitrile butadiene styrene

Polymethyl methacrylate

Ground Housing Acrylonitrile butadiene styrene

Battery Cover Acrylonitrile butadiene styrene

Button Acrylonitrile butadiene styrene

Polymethyl methacrylate

LCD Glass

Robber key Silicone Rubber

Cloth Bag Polyester

Polyvinyl chloride

Air bag Polyvinyl chloride

Nipple Polyvinyl chloride

Ring Low Carbon Steel Wire Rods

Collar Polypropylene

PM-1771-E-01-03/2018

Title page of Instruction Manual

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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 90

91 x 13.4 x 63.4 mm

Packa

e 1 297

90 x 90 x 115 mm

Master Carton 10 3.2k

472 x 198 x 144 mm

PM-1771-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.

Andere Handbücher für RS7 Intelli IT

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