we keep our digital guides up to date with helpful videos ... · we keep our digital guides up to...

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® We keep our digital guides up to date with helpful videos and FAQ’s based on questions from our users. Follow the link to view setup information, activate your warranty, and contact customer support.

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®

We keep our digital guides up to date with helpful videos and FAQ’s based on questions from our users. Follow the link to view setup information,

activate your warranty, and contact customer support.

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Symbol for “MANUFACTURER”

Symbol for “SERIAL NUMBER”

Symbol for “TYPE BF APPLIED PARTS”

Symbol for “DIRECT CURRENT”

Symbol for “MANUFACTURE DATE”

Symbol for “THE OPERATION GUIDE MUST BE READ”

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CAUTION

when

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Welcome to your new Balance Blood Pressure Monitor. We have designed this monitor to be as user-friendly as possible to ensure that you can use it with ease.

This model detects your blood pressure measurement by using the oscillometric method, which turns your blood pressure into a digital reading. With the oscillometric method, no stethoscope is needed. The model features blood pressure measurement, pulse rate measurement, two user modes, 60-entry memory storage per user, and a backlit LCD display for easy readability.

Please read the manual thoroughly before using this product.

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Blood pressure monitor is detecting an irregular heartbeat during measurement.

The displayed measurement value is from the memory feature

Cuff is deflating

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Remove batteries if the device is not likely to be used for some time.The old battery is harmful to the environment. Do not dispose with other daily trash.Remove the old battery from the device and follow your local recycling guidelines.Do not dispose of batteries in fire. Batteries may explode or leak.

CAUTION

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2~3cm

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1. When using this device, pay attention to the following situation, which may

interrupt blood flow and influence blood circulation of the patient, thus causing injury to the patient: too frequent and consecutive measurements; the application of the cuff and its pressurization on any arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; or inflating the cuff on the arm on the side of a mastectomy. 2. Do not apply the cuff over a wound, otherwise it can cause further injury.

3. Do not inflate the cuff on the same limb to which other monitoring ME EQUIPMENT is applied because this could cause temporary loss of function of the monitoring ME EQUIPMENT.4.continuously increase, which can prevent blood flow and result in injuryto the patient.

CAUTION

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;

Indications for UseThe Balance Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate for adults with an arm circumference ranging from 22cm to 42cm. It is intended for adult indoor use only.

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The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart-beat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

CAUTION

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About 22cm~42cm

Type BF applied part

WARNING: No modification of this equipment is allowed.

Power supply Battery powered mode:

Display mode

Measurement mode Oscillographic testing mode

Measurement range

Measurement perimeterof the upper arm

Net Weight Approx.175 g(Excluding the dry cells)

External dimensions

Attachment

Mode of operation Continuous operation

Degree of protectionProtection against ingress of water IP21

Accuracy

Normal working condition

Storage & transportationcondition

Software Version V01

Rated cuff pressure:

(40mmHg-230mmHg)pulse value: (40-199) beat/minute

Adaptor powered mode: 6V AC Use recommended cord

Atmospheric Pressure: 645mmHg ~ 795mmHg

Atmospheric Pressure: 375mmHg ~ 795mmHg

AC adapter, insert card

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Risk management

Labeling

User manual

Performance requirements and Clinical Investigation

Software life-cycle processes

ISO/EN 14971:2012 Medical devices — Application of risk management to medical devices

ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information tobe supplied. General requirements

EN 1041: 2008 Medical equipment manufacturers toprovide information

IEC 60601-1: 2005+A1:2012 Medical electricalequipment - Part 1: General requirements for basic safety and essential performance

IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard:Electromagneticcompatibility - Requirements and tests

IEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers

IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle processes

GeneralRequirementsFor Safety

Electromagneticcompatibility

ISO 14971: 2007

IEC 62304:2006

ISO 15223-1: 2012

IEC 60601-1-2:2007

ISO 81060-2:2009 Non-invasive sphygmomanometersPart 2: Clinical investigation of automated measurement type.

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in.

B

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DISTRIBUTED BY: Greater Goods LLC | 125 N Main St. | Suite 202 | St. Louis, MO 63301

CONTACT US800.481.0233 | M-F 9-5 CST

greatergoods.com/0602 | online guide

[email protected] | any time