Avita BPM83 Bedienungsanleitung

Arm Type Blood Pressure Monitor

Model: BPM83

INSTRUCTION MANUAL

PLEASE READ THIS INSTRUCTION MANUAL COMPLETELY

BEFORE OPERATING THIS UNIT

RoHS REACH

MDSS GmbH

Schiffgraben 41

30175 Hannover Germany

AViTA Corporation

9F., No. 78, Sec. 1, Kwang Fu Rd.,

San Chung Dist., New Taipei City 24158, Taiwan

China, AViTA(WUJIANG)

Importer

Distributor

Contents

Intended Use....................................................................................................................... 1

Type of Use/ Reuse........................................................................................................... 1

Intended User..................................................................................................................... 1

Important Information before Use ........................................................................... 3

Product Identification ..................................................................................................... 5

Description of LCD Display........................................................................................... 6

Battery Installation ........................................................................................................... 7

Setting the Date and Time............................................................................................ 8

Placement of the Pressure Sleeve.............................................................................. 9

Measurement of Pulse Rate and Blood Pressure .............................................11

World Health Organization (WHO).........................................................................12

Irregular Heartbeat Detector.....................................................................................13

Atrial Fibrillation (AFIB).................................................................................................14

Memory Function ...........................................................................................................15

Error Codes........................................................................................................................17

Troubleshooting ..............................................................................................................18

Cleaning and Disinfecting...........................................................................................19

Technical Specification .................................................................................................20

EMC Tables.........................................................................................................................21

Explanation of Symbols................................................................................................23

Intended Use

The BPM83 automatically measures human begins Systolic, Diastolic

blood pressure and pulse rate by oscillometric method. The

measurement results are displayed on the LCD. Measurement position

is at human being's upper arm. The intended use of this

over-the-counter device is for adults with upper arm circumference

ranging from 220 mm to 420 mm (Approx. 8.7 ~ 16.6 inches) and for

home use. When the device detects the appearance of irregular

heartbeats such as atrial or ventricular premature beats during

measurement, an indicated symbol will appear with measuring

readings.

This device is designed only for adults.

Type of Use/ Reuse

Multiple patient multiple use

Intended User

The Arm type blood pressure monitor is intended or both professional

and consumer, and the patient is the intended operator.

Patient selection criteria: Handicapped persons and children are the

exception of handicapped persons and children need assistance by

another person to use the device.

Contra-indications

Do not use in this case. (e.g. common arrhythmias such as atrial or

ventricular premature beats or atrial

fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy,

pre-eclampsia, renal diseases, patient motion, trembling, shivering)

Warnings

•Do not use with pregnant or pre-eclamptic patients

•Regarding the effect of blood flow interference and resulting harmful

injury to the patient caused by continuous cuff pressure due to

connection tubing kinking.

•Regarding the information that pressurization of the cuff can

temporarily cause loss of function of simultaneously used monitoring

ME equipment on the same limb.

•Regarding the need to check that operation of the automated

sphygmomanometer does not result in prolonged impairment of

patient blood circulation.

•An explanation that any reading can be affected by the measurement

site, the position of the patient, exercise, or the patient's physiologic

condition.

•Details of what the operator should do if unexpected readings are

obtained.

•An explanation of the need to avoid compression or restriction of the

connection tubing.

•Ensure that the cuff is not placed on an arm in which the arteries or

veins are undergoing medical treatment, e.g. intravascular access or

therapy, or an arteriovenous (AV) shunt.

•Do not use the cuff on people who have undergone a mastectomy.

•Do not too frequent measurements can cause injury to the patient

due to blood flow interference.

•Do not application of the cuff over a wound, as this can cause further

injury.

•Cuff pressure 0 –300 mmHg

CAUTION:

•automated sphygmomanometer can be affected by extremes of

temperature, humidity and altitude.

•Reduction rate: Refer to IEC 80601-2-30 ≦30S

•This product is not suitable for use with pregnant, including neonatal

or pre-eclamptic patients

Important Information before Use

1. Blood pressure measurements should only be interpreted by a

physician or a trained health care professional who is familiar with

your medical history. Through regular use of this device and

recording of your measurements, you can keep your physician

informed of the changes in your blood pressure.

2. Perform your measurement in a quiet place. You should be seated in

a relaxed position.

3. Avoid smoking, eating, taking medication, alcohol consumption or

physical activity 30 minutes prior to taking a reading. If you are

exhibiting signs of stress, avoid taking your measurement until the

feeling subsides.

4. Rest 15 minutes prior to taking a reading.

5. Remove any constrictive clothing or jewelry that may interfere with

the cuff placement.

6. Keep the monitor stable during measurement to achieve an

accurate reading. Remain still; do not talk during the measurement.

7. Record your daily blood pressure and pulse readings on a chart.

8. Take your readings at the same time, each day or as recommended

by your physician to get an accurate indication of change in your

true blood pressure.

9. Wait a minimum of 15 minutes between readings to allow for the

blood vessels to return to normal. The wait time may vary

depending on your individual physiological characteristics.

10. Although such cases are rare, for those with an extremely weak

pulse or irregular pulse, errors may result which prevent proper

measurement. If abnormal variations are noticed, consult with your

physician or trained healthcare professional.

11. This device is intended for adult use. While taking a measurement,

you can stop the inflation or deflation process of the cuff at any

time by pressing the POWER button.

For Customer Service, It is recommended that the accuracy should be

checked by manufacture every 2 years. To obtain the service please

contact AViTA Corp. for the address of the repair location. Enclose the

Proof of Purchase. Include $10.00 USD for the return shipping and

handling. Include a letter, with your name, address, phone number, and

description of the specific problem. Pack the product carefully to

prevent damage in transit. Because of possible loss in transit, we

recommend insuring the product with return receipt requested. If in

need of assistance of setting up, using, maintaining or to report

unexpected operation/events please contact manufacturer or local

representative for further information and assistance. Avoid the sensor

degrading, it is needed calibrate the device every 2 year.

•Do not use in this case. (e.g. Device for use in an ambulance or

helicopter, For use in the professional environment.)

•This product is suitable for use in the home healthcare environment.

•The performance of the device can be affected by extremes of

temperature, humidity and altitude, Please refer to the instructions

for use.

CAUTION:

-Keep this device out of the reach of children. Strangulation

resulting from baby or child entanglement in cables.

-Please keep this device away from pets, pests, and children.

-Avoid potential allergic reactions; please avoid the device in direct

contact to patient's wound.

-No modification of this equipment is allowed.

Product Identification

Air socket

WHO Indicator

Start/Stop button (Power key)

Memory button ( M key)

Set button (S key)

Display

Cuff

Cuff connector

Cuff tube

Description of LCD Display

Low battery indicator

WHO indicator

Date & Time

Irregular Heartbeat Symbol

AF Symbol

Memory Symbol

Memory Set

Heartbeat Symbol

Pulse rate

Release air

Systolic Pressure

Diastolic Pressure

Battery Installation

Low battery warning:

It is necessary to replace the batteries when the Low Battery symbol

“ ” appears on the display, or when the display does not turn on

after the POWER key is pressed.

Replacing the Battery::

1. Press down on latch and lift the cover on the bottom of the monitor.

2. Insert or replace 4x 1.5 V AAA batteries into the battery

compartment, ensuring to match the indicated polarity symbols.

Always use new batteries.

3. Replace the battery cover.

CAUTION:

Risk of explosion if battery is replaced by an incorrect type. Dispose of

used batteries according to the instructions.

NOTE: Battery-operated

1. Please properly dispose of the batteries away from small children

and heat. Avoid the children accidentally swallow the battery.

2. It is recommended to remove the batteries if the unit will not be

used for more than 1 month.

3. Batteries must be disposed of in accordance with local

environmental and institutional policies.

Setting the Date and Time

It is necessary to set the date and time for the unit every time batteries

are initially installed or replaced.

To set the date and time, proceed as follows:

•While in power off mode, press and hold the “SET” key for at least 3

seconds to enter Date and Time setting procedure and the Year value

will begin to flash.

•Press the “SET” key to advance the display to the desired year, press

the “M” key to confirm the year.

•Next, the month will blink. Repeat step 2 to set the month and date,

then hours, then minutes.

•After setting the minutes, the unit will automatically exit out of the

date/time setting mode and shut off.

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