Avita BPM67 Bedienungsanleitung

Arm Type Blood Pressure Monitor

Model: BPM67

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

China, AViTA(WUJIANG)

Importer

Distributor

Contents

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

Important Information before Use ........................................................................... 2

Product Identification ..................................................................................................... 6

Description of LCD Display........................................................................................... 7

Battery Installation ........................................................................................................... 8

Setting the Date and Time............................................................................................ 9

Placement of the Pressure Sleeve............................................................................10

Measurement of Pulse Rate and Blood Pressure .............................................12

Hypertension Indicator ................................................................................................13

Irregular Heartbeat Detector.....................................................................................14

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

Memory Function ...........................................................................................................16

Error Codes........................................................................................................................18

Troubleshooting ..............................................................................................................19

Cleaning and Disinfecting...........................................................................................20

Technical Specification .................................................................................................21

EMC Tables.........................................................................................................................22

Explanation of Symbols................................................................................................24

Intended Use

The product automatically measures human being‟s 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 ~ 16.5 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, as of handicapped persons and children need assistance by

another person to use the device.

Contra-indications

Do not use in these cases: common arrhythmias such as atrial or

ventricular premature beats, atrial fibrillation, arterial sclerosis, poor

perfusion, diabetes, age, renal diseases, patient motion, trembling,

shivering.

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 making a measurement. 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 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.

12. If any serious incident that has occurred in relation to the device

should be reported to the manufacturer and the competent

authority of the Member State in which the user is established.

13. Do not expose the device to extreme temperatures, humidity dust or

direct sunlight as this may cause it to malfunction.

14. Please comply with the storage and operating conditions defined in

„Technical Specification‟. Storing or using the device outside of

the specified temperature and humidity range can affect

measurement accuracy or the function of the device.

15. If the device was not stored within the minimum/maximum

permissible storage conditions, a waiting period of at least 2 hours

must be observed before using it under the specified operating

conditions („Technical Specification‟) or an ambient temperature

of approx. 20 °C.

For Customer Service, the blood pressure monitor is calibrated when

manufactured; it is recommended that the accuracy should be

maintained and calibrated by manufacture triennially (every 3 years). To

obtain the service please contact AViTA Corp. for the address of the

repair location. Enclose with the Proof of Purchase. Include $10.00 USD

for the return shipping and handling. Accompany with a letter, with your

name, address, phone number, and description of the specific problem

or routine check-up. Pack the device carefully with bubble wraps (if

there is) to prevent damages cause during transit. Due to possible

losses in transit, it is recommended insuring the device with return

receipt requested. If in any way of assistance of setting up, using,

maintaining or to report unexpected operation/adverse events please

contact manufacturer or local representative for further assistance.

CAUTION:

•Beware of blood flow interference and resulting harmful injury to the

patient caused by continuous cuff pressure.

•While using monitoring ME equipment and blood pressure monitor

simultaneously being used on the same limb, pressurization of the

cuff may cause monitoring ME equipment temporarily dysfunction.

•Reading can be affected by the measurement site, the position of the

patient, exercise, or patient's physiologic condition.

•Automated sphygmomanometer can be affected by extremes of

temperature, humidity and altitude.

•Frequent measurements can cause injury to the patient due to blood

flow interference.

•Improper operation of automated sphygmomanometer may result in

prolonged impairment of patient blood circulation, please read

manual for proper use, if still not clear, contact professional health

care personnel or local distributor for assistant.

•Retake the measurement if unexpected readings are obtained.

•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.

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

•Keep this device out of the reach of children. Strangulation may result

from baby or child entanglement in cables.

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

•Preventing potential allergic reaction, please avoid the device in

direct contact to patient's wound.

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

•Do not apply the cuff over a wound, as this can cause further injury.

•Do not apply the cuff other then the original manufacturer provided.

•Do not use in these cases (e.g. Device for use in an ambulance,

helicopter or professional environment)

•Cuff pressure 0 –300 mmHg

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

•No modification of this equipment is allowed.

•High BMI health condition users may result varied.

•Users shall notify serious adverse event to the central competent

authority or its commissioned agency, legal entity, or manufacture.

Product Identification

Display

Cuff

Memory button (M key)

Start/Stop button (Power key)

Set button (S key)

Description of LCD Display

Low battery indicator

WHO indicator

Date & Time

Irregular Heartbeat Symbol

AF Symbol

Memory Symbol

Memory Set

Heartbeat Symbol

Pulse rate

Inflation / Releasing air

Systolic Pressure

Diastolic Pressure

User Symbol

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 device will not be

used for more than 1 month.

3. Batteries must be disposed of in accordance with local

environmental and institutional policies.

4. It is recommended not to use rechargeable, unqualified or different

spec battery may damage the device or cause circuit shortcut.

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