Bedienungsanleitung iHealth BP7 - Sense (Seite 9 von 24) (Englisch)

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SPECIFICATIONS

1. Product name: Wireless Blood Pressure Wrist Monitor

2. Model: BP7

3. Classiﬁcation: Internally powered; Type BF applied part; IPX0, No AP or APG; Continuous operation

4. Machine size: approx. 2.8"×2.9"×0.7" (72mm×74mm×17.6mm)

5. Cuff circumference: 5.3"- 8.7" (13.5cm-22cm), one size only

6. Weight: approx. 3.7oz(106g)(including cuff)

7. Measuring method: Oscillometric method, automatic inﬂation and measurement

8. Memory volume: 120 times with time and date stamp (off-line measurement only)

9. Power: DC:5.0V 1.0A, Battery: 1*3.7V Li-ion 400mAh

10. Measurement range:

Cuff pressure: 0-300 mmHg

Systolic: 60-260 mmHg

Diastolic: 40-199 mmHg

Pulse rate: 40-180 beats/minute

11. Accuracy:

Pressure: ±3 mmHg

Pulse rate: ±5%

12. Wireless communication:

Bluetooth V3.0 + EDR Class 2 SPP

Frequency Band: 2.402-2.480 GHz

13. Environmental temperature for operation: 5°C~40°C(41°F~104°F)

14. Environmental humidity for operation: ≤90%RH

15. Environmental temperature for storage and transport:-20°C~55°C(-4°F~131°F)

16. Environmental humidity for storage and transport: ≤90%RH

17. Environmental pressure: 80kPa-105kPa

18. Battery life: more than 80 measurements on a full charge

19. The blood pressure measurement system includes accessories: pump, valve, cuff, and sensor.

Note: These speciﬁcations are subject to change without notice.

GENERAL SAFETY AND PRECAUTIONS

1. Read all of the information in the Owner’s Manual and other provided instructions before

operating the unit.

2. Consult your physician for any of the following situations:

a) The application of the cuff over a wound or inﬂamed area.

b) The application of the cuff on any limb with intravascular access or therapy, or an arterio-

venous (A-V) shunt.

c) The application of the cuff on the wrist on the side of a mastectomy.

d) Simultaneous use with other medical monitoring equipment on the same limb.

e) The blood circulation of the user needs to be checked.

3. Do not use this product in a moving vehicle as this may result in inaccurate measurements.

4. Blood pressure measurements determined by this product are equivalent to those obtained by

professional healthcare practitioners using the cuff/stethoscope auscultation method within the

limits prescribed by the American National Standard, Electronic or Automated Sphygmomanom-

eter.

5. When a call comes in during the measurement, the measurement process will be terminated

automatically. It is recommended that the iOS device be set in Airplane mode during measure-

ment to avoid strong magnetism interference.

6. If Irregular Heartbeat (IHB) is detected during the measurement procedure, the IHB symbol will

be displayed. Under this condition, the Wireless Blood Pressure Wrist Monitor can keep

functioning, but the results may be inaccurate. Please consult your physician for accurate

assessment.

There are 2 conditions under which the signal of IHB will be displayed:

1) The coefﬁcient of variation (CV) of pulse period >25%.

2) The difference of adjacent pulse period ≥0.14s and the number of such pulse takes more than

53 percent of the total number of pulses.

7. Please do not use any other cuff other than that supplied by the manufacturer as this may result

in measurement errors and a biocompatible hazard.

8. Information regarding potential electromagnetic or other interference between the blood

pressure monitor and other devices together with advice regarding avoidance of such interfer-

ence, please see ELECTROMAGNETIC COMPATIBILITY INFORMATION. It is suggested that the

blood pressure monitor be kept 10 meters away from other wireless devices, such as WLAN

unit, microwave oven, etc.

9. This product should not be used as a USB device.

10. This product is veriﬁed by auscultatory method. It is recommended that you check Annex B of

ANSI/AAMI SP-10:2002+A1:2003+A2:2006 for veriﬁcation method details if needed.

11. If the determined blood pressure (systolic or diastolic) is outside the rated range speciﬁed in

part SPECIFICATIONS, the app will immediately display a technical alarm on screen. In this

case, consult a physician or ensure that proper measurement procedures are followed. The

technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical

alarm is assigned as low priority according to IEC 60601-1-8.The technical alarm is

non-latching and does not need to be reset.

12. A medical AC adapter with an output of DC 5.0V and complies with IEC 60601-1/UL 60601-1

and IEC 60601-1-2/EN 60601-1-2 is suitable for this monitor, such as ASP5-05010002JU

(input: 100-240V, 50/60Hz, 200mA; output: DC 5.0V, 1.0A). Please note that the monitor jack

size is USB mini B.

This Wireless Blood Pressure Wrist Monitor is designed for adults and should never be used

on infants, young children, pregnant or pre-eclamptic patients. Consult your physician before

use on children.

This product might not meet its performance speciﬁcations if stored or used outside the

speciﬁed temperature and humidity ranges.

Please do not share the cuff with any infectious person to avoid cross-infection.

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