Indications For Use Statement; Guidance And Manufacture's Declaration; Electromagnetic Emission - Orbegozo TES 3650 Manuel D'instructions

TES 3650

INDICATIONS FOR USE STATEMENT

− The unit is intended to be used by adults to measure blood pressure and pulse rate.
− The unit is intended of using in only adult population, not applied to the other populations such as
neonatal baby.
− It cannot be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound
in pressuring.
− The device, part and batteries have to be disposed of waste correctly at the end of the usage.
− Please follow local ordinances or regulations for disposal.
− Applied part: cuff
− Protection class: internally powered equipment.
− Applied part type: type BF.
− Moisture protection: IPX0, continue operation.
Altitude <2000 m.
Overvoltage: II
Pollution degree: 2
− The risk of patient and user can be lowered to acceptable level
− The unit might not meet its performance specifications if stored or used outside the following specified
temperature and humidity ranges.
− The unit satisfies the requirements of IEC60601-1 Medical electrical equipment; IEC60601-1-2:2007:
Electromagnetic compatibility-Requirements and tests; EN1060-1; Non-invasive sphygmomanometers-Part
1: requirements and test methods for non-automated measurement type; EN1060-3: Non-invasive
sphygmomanometers – Part 3: supplementary requirements for electro-mechanical blood pressure
measuring systems.

GUIDANCE AND MANUFACTURE'S DECLARATION

The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The
customer of the user of the Digital Blood Pressure Monitor should assure that it is used in such an environment.
Emission test
Radio frequency (RF) emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3

ELECTROMAGNETIC EMISSION

Compliance
The Digital Blood Pressure Monitor use RF energy only for
its internal function. Therefore, its RF emissions are very
Group 1
low and are not likely to cause any interference in nearby
electronic equipment.
Class B
The Digital Blood Pressure Monitor is suitable for use in all
Not applicable establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Not applicable
Electromagnetic environment – guidance
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