Indications For Use Statement; Statement; Additional Information - Orbegozo TES 4650 Manual De Instrucciones

TES 4650

INDICATIONS FOR USE STATEMENT

− The unit is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the
upper arm by using the oscillometric method.
− The unit is intended for using in only adult population, not applied to the other populations such as
neonatal baby.
− It can't be used while the wirst (arm) has bleeding or wound to avoid the blood flowing from the wound
in pressurzing.

STATEMENT

− The unit satisfies the requirements of IEC60601-1 Medical electrical equipment, EN1060-1: Non-invasive
sphygmomanometer, EN1060-3: Non-invasive sphygmomanometer.
− The unit has passed the EMC test.
− The Unit complies with IEC 80601-2-30.
− The risk of patient and user can be lowered to acceptable level.
− Substitution of a cuff different from that supplied might result in measurement error.
− Specifications are subject to change without notice due to improvements in performance.
− The unit might not meet its performance specifications if stored or used outside the following specified
temperature and humidity ranges.

ADDITIONAL INFORMATION

Protection Class: Internally powered equipment
Applied Part Type: Type B
Moisture Protection: IPX0, continue operation
WARNING: No modification of this equipment is allowed.
Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, this machine should be observed to verify normal operation in the configuration
in which it will be used.
Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
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The unit satisfies the requirements of
- EN60601-1：Medical electrical equipment Part 1: General requirements for basic safety and
essential performance;
- EN60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility – Requirements and
tests;
- EN1060-1: Non-invasive sphygmomanometers – requirements;
- EN1060-3: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring system.
- EN1060-4：Non-invasive sphygmomanometers – Part 4: Test procedures to determine the
overall system accuracy of automated non-invasive sphygmomanometers.
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in this manual
WARNING: The use of other accessories, transducers and cables other than those provided may result in
increased emissions or decreased immunity of the equipment.
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