SHL-989XT - Blood pressure monitor HealthyLine - Free user manual and instructions

USER MANUAL SHL-989XT HealthyLine

Abstract 3D spiral shape with gradient shading, no text or symbols present

xcrystal™

Innovative See-through Display

SOLUȚII PENTRU O SĂNĂTATE PERFECTĂ

CUPRINS

Atentionari 02

Top-down schematic of a device layout with no visible text or symbols

Diagram of a battery pack with multiple compartments and polarity indicators (no text or labels)

Atentie!

Line drawing of a person using a blood pressure monitor (no text or symbols present)

MĂSURAREA TENSIUNII

NOTĂ!

NOTĂ!

Importer: S.C. Deck Computers Int. S.R.L.

Consumator:

This blood pressure monitor complies with the EC Directive and bears the CE mark "CE0197". This blood pressure monitor also complies with mainly following standards (included but not limited):

Safety standard:

EN 60601-1 Medical electrical equipment part 1: General requirements for safety

EMC standard:

EN 60601-1-2 Medical electrical equipment part 1-2: General requirements for safety- Collateral standard: Electromagnetic compatibility- Requirements and tests

Performance standards:

EN 1060-1 Non-invasive sphygmomanometers - General requirements

EN 1060-3 Non-invasive sphygmomanometers - Supplementary requirements for electromechanical blood pressure measuring systems.

EN 1060-4 Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.

Important/Caution/Note!

Read the operating instructions.

Consult instructions thoroughly before use.

NOTE

Classification:

• Internally powered equipment
• BF type applied part
• IPX0
• Not suitable for use in presence of flammable anesthetic mixture with air or with Oxygen or nitrous oxide
• Continuous operation with short-time loading

To avoid inaccurate results caused by electromagnetic interference between electrical and electronic equipments, do not use the device near a mobile phone or microwave oven.

Discard the used product to the recycling collection point according to local regulations.

EC REP

EMERGO EUROPE

Molenstraat 15, 2513 BH, The Hague, The Netherlands

Phone: [phone]

Fax: [phone]

Appendix

Guidance and manufacturer's declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
Emissions test	Compliance	Electromagnetic environment – guidance
RF emissions CISPR 11	Group 1	The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class B	The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2	Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3	Complies

Guidance and manufacturer's declaration – electromagnetic immunity

The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:

Appendix

Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment –guidance
Electrostatic discharge (ESD)IEC 61000-4-2	±6 kV contact±8 kV air	±6 kV contact±8 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrical fast transient/burstIEC 61000-4-4	±2 kV for power supply lines±1 kV for input/output lines	±2 kV for power supply lines±1 kV for input/output lines	Mains power quality should be that of a typical commercial or hospital environment.
SurgeIEC 61000-4-5	±1 kV line(s) to line(s)±2 kV line(s) to earth	±1 kV line(s) to line(s)±2 kV line(s) to earth	Mains power quality should be that of a typical commercial or hospital environment.
interruptions and voltage variations on power supply input linesIEC 61000-4-11	<5 % UT(>95 % dip in UT)for 0,5 cycle	<5 % UT(>95 % dip in UT)for 0,5 cycle	Mains power quality should be that of a typical commercial or hospital environment. If the user of the device] requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
	40 % UT(60 % dip in UT)for 5 cycles	40 % UT(60 % dip in UT)for 5 cycles
	70 % UT(30 % dip in UT)for 25 cycles	70 % UT(30 % dip in UT)for 25 cycles
	<5 % UT(>95 % dip in UT)for 5 sec	<5 % UT(>95 % dip in UT)for 5 sec
Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8	3 A/m	3 A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Appendix

Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should only be used in such environments:
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6Radiated RF IEC 61000-4-3	3 Vrms150 kHz to 80 MHz3 V/m80 MHz to 2,5 GHz	3 Vrms3 V/m	Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended separation distance d = 1,2 d = 1,2 80 MHz to 800 MHz d = 2,3 800 MHz to 2,5 GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m)Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveys, should be less than the compliance level in each frequency range.Interference may occur in the vicinity of equipment marked with the following symbol:_
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propa is affected by absorption and reflection from structures, objects and people.

Appendix

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communication equipment and the device.

The device is intended for use in an electromagnetic environment where radiated RF disturbances are under control. User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment (transmitters). Below table details the maximum output power of transmitter:

Rated maximum output power of transmitter W	Separation distance according to frequency of transmitter m
	150 kHz to 80 MHz d = 1,2	80 MHz to 800 MHz d = 1,2	800 MHz to 2,5 GHz d = 2,3
0,01	0,12	0,12	0,23
0,1	0,38	0,38	0,73
1	1,2	1,2	2,3
10	3,8	3,8	7,3
100	12	12	23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

JURNAL DATE MĂSURATE

DATA ORA

SISTOLICA/DIASTOLICA PULS

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JURNAL DATE MĂSURATE

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CE _0197 RoHS

CertifiedbyTUVRheinland, Germany