advertisement
Model No.
Display
Measuring Principle
Measurable
Circumference of Wrist
Electric Shock Protection
Back Light
Measurement
Range
Pressure
Accuracy
Pulse
Pressure
Pulse
LCD
Indication
Pressure
Pulse
Symbol
Specifications
BW2119
LCD Digital Display
Oscillometric Method
13.5~21.5cm (5.3''~8.5'')
Internal power supply appliance type B
White
0 to 299 mmHg (0~39.9 kPa)
40 to180 Pulses/min
3 mmHg (0.4kPa)
5% of reading
3 Digits Display of mmHg or kPa
3 Digits Display
Memory/IHB/Heartbeat/Low Battery,etc.
33
Statement
The intended use: The unit is intended to be used by adults at home or medical centre to measure blood pressure and pulse rate.
The unit satisfies the requirements of IEC60601-1 Medical electrical equipment,
EN1060-1: Non-invasive sphygmomanometer, EN1060-3: Non-invasive sphygmomanometer,IEC80601-2-30: Medical electrical equipment.
The unit has passed the EMC Test.
Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard,
Manual, electronic, or automated sphygmomanometers.
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.
Please contact us if you need the circuit diagrams, component part lists etc.
Specifications are subject to change without notice due to improvements in performance.
35
Specifications
Inflation
Rapid Air Release
Memory Function
Power Source
Automatic Power-Off
Dimensions
Gross Weight
Automatic by Internal Pump
Automatic by Air Valve
Memory 180 (2*90) Sets Measurement Values
2 AAA Alkaline Batteries
In 2 Minutes
Approx. 87*84*36mm
Approx. 160g (Batteries not included)
Operating
Environment
Transport and
Storage
Environment
Temperature
Humidity
Barometric Pressure
Temperature
Humidity
34
10 ~ 40 C (50 ~ 104 F)
15 ~ 90%RH (Noncondensing)
80~105 kPa
-20 ~ 60 C (-4 ~ 140 F)
10 ~ 95%RH (Noncondensing)
Warranty Information
Federal law restricts this device to sale by or on the order of a physician.
The unit, excluding the unit cuff, is guaranteed to be free of defects in workmanship and materials for a period of two years from the date listed on the purchase record, when used in accordance with the instructions provided with the unit.The unit cuff is warranted to be free from defects in materials and workmanship appearing within one year from the date listed on the purchase record when the unit is used in accordance with the instructions provided with the unit.
For repair under this warranty.Our authorized service agent must be advised of the fault within the period of the warranty.This warranty covers parts and labor only under normal operations.A transportation fee or freight fee that may be incurred will be the owner’s responsibility.Any defect resulting from natural causes, e.g.,flood,hurricane etc., is not within this guarantee.
This guarantee does not cover damage incurred by use of the unit not in accordance with the instructions, accidental damage, or being tampered with or serviced by unauthorized service agents.
Unit subjected to misuse, abuse, and neglect of these manual contents, non-instructional purposes;unauthorized repair or modifications will be excluded from this warranty. This guarantee specifically excludes expendables and consumables, for example batteries.All warranty claims must be directed to the distributor responsible for the sale of the device. The content of this warranty is subject to change without further notice.
36
Warranty Information
Periodical check:
Sensitive measuring devices must be checked from time to time for accuracy and leakage, we therefore recommend that the performance should be checked every 2 years and after maintenance and repair.
Please contact the local distributor for details.
Clean the cuff with a soft dry cloth.
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 – Part 1: General 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.
37
Warranty Information
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.
*MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS.
*Portable and mobile RF communications equipment can affect MEDICAL
ELECTRICAL EQUIPMENT.
* Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!
WARNING:
The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the COMPRESSOR NEBULIZER as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
39
Warranty Information
Warning: Do not use luer lock connector in the construction of tubing. There
Is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel.
It can’t be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
It can’t be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
Applied parts contains cuff.
The device，accessories and the packaging have to be disposed of waste correctly at the end of the usage. Please follow Local Ordinances or
Regulations for disposal.
Protection Class: Internally powered equipment
Applied Part Type: Type B
Moisture Protection: IPX0, continue operation
WARNING: No modification of this equipment is allowed.
Manufacturer will make available on request circuit diagrams, component part lists etc for the service personnel in parts repair.
38
Warranty Information
Guidance and manufacture’s declaration
Guidance and manufacture’s declaration – electromagnetic emission
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
RF emissions
CISPR 11
Compliance
Group 1
Electromagnetic environment – guidance
The Digital Blood Pressure Monitor use 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 emission
CISPR 11
Harmonic emissions
IEC 61000-3-2
Class B
Not applicable
The Digital Blood Pressure Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not applicable
40
Warranty Information
Guidance and manufacture’s declaration – electromagnetic immunity
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor should assure that it is used in such an environment.
Immunity test
IEC 60601 test Compliance level level
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
Power frequency
(50Hz/60Hz) magnetic field IEC
61000-4-8
±6 kV contact
±8 kV air
3A/m
±6 kV contact
±8 kV air
3A/m
Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
41
Warranty Information
Immunity test
Radiated RF
IEC 61000-4-3
IEC 60601 test Compliance level level
3A/m
80 MHz to 2.5
GHz
3A/m
Electromagnetic environment - guidance survey,a should be less than the compliance level in each frequency range.b
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 propagation is affected by absorption and reflection from structures, objects and people.
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 Digital Blood Pressure
Monitor is used exceeds the applicable RF compliance level above, the Digital Blood
Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Digital Blood Pressure Monitor.
43
Warranty Information
Guidance and manufacture’s declaration – electromagnetic immunity
The Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Digital Blood Pressure Monitor should assure that it is used in such an environment.
Immunity test
IEC 60601 test Compliance level level
Electromagnetic environment - guidance
Radiated RF
IEC 61000-4-3
3A/m
80 MHz to 2.5
GHz
3A/m
Portable and mobile RF communications equipment should be used no closer to any part of the Digital Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where 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
42
Warranty Information
Recommended separation distances between portable and mobile RF communications equipment and the Digital Blood Pressure Monitor.
Pressure Monitor is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Digital Blood Pressure
Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Digital
Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment.
output power of transmitter
Separation distance according to frequency of transmitter
(m)
80 MHz to 800 MHz
80 MHz to 800 MHz
0.01
0.1
1
0.117
0.369
1.167
0.233
0.738
2.333
10
100
3.689
11.667
7.379
23.333
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.
44
advertisement
Related manuals
advertisement