BPM-100
Specifications for BPM-200 are, in most cases, same or very similar to BPM-100.
Item |
Specification |
Blood Pressure Range |
0 to 290 mmHg |
Blood Pressure Accuracy |
Complies with ANSI/AAMI SP10:1992. Greater of 3 mmHg or 2%. |
Systolic Blood Pressure Range |
60 to 250 mmHg |
Diastolic Blood Pressure Range |
40 to 160 mmHg |
Pulse Rate Range |
40 to 200 beats per minute |
Blood Pressure Measurement Efficacy
|
Meets or exceeds ANSI/AAMI SP10:1992 standard for overall efficacy of blood pressure measurements versus standard auscultation (using the 5th Korotkoff sound). Average error within +/- 5 mmHg Standard deviation within 8 mmHg. |
Pulse rate measurement
efficacy |
Meets or exceeds specification against a clinical reference Average error within +/- 1
beats per minute Standard deviation within 3 beats per minute |
Maximum operating cuff
pressure |
290 mmHg |
Maximum possible cuff
pressure |
330 mmHg |
Maximum possible cuff
inflation time |
Over 10 mmHg for 3 minutes |
Input power requirements
to regulated power supply |
North American AC power supply range of 104 to 127 Vrms (nominally 60 Hz), European AC power supply range of 207 to 253 Vrms (nominally 50 Hz). Australian AC power supply range of 216 to 264 Vrms (nominally 50Hz) |
Output power of
regulated power supply |
8 V, 1 A |
Environmental operating
ranges |
Temperature: 10 to 40 degrees Celsius Humidity: 15 to 90 % RH (non-condensing)
Elevation: -170 to 1,700 m (from sea level) |
| Device lifetime |
10,000 full scale NIBP cycles of 0 to 290 mmHg and back |
| Physical dimensions |
Height: 13 cm Width: 23 cm Depth: 10 cm |
| Weight |
2.5 kg (5.5 lb) including accessories |
Standards Compliance
The BPM-100 with serial numbers less than 008000 are certified to or comply with the following standards:
- CAN/CSA C22.2 No. 601.1-M90, Medical Electrical Equipment – Part 1: General requirements for safety, 1990.
- UL 2601-1:1998, Medical Electrical Equipment – Part 1: General requirements for safety, 1998.
- ANSI/AAMI, SP10:1992, Electronic or automated sphygmomanometers, 1992.
- IEC 60601-1 (1998), Medical Electrical Equipments – Part 1. General Requirements for Safety, 1998 (equivalent to EN 60601-1).
- IEC 60601-1-2 (1993), Medical Electrical Equipment – Part 1. General Requirements for Safety; Electromagnetic Compatibility – Requirements and Tests, 1993 (equivalent to EN 60601-1-2).
- IEC 60601-2-30 (1995), Medical Electrical Equipment – Part 2. Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment, 1995 (equivalent to EN 60601-2-30).
- International Safe Transit Association, Pres-shipment test procedures (Procedure
2-A), 1996.
The BPM-100 with serial numbers 008000 or greater are certified to or comply with the following standards:
- CAN/CSA C22.2 No. 601.1-M90, Medical Electrical Equipment – Part 1: General requirements for safety, 1990.
- UL 2601-1:1998, Medical Electrical Equipment – Part 1: General requirements for safety, 1998.
- ANSI/AAMI, SP10:1992, Electronic or automated sphygmomanometers, 1992.
- IEC 60601-1 (1988), Medical Electrical Equipments – Part 1. General Requirements for Safety, 1988 (equivalent to EN 60601-1).
- IEC 60601-1-2 (2001), Medical Electrical Equipment – Part 1. General Requirements for Safety; Electromagnetic Compatibility – Requirements and Tests, 2001 (equivalent to EN 60601-1-2).
- IEC 60601-2-30 (1999), Medical Electrical Equipment – Part 2-30: Particular Requirements for Safety, including Essential Performance of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment, 2000 (equivalent to EN 60601-2-30).
- International Safe Transit Association, Pres-shipment test procedures (Procedure 2-A), 1996.
Electromagnetic Emission Compliance
The BPM-100 complies with following Electromagnetic Em mission tests:
| Test |
Compliance |
Guidance |
RF emissions
CISPR 11: 2003 |
Group 1 |
The BPM-100 uses RF energy only for their internal function.
Therefore, their RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment. |
RF emissions
CISPR 11: 2003 |
Class A |
The BPM-100 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. |
Harmonic emissions
IEC 61000-3-2:2000 +
A1:2001 |
Class A |
Voltage fluctuations/
flicker emissions
IEC 61000-3-3: 1995 +
A1:2001 |
Complies |
|
Electromagnetic Environment Guidance
The BPM-100 is intended for use in the electromagnetic environment specified below.
| Test |
IEC 60601 test level |
Compliance Level |
Electromagnetic Environment - Guidance |
Electrostatic discharge
(ESD)
IEC 61000-4-2:1995 +
A1:1998 + A2:2000 |
±6 kV contact
±8 kV air |
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 transients/
burst
IEC 61000-4-4: 2004-07 |
±2 kV for
power supply
lines
±1 kV for
input/output
lines |
±2 kV for power
supply lines
Not applicable |
Mains power quality should be that of a
typical commercial or hospital environment. |
Mains power quality should be that of a
typical commercial or hospital environment. |
±1 kV
differential
mode
±2 kV
common mode |
±1 kV
differential
mode
±2 kV common
mode |
Mains power quality should be that of a
typical commercial or hospital environment. |
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11:2004-03 |
<5 % UT
(>95 % dip in
UT) for 0.5
cycle
40 % UT
(60 % dip in
UT) for 5
cycles
70 % UT
(30 % dip in
UT) for 25
cycles
<5 % UT
(>95 % dip in
UT) for 5 sec |
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT) for 5 sec |
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the BPM-100 requires continued
operation during power mains interruptions, it
is recommended that the BPM-100 be
powered from an uninterruptible power supply
or battery. |
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8:1993 +
A1:2000 |
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. |
Conducted RF
IEC 61000-4-6:2003-05 |
3 Vrms
150 kHz to
80 MHz |
3 Vrms |
Recommended distance from portable or mobile RF communication devices:
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).
|
Radiated RF
IEC 61000-4-3:2002-03 |
3 V/m
80 MHz to
2.5 GHz |
3 V/m |
, 80-800 MHz
 , 800 MHz-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). |
| Note: UT is the a.c. mains voltage prior to application of the test level. |
Tests and Checks
Multiple tests and checks are available to assure BPM-100 is working in peak condition. These checks are described in more detail in our user manual:
- Visual Inspection Check
- Zero Calibration Check
- Reference Gauge Calibration Check
- Functional / Safety Check
- Performance Check against BIO-TEK's BP Pump, NIBPM Tester
For further information, please contact Ancillare Sales Department. |
|
Learn More
Clinically Proven Accuracy
"The use of a single measurement to define
a patient's blood pressure would over diagnose
hypertension in 20% - 30% of the population
and miss a third who are truly hypertensive."
Mcalister, F.A. et al,
BMJ 2001; 322; 908-911
"The BpTRU ... increases the accuracy of BP measurements by reducing the observer
errors
such as digit bias, zero preference, incorrect deflation rates and failure to perform multiple BP measurements."
Graves, J.W. et al,
journal of Human Hypertension 2003, 17 823-827
Choosing the BpTRU over Mercury
Studies have shown that:
| » |
Both aneroid and Mercury devices are often significantly out of calibration |
| » |
Many are used in situations without a maintenance or calibration protocol |
| » |
Observer bias remains a general problem |
| » |
Mercury is a known environmental risk that is being phased out in most jurisdictions |
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