BC Biomedical NIBP-1020 User manual

Non-Invasive Blood Pressure
Simulator
NIBP-1010
NIBP-1020
USER MANUAL
BC BIOMEDICAL
NIBP-1000 SERIES
TABLE OF CONTENTS
DESCRIPTION.............................................................................................................
3
OVERVIEW..................................................................................................................
5
KEYS............................................................................................................................
7
SCREENS....................................................................................................................
8
SETUP ......................................................................................................................... 13
OPERATIONS.............................................................................................................. 15
CONNECTING PRESSURE CUFFS............................................................... 15
CONNECTING PATIENT LEADS .................................................................... 16
AUX CONNECTOR.......................................................................................... 16
THEORY OF OPERATIONS........................................................................... 17
RUNNING A TEST .......................................................................................... 18
MANUAL REVISIONS.................................................................................................. 19
WARRANTY................................................................................................................. 19
SPECIFICATIONS ....................................................................................................... 20
NOTES......................................................................................................................... 23
1
WARNING
All connections to patients must be removed before
connecting the Device Under Test (DUT) to the
Simulator. A serious hazard may occur if the patient
is connected when testing with the Simulator.
Do not connect any leads from the patient directly to
the Simulator or DUT.
NOTICE
BC GROUP INTERNATIONAL, INC. RESERVES THE RIGHT
TO MAKE CHANGES TO ITS PRODUCTS OR
SPECIFICATIONS AT ANY TIME, WITHOUT NOTICE, IN
ORDER TO IMPROVE THE DESIGN OR PERFORMANCE AND
TO SUPPLY THE BEST POSSIBLE PRODUCT. THE
INFORMATION IN THIS MANUAL HAS BEEN CAREFULLY
CHECKED AND IS BELIEVED TO BE ACCURATE. HOWEVER,
NO RESPONSIBILITY IS ASSUMED FOR INACCURACIES.
Manual NIBP-1000 Series
www.bcgroupintl.com
7/06
Copyright © 2006
Made in the USA
Rev 06
2
BC GROUP
NIBP-1000 SERIES
NON-INVASIVE BLOOD PRESSURE SIMULATORS
The Model NIBP-1000 Series is a family of Microprocessor based, High Precision NonInvasive Blood Pressure (NIBP) Simulators. The units are small, easy to use and have
multiple features to fit many different applications. The NIBP-1020, offers ECG waveforms
that are full QRS and respiration waveforms that look real.
The graphics display not only provides multiple screens that give the pressure digitally in
mmHg, but also offers views of the plot of the overall pressure or a close-up of the BP
waveform.
The following are highlights of some of the main features:
NIBP-1010 (BASIC FEATURES, NIBP ONLY):
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
LARGE GRAPHICS DISPLAY WITH CURSOR SELECTION OF OPTIONS
AND SETUP OF PARAMETERS
FULL RANGE MANOMETER
ADULT, NEONATAL AND HYPERTENSIVE MODES
0-500 mmHg PRESSURE RANGE
+/- 1% OF READING PRESSURE ACCURACY
OPTIONAL PEAK PRESSURE DETECT WITH SIMPLE RESET
SpO2 READY – COMPATIBLE WITH MSP-2100 MODULE
DIGITAL CALIBRATION – NO POTS TO TURN
SELECTABLE DISPLAY OPTIONS AND DIGIT SIZES
SOFTWARE ADJUSTABLE CONTRAST
FLASH PROGRAMMABLE
BATTERY LIFE DISPLAY (0 TO 100%)
OPTIONAL RECHARGEABLE NiMH BATTERIES
BATTERY ELIMINATOR
RS232 INTERFACE
NIBP-1020 (NIBP, ECG PACE & RESP)
HAS ALL THE BASIC MODEL FEATURES PLUS:
•
•
•
•
ECG OUTPUT WITH FULL NSR WAVEFORM
SINUSOIDAL RESPIRATION SIMULATION
ECG TEST WAVEFORMS
PACE WAVEFORM
• OPTIONAL PEAK PRESSURE DETECT WITH ECG ALARM TEST
• ECG SYNCRONIZED WITH BLOOD PRESSURE
3
AVAILABLE MODELS:
NIBP1010
NIBP1010-P
NIBP1010-BP
NIBP1020
NIBP1020-PA
NIBP1020-BPA
NIBP1000-KIT
BASIC UNIT
+ PEAK
+ BATTERY & PEAK
BASIC UNIT WITH EKG
+ PEAK & ALARM
+ BATTERY, PEAK & ALARM
NIBP1020-BPA, 5 ADAPTERS & SOFT CARRYING CASE
OPTIONAL ACCESSORIES:
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•
•
•
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BC20-30111
BC20-40714
BC20-40715
BC20-40716
BC20-40717
BC20-40608
BC20-40602
•
BC20-40605
SOFT CARRYING CASE
DINAMAP/CRITIKON ADAPTER
QUICK DISCONNECT ADAPTER
LUER ADAPTER
MARQUETTE ADAPTER
BULB ADAPTER
NIBP FITTING KIT (HP CUFF ADAPTER,
INFLATION BULB, CPC CONNECTOR, QUICK
COUPLER WITH 1/8” MNPT AND SILICONE
TUBING AND TEE)
NIBP ADAPTER KIT (11 CONNECTORS)
4
OVERVIEW
This section looks at the layout of the NIBP-1010 and gives descriptions of the elements
that are present.
LCD Graphical
Display:
Shows Test Data and
Configuration Data
Male Quick
Connect for
Pressure
Input
6 Light Touch Keys for
Selecting Parameters
and Settings:
POWER for Turning Unit
On and Off
UP and DOWN Arrows
for Scrolling Through
Selected Options.
(When No Options are
Selected, for Changing
Display Screen.)
SELECT for Choosing
Setting or Parameter to
Change
SETUP/RETURN for
Entering and Exiting
Setup Menu
RESET for resetting
peak pressure reading.
7 pin MiniDin
connector for
RS-232 and
Power
2.1 mm Jack
5
This section looks at the layout of the NIBP-1020 and gives descriptions of the elements
that are present.
LCD Graphical
Display:
Shows Test Data and
Configuration Data
Male Quick
Connect for
Pressure
Input
6 Light Touch Keys for
Selecting Parameters
and Settings:
POWER for Turning Unit
On and Off
UP and DOWN Arrows
for Scrolling Through
Selected Options.
(When No Options are
Selected, for Changing
Display Screen.)
SELECT for Choosing
Setting or Parameter to
Change
SETUP/RETURN for
Entering and Exiting
Setup Menu
RESET for resetting
peak pressure reading.
10 Snap Patient
Lead Connectors:
RA R
LA
L
RL N
LL
F
V1 C1
V2 C2
V3 C3
V4 C4
V5 C5
V6 C6
7 pin MiniDin
connector for
RS-232 and
Power
2.1 mm Jack
6
KEYS
Six tactile-touch keys are provided for system operation:
– This key turns the unit off and on. The unit will return to the screen that was
active when it was turned off.
– In the DISPLAY MODE, these keys toggle the display through the available
main screens.
In the SELECT MODE, if a parameter has been highlighted, these keys will scroll through
the available settings.
– On the Main screen, this key sequences through the available NIBP or ECG
simulations. On the Setup screen, there are a number of parameters that may be selected
and changed. This key sequences the cursor (Highlight) through those parameters.
– This key is used to RESET the peak pressure reading
– This key toggles the unit into and out of the Setup Mode. Depressing this key
will enter the Setup screen where the configuration can be viewed and adjusted.
Depressing the key again will exit the Setup Mode and return to the previously viewed
main screen.
7
SCREENS
MAIN SCREENS – There are five main screens: Pressure Only, Pressure with Output
Waveform, Pressure with Pressure Graph, ECG (optional) and Battery Indicator (optional).
The available screens can be toggled using
.
PRESSURE ONLY –This screen has a large pressure display, as shown below. Also
displayed on this screen is the peak pressure and selected output waveform
The display will resemble the following:
PEAK PRESSURE
(Optional)
PRESSURE
PRESSURE ENVELOPE
OFFSET
This line is only displayed
if a non-zero value is
programmed into the
Systolic &/or Diastolic
Shift. (See Setup for
more information).
OUTPUT SELECTION
Systolic/Diastolic
(mean)
Adult 120/80
Neonatal (Neo) 70/40
Hypertensive (High)
190/120
Manometer
Alarm Test (Optional)
(Alternates every 30 sec)
Adult 120/80
Mean
Heart Rate
93
55
80
94
Respiration
Rate (Optional)
35
47
150
80
35
-
47
160
Pacemaker 70
00
80
35
93
8
OUTPUT WAVEFORM– This screen shows the output waveform as well as the pressure,
peak pressure, and output selection.
NOTE
This waveform is not intended to be
physiologically correct.
The display will resemble the following:
PRESSURE
PEAK PRESSURE
(Optional)
OUTPUT
WAVEFORM
(as generated by
the NIBP-1000
S i )
Dependant on
pressure
OUTPUT SELECTION
Systolic/Diastolic
(mean)
Adult 120/80
Neonatal (Neo) 70/40
Hypertensive (High)
190/120
Manometer
Alarm Test (Optional)
(Alternates every 30 sec)
Adult 120/80
Mean
Heart Rate
93
55
80
94
Respiration
Rate (Optional)
35
47
150
80
35
-
47
160
Pacemaker 70
00
80
35
93
9
PRESSURE GRAPH SCREEN – This screen provides a graph of the pressure, as well as,
the pressure, peak pressure, and output selection
PRESSURE
PEAK PRESSURE
(Optional)
PRESSURE
GRAPH
2mmHg per
pixel
OUTPUT SELECTION
Systolic/Diastolic
(mean)
Adult 120/80
Neonatal (Neo) 70/40
Hypertensive (High)
190/120
Manometer
Alarm Test (Optional)
(Alternates every 30 sec)
Adult 120/80
Mean
Heart Rate
93
55
80
94
Respiration
Rate (Optional)
35
47
150
80
35
-
47
160
Pacemaker 70
00
80
35
93
10
ECG OUTPUT SCREEN – This screen shows the selected ECG output mode.
(NIBP-1020 units only)
NOTE: While in this mode, the NIBP simulation does not run.
NOTE: NRS ECG output is active during NIBP testing at the rate stipulated for the selected
test.
The display will resemble the following:
LIST OF AVAILABLE
OUTPUTS
SELECTED
OUTPUT
NSR
NSR
NSR
NSR
Sine Wave
Sine Wave
Sine Wave
Square Wave
Square Wave
Triangle Wave
11
30 Bpm
60 Bpm
120 Bpm
240 Bpm
10 Hz
60 Hz
100 Hz
0.125 Hz
2 Hz
2 Hz
BATTERY INDICATOR SCREEN – This screen shows the status of the battery voltage
level with Built-In Battery Option only.
NOTE: It is only an estimate of the battery life remaining.
When the level reaches 10%, the BP simulation mode will be disabled; however, the
Manometer and ECG (optional) will continue to function. Once the battery level reaches
0%, the unit will automatically turn itself off to avoid damaging the batteries.
The display will resemble the following:
Batteries charge from provided wall transformer. The charge time is about 4 hours from full
discharge. While the batteries are charging, the display will flash “charging.”
CAUTION
USE ONLY THE WALL TRANSFORMER PROVIDED
WITH THE NIBP-1010 AND NIBP-1020.
12
SETUP
The Setup Mode allows the user to adjust the configuration of the simulator. The Setup
screen can be entered using the
key. The parameters can be changed by using
key to highlight the line and
to toggle the available options.
The Setup screen can be exited using the
key.
The following is a breakdown of the parameters available in the configuration of the unit
and their available options:
System Setup Configuration
Parameter
Description
Range
Systolic Shift
Adjusts the Systolic Output of the NIBP
Simulation. This is not a direct mmHg adjustment.
Adjusts the Diastolic Output of the NIBP
Simulation. This is not a direct mmHg adjustment.
This parameter determines whether the SpO2
output pulse is active. The output drives an MSP2100 FingerSim Module.
Determines the period of inactivity before the unit is
turned OFF. A timer is started when the unit is
turned ON and is reset each time a key is pressed.
When the timer reaches the value set in this
parameter, the power is automatically turned OFF.
(NOTE: Setting this parameter to 0 disables the
Auto Off timer. When running from line power, the
unit does not automatically shut off. Auto Off timer
is inactive during a test.)
±50.0
Diastolic Shift
SpO2 Output
Auto Off Timer (Min)
Contrast Adjust
Battery Life
Software
Sets the contrast of the display screen.
±50.0
Off/On
0-30 Minutes
0-20
Available only with Battery Option installed.
Displays current life of the battery.
At 10%, a warning screen will appear.
At 0%, the unit will power down automatically.
0-100%
(Read Only)
Displays current software program.
(Read Only)
13
SYSTOLIC AND DIASTOLIC SHIFT – The NIBP-1000 Series is equipped with the option
to shift test results to compensate for different methods of measuring Oscillometric NIBP by
various manufacturers and models of devices under test.
CAUTION
These adjustments must be used with caution as they will
allow the user to adjust the output results to invalid values.
These adjustments should only be used to aid in the
simplification of testing and with documented controls.
There are no absolute standards for Oscillometric NIBP readings; therefore, for a number
of reasons (including patents, technology, etc.), each manufacturer has established a
different method for evaluating the oscillometric pulses. Due to these varying methods,
precisely the same waveforms will give different results on different manufacturer’s units.
The normal technique used is to run the monitor against a fixed source like the NIBP-1000,
with the understanding that each manufacturer has a predictable error from this norm.
While this is generally the most direct method, users have asked for a method to correct
for this difference, making the monitors read the same as the test unit. The Systolic and
Diastolic Shift settings allow for just such correction.
These adjustments are indicated in a line added to the main display to inform the user of
any shift that has been programmed into the system. This is done so there is no
misunderstanding of the meaning of the results.
14
OPERATIONS
CONNECTING PRESSURE
The NIBP-1010 and NIBP-1020 Blood Pressure Simulators are connected between the
blood pressure cuff and the monitor (Device Under Test, DUT).
The blood pressure cuff should be disconnected from the DUT and a ‘T’ adapter inserted
between the cuff and the DUT. The NIBP simulator is then connected to the open side.
Blood
Pressure
Cuff
Monitor
(Device Under Test)
(DUT)
NIBP1010
or
NIBP1020
Roll the cuff tightly on itself or around a mandrel.
15
CONNECTING PATIENT LEADS
For the NIBP-1020, with ECG output, test snaps are provided along the sides and are
identified by the markings on the overlay.
AUX CONNECTOR
16
THEORY OF OPERATIONS
A motor and piston assembly is used to generate the output waveforms. A differential
pressure sensor is used to measure the pressure of the cuff. The pressure sensor is read
by a 16-bit differential Digital to Analog converter. The ECG output is performed by a 12-bit
Digital to Analog converter. A second 12-bit Digital to Analog converter is used to generate
the respiration waveform.
17
RUNNING A TEST
NIBP:
To run an NIBP simulation, the cuff and monitor are connected to the pressure input. Then
the measurement is initiated by the monitor and the NIBP-1010 and NIBP-1020 will output
the proper waveform based on the cuff pressure.
The NIBP output mode can be changed by pressing the Select key. Once the desired
operating mode is selected, the output will automatically begin once the correct pressure is
detected.
ECG (NIBP-1020 Only):
The ECG output is selected by pressing the UP arrow until the ECG Waveforms menu is
displayed. While in this mode, the NIBP simulation is disabled. The select key is used to
choose the desired ECG output.
ECG Alarm Mode:
This mode tests the alarms of the monitor under test. The ECG output will alternate from a
47 BPM NSR with apnea respiration (0 brpm) to 160 BPM NSR with 80 brpm respiration.
The time interval between alternations is 30 seconds.
simulation output is disabled.
18
While in this mode, the BP
MANUAL REVISIONS
Revision #
Program #
Revisions Made
Rev 01
Rev 02
Rev 03
Rev 04
Rev 05
Rev 06
DT7355CA
DT7355CA
DT7355CA
DT7355CF
DT7355CG
DT7355CI
Origination
Specification Information Updated
Miscellaneous Edits
Add Systolic/Diastolic adjustments
Output Selection edited
Miscellaneous Edits
LIMITED WARRANTY
WARRANTY: BC GROUP INTERNATIONAL, INC. WARRANTS ITS NEW PRODUCTS TO BE FREE
FROM DEFECTS IN MATERIALS AND WORKMANSHIP UNDER THE SERVICE FOR WHICH THEY
ARE INTENDED. THIS WARRANTY IS EFFECTIVE FOR TWELVE MONTHS FROM THE DATE OF
SHIPMENT.
EXCLUSIONS: THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESSED OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE.
BC GROUP INTERNATIONAL, INC. IS NOT LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL
DAMAGES.
NO PERSON OTHER THAN AN OFFICER IS AUTHORIZED TO GIVE ANY OTHER WARRANTY OR
ASSUME ANY LIABILITY.
REMEDIES: THE PURCHASER'S SOLE AND EXCLUSIVE REMEDY SHALL BE: (1) THE REPAIR OR
REPLACEMENT OF DEFECTIVE PARTS OR PRODUCTS, WITHOUT CHARGE. (2) AT THE OPTION
OF BC GROUP INTERNATIONAL, INC., THE REFUND OF THE PURCHASE PRICE.
19
SPECIFICATIONS
NIBP-1010
Blood Pressure
RANGE
ACCURACY
0-500 mmHg @ 20°C
+/- (1% of Reading + .5 mmHg)
RATE
80, 94 bpm
ACCURACY
+/- 1%
Physical
DISPLAYS
ENCLOSURE
WEIGHT
FACE PLATE
OPERATING RANGE
STORAGE RANGE
LCD Graphical 128 X 64 Pixels
7 x 5 x 4 Inches
(177.8 x 127.0 x 101.6 mm)
ABS Plastic
< 3 Lbs
(< 1.36 Kg)
Lexan, Back printed
15 to 40 C
-20 to 65 C
Electrical
12VDC, 500mA
BATTERY ELIMINATOR
BATTERY
(OPTIONAL)
BATTERY
RUNTIME
BATTERY
STORAGE LIFE
6 AA NiMH Rechargeable
(Not user serviceable)
500 Test Cycles between charges
1 Year from full charge
20
NIBP-1020
Blood Pressure
RANGE
0-500 mmHg @ 20°C
ACCURACY
+/- (1% of Reading + .5 mmHg)
RATE
80, 94 bpm (synchronized to ECG)
ACCURACY
+/- 1%
ECG NSR
RATE
30,60,120,240 BPM
ACCURACY
+/- 1%
AMPLITUDE
2.75 mV
ACCURACY
+/- 2% @ Lead II
ECG Performance
SINE WAVE
SQUARE WAVE
10,60,100 Hz
0.125, 2.000 Hz
TRIANGLE WAVE
2.000 Hz
RATE ACCURACY
AMPLITUDE
AMPLITUDE
ACCURACY
+/- 1%
2.75 mV
+/- 2% @ Lead II
Pacemaker Waveforms
AMPLITUDE
ACCURACY
WIDTH
ACCURACY
3 mV
+/- 10%
3 ms
+/- 5%
21
Respiration
RATE ACCURACY
IMPEDANCE DELTA
ACCURACY
BASELINE
ACCURACY
+/- 1%
3.0 ohms
+/- 10%
1000 ohms
+/- 5%
Physical
DISPLAYS
ENCLOSURE
WEIGHT
FACE PLATE
OPERATING RANGE
STORAGE RANGE
LCD Graphical 128 X 64 Pixels
7 x 5 x 4 Inches
(177.8 x 127.0 x 101.6 mm)
ABS Plastic
< 3 Lbs
(< 1.36 Kg)
Lexan, Back printed
15 to 40 C
-20 to 65 C
Electrical
12VDC, 500mA
BATTERY ELIMINATOR
BATTERY
(OPTIONAL)
BATTERY
RUNTIME
BATTERY
STORAGE LIFE
6 AA NiMH Rechargeable
(Not user serviceable)
500 Test Cycles between charges
1 Year from full charge
P:\Manuals\BCGroup\…\NIBP1000_UM_Rev06.doc
22
NOTES
23
24