Professional Documents
Culture Documents
ANALIZADOR DE NIBP SmartArm INGLES
ANALIZADOR DE NIBP SmartArm INGLES
NIBP Simulator
Operation Manual
MAGNETIC MEDIA CAUTION: A strong magnetic field exists at the left rear of the SmartArm
chassis. Please avoid placing magnetically-sensitive materials, such as computer diskettes, in this
vicinity.
The contents of this document, including all figures and drawings, is proprietary information of Clinical
Dynamics Corporation, provided solely for purposes of opera-tion, maintenance or repair, and
dissemination for other purposes or publication or copying thereof is prohibited without prior written
consent by Clinical Dynamics Corporation, Wallingford, Connecticut.
In the interest of continued product improvement, all specifications are subject to change without notice.
Copyright © 1996-2004
Clinical Dynamics Corporation. All rights reserved.
Printed in U.S.A.
All repairs on products under warranty must be performed or approved in writing by Clinical Dynamics
Service personnel. Unauthorized repairs will void the warranty.
Assistance
If the product fails to function properly, or if assistance, service or spare parts are required, contact Clinical
Dynamics Customer Service at 800 247-6427 or visit our web site, www.clinicaldynamics.com and select the
SERVICE Key to fill out a Request for Calibration/Service Form. After this form has been submitted, a
Clinical Dynamics' Service Representative will contact you to help solve your problem. Before contacting
Clinical Dynamics, please attempt to duplicate the problem and to check all accessories to ensure that they
are not the cause of the problem. Prior to calling please be prepared to provide:
2. Complete description of the problem including the conditions under which the problem occurred. Ideally,
a written problem description would be provided, allowing for more efficient handling of your initial
service request and the subsequent diagnosis and remedy of the problem.
3. Your institution's complete name and address. Please also provide a contact name and phone number.
4. A purchase order number if the product needs non-warranty service or you are ordering spare parts.
1. Remove all hoses, cables, power cords and any other accessories from the instrument and, if possible.
Note: if you are using substitute packaging, it is essential that you seal the instrument in a clean, static
free plastic bag or in clean bubble wrap in order to prevent packing material from entering the product.
2. Pack only the accessories you are requested to return; place them in a separate bag.
3. If you are using substitute packaging, create a foundation of 4 to 6 inches of packing material (either
bubble wrap or packing "peanuts") at the bottom of the carton.
4. Insert the instrument and the accessory bag into the shipping carton.
5. If you are using substitute packaging, fill the 4 sides and the top of the carton with 4 to 6 inches of packing
material (either bubble wrap or packing "peanuts"). Ensure that the instrument and accessory bag are held
firmly in place by the packing material.
6. Please place paperwork such as the purchase order, contact info and reasons for return in the top of the
carton.
7. Close the carton and securely seal it with tape; since in most cases the carton will have been previously
used, it may be necessary to reinforce the original tape on the bottom of the carton.
8. Ship the product via whatever carrier (UPS, FedEx, etc.) is most convenient. However, please be aware
that, depending on where you are shipping from, standard UPS ground shipping could take as long as 7
business days. Unless other arrangements are made, Clinical Dynamics will return the repaired product to
you via UPS.
9. Shipping insurance is optional. Claims for damage to the product during shipping must be initiated by the
shipper.
The use of any other product name could add unnecessary delays when shipping internationally.
Notices..................................................................................................................................... i
Contents................................................................................................................................. vii
Warranty.................................................................................................................................viii
Precautions............................................................................................................................. ix
Section 1: Introduction......................................................................................................... 1
This warranty is made on the condition that prompt notification of a defect is given to Clinical Dynamics
within the warranty period. Clinical Dynamics shall have the sole right to determine whether a defect exists.
This warranty extends to the original purchaser only. This warranty does not apply to a SmartArm NIBP
Simulator that has its tamper seals removed or cut, altered, subjected to misuse, negligence, unauthorized
repair, or accident, or operated other than in accordance with the instructions.
This warranty represents the exclusive obligation of Clinical Dynamics and the exclusive remedy of the
purchaser regarding defects in a SmartArm NIBP Simulator. This warranty is given in lieu of any
expressed or implied warranties, including the warranty of merchantability or fitness for a particular
purpose, which warranties are disclaimed. No person is authorized to modify, in any manner, Clinical
Dynamics’ obligation described above.
Clinical Dynamics shall not, in any case, be liable for special, incidental or consequential damages arising
from breach of warranty, breach of contract, negligence or any other legal theory.
For optimum SmartArm performance, it is recommended that the SmartArm be allowed to “warm up” for 5
minutes before use.
For accurate results, it is recommended that you use the hoses provided with the SmartArm. If you should
damage or misplace these hoses, please contact the factory for replacement. Use of hoses other than those
provided by Clinical Dynamics may result in inaccurate test results.
Leak Test Mode: Automatically tests the leak rate of the blood pressure monitor, cuff and hose assembly.
This mode also provides a high accuracy digital manometer.
Over-Pressure Test Mode: Automatically tests operation of the blood pressure monitor’s pressure relief
valve and records the setpoint when pressure is released by the relief valve.
Blood Pressure Test: Simulates physiologically correct Adult and Neonate non-invasive blood pressures
for verification testing of blood pressure monitors. SmartArm provides the widest neonatal simulation range
any NIBP Simulator.
In addition to these test modes, SmartArm also incorporates a high-resolution graphic display, internal
battery (optional on base model SmartArm), internal pump (optional on base model SmartArm), built-in
adult and neonatal cuff supports, and a compact and lightweight enclosure.
Intended Audience
This Operation Manual is intended for end users of the SmartArm NIBP Simulator. It contains installation
and operation instructions, applications notes, performance limitations and routine performance verification
procedures. To achieve satisfactory results, it is imperative that the operator read this manual thoroughly
before attempting to use the Simulator.
Documentation Comments
Clinical Dynamics has attempted to present all information as clearly and error-free as possible. However, if
you detect any errors or omissions, or wish to suggest improvements to the manual, please mail, fax or email
your comments to:
Related Publications
The Operation Manual provides information for operation of the SmartArm. For service or parts
replacement, please refer to the SmartArm Non-Invasive Blood Pressure Service Manual. The Service
Manual is intended for qualified personnel only.
SmartArm NIBP Simulator is the World Class NIBP Simulator & Tester. The following list presents
some of the important benefits / features of SmartArm:
• SmartArm simulates physiologically correct waveforms, the only way to correctly test and validate a
NIBP monitor.
• SmartArm's Simulation Engine is designed with very low friction components, resulting in virtually no
wear.
• SmartArm always tests the NIBP Monitor cuff, which can be a major source of problems.
• SmartArm has the smallest footprint of any NIBP Simulator, which benefits customers with limited
bench space.
• SmartArm is half the weight of other NIBP Testers, has an internal battery and includes built-in cuff
supports. All-important features for mobile biomedical engineers.
• SmartArm has a 320 x 240 High Resolution Graphical Display. It's the only NIBP Simulator that
displays the cuff inflation/deflation waveform, which can be useful for diagnosing unusual NIBP
Monitor behavior.
• SmartArm is the only NIBP Simulator that has built in Adult and Neonatal Cuff Supports.
• SmartArm's best-in-class reliability means that only Clinical Dynamics can offer a lifetime warranty
on the Simulation Engine.
Oscillometric NIBP Calibration Tables: Please contact the factory for the availability of other
oscillometric calibration tables.
Displayed Graphics
Digital Manometer
Pressure Range: 0.0 to 410 mmHg
Measurement Parameters: Instantaneous and peak
Input Overpressure Limit: ± 1500 mmHg
Accuracy: ± 0.5 mmHg, traceable to NIST
Standards Resolution: ± 0.1 mmHg
Accuracy
Systolic/Diastolic (mean)
Arterial Pressure: Based on programmed set points on the oscillometric pulse envelope.
Static Pressure: ± 0.5 mmHg
Autosequences
User can utilize autosequences to test NIBP monitors with a specific series of SmartArm NIBP
performance tests.
Cuff Mandrels
• Plastic & Aluminum Cylinders
• Adult (3.75" OD, 7" width)
• Neonate (1 .25" OD, 1 .7" width)
Adult & Neonate mandrels are built into SmartArm for portability and ease of use.
Cuff Adapters
Cuff adapters insert between the NIBP device, cuff and analyzer. These adapters are compatible with
oscillometric and selected auscultatory NIBP monitors.
• Male/Female LUER
• Male/Female Clippard (Critikon, Siemens)
• Colder/CPU (Marquette, Protocol Systems)
• OBAC Quick Release (Hewlett-Packard)
• Universal 5/32" I.D. hose
Display
Full Alphanumeric/Non-glare Graphic LCD
Resolution: 240 vertical x 320 horizontal with contrast controls
Power
100-240 VAC, 50 watts, 50-60 Hz, Desktop Switcher
• Leak Test Mode for testing the leak rate of the blood pressure monitor, cuff and hose assembly.
• Over-Pressure Test Mode for testing operation of the blood pressure monitor’s pressure relief valve.
Because the oscillation envelope completely defines the blood pressure, the primary job of the SmartArm
is to reproduce the envelope as accurately as possible. Because of the variety of systolic and diastolic
determination algorithms, it is essential that the SmartArm generate “physiologically correct” waveforms.
Figure 4-1. Cuff pressure waveform during a typical oscillometric blood pressure measurement.
Figure 4-2. The Oscillation Envelope derived from a typical oscillometric blood pressure measurement.
Please see the drawing of the Contents Checklist on the next page.
1. Connect the external power supply to a power source, or if charged, operate from the internal battery.
2. Connect the Power Supply output plug to the DC Voltage jack located at the rear of the right panel of
the SmartArm. The green LED will illuminate to indicate the presence of power.
4. Adjust the CONTRAST control for the optimum contrast. This control panel is located on the right
panel, under the overhang of the front panel.
5. The screen momentarily displays its power-up message indicating the firmware (software) version in
use. This version number is needed for any telephone technical support.
6. The next power-up screen is the Self-Test Diagnostics. Upon entering this screen, the SmartArm
executes its self-test sequence, which checks each of the major hardware subsystems and posts the
results of each test.
7. After the final test, it enters an “un-zeroed”digital manometer mode wherein the pressure at the Pressure
Port is displayed in 0.1mmHg units with a temperature-dependent offset. If the SmartArm is
functioning correctly, the offset should be between 10 and 110 and the display should not fluctuate more
than +/- 3 digits.
8. Press any “F” (function) key to auto-zero the pressure transducer. NOTE: Ensure that the Pressure
Port is at zero pressure before performing the auto-zero. If the SmartArm determines that the
Pressure Port is not at zero, a “Failed” message will be posted. Simply zero the Pressure Port and press
any “F” key to repeat the transducer auto-zero.
9. The SmartArm is now at the main menu and the keys are displayed on the top of next page:
If none of the above hoses appear to match your tubing/cuff interface and if your cuff has a standard
“Universal-style” 5/32" ID rubber hose, you can use the Universal hose.
If you have questions regarding selection of the adaptor hose, please contact:
Technical Support
Clinical Dynamics Corp.
10 Capital Drive
Wallingford, CT 06492
Phone: (203) 269-0090 Fax: (203) 269-3402
Email: info@clinicaldynamics.com
2. Assuming you are using an adult cuff, wrap the cuff around the SmartArm cuff support on the back of
the SmartArm just as you would wrap it around a patient’s arm. For best results, make sure the cuff is
slightly snug and squeeze excess air from the cuff. Please see “Wrapping the Cuff Around Cuff
Support” illustration below:
4. Disconnect the cuff from the blood pressure monitor hose. (As if you were going to replace the cuff.)
In the case of a dual-lumen hose, only one of the hoses should be connected.
5. Connect the cuff to the short one side of the adaptor hose “T” and the tubing to the other side of the “T”.
Ensure that an airtight seal is achieved. Please refer to the “Connecting SmartArm to the NIBP monitor
Illustration below:
The Leak Test mode is used to determine the rate of leakage of the pneumatic system. If this rate exceeds
the manufacturers’ specifications, the Leak Test mode may then be used to determine the source of those
leaks. By performing the test while using a clamp to isolate portions of the pneumatic circuit, the user can
isolate the leak component.
1. From the Main Menu, Press the F1 (LEAKTST) key and place the monitor in the calibration or service
mode. (See Service Manual for your NIBP Monitor for instructions on how to enter calibration or
service mode.)
3. After the pressure stabilizes, the Leak Test will begin automatically and last 60 seconds. NOTE: If
your SmartArm did not come with an internal pump or you wish to use manual inflation mode,
press F3 (AUTO), which will then become F3 (MANUAL) and use the inflation bulb provided
with the SmartArm to pump up the NIBP monitor under test then press the F4 (START) key to
begin the test.
4. When in Leak Test mode, the top of the display has digital readouts labeled “Start P.” (P=Pressure), “P.
Drop”, “Timer” and “Manometer”. At the end of sixty seconds the “Pressure Drop” and “Timer”
displays will freeze and display the pressure drop as the leak rate in mmHg per minute. This should be
within specifications for the NIBP monitor.
5. While this test is running, you can check the Static Calibration of your NIBP monitor.
6. Compare the SmartArm manometer in the upper right corner to the pressure on the NIBP monitor.
The pressure is displayed in the upper right hand corner of the SmartArm screen. The bottom section of
the display in Leak Test mode describes the function keys. F2 (ZERO) resets the electrical zero on the
pressure transducer. Temporarily remove the input from the pressure port and press F2 (ZERO). To exit
the Leak Test mode, press the F5 (PREV) key.
2. Press the F4 (INFLATE) key to start the Over-Pressure Test and use SmartArm’s internal pump.
NOTE: If your SmartArm did not come with an internal pump or you wish to use manual
inflation mode, press F3 (AUTO), which will then become F3 (MANUAL) and press the F4
(START) key and use the inflation bulb provided with the SmartArm to pump up the NIBP
monitor under test.
Please also note the Over-Pressure Test will determine whether the over pressure valve is releasing at
the correct pressure (consult the NIBP monitor’s Service Manual for over pressure valve
specifications).
3. At the over pressure point, the monitor should release the pressure. The display will indicate the over
pressure point and the pressure waveform will be displayed. On some monitors the pressure will not
drop to zero but just below the set point. In this case set point pressure can be read from the screen.
2. Start the NIBP Monitor to run a BP Test at the default 120/80 (95) 75 setting. NOTE: It is suggested
that at least 3 readings be taken at each setting. Also, the accuracy of the first reading after the
cuff is wrapped is usually inaccurate because the cuff if “seating” during the test. After your
testing is complete, compare the readings of the monitor with the BP Setting on the SmartArm.
Normal test results are typically within +/- 5 mmHg of each setting.
4. Press F2 (NEXT BP) to select the next BP setting without having to leave the BP Test Screen.
To utilize auto sequence testing, which allows you to step through SmartArm’s BP settings, press F4
(MORE) key. Then press F2 (SEQ:Off) key and the F2 key will read (SEQ: 1). Continue to press the F2
key to select the amount of cycles per pressure (1-5 and 10 consecutive tests per BP setting available).
After the selected number of measurements at one BP setting, the simulator will increment to the next BP
setting for continued testing. After BP Setting 6 (200/136) has completed, SmartArm will disable
simulation. (This causes the BP Monitor’s alarm to signal when the full test sequence has completed.)
Press the F5 (PREV) key to return to the BP Test mode. NOTE: The F1 (SIM:On) key turns NIBP
Simulation off and on. The (MORE) key advances one screen further in the menu structure. The
(PREV) key retreats one screen previous in the menu structure.
Configuration Mode
SmartArm can be controlled remotely via PC, which automates NIBP test procedures. The Configuration
Mode allows you to disable/enable the remote control of the SmartArm. Please note that turning the
remote control on and off does not affect the performance of SmartArm.
1. To enter the Configuration Mode, press F4 (CONFFIG) from the Main Menu.
2. To turn the remote control off, Press F1 (Rem:On). The F1 key will then read (Rem:Off). To turn the
remote control back on, press the F1 key again.
Battery Check
SmartArm has an internal NiMH battery (optional on base model SmartArm), which eliminates the need for
a power supply.
1. Plug in the power supply and fully charge the internal battery for 12 hours. For efficiency, most
SmartArm users charge SmartArm overnight. NOTE: It is recommended that you fully charge and
discharge the battery every 30 to 45 days to properly maintain the battery.
2. Remove the power cord from the 24V DC jack on the side of the SmartArm after charging the battery.
3. Press the F5 (BATT CHK) key. The F5 key will then display the voltage of the battery. For example, it
could read 21.35V. Low Battery Level is approximately 19.00V. Shutoff is about 16V.
Figure 5-1. Pneumatic connection between the SmartArm and the NIBP Monitor.
Introduction
Remote control of the SmartArm is possible via an RS-232 serial port. Physically, this port is a 9-pin
female “D-shell” located on the right panel of the SmartArm. The serial link operates with the following
communications parameters:
This serial port is configured as a “DCE” allowing direct connection (i.e., using a standard rather than a null
modem cable) to the serial port on IBM-compatible computers. Flow control signals (CTS, RTS, etc.) are
ignored.
Communication between the SmartArm and the Host device consists of two categories:
In order to facilitate Host operation via a “dumb terminal” or a computer running communications software
(e.g. PROCOMM PLUS or Crosstalk), most messages are comprised exclusively of ASCII printable
characters. A checksum is not used because it will not, in general, be printable and it is awkward to generate
and to transmit checksums with an ASCII terminal. Message integrity checking is achieved via a structured
message format and limit tests for all transmitted data.
Before developing a software communications driver for use in your SmartArm application, it is
recommended that the developers familiarize themselves with the communications protocol using a dumb
terminal or a PC operating as a dumb terminal.
The possible Host Commands are listed below and are described in detail on the following pages:
The possible SmartArm Test Results messages are listed below and are described in detail on the
following pages:
Lock Keypad
The Lock Keypad command locks and unlocks the SmartArm front panel keypad.
Command Byte: A
Command Format: [S] [A] [A] [L] <CR>
where
L is the data byte, a single ASCII digit indicating the lock or unlock operation. Valid digits for L are:
Set Mode
The Set Mode command switches the SmartArm into the desired operating mode.
Command Byte: B
Command Format: [S] [A] [B] [M] <CR>
where
M is the data byte, a single ASCII digit indicating the desired operating mode. Valid digits for M are:
Set Patient
The Set Patient command selects the patient type used by the SmartArm during a blood pressure simulation.
This command selects one of two patient groups:
1. Virtual Adult
2. Virtual Neonatal
In addition, the Set Patient command selects a particular patient, and thus a particular blood pressure setting,
from within the patient group.
Command Byte: C
Command Format: [S] [A] [C] [G] [P] <CR>
where
G is a single ASCII digit specifying the patient group. Valid digits for G are:
P is a single ASCII digit indicating the particular patient within the patient group. Each patient has an
associated blood pressure setting and default pulse rate. The blood pressure and pulse rate settings are listed
in the following format: Systolic/Diastolic (Mean Arterial), HR = Pulse Rate. Valid digits for P are patient
group dependent as specified below:
Virtual Neonatal
0 (Hex 30) = 150/120 (130), HR = 120
1 (Hex 31) = 120/90 (100), HR = 120
2 (Hex 32) = 100/70 (80), HR = 120
3 (Hex 33) = 80/50 (60), HR =120
4 (Hex 34) = 60/30 (40), HR =120
5 (Hex 35) = 35/15 (22), HR = 120
Virtual Adult
0 (Hex 30) = 250/180 (216), HR = 75
1 (Hex 31) = 200/136 (160), HR = 75
2 (Hex 32) = 150/94 (116), HR = 75
3 (Hex 33) = 120/80 (95), HR = 75
4 (Hex 34) = 100/65 (77), HR = 75
5 (Hex 35) = 80/50 (60), HR = 75
6 (Hex 36) = 60/30 (40), HR = 75
Command Byte: D
Command Format: [S] [A] [D] [PPP] <CR>
where
PPP is a string of 3 ASCII digits denoting the desired pulse rate in bpm. Note that 3 digits are always
required; that is, for pulse rate less than 100, either a leading or trailing ASCII space (hex 20) must be
inserted.
Set Systolic/Diastolic
The Set Systolic/Diastolic command independently sets the systolic and diastolic pressures used by the
SmartArm during a blood pressure simulation.
Command Byte: E
Command Format: [S] [A] [E] [SSS] [DDD] <CR>
where
SSS is a string of 3 ASCII digits denoting the desired systolic pressure in mmHg and DDD is a
string of 3 ASCII digits denoting the desired diastolic pressure in mmHg. Note that 3 digits are always
required; that is, for pressures less than 100, either a leading or trailing ASCII space (hex 20) or a leading “0”
(hex 30) must be inserted. Also note the following restrictions on the systolic pressure, diastolic pressure and
pulse pressure (pulse pressure = systolic – diastolic):
Attempts to set a parameter outside these ranges will result in the violating parameter being set to the
exceeded limit.
NOTE: This command must be entered while in Envelope/Setup Mode (SAB1).
Example sequence: SAB1 (Envelope/Setup mode)
SAE[SSS][DDD] (Set systolic/diastolic)
SAB2 (BP Test mode)
where
SSS is a string of 3 ASCII digits denoting the target systolic blood pressure in mmHg.
DDD is a string of 3 ASCII digits denoting the target diastolic blood pressure in mmHg.
MMM is a string of 3 ASCII digits denoting the target mean arterial pressure (MAP) in mmHg.
PPP is a string of 3 ASCII digits denoting the target pulse rate in bpm.
Mode Identifier: 4
Test Results Format: [S] [A] [4] [SSS] [DDD] <CR>
where
SSS is a string of 3 ASCII digits denoting the leak test start pressure in mmHg.
DDD is a string of 3 ASCII digits denoting the leak test pressure drop in mmHg.
where
SSS is a string of 3 ASCII digits denoting the over-pressure setpoint in mmHg.
Upon power up or at the end of the first BP Test performed, the SmartArm will print a document
header. Please see below:
Location: _________________________________
After each successful completed NIBP simulation, the SmartArm will print the simulator settings and a
space for results to be recorded manually.
The SmartArm can communicate with a NIBP monitor that provides RS232 serial output.
SmartArm RS 232 pinout:
Pin 2: RX
Pin 3: TX
Pin 4: DTR
Pin 5: GND
Pin 6: DSR
PLEASE NOTE: Contact the NIBP monitor manufacturer to have the correct communications
protocols provided.