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PAD M2703A |
Software Revision D.0 |
Data Sheet |
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Avalon FM30
Fetal / Maternal Monitor
The Philips Avalon FM30 fetal/maternal monitor offers a state-of-the-art solution for all external and internal fetal monitoring measurements in doctors’ practices, clinics and hospitals, during labor and delivery and for antepartum monitoring of high-risk patients.
With a cutting-edge feature set, including advanced transducers, high quality signal processing, and a touchscreen interface, the Avalon FM30 sets new standards for performance, flexibility, convenience, and ease of use.
Measurements
The Avalon FM30 lets you monitor and document:
•Up to three1 fetal heart rates externally using ultrasound
•DECG via combined Toco/ECG “Toco+” transducer (also can measure MECG)
•Uterine activity externally, or intrauterine pressure
•Maternal heart rate with ECG waveform display
1. Triplets monitoring is not currently available in the USA.
•6 second maternal ECG strip, with a choice of real-time recording or “snapshot” together with the fetal trace
•Maternal blood pressure and pulse oximetry (optional)
Features
•Touchscreen for intuitive, easy operation
•Tilt and fold 6.5-inch TFT color display with a wide viewing angle and large numerics
•Built-in 6-inch recorder for automatic printing of fetal and maternal parameters on the trace
•Intelligent transducers are waterproof, light, comfortable to wear and easy to clean
•Automatic channel management lets you connect any fetal transducer, patient module or remote event marker to any fetal sensor socket
•Cross-Channel Verification between all fetal and maternal heart rates
•The blue transducer Finder LED lets you identify at a glance which transducer is monitoring which measurement
•Transmission of fetal and maternal parameters to an obstetrical surveillance system
•Network connectivity to an OB TraceVue2 system via LAN connection using the optional system interface, where OB TraceVue controls all patient admit/discharge events
•Internal backup memory allows recovery of up to one hour of trace data, either to paper or to an OB TraceVue2 system over a LAN connection
•Cordless monitoring using the award-winning Avalon CTS Cordless Fetal Transducer System3
•Compact and light, with built-in carrying handle, and stand for angled stance on any flat surface
•Comprehensive patient data presentation, including at-a-glance patient identification, and
2.OB TraceVue Revision E.00.00 or later.
3.Requires Avalon CTS interface cable M2731-60001 (see Avalon CTS data sheet for details), and monitor software revision D.00.00 or higher.
the choice to add user-configurable notes4
•Automatic screen layouts optimize size and presentation of measurements
•Fetal Movement Profile (FMP) detects and automatically records gross fetal body movements for antepartum applications
•NST timer for antepartum applications
Description of Main Components
TFT Color Display
The monitor has an integrated, tiltable color TFT display, with a wide viewing angle, providing high resolution data presentation. Fetal and maternal measurements are displayed as large, easy-to-read numerics.
Information such as patient identification (including the bed label when connected to a surveillance system such as OB TraceVue), date and time, alarm information, icons for recorder status, and prompt and error messages are also clearly shown.
Touchscreen User Interface
The monitor is operated using the touchscreen. All user functions (apart from the On/Off switch) are controlled directly from the screen, and the intuitive, color, graphical user interface not only makes it quick and easy to learn and use, but the lack of mechanical controls also makes cleaning the Avalon fetal monitor much quicker and simpler.
A number of SmartKeys at the bottom of the main screen allow fast access to functions, for starting a recording, or resetting a Toco baseline, for instance.
Heart rate and alarm volume adjustment, with an indication of the current setting, are always available at the top of the screen.
Integrated Recorder
The Avalon fetal monitor has an integrated, high resolution thermal array recorder, with paper-out/- end detection.
Traces are recorded at either 1, 2 or 3 cm/min.
Continuous traces are made for:
•Fetal Heart Rate(s)
•Maternal Heart Rate
4. Using standard Roman-8 character sets.
•Fetal Movement
•Uterine Activity
The monitor prints the time, the date, trace identification symbols, the monitoring mode and the paper speed when first switched on, every ten minutes after, and whenever the monitoring modes change.
Maternal heart rate and the maternal pulse oximetry value is printed every 5 minutes. In the case of maternal noninvasive blood pressure measurement, the annotation is made at the end of the measurement.
Depending on the geography, there are two possible paper scales:
•FHR Scale:
-Red paper: 30 to 240 bpm @ 30 bpm/cm
-Green paper: 50 to 210 bpm @ 20 bpm/cm
•Labor Scale:
-0 to 100 units @ 25 units/cm
Alarms
When an alarm limit is exceeded, it is signalled by the monitor in the following ways:
•An alarm tone sounds
•An alarm message is shown on the screen
•The numeric of the alarming measurement flashes on the screen
Alarm categories:
•Physiological Alarms for fetal and maternal parameters (to indicate vital sign alarm limit violations, for instance)
•Technical Alarms (INOPS) are triggered by signal quality problems, equipment malfunction or equipment disconnect.
Alarm modes:
•INOP only: only INOPs are enabled, with audible and visual indication active. This is the default.
•All: patient alarms and INOPs are enabled, with audible and visual indicators active.
Alarm suspension:
•Alarms Off/Pause Alarms function
•Alarm pause period: indefinite, or one, two, or three minutes.
Alarm latching/non-latching:
•Visual
•Audible
•Visual and audible
Interfaces
LAN/RS-232 System Interface
The monitor has an optional LAN/RS-232 interface board with two fully-isolated ports:
-The LAN connection is for connecting the monitor to an OB TraceVue obstetrical
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information and surveillance system on a network, or to a PC for configuration or upgrade using the Support Tool
-The RS232 connection can be used for connecting the monitor to an obstetrical information and surveillance system, such as OB TraceVue
Input Device Interface (Dual PS/2 Interface)
This optional interface provides two PS/2 ports to enable the monitor to be connected to off-the-shelf, “plug-and-play” input devices:
-Mouse: any specified PS/2 mouse or trackball may be used for navigation and data entry.
-Computer keyboard: a PS/2 computer keyboard can be used for data entry instead of the onscreen pop-up keyboard.
Service Features
•The Support Tool helps technical personnel to
–carry out configuration, upgrades and troubleshooting on an individual monitor.
–share configuration settings between monitors.
–back up the monitor settings.
•The Service Mode is password-protected and ensures that only trained staff can access service tests and tasks.
•The Configuration Mode is password-protected and allows trained users to customize the monitor configuration.
•The Demo Mode is password-protected and is intended for training and educational purposes.
Related Products
Monitors with software revision D.00.00 (or higher) are compatible with the Avalon CTS Cordless Fetal Transducer System (M2720A), allowing expectant mothers to be continuously monitored without wires, whether in the bath or shower, in the bed, or while ambulating. Monitors with earlier software revisions can be upgraded to the lastest software version (see “Upgrade Options” on page 14). Refer to the Avalon CTS Data Sheet for the required Avalon CTS interface cable (M2731-60001) and further information.
Standards Compliance
US Federal Law restricts this device to sale by or on the order of a physician.
The monitor is in conformity with the essential requirements of the European Medical Devices Directive 93/42/EEC and the following major international standards:
Safety, Performance
•EN 60601-1:1990+A1:1993+A2:1995/IEC 60601-1:1988+A1:1991+A2:1995
•EN 60601-1-1:2001/IEC 60601-1-1:2000
•EN/IEC 60601-2-27:1994
•EN/ISO 9919:2005
•EN 60601-2-30:2000/IEC 60601-2-30:1999
•EN/IEC 60601-2-37:2001+A1:2004
•EN 60601-2-49:2001/IEC 60601-2-49:2001
•UL 60601-1:2003
•CAN/CSA C22.2#601.1-M90
•AS/NZS 3200.1.0-1998
The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2000+A1:2003, EN60601-1- 4:1996+A1:1999 and IEC 60601-1- 4:1996+A1:1999.
Alarm sounds are compliant with the draft ISO/ IEC 9703-2 Standard.
Electromagnetic Compatibility
•EN/IEC 60601-1-2:2001+A1:2004
•ICES-001:1988
The Avalon fetal monitor is classified as electromagnetic emissions Class B, except whenever used with the IUP/ECG patient module M2738A, when it is classified as Class A.
This ISM device complies with Canadian ICES001. Cet appareil ISM est conforme a la norme NMB-001 du Canada.
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Environmental Specifications
The monitor may not meet the given performance specifications if stored and used outside the specified temperature and humidity ranges.
FM30 Monitor |
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Temperature Range |
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Operating |
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0°C to 45°C (32°F to 113°F) |
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Storage |
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-20°C to 60°C (-4°F to 140°F) |
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Humidity Range |
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Operating |
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<95% relative humidity @ 40°C/104°F |
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Storage |
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<90% relative humidity @ 60°C/140°F |
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Altitude Range |
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Operating |
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-500 to 3000 m/-1640 to 9840 ft. |
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Storage |
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-500 to 13100 m/-1640 to 43000 ft. |
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Transducers (M2734A/M2735A/M2736A/M2738A) |
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Temperature Range |
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Operating |
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0°C to 40°C (32°F to 104°F) |
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Storage |
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-20°C to 60°C (-4°F to 140°F) |
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Humidity Range |
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Operating |
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<95% relative humidity @ 40°C/104°F |
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Storage |
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<90% relative humidity @ 60°C/140°F |
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Altitude Range |
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Operating |
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-500 to 3000 m/-1640 to 9840 ft. |
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Storage |
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-500 to 13100 m/-1640 to 43000 ft. |
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SpO2 Sensors |
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Operating Temperature Range |
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0°C to 37°C (32°F to 98.6°F) |
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Physical Specifications |
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FM30 Monitor |
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Power |
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Supply Voltages |
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100 VAC to 240 VAC ± 10% |
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Supply Frequency Range |
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50 Hz to 60 Hz |
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Power consumption (maximum) |
60 VA |
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Dimensions and Weight |
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Size mm/(in) ±1%: width x height x depth |
286 x 133 x 335 (11.3 x 5.2 x 13.2 in) |
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(without options) |
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Weight |
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< 5.1 kg/11.2 lbs |
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Degree of Protection Against |
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Type CF |
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Electrical Shock |
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Electrical Class |
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Class II equipment |
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Mode of Operation |
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Continuous operation |
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Startup Time |
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Time taken from switching on the monitor to |
< 30 seconds |
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seeing the first parameter labels |
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Transducers (M2734A/M2735A/M2736A) |
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Shock Resistance |
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Withstands ten 1m drops to concrete surface with possible cosmetic damage only |
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Water Ingress Protection Code |
M2734/35/36A |
IP 68 (immersion up to 1 m water depth for 5 hours) |
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M2738A |
IP 67 (immersion up to 0.5 m water depth for 30 minutes) |
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Dimensions and Weight |
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M2734/35/36A |
Size (diameter) |
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83 mm/3.27 in |
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Weight (without cable) |
< 220 g/7.8 oz. |
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M2738A |
Maximum size mm/(in): |
50 x 28 x 135 (2.0 x 1.1 x 5.3 in) |
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width x height x depth |
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Cable length |
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2.5 m |
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Weight |
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< 150 g/5.3 oz. |
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Water Ingress Protection Code |
IP 68 (immersion up |
to 1m water depth of for 5 hours) |
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Degree of Protection Against |
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Type CF |
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Electrical Shock |
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Performance Specifications
Complies with EN/IEC EN 60601-2-37:2001+A1:2004. ECG measurement follows EN/IEC 60601-2- 27:1994.
Fetal / Maternal
Fetal/Maternal Performance Specifications
Ultrasound |
Measurement Method |
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Ultrasound Pulsed Doppler |
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Measurement Range |
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US |
50 to 240 bpm |
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Resolution |
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Display |
1 bpm |
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Printer |
1/4 bpm |
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Jitter @ 200 bpm |
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≤ 3 bpm |
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Display Update Rate |
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1 / second |
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US Intensity |
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Average output power |
P = (4.3 ± 0.4) mW |
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Peak-negative acoustic pressure |
p_ = (33.9 ± 3.6) kPa |
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Output beam intensity (Iob) |
Isata = (2.38 ± 0.75) mW/cm2 |
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(= spatial average - temporal average intensity) |
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Spatial-peak temporal average intensity |
Ispta = (10.3 ± 2.2) mW/cm2 |
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Effective radiating area @ -6 dB |
1.81 cm2 |
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Signal Quality |
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Poor |
Empty |
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Indication |
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Acceptable |
Two-thirds full |
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Good |
Full |
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Beat to Beat Change (max.) for Ultrasound |
28 bpm |
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US Frequency |
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1 MHz ± 100 Hz |
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US Signal range |
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3.5 μVpp to 350 μVpp @ 200 Hz |
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US Burst |
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Repetition Rate |
3.0 kHz |
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Duration |
≤ 100 μs |
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US LF Frequency Passband @ -3dB |
100 to 500 Hz ± 20% |
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FMP Signal Range @ 33 Hz |
200 μVpp to 40 mVpp |
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FMP Frequency Passband @ -3dB |
10 to 100 Hz |
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Toco |
Measurement Method |
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Strain Gauge Sensor Element |
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Sensitivity |
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1 unit = 2.5 g |
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Resolution |
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Display |
1 unit |
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Printer |
1/4 unit |
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Measurement Range |
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400 units |
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Signal Range |
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0 to 127 Units |
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Maximum Offset Range |
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-300 units |
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Baseline Setting |
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20 units |
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Update Rate |
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Display |
1 / second |
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Printer |
~4 / second |
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Auto Offset Correction |
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3 seconds after connecting the |
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transducer, the TOCO value is set to 20 |
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units |
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Auto Zero Adjust |
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TOCO value is set to zero following a |
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negative measurement value for 5 |
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seconds |
IUP |
Measurement Method |
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Passive Resistive Strain Gauge Elements |
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Measurement Range |
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-100 to +300 mmHg |
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Signal Range |
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-99 to 127 mmHg |
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Resolution |
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Display |
1 mmHg |
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Printer |
1/4 mmHg |
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Sensitivity |
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5 μV/V/mmHg |
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Offset Compensation |
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+100 to -200 mmHg |
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Baseline Setting |
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0 mmHg |
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Accuracy (not including sensor accuracy) |
± 0.5% per 100 mmHg |
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Update Rate |
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Display |
1 / second |
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Printer |
~4 / second |
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Auto Offset Correction |
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3 seconds after connecting the |
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transducer, the IUP value is set to 0 |
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mmHg |
5
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