The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure. The intended user is a trained biomedical equipment technician who is performing periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, clinics, original equipment manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology. The ProSim is intended to be used in the laboratory environment and is not intended for use on patients, or to test devices while connected to patients. This product line is not intended to be used to calibrate medical equipment. ProSim is intended for over-the counter use.
Device Story
ProSim 4, 6, and 8 are portable, battery-powered vital signs simulators used by biomedical technicians in laboratory settings to test/verify patient monitor performance. Devices generate electrical signals (ECG, respiration, IBP, temperature, cardiac output) and pneumatic pulses (NIBP) to simulate patient physiology; ProSim 6/8 also provide optical signals for pulse oximetry testing. Input is via touchscreen/soft keys; output is simulated physiological signals delivered to the monitor under test. Devices replace multiple legacy simulators by combining functions into a single, compact, plastic-cased unit. Data is processed via embedded firmware on PCBs. Results are used by technicians to perform preventive maintenance and verify monitor specifications. Benefits include improved portability, consolidated testing capabilities, and reduced maintenance time for healthcare facility equipment.
Clinical Evidence
No clinical data. Bench testing only. Laboratory studies verified performance against published specifications using representative patient monitors. Software validation confirmed device functionality.
Technological Characteristics
Plastic injection-molded case; embedded processors with firmware; stepper motor/piston pump for NIBP; LCD touch/soft screen; Li-Ion rechargeable battery; USB communication port. Simulates ECG, respiration, IBP, NIBP, temperature, cardiac output, and SpO2. Sterilization not applicable (laboratory use).
Indications for Use
Indicated for biomedical technicians to test/verify patient monitor performance via electronic/pneumatic simulation of physiological parameters (ECG, respiration, invasive/non-invasive blood pressure, temperature, cardiac output, SpO2, and fetal/maternal signals). Not for use on patients or for calibration.
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
{0}------------------------------------------------
K110429
SEP - 2 2011
Image /page/0/Picture/2 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, sans-serif font. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. There is a line above the word "Biomedical".
#### Section III -510(k) Summary of Safety and Effectiveness
#### Submitter:
Fluke Biomedical 6920 Seaway Blvd Everett WA. 98203 (440) 498-2579 -Phone (440-349-2307) - Fax John Nelson -Contact Person
#### Device Name:
- ◆ Trade Name - ProSim 4
- . Common Name -Vital Signs Simulator
- Classification Name Monitor, Cardiac /System, Measurement, Blood-Pressure, Non-Invasive per . 21 CFR 870.2300/870.1130
- Product Codes -DRT, DXN .
#### Devices for Which Substantial Equivalence is Claimed:
- MedSim300B Submitted as MedSim300 under 510(k) K935817 ◆
- Cufflink .
#### Device Description:
#### Principles of Operation
Fluke Biomedical's ProSim 4 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals and non-invasive blood pressure pulses. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
#### Technological Characteristics
ProSim vital signs simulator consists of the following components:
1) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2) Plastic iniection molded case parts.
3) Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
4) Liquid Crystal Touch Screen Display for user interface. User interface follows modern and ergonomic concepts.
5) Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Fluke Biomedical. The word "FLUKE" is in large, bold, sans-serif font on a gray background. Below the word "FLUKE" is the word "Biomedical" in a smaller, bold, sans-serif font. There is a black line above the word "Biomedical".
#### Intended Use of the Device:
The intended us of ProSim 4 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure and Non-invasive blood pressure.
The intended user is a trained biomedical equipment technician who is performing periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, clinics, original equipment manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology.
The ProSim is intended to be used in the laboratory environment and is not intended for use on patients, or to test devices while connected to patients. This product line is not intended to be used to calibrate medical equipment.
ProSim is intended for over-the counter use.
#### Summary of Technological Characteristics:
The ProSim 4 is substantially equivalent to one other legally marketed device in the United States. The ProSim functions in a manner similar to and is intended for the same use as the MedSim300B and Cufflink manufactured by Fluke Biomedical.
The ProSim 4 is similar to the MedSim300B and Cufflink in that it is a cordless battery-operated device, uses LCD display, and allows user to simulate physiological parameters to verify the operation of patient monitors. The ProSim differs from the MedSim300B and Cufflink in that the ProSim combines the features of each of these devices into one device and is touch screen operated.
| Features | ProSim 4 | MedSim 300B<br>(K935817) | Cufflink<br>(K942546) | Difference |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use | The intended use of<br>ProSim 4 is to test and<br>verify the basic<br>operation of patient<br>monitoring devices or<br>systems used to monitor<br>various physiological<br>parameters of a patient,<br>including ECG,<br>Respiration, Invasive<br>blood pressure and<br>Non-Invasive blood<br>pressure.<br>The intended user is a<br>trained biomedical<br>equipment technician<br>who is performing<br>periodic preventative<br>maintenance checks on<br>patient monitors in<br>service. Users can be<br>associated with<br>Hospitals, clinics,<br>original equipment<br>manufacturers or<br>independent service<br>companies that repair<br>and service medical | To test operation<br>of patient monitors<br>by simulating<br>physiological<br>parameters,<br>including: ECG,<br>respiration, blood<br>pressure,<br>temperature and<br>cardiac output. | To test operation of<br>Non-Invasive Blood<br>Pressure (automated<br>Sphygmomanometers<br>simulator). | None |
| | equipment. The end<br>user is a technically<br>trained individual,<br>specializing in medical<br>instrumentation<br>technology.<br>The ProSim product line<br>is intended to be used in<br>the laboratory<br>environment and is not<br>intended for use on<br>patients, or to test<br>devices while connected<br>to patients. This product<br>line is not intended to be<br>used to calibrate<br>medical equipment and<br>not intended for over the<br>counter use. | | | |
| Construction | Plastic case. | Aluminum case. | Aluminum case. | Lighter more<br>compact plastic<br>casing. |
| Size | ProSim 4: 7.1 L x 3.7 W<br>x 2.2 H inches. | 10 L x 7 W x 3 H<br>inches. | 15 L x 12.5 W x 5 H<br>inches. | Combination<br>instrument<br>smaller than<br>sum of<br>predicate<br>devices. |
| Weight | ProSim 4: 1.9 lbs. | 3.55 lbs. | 15 lbs. | Lighter. |
| Display | ¼ VGA graphic LCD<br>Touch Color Display. | 2 by 24 character<br>LCD. | 8 by 20 character<br>alphanumeric<br>display & 64 by 240<br>graphical display. | More display,<br>Touch Screen<br>and Color. |
| Function Key | ProSim 4: Touchscreen. | Soft. | Soft. | ProSim 4:<br>Touchscreen. |
| ECG leads | 10 binding posts;<br>compatible w/<br>disposable snaps, 3.2<br>mm or 4.0 mm<br>electrodes, and banana<br>plugs (with or without<br>adapter). | 10 binding posts;<br>compatible w/<br>disposable snaps.<br>3.2 mm or 4.0 mm<br>electrodes, and<br>banana plugs. | N/A | None. |
| IBP Channels | Independent BP<br>channels w/ sensitivity<br>control (5 or 40<br>uV/V/mmHg); cable<br>interface w/ monitors.<br>ProSim 4: 1 channel. | 4 independent BP<br>channels w/<br>sensitivity control<br>(5 or 40<br>uV/V/mmHg);<br>cable interface w/<br>monitors. | N/A | Number of<br>channels<br>reduced per<br>market<br>requirements<br>and use. |
| Communications<br>Port | USB. | RS232. | RS232. | Change from<br>RS232 to USB<br>data port with<br>advancement in<br>technology. |
| Battery test | Multiple levels of battery life indication. | Limited low battery indication. | No battery. | Predicate devices only check at one level. ProSim checks battery status at multiple charge levels. |
| Power | Li-Ion rechargeable battery w/ low battery indicator; or battery eliminator (115VAC) transformer certified to CSA. | 2 X 9V alkaline battery w/ low battery indicator; or battery eliminator (115VAC) transformer certified to CSA C22.2. 231 series M89). | No Battery- AC line powered only. | Longer operating life with modern battery technology. |
| Lead configuration | 12 leads. | 12 leads. | N/A | None. |
| Output impedances | 500 to 2000ohms to RL. | 500 to 2000ohms to RL. | N/A | None. |
| Amplitude accuracy | +/- 2% setting lead II. | +/- 5%, 2Hz @ 1.0 mV p-p SQ wave Lead II. | N/A | More accurate on newer devices due to market preferences and technology improvements. |
| NSR rates | ProSim 4: 30 to 320 BPM. | 30 to 300 BPM. | N/A | Wider range due to market preferences. |
| NSR amplitudes | ProSim 4: 1mV | 50 uV to 5.5mV. | N/A | ProSim 4: Limited amplitude for basic simulation. |
| Pediatric or Neonatal ECG | R Wave width reduced to 40 ms. | R Wave width reduced to 40 ms. | N/A | None. |
| Square and/or Pulse waves | ProSim 4: Pulse at 60ms / 2Hz. | Square at 2 Hz and 0.125 Hz. | N/A | ProSim 4: Provides what is required for a basic simulation. |
| Pacemaker | ProSim 4: 1 ms width, 3mV. | 0.1 to 2.0 ms width, -700 to +700 mV | N/A | ProSim 4: Basic simulation for targeted market. |
| Cable connector | ECG leads, 10 binding postings. | ECG leads, 10 binding postings. | N/A | None. |
| Normal baseline impedances | 500 to 2000 ohms ref. to RL. | 500 to 2000 ohms ref. to RL. | N/A | None. |
| Lead selections | LA or LL. | I or II (LA or LL). | N/A | None. |
| Impedance variation | ProSim 4: 1.0 ohm | 0 to 3 ohms. | N/A | ProSim 4: Basic simulation for targeted market. |
| Respiration<br>rates | ProSim 4: 10, 20, 30,<br>40, 50, 60, 70, 80, 90 &<br>100 brpm. | 15, 20, 30, 40, 60,<br>120 brpm. | N/A | More<br>Respiration<br>rates due to<br>market<br>requirements<br>and use. |
| Apnea | ProSim 4: Off &<br>Continuous. | Off, Continuous,<br>momentary, 12 &<br>32 s. | N/A | ProSim 4: Less<br>apneas for<br>basic simulation<br>and target<br>market. |
| Cable connector | ECG leads, binding<br>posts. | ECG leads,<br>binding posts. | N/A | None |
| I/O impedance | 300 ohms. | 300 ohms. | N/A | None. |
| Exciter range | 2 to 16 V/DC to 5kHz. | 2 to 16 V/DC to 4<br>kHz | N/A | Higher<br>frequency<br>range driven by<br>market trend<br>and technology. |
| Transducer<br>Sensitivity | ProSim 4: 5 uV/V/mmHg | 5 or 40<br>uV/V/mmHg. | N/A | ProSim 4:<br>Fewer<br>selections for<br>basic simulation<br>and target<br>market. |
| Level accuracy | +/- (1% setting +<br>1mmHg). | +/- 1% full scale;<br>+/- 1mmHg. | N/A | None. |
| Static pres.<br>Selection | Manual. | Manual and<br>automatic. | N/A | Limited<br>selection mode<br>per target<br>market and use. |
| Dynamic BP<br>selections | ProSim 4: Arterial and<br>left ventricle. | Arterial, left and<br>right ventricle,<br>pulmonary artery,<br>pulmonary wedge,<br>Swan-Ganz. | N/A | ProSim 4:<br>Fewer<br>selections for<br>basic simulation<br>and target<br>market. |
| Static BP<br>selections | ProSim 4: 0, 80, 160 &<br>250 mmHg | -10, -5, 0, 20, 30,<br>40, 80, 100, 200,<br>250 & 300 mmHg. | N/A | ProSim 4:<br>Fewer<br>selections for<br>basic simulation<br>and target<br>market. |
| Cable connector | DIN style. | DIN style. | N/A | None. |
| Manometer | 0 to 400 mmHg | N/A | Max. 499.75 mmHg | Lower range<br>following<br>market<br>requirements. |
| Leak Test | Source pressure, seal<br>off, measure change in<br>pressure over time. | N/A | Source pressure,<br>seal off, measure<br>change in pressure<br>over time. | None. |
| Over Pressure<br>Test | Increase pressure until<br>device under tests vents<br>to atmosphere. | N/A | Increase pressure<br>until device under<br>tests vents to<br>atmosphere. | None. |
| Simulation | ProSim 4:<br>Systolic/Diastolic Adult –<br>60/30, 120/80, 150/100<br>& 200/150; Neonatal<br>35/15 & 70/40. | N/A | Systolic/Diastolic<br>simulations. Adult<br>60/30 to 255/195. | ProSim 4:<br>Fewer<br>selections for<br>basic<br>simulation.<br>Adult and<br>Neonatal. |
| Synchronization<br>to ECG | ProSim 4: Up to 150<br>BPM | N/A | 30 to 240 BPM | ProSim 4:<br>Limited for<br>basic<br>simulation. |
. 0000006
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Image /page/2/Picture/0 description: The image shows the word "FLUKE" in a bold, sans-serif font. Below the word "FLUKE" is the word "Biomedical" in a smaller, sans-serif font. The word "Biomedical" is underlined with a thick, black line. The background of the image is a light gray color.
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〜 000007
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Image /page/3/Picture/2 description: The image shows a sequence of numbers, specifically "000008". The numbers are printed in a bold, sans-serif font. The image appears to be a close-up of the numbers, with some minor imperfections or artifacts visible around the edges of the numbers.
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Image /page/4/Picture/0 description: The image shows the word "FLUKE" in large, bold letters. Below the word "FLUKE" is the word "Biomedical" in a smaller font. There is a black line above the word "Biomedical".
. په چهاچ پ
5/14
. 000009
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Image /page/5/Picture/0 description: The image shows the word "FLUKE" in large, bold, black letters. Below the word "FLUKE" is the word "Biomedical" in a smaller font. The background of the image is a light color, and there are some dark spots around the letters.
#### Non-Clinical Test Data:
Laboratory studies have been conducted with a representative patient monitor to verify and validate the ProSim 4 will perform within its' published specifications.
- NPI-02042011-00001 ProSim 4 Bench test summary and results. .
The ProSim 4 software has been successfully validated to confirm the performance of the device.
#### Clinical Test Data:
Clinical testing has not been conducted on this product.
#### Conclusion:
Based upon the laboratory studies, similar technological/performance characteristics as compared to the predicate devices, and successful validation of the ProSim 4 software, the performance of the ProSim 4 is deemed to be substantially equivalent to the MedSim300B and Cufflink.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Fluke Biomedical. The logo consists of the word "FLUKE" in a bold, sans-serif font, with the word "Biomedical" underneath it in a smaller font. The logo is surrounded by a textured background, which gives it a slightly distressed look. The image also contains a handwritten number, "7/".
#### Device Name:
- Trade Name -ProSim 6, ProSim 8 .
- . Common Name -Vital Signs Simulator
- Classification Name Monitor, Cardiac /System, Measurement, Blood-Pressure, Non-Invasive per . 21 CFR 870.2300/870.1130
- Product Codes -- DRT, DXN .
#### Devices for Which Substantial Equivalence is Claimed:
- MedSim300B Submitted as MedSim300 under 510(k) K935817 .
- Index 2MF SPO2 Originally submitted and cleared under 510(k) K933519. Currently marketed . as Index 2MF which was ruled as a general purpose device on Feb 11, 1998 (K974293)
- . Cufflink
#### Device Description:
#### Principles of Operation
Fluke Biomedical's ProSim 6 and ProSim 8 (hereafter referred to as the ProSim) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG electrical signals, respiration electrical signals, invasive blood pressure (IBP) electrical signals, non-invasive blood pressure (NIBP) pressure pulses, temperature electrical signal, cardiac output electrical signal, and pulse oximetry SPO2 optical simulated light attenuation. The ProSim is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
#### Technological Characteristics
ProSim vital signs simulator consists of the following components:
l ) Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
- 2) Plastic injection molded case parts.
- 3) Stepper Motor and piston pump for pneumatic simulation that makes reliable pressure pulses.
- 4) Liquid Crystal Display for user interface. User interface follows modern and ergonomic concepts.
- 5) Lithium Ion rechargeable battery for portable operation, giving user flexibility and portability.
#### Intended Use of the Device:
The intended us of ProSim 6 and ProSim 8 is to test and verify the basic operation of patient monitoring devices or systems used to monitor various physiological parameters of a patient, including ECG, Respiration, Invasive blood pressure, Non-invasive blood pressure and Cardiac output. Additionally, the devices provide an optical signal to verify that the electronics within the pulse oximeter probe are functional.
The intended user is a trained bioment technician who is performing periodic preventative maintenance checks on patient monitors in service. Users can be associated with hospitals, cliginal equipment manufacturers and independent service companies that repair and service medical equipment. The end user is a technically trained individual, specializing in medical instrumentation technology,
000011
{7}------------------------------------------------
The ProSim is intended to be used in the laboratory environment and is not intended for use on patients, or to test devices while connected to patients. This product line is not intended to be used to calibrate medical equipment.
ProSim is intended for over-the counter use.
#### Summary of Technological Characteristics:
The ProSim is substantially equivalent to one other legally marketed device in the United States. The ProSim functions in a manner similar to and is intended for the same use as the MedSim300B, Index 2 and Cufflink manufactured by Fluke Biomedical.
The ProSim is similar to the MedSim300B, Index 2 and Cufflink in that it is a cordless battery-operated device, uses LCD display, and allows user to simulate physiological parameters to verify the operation of patient monitors. The ProSim differs from the MedSim300B, Index 2 and Cufflink in that the ProSim combines the features of each of these devices into one device.
| Features | ProSim 6 &<br>ProSim 8 | MedSim 300B<br>(K935817) | Index 2<br>(K 933519) | Cufflink<br>(K942546) | Difference |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The intended use of<br>ProSim 6 and<br>ProSim 8 is to test<br>and verify the basic<br>operation of patient<br>monitoring devices<br>or systems used to<br>monitor various<br>physiological<br>parameters of a<br>patient, including<br>ECG, Respiration,<br>Invasive blood<br>pressure, Non-<br>invasive blood<br>pressure,<br>Temperature,<br>Cardiac output and<br>SpO2.<br>The intended user is<br>a trained biomedical<br>equipment<br>technician who is<br>performing periodic<br>preventative<br>maintenance checks<br>on patient monitors<br>in service. Users can<br>be associated with<br>Hospitals, clinics,<br>original equipment<br>manufacturers or<br>independent service<br>companies that<br>repair and service<br>medical equipment.<br>The end user is a<br>technically trained<br>individual,<br>specializing in | To test operation<br>of patient monitors<br>by simulating<br>physiological<br>parameters,<br>including: ECG,<br>respiration, blood<br>pressure,<br>temperature and<br>cardiac output. | To test operation of<br>Pulse Oximeters by<br>simulating the visible<br>and infrared light<br>absorption. | To test operation<br>of<br>Non-Invasive Blood<br>Pressure (automated<br>Sphygmomanometers<br>simulator). | Additional<br>functions of<br>noninvasive<br>blood pressure<br>and pulse<br>oximetry<br>simulation |
| | medical<br>instrumentation<br>technology.<br><br>The ProSim product<br>line is intended to<br>be used in the<br>laboratory<br>environment and is<br>not intended for use<br>on patients, or to<br>test devices while<br>connected to<br>patients. This<br>product line is not<br>intended to be used<br>to calibrate medical<br>equipment and not<br>intended for over<br>the counter use. | | | | |
| Construction | Plastic case. | Aluminum case. | Plastic case. | Aluminum case. | Lighter more<br>compact<br>plastic casing |
| Size | 5.7 L x 11.9 W x 3.4<br>H inches. | 10 L x 7 W x 3 H<br>inches. | 10 L x 10.5 W x 4 H<br>inches. | 15 L x 12.5 W x 5 H<br>inches. | Combination<br>instrument<br>smaller than<br>sum of<br>predicate<br>devices. |
| Weight | 4.1 lbs. | 3.55 lbs. | 4 lbs. | 15 lbs. | Lighter. |
| Display | ¼ VGA graphic<br>LCD Color Display. | 2 by 24 character<br>LCD. | 2 by 24 character<br>LCD. | 8 by 20 character<br>alphanumeric<br>display & 64 by 240<br>graphical display. | More display,<br>Color. |
| Function<br>Key | Soft. | Soft. | Soft. | Soft. | None. |
| ECG leads | 10 binding posts;<br>compatible w/<br>disposable snaps,<br>3.2 mm or 4.0 mm<br>electrodes, and<br>banana plugs (with<br>or without adapter). | 10 binding posts;<br>compatible w/<br>disposable snaps,<br>3.2 mm or 4.0 mm<br>electrodes, and<br>banana plugs. | N/A | N/A | None. |
| High level<br>ECG | BNC jack for<br>0.5V/mV output<br>into 50 Ohm<br>impedance. | ¼" standard phone<br>jack w/ lead II<br>waveform at<br>.2V/mV of ECG<br>lead II signal. Use<br>w/ analog input,<br>high level, central<br>station monitors or<br>recorders. | N/A | N/A | Output to<br>oscilloscope<br>via BNC is<br>preferred by<br>customers. |
| IBP<br>Channels | Independent BP<br>channels w/<br>sensitivity control (5<br>or 40 uV/V/mmHg);<br>cable interface w/<br>monitors.<br>2 channels. | 4 independent BP<br>channels w/<br>sensitivity control<br>(5 or 40<br>uV/V/mmHg);<br>cable interface w/<br>monitors. | N/A | N/A | Number of<br>channels<br>reduced per<br>market<br>requirements<br>and use. |
| | (500 – 2000)<br>control; lead select<br>control. | Impedance (500 –<br>2000) control; lead<br>select control. | | | |
| Temperature | Yes, fixed temp.<br>probe select control<br>(400 or 700 YSI)<br>series probes. | Yes, fixed or<br>variable temp.<br>probe select<br>control (400 or 700<br>YSI) series probes. | N/A | N/A | None. |
| Cardiac<br>output | Yes, cable connect<br>w/ monitor. | Yes, cable connect<br>w/ monitor. | N/A | N/A | None. |
| Communicat<br>ions Port | USB. | RS232. | RS232. | RS232.…
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