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700 SERIES Troubleshooting Guide CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USA Telephone: 203 488 6056 Toll Free: 800 227 4414 www.casmed.com 09-08 REV01

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Page 1: 700 SERIES Troubleshooting Guide - FORE-SIGHTcorporate.casmed.com/files/techsupport/vital_signs/700 Series...700 SERIES Troubleshooting Guide CAS Medical Systems, Inc. 44 East Industrial

700 SERIESTroubleshooting

Guide

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

09-08 REV01

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Table of Contents

• Decision Trees Can’t Turn The Monitor On Power-Up Response No NIBP Response Does Not Take A Temperature Measurement No SpO2 Response No ECG Response No Respiration Response No CO2 Response

• Helpful Information Quick Tips for taking an accurate NIBP White Paper on Calibration

• Organizing a Return Calling CASMED for an RMA Asking for a Loaner unit

• Preventative Maintenance Package for 740 units Package for 750 units

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

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Can't Turn The Monitor On

AC or Battery Operating ?

Plug in Line Cord Ensure good outlet and Line Cord

Green Charging

Indicator ON?

Bad/Disconnected Power Supply Blown Fuse

Bad/Disconnected Front Panel Keyswitch

AC

YES

Battery

NO

Operating?

Dead or Disconnected

Battery

YES

Failed Electronics

Repair/Service Required

NO

Can’t Turn The Monitor On

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

All Monitors

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

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To purchase a new battery please contact CASMED at 800.227.4414

If your customer ID is available, this information will expedite the ordering process.

Reminders…

• Battery warranty is 1 year

• Batteries should be used regularly to work properly

Notes…

Helpful Hints…

• Batteries can not sit for long periods of time and still work properly

• Recommend changing battery every 2 years

• Make sure the power cord is inserted completely into the AC input receptacle

Page 6: 700 SERIES Troubleshooting Guide - FORE-SIGHTcorporate.casmed.com/files/techsupport/vital_signs/700 Series...700 SERIES Troubleshooting Guide CAS Medical Systems, Inc. 44 East Industrial

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

Power-Up Response

Pass "888" sequence"NIBP Err"

Pass "888" sequence"READY"

"Err" in SpO2

Display Window"Low Batt" in

Message Window

Charge monitor for at least 4-6 hours before

putting back into service

Bad / Disconnected NIBP Module

Bad / Disconnected SpO2 Module

Power-UpResponse 740-1, 740-2

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Notes…

Reminders…

• Warranty on monitor is 2 years, battery 1 year, and accessories 6 months

• 740-1 monitor is Blood Pressure only

• 740-2 monitor is Blood Pressure and SpO2 , with choice of SpO2 technology:

Nellcor, Masimo, or Nonin

Helpful Hints…

• On the front panel is the BATTERY icon. This should be lit GREEN when

connected to a main power source, Yellow when running on battery

and Red when at low battery

• Battery is recommended to be changed every two years.

To purchase a new battery please contact CASMED at 800.227.4414

If your customer ID is available, this information will expedite the ordering process.

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No NIBP Response

Check the hose connection at the monitor.

Any Error message?

Return monitor for service

YesNo

Check the condition of the NIBP Hose and Cuff and replace if

needed.

Is the monitor set -up correctly?

Select the proper Cuff Size.

NoYes

Is the cuff attached properly? No

Refer to manual for patient set-up.

Return monitor for service

Yes

No NIBP Response

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

All Monitors

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Reminders…

• Cuff should be positioned one inch above the elbow at heart level

Wrap the cuff snugly. Make sure it doesn’t slip during readings. (See the Manual

section on cuff and site selection.) If during the measurement, the monitor indicates

a pulse rate is abnormally low, reposition the cuff and make sure

it is securely wrapped.

Helpful Hints…

• The cuff position should be at the approximate level of the right atrium

• If an ‘Air Leak’ message occurs, make sure the blood pressure cuff is not too loose

• If an ‘Appl Err’ message occurs, it means the monitor detects the wrong size cuff

(an example would be using a neonatal cuff in Adult mode)

• If the monitor displays a ‘Flow Error’ it means the system cannot maintain a stable

cuff pressure. Make sure the hose is not kinked or try another cuff. You can also

perform a pneumatic check.

Notes…

To purchase new accessories, please contact CASMED at 800.227.4414.

If your customer ID is available, this information will expedite the ordering process.

Page 10: 700 SERIES Troubleshooting Guide - FORE-SIGHTcorporate.casmed.com/files/techsupport/vital_signs/700 Series...700 SERIES Troubleshooting Guide CAS Medical Systems, Inc. 44 East Industrial

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

Does Not Take A Temperature Measurement

Remove temperature probe and adapter from

monitor.

Temperature function is out of service.

Return monitor for service.

Check the cable connection at the monitor.

Any Error Message?

Return monitor for service.

YesNo

No YesUse Test Plug to

verify temperature calibration.

Replace Adapter Yes

Place monitor back in service.

Place monitor back in service.

No

Replace Probe Yes

Return monitor and accessories

for service.

No

Does Not Take ATemperatureMeasurement 740-3

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Reminders…

• Pulling on the temperature probe may damage the Temperature Input

Connector causing the temperature not to function properly

• Temperature can be displayed in either Fahrenheit or Celsius. Refer to the

Set Up Menu to change display.

• Life expectancy of the Welch Allyn Temperature Probes is 6000 cycles.

Notes…

To purchase new accessories, please contact CASMED at 800.227.4414.

If your customer ID is available, this information will expedite the ordering process.

Helpful Hints…

• Welch Allyn recommends not taking temperature readings too close together.

Wait three minutes between readings.

• When the probe is removed from the well, temperature reading is initiated by a

micro switch in the temperature module (Sure Temp technology only). Over time

the micro switch can become intermittent and will need to be replaced

(P/N 03-09-0239, this is also included in our Preventative Maintenance package).

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No SpO 2 Response

Check the cable connection at the monitor.

Sensor LED ON?

Replace probe and re-check

No

Yes

Any Error message?

Replace probe and re-check

YesNo

Replace probe and cable

Does SpO2

work?

Send in for service.

No

Return monitor to floor

Yes

No SpO2 Response

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

740-2, 740-3750C, 750E-2MS

750E-2NL, 750E-3+4

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Helpful Hints…

• Use only a cuff/catheter-free extremity

• Cover site with opaque material (ex. blue surgical towels) to minimize interference

from bright lights directed toward the patient

• For long term use, it is best to move the sensor to a new site every few hours to

preserve skin integrity

• Dark colored nail polish may interfere with readings

Reminders…

• SpO2 probe must be kept as motionless as possible to display an accurate reading

• --- will appear when no oximeter probe is attached to the monitor

• Do not pull on the wire to get the probe off of the patient. This action has a

tendency to ruin the probe.

• Technology inside the unit must be the same as the sensor. Ex (Masimo unit needs

to have Masimo sensor.)

To purchase new accessories please contact CASMED at 800.227.4414

If your customer ID is available, this information will expedite the ordering process.

Notes…

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No ECG Response

Check the cable connection at the monitor.

Any Error message?

Return monitor for service

YesNo

Check the condition of the Patient Cable and Lead Wires

and replace if needed.

Is the monitor set-up correctly?

Select the proper Lead selection.

NoYes

Are the lead wires attached properly? No

Refer to manual for patient set-up.

Return monitor for service

Yes

No ECG Response

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

All 750Es

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Helpful Hints…

• Do Not use ultrasound gel, as this has the opposite effect of the electrode paste

and will block the signal

• Inspect for any breaks in the wire prior to use.

• If interference is encountered, turn off each monitor one-by-one to

determine the source, and try moving the unit to different locations

Reminders…

• To ensure proper lead selection, see the parameter menu in the manual

• If you are monitoring for a period of time over 30-60 minutes, electrode paste

should be used

• When detaching the lead wires, always remove by plastic portion not by wire itself

• Always check the expiration date code of the electrodes being used.

To purchase new accessories please contact CASMED at 800.227.4414

If your customer ID is available, this information will expedite the ordering process.

Notes…

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No Respiration Response

Check the cable connection at the monitor.

Any Error message?

Return monitor for service

YesNo

Is the monitor displaying RR

values?

Verify the correct placement of the Lead Wires per the instructions.

NoYes

Do you want a Respiration trace? No

Continue Monitoring

Refer to the Parameters Menu

and select a Trace location.

Yes

Continue Monitoring

YesIs the monitor displaying RR

values?

Return monitor for service

No

Is Respiration

turned OFF?No

Refer to the Parameters Menu

and turn ON Impedance Resp.

Yes

9403, 9404, 94059454, 9456

No RespirationResponse

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

All 750Es

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Helpful Hints…

• When detaching the lead wires do not pull on the wire itself.

• Inspect for any breaks in the wire prior to use.

Reminders…

• The respiration signal uses the Left Arm and Right Arm lead wires

• Lead wires that have become corroded or pitted should be replaced

• Always check the expiration date code of the electrodes being used

To purchase new accessories please contact CASMED at 800.227.4414

If your customer ID is available, this information will expedite the ordering process.

Notes…

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CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

No CO2 Response

Check the Filter Line connection at the monitor.

Any Error message? YesNo

Check the condition of the Filter Line and replace if needed.

Is the monitor displaying CO2

and RR values?

Verify the correct placement of the Filter Line per the

instructions.

NoYes

Do you want a CO2 trace? No

Continue Monitoring

Refer to the Parameters Menu

and select a Trace location.

Yes

Continue Monitoring

YesIs the monitor

displaying CO2

and RR values?

Return monitor for service

No

Flow Error?

Replace FilterLine

Yes

Return monitor for service

No

No CO2 Response 750E-3c750E-4750C

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Reminders…

• CO2 is also referred to as the Capnography

• Monitor is under warranty for 2 years, battery 1 year, all accessories 6 months

• Blowing out the filter line to clean it will damage the transducer

Helpful Hints…

• Clean the sensor after each use and during long procedures

• Check the sensor by breathing through the opening

• When attaching the sensor between the endotracheal tube adaptor

and the breathing tube, make sure the fitting is secure

To purchase new accessories please contact CASMED at 800.227.4414

If your customer ID is available, this information will expedite the ordering process.

Notes…

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Quick Tips for Taking an Accurate Blood Pressure

Things to Remember:

• Monitor should be powered off between patients to clear patient data and ensure patient comfort clear patient data and ensure patient comfort.

• Patient should be seated quietly, both feet flat on floor, back supported.

• Patient should rest for 2-3 minutes prior to the reading.

• Patient & Clinician should not speak during the reading.

• Clinician should support patient’s arm, keeping cuff at heart height and impeding movement during the reading.

• Cuff should be positioned 1” above the elbow.

• Cuff should be wrapped around upper arm tightly enough for the 2-finger-test.

• Cuff and artery should be properly aligned.

• Cuff should not be placed over clothing.

• Cuff should be the proper size for the patient.• A cuff that is too small will cause a high reading.• A cuff that is too large will cause a low reading.

References:1. Accurate blood pressure measurement: Why does it matter? Norman R.C. Campbell, MD; Donald W. McKay, PhD, CMAJ

1999;161:277‐8.2. Recommendations for Blood Pressure Measurement in Humans and Experimental Animals, AHA Scientific Statement, Thomas G. 

Pickering, MD, Dphil, et.al., Published online before print Dec 20, 2004, doi:10.1161/01.HYP.0000150859.47929.8e.3. Recommendations for Human Blood Pressure Determination by Sphygmomanometers, Report of a Special Task Force Appointed by 

the Steering Committee, American Heart Association,  Edward D. Frohlich, MD, Chairman, et.al., Reprinted in Circulation 1988; 77:501A‐514A and Hypertension 1988; 11:209A‐222A.

4. The Importance of Large Blood Pressure Cuffs, by Kmom, Updated April 2003.

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Performance Of The CAS Oscillometric Algorithm When Compared Against Various Commercially Available NIBP Simulators

Introduction As the use of automated oscillometric non-invasive blood pressure (NIBP) monitors becomes more wide spread, so does the use of oscillometric NIBP simulators. The main function of an oscillometric NIBP simulator is to dynamically reproduce the pressure profile of a live subject during a blood pressure measurement cycle. A common question that arises when using an NIBP simulator is, “why are the results produced by my blood pressure monitor different than the settings on the NIBP simulator?”. This paper will explore the underlying factors that lead to the disagreement between the blood pressure measurement results acquired by an NIBP monitor using the oscillometric method and the settings on an oscillometric NIBP simulator. Specifically, this paper will address the blood pressure measurement differences between the CAS oscillometric blood pressure measurement algorithm and various commercially available NIBP simulators. By comparing the results produced by the CAS oscillometric blood pressure measurement algorithm to settings on various simulators, an offset measurement table of expected results will be created for each NIBP simulator. This table can then be used to establish an expected range of performance between the CAS NIBP algorithm and the settings on a particular NIBP simulator. Background General Description of the Oscillometric Method

The oscillometric method measures blood pressure by monitoring the pulsatile changes in pressure that are caused by the flow of blood through an artery that is restricted by an occluding cuff. At the start of a measurement, the cuff around a subject’s limb is inflated to a pressure that completely occludes the underlying artery. The cuff is then deflated in a controlled manner. As the pressure in the cuff decreases, blood begins to flow through the artery.

The increasing blood flow causes the amplitude of the pressure pulses detected by the cuff to increase; refer to figure 1. As the pressure in the cuff decreases further, the pulses reach a maximum amplitude (Am). The pressure in the cuff that corresponds to the point of maximum oscillation has been shown to correlate to a subject’s mean arterial pressure (MAP)1,2. As the pressure in the cuff is decreased further, the pulses begin to decrease in amplitude. The rising and falling amplitude of the pressure pulses creates an envelope that is used to determine the subject’s systolic (Ps) and diastolic (Pd) pressures.

Figure 1 - Cuff pressure and oscillations in cuff pressure

(As, Am and Ad) used to identify a subject’s Systolic (Ps), MAP and Diastolic(Pd) pressures.

The CAS oscillometric algorithm determines a subject’s systolic and diastolic pressures by locating the points on the pulse pressure envelope that correspond to predetermined percentage of the maximum amplitude (Am). General Principles Of An Oscillometric NIBP Simulator

The main function of an oscillometric NIBP simulator is to dynamically reproduce the pressure profile of a live subject during a blood pressure measurement cycle. An oscillometric NIBP simulator accomplishes this by creating a series of pulses that vary in amplitude as a function of cuff pressure. The relationship between cuff pressure

October 4, 2007 © 2007 CAS Medical Systems Inc. 1

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and the varying amplitude of each pressure pulse is made to match, as close as possible, the response that would occur from a live subject during a blood pressure measurement. The manufacturers of NIBP simulators use various means to create the pulsatile pressure changes that are detected by the NIBP monitor. Some simulator manufacturers use an audio transducer (speaker), some use a stepper motor to pulse a piston and some use a cam to push against an air bladder to create these pressure pulses. How these pressure pulses are created is less important than how well these pressure pulses and the corresponding pressure profile emulate the response of an actual subject. Ultimately it is how repeatable an NIBP simulator is that determines how useful it is as a test platform for evaluating the performance of an NIBP monitor.

85 subjects and that these measurements be compared against the averaged results acquired by 2 trained observers. To pass the more stringent requirements of the SP10 standard (Method 2), 68 percent of the measurements reported by the NIBP monitor must be within less than 10 mmHg as compared to the results obtained by the trained observers. So what causes the discrepancy between a blood pressure monitor that has been cleared by the FDA for clinical use and an NIBP simulator? Some variation in blood pressure measurement results can be expected. This variation is mainly caused by the sampling error that can be attributed to the way the oscillometric method is implemented. Ideally, the oscillometric algorithm would be allowed to sample the pulse amplitude at every cuff pressure along the measurement profile; however, in practice this is not practical. There are limits to how long the blood flow in a limb can be restricted by an occluding cuff. So compromises are made to acquire as many pressure pulses as possible to achieve an accurate blood pressure measurement and still maintain the safety and comfort of the subject.

A typical test setup between an NIBP monitor and an NIBP simulator can be seen in figure 2.

An example of a typical pulse pressure envelope acquired from a normotensive adult subject during an oscillometric blood pressure measurement can be seen in figure 3.

Figure 2 – Typical Setup For An NIBP Monitor Test

Using An NIBP Simulator The NIBP monitor in figure 2 is connected directly to the simulator through a pneumatic hose. The blood pressure cuff wrapped around a mandrel is there strictly to provide an appropriate sized air volume. Some NIBP simulators have an internal air volume and the use of an external blood pressure cuff is not required.

Discussion Figure 3 – Pulse Pressure Envelope Produced By a Normotensive Adult Subject During An Oscillometric Blood Pressure Measurement

Before an NIBP monitor is approved by the Food and Drug Administration (FDA) for clinical use, evidence must be supplied to the FDA that clinical trials have been performed on the blood pressure monitor. The current accepted standard used to establish clinical accuracy is the AAMI SP10:2002. When using an auscultatory reference the SP10 standard requires that 3 blood pressure measurements be taken on

Let us see how the stepped down implementation of the oscillometric method affects the accuracy of an oscillometric blood pressure reading. What stepped down means is that discrete cuff pressures are held while pressure pulses are qualified; then the pressure in the cuff is reduced to the next pressure step. While this does increase the noise immunity of the

October 4, 2007 © 2007 CAS Medical Systems Inc. 2

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oscillometric algorithm, it does add a slight bit of uncertainty to the developing pulse pressure envelope. Since it cannot be guaranteed that a sample will be acquired precisely at the cuff pressure corresponding to the peak amplitude, an estimate of the peak amplitude and the corresponding cuff pressure must be made. This approximation adds a slight degree of error to the determination of the mean arterial pressure (MAP). Since the mean arterial pressure is used to derive both the systolic and diastolic pressures, any error in the approximation of the MAP is carried through to the derivation of the systolic and diastolic pressures as well.

difference is a constant offset that can be accounted for if the performance between the NIBP monitor and the simulator has been previously established. So what contributes to the major source of error when using an NIBP simulator? The major source of error between an NIBP simulator and an oscillometric blood pressure monitor is caused by the way the two devices create and interpret the pulse pressure envelope. This difference translates directly into the mean difference error between the monitor’s results and the setting on the NIBP simulator. Manufacturers of oscillometric blood pressure monitors all use proprietary methods to determine the systolic and diastolic pressure values. The same applies to manufacturers of NIBP simulators, but with simulators the difference is in the way the pulse pressure envelopes are created.

The same problem arises when using the linear bleed method. The blood pressure monitor cannot allow the air pressure in the cuff to decrease so slowly that there is a pressure pulse at every cuff pressure. Once again an estimate of the maximum pressure pulse amplitude must be made. As with the stepped down method, the process of estimating the peak amplitude of the pressure profile induces some degree of error into the measurement.

The most common criteria used to determine a subject’s systolic and diastolic pressures when using the oscillometric method is to identify these pressure values as a percentage of the maximum pressure oscillation (Am); refer to figure 3. Typically, the systolic blood pressure is identified as the cuff pressure that is greater than MAP where the amplitude of the pulse pressure envelope is equal to 50 percent of the maximum oscillation (A

Even if an NIBP simulator was capable of producing the same pressure profile every time a simulation was performed, the process of approximating the MAP would add some degree of variation in the final measured results. m). The diastolic blood pressure is identified as

the cuff pressure that is less than MAP where the amplitude of the pulse pressure envelope is equal to 80 percent of the maximum oscillation.

In practice this variation is not a significant source of error. Table 1 shows the results from 100 measurements taken using the CAS oscillometric algorithm and a DNI Nevada NIBP simulator. The NIBP simulator was set to adult mode with a blood pressure setting of 120 mmHg systolic, 80 mmHg diastolic and a pulse rate of 80 beats per minute (BPM).

A study was conducted in 1982 on 23 adult subjects3 in an attempt to determine the precise ratios that correspond to the oscillometric, systolic and diastolic pressures. This study used the auscultatory method as a reference to determine the subject’s actual blood pressure. When the blood pressure measurement results were compared to the amplitude of the oscillometric pulse pressure envelope, the ratios of the maximum pressure oscillation that corresponded to the systolic and diastolic pressure points were found to range from 57 to 45 percent and from 82 to 74 percent respectively. This study demonstrates the wide range of ratios that can be used to accurately calculate the systolic and diastolic pressures.

Adult Mode - 120/80 (93) 80 BPM

Systolic Diastolic MAP 117.62 80.96 91.68 Average

Mean

-2.38 0.96 1.68 Difference Standard

1.05 0.49 0.77 Deviation Max Error

3.43 1.45 2.45 One STD Table 1 – Results from 100 measurements taken using the CAS oscillometric algorithm and the DNI Nevada simulator (all values are in mmHg)

When an oscillometric algorithm is in the process of being fine tuned, the ratios used to determine the systolic and diastolic pressures are based on data acquired from a particular group of subjects. As no two groups of subjects will yield the same results, each manufacturer will arrive at a slightly different value for the ratios that are used to determine the systolic and diastolic pressures.

What is important to note from Table 1, is the standard deviation of the measured results. The standard deviation represents the true measurement error between the oscillometric algorithm and the NIBP simulator. The mean

October 4, 2007 © 2007 CAS Medical Systems Inc. 3

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simulator, an offset table must be employed. The offset tables at the end of this paper establish the expected performance of the CAS oscillometric algorithm as compared with various commercially available NIBP simulators.

If the algorithm used by a particular blood pressure monitor agrees with the pulse pressure envelope generated by the simulator, then the measured results reported by the monitor and the settings on the simulator will be within a clinically acceptable margin of error and should have a mean difference of no more than 5 mmHg. If the pulse pressure envelope generated by the simulator does not agree with the selection criteria used by the monitor to determine the systolic and diastolic pressure values, the results reported by the monitor can easily have a mean difference error that is greater than 10 mmHg.

Literature Cited

1 Posey JA, Geddes LA, Williams H, and Moore AG. 1969. The meaning of the point of maximum oscillations in cuff pressure in the indirect measurement of blood pressure. Part 1. Cardiovasc. Res. Cent. Bull. 8:15-25. There can be a disagreement between the

NIBP monitor and the simulator even if the simulator is using actual recorded data to create the pulse pressure envelope. To be approved for clinical use, the AAMI SP10 standard requires 68 percent of the measurements reported by the NIBP monitor be within 10 mmHg as compared with the measurement taken by the auscultatory reference. This means that 32 percent of the measurements taken by the monitor can fall outside of the 10 mmHg window. If the recorded subject data used by the simulator was recorded from a subject that is outside the monitor’s 10 mmHg window, then the results produced by the monitor will reflect this. The simulator may be using actual recorded data, but that data will produce the same measurement error every time it is run through the monitor’s implementation of the oscillometric algorithm. This is why the AAMI SP10 standard requires a wide variety of subjects be used in the clinical validation process.

2 Ramsey III M. 1979. Noninvasive blood pressure

determination of mean arterial pressure. Med. Biol. Engng. Comp., 17:11-18

3 Geddes, L.A., Voelz, M., Combs, C., Reiner, D.,

and Babbs, C. F. 1982, Characterization of the oscillometric method for measuring indirect blood pressure. Ann. Biomed. Eng., 10:271-280

Conclusion Non-invasive blood pressure simulators are excellent tools for verifying a host of safety and performance requirements that NIBP monitors approved for clinical use must meet. In the area of blood pressure simulation, it is not the absolute agreement between the oscillometric blood pressure monitor and an NIBP simulator that matters, but how repeatable the results produced by the monitor under test are when using the simulator. With each manufacturer using a different criteria to calculate the systolic and diastolic pressure values, it is unreasonable to expect a single NIBP simulator to achieve universal agreement with all clinically approved oscillometric blood pressure monitors. To establish the absolute performance between an NIBP monitor and a particular NIBP

October 4, 2007 © 2007 CAS Medical Systems Inc. 4

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Measurement Tables Measurement Tables for the Fluke DNI CuffLink and the CAS oscillometric algorithm cont.

An NIBP simulator can be used to gauge the absolute performance of an NIBP monitor if the expected results produced are known before hand.

DNI Nevada CuffLink Simulator

Adult Mode (hypertensive) - 200/150 (165) 80 BPM

The following tables represent the expected results from various commercially available simulators at various settings when using an NIBP monitor implementing the CAS oscillometric algorithm. The NIBP monitor and the NIBP simulator were set up as shown in Figure 2 during these tests. Ten measurements were taken at each simulator setting and the average result, mean difference and standard deviation were calculated and recorded for the data set. Measurement Tables for the Fluke DNI CuffLink and the CAS oscillometric algorithm

DNI Nevada CuffLink Simulator Adult Mode (hypotensive) - 80/50 (62) 80 BPM Systolic Diastolic MAP Average Result 83.70 52.62 63.94

Mean Difference 3.70 2.62 1.94

Standard Deviation 0.61 0.67 0.55

Table 2 1

DNI Nevada CuffLink Simulator Adult Mode (normotensive) - 120/80 (90) 80 BPM

Systolic Diastolic MAP Average Result 121.32 83.62 94.96

Mean Difference 1.32 3.62 4.96

Standard Deviation 0.74 0.53 0.60

Table 3 1

Systolic Diastolic MAP Average 204.14 151.38 172.66 Result Mean 4.14 1.38 7.66 DifferenceStandard 0.88 1.37 1.12 Deviation

1Table 4

DNI Nevada CuffLink Simulator Neo Mode (normotensive) - 80/50 (62) 120 BPM

Systolic Diastolic MAP Average 81.62 50.26 63.53 Result Mean 1.62 0.26 1.53 DifferenceStandard 0.64 0.56 0.50 Deviation

1Table 5

DNI Nevada CuffLink Simulator Neo Mode (hypertensive) - 120/80 (90) 120 BPM

Systolic Diastolic MAP Average 118.52 81.00 94.00 Result Mean -1.48 1.00 4.00 DifferenceStandard 0.71 0.29 0.64 Deviation

1Table 6

1 Results from 10 measurements on each of 5 different modules taken using the CAS oscillometric algorithm and the DNI

Nevada simulator (all values are in mmHg).

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Measurement Tables for the BioTek BP Pump and the CAS oscillometric algorithm

Measurement Tables for the BioTek BP Pump and the CAS oscillometric algorithm cont.

BioTek BP Pump Simulator BioTek BP Pump Simulator Adult Mode (hypotensive) - 80/50 (60) 80 BPM Neo Mode (normotensive) - 80/50 (60) 120 BPM Systolic Diastolic MAP Average Result 85.64 55.22 65.18

Mean Difference 5.64 5.22 5.18

Standard Deviation 0.95 0.82 1.02

Table 7 2

BioTek BP Pump Simulator

Adult Mode (normotensive) - 120/80 (93) 80 BPM Systolic Diastolic MAP Average Result 125.72 87.34 99.50

Mean Difference 5.72 7.34 6.50

Standard Deviation 1.31 1.14 1.31

Table 8 2

BioTek BP Pump Simulator Adult Mode (hypertensive) - 200/150 (166) 80 BPM

Systolic Diastolic MAP Average Result 205.30 156.86 171.96

Mean Difference 5.30 6.86 5.96

Standard Deviation 1.40 1.22 1.17

Table 9 2

Systolic Diastolic MAP Average 83.66 52.50 64.78 Result Mean 3.66 2.50 4.78 DifferenceStandard 1.24 0.61 0.62 Deviation

2Table 10

BioTek BP Pump Simulator Neo Mode (hypertensive) - 120/80 (93) 120 BPM

Systolic Diastolic MAP Average 122.58 83.62 98.46 Result Mean 2.58 3.62 5.46 DifferenceStandard 1.33 0.90 1.05 Deviation

2Table 11

2 Results from 10 measurements on each of 5 different modules taken using the CAS oscillometric algorithm and the BioTek BP

Pump simulator (all values are in mmHg).

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Measurement Tables for the Fluke BP Pump 2 and the CAS oscillometric algorithm

Measurement Tables for the Fluke BP Pump 2 and the CAS oscillometric algorithm cont.

Fluke BP Pump 2 Simulator Fluke BP Pump 2 Simulator Adult Mode (hypotensive) - 80/50 (60) 80 BPM Neo Mode (normotensive) - 80/50 (60) 120 BPM Systolic Diastolic MAP Average Result 82.10 51.98 61.98

Mean Difference 2.10 1.98 1.98

Standard Deviation 0.46 0.47 0.43

Table 12 3

Fluke BP Pump 2 Simulator Adult Mode (normotensive) - 120/80 (93) 80 BPM Systolic Diastolic MAP Average Result 121.08 83.08 95.76

Mean Difference 1.08 3.08 2.76

Standard Deviation 0.70 0.49 0.48

Table 13 3

Fluke BP Pump 2 Simulator Adult Mode (hypertensive) - 200/150 (166) 80 BPM Systolic Diastolic MAP Average Result 201.62 153.56 169.40

Mean Difference 1.62 3.56 3.40

Standard Deviation 1.05 0.61 0.53

Table 14 3

Systolic Diastolic MAP Average 80.76 50.94 62.76 Result Mean 0.76 0.94 2.76 DifferenceStandard 1.30 0.79 1.02 Deviation

3Table 15

Fluke BP Pump 2 Simulator Neo Mode (hypertensive) – 120/80 (93) 120 BPM Systolic Diastolic MAP Average 119.06 82.52 96.96 Result Mean 0.94 2.52 3.96 DifferenceStandard 0.87 1.31 0.78 Deviation

3Table 16

3 Results from 10 measurements on each of 5 different modules taken using the CAS oscillometric algorithm and the Fluke BP

Pump 2 simulator (all values are in mmHg).

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Measurement Tables for the AccuPulse and the CAS oscillometric algorithm

Measurement Tables for the AccuPulse and the CAS oscillometric algorithm cont.

AccuPulse Simulator AccuPulse Simulator Adult Mode (hypotensive) - 80/50 (60) 80 BPM Neo Mode (hypotensive) - 60/30 (42) 120 BPM Systolic Diastolic MAP Average Result 79.54 50.60 60.08

Mean Difference -0.46 0.60 0.08

Standard Deviation 0.58 0.49 0.49

Table 17 4

AccuPulse Simulator Adult Mode (normotensive) - 120/80 (93) 80 BPM Systolic Diastolic MAP Average Result 119.28 80.30 92.52

Mean Difference -0.72 0.30 -0.48

Standard Deviation 0.64 0.74 0.95

Table 18 4

AccuPulse Simulator Adult Mode (hypertensive) - 200/150 (166) 80 BPM Systolic Diastolic MAP Average Result 199.54 148.98 164.96

Mean Difference -0.46 -1.02 -1.04

Standard Deviation 0.97 1.04 1.28

Table 19 4

Systolic Diastolic MAP Average 59.76 29.86 41.34 Result Mean -0.24 -0.14 -0.66 DifferenceStandard 0.92 0.83 0.59 Deviation

4Table 20

AccuPulse Simulator Neo Mode (normotensive) - 80/50 (62) 120 BPM Systolic Diastolic MAP Average 79.82 49.80 61.72 Result Mean -0.18 -0.20 -0.28 DifferenceStandard 0.83 0.49 0.54 Deviation

4Table 21

AccuPulse Simulator Neo Mode (hypertensive) – 120/80 (103) 120 BPM Systolic Diastolic MAP Average 120.30 90.32 102.64 Result Mean 0.30 0.32 -0.36 DifferenceStandard 0.65 0.47 0.60 Deviation

4Table 22

4 Results from 10 measurements on each of 5 different modules taken using the CAS oscillometric algorithm and the AccuPulse

simulator (all values are in mmHg).

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Measurement Tables for the SimCube and the

CAS oscillometric algorithm

SimCube Simulator Adult Mode (normotensive) - 120/80 (100) 70 BPM

Systolic Diastolic MAP Average 117.08 85.26 94.80 Result Mean -2.92 5.26 -5.20 Difference Standard 1.21 0.69 1.12 Deviation

5Table 23

SimCube Simulator Adult Mode (hypertensive) - 190/120 (150) 70 BPM

Systolic Diastolic MAP Average 182.58 125.04 141.60 Result Mean -7.42 5.04 -8.40 Difference Standard 1.20 0.75 1.93 Deviation

5Table 24

SimCube Simulator Neo Mode (normotensive) - 70/40 (55) 94 BPM Systolic Diastolic MAP Average 70.22 42.86 52.20 Result Mean 0.22 2.86 -2.80 Difference Standard 0.84 0.93 1.65 Deviation

5Table 25

5 Results from 10 measurements on each of 5 different modules taken using the CAS oscillometric algorithm and the SimCube

simulator (all values are in mmHg).

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Calling CASMED for an RMA

In order to have a monitor returned to CASMED for repair, there must be an RMA number (Return Merchandise Authorization) assigned by CASMED.

In order to issue an RMA number CASMED will need:

- Model number (ex. 740-3NL)

- Serial number (can be located on the bottom of the monitor right below the bar code). If the monitor is close to being out of warranty (2 years old), a proof of purchase maybe required.

- Customer ID (if you do not have a customer ID you will need the name of your facility, a shipping address and a billing address).

- Credit card may be required if it is a new account being set up. All EMS accounts are set up as prepayment, if charges apply a credit card or a check will be required before the repairs are started.

- P.O. number may be necessary if the customer has NET 30 terms and the repair is billable. Please note that a customer can use a P.O. to approve a certain amount and CASMED will call for approval if the repair exceeds the amount.

- Issue with the unit should be as specific as possible. The more detail available, the more accurately we will be able to ‘pin point’ the issue. An example would be a complaint of intermittent temperature. It would be very helpful for the customer to know when the temperature does work and when it doesn’t (is it every 3rd time, do you have to turn the monitor off and back on to get it to work?).

- Once the RMA number is given to the customer, it is important that they keep the number for their reference.

- All repairs should be sent to the address below:

CAS Medical SystemsAttn. RMA # 32 East Industrial Rd.Branford, CT 06405

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

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Loaners

At CASMED we strive to provide the highest level of service possible to all of our customers. This is why we take great pleasure in being able to provide loaner monitors for all of our customers.

When calling CASMED for an RMA number (Return Merchandise Authorization):

- Ask for a loaner monitor. If the monitor is coming back under warranty, the use of a loaner is free of charge. If this request is billable, the cost to the customer is $30.00 for the duration of the repair plus freight.

- Loaners are generally sent out within 3 days of receiving the loaner request from the customer. Once the loaner monitor is received, please feel free to use the same box and ship it back to CASMED. There will be no call tags (UPS Label) issued for customer owned property coming back for repair. (Warranty monitors, CASMED pays three out of the four shipments, the loaner both ways and the customer owned unit back.)

- Accessories generally will not be shipped with our loaner monitors. Accessories are not covered under our warranty, and therefore if the accessories are defective should be replaced by the customer. If a customer wishes to send in their accessories in with the monitor to have them tested, they may do so. However, if nothing is found wrong with the monitor and the accessories are found to be defective our $100.00 estimate fee will apply. An exception to this is monitors that the accessories still are covered under warranty (6 months) or if our service department requests the customer to send in their accessories.

- After one week of having the repaired unit back, it is the customer’s responsibility to call CASMED and arrange to have a call tag( UPS Label) sent out to get the unit back.

- If CASMED has not heard back from the customer within two weeks of their unit being delivered, there will be an additional charge, which will be re-assessed every two weeks. A sheet of paper will come with the loaner monitor with all important information on it.

CAS Medical Systems, Inc. 44 East Industrial Road Branford, CT 06405 USATelephone: 203 488 6056 Toll Free: 800 227 4414

www.casmed.com

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Service Support

Customer Support ProgramsListening to your equipment support needs

CASMED is proud to serve

the needs of the worldwide

healthcare community.

Everyday, CASMED products

are being used as critical

components in the patient

care process. The customer

support team understands

this responsiblity and is

committed to providing the

highest level of support

and attention.

How to Reach Us: CAS Medical Systems: 44 East Industrial Road, Branford, CT 06405

Telephone: 203.488.6056 - Tech Support: 800.581.7806 - Toll Free: 800.227.4414www.casmed.com

Preventative Maintenance Program

Our service department is dedicated to keeping CASMED equipment runningat peak condition. Our comprehensive preventative maintenance program has been designed to ensure facilities the longest monitor life span with the maximum uptime possible; resulting in an overall cost savings.

By going through a like new process, we are able to:

• Perform internal design revisions and update software

• Replace the NIBP receptacle along with any other connections that may have become loose to prevent air leaks at hose connection

• Functional checks and calibration of the unit for more accurate readings

• Battery replacement to ensure full charging capabilities

• Replacement of the temperature module switch board (SureTemp® Technology only) to prevent intermittent temperature readings

• NIBP Pneumatic check

• Monitor Safety Leakage Check/ Hi-Pot Test in compliance with JCAHO

• Updated labeling

• Test all accessories sent in with the monitor

• Front panel and housing replaced as needed returning it to a like new condition

As a Thank You for allowing us to support your equipment servicing needs a new cuff will be provided at no additional charge with all PM’s performed

If you are interested in our Preventative Maintenance Program, please contact CASMED Customer Support for current pricing and to set up an RMA for return

SureTemp is a Trademark of Welch Allyn