SmartSat Manual

SmartSat™

Pulse Oximetry Analyzer

Operation Manual

mtk Peter Kron GmbH Medical Test Devices, Software & Services

Zossener Straße 41 10961 Berlin / Germany Tel.: +49 (0)30 / 69 81 88 - 40 Fax: +49 (0)30 69 81 88 - 49

Email: [email protected] www.mtk-biomed.de

Notices

Shipping Address:

mtk Peter Kron GmbH

Zossener Strasse 41 - 10961 Berlin - GERMANY

Sales & Service,

Technical Support: 0049 - 30 - 69 81 88 40

Facsimile:

0049 - 30 - 69 81 88 49

Email: [email protected]

Web Site:

www.

mtk-biomed.de

In the interest of continued product improvement, all specifications are subject to change without notice.




Revision History

1 May 1995

10 December 1998

14 January 1999

19 August 2002

3 December 2002

10 October 2003

15 December 2003

05 January 2004

Release at revision 00.

Release at revision 01






Release at revision 07 mtk Peter Kron GmbH Medical Test Devices, Software & Services



iii

Revision History iv




Warranty Service & Shipping Instructions

Warranty Service

All repairs on products under warranty must be performed or approved in writing by mtk Peter Kron GmbH

Service personnel. Unauthorized repairs will void the warranty.

Assistance

If the product fails to function properly, or if assistance, service or spare parts are required, contact mtk or send an email. After this form has been submitted, an mtk Representative will help you to solve your problem.

Before contacting, please attempt to duplicate the problem and to check all accessories to ensure that theyare not the cause of the problem. Prior to calling please be prepared to provide:

1. Product Name, Model Number, Serial Number and Software version.

2. Complete description of the problem including the conditions under which the problem occurred. Ideally, a written problem description would be provided, allowing for more efficient handling of your initial service request and the subsequent diagnosis and remedy of the problem.

3. Your institution's complete name and address. Please also provide a contact name and phone number.

4. A purchase order number if the product needs non-warranty service or you are ordering spare parts.




v

Returning a Product for Service

Warranty &Factory Service Instructions

If it is determined that you need to ship the unit back, it is highly recommended that you pack the product in its original shipping carton and packing materials, provided that they are still useable. If the original packaging is not available, select a sturdy corrugated carton large enough to hold whatever items you are returning, and also to allow 4 to 6 inches of packing material on all sides of the items. Whether you use the original packaging or an appropriate substitute, please follow these packing instructions:

1. Remove all hoses, cables, power cords and any other accessories from the instrument and, if possible.

Note: if you are using substitute packaging, it is essential that you seal the instrument in a clean, static free plastic bag or in clean bubble wrap in order to prevent packing material from entering the product.

2. Pack only the accessories you are requested to return; place them in a separate bag.

3. If you are using substitute packaging, create a foundation of 4 to 6 inches of packing material (either bubble wrap or packing "peanuts") at the bottom of the carton.

4. Insert the instrument and the accessory bag into the shipping carton.

5. If you are using substitute packaging, fill the 4 sides and the top of the carton with 4 to 6 inches of packing material (either bubble wrap or packing "peanuts"). Ensure that the instrument and accessory bag are held firmly in place by the packing material.

6. Please place paperwork such as the purchase order, contact info and reasons for return in the top of the carton.

7. Close the carton and securely seal it with tape; since in most cases the carton will have been previously used, it may be necessary to reinforce the original tape on the bottom of the carton.

8. Ship the product via whatever carrier (UPS, FedEx, etc.) is most convenient. However, please be aware that, depending on where you are shipping from, standard UPS ground shipping could take as long as 7 business days. Unless other arrangements are made, mtk will return the repaired product to you via UPS.

Additional Instructions for International Shipments

9. Shipping insurance is optional. Claims for damage to the product during shipping must be initiated by the shipper.

Customers outside the United States must include a "pro-forma invoice" for customs purposes as part of their shipping documents. It is imperative that the name of the product appears exactly as follows:

SmartArm Test Equipment

Or

SmartSat Test Equipment

The use of any other product name could add unnecessary delays when shipping internationally. mtk Peter Kron GmbH Medical Test Devices, Software & Services



Table of Contents

Notices..................................................................................................................................... ii

Revision History..................................................................................................................... iii

Warranty Service & Shipping Instructions......................................................................... v

Contents................................................................................................................................. vii

Warranty................................................................................................................................. vii

Precautions............................................................................................................................. ix

Section 1: Introduction......................................................................................................... 1-1

Section 2: Product Description............................................................................................ 2-1

Section 3: Physical Description............................................................................................ 3-1

Section 4: Installation and Operation................................................................................. 4-1

Section 5: Frequently Asked Questions.............................................................................. 5-1

Section 6: Oximeter Compatibility Chart.......................................................................... 6-1

Section 7: Remote Control................................................................................................... 7-1




vii

Warranty

mtk Peter Kron GmbH (mtk) warrants to the purchaser that the SmartSat Pulse Oximetry Analyzer shall be free from defects in material and workmanship for 3 years for U.S. customers and 1 year for international Customers. mtk's sole obligation with respect to any such defect is limited to the repair with new or remanufactured parts, or at mtk's option, replacement of the SmartSat, or refund of the purchase price.

This warranty is made on the condition that prompt notification of a defect is given to mtk within the warranty period. mtk shall have the sole right to determine whether a defect exists.

This warranty extends to the original purchaser only. This warranty does not apply to a SmartSat that has its tamper seals removed or cut, altered, subjected to misuse, negligence, unauthorized repair, or accident, or operated other than in accordance with the instructions.

This warranty represents the exclusive obligation of mtk and the exclusive remedy of the purchaser regarding defects in a SmartSat. This warranty is given in lieu of any expressed or implied warranties,

including the warranty of merchantability or fitness for a particular purpose, which warranties are disclaimed. No person is authorized to modify, in any manner, mtk's obligation described above.

mtk shall not, in any case, be liable for special, incidental, or consequential damages arising from breach of warranty, breach of contract, negligence or any other legal theory.

viii




Precautions

To maintain battery life, it is recommended that the battery be cycled (discharged and fully recharged) after every 30 hours of use. This will provide optimum battery performance throughout the life of the battery.

For optimum SmartSat performance, it is recommended that the SmartSat be allowed to "warm up" for 5 minutes before use.

For accurate results, it is recommended that you use the oximeter interface cables provided with the

SmartSat. If you should damage or misplace these cables, please contact the factory for replacement. Use

of cables other than those provided by mtk may result in inaccurate test results.




ix

x




Section 1. Introduction

General

The SmartSat Pulse Oximetry Analyzer is the first test system available to test both the probe and pulse oximeter independently. This method allows the user to diagnose problems to either the probe or pulse oximeter. The SmartSat has two probe test modes and a SpO2 simulator mode with user programmable

Auto Sequences for automated testing.

The first probe test is the Probe Continuity Test. This tests the probe for opens, shorts, and intermittent probe problems. The Probe Continuity Test provides an electrical integrity test of the probe.

The second probe test is the Probe Sensitivity Test. This tests the sensitivity of the RED and IR LEDS and the ratio of the Red to IR sensitivity. This test is valuable for testing a probe during its functional life. The user can then determine if the probe is within an acceptable sensitivity range.

The SpO2 Simulator tests the pulse oximeter through a complete range. The full featured SpO2 simulator provides the following features: Oxygen Saturation; Pulse Rate; R-Curves for testing pulse oximeters and user programmable Auto Sequences for automated testing.

In addition to these testing features, the SmartSat incorporates a high-resolution graphic display, an internal battery, built in probe test ports and a compact, lightweight enclosure.

Intended Audience

The Operation Manual is intended for end users of the SmartSat Pulse Oximetry Analyzer. It contains installation and operation instructions, applications notes, performance limitations and routine performance verification procedures. To achieve satisfactory results, it is imperative that the operator read this manual thoroughly before attempting to use the SmartSat.




1-1

Section 1. Introduction

Documentation Comments

mtk Peter Kron GmbH has attempted to present all information as clearly and error-free as possible. However, if you detect any errors or omissions, or wish to suggest improvements to the manual, please mail, fax or email your comments to:

mtk Peter Kron GmbH

Zossener Strasse 41

10961 Berlin

GERMANY

Fax: 0049(30) 69 81 88 49

Email: [email protected]

1-2 mtk Peter Kron GmbH Medical Test Devices, Software & Services



Section 2. Product Description

Overview

SmartSat Pulse Oximetry Analyzer is a state-of-the-art instrument designed to provide accurate and

reliable performance. The following list presents some of the more salient features of the SmartSat.

• Standardized scientific procedure for electronically testing pulse oximeters.

• The first available Probe Analyzer for probe testing. The Probe Analyzer has two tests: The Probe

Continuity Test and The Probe Sensitivity Test.

• Full featured SpO2 Simulator: Oxygen Saturation and Pulse Rate; Ambient Light; Pulse Modulation

Simulation and user programmable Auto Sequences to automate common test procedures.

• Internal Battery allows testing in remote sites such as ICU, OR and other patient floors.

• 320 x 240 high resolution graphic display allows visualization of waveforms.




2-1

Section 2. Product Description




Section 3. Physical Description

The SmartSat Pulse Oximetry Analyzer is a microprocessor controlled patient simulator and probe analyzer housed in a compact (8 x 8 x 5 inch) and portable (6 pounds with battery) aluminum case. Performance and technical specifications are listed below.

SpO2 Simulator

Oxygen Saturation (SpO2)

• Range: 0-100%

• Resolution: 1%

• Accuracy: ±0.5% from 70-100%

±1% from 50-69%

R-Curves

• Preset manufacturer's R-curves: BCI, Criticare, Criticare SPOT, Datascope, Datex, Hewlett-Packard,

Masimo, Nellcor, Nihon Kohden, Nonin, Novametrix, Ohmeda and Sensormedics(contact the factory for availability of others)

Pulse Rate

• Range: 20-300 bpm

• Resolution: 1 bpm

• Accuracy: ± 1 from 20-199 bpm

± 2 from 200-300 bpm

Pulse Modulation

• Range: 0.10-20% of nominal amplitude

• Resolution: 1%

• Accuracy: ±1%

Probe Analyzer

Probe Continuity Test

Simultaneous Channels:

• 2 for Nellcor style probes: LED & photodiode circuits

• 3 for Ohmeda style probes: Red LED, IR LED, and photodiode circuits

Probe Connection

• Integral connectors for Nellcor & Ohmeda probes

• Adapters available for other manufacturer's probes mtk Peter Kron GmbH Medical Test Devices, Software & Services



3-1


General

Display

• Type: backlit graphics LCD (Liquid Crystal Display)

• Resolution: 320h X 240w, 0.36mm dot pitch

• Control: contrast adjustment

Serial Interface

• Type: RS232C, 9 pin D-connector, DCE

• Baud Rate: 1200 bps for Remote Control

• Mode: Remote Control

Printer Interface

• Type: Centronics type connector, 25 pin

Battery

• Type: Nickel Metal Hydride (NimH)

• Voltage: 19.2V

• Capacity: 2.1 Amp-Hour (Approximately 5 to 6 Hours operating Time)

• Charge time: 18 Hours

External Power Supply

• Type: Desk-mount linear

• Input: 120 VAC, 60Hz or 230 VAC, 50Hz or 100 VAC, 60 Hz

• output: 24VDC, 500mA, 6 foot cable

• Safety Agency Approvals: UL, CSA, CE, TUV

Physical

• Case: Aluminum, non skid feet, carry handle

• Dimensions: 8" wide, 8" deep, 5" high

• Weight: 6 pounds (including battery)




Section 4. Installation & Operation

Unpacking

The SmartSat, manual, and accessories are shipped in one carton. Please note cables may be different, depending on what cables were ordered with SmartSat. Inspect the carton carefully for any signs of damage.

Remove the SmartSat from the carton and inspect the SmartSat. Retain all shipping materials for inspection by the carrier in case of shipping damage or for reshipment. The original carton and packing materials are to be used when the unit is shipped back to mtk for annual calibration.

Contents Checklist

1

1

1

1

1

1

QTY.

1

Checklist

SmartSat Pulse oximetry Analyzer

Service Manual

Nellcor SpO2 Simulation Cable

Ohmeda SpO2 Simulation Cable

External AC Adapter

Detachable Power Cord (US)

Foam Insert Set

Missing Items

If an item is missing or damaged, call Customer Service,

0049(30) 69 81 88 40

Indications and Contradictions

The SmartSat Pulse Oximetry Analyzer is intended for testing pulse oximeters and pulse oximeter probes.

The device is not designed, sold, or intended for use except as indicated.

The SmartSat Pulse Oximetry Analyzer is not to be used on patients either directly or indirectly.




4-1


General

Display

• Type: backlit graphics LCD (Liquid Crystal Display)

• Resolution: 320h X 240w, 0.36mm dot pitch

• Control: contrast adjustment

Serial Interface

• Type: RS232C, 9 pin D-connector, DCE

• Baud Rate: 1200 bps for Remote Control

• Mode: Remote Control

Printer Interface

• Type: Centronics type connector, 25 pin

Battery

• Type: Nickel Metal Hydride (NimH)

• Voltage: 19.2V

• Capacity: 2.1 Amp-Hour (Approximately 5 to 6 Hours operating Time)

• Charge time: 18 Hours

External Power Supply

• Type: Desk-mount linear

• Input: 120 VAC, 60Hz or 230 VAC, 50Hz or 100 VAC, 60 Hz

• output: 24VDC, 500mA, 6 foot cable

• Safety Agency Approvals: UL, CSA, CE, TUV

Physical

• Case: Aluminum, non skid feet, carry handle

• Dimensions: 8" wide, 8" deep, 5" high

• Weight: 6 pounds (including battery)





The SmartSat Main Menu

The SmartSat Main Menu will be displayed following power-up of the system.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%

Probe Continuity

Open

L

E

D

Good

Short

O

T

O

P

H

Open

Good

Short

SglSwp

SpO2s im

F1

Probe-C

F2

Probe-S

F3

Setup

F4

BatChck

F5 MORE PREV

The main display is subdivided into three major windows:

1. Upper window (SpO2 Simulator)

2. Middle window (Graphic Display Measurements)

3. Bottom window(Control Panel Soft-keys)

The SpO2 Simulator features include:

• Oximeter Selection

• Oxygen Saturation (SpO2) ; range 0 to 100%

• Pulse Rate ; range 20-300 bpm

• Pulse Modulation; range 0.10-20%

• Programmable Auto Sequences

The SpO2 Simulator window has 4 main features. The Oximeter field displays the pulse oximeter being tested. The OXYGEN SAT field displays the oxygen saturation simulated. The PULSE RATE field selects the pulse rate simulated. The PulseMod field selects the perfusion of the pulse.

The Graphic Display Measurement (middle) window displays:

• Nellcor and other Two Trace type LED and Photo-diode continuity tracing

• Ohmeda and other Three Trace type RED, IR and Photo-diode continuity tracing

• Programmable Auto Sequences

• Advanced Simulation Features: Arrhythmia, Motion Artifact and Ambient Light, Set Up mtk Peter Kron GmbH Medical Test Devices, Software & Services



4-3


Control Panel Options:

Soft-keys can be utilized to navigate through screens to control all SmartSat features. From the main menu, the following options are available:

• F1 (SpO2Sim) accesses the SpO2 Simulator Menu.

• F2 (Probe-C) activates the probe continuity test

• F3 (Probe-S) activates the probe sensitivity feature.

• F4 (Setup) changes basic setup features.

• F5 (BatChk) Displays Battery Voltage

• MORE - advances the system to the next lower level in the menu tree. If there is no lower level the key will be inactive.

• PREV - returns SmartSat to the previous menu and saves any changes made to SmartSat





The SpO2 Simulator Menu

Purpose of SpO2 Simulator Menu: Used on a routine basis for preventive maintenance, quality assurance, trouble shooting and repair of pulse oximeters.

From the main menu, Press F1 (SpO2Sim) to enter the SpO2 Simulator menu. The PREV key will return the system to the main menu.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%

Open

L

E

D

Good

Short

P

T

O

H

O

Open

Good

Short

SglSwp

Manual

F1

AutoSeq

F2 F3 F4

F5 MORE

PREV

From the SpO2 Simulator Menu the following options are available:

• F1 (Manual) enters the SpO2 Simulator manual test mode

• F2 (AutoSeq) enters the programmable Auto Sequences Directory

• F3, F4 and F5 are not used on this screen.

• PREV - will step back in the menu tree to the main menu.

• MORE is not used on this screen.




4-5


The SpO2 Simulator Menu, Manual Mode

Purpose of SpO2 Simulator Menu, Manual Mode: Used on a routine basis for preventive maintenance, quality assurance, trouble shooting and repair of pulse oximeters.

From the SpO2 Simulator Menu, Press F1 (Manual) to enter the SpO2 Simulator menu, manual mode. The

PREV key will return the system to the main menu.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%


Open

L

E

D

Good

Short

P

T

O

H

O

Open

Good

Short

SglSwp

Advancd

F1

Select

F2

Select

F3

Change+

F4

Change-

F5 MORE

PREV

From the SpO2 Simulator Menu, Manual Mode, the following options are available:

• F1 (Advancd) introduces simulation features such as Arrhythmias, Motion Artifact and Ambient Light

Simulation. Note: When this is pressed, the Probe Continuity Test Window will be replaced with the

Advanced Simulation Mode Screen and return when you utilize the Probe Continuity Test, described in detail on the following page.

• F2 (Select) scrolls cursor upward through the selectable parameters.

• F3 (Select) scrolls cursor downward through the selectable parameters.

• F4 (Change+) changes parameter upward.

• F5 (Change-) changes parameter downward.

• PREV - will step back in the menu tree to the main menu.






The SpO2 Simulation Menu, Advanced

Simulation Mode

Purpose of the SpO2 Simulator Menu's Advanced Simulation Mode: The advanced simulation features can be used for preventative maintenance, quality assurance, trouble shooting and repair of pulse oximeters and pre-purchase evaluations of pulse oximeters.

From the SpO2 Simulator Menu, Manual Mode, Press F1 (Advancd) to enter the SpO2 Simulator Menu,

Advanced Simulation Mode.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%

Arrhythmia: Off

Motion Artifact: 0

Ambient Light

DC Level: 5

AC Level: 0

Frequency: Off

Standrd

F1

Select

F2

Select

F3

Change+

F4

Change-

F5 MORE PREV

From the SpO2 Simulator Menu, Advanced Simulation Mode, the following options are available:

• F1 (Standrd) returns SmartSat to standard SpO2 Simulation.






• PREV will return the system to first screen in the SpO2 Simulation Mode.




4-7


The SpO2 Simulation Programmable Auto

Sequences Directory

Purpose of Programmable Auto Sequences Directory: Used on a routine basis for preventive maintenance and quality assurance, trouble shooting and repair of pulse oximeters. Each selectable brand of pulse oximeter is represented by an auto sequence test. These can be modified and saved for special testing needs.

From the SpO2 Simulator Menu, selecting F2 (AutoSeq) will place you in the Programmable Auto

Sequences Directory screen. From the Programmable Auto Sequences Directory, the following options are available:

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

PULSE RATE

(BPM)

–DataLog–

75

PulseMod

5.00%

BCI : 58 - 100

CRITICARE

CSI SPOT

DATASCOPE

DATEX

HP

Programmable AutoSequence Directory

MASIMO

NELLCOR

NELL: 50 - 81

NELLOxiMAX

NONIN

NOVAMETRIX

OHMEDA

OHMD: 50 - 81

SENSORMEDX

TREND LOOP

4 POINTS

PR: 40 - 200

Select

F1

Select

F2 F3

Program

F4

Run

F5 MORE PREV

• F1 (Select) scrolls cursor upward through the auto sequences.

• F2 (Select) scrolls cursor downward through the auto sequences.

• F3 is not used on this screen.

• F4 (Program) modifies auto sequences.

• F5 (Run) selects auto sequence, then press F1 (Start/Stop) to start the auto sequence.


• PREV - will return

Smart

Sat to the previous screen, pressing PREV multiple times will return

Smart

Sat to the Main Menu.






Sequences Directory, Program Mode

Purpose of Programmable Auto Sequences Directory, Program Mode: User can modify and save each auto sequence test for their specific testing requirements.

From the SpO2 Simulation Programmable Auto Sequences Directory, pressing F4 (Program) will place you in the Programmable Auto Sequences Directory, Program Mode screen.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

PULSE RATE

(BPM)

–DataLog–

75

PulseMod

5.00%

AutoSeq: Nellcor Oximeter: Nellcor

Step Time Mod Sp02 Rate

1

2

3

4

5

6

20s

20s

20s

20s

20s

20s

5.00

5.00

5.00

5.00

5.00

5.00

100 70

99 70

98 70

97 70

96 70

95 70

7

8

9

10

20s

20s

20s

20s

5.00

5.00

5.00

5.00

94 70

93 70

92 70

91 70

SelectMode: Step / (Use MORE to change)

Change Char

F1

Char

F2

Select

F3

Change+

F4

F5 MORE

PREV

From the Programmable Auto Sequences Screen, Program Mode, the following options are available:

• F1 (<Char) scrolls cursor upward through each character. F1 becomes (Select?) when the cursor is in oximeter:_______ or in the auotsequence itself.

• F2 (Char>) scrolls cursor downward through each character. F2 becomes (Select?) when the cursor is in oximeter:______ or in the autosequence itself.

• F3 (Select < >) scrolls cursor between.

• F4 (Change+) changes the highlighted character and field.

• F5 (Change-) selects auto sequence, then press F1 (Start/Stop) to start the auto sequence.


• PREV - will return SmartSat to the previous screen, and save any changes made to the programmable autosequence.




4-9



Sequences Directory, Run Mode

Purpose of Programmable Auto Sequences Directory, Run Mode: Starts the selected autosequence test for their specific testing requirements.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%

AutoSeq: Nellcor Oximeter: Nellcor

Step Time Mod Sp02 Rate

1

2

3

4

5

6

7

8

9

10

20s

20s

20s

20s

20s

20s

20s

20s

20s

20s

5.00 100

5.00 99

5.00

5.00

5.00

5.00

98

97

96

95

5.00 94

5.00 93

5.00 92

5.00 91

70

70

70

70

70

70

70

70

70

70

Start

F1 F2 F3 F4 F5 MORE PREV

From the SpO2 Simulation Programmable Auto Sequences Directory, select the desired autosequence and press F5 (Run).

From the Programmable Auto Sequences Directory, Run Mode, the following options are available:

• F1 (Start) starts the selected autosequence test. Press F1 (Stop) to stop test. This switch will toggle between Start/Stop.

• F2 not used in this screen.



• F5 is not used in this screen.


• PREV - will return SmartSat to the previous screen. Note: You must stop the autosequence by pressing the F1 (Stop) key otherwise the autosequence will continue to run until completed. This allows the user to perform probe testing concurrently with simulation.

Note: When using autosequences, the programmed oximeter type will take precedence and change the oximeter selection displayed at the upper left when the test starts.





The Probe Continuity Test Menu

Purpose of Probe Continuity Test: Confirms proper electrical and insulation properties within the pulse oximeter probe. In an intact/normal probe the continuity trace will sweep across the screen within the

GOOD zone. If an open or short connection is detected the trace will shift in the appropriate direction.

When the probe is being tested, the cabling should be gently wiggled as a stress test to check for intermittent abnormal electrical connections. This is useful for intermittent problems, isolating the problems and ruling out human error.

From the main menu, Press F2(Probe-C) to enter the Probe Continuity Test screen. The PREV key will return the system to the main menu.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%


L

E

D

Open

Good

Short

P

H

O

T

O

Open

Good

Short

SglSwp

Oximtr+

F1

Oximtr -

F2

SwpMode

F3

Center

F4

Reset

F5 MORE

PREV

From the Probe Continuity Test Menu, the following options are available:

• F1 (oximtr+) scrolls upward through the brands of oximeter probes

• F2 (oximtr-) scrolls downward through the brands of oximeter probes

• F3 (SwpMode) toggles between Single Sweep and Repetitive Sweep test modes. Single Sweep stops sweeping on any fault while Repetitive Sweep tests continuously.

• F4 (Center) Centers the baseline waveform on the Good levels on the display and displays the baseline

LED and PhotoDiode voltage drops.

• F5 - Reset will restart the trigger function.

• PREV - returns the user to the main menu.

• MORE - currently not utilized.




4-11


The Probe Sensitivity Test Menu

Purpose of Probe Sensitivity Test: Determines if the sensory diodes are receiving the appropriate signals. In some cases, cleaning the surface of the LED and sensor lens with a solvent solution will improve probe performance. on the following page, there are some reference values for the Probe Sensitivity Test.

From the main menu, press F3 (Probe-S) to enter the Probe Sensitivity Test Menu. The PREV key will return the system to the main menu.

Oximeter

Nellcor

R

A

T

I

O

R

I

R

E

D

Oximtr+

F1

Oximtr -

F2

OXYGEN SAT

(SPO2 %)

100

PULSE RATE

(BPM)

–DataLog–

75

PulseMod

5.00%

Probe Sensitivity

0

F3 F4 F5 MORE PREV

From the Probe Sensitivity Test menu, the following options are available:

• F1 (Oximtr+) scrolls upward through the brands of oximeter probes.

• F2 (Oximtr-) scrolls downward through the brands of oximeter probes

• F3 , F4 & F5 not currently utilized.

• PREV returns user to the main menu.

• MORE not used in this screen.





Probe Sensitivity Test: Reference Values

The values labeled "Typical" in the table below were obtained by averaging the readings obtained by performing the SmartSat's Probe Sensitivity test on a large number of good pulse oximeter probes. The values labeled "Typical Range" are values at which, when the "probe under test" measures outside this range, it should be considered suspect. Since the pulse oximeter manufacturers have thus far declined to provide absolute limits for these ranges, we can not positively state that probes that exceed these limits are "bad."

However, we can state that they deviate significantly from the "typical" probes of that make and model. In general, when evaluating probes using the Probe Sensitivity test, if you obtain a reading outside the limits, you should take into account other factors. For example, multiple readings (such as Red and Ratio) outside the limits or an out-of-limit reading on a probe that is old or looks worn, is probably an indication of a probe that may malfunction under certain clinical conditions.

Probe

Nellcor DS-100A

Ohmeda Clip Tip

Red

Typical

Red

Typical

Range

IR

Typical

158

168

>79

>168

262

268

IR

Typical

Range

>196

>244

Ratio

Typical

60

63

Ratio

Typical

Range

30 to 90

40 to 100 mtk Peter Kron GmbH Medical Test Devices, Software & Services



4-13


The Setup Menu

Allows configuration of Key Beep (on/off), selection of Remote Control or Datalog for the RS-232 port and enter information which will print on a datalogged test report.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

PULSE RATE

(BPM)

–DataLog–

75

PulseMod

5.00%

Key Beep: On

Serial Port: DataLog

Printing

Stored Printing: Off

Work Order #:

Oximeter # :

Date:

–

Tested By:

–02

Select

F1

Select

F2 F3

Change+

F4

Change -

F5 MORE

PREV

From the Setup Menu the following options are available:



• F3 is blank when Key Beep and Serial Port parameters are selected. F3 becomes F3 (Char) when Work

Order, Oximeter, Date and Tested By parameters are selected.




• PREV will return user to the main menu.





The Battery Check Menu

Purpose of the SmartSat's Battery Check Menu: Displays SmartSat's battery voltage.

From the Main Menu, Press F5 (BatChk) to enter SmartSat's Battery Check Menu.

Oximeter

Nellcor

OXYGEN SAT

(SPO2 %)

100

–DataLog–

PULSE RATE

(BPM)

75

PulseMod

5.00%


Open

L

E

D

Good

Short

P

T

O

H

O

Open

Good

Short

SglSwp

SpO2s im

F1

Probe-C

F2

Bat:19.82V (19.00V=LoBat)

Probe-S Setup BatChck

F3 F4

F5 MORE

PREV

From the Battery Check Menu all Main Menu options are available:





• F5 (BatChck) displays current battery voltage. Pressing it will turn off/on the battery indicator.

• MORE returns user to the main menu.

• PREV returns user to the main menu.

Note:

1. When connected to the external power supply, the value displayed is the power supply voltage, not the battery voltage.

2. "Low Battery" indicator comes on at approximately 19V as the remaining battery life approaches 1 hour.

3. SmartSat will shut off when the battery discharges to approximately 16V.




4-15





Section 5. Frequently Asked Questions

Q: How do I test my probes with the SmartSat?

A: Simply connect a Nellcor, BCI, Nonin or Ohmeda probe into the Nellcor or Ohmeda Probe Analyzer ports on the side of the SmartSat. For other brands of probes, use the appropriate Probe Analyzer Cable and connect it into the Ohmeda Probe Analyzer port. Then connect the probe to the Probe Analyzer cable to test the probe.

Q: Why does the SmartSat test the probe and oximeter independently?

A: During the extensive market research when developing SmartSat, we found that over 96% of all oximetry problems occur within the probe. SmartSat is a "True Test Standard" utilized by major pulse oximetry manufacturers for electrically testing the functional accuracy of pulse oximeters. With both a

SpO2 simulator and Probe Analyzer in one test system, problems are correctly identified and can be repaired. There is no guesswork involved.

Q: What types of probes can be tested?

A: All types of probes (except MRI probes) can be tested with SmartSat:

1. Adult size permanent probes

2. Adult size disposable probes

3. Neonate size permanent probes

4. Neonate size disposable probes

Q: How does the Probe Continuity Test work?

A: The Probe Continuity Test completely checks each probe for open, short, and intermittent failures. The probe can be tested correctly throughout its useful life cycle.

Q: I am using the Probe Sensitivity Test and when I open the finger probe or hold it towards the light, my readings are affected. Why does this happen?

A: When the probe is opened, it separates the LED's and the Photodiode paths. The farther the Photodiode is from the LED's, the less red and infrared light reaches the Photodiode, which affects the readings.




5-1

Section 5. Frequently Asked Questions

Q: What pulse oximeters does SmartSat test?

A: SmartSat works with the following pulse oximeters; BCI, Criticare, Criticare SPOT, Datascope, Datex,

Hewlett-Packard, Masimo, Nellcor, Nihon Kohden, Nonin, Novametrix, Ohmeda and Sensormedics.

Q: How are the R-Curves obtained?

A: Our engineers obtained the information from and worked with each manufacturer to assure a "True Test

Standard" for testing pulse oximeters. We thank those manufacturers for their help. Because of our relationships with these manufacturers through non-disclosures and supplier agreements, we are assured future compatibility by these manufacturers using SmartSats for testing their pulse oximeters throughout their organizations.




Section 6. Pulse Oximeter Compatibility Chart

The following manufacturers use Nellcor™ technology with their systems:

1.

Philips Medical Systems

2.

Atom Medical Corp.

3.

Baxter Healthcare Corp.

4.

Century Medical Inc.

5.

Colin

6.

GEMedical Services

7.

Welch Allyn

8.

Datascope

9.

Drager

10. Edentec

11. Fukuda Denshi

12. Ivy Biomedical Systems

13. Marquette (Eagle)

14. MDE

15. Mennen Medical

16. Drager

17. Respiroinics

18. CAS Medical Systems

19. Zoll

20. Siemens

21. Sleeptrace/Areca Science

22. SpaceLabs

23. Synetics

24. Schiller

The following manufacturers use Masimo® technology with their systems:

1.

2.

3.

4.

4.

6.

7.

8.

9.

Ohmeda-Medical

Drager

Welch Allyn

Atom Medical

Alaris Medical Systems

Bitmos

Invivo Research

MDE

Mennen Medical

10. Datascope

11. GE Medical Systems

12. Zoll

13. Colin

14. Allegiance

15. Critikon

16. Ivy Biomedical Systems

17. Medtronic

18. Respironics

19. SS Corpulus

20. Getemed

21. Graseby

22. Kohken Medical

23. Mindray

24. Schiller

25. Stephan

26. CAS Medical Systems

27. Nascor Neonatal

28. Hill-Rom mtk Peter Kron GmbH Medical Test Devices, Software & Services



6-1

Section 6. Pulse Oximeter Compatibility Chart




Section 7: Remote Control, Version 0.4

Remote control of the SmartSat‘ by a host computer is possible via an RS-232 serial port located on its right panel. This RS-232 port, a 9-pin female D-shell, is configured as a "DCE," allowing direct connection to the serial port on IBM-compatible computers. Therefore, to connect the SmartSat to an IBM-compatible PC, a standard cable, rather than a null modem cable, should be used. (A CGA video monitor extension cable, readily available in computer stores and mail-order catalogs, can be used. Alternatively, mtk can supply the appropriate cable.)

The serial port on the host computer should be configured with the following communications parameters:

Baud Rate:

Data Bits:

Stop Bits:

Parity:

1200 baud

8

1

None

The SmartSat’s communication protocol is essentially an all-ASCII, all-uppercase format. (The only exceptions are messages that contain waveform datapoints in binary code.) An ASCII format facilitates using popular PC communications software such as Windows Terminal, ProComm or Crosstalk as a

“control console” to interact with the SmartSat. Before developing the remote control software for use in your application, it is recommended that the programmer familiarize themselves with the communications protocol using PC communications software.

To send remote control commands using the Windows 3.11 Terminal program:

• Select the -Communications option under the Settings pulldown menu and set the following:

Baud Rate:

Data Bits:

1200 baud

8

Stop Bits: 1

Parity: None

• Then select the -Terminal Preferences option under the Settings pulldown menu and set the following:

Enable “Local Echo” under “Terminal Modes”

Enable “Outbound” under “CR->CR/LF”

Communication between the SmartSat and the host device consists of two categories:

1) Command messages sent by the host to the SmartSat

2) Response messages sent by the SmartSat to the host

The following pages describe the command messages and response messages in detail.

Please note that if the terminal is receiving repeated strings of “SRP” it is because the SmartSat RS-232 port is set to “DataLog” not “Remote Control” This can be changed via the “Advanced” settings on the SmartSat.




7-1

Section 7. Remote Control, Version 0.3

Generic Command Message Format

[SS] [Command Character] [Data Characters] <cr><lf>

Optional Termination

(ASCII Line Feed)

Termination Character

(ASCII Carriage Return)

Data Field

Command Field

Preamble

Note: Brackets are for documentation only and are not part of the command format.

As shown above, host command messages consist of four (4) fields:

1. Preamble: [SS]

2. Command Field: a single uppercase letter (described below)

3. Data Field: 0 or more bytes (command dependent)

4. Termination Character: <cr> (i.e., hexadecimal “0d”, the ASCII carriage return control code)

5. Optional Termination Character: <lf> (i.e., hexadecimal “0f”, the ASCII line feed control code); Note use this character to improve readability of commands and responses when controlling the SmartSat using PC communications software.

A checksum is not used because it is awkward to generate and transmit checksums with an ASCII terminal.

Message integrity checking is achieved via a structured message format; limit tests for all transmitted data; and command and data acknowledgment.

See the attached table for a list of commands and the associated data field contents.





Generic Response Message Format

<cr><lf>[SyntaxError]<cr><lf>

As The SmartSat receives and parses the incoming command message, if it encounters an illegal command syntax, it will generate a "SyntaxError" response.

[DataError]<cr><lf>

If the SmartSat encounters an illegal data value, it will generate a "DataError" response.

[SS] [Command Character] [=] [Data Characters] <cr><lf>

After receipt of a valid command and valid data, and after the SmartSat has successfully executed the command, it will acknowledge that fact to the host by echoing the preamble and command field followed by an "=" sign, the data field and the termination character. mtk Peter Kron GmbH Medical Test Devices, Software & Services



7-3


Command

K

S

R

O

A

Description

Locks front panel keypad

Sets SpO

2 value

Sets Pulse Rate value

Sets Oximeter Type

Sets Pulse Modulation value scaled at 001=0.05%

Data Field Range

0 = Unlock

1 = Lock

000 to 100

Example

S S K 0 <cr>

S S K 1 <cr>

S S S 0 9 1 <cr>

020 to 300 S S R 0 7 5 <cr>

B=BCI

C=Criticare

P=CSI Spot

D=Datascope

X=Datex

H=HP

M=Masimo

N=Nellcor

Q=N. OxiMax

K=NihonKohden

Z=Nonin

V=Novametrix

O=Ohmeda

S=Sensormedics

S S o B <cr>

000 to 200 S S A 1 1 0 <cr>

Max setting is 200=10.00%

D Sets DC Level of Ambient

Light

000 to 255 S S D 1 0 0 <cr>





Reserved commands for future use:

Command

T

F

Description

IR Tissue Transmissivity

Red Tissue Transmissivity is set to 0.5 IR Tissue

Transmissivity

Sets Frequency of Ambient

Light (Flicker Frequency)

L Sets AC Level of Ambient

Light (Flicker Level)

Data Field Range

000 to 255

0=Off

1= 60 Hz

2=120Hz

3=121Hz

4= 50 Hz

5=100Hz

6=101Hz

0 to 255

Example

not yet implemented not yet implemented not yet implemented




7-5


SmartSat RS-232 Serial Communications Pin Assignments

5 4 3 2 1

9 8 7 6

9 Pin D-Type Female Connector

Pin Signal

1 (Not Used)

2 Rx (Receive Data, Input to SmartSat)

3 Tx (Transmit Data, Output from SmartSat)

4 DTR (Data Terminal Ready, Input to SmartSat)

5 GND (Signal Ground)

6 DSR (Data Set Ready, Output from SmartSat)

7 (Not Used)

8 DSR (Data Set Ready, Output from SmartSat)

9 (Not Used) mtk Peter Kron GmbH Medical Test Devices, Software & Services












SmartSat Manual

SmartSat™

Pulse Oximetry Analyzer

Operation Manual

Notices

Shipping Address:

Sales & Service,

Technical Support: 0049 - 30 - 69 81 88 40

Facsimile:

Email: [email protected]

Web Site:

Revision History

Warranty Service & Shipping Instructions

Warranty Service

Assistance

Returning a Product for Service

Additional Instructions for International Shipments

SmartArm Test Equipment

SmartSat Test Equipment

Table of Contents

Warranty

including the warranty of merchantability or fitness for a particular purpose, which warranties are disclaimed. No person is authorized to modify, in any manner, mtk's obligation described above.

Precautions

SmartSat. If you should damage or misplace these cables, please contact the factory for replacement. Use

Section 1. Introduction

General

Intended Audience

Documentation Comments

Section 2. Product Description

Overview

SmartSat Pulse Oximetry Analyzer is a state-of-the-art instrument designed to provide accurate and

Section 3. Physical Description

SpO2 Simulator

Oxygen Saturation (SpO2)

R-Curves

Pulse Rate

Pulse Modulation

Probe Analyzer

Probe Continuity Test

Probe Connection

General

Display

Serial Interface

Printer Interface

Battery

External Power Supply

Physical

Section 4. Installation & Operation

Unpacking

Contents Checklist

QTY.

Checklist

SmartSat Pulse oximetry Analyzer

Missing Items

Indications and Contradictions

General

Display

Serial Interface

Printer Interface

Battery

External Power Supply

Physical

The SmartSat Main Menu

The SpO2 Simulator Menu

The SpO2 Simulator Menu, Manual Mode

The SpO2 Simulation Menu, Advanced

Simulation Mode

The SpO2 Simulation Programmable Auto

Sequences Directory

The SpO2 Simulation Programmable Auto

Sequences Directory, Program Mode

The SpO2 Simulation Programmable Auto

Sequences Directory, Run Mode

The Probe Continuity Test Menu

The Probe Sensitivity Test Menu

Probe Sensitivity Test: Reference Values

Probe

Nellcor DS-100A

Ohmeda Clip Tip

Red

**Generic Command Message Format**

**Generic Response Message Format**