mtk biomed SmartSat Operation Manual

SmartSat™

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

Pulse Oximetry Analyzer

Operation Manual

Notices

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

Shipping Address: mtk Peter Kron GmbH

Sales & Service,
Technical Support: 0049 - 30 - 69 81 88 40

Facsimile: 0049 - 30 - 69 81 88 49

Email: [e-mail]

Web Site: www.mtk-biomed.de

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

Zossener Strasse 41 - 10961 Berlin - GERMANY

Revision History

1 May 1995 Release at revision 00.

10 December 1998 Release at revision 01

14 January 1999 Release at revision 02

19 August 2002 Release at revision 03

3 December 2002 Release at revision 04

10 October 2003 Release at revision 05

15 December 2003 Release at revision 06

05 January 2004 Release at revision 07

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mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

iv

Revision History

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

Warranty Service & Shipping Instructions

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

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.

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Warranty &Factory Service Instructions

Returning a Product for Service

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

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.

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

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

Warranty

viii

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

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.

Precautions

ix

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

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.

x

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

Section 1. Introduction

General

Intended Audience

1-1

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.

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.

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

1-2

Section 1. Introduction

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

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: [phone]

Email: [e-mail]

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

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de

Section 2. Product Description

2-2

mtk Peter Kron GmbH Medical Test Devices, Software & Services

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

Email: [e-mail] www.mtk-biomed.de