Envitec MySign s Guida

Pulse oximeter

Technical Documentation

066-07-1002197_GA_MySignS_FDA-0

USA

Subject to technical changes!

Pulse oximeter MySign®S

Contents

1 General information ....................................................................................................................................................5

2 Safety information .......................................................................................................................................................6

3 Designated use and functional description ...............................................................................................................9

3.1 Indications for use (designated purpose)............................................................................................................9

3.2 General functional principles and conditions ................................................................................................... 10

3.3 Signal quality, pulsation index, disruptions ...................................................................................................... 10

4 Commissioning ........................................................................................................................................................ 12

4.1 Unpacking and testing the delivery .................................................................................................................. 12

4.2 Parts list .............................................................................................................................................................. 12

4.3 Function test....................................................................................................................................................... 12

4.4 Installation .......................................................................................................................................................... 12

4.5 Charging the battery.......................................................................................................................................... 13

4.5.1 Charging the battery at an external power supply ....................................................................... 13

4.5.2 Charging on a USB port............................................................................................................... 13

4.6 Set up / mounting............................................................................................................................................... 14

5 Operating elements and symbols........................................................................................................................... 15

5.1 Keys and LEDs.................................................................................................................................................. 16

5.2 Display................................................................................................................................................................ 17

5.3 Symbols on the label ......................................................................................................................................... 18

5.4 Symbols shown on the display ......................................................................................................................... 19

6 Operation.................................................................................................................................................................. 20

6.1 Switching the unit on / off .................................................................................................................................. 20

6.2 Main menu ......................................................................................................................................................... 22

6.3 Key lock .............................................................................................................................................................. 23

6.4 Patient type ........................................................................................................................................................ 24

6.5 View .................................................................................................................................................................... 24

6.5.1 Measured value ........................................................................................................................... 25

6.5.2 PTM.............................................................................................................................................. 26

6.5.3 Trend............................................................................................................................................ 27

6.6 Data memory ..................................................................................................................................................... 28

6.6.1 Set flag......................................................................................................................................... 28

6.6.2 Save interval ................................................................................................................................ 28

6.6.3 Measurement series .................................................................................................................... 29

6.6.4 Delete all ...................................................................................................................................... 29

6.7 Alarm settings .................................................................................................................................................... 30

6.7.1 Alarm limits .................................................................................................................................. 31

6.7.2 Alarm volume ............................................................................................................................... 31

6.7.3 Audio alarm.................................................................................................................................. 32

6.7.4 Reminder signal ........................................................................................................................... 32

6.7.5 Application indicator..................................................................................................................... 33

6.8 General settings................................................................................................................................................. 34

6.8.1 Language ..................................................................................................................................... 34

6.8.2 Date/Time .................................................................................................................................... 34

6.8.3 Display ......................................................................................................................................... 34

6.8.4 Reset device (factory setting) ...................................................................................................... 35

6.8.5 Key sound .................................................................................................................................... 35

6.8.6 Pulse sound ................................................................................................................................. 35

6.9 Info ...................................................................................................................................................................... 36

6.9.1 System information ...................................................................................................................... 36

6.9.2 Device personalization................................................................................................................. 36

7 EnviteC SpO2 sensors and accessories ............................................................................................................... 37

7.1 Selection and application of a sensor .............................................................................................................. 37

7.2 Overview of EnviteC sensors and cables........................................................................................................ 38

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Pulse oximeter MySign®S

8 Maintenance / cleaning............................................................................................................................................ 39

8.1 Replacing the battery......................................................................................................................................... 40

8.2 Replacing the sensor......................................................................................................................................... 40

9 PC software .............................................................................................................................................................. 41

10 Alarm messages ...................................................................................................................................................... 42

11 Info............................................................................................................................................................................. 43

12 Error Descriptions and Troubleshooting................................................................................................................. 43

13 Technical specifications........................................................................................................................................... 44

13.1 Clinical Accuracy................................................................................................................................................ 46

14 Warranty ................................................................................................................................................................... 50

15 Order information ..................................................................................................................................................... 51

16 EMC Declaration ...................................................................................................................................................... 53

066-07-1002197_GA_MySignS_FDA / 06.14 3

Pulse oximeter MySign®S

This manual was created with great care - should you nevertheless find conflicting details during use of the system,

we request that you inform us in a brief message so that we can correct the discrepancies as quickly as possible.

We reserve the right to make changes to the product due to advancements in optical or other technologies that

are not reflected in the information and figures in this technical documentation. All trademarks mentioned in the

text are registered trademarks of the respective owners and are recognized as protected.

Reprinting, translation and reproduction in any form – even excerpts – require the written approval of the

manufacturer.

This manual is subject to revision by EnviteC-Wismar GmbH.

The latest edition of this technical documentation can be downloaded from our web page

www.envitec.com.

(Printed in Germany)

EnviteC-Wismar GmbH

a Honeywell Company Tel.: +49 - (0) 3841-360-1

Alter Holzhafen 18 Fax: +49 - (0) 3841-360-222

23966 Wismar E-mail: [email protected]

Germany Internet: www.envitec.com

4 066-07-1002197_GA_MySignS_FDA / 06.14

Pulse oximeter MySign®S

1 General information

The pulse oximeter MySign®S may only be used by operators with sufficient knowledge and due

consideration of this technical documentation and the operating manual. The system must only be

used for the purpose described.

Symbols used in this manual

Danger of death, serious injury or considerable material damage if the relevant safety measures are

not observed.

Important information about the product or a specific part of the manual which should be read with

particular attention.

Commissioning

Always note whether there is any damage to the unit, sensor or adapter cable before starting the system it up. Do

not use units, sensors or adapter cables if damaged.

Storage and packaging

The MySign®S and SpO2 sensors must be stored in their original packaging at temperatures of between -25 °C

and 70 °C.

Maintenance

The pulse oximeter must only be maintained and serviced by the hospital/dealer's technical service personal or

by EnviteC-Wismar GmbH staff.

Disposal

In accordance with Directive 2002/96/EC

(WEEE), the manufacturer will accept the return of the

electrical and electronic device for proper disposal after dismantling!

MR Unsafe

MR Unsafe – keep away from magnetic resonance imaging (MRI) equipment.

066-07-1002197_GA_MySignS_FDA / 06.14 5

Pulse oximeter MySign®S

2 Safety information

Unit

•The MySign®S may not be operated in atmospheres that pose explosion risks.

•The MySign®S may not be used during defibrillation.

•A defective unit may not be used. Parts that are broken, worn out or contaminated must be

replaced.

•The MySign®S and all accessory parts may

only be used by persons who have the

appropriate education to guarantee proper handling.

•Portable and mobile RF (radio frequency) communication devices (e.g. mobile phones) can

interfere with and disrupt electrical medical devices.

Additional information about

electromagnetic compatibility (EMC) can be found in this manual or on our homepage.

•

Medical electrical equipment needs special precautions regarding electromagnetic

compatibility (EMC) and needs to be installed and put into service according to the EMC

information provided in this Operating Manual.

•MySign®S is not suitable for operation in the vicinity of MRI devices or X-ray radiation and

may not be operated in the above environments.

•Exceeding the operating parameters or disregarding the measurement conditions will lead

to incorrect measurements or, in severe cases, damage to the MySign®S

•Incorrect use or positioning of the sensors can result in measurement errors and can lead to

constriction of body parts by the sensor cable, shearing off of skin portions by the sensor, etc.

•Only the sensors and accessory parts approved by EnviteC-Wismar GmbH may be used

with the MySign®S. Sensors and accessories must be in flawless condition. The use of

foreign articles can lead to functional failures or loss of biocompatibility and may endanger

the patient.

•The use of accessories, transducers and cables other than those specified could result in

increased EMC emissions or decreased EMC immunity. See section “15. Order Information”

for details.

•

The equipment should not be used adjacent to or stacked with other equipment and if

adjacent or stacked use is necessary, the equipment should be observed to verify normal

operation in the configuration in which it will be used.

•The taking of medications that alter the blood color, the administration of intravascular dyes

(such as methylene blue or indocyanine green and other dyes) or a high level of

dysfunctional haemoglobin (e.g. carbon monoxide poisoning) can significantly falsify the

measurement result.

•MySign®S is intended to support a diagnosis. MySign®

S may only be used for

determination of a diagnosis within the context of other clinical evidence and symptoms. A

clinical evaluation based solely on the use of MySign®S is not permitted.

•MySign®S is delivered in an appropriate shipping packaging. Do not use MySign®S or the

compatible sensors if one of the parts exhibits transport damage or other damage.

•When using the system with patients, the system may not be connected to a computer by

the data cable.

•

The setting of extreme alarm limits can override the alarm function, which could be

dangerous for the patient.

Rechargeable battery

•Do not throw into fires.

•Do not damage or change the battery's structure in any way.

•Do not allow to come into contact with fluids.

•

Do not store with other metallic objects as this could cause the battery to short-circuit.

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Pulse oximeter MySign®S

Risk of Electrostatic Discharge

•Usage in environments with synthetic floor materials (e.g. carpeting) or a relative humidity below

30% is not recommended. Environments with antistatic floor materials are to be preferred.

•If the unit is used in environments with synthetic floor materials, a relative humidity below 30%

or if you are in doubt, discharge any static electricity you may be carrying by touching a grounded

metallic surface or item before touching the unit.

Sensor

•Do not use sensors if damaged.

•

Do not put any mechanical stress (through pulling, stretching or twisting) onto the sensor cable.

Unit

•

This technical documentation is considered part of the unit. Precise compliance with the

technical documentation and the operating manual is a requirement of proper use and correct

handling of the unit as well as for ensuring the safety of the patient and user.

•

Read the technical documentation and the operating manual carefully and completely, as

information that concerns multiple sections is only included once.

•EnviteC only considers itself responsible with regard to the safety, reliability and function of the

units if the assembly, extensions, reconfigurations, changes and repairs are performed by

EnviteC or by a party expressly authorized for this by EnviteC and the unit is used in accordance

with the operating manual and the technical documentation.

•If the unit is not used for a prolonged period of time, the capacity of the battery must be checked

before mobile use and charged first, if necessary.

•Should reasons exist to doubt the accuracy of the measurement, the vital functions of the patient

must first be examined in another way and then inspect the functionality of the MySign®S.

•

The device must be positioned such that the optical and acoustic alarm signals can be

recognized from a minimum distance of 4 m.

Rechargeable battery

•Do not dispose of batteries as household waste.

Sensor

•Before using the sensors, carefully read the associated operating manual as well as all warnings

and other instructions.

•When selecting the sensor, consider the weight and activity level of the patient. Also evaluate

whether there is sufficient blood circulation at the application site.

•Movement artifacts can falsify the measurement result. Make certain that the application site is

kept still.

•The sensor should be protected from heavy exposure to light since this can cause measurement

errors. If the signal quality is not sufficient after about 10 seconds, try affixing the sensor at a

different application site.

•Check sensor and application at least every 4 hours for proper functioning (check position and

patient skin for damage), and reposition if necessary.

•

The sensor contains no latex. The materials used in manufacturing are free of natural latex

proteins. The materials that come into contact with the patient have undergone extensive

biocompatibility testing.

066-07-1002197_GA_MySignS_FDA / 06.14 7

Pulse oximeter MySign®S

Essential Performance

Essential Performance is performance, the absence or degradation of which, would result in an

unacceptable risk, and includes the following functionalities:

•Accuracy of blood oxygen saturation (SpO2) measurement

•Accuracy of pulse rate measurement

•Alarm indication

•Alarm adjustment within safe limits and silence/pause

•Indication of measured results (saturation, pulse) and associated alarm limits on displays

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Pulse oximeter MySign®S

3 Designated use and functional description

3.1 Indications for use (designated purpose)

MySign®S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive

monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and

pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile units.

For professional use only.

The device is calibrated to functional oxygen saturation.

The areas in the hospital where the unit can be used include general nursing wards, operating rooms,

areas for special procedures and intensive care units both in hospitals and in hospital-like institutions.

Hospital-like areas include, for example, out-patient clinics, sleep laboratories, care facilities, surgical

centers and day clinics.

MySign®S allows for comprehensive basic monitoring of SpO2 and pulse rate including:

•Configuring of upper and lower alarm limits

•Standard alarm limits

•Visual and audible monitoring

The monitor provides retrospective access to the monitoring data via a USB connection to a PC

utilizing the optional MySign PC Software.

The data is stored by the monitor in a trend and event database. It is possible to display trend tables

(vital parameters), store them on a central server for documentation or print them out at any location.

The measurements can also be displayed as a trend diagram.

The sensors are applied to the corresponding body parts of the patient, such as the finger. Based on

the measurement values, pulse-oximetric oxygen saturation (SpO2), pulse rate, pulsation index and

the quality of these signals are made available to the user.

The MySign®S may only be used by persons who have the appropriate education to guarantee

proper handling.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

066-07-1002197_GA_MySignS_FDA / 06.14 9

Pulse oximeter MySign®S

3.2 General functional principles and conditions

The technology of non-invasive pulse oximetry is based on two principles. On one hand, the color of the blood

influenced by oxygen saturation is determined at the two wavelength ranges of red and infra-red

(spectrophotometry). On the other hand, the quantity of arterial blood in tissue (and therefore also the light

absorption of this blood) varies during the pulsation caused by the ejection of blood from the heart into the arteries

(plethysmography).

The color difference caused by the blood saturation can be attributed to the optical properties of the hemoglobin

molecule, or more precisely, to the organic hem component. The hemoglobin is responsible for transporting

oxygen in the blood via oxygenation (O2Hb).

The oxygen can be released again; i.e. the blood is deoxygenated (oxygen saturation decreases), losing its red

color accordingly. As a result, the absorption of red light is more heavily influenced, and the absorption of infra-

red light is less influenced. The pulsation of the arterial blood flow, which changes the blood volume during the

systole and diastole and thereby alters the light absorption, is used for determination of the arterial oxygen

saturation.

Because only the change in light absorption is evaluated, non-pulsing but absorbing substances such as tissue,

bone and venous blood have no effect on the measurement. One red and one infra-red diode serve as light

sources for the measurement. The receiver is a photodiode.

The pulse oximeter measures the ratio of the red and infra-red pulsating absorption, which correlates directly with

oxygen saturation, and displays the oxygen saturation on this basis. In addition, the time intervals between

pulsations are converted into a pulse rate and also displayed.

3.3 Signal quality, pulsation index, disruptions

The pulse oximeter requires a measurable pulse wave in order to correctly determine oxygen saturation values

and pulse rate values. If no or only a very weak pulse wave is detected, incorrect values may be obtained.

The values can also be incorrect if significant movement artifacts occur. The displayed measurement values only

lie within the defined precision range if the bar graph (signal quality indicator) is shown in blue.

Signal quality:

Blue = Good

Yellow =Moderate

Orange =Poor

The sensor’s reading will only be accurate if it is correctly positioned. If attached incorrectly, the sensor’s light

signal will not be aimed straight at the tissue, which can affect the SpO2 reading.

Pulsation Index (PI): PI is a measure of the level of blood pulsation in the tissue and is defined as the quotient of

the pulsatile (IAC) and non-pulsatile (IDC) components of the infra-red light. PI values below 1 can result in

measurement errors.

Utility of PI: Adequate blood flow (pulsation) at the application site is required for a correct measurement. The

pulsation index (PI) is a general indicator of the pulsation strength obtained at the measurement site, and provides

an additional means of signal quality assessment.

Testing of PI: The pulsation index has been evaluated by testing the MySign®S monitor and sensors with a listed

pulse oximeter simulator at pulse modulation levels ranging from 0.2% to 20%.

The pulsation may be negatively influenced by, for example, the use of blood pressure cuffs, arterial

catheters, arterial occlusion or overly tight application of the sensor. Venous pulsation or defibrillation

can also affect the measurement result.

10 066-07-1002197_GA_MySignS_FDA / 06.14

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