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Pulse oximeter MySign

®

S

16 EMC Declaration

Manufacturer`s Declaration – Electromagnetic Emissions IEC 60601-1-2

for the Equipment or System MYSIGN S

General information requirements of IEC 60601-1-2 sect. 5.2 Instructions for use:

5.2.1.1) Requirements applicable to all EQUIPMENT and SYSTEMS: Instructions for use shall include the
following:

a) a statement that MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and

needs to be installed and put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS;

b) a statement that portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL

EQUIPMENT.

Table 1: Guidance and manufacturer`s declaration - electromagnetic emissions

Guidance and manufacturer`s declaration electromagnetic emissions

The MYSIGN S is intended for use in the electromagnetic environment specified below. The customer or the
user of the MYSIGN S should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The MYSIGN S uses RF energy only for its internal
function. Therefore, RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.

RF emissions
CISPR 11

Class B

The MYSIGN S is suitable in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.

Harmonic emissions
IEC 61000-3-2

Class A

Flicker Voltage
fluctuations/flicker emissions
IEC 61000-3-3

Complies

066-07-1002197_GA_MySignS_FDA / 06.14

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Содержание MySign s

Страница 1: ...Pulse oximeter Technical Documentation 066 07 1002197_GA_MySignS_FDA 0 USA Subject to technical changes 06 2014 EnviteC Wismar GmbH ...

Страница 2: ...bols 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 Remin...

Страница 3: ...0 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 ...

Страница 4: ...ed 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 Doc no 066 07 1002197_GA_M...

Страница 5: ...g 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 techni...

Страница 6: ...n 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 s...

Страница 7: ...chnical 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 ...

Страница 8: ...cceptable 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 8 066 07 1002197_GA_MySignS_FDA 06 14 ...

Страница 9: ...ows 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 ...

Страница 10: ...ys 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 ...

Страница 11: ...ration measurement CO oximeter If the level of dysfunctional hemoglobin is high the precision of the measurement is impaired Intravascular dyes nail polish and artificial fingernails can also impair the precision of the measurement In addition the measurement precision can be impaired by strong ambient light or direct sunlight In such cases the sensor can be covered If you doubt the precision of t...

Страница 12: ...ating manual unit 1 x CD technical documentation unit 1 x USB cable 4 3 Function test Verify the proper functioning of the MySign S before using it the first time Do this by following the further instructions in section 6 1 4 4 Installation Connect the SpO2 sensor to the MySign S unit as shown below Note the arrow on the sensor plug and the unit socket to ensure the correct connection orientation ...

Страница 13: ...n as the battery symbol is shown as full 4 5 2 Charging on a USB port To charge the battery at a USB port connect it to the USB port on the computer using the enclosed cable As the charge current at the port is only around 500 mA it can take up to 6 hours to charge the battery at a computer Only use power supplies that correspond to the system s specifications see 13 Technical specifications For m...

Страница 14: ...p the unit Hold the fixed tension arm against the bed frame for example and attach the holder by turning the threaded spindle c in a clockwise direction Now insert the holder s mounting plate into the guide d on the back of the MySign S and fasten by turning the hand wheel e in a counter clockwise direction The device must be positioned so that the optical and acoustic alarm signals can be recogni...

Страница 15: ...he front All of the system s status and error messages are shown in plain text on the illuminated screen Front Back No Description No Description c Housing h ON OFF key d Display i Sensor socket e Operating keys j Sound emitter f USB port k Support g Alarm LED red yellow 066 07 1002197_GA_MySignS_FDA 06 14 15 ...

Страница 16: ... main menu or brings you back to the main screen Pause audio alarm key with yellow LED Acknowledges an alarm Î Mutes it for 120 seconds Pressing this key briefly twice double click fully switches off the current audio alarm Switches the audio alarm off LED on Î as soon as the audio alarm has been switched off LED flashes Î as soon as the reminder signal has also been switched off ON OFF key For sw...

Страница 17: ... DOWN 7 Current SpO2 measurement value 8 Upper SpO2 alarm limit 9 Lower SpO2 alarm limit 10 Current pulse measurement value 11 Upper pulse alarm limit 12 Lower pulse alarm limit 13 Bar graph Shows the plethysmogram as a bar graph and indicates the signal quality with color changes Blue means good signal quality yellow moderate and orange poor See also section Precision disruptions 14 Pulsation ind...

Страница 18: ...Protected against spray water and dust Manufacturer date of manufacture Unit corresponds to type BF Not protected from the effects of defibrillators PN Product number Follow the disposal instructions SN Serial number CE Conformité Européenne European conformity MR Unsafe 18 066 07 1002197_GA_MySignS_FDA 06 14 ...

Страница 19: ... settings Information Help Info Up Low level priority warning Down Medium level priority warning Audio alarm off Bar graph signal quality Audio alarm off only for current alarm Switch off Pause sound For pulsation index PI bar graph see section 11 Application indicator see also section Application indicator Pulse sound volume Patient type Pulse heart beat Sensor off Pulse sound off Plug disconnect...

Страница 20: ...ications repeat the switching on process If the problem persists please contact customer service The sensor is also checked during the function test so ensure it is connected However it is not checked for accuracy Switching on the unit Hold down the key for around 1 second The unit will be ready to take measurements after approx 5 seconds Example Information displayed while the unit is being switc...

Страница 21: ... the shutdown process starting with the number 3 If the ON OFF key is released at any time during the countdown the countdown is stopped and the unit stays on Hold the key pressed for about 3 seconds Example Information displayed while the unit is being switched off Once the unit has been switched off the data from the measurements that have been performed are stored inside the unit s memory and c...

Страница 22: ...Pulse oximeter MySign S 6 2 Main menu Overview 22 066 07 1002197_GA_MySignS_FDA 06 14 ...

Страница 23: ...vent changes from being made to the device settings Select Key lock from the main menu Deactivate the key lock by pressing Unlock Confirm the subsequent query by pressing OK The keys are now unlocked and can be used to operate the unit 066 07 1002197_GA_MySignS_FDA 06 14 23 ...

Страница 24: ...alarm limits Upper Lower 100 90 Pulse alarm limits Upper Lower 140 bpm 75 bpm 6 5 View The properties of the unit display can be modified in the View menu One differentiates here between Measured value PTM plethysmogram and Trend The display can also be modified with function key 2 right View Select View in the main menu Once this menu has opened you will be able to select from any of the above mo...

Страница 25: ...lity are displayed To view an overview of the measurements that have already been performed go to Measurement series in the Data memory menu Select Measured value from the View menu Horizontal position Î Measurement value view When holding the unit horizontally the measurement value will also be displayed horizontally 066 07 1002197_GA_MySignS_FDA 06 14 25 ...

Страница 26: ...e the unit will show both the Measured value and Plethysmogram Select PTM from the View menu Horizontal position Î PTM view When holding the unit horizontally the PTM view will also be displayed horizontally 26 066 07 1002197_GA_MySignS_FDA 06 14 ...

Страница 27: ...nd of the measurements taken over the past three hours This gives a comprehensive overview of any changes in the measurements Select Trend from the View in the menu Horizontal position Î Trend view When holding the unit horizontally it will extend the measurement period shown to 4 hours 066 07 1002197_GA_MySignS_FDA 06 14 27 ...

Страница 28: ... not affect the data stored in the memory 6 6 1 Set flag This function can be used to insert flags into the data memory in order to for example document the administration of medications Select Set flag from the Data memory menu Flagged appears for a brief time on the display and the flag is indicated in Trend view as a vertical dotted line 6 6 2 Save interval You can configure here the time inter...

Страница 29: ...ory menu Then select a measurement series It is also possible to move within the measurement series using the arrow keys The data can also be displayed graphically The Zoom function changes the time axis of the graph Low level priority warning e g battery charge low Medium level priority warning e g value below lower alarm limit Flagged For additional information on the priority levels see section...

Страница 30: ...The alarm settings contain all configuration options for alarms Select Alarm settings from the main menu Once the Alarm settings menu has opened you will be able to select from a number of different options 30 066 07 1002197_GA_MySignS_FDA 06 14 ...

Страница 31: ...n key Next At the last value lower pulse alarm limit all changes are confirmed and accepted with OK You can move back one step with the function key Back until eventually leaving the alarm settings The alarm limits can also be changed with the function key 1 left Alarm limits 6 7 2 Alarm volume This function can be used to individually adjust the volume for the audio alarms and reminder signal Sel...

Страница 32: ...ights symbol red We advise against switching the audio alarm off Even when the audio alarm is switched off a reminder signal is emitted every 4 minutes unless this has also been additionally switched off 6 7 4 Reminder signal The reminder signal is emitted every 4 minutes if the audio alarm has been switched off and an alarm condition exists This function can be switched on or off under Alarm sett...

Страница 33: ... switched on or off with the right function key The symbol flashes if more than 4 hours have passed After 8 hours the following symbol is shown The time is only reset to zero by the error message Sensor off Check sensor and application at least every 4 hours for proper functioning check position and patient skin for damage and reposition if necessary For older people it is recommended that checks ...

Страница 34: ...time are shown in the international format Date Î YYYY MM DD year month day Time Î HH MM hours minutes Select Date Time from the General settings menu Pressing the key again will enable you to change the next value The change is entered using the select keys and confirmed with OK 6 8 3 Display This menu can be used to adjust the brightness settings the automatic reduction of the display brightness...

Страница 35: ...isplay brightness 8 Auto off display 1 when not connected to power supply Auto rotation Off Saving interval 10 s Language English 6 8 5 Key sound This menu can be used to switch on or off the audio signal that is sounded when a key is pressed Switch the function Key sound on or off in the General settings menu 6 8 6 Pulse sound This menu can be used to switch on or off the audio signal for the pul...

Страница 36: ...stem information menu contains the most important data about the system Unit Module 1 Serial number Serial number Software version Software version Hardware version Date of manufacture Select System information from the Info menu 6 9 2 Device personalization Freely selectable start text which can be changed using the PC software For example information can be entered identifying the department to ...

Страница 37: ... the associated operating manual as well as all warnings and other instructions Never use damaged sensors Never use a sensor with unprotected optical components Only use sensors approved by EnviteC for SpO2 measurements 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 The sensor shoul...

Страница 38: ...ension and adapter cables X 4211 3 MySign Extension and adapter cables X 4211 1 MySign SoftTip Large R 3212 9 MySign SoftTip Medium RM 3212 9 MySign SoftTip Small RS 3212 9 MySign FingerClip F 3212 9 MySign Ear sensor ES 3212 9 MySign Disposable sensor DA 2211 1 MySign Disposable sensor DP 2211 2 MySign The display of both the SpO2 value and the pulse rate can be influenced by certain ambient cond...

Страница 39: ...966 Wismar Germany To speed up the repair process please obtain an RMA Return Material Authorization number through our website www envitec com under Service Returns Please state your RMA number in all your correspondence Cleaning and disinfection of the MySign S Only perform a wipe disinfection by gently wiping the unit with a soft disposable cloth soaked with isopropyl alcohol Keep the battery c...

Страница 40: ...laced After this time all settings must be reconfigured Disposing of the unit SpO2 sensor battery Do not dispose of the unit SpO2 sensor or battery as household waste Please return all of these to EnviteC clearly labelled Entsorgung Please dispose of EnviteC Wismar GmbH Alter Holzhafen 18 23966 Wismar Germany Germany Danger of explosion Do not throw batteries into fire or force them open 8 2 Repla...

Страница 41: ...tor by connecting it to the PC via a USB connection The PC software is not intended for diagnosis and analysis purposes No measuring is possible while the MySign monitor is connected to a PC No fundamentally essential or safety relevant functions of the MySign monitor can be changed in the MySign monitor configuration Please refer to the Help section of the PC software for more information on oper...

Страница 42: ... if necessary Flashing yellow orange symbol Poor signal quality Check the correct seat of the sensor at the application site e g finger Re apply if necessary Flashing yellow every second Pulse search too long Check the correct seat of the sensor at the application site e g finger Re apply if necessary Lower SpO2 or pulse alarm limit Flashing yellow After 10 s delay 3 x every 10 s Oxygen concentrat...

Страница 43: ...Switch the unit off and then on again If the fault persists please contact customer service Rechargeable battery Battery charge too low no battery connected or battery faulty Check and charge the battery or replace it if necessary Self test non critical Time Time was reset Set the time again If the fault persists please contact customer service Memory Internal memory error Data memory menu item mi...

Страница 44: ...ion outside this range refer to the safety information Risk of Electrostatic Discharge Ambient pressure 700 to 1060 hPa Rechargeable battery Li ion 3 6 V 2900 mAh Operating time per charge 18 hours standard settings 24 hours with auto off activated Function with the lowest display brightness setting Charger Mini USB type B protection class II Input AC 110V 230V 50 60 Hz 125 mA Output DC 5V 1 A 15 ...

Страница 45: ... values date time alarm limits events Personalization Unit and data in connection with MySign software e g name ward patient ID Protection class II type BF Class IIb CE marking CE 0123 Standards This unit complies with the requirements of MDD 93 42 EEC concerning medical devices and the corresponding standards It also complies with DIN EN 1789 Medical vehicles and their equipment Ambulances with S...

Страница 46: ...erClip EarClip SoftTip and disposable sensors The reported accuracy for each sensor type is listed in the table and in the graphical plots below Parameter F 3212 9 ES 3212 9 R 3212 9 DW 2211 6 DS100A ARMS 70 80 2 35 2 90 1 85 2 41 2 41 ARMS 80 90 2 09 1 33 1 73 2 14 1 44 ARMS 90 100 1 50 1 33 1 40 1 90 1 48 ARMS 1 70 100 1 86 1 98 1 60 2 01 1 79 Upper 95 LOA2 1 673 3 937 2 063 2 331 3 989 Lower 95...

Страница 47: ...Pulse oximeter MySign S F 3212 9 Reusable FingerClip SpO2Sensor ES 3212 9 Reusable EarClip SpO2 Sensor 066 07 1002197_GA_MySignS_FDA 06 14 47 ...

Страница 48: ...Pulse oximeter MySign S R 3212 9 SoftTip Reusable Rubber Finger Sensor DW 2211 6 Disposable Adhesive Tape Sensor 48 066 07 1002197_GA_MySignS_FDA 06 14 ...

Страница 49: ...0A has been validated for use on the MySign S The DS 100A is not manufactured by EnviteC Refer to the manufacturer s DS 100A instructions for use for more information on this sensor 1 Nellcor is a registered trademark of Covidien Inc Mansfield MA USA 066 07 1002197_GA_MySignS_FDA 06 14 49 ...

Страница 50: ...tempts In these cases the liability is transferred to the operator Transport to customer service and back for repairs not covered under warranty takes place at the customer s expense Please contact your dealer if you wish to make a warranty claim To return the unit directly to EnviteC under the warranty you will need an RMA Return Material Authorization number please always state this number in al...

Страница 51: ...2080 optional SpO2 sensors Part number SoftTip Large R 3211 31 MySign FDA 1002198 SoftTip Large R 3211 12 MySign FDA 1002199 SoftTip Medium RM 3211 31 MySign FDA 1002200 SoftTip Medium RM 3211 12 MySign FDA 1002201 SoftTip Small RS 3211 31 MySign FDA 1002202 SoftTip Small RS 3211 12 MySign FDA 1002203 FingerClip F 3211 31 MySign FDA 1002204 FingerClip F 3211 12 MySign FDA 1002205 Ear sensor ES 321...

Страница 52: ...Sign FDA 1002216 1 The power supply Part No 1001829 is not included and must be ordered separately if needed The SpO2 sensors previous page and SpO2 sensors with adapter cable listed above have been tested to comply with applicable emissions and immunity requirements Representative sensors of each type were tested with the maximum cable length of 390 cm which includes the X 4211 3 Extension and Ad...

Страница 53: ...netic emissions Guidance and manufacturer s declaration electromagnetic emissions The MYSIGN S is intended for use in the electromagnetic environment specified below The customer or the user of the MYSIGN S should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The MYSIGN S uses RF energy only for its intern...

Страница 54: ...p in UT 25 cycles 95 dip in UT 5 sec 95 dip in UT 0 5 cycles 60 dip in UT 5 cycles 30 dip in UT 25 cycles 95 dip in UT 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the MYSIGN S requires continued operation during power mains interruption it is recommended that the Equipment or System be powered from an UPS or a battery magnetic field Power...

Страница 55: ... supporting Recommended separation distances between portable and mobile RF communication equipment and the MYSIGN S The MYSIGN S is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MYSIGN S can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications ...

Страница 56: ...EnviteC Wismar GmbH a Honeywell Company Alter Holzhafen 18 Phone 49 0 3841 360 200 23966 Wismar Germany Fax 49 0 3841 360 222 Internet www envitec com ...

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