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Sleep&Go

User’s Manual

534-7AB-MU2 • REV. 1.07

User
’s Manual -

Cardior

espiratory polygraph - Sleep&Go

2.5 MAKING POLYGRAPHY TESTS IN ONLINE MODE

In this mode, the polygraph transmits the real-time data to the PC

via Bluetooth connection, displaying the signals on the computer

screen. The Bluetooth module in the Sleep&Go must be enabled

(optional in the A model, supplied by default in the B model).

Make sure the device is switched on and the Bluetooth

communication is enabled (see above).

All new online tests are to be started from the BitmedLab software.

Please refer to the software’s manual for information on how to

make an online test.

2.6 MAKING POLYGRAPHY TESTS IN HOLTER MODE

When the device operates in holter there are two different ways

to start and stop the tests, either manually or automatically

(scheduled).

2.6.1 STARTING AND ENDING A TEST MANUALLY

In this mode either the patient or the technician will start and end

the test:

•

Switch on the device by pressing for 3 seconds the ON/OFF

button.

• Once in the main screen press the joystick (A) to select the

“MANUAL START” icon.

•

This starts the recording of the test. If all sensors are properly

connected then the signals are displayed on the screen and

the LED on the front panel starts flashing. If any of the

sensors to be acquired is not properly connected the message

“CHECK SENSOR” is displayed, giving the opportunity to test

the connection. After a few seconds the screen switches off

automatically.

• To stop the test just select the “STOP”

option or hold down

the ON/OFF button for 3 seconds (B).

Содержание SLEEP&GO

Страница 1: ...SLEEP GO CARDIORESPIRATORY POLYGRAPH USER S MANUAL 534 7AB MU2 REV 1 07 2014 06 manual START SYSTEM CONFIG 19 06 10 75 11 15 ...

Страница 2: ...ibed stored in a back up system or translated into any language or computer language in any form or by any means electronic mechanical optical chemical or manual without the express written consent from SIBEL S A DISCLAIMER SIBEL S A is responsible for the security reliability and performance of this equipment only if The place where the systrem is installed or used meets the requirements for elec...

Страница 3: ...e best guarantees of quality Applications SLEEP GO and its related software will open a world of possibilities in the sleep study If you have any possible improvement for this product we welcome your suggestions may be directed to Customer Service Department Revised Approved Date 2014 06 Date 2014 06 Technical Director Sales Director 534 7AB MU2 REV 1 07 0197 ...

Страница 4: ...EL 20 1 3 2 LEFT PANNEL 20 1 3 3 REAR PANNEL 21 1 4 INSTALLATION AND start UP 21 1 4 1 BATTERy PLACEMENT 21 1 4 2 POWER SAVING MODE 22 1 4 3 BLUETOOTH MODULE INSTALLATION 22 1 4 4 PLACEMENT OF SENSORS AND ELECTRODES 22 1 4 4 1 PLACEMENT OF THE Sleep Go POLYGRAPH 22 1 4 4 2 NASAL CANNULA 23 1 4 4 3 thermocouple AIRFLOW SENSOR 24 1 4 4 4 THORACIC AND ABDOMINAL EFFORT BANDS 25 1 4 4 5 PULSE OXIMETER ...

Страница 5: ...LAYING THE SCHEDULED TESTS 42 2 6 2 3 CHANNEL configurations 43 2 7 TRANSFER AND REVIEW OF THE TESTS 43 2 8 FIRMWARE UPDATE 44 2 9 DEVICE OPTIONS UPDATE 44 3 TECHNICAL SPECIFICATIONS 46 3 1 general data 46 3 2 PULSE OXIMETER TECHNICAL SPECIFICATIONS 50 3 3 CONDITIONS of OPERATION and storage of accessories 51 3 4 APPLICABLE STANDARDS 51 4 SYMBOLOGY 55 4 1 SYMBOLOGY OF THE SLEEP GO 55 4 2 SYMBOLOGY...

Страница 6: ...Index Sleep Go User s Manual 6 534 7AB MU2 REV 1 07 ...

Страница 7: ...ve1999 5 EConradioequipmentandtelecommunications terminal equipment For other countries complies with FCC rules parts 15c and Canada Industry IC 5123A BGTWT11A The Sleep Go also complies with the following directives and regulations Packaging and packaging waste directive 94 62 EC Waste Electrical and Electronic Equipment Directive WEEE 2002 96 EC Regulation EC 1272 2008 on classification labellin...

Страница 8: ...ot recommended that the configuration of the device is changed without understanding the principles of signal digitalizing Minimum age of patients is 5 years weighing over 15 kg and a minimum height of 70 cm The medical staff will instruct the patient for a correct test execution to avoid interferences in the measurement and to replace the sensors in case of movement It is therefore important that...

Страница 9: ...may cause injuries or the death of the patient This product does not maintain nor does it help to maintain the life of the patient The term CONTINUOUS MONITORING is specified in regulation EN60601 1 The Sleep Go is classified as Class IIa in accordance with Directive 93 42 EEC on medical devices The pulse oximeter is not provided with physiological type alarms The pulse oximeter is calibrated to d...

Страница 10: ...ct Do not use the system in and MRI environment The system is not designed to work in an explosive environment or in the presence of flammable anesthetics or gases of any kind MAY CAUSE EXPLOSION This product is intended for indoor use e g at the patient s home or hospital and is not suitable for use during patient transportation The polygraph is not intended to be used outdoors or with other cond...

Страница 11: ...cked with other equipment The system shall be stored and used within the temperature ranges pressure and humidity specified in section number 3 Artefacts in the signal may be produced as a result of ESD A trained operator should be able to recognize these artefacts easily The operator must be trained to be able to recognize the differences between a biological signal and signal artifacts caused by...

Страница 12: ... particular avoid bending any part of the sensors This means that the material should not bend more than necessary in normal use The polygraph is designed to be used exclusively by medical staff who should be supervised and instructed by a physician Medical personnel should inform the patient about precautions to be found in the WARNINGS AND PRECAUTIONS section and to be taken when using the equip...

Страница 13: ...specially careful in the usage of collodion Always follow the recommendations for use provided by your collodion manufacturer The conductive part of the electrodes and connectors including the ground electrode must not touch other conductive parts including the ground DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION Never dispose of the Sleep Go its accessories...

Страница 14: ...ense cannulas and Pro Tech cannulas The device and all the accesories are latex free Materials according to the REACH regulation neither the device nor its accessories use any hazardous substance according to REACH regulation In the event that the device or its accessories are infected at the time of recycling it must be disinfected or disposed by following the national regulations regarding the d...

Страница 15: ...n two different models A and B with the following features Sleep Go Channels A model B model Nasal cannula Airflow Snore CPAP Thermocouple Inductive plethysmography band thoracic Inductive plethysmography band abdominal Auxiliary channel External snore Limb movements External EXG module EXG 1 EXG 2 EXG 3 External Xpod SpO2 BPM Pulse wave Position Activity Marks Bluetooth real time tests Default Op...

Страница 16: ...PAR THERMOCOUPLE SENSOR 08088 06314 01420 07678 1 1 1 1 MÓDULO DE ESFUERZO TORÁCICO INDUCTIVO INCLUYE ACTIVACIÓN DEL CANAL INDUCTIVE THORACIC EFFORT MODULE INCLUDES CHANNEL ACTIVATION INTERFAZ DE AMPLIFICACIÓN BANDA INDUCTIVA ESFUERZO TORÁCICO THORAX EFFORT INDUCTIVE BAND AMPLIFICATION INTERFACE BANDA INDUCTIVA ELÁSTICA TAMAÑO EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL ANILLA SUJECI...

Страница 17: ...O SLEEP GO Canales SPO2 BPM ADULT PULSE OXIMETRY KIT FOR SCREEN GO SLEEP GO Channels SpO2 BPM MODULO PULSIOXIMETRIA XPOD XPOD PULSE OXIMETRY MODULE SENSOR PULSIOXIMETRIA SOFT ADULTO SOFT PULSE OXIMETRY SPO2 SENSOR ADULT MUÑEQUERA DE SUJECIÓN WRISTBAND 08069 08098 08013 07677 1 1 1 1 KIT DE PULSIOXIMETRÍA PEDIÁTRICO PARA SCREEN GO SLEEP GO Canales SPO2 BPM PEDIATRIC PULSE OXIMETRY KIT FOR SCREEN GO...

Страница 18: ...u DISPOSABLE PROTECH ORO NASAL CANNULA 40cm PACK OF 30u 07681 1 CÁNULA ORO NASAL DESECHABLE SLEEPSENSE PAQUETE DE 5u DISPOSABLE SLEEPSENSE ORO NASAL CANNULA 60cm PACK OF 5u 08049 1 CÁNULA NASAL DESECHABLE SLEEPSENSE DISPOSABLE SLEEPSENSE NASAL CANNULA 06311 1 BANDA DE SUJECIÓN TAMAÑO PEQUEÑO S FASTENING BELT SMALL SIZE S 06313 1 BANDA DE SUJECIÓN TAMAÑO EXTRA GRANDE XL FASTENING BELT XTRA LARGE SI...

Страница 19: ...TERIAL O EQUIPO EN DEPOSITO ROGAMOS NOS LO ENVÍEN EN PERFECTO ESTADO COMPLETO DE ACCESORIOS Y DEBIDAMENTE EMBALADO CUALQUIER DESPERFECTO OCASIONADO PROVOCARÍA UN CARGO CORRESPONDIENTE EN LA REPARACIÓN O EN LA REPOSICIÓN WARNING THE ITEMS AND QUANTITIES RELATED BEFORE HAVE BEEN CAREFULLY CHECKED IN CASE OF ANY PART IS MISSING OR IS DAMAGED NOTIFY US AS QUICKLY AS YOU CAN IF YOU DETECT ANY DAMAGE IN...

Страница 20: ...pO2 XPod pulse oximeter connector Color LCD Status LED Joystick Ther thermocouple airflow sensor connector Tho thoracic effort band connector Abd abdominal effort band connector Aux auxiliary channel connector suitable for both snore and limb movement sensors ExG ExG module connector Nasal cannula nasal cannula connector 1 3 2 LEFT PANNEL MicroSD memory card slot ON OFF button ...

Страница 21: ...ies prior to installation If you detect a deterioration in the package please contact the transport company and your supplier immediately prior to installation Do not dispose the packaging until completely verifying the proper functioning of the system Use only accessories described in this manual The use of not recommended accessories could adversely affect both the patient safety and the equipme...

Страница 22: ... the driver and software for the PC Bluetooth module as detailed in the module user s manual You must then search the Sleep Go from the Bluetooth software in Windows and pair the PC with the Sleep Go The pairing code corresponds to the last three digits of the Sleep Go serial number You will find the serial number on the label on the back of the Sleep Go device 1 4 4 PLACEMENT OF SENSORS AND ELECT...

Страница 23: ... 2 NASAL CANNULA The nasal airflow cannula refs 07679 07680 07681 08049 is used to acquire the airflow snoring and CPAP pressure level signals by means of the device s internal pressure transducer The placement of the nasal cannula has a significant impact in obtaining high quality signals Follow these steps to place it properly ...

Страница 24: ...so use the thermocouple sensor ref 06309 in order to measure the respiratory airflow The thermocouple sensor is to be connected to the connector labeled as Ther The quality of the registered signal depends on variables such as the filters selected in the software the sensor placement the patient s respiration room temperature and CPAP pressure Filters can reduce the noise in the respiratory signal...

Страница 25: ...led as Ther The ambient temperature affects the magnitude of the signal If the temperature is similar to the patient s temperature the signal level may be very low On the other side if the ambient temperature is very different from the patient s temperature the signal level will be higher The placement of a CPAP mask over the thermocouple sensor may affect the difference between the patient and th...

Страница 26: ...14 and the one going to the abdominal band is labeled as Abd ref 06308 Insert the connector from each the respiratory effort belt in the corresponding input connector of the Sleep Go labeled as Thor for the thoracic belt and Abd to the abdominal belt Fix each of the little boxes to the corresponding belt with the aid of the provided strips 1 4 4 5 PULSE OXIMETER The system is able to provide the p...

Страница 27: ...ect it to SpO2 of Sleep Go Furthermore the following conditions of use should be observed The oximeter must not be used by itself to reach important medical conclusions Medical caution must always be taken and other means must be used whenever possible for confirmation Incorrect use or inappropriate handling of the sensor can cause damage to the sensor or cable This would lead to incorrect measure...

Страница 28: ...er s safety instructions as well as those specified in this manual The maximum recommended time of application of an pulse oximeter in the same place is 24 hours The point of placement must be checked frequently to determine the position circulation and cutaneous sensitivity of the patient Reaction to the sensors by the patients may be different depending on their state of health and skin conditio...

Страница 29: ...tional The snoring sensor is placed on the throat of the patient and it generates a signal in response to the vibration produced during snoring The piezoelectric sensors are based on the movement produced by the vibrations and not on the sounds Therefore they cancel artefacts related to external noise The snoring signal is converted into analogical voltage which can be measured To place a piezoele...

Страница 30: ...l as shown in the figure below If you put the sensor in the ankle then fix it by using the provided strap Secure the sensor cable to the patient s skin with hypoallergenic tape Insert the movement sensor connector in the corresponding input of the Sleep Go connector labeled as Aux or any of the input channels available in the ExG module 1 4 4 9 EKG ELECTRODES We recommend using the electrodes ref ...

Страница 31: ... effort band Interferences may be reduced by tying together the electrode wires Place a third electrode on the patient s forehead and connect it to the neutral input in the ExG module The EKG signal should not be acquired if the device is used at patient s home According to electrical safety standards and due to the use of electrodes in contact with the patient the technician must not touch any in...

Страница 32: ... in the module Hold the ExG module to the thoracic effort band To use a common reference for several EEG channels each electrode must be connected to one of the connectors of the wire adaptors ref 01644 Use one or more interconnection bridges ref 02741 to interconnect the remaining pole of all referenced channels so that every channel uses the same reference Interferences may be reduced by tying t...

Страница 33: ...ting leakage currents which can become dangerous for the patient Reduce to the absolute minimum the number of devices connected to the patient To protect the patient against the effects of electric shock all electrodes must be removed from the patient before using a cardiac defibrillator 1 4 4 11 EVENT MARKER During the test either online or in holter mode the patient is allowed to make a mark by ...

Страница 34: ...er mode The icon MANUAL START is selected by default The patient can not modify the device configuration Use the joystick to navigate through the different screens that will be introduced The joystick supports four directions while pressing it is used to click an option 2 1 WORKING MODES Two working modes are available depending on the way tests are handled Holter mode in this mode the Sleep Go st...

Страница 35: ...y after the test This mode is intended for use in the clinic hospital or the sleep lab The device s batteries last up to 12 hours in online mode with a single charge 2 2 SYSTEM CONFIGURATION The setup mode in the Sleep Go is designed to change the device configuration date and time language type of batteries used and schedule new tests Only healthcare personnel should access the device settings To...

Страница 36: ...creen follow these steps in order to change the date and time in the Sleep Go Select DATE AND TIME Use and to access each of the options to set the date and time in the device Use and to modify the values in each field Once you have set the date and time select OK To cancel setting the date and time select CANCEL 2 3 2 SETTING THE LANGUAGE Once in the CUSTOMIZE screen follow these steps in order t...

Страница 37: ...follow these steps Select BATTERY or MORE OPTIONS BATTERY in case the CPAP channel is available Use and to select the type of batteries used in the device The type of batteries is marked with the mark When finished select OK If you want to cancel setting the type of batteries then select CANCEL 2 3 4 seting THE UNITS OF THE CPAP CHANNEL Select MORE OPTIONS Select BATTERY Select CPAP UNITS Select c...

Страница 38: ...d displays a new icon SYSTEM CONFIG A Select SYSTEM CONFIG and press the joystick to move to the setup screen Select MORE OPTIONS B Select BLUETOOTH C If the Bluetooth module is switched on you will be prompted to turn it off If the module is switched off you will be prompted to turn it on D Select OK or CANCEL When the Bluetooth module is powered a Bluetooth logo is displayed in the status bar Ot...

Страница 39: ...r mode When the device operates in holter there are two different ways to start and stop the tests either manually or automatically scheduled 2 6 1 Starting and ending a test manually In this mode either the patient or the technician will start and end the test Switch on the device by pressing for 3 seconds the ON OFF button Once in the main screen press the joystick A to select the MANUAL START i...

Страница 40: ...y be scheduled right from the Sleep Go device or by using the BitmedLab software in the PC This manual describes the programming procedure in the Sleep Go Refer to the software manual for information on the programming process in BitmedLab 2 6 2 1 SCHEDULING A TEST IN THE SLEEP gO Switch on the Sleep Go and gain access to the setup mode by making the following keystrokes on the joystick one after ...

Страница 41: ...ablishes which channels are recorded during the test as well as their sampling rates There may be up to 10 different channel configurations A detailed explanation on how to change these configurations is given below Select which configuration is more suitable for the type of test you want to do G Select SAVE once all parameters are configured You may switch off now the Sleep Go The device will sta...

Страница 42: ...mode by making the following keystrokes with the joystick Select the SYSTEM CONFIG icon and press the joystick to move to the setup screen Select SCHEDULED TEST Select SHOW TEST A All scheduled tests are displayed For more info on any scheduled test select it B The screen shows the programming data of the test onset date and time duration channel configuration C To view the channel configuration e...

Страница 43: ...ome channels such as pulse oximetry or body position have a fixed sampling frequency while in others such as the respiratory effort bands or the ExG channels the sampling rate can be chosen among several values The creation and modification of channel configurations is made in the BitmedLab software then they are transferred to the MicroSD memory card See the software s manual for more information...

Страница 44: ...mory card before downloading the tests to the PC 2 8 FIRMWARE UPDATE Over time new versions of the program managing the Sleep Go firmware might be released either to improve the operation of the equipment or to add new features The Technical Service will provide one or several files to be copied to the MicroSD memory card of the Sleep Go Insert the memory card in the Sleep Go and switch it on The ...

Страница 45: ...vice will provide one file to be copied to the MicroSD memory card of the Sleep Go Insert the memory card in the Sleep Go and switch it on The update starts automatically When prompted confirm that you want to update the device s features When the update is complete the Sleep Go switches off automatically Your device is already updated and the new channels are available from now on ...

Страница 46: ...line mode 24h in holter mode Enclosure protection degree IP22 Memory type MicroSD Device classification EN60601 1 Class internally powered Type BF applied parts not protected against defibrillator Input impedance 20 MW CMRR common mode rejection ratio 95dB Signal input connectors Pressure transducer airflow snoring CPAP pressure Thermocouple thoracic effort abdominal effort polygraphic auxiliary E...

Страница 47: ...able 25 50 100 samples s Selectable 50 100 250 samples s 1 sample s Selectable 10 25 samples s Selectable 10 25 samples s Selectable 10 25 samples s Selectable 25 50 100 samples s Selectable 100 250 samples s 1 sample s 1 sample s 75 samples s Selectable 10 25 50 samples s 1 sample s 1 sample s Resolution Airflow pressure transducer snore pressure transducer thermocouple thoracic effort abdominal ...

Страница 48: ...e rate Oxygen saturation Plethysmographic wave Actimetry Body position 5 mVpp 4 cmH2 O 3 9 hPa over the cannula aprox 0 20 cmH2 O 19 6 hPa 0 5 cmH2 O 0 49 hPa over the cannula aprox 18 300 BPM 1 min 0 100 0 255 aprox 30 mg 300 m s2 Supine prone left right seated Linearity Resp airflow pressure transducer snore pressure transducer Thermocouple thoracic effort abdominal effort polygraphic aux ExG ch...

Страница 49: ...Hz 0 05 250 Hz 0 05 50 Hz 0 02 Hz 30 250 Hz 0 5 25 Hz PC communication interface Bluetooth option Environmental conditions In operation Transportation and storage Temperature 5ºC to 40ºC Relative humidity 15 93 without condensation Barometric pressure 700hPa to 1060hPa approx 2950 to 350m Temperature 20ºC to 60ºC Relative humidity 93 without condensation Dimensions 90 x 90 x 25 mm Weight 200 g The...

Страница 50: ...sensor adults paediatric 2 digits neonates 3 digits Flexible sensor adults paediatric 3 digits neonates 4 digits Low perfusion All sensors adults paediatric 2dígitos neonates 3 digits No movement 18 300 BPM Finger clip sensor flexible sensor adults paediatric neonates 3 digits Movement 40 240 BPM Finger clip sensor flexible sensor adults paediatric neonates 5 digits Low perfusion 40 240 BPM Finger...

Страница 51: ...60 C in order to ensure the proper storage of most accessories Exceptionally ECG electrodes Ref 02646 silver cup EXG electrodes Ref 08701 and the cable for button stud type electrodes Ref 08093 support lower storage temperatures The following table shows the conditions for these accessories Temperature transportation storage Humidity transportation storage ECG electrodes Ref 02646 10 to 40ºC 93 wi...

Страница 52: ...myographs EN 60601 1 11 2010 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment EMC EN 60601 1 2 2007 AC 2010 EMC in medical devices No life support See Annex 1 Electromagnetic compatibility Software EN 62304 2006 AC 2008 Medical device software Soft...

Страница 53: ...e suplplied Packaging and labelling Packaging and packaging waste directive 94 62 EC Regulation EC 1272 2008 on classification labelling and packaging of substances and mixtures REACH Information supplied by the manufacturer EN 1041 2008 Information supplied by the manufacturer of medical devices Electrical and electronic waste Electrical and electronic equipment and waste management Transposition...

Страница 54: ...07 User s Manual Cardiorespiratory polygraph Sleep Go 54 In addition although outside the scope and intended use of the device some security aspects from the following standards have been applied EN 60601 2 49 2001 EN 60601 2 27 2006 CORR 2006 ...

Страница 55: ...EP GO SERIAL NUMBER MANUFACTURER manufacture date name and address of the manufacturer BATCH NUMBER REFERENCE CONSULT INSTRUCTIONS FOR USE WARNING START UP STANDBY BF APPLIED PARTS NO SPO2 ALARMS IP22 see section WARNINGS AND PRECAUTIONS DISPOSAL OF WASTE ELECTRICAL ELECTRONIC ACORDING TO THE RAEE DIRECTIVE NEUTRAL CONNECTOR BATTERIES ...

Страница 56: ... AND PACKAGING CE MARKING WARNING DO NOT REUSE BATCH NUMBER REFERENCE LATEX FREE PHT CONTAINS PHTHALATES MANUFACTURER manufacture date name and address of the manufacturer AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY DISPOSAL OF WASTE ELECTRICAL ELECTRONIC ACORDING TO THE RAEE DIRECTIVE TEMPERATURE LIMITATION SERIAL NUMBER ...

Страница 57: ...ATE LATEX FREE DO NOT STERILIZE U S FEDERAL REGULATION RESTRICTS THIS DEVICE TO SALE BY ORDER OF PHYSICIAN MAY ALSO BE APPLICABLE IN OTHER COUNTRIES PHT CONTAINS PHTHALATES DEHP CONTAINS DIETILHEXIL PHTALATE HUMIDITY LIMITATION USE BY STACKING LIMITATION THIS WAY UP FRAGILE KEEP AWAY FROM WATER PREASURE LIMITATION ...

Страница 58: ...CANNULA S L P INC 08049 15805 2 FT DISPOSABLE PROTECH NASAL CANNULA PACKAGE 60PC PRO TECH 07679 P1328 60 DISPOSABLE PROTECH ORO NASAL CANNULA PACKAGE 30PC PRO TECH 07680 P1343 DISPOSABLE SLEEPSENSE ORO NASAL CANNULA PACKAGE 5PC S L P INC 07681 14802 2 FT DISPOSABLE SLEEPSENSE NASAL CANNULAR S L P INC 08049 15805 2 FT THORAX EFFORT INDUCTIVE BAND AMPLIFICATION INTERFACE S L P INC 06314 9102S BI ABD...

Страница 59: ...LIMB MOVEMENT SENSOR KIT S L P INC 06310 1770S KIT BI PIEZOELECTRIC SNORE SENSOR S L P INC 06346 1250S BI EXG GOLD CUP ELECTRODE PACKAGE 10PC GRASS TECHNOLOGIES 08701 F E5GH 30 CABLE ADAPTER 1MM TO 1 5MM PLASTICS ONE INC 01644 249497X04010XXX INTERCONNECTION BRIDGE PLASTICS ONE INC 02741 455455X01010XXX CABLE FOR BUTTON STUD TYPE ELECTRODES PACKAGE 10PC SPES MEDICA S R L 08093 S2231050261 ECG ELEC...

Страница 60: ...ic use Please read carefully the SAFETY section Properly dispose the disposable sensors and single use electrodes immediately after use Nasal cannulas are single use and must be replaced with each patient For the cleaning and disinfection of reusable sensors and electrodes please refer to the information provided by its manufacturer The device can not be sterilized For the cleaning and disinfectio...

Страница 61: ...ing part of the device must be made according to the Procedure of Verification and Adjustment for the Sleep Go of SIBEL S A These operations must be carried out by service personnel from the manufacturer or distributor The latter must be in possession of a written authorization from SIBEL S A at least during the warranty period in order to perform such maintenance The manufacturer is not responsib...

Страница 62: ...ENANCE Corrective maintenance is the process of leaving the device in good conditions of use when it stops working due to malfunction or misuse If you detect a fault in the equipment that prevents normal operation please contact the SIBEL S A Customer Service Centre specifying the type of problem suffered ...

Страница 63: ...t Compliance level Guide Electromagnetic environment Radiated RF Emissions CISPR 11 EN 55011 Group 1 Class B The SCREEN GO SLEEP GO uses RF energy only for internal use Therefore its emissions are very low and unlikely to cause any interference to nearby electronic devices Conducted RF Emissions CISPR 11 EN 55011 Not applicable The SCREEN GO SLEEP GO runs on batteries Harmonic Emissions EN IEC 610...

Страница 64: ...l fast transient burst EN IEC 61000 4 4 2 kV feeder cables and earth lines 1 kV for input output lines Not applicable Not applicable The SCREEN GO SLEEP GO runs on batteries The length of the E S lines is less than 3 m Surge EN IEC 61000 4 5 1 kV in differential mode 2 kVin common mode Not applicable Not applicable The SCREEN GO SLEEP GO runs on batteries Voltage dips short interruptions and volta...

Страница 65: ...nce Conducted RF EN IEC 61000 4 6 3 Vrms from 150KHz to 80 MHz 3 Vrms from 80 MHz to 800 MHz Radiated RF EN IEC 61000 4 3 3 V m from 80 MHz to 2 5 GHz 3 V m from 80 MHz to 800 MHz from 800 MHz to 2 5 GHz where P is the maximum power output of the transmitter in watts W according to the manufacturer of the transmitter and d is the recommended separation distance in metres m Field intensities from p...

Страница 66: ...curacy To know the electromagnetic environment due to permanent RF transmitters electromagnetic measurements of the place of use must be considered If the field intensity of the place of use is superior to the level of compliance it must be observed whether the behaviour of the SCREEN GO SLEEP GO is normal Otherwise additional measurements such as the reorientation or change in placement of the SC...

Страница 67: ...ximum power output of the transmitter W Separation distance depending on the transmitter frequency m From 150 kHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters with a maximum power output not listed above the recommended separation distance d in metres m can be estimated usin...

Страница 68: ... Go Verify that the Bluetooth module in the PC is enabled and working properly In a new test the message CHECK SENSOR is displayed on screen Check that the erroneous sensor is correctly connected If the problem is not solved after 5 minutes the message will disappear The signals of the electrodes look noisy or distorted In the case of the electrodes make sure that the skin electrode impedance is g...

Страница 69: ...the pulse oximeter sensor is correctly connected to the patient as indicated the PLACEMENT OF SENSORS AND ELECTRODES section Make sure the pulse oximetry sensor connector is properly plugged into the top panel of the Sleep Go Make sure the red light in the pulse oximetry sensor switches on when connected to the Sleep Go ...

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