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SLEEP&GO

1. enuen s sN A TEE EE EEN a3 02 114 12 38 SCHEDULED TEST F CHANNELS CONF REC MORE OPTIONS MANUAL SYSTEM START CONF IG 09 92 11 d 12052 W CUSTONI ZE AND TIME BATTERY j BLUETOOTH G INTERNAL CONF BACK BACK e If CPAP channel is activated BATTERY menu changes to OTHER OPTIONS Once in the CUSTOMIZE screen follow these steps in order to change the date and time in the Sleep amp Go e Select DATE AND TIME Use 4 and y to access each of the options to set the date and time the device Use to modify KLEIN the values in each field 00 op e Once you have set the date and time select OK To cancel setting the date and time select CANCEL 12705710 09 45 m OK 3f CANCEL Once in the CUSTOMIZE screen follow these steps in order to change the language in the Sleep amp Go e Select LANGUAGES 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 12705710 93 09 46 e Use and e move along the different available languages The selected language is marked with ENGLISH the V symbol CATALA e When you have set the desired language select OK If you want FRANCAIS to cancel the language settings then OK CANCEL select CANCEL 2 3 3 SETTING THE TYPE OF BATTERIES It is very important that the type of batteries is correctly configured for the remaining
2. 60 5 2 1 ACTIONS TO BE TAKEN BY THE USER Raid 60 5 2 2 ACTIONS TO BE TAKEN BY QUALIFIED PERSONNEL61 5 3 CORRECTIVE MAINTENANCE 62 ANNEX 1 ELECTROMAGNETIC COMPATIBILITY M 63 ANNEX 2 TROUBLESHOOTING GUIDE 68 534 7AB MU2 e REV 1 07 xopu Index Sleep amp Go User s Manual 534 7AB MU2 REV 1 07 Sleep amp Go User s Manual SAFETY The Sleep amp Go cardiorespiratory polygraph has been developed by the R D i Department of SIBEL S A with the collaboration of reference Health Centers and doctors specialized in the area of Sleep Disorders The Sleep amp Go cardiorespiratory polygraph is designed and manufactured in accordance with the Quality Manual of SIBEL S A which is in consistency with the quality standards EN 13485 and ISO 9001 and European Directive 93 42 EEC concerning medical devices and 2007 47 EC According to this directive the equipment is Class IIa The Sleep amp Go also complies with the EN 60601 1 Electrical Safety and Electromagnetic Compatibility EN 60601 1 2 standards as specified in the ELECTROMAGNETIC COMPATIBILITY annex The Sleep amp Go can transmit data via Bluetooth and therefore follows the Directive 1999 5 EC on radio equipment and telecommunications terminal equipment For other countries complies with FCC rules parts 15c and Canada Industry IC 5123A BGTWT114 The Sleep amp Go also complie
3. Ther thermocouple airflow Color LCD sensor connector Tho thoracic effort band connector Joystick icin Abd abdominal effort band Status LED connector Aux auxiliary channel connector suitable for both snore and limb movement sensors 1 3 2 LEFT PANNEL MicroSD memory card slot ON OFF button 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 1 3 3 REAR PANNEL 08251 Battery cover Battery compartment blocking piece only with 2x AA alkaline or EXG module rechargeable batteries 1 4 INSTALLATION AND START UP This system is made of solid state professional components manufactured under stringent quality controls However accidents may occur during the transportation or storage being convenient an initial checking of the device and accessories 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 equipment 1 4 1 BATTERY PLACEMENT The Sleep amp Go system uses two 1 5V AA batteries You can use alkaline or rechargeable batteries with at least 2450mA h Using smaller capacity batteries diminishes the autonomy The autonomy in normal use is
4. BATTERIES 534 7AB MU2 REV 1 07 o gt doo S ydeasdAjod enuen 5 1251 User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual 4 2 SYMBOLOGY OF THE ACCESORIES 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 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual DDOL m ele uU gt vr Gei SS MANUFACTURING DATE 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 534 7AB MU2 e REV 1 07 1 6 ydevasdAjod enuen 5 1251 Sleep amp Go User s Manual 4 3 VALIDATED ACCESSORIES The Screen amp Go device is used in combination with other medical accessories manufactured by SIBEL S A or by other manufactures We only recommend the use of these access
5. Sleep amp Go User s Manual Sample storage size Input range Thermocouple thoracic effort abdominal effort polygraphic aux ExG channels x3 Airflow pressure transducer CPAP pressure Snoring pressure transducer Pulse rate Oxygen saturation Plethysmographic wave Actimetry Body position Linearity Resp airflow pressure transducer snore pressure transducer Thermocouple thoracic effort abdominal effort polygraphic aux ExG channels x3 actimetry Precision CPAP pressure Pulseoximeter 16 bits per sample 5 mVpp 4 cmH O 3 9 hPa over the cannula aprox 0 20 cmH O 19 6 hPa 0 5 cmH O 0 49 hPa over the cannula aprox 18 300 BPM 1 min 0 100 0 255 aprox 30 mg 300 m s Supine prone left right seated 2cmH O 1 96 hPa See pulseoximeter table 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Fixed hardware filters Thermocouple thoracic effort 0 05 10 Hz abdominal effort Polygraphic aux 0 05 50 Hz ExG channels x3 0 05 250 Hz Airflow pressure transducer 0 05 50 Hz CPAP pressure 0 02 Hz Snoring pressure transducer 30 250 Hz Pulse rate Oxygen saturation Plethysmographic wave Actimetry Body position PC communication interface Bluetooth option Transportation and In operation storage Temperature 59C to 409C Environmental conditions Relative humidity 15 9396
6. Sleep amp GO Manual Revision 534 7AB MU2 Rev 1 07 All rights reserved Please refer to the device s Service Manual for additional information This manual can be purchased through the After Sales Service SIBEL S A Rossell 500 08026 Barcelona Spain National Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00 07 E mail export sibelmed com Technical service Tel 34 93 433 54 50 E mail sat sibelmed com Fax 34 93 436 16 11 Website www sibelmed com SIBEL S A belongs to SIBELGROUP COPYRIGHT No part of this publication may be reproduced transmitted transcribed stored 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 e The place where the systrem is installed or used meets the requirements for electrical installations IEC and other applicable regulations e All repairs revisions or modifications both in and out of the warranty period are made by technical staff of Meditel Ingenier a M dica S L o SIBEL S A e The system is used by qualified staff in accordance with the recommendations stated in this User s Manual BRANDS Bitmed is a registered trademark of Sibel S A 534 7AB MU2 e REV 1 07
7. without condensation Barometric pressure 700hPa to 1060hPa approx 2950 to 350m The conditions may vary in some of the accessories like AgCl electrodes Ref 02646 EXG silver cup electrodes Ref 08701 or Cable for button stud type electrodes Ref 08093 Temperature 209C to 602C Relative humidity 9396 without condensation 534 7AB MU2 e REV 1 07 6 8 enuen 5 1281 User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual 3 2 PULSE OXIMETER TECHNICAL SPECIFICATIONS The pulse oximeter of the unit is based on the technology of NONIN MEDICAL INC Range of values resolution Oxygen saturation 0 100 196 Pulse rate 18 321 1 pulse 0 erroneous value Precision 1 No movement Finger clip sensor adults paediatric 2 digits E 0 2 SPO neonates 3 digits Flexible sensor adults paediatric neonates 3 digits Movement Finger clip sensor adults paediatric 2 digits neonates 3 digits Flexible sensor adults paediatric 3 digits Pulse rate neonates 4 digits Low perfusion All sensors adults paediatric 2d gitos neonates 3 digits No movement 18 300 BPM Finger sensor flexible sensor adults paediatric neonates 3 digits Movement 40 240 BPM Finger clip sensor flexible sensor adults paediatric neonates 5 digits Low perfusion
8. 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 amp Go Make sure the red light in the pulse oximetry sensor switches on when connected to the Sleep amp Go 534 7AB MU2 e REV 1 07 opina Sunoouso qnoa 7 xouuy
9. channel configuration C e To view the channel configuration enabled channels and sampling frequencies select CHANNELS CONF D 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 03 02211 339 13 05 11 92211 332 13 03 NEU TEST DE 02132200 DELETE TEST BACK BACH 93 02 11532 13 09 09 9211 994 13 08 DR LM DURATION Sh 0 E THORA 25Hz VES DELETE E 25Hz TES BACK MOVEMENT 100 2 6 2 3 CHANNEL CONFIGURATIONS he Sleep amp Go may hold up to 10 channel configurations Each configuration stores which of the available device s channels will be acquired as well as the sampling rates for each of them The available sample rates depend on each type of channel Some 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 on this point 2 7 TRANSFER AND REVIEW OF THE TESTS Tests must be transferred to the PC prior to review Several tests may be stored in the memory of the Sleep amp Go before transferring 534 7AB MU2 e REV 1 07 User s Manual Cardiorespiratory polygraph Sleep amp Go Sle
10. environment that allows the patient to sleeping normally The system cannot be used for DIRECT CARDIAC APPLICATION The system is not an electrocardiograph and therefore can not be used to generate a separable ELECTROCARDIOGRAM for diagnostic purposes electrocardiographic monitoring or for ambulatory electrocardiography The EKG signal is only intended for bradycardia and tachycardia detection during sleep analysis As for the electrodes a proper contact of the skin with the electrodes must be achieved by using conductive paste Otherwise there is a risk of inaccurate measurements Avoid contact with the eyes or mucus membranes of gels collodion alcohol acetone or any substance used in the placement or removal of electrodes Be especially 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 amp Go its accessories and its batteries in the household trash It must be disposed of properly and may need to be recycled in accordance with the statutory requirements in your country e Materials according to the RoHS Directive 2011 65 UE Conform from July 22th 2014 The device uses a lithium battery and could use an op
11. 40 240 BPM Finger clip sensor flexible sensor adults paediatric neonates 3 digits Measuring wavelength power Red 660nm 0 8W Infrared 910nm 1 2mW Maximum application time Consult the operating instructions of the pulsioximetric sensor Biocompatibility and toxicity Consult the operating instructions of the pulsioximetric sensor 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 1 All precision specifications were determined from studies of hypoxia induced in healthy adult volunteers of both sexes from Caucasian Indian and African ethnic group 2 Standard Deviation Due to the statistic distribution of the pulse oximeter measurements only about two thirds of the pulse oximeter measurements can be expected to be found within Arms of the value measured by a CO oximeter 3 3 CONDITIONS OF OPERATION AND STORAGE OF ACCESSORIES Although the device and the EXG module stands temperatures between 25 and 70 C the specified temperature range is lower 20 C and 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 Humidity transportation transportation storage storage ECG electrodes Ref lt 93 without 02646 10o 5 conden
12. CHANNEL eC 2 4 SWITCHING ON OFF THE BLUETOOTH MODULE 37 2 5 MAKING POLYGRAPHY TESTS IN ONLINE MODE 39 2 6 MAKING POLYGRAPHY TESTS IN HOLTER MODE 39 2 6 1 STARTING AND ENDING A TEST MANUALLY C Sl 26 2 SCHEDULED TESTS ssaxupMiAuAn RUE AN NUMAE MIR RDUM 40 2 6 2 1 SCHEDULING A TEST IN THE SLEEP amp GO 40 2 6 2 2 DISPLAYING THE SCHEDULED TESTS 42 2 6 2 3 CHANNEL CONFIGURATIONS 43 2 7 TRANSFER AND REVIEW OF THE TESTS 43 2 8 FIRMWARE UPDATE ont 44 2 9 DEVICE OPTIONS UPDATE ean 44 TECHNICAL SPECIFICATIONS 46 SL GENERAL wk vA d REM 46 3 2 PULSE OXIMETER TECHNICAL SPECIFICATIONS 50 3 3 CONDITIONS OF OPERATION AND STORAGE OF ACCESSORIES M errr Em 51 3 4 APPLICABLE STANDARDS t RER 51 4 SYMBOLOGY n REENEN Rand iq 4 1 SYMBOLOGY OF THE SLEEP amp GO 55 4 2 SYMBOLOGY OF THE ACCESSORIES 56 4 3 VALIDATED ACCESSORIES 58 5 CLEANING AND MAINTENANCE 60 D1 RE Ji ps 60 5 2 PREVENTIVE MAINTENANCE
13. EN 1041 2008 Information supplied by the manufacturer of medical devices Electrical and electronic waste e Electrical and electronic equipment and waste management Transposition of the directive WEEE 2002 96 EC System quality e Manufactured according to the SIBEL S A Quality Manual which is compliant with EN ISO 13485 2012 AC 2012 and EN ISO 9001 2008 Risk Management e EN ISO 14971 2012 Radio equipment and communication terminals e EN 300328 v1 7 1 2006 The user should follow e Data protection Directive 95 46 EC 534 7AB MU2 e REV 1 07 Tenuen S 9S 5 01e doo S ydge134jod User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual 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 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 4 SYMBOLOGY 4 1 SYMBOLOGY OF THE SLEEP amp GO SERIAL NUMBER MANUFACTURER manufacture date name and address of the manufacturer E d O BATCH NUMBER REFERENCE CONSULT INSTRUCTIONS FOR USE WARNING START UP STANDBY BF APPLIED PARTS PCP HR NO SPO ALARMS spo IP22 see section WARNINGS AND PRECAUTIONS DISPOSAL OF WASTE ELECTRICAL ELECTRONIC ACORDING TO THE RAEE DIRECTIVE NEUTRAL CONNECTOR
14. PRODUCT IN COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE 93 42 EEC CLASS 0197 Thank you for choosing this product SLEEP amp GO system is designed and manufactured with the best guarantees of quality Applications SLEEP amp 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 e REV 1 07 Index Sleep amp Go User s Manual TABLE OF CONTENTS SAFETY asi viii UDINE TUEREPLEREO DEN EEUU te rrr rer er fe INTENDED USE EE aqu i INDICATIONS FOR USE M 8 LIMITATIONS IN USE CONTRAINDICATION WARNING AND PRECAUTIONS 9 DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION 13 1 INSTRUCTIONS OF INSTALLATION AND USE eee 15 1 1 MODELS RR MARE 15 1 2 PACKING WT TTT 16 1 3 LAYOUT OF CONTROLS INDICATORS AND CONNECTORS TTT 1 3 1 FRONT TOP RIGHT PANNEL Ce 20 1 3 2 LEFT PANNPEL u u nn Ei enin eee NUES eege 20 1 3 3 REAR PANNEL inni oe n CR SEQQ ERR usss eee rer ee 21 1 4 INSTALLATION AND START UP T mes 1 4 1 BATT
15. 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 patient movements RF interference or poor placement of the electrodes or sensors The presence of ESD or RF devices will not lead to wrong conclusions Unusable data is not considered a risk to the patient safety Cables or sensors should not surround the patient s neck especially when the patient is a child The Sleep amp Go system does not increase the safety risk for patients with pacemakers in accordance with the EN50061 standard Medical electrical equipment Safety of implantable cardiac pacemakers Before using the system in patients with pacemakers the operator should check the documents accompanying the pacemaker with respect to its certification and requirements of use and if necessary 534 7AB MU2 e REV 1 07 Ayoyes safety Sleep amp Go User s Manual contact the manufacturer Patients must be insistently warned that they must not open the Sleep amp Go or attempt to adjust it Sensors or accessories in bad condition should not be used Use only the Sleep amp Go with accessories sensors and electrodes provided by the manufacturer or
16. about 12 hours operating in online mode and 24 hours in holter mode 534 7AB MU2 e REV 1 07 01 pdoo S ydvasdAjod enuen 5 1981 User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual The battery compartment is located on the rear panel protected by a cap that needs to be removed to proceed to change the batteries Before opening the battery compartment to replace the batteries please switch off the Sleep amp Go 1 4 2 POWER SAVING MODE To save power the device switches off the display after 50 seconds of inactivity even if it is running a test and the whole device after 5 minutes if the user does not start a test nor interacts with the joystick 1 4 3 BLUETOOTH MODULE INSTALLATION The PC must have enabled and available this type of communication in order to use the Bluetooth link with the Sleep amp Go optional module Install the driver and software for the PC Bluetooth module as detailed in the module user s manual You must then search the Sleep amp Go from the Bluetooth software in Windows and pair the PC with the Sleep amp Go The pairing code corresponds to the last three digits of the Sleep amp Go serial number You will find the serial number on the label on the back of the Sleep amp Go device 1 4 4 PLACEMENT OF SENSORS AND ELECTRODES 1 4 4 1 PLACEMENT OF THE SLEEP amp GO POLYGRAPH The small size and weight of the Sleep amp Go s
17. and damage to the device and or accessories The Sleep amp Go has been designed for being used by a doctor or a technician trained in the acquisition of cardiorespiratory signals and the transmission of these signals to a PC during polygraphic tests The user is allowed to configure the device under these conditions However it is not 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 the patient can understand the instructions given by medical staff The intended environments of use are hospitals sleep centres and sleep clinics Tests may also be carried out at the patient s home with the exception of ExG signals EEG EMG EOG EKG In this case the patient is only authorized to start and stop the test and should be adequately instructed by the doctor on this respect The Sleep amp Go is not designed to be used outdoors nor in other conditions or with energy sources not covered in this manual Using the Sleep amp Go systems does not involve any monitoring or diagnosis of the patient 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual LIMITATIONS IN USE CONTRAINDICATION The in
18. dealer or those that meet the specifications of this manual The use of other sensors with the Sleep amp Go can cause damage to the device or the quality of the signals Sensors should be handled by their strongest parts which are the connectors Also they should not get wet or exposed to very abrupt changes of temperature To clean the sensors do not use abrasive chemicals Do not apply excessive stress to the sensors In 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 equipment Use the provided carrying case when transporting the device and its accessories Do not reuse single use accessories as there is risk of infection to the patient In case of doubt or unexpected event contact the manufacturer You can find contact details on page 2 of this manual The use of nasal cannulas is not recommended in pregnant women or children because they contain phtalates Do not leave the batteries inside the device if it won t be used for a long period of time Ensure to perform the adquisition of signals in an acustic and light 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual
19. 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 condition Adhesive material must not be used if the patient shows an allergic reaction to such material For long term measurements it is recommended to use flexible or disposable sensors The adult sensor is for people over 12 years of age 40 kg The pediatric sensor is for children aged between 5 and 12 years of age 15 40 kg The system can measure the pulse rate and functional oxygen saturation A functional meter can not be used to evaluate the accuracy of a pulse oximetry sensor or a pulse oximetry monitor Do not use blood flow restrictors because they can lead to loss of signal 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 1 4 4 6 BODY POSITION AND ACTIVITY The Sleep amp Go records information aboutthe patient s body position and actigraphy Both sensors are place inside the Sleep amp Go device so no external accessory is needed 1 4 4 7 SNORING SENSOR Apart from the snoring signal obtained from the nasal cannula you may also use a piezoelectric snoring sensor ref 06346 to detect the patient s tracheal sounds during sleep The piezoelectric snoring sensor can be plugged into the connector labeled as Aux if you re not using the limb movement sensor Also you may connect the sensor in any of the channe
20. sensor cable on the chin e Bend the oral probe softly in its position in front of the mouth so that the end of the sensor is exposed to the greatest oral flow possible approximately 1 cm from the mouth The probe should not touch the skin or the lips nor penetrate the oral cavity e Insert the sensor connector in the connector of the Sleep amp Go labeled 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 the room temperature and may also affect the placement of the thermocouple sensor 1 4 4 4 THORACIC AND ABDOMINAL EFFORT BANDS The inductive plethysmography belts refs 01425 01424 01421 01420 01417 supplied with the Sleep amp Go are based in the RIP technology Respiratory Inductive Plethysmography e Strapthe sensor bands around the patient s chest and abdomen over any clothing e Attach the first wire to the snap that is on the same side of the 534 7AB MU2 REV 1 07 0x pdoo S udeasA od enuen s sN User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual band as the Velcro patch e W
21. the battery compartment e Be sure to use AA alkaline or NiMH rechargeable batteries of at least 2450mAh e Make sure you press the power button for at least 3 seconds The PC can not communicate with the device e Make sure you have purchased the Bluetooth option in your Sleep amp Go e Make sure the Sleep amp Go is switched on and the LED on the front panel is lighting e Verify that the Bluetooth option is activated in the Sleep amp Go e 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 e 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 e Inthe case of the electrodes make sure that the skin electrode impedance is good Check the PLACEMENT OF SENSORS AND ELECTRODES section with suggestions on the placement of the electrodes e Check the connection of the ground electrode This electrode plays an important role in signal quality e Twist the wires of the different electrodes to reduce the environmental noise e In the BitmedLab software check that the filters currently selected are appropriate for the type of signal being acquired 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Pulse oximetry signals are null Make sure the pulse oximeter sensor is correctly connected to the patient
22. 1 e PIEZA ANTI APERTURA TAPA BATER AS BATTERY COVER BLOCKING PIECE 2 4 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual RELACION DE CONTENIDO PACKING LIST 534 708 120 REV 4 SCREEN amp GO SLEEP amp GO 2014 06 08085 1 KIT DE ELECTRODOS EEG PARA SLEEP amp GO EEG D SENSOR KIT FOR SLEEP amp GO 08701 1 ELECTRODO CUCHARA ENG PAQUETE 10U EXG GOLD CUP ELECTRODES PACKAGE 10PC 01644 3 CABLE ADAPTADOR 1MM A 1 5MM CABLE ADAPTER 1MM TO 1 5MM 02741 3 PUENTE DE INTERCONEXI N INTERCONNECTION BRIDGE KIT DE ELECTRODOS ECG PARA SLEEP amp GO EKG SENSOR KIT FOR SLEEP amp GO CABLES PARA ELECTRODOS DE CORCHETE PAQUETE 10U CABLES FOR BUTTON STUD TYPE ELECTRODES PACKAGE 10 PC ELECTRODO DE ECG PAQUETE 50 uni ECG ELECTRODE PACKAGE 50 units CABLE ADAPTADOR 1MM A 1 5MM CABLE ADAPTER 1MM TO 1 5MM SENSOR RONQUIDO PIEZOEL CTRICO PIEZOELECTRIC SNORE SENSOR C NULA NASAL DESECHABLE PROTECH PAQUETE DE 60u DISPOSABLE PROTECH NASAL CANNULA PACK OF 60u C NULA ORO NASAL DESECHABLE PROTECH PAQUETE O DE 30u DISPOSABLE PROTECH ORO NASAL CANNULA 40cm PACK 30u C NULA ORO NASAL DESECHABLE SLEEPSENSE PAQUETE DE 5u DISPOSABLE SLEEPSENSE ORO NASAL CANNULA 60cm PACK OF 5u C NULA NASAL DESECHABLE SLEEPSENSE DISPOSABLE SLEEPSENSE NASAL CANNULA BANDA DE SUJECI N TAMANO PEQUE O S FASTENING BELT SMALL SIZE S BAN
23. 1644 for connecting the couple of electrodes to the appropriate channel In order to acquire the EKG signal you must have the ExG module optional ref 08022 Connect the adapter to any of the three ExG channels included in the module Hold the ExG module to the thoracic 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 N 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 internal part of the device that is accessible without the use of a tool For this reason use the piece 08251 battery cover blocking piece on the battery cover when using the electrodes and the EXG Module 1 4 4 10 EMG EOG AND EEG ELECTRODES We recommend using the cup electrodes ref 08701 provided by the manufacturer If you are using other electrodes please carefully read the instructions before using them and make sure they are compatible with the Sleep amp Go system 534 7AB MU2 e REV 1 07 o gt doo S ydevasdAjod enuen 5 1981 CI OD e Sleep amp Go h poly ardiore Manual User s Sleep amp Go User s Manual The following steps should be taken to place these cup electrodes P
24. B MU2 e REV 1 07 Ayayes safety Sleep amp Go User s Manual The system is only resistant to moderate splashing and dripping Protection level IP22 protection against access to hazardous parts with a finger protected against solid objects with a diameter of 12 5 mm and above protected against water drops falling vertically with a maximum inclination of 15 degrees of the envelope Do not submerge the parts of the device in any liquid MAY CAUSE ELECTRIC DISCHARGE No parts are allowed for temporary immersion The cleaning instructions in this manual and also in the instructions of use of any sensor supplied but not manufactured by SIBEL S A must be carefully followed Keep your device protected from shock and vibration During transportation place all the items in the carrying case The material provides enough protection against small accidental impact 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 conditions or energy sources that are not covered in this manual The Sleep amp Go is not protected against defibrillation shocks Therefore never use a defibrillator on
25. DA DE SUJECI N TAMANO EXTRA GRANDE XL FASTENING BELT XTRA LARGE SIZE XL BANDA INDUCTIVA EL STICA TAMANO PEQUENA S ELASTIC INDUCTIVE BAND SMALL SIZE S BANDA INDUCTIVA EL STICA TAMANO MEDIANA M ELASTIC INDUCTIVE BAND MEDIUM SIZE M BANDA INDUCTIVA EL STICA TAMANO GRANDE L ELASTIC INDUCTIVE BAND LARGE SIZE L BANDA INDUCTIVA EL STICA TAMANO EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL 01417 BANDA INDUCTIVA EL STICA TAMANO EXTRA EXTRA GRANDE XXL ELASTIC INDUCTIVE BAND XTRA XTRA LARGE SIZE XXL 08701 1 ELECTRODO CUCHARA ORO EXG PAQUETE 10 EXG EN GOLD CUP ELECTRODES PACK OF 10u 08093 1 CABLES PARA ELECTRODOS DE CORCHETE PAQUETE DE 10u CABLES FOR BUTTON STUD TYPE ELECTRODES 10 01027 1 ELECTRODO DE PAQUETE DE 50u ECG ELECTRODE PACK OF 50u ESTANDAR OPCIONAL NO DISPONIBLE STANDARD OPTIONAL NOT AVAILABLE 3 4 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual RELACI N DE CONTENIDO PACKING LIST 534 708 120 REV 4 SCREEN amp GO SLEEP amp GO 2014 06 ADVERTENCIA LOS ART CULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS EN CASO DE FALTAS O DESPERFECTOS PROCEDAN A COMUNIC RNOSLO LO MAS PRONTO POSIBLE SI DETECTA CUALQUIER DANO EN EL EMBALAJE CONTACTE CON SU DISTRIBUIDOR ANTES DE PROCEDER A LA INSTALACI N DEL EQUIPO NO SE DEBE DESPRENDER DE LOS EMBALA
26. ERY PLACEMENT EAM MASA MAS 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 amp GO POLYGRAPH 22 1 4 4 2 NASAL CANNULA De 1 4 4 3 THERMOCOUPLE AIRFLOW SENSOR 11 24 1 4 4 4 THORACIC AND ABDOMINAL EFFORT BANDS 25 1 2145 PULSE EES KEEN 26 1 4 4 6 BODY POSITION AND 29 1 4 4 7 SNORING SENSOR Cee 29 1 4 4 8 LIMB MOVEMENT SENSQOR 30 1 4 4 9 EKG ELECTRODES Ee 30 1 4 4 10 EMG AND EEG ELECTRODES 31 1 4 4 11 EVENT sx ME ME 33 z DPERATIOB TN eege 34 2 1 WORKING MODES 34 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 2 2 SYSTEM CONFIGURATIDON 35 2 3 INITIAL DEVICE SETUP ATTI LET 36 2 3 1 SETTING THE DATE AND 36 2 3 2 SETTING THE LANGUAGE KENE R M 36 2 3 3 SETTING THE TYPE OF BATTERIES 37 2 3 4 SETTING THE UNITS OF THE CPAP
27. JES BOLSAS ETC HASTA QUE VERIFIQUE TOTALMENTE EL CORRECTO FUNCIONAMIENTO DEL EQUIPO EN CASO DE DEVOLUCI N DE MATERIAL O EQUIPO EN DEPOSITO ROGAMOS NOS LO ENV EN EN PERFECTO ESTADO COMPLETO DE ACCESORIOS Y DEBIDAMENTE EMBALADO CUALQUIER DESPERFECTO OCASIONADO PROVOCAR A UN CARGO CORRESPONDIENTE EN LA REPARACI N O EN LA REPOSICI N 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 THE PACKAGING CONTACT WITH YOUR DISTRIBUTOR BEFORE PROCEEDING TO INSTALL IT DO NOT THROW AWAY THE PACKAGING BAGS ETC UNTIL THE CORRECT FUNCTIONING OF THE DEVICE IS VERIFIED IN THE CASE OF RETURNING THE GOODS IT WILL BE APPRECIATED THAT YOU SEND THE DEVICE IN PERFECT ORDER WITH ALL THE ACCESSORIES AND PROPERLY PACKAGED ANY DAMAGE SUFFERED WILL MAKE A CHARGE CORRESPONDING TO REPAIR OR NEW PARTS PREPARADO PREPARED 4 4 534 7AB MU2 e REV 1 07 0x pdoo S ydevasdAjod enue 6 125 xO oraph Sleep amp C Oo s tory poly User s Manual Cardiorespir Sleep amp Go User s Manual 1 3 LAYOUT OF CONTROLS INDICATORS AND CONNECTORS 1 3 1 FRONT TOP RIGHT PANNEL SpO XPod pulse oximeter connector ExG ExG module connector Nasal cannula nasal cannula connector Erw
28. METR A ADULTOS PARA SCREEN amp GO SLEEP amp GO Canales SPO BPM ADULT PULSE OXIMETRY KIT FOR SCREEN amp GO SLEEP amp GO Channels 5 BPM 08098 1 MODULO PULSIOXIMETRIA XPOD XPOD PULSE OXIMETRY MODULE 08012 1 SENSOR PULSIOXIMETRIA SOFT ADULTO SOFT PULSE OXIMETRY SPO SENSOR ADULT 07677 1 MU EQUERA DE SUJECI N WRISTBAND 08069 1 KIT DE PULSIOXIMETR A PEDI TRICO PARA SCREEN amp GO SLEEP amp GO Canales SPO BPM PEDIATRIC PULSE OXIMETRY KIT FOR SCREEN amp GO SLEEP amp GO Channels SpO BPM 08098 1 e MODULO PULSIOXIMETRIA XPOD XPOD PULSE OXIMETRY MODULE 08013 1 SENSOR PULSIOXIMETRIA SOFT PEDI TRICO SOFT PULSE OXIMETRY SPO SENSOR PEDIATRIC 07677 1 e MUNEQUERA DE SUJECI N WRISTBAND 08078 1 OPCI N FIRMWARE CANAL DE RONQUIDO POR PRESI N PRESSURE SNORING CHANNEL FIRMWARE OPTION 08079 1 OPCI N FIRMWARE CANAL DE POSICI N CORPORAL BODY POSITION CHANNEL FIRMWARE OPTION 08080 1 OPCI N FIRMWARE CANAL DE ACTIGRAF A ACTIGRAPHY CHANNEL FIRMWARE OPTION 08081 1 OPCI N FIRMWARE CANAL DE MARCAS DEL PACIENTE PATIENT S MARKS CHANNEL FIRMWARE OPTION 08082 1 OPCI N FIRMWARE CANAL DE PRESI N CPAP CPAP PRESSURE CHANNEL FIRMWARE OPTION 08083 1 OPCI N FIRMWARE CANAL DE ONDA DE PULSO PULSE WAVE CHANNEL FIRMWARE OPTION 08084 1 OPCI N FIRMWARE M DULO BLUETOOTH BLUETOOTH MODULE FIRMWARE OPTION 08022 1 M DULO DE SENSORES EXG EXG SENSOR MODULE 08251
29. RA POR SEPARADO WHEN THE REFERENCE 08089 IS SUPPLIED WITH A SCREEN SLEEP amp GO DOES NOT INCLUDE REFERENCE 01420 PACK OF 2 BAND INDUCTIVE SIZE XL SINCE IT IS ALREADY INCLUDED IN THE REFERENCE 08088 THE REFERENCE 01420 IS INCLUDED ONLY IF THE MODULE 08089 IS DELIVERED SEPARATELY 1 4 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual RELACI N DE CONTENIDO PACKING LIST 534 708 120 REV 4 SCREEN amp GO SLEEP amp GO 2014 06 PILAS ALCALINAS AA 1 5V AA 1 5V ALKALINE BATTERY MALET N TRANSPORTE SCREEN amp GO CARRYING CASE SCREEN amp GO MALET N TRANSPORTE SLEEP amp GO CARRYING CASE SLEEP amp GO 08070 CD SOFTWARE BITMEDLAB CON LICENCIA 1 CD BITMEDLAB SOFTWARE WITH LICENSE 03673 2 08011 1 08010 1 1 MANUAL DE USO USER S MANUAL MEM Doc 534 740 MU 08072 1 e M DULO BASE DE DATOS DATABASE MODULE 08071 1 M DULO ANALISIS AUTOM TICO EVENTOS AUTOMATIC EVENTS DETECTION MODULE 1 SCREEN amp GO MANUAL DE USO SCREEN amp GO USER S MANUAL Doc 534 70S MU 1 SLEEP amp GO MANUAL DE USO SLEEP amp GO USER S MANUAL Doc 534 7AB MU 1 GU A R PIDA SCREEN SLEEP amp GO SCREEN SLEEP amp GO QUICK GUIDE Doc 534 7AB GR Accesorios Opcionales Optional Accessories 08094 1 LECTOR TARJETAS MEMORIA USB PARA PC USB MEMORY CARD READER FOR PC 08073 1 M DULO BITMED VISION PARA BITMEDLAB BITMED VISION MODULE FOR BITMEDLAB 06976 1 KIT DE PULSIOXI
30. RFACE e BANDA INDUCTIVA EL STICA TAMA O EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL ANILLA SUJECI N FASTENING RING M DULO DE ESFUERZO ABDOMINAL INDUCTIVO PARA SLEEP amp GO INCLUYE ACTIVACI N DEL CANAL INDUCTIVE ABDOMINAL EFFORT MODULE FOR SLEEP amp GO INCLUDES CHANNEL ACTIVATION INTERFAZ DE AMPLIFICACI N BANDA INDUCTIVA ESFUERZO ABDOMINAL ABDOMINAL EFFORT INDUCTIVE BAND AMPLIFICATION INTERFACE BANDA INDUCTIVA EL STICA TAMA O EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL ANILLA DE SUJECI N FASTENING RING CANAL AUXILIAR MOVIMIENTO EXTREMIDADES PARA SLEEP amp GO INCLUYE ACTIVACI N DEL CANAL AUXILIARY CHANNEL LIMB MOVEMENT FOR SLEEP amp GO INCLUDES CHANNEL ACTIVATION KIT SENSOR MOVIMIENTO EXTREMIDADES LIMB MOVEMENT SENSOR KIT 08091 06346 CANAL AUXILIAR RONQUIDO PARA SLEEP amp GO INCLUYE ACTIVACI N DEL CANAL AUXILIARY CHANNEL SNORING FOR SLEEP amp GO INCLUDES CHANNEL ACTIVATION e SENSOR RONQUIDO PIEZOEL CTRICO PIEZOELECTRIC SNORE SENSOR 08060 TARJETA MEMORIA MICRO SD CON ADAPTADOR SD MICROSD MEMORY CARD WITH SD ADAPTER CUANDO SE ENTREGA LA REFERENCIA 08089 JUNTO CON UN SCREEN SLEEP amp GO NO SE INCLUYE LA REFERENCIA 01420 PAQUETE DE 2 BANDAS INDUCTIVAS TAMA O XL PUESTO QUE YA EST INCLUIDA EN LA REFERENCIA 08088 LA REFERENCIA 01420 SE INCLUIR S LO SI EL M DULO 08089 SE SUMINIST
31. SIBEL Manufacturer reference reference ELASTIC INDUCTIVE BAND XTRA STARRING 01417 9002 L150 XTRA LARGE SIZE XXL LIMB MOVEMENT SENSOR KIT SUE PING 06310 1770S KIT BI PIEZOELECTRIC SNORE SENSOR S P INC 06346 12505581 EXGGOLD CUP ELECTRODE GRASS 08701 F E5GH 30 PACKAGE 10PC TECHNOLOGIES CABLE ADAPTER 1MM TO 1 5MM PLASTICS ONE INC 01644 249497X04010XXX INTERCONNECTION BRIDGE PLASTICS ONE INC 02741 455455X01010XXX CABLE FOR BUTTON STUD TYPE SPES MEDICA S R L 200095 S2231050261 ELECTRODES PACKAGE 10PC ECG ELECTRODE PACKAGE 50PC DELE 01027 534 7AB MU2 REV 1 07 00 27 9991 ydvasdAjod enuen 5 1981 Annex 1 Electromagnetic compatibility Sleep amp Go User s Manual 5 CLEANING AND MAINTENANCE The Sleep amp Go polygraph requires like any electronic equipment a maintenance in order to e Ensure the safety of the patient the operator and its environment e Ensure the reliability and accuracy of the functions for which the Sleep amp Go was developed 5 1 CLEANING To clean the unit and its accessories excluding the sensors and electrodes use a damp cloth and mild hand soap To disinfect the device you can use alcohol ethyl or isopropil Do not use other chemical products or detergents for domestic use Please read carefully the SAFETY section Properly dispose the disposable sensors and single use electrodes immediately after use Nasal cannulas are s
32. 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 Otherwhise no icon is displayed The blue Bluetooth logo indicates that the module is on while the green logo means that data is being transmitted to the PC A 29 92 11 12 29 29 92 11 12 38 rer SCHEDULED TEST E F CHANNELS CONF 7 S MANUAL SYSTEM BACK START CONFIG GATE E 0992 11 62524 12 45 CUSTOMIZE M MAINTENANCE TURM OFF BLUETOOTH BACK CANCEL 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 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 amp 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 TES
33. Sleep amp Go cardiorespiratory polygraph is available in two different models A and B with the following features Sleep amp Go Nasal cannula Inductive plethysmography band abdominal External snore Auxiliary channel y Limb movements External Xpod Bluetooth real time tests un Default EN Option 534 7AB MU2 e REV 1 07 012p doo S 12 enuen 5 125 Sleep amp Go User s Manual 1 2 PACKING LIST RELACI N DE CONTENIDO PACKING LIST SCREEN amp GO SLEEP amp GO 534 708 120 REV 4 2014 06 MODELOS MODELS C DIGO CANT DESCRIPCI N SLEEP amp GO CODE QTY DESCRIPTION SCREEN amp GO POL GRAFO POLYGRAPH 1 SCREEN amp GO SLEEP amp GO SN 347 Accesorios Est ndar Standard Accessories 06312 BANDA DE SUJECI N TAMANO GRANDE L FASTENING BELT LARGE SIZE L 08049 C NULA DESECHABLE NASAL DISPOSABLE NASSAL CANNULA 08087 06309 M DULO TERMOPAR INCLUYE ACTIVACI N DEL CANAL THERMOCOUPLE MODULE INCLUDES CHANNEL ACTIVATION e SENSOR TERMOPAR THERMOCOUPLE SENSOR 08088 06314 01420 07678 06310 M DULO DE ESFUERZO TOR CICO INDUCTIVO INCLUYE ACTIVACI N DEL CANAL INDUCTIVE THORACIC EFFORT MODULE INCLUDES CHANNEL ACTIVATION INTERFAZ DE AMPLIFICACI N BANDA INDUCTIVA ESFUERZO TORACICO THORAX EFFORT INDUCTIVE BAND AMPLIFICATION INTE
34. TS 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 the ON OFF button for 3 seconds B option or hold down 534 7AB MU2 e REV 1 07 6 ydevasdAjod enuen s sN Sleep amp Go User s Manual A FER oe ee 20 0212 99 25 56 PRESSURE AIRFLOW BATTE RY dl MEMORY 1880HB 398 START T M T REC xd 2 6 2 SCHEDULED TESTS The Sleep amp Go is built with an internal clock suitable for scheduling new tests in holter mode at certain dates and times which also end at the right time as programmed by medical personnel In this way t
35. To place pulse oximeter sensor follow these steps Place the wristband provided in the patient s wrist and insert the XPod module into the socket Insert a finger preferably the index finger in the sensor until the finger tip reaches the stop It is not recommended to place this sensor in the thumb Keep the fingernail of the patient pointing toward the top side of the sensor Make sure that long fingernails do not interfere with the adequate positioning of the finger To obtain the best results fasten the cable to the finger using surgical tape preferably around the base of the finger Make sure that the tape fastening the cable does not restrict blood circulation Take the cable coming out of the wristband over the arm and connect it to SpO of Sleep amp 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 measurements and readings Remove nail polish or artificial nails before applying the sensor as they could cause incorrect readings The sensors cannot be sterilized Do not submerge the sensors in liquid The sensors must be disconnected from the Sleep amp Go prior to cleaning or disinfection The
36. a patient connected to a Sleep amp Go system Do not use an electric scalpel or a high frequency surgical device while the patient is connected to any sensors or electrodes of the Sleep amp Go The use of mobile phones transmitters and similar equipment generating radio frequency emissions and placed next to the system is not allowed during the tests Therefore do not use the system in the presence of radio equipment mobile phones walkie talkie Follow the recommendations regarding the separation 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual distance specified in the manufacturer s declaration for EMC in this manual Remember that when multiple devices are connected to a patient there is a risk of accumulation of leakage current Minimize the number of devices Do not remove the device cover The service and repair of the device should be carried out only by trained personnel The Sleep amp Go system is prepared to work at room temperature Avoid exposing any part of the system to heat sources Also avoid direct exposure to sunlight Temperature changes cause condensation and moisture Before using the system allow the device to acclimate to ambient temperature For reference if the temperature difference between the system and the environment is above 109 C a 20 minutes wait time in an intermediate temperature is recommended The polygraph should not be placed adjacent to or stacked with other equipment
37. amp GO is designed to be used in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the SCREEN amp GO SLEEP amp GO can help to prevent interferences by keeping a minimum distance between mobile and portable RF communications units transmitters and the SCREEN amp GO SLEEP amp GO as recommended below according to the power output of the communications unit Maximum Separation distance depending on the transmitter frequency power m output of the opina Sunoouso qnoa 7 xouuy transmitter From 800 MHz to 2 5 GHz 3 5 dui P From 150 kHz to 80 MHz 3 5 dei P From 80 MHz to 800 MHz bee p W For transmitters with a maximum power output not listed above the recommended separation distance d in metres m can be estimated using the applicable equation according to the transmitter frequency where P is the maximum power of the transmitter in watts W according to the manufacturer of the transmitter Note 1 At 800 MHz apply the highest frequency margin Note 2 These recommendations may not apply in all possible situations Electromagnetic propagation is affected by the absorption and reflection of structures objects and persons 534 7AB MU2 e REV 1 07 Annex 2 Troubleshooting guide Sleep amp Go User s Manual ANNEX 2 TROUBLESHOOTING GUIDE The Sleep amp Go does not start e Make sure the batteries are placed according to the polarity in
38. battery life information to be displayed properly Alkaline or rechargeable Nickel Metal Hydride minimum 2450mAh AA batteries should be used In the CUSTOMIZE screen follow these steps e Select BATTERY or MORE 397 12 35 OPTIONS gt BATTERY in case the CPAP channel is available e Use and to select the type of Hi MH batteries used in the device The of batteries is marked with the mark e When finished select OK If you want to cancel setting the type of SEMIS batteries then select CANCEL 2 3 4 SETING THE UNITS OF THE CPAP CHANNEL Select MORE OPTIONS Select BATTERY Select CPAP UNITS Select cmH O or hPa and press OK If you want to cancel the setting select CANCEL 2 4 SWITCHING ON OFF THE BLUETOOTH MODULE The Bluetooth module can be turned on and off at any time in order to reduce battery consumption and increase the battery life You need to switch on the Bluetooth module when making real time tests online mode If you are making holter tests there is no need of keeping the module powered 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual The Bluetooth module is supplied by default in the Sleep amp Go B Model and is optional in the A Model To switch on off the Bluetooth module follow these steps With the Sleep amp Go in the home screen make the following keystrokes with the joystick y v 4 4 The screen changes and displays a new icon
39. edical electrical systems used in the home healthcare environment EMC e EN 60601 1 2 2007 AC 2010 EMC in medical devices No life support See Annex 1 Electromagnetic compatibility Software e EN 62304 2006 AC 2008 Medical device software Software life cycle processes Usability e EN 60601 1 6 2010 Medical Electrical Equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability e EN 62366 2008 Medical Devices Application of usability engineering to medical devices Pulse oximetry e ISO 80601 2 61 2011 Special requirements for basic safety and essential operation characteristics of pulse oximeters for medical use 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Biocompatibility e EN ISO 10993 1 2009 AC 2010 Biological evaluation of medical devices Vibration and temperature e Levels according to EN 60601 1 11 2010 covers ISO 80601 2 61 e Tests according to EN 680068 2 27 1993 and EN 680068 2 64 1994 Environmental conditions e Levels and tests according to EN 60601 1 11 2010 Symbology e EN ISO 15223 1 2012 and EN 980 2008 Symbols to be used with medical device labels labelling andi nformation to be suplplied Packaging and labelling e Packaging and packaging waste directive 94 62 EC e Regulation EC 1272 2008 on classification labelling and packaging of substances and mixtures REACH Information supplied by the manufacturer e
40. eep amp Go is available in two different models with increasing features The available channels may be expanded though In case new features are 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual purchased please follow these steps in order to update your device The Technical Service will provide one file to be copied to the MicroSD memory card of the Sleep amp Go Insert the memory card in the Sleep amp 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 amp Go switches off automatically Your device is already updated and the new channels are available from now on 534 7AB MU2 e REV 1 07 6 ydevasdAjod enuen 5 128 User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual 3 TECHNICAL SPECIFICATIONS 3 1 GENERAL DATA Useful life for Sleep amp Go and ExG module Useful life for Xpod pulseoximeter module 2x AA alkaline batteries or AA NiMh rechargeable Battery type battery life batteries 2450mAh minimum 12h in online mode 24h in holter mode Enclosure protection degree IP22 Device classification EN60601 1 Class internally powered Type BF applied parts not protected against defibrillator Input impedance 20MW CMRR common mode rejection S95dB ratio Signal input connectors Pr
41. ep amp Go User s Manual them to the PC Transferring the test immediately after it is finished is not necessary In order to transfer the tests to the PC extract the MicroSD memory card from Sleep amp Go and insert it into your PC s card reader Most computers are supplied by default with a memory card reader If your computer does not have one you can use an USB card reader After inserting the memory card in your PC run the BitmedLab software and download the tests as explained in the software s manual The tests are automatically deleted from the memory card when they are transferred to the PC Do not delete the files in the memory card before downloading the tests to the PC 2 8 FIRMWARE UPDATE Over time new versions of the program managing the Sleep amp Go firmware might be released either to improve the operation of the equipment or to add new features e he Technical Service will provide one or several files to be copied to the MicroSD memory card of the Sleep amp Go e Insert the memory card in the Sleep amp Go and switch it on e The firmware update starts automatically When prompted confirm that you want to update the firmware e When the update is complete the Sleep amp Go switches off automatically Your device is already updated e n case you are provided with several files the process will be repeated as many times as needed 2 9 DEVICE OPTIONS UPDATE As mentioned in paragraphs 1 2 and 1 3 the Sl
42. essure transducer airflow snoring CPAP pressure LUER connector Thermocouple thoracic effort abdominal effort polygraphic auxiliary ExG channels x3 1 mm key connector Pulse oxymeter Specific 3 pin connector Actimetry Internal Body position Internal Event marker Joystick 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Storage sampling rate software selectable Airflow pressure transducer Snoring pressure transducer CPAP pressure Thermocouple Thoracic effort Abdominal effort Polygraphic aux ExG channels x3 Pulse rate Oxygen saturation Plethysmographic wave Actimetry Body position Event marker Resolution Airflow pressure transducer snore D UE transducer thermocouple thoracic effort abdominal effort polygraphic aux ExG channels x3 actimetry Pulse rate oxyen saturation plethysmographic wave Body position Event marker CPAP pressure Selectable 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 12 bits 8 bits 8 bits 1cmH 0 or 1hPa 534 7AB MU2 oDd ydeasdAjod enuen ssn User s Manual Cardiorespiratory polygraph Sleep amp Go
43. hannels To place a limb movement sensor follow these steps Place the sensor in the wrist inner side of the wrist over the tendons or the patient s ankle front side of the ankle in an area that provides the maximum movement signal 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 amp 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 02646 provided by the manufacturer If you are using other electrodes carefully read the instructions before using them and make sure they are compatible with the Sleep amp Go system The following steps should be taken to place these electrodes Prepare the area where the electrodes are to be placed The skin must be cleaned adequately using abrasive paste This allows a good contact impedance typically less than 10K 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Attach the electrode to the patient s skin by removing the electrode film that protects the adhesive Place one electrode on each collar bone Connect the cables ref 08093 to the button stud connectors in the electrodes Use a wire adaptor with 2 1 5mm TouchProof connectors to 1mm key connector ref 0
44. he patient does not have to interact at all with the Sleep amp Go for starting or ending the test You can schedule up to 5 consecutive tests These tests may be scheduled right from the Sleep amp Go device or by using the BitmedLab software in the PC This manual describes the programming procedure in the Sleep amp Go Refer to the software manual for information on the programming process in BitmedLab 2 6 2 1 SCHEDULING A TEST IN THE SLEEP amp GO e Switch on the Sleep amp Go and gain access to the setup mode by making the following keystrokes on the joystick one after another and leaving a short interval of time between each of them y v 4 e Select the SYSTEM CONFIG icon and press the joystick to move to the setup screen e Select SCHEDULED TESTS A e Select NEW TEST B e Select the DATE field and set the starting date for the test Select OK when finished C D 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Select the TIME field and set the starting time for the test Select OK when finished E Move to the DURATION field and enter the number of hours and minutes for the test F Select the option CHANNELS CONF The device displays all channel configurations stored on the memory card A channel configuration establishes 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
45. hile holding this end to the left of the patient s center line wrap the e of a band around the patient s chest or 742 e Pull the other end over the first end and secure the band on the right side of the center line The band should be snug but not too tight e Attach the second wire to the exposed snap Make the connection and disconnection of the snaps with the interface box disconnected from the computer e Make sure the box in the cable that goes to the chest band is labeled as Chest ref 06314 and the one going to the abdominal band is labeled as Abd ref 06308 e Insert the connector from each the respiratory effort belt in the corresponding input connector of the Sleep amp Go labeled as Thor for the thoracic belt and Abd to the abdominal belt e 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 pulse wave as well as the measurement of the pulse rate and the functional oxygen saturation based on the technology developed by Nonin Medical Inc The external pulse oximeter named XPod ref 08098 is to be connected on the top side of the device The SpO sensor is to be connected on the free end Pay special attention to the sensor being used Please consult the manufacturer before using non recommended sensors 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual
46. 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 amp Go The device will start automatically the test at the designated date and time The screen will light for 50 seconds displaying the signals acquired by the sensors The front panel LED will blink during the whole test 09 02711 12158 sss 2 SHOW TEST DELETE TEST BACK A EC OESTHSESS ESL MM CHANNELS CONF MORE OPTIONS BACK C TIME DURATION CHANNELS CONF SAVE 39 43 02 zio FETCEETIT CANCEL 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 09 02711994 13 02 09 22 11 gg 13 03 WE EE A CANCEL CANCEL 12 085 104 5 324 Jorde POLI SCREENIN TERHOPAR OK CANCEL 2 6 2 2 DISPLAYING THE SCHEDULED TESTS You can see the scheduled tests in the Sleep amp Go up to a maximum of 5 tests e Switch on the Sleep amp Go and enter the setup mode by making the following keystrokes with the joystick y v 4 4 e Select the SYSTEM CONFIG icon and press the joystick to move to the setup screen e Select SCHEDULED TEST e Select SHOW TEST A e All scheduled tests are displayed For more info on any scheduled test select it B e The screen shows the programming data of the test onset date and time duration
47. 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 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual ANNEX 1 ELECTROMAGNETIC COMPATIBILITY Manufacturer s guide and statement electromagnetic emissions The SCREEN amp GO SLEEP amp GO is designed to be used in the electromagnetic environment specified below The customer or user must ensure that it is used within this environment Emissions Test Compliance level Radiated RF Emissions Group 1 CISPR 11 EN 55011 Class B Conducted RF Emissions Not applicable CISPR 11 EN 55011 Harmonic Emissions Not applicable EN IEC 61000 3 2 Flicker and tension fluctuations Not applicable EN IEC 61000 3 3 Guide Electromagnetic environment The SCREEN amp GO SLEEP amp GO uses RF energy only for internal use Therefore its emissions are very low and unlikely to cause any interference to nearby electronic devices Ayyiqneduros onouSeurodjoo q x uuv The SCREEN amp GO SLEEP amp GO runs on batteries The SCREEN amp GO SLEEP amp GO runs on batteries The SCREEN amp GO SLEEP amp GO runs on batteries 534 7AB MU2 e REV 1 07 Annex 1 Electromagnetic compatibility Sleep amp Go User s Manual Manufacturer s guide and statement electromagnetic immuni
48. ingle 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 disinfection of sensors and electrodes please refer to the information provided by its manufacturer All sensors should be cleaned properly after each use and before use in a new patient 5 2 PREVENTIVE MAINTENANCE Preventive maintenance consists of all actions needed to keep the equipment in good working order 5 2 1 ACTIONS TO BE TAKEN BY THE USER Check periodically that all cables external accessories and other 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual items are in perfect condition not broken and with no external damage Pay special attention to the cables and connectors It is also advisable from time to time to start a test and check that the connected sensors respond correctly If you detect any problems that you can not solve please get in contact with the customer service of SIBEL S A or your distributor for servicing and repair You can also check the Known abnormalities report 534 701 MU2 available to the user from SIBEL S A 5 2 2 ACTIONS TO BE TAKEN BY QUALIFIED PERSONNEL The Medical Device Directive 93 42 EEC recommends the regular servicing and or calibration to ensure the reliability of the medical devices and the safety of patients users a
49. ion and so on 534 7AB MU2 e REV 1 07 0x pdoo S udeisS od enuen ssn 0 C ana O e leen N le C J ON Le praph grap U atory Cardiore spir Sleep amp Go User s Manual 2 OPERATION The Sleep amp Go is fitted with a color screen and a joystick to interact with the options exposed by the device s software The top part of the screen displays an info bar with the device status at any time Free spacein Battery memory card status This is the screen displayed when the Sleep amp Go is switched on 1944241 99 12 27 BATIERT lt MEMORY 1880HB 239h MANUAL START This screen displays status information and enables starting a new test in holter 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 A 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 amp Go stores the tests in a memory card Later the tests are transferred to the computer for evaluation It is designed for home use or at the hospital or clinic There are two ways of starting a test in holter mode 534 7AB MU2 e REV 1 07 Sleep amp Go User
50. ls provided by the ExG module optional 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 piezoelectric snoring sensor follow these steps e Tell the patient to imitate a snore while you place your fingers slightly off centre upon the throat Try to select a point where the greatest vibration related to the snoring sound is produced e Do not place the sensor directly over the larynx e Place the sensor with the flattest part in contact with the skin and secure it with surgical tape e Insert the snoring sensor connector into the corresponding input of the Sleep amp Go Aux connector or any connector in the ExG module 534 7AB MU2 e REV 1 07 0x pdoo S ydeasdAjod Kiopjgaids rorpigO enuen 5 1981 User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual 1 4 4 8 LIMB MOVEMENT SENSOR The limb movement sensor ref 06310 is used to detect the movements of the patient s limbs during sleep The limb movement sensor is to be connected to the Aux connector However if you purchased the ExG module you may also connect the sensor to any of its c
51. n contact with the patient the technician must not touch any internal part of the device that is accessible without the use of a tool For this reason use the piece 08251 battery cover blocking piece on the battery cover when using the electrodes and the EXG Module In addition to the aforementioned explanations the following precautions and considerations should be taken into account while 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual using the electrodes The conductive part of the electrodes and connectors must never touch other conductive parts including the earth connection To prevent the risk of burns all electrodes must be removed from the patient before using a high frequency HF surgical unit When several devices are connected to a patient there is a risk of accumulating 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 simply pressing the joystick for at least 3 seconds After these 3 seconds the screen lights on and the mark is registered These marks are used to indicate certain events such as the patient getting up to the bathroom taking medicat
52. n each margin of frequency b Interferences may appear in the vicinity of units marked with this symbol t Note 1 At 80 MHz and 800 MHz apply the highest frequency margin Note 2 These recommendations may not be applicable in all possible situations Electromagnetic propagation is affected by the absorption and reflection of structures objects and persons 534 7AB MU2 e REV 1 07 Annex 2 Troubleshooting guide Sleep amp Go User s Manual a he field intensities emitted by permanent transmitters such as base stations for radiotelephones mobile cell phones wireless and mobile radios amateur radio operators AM FM radio and TV transmissions cannot be theoretically calculated with any accuracy 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 amp GO SLEEP amp GO is normal Otherwise additional measurements such as the reorientation or change in placement of the SCREEN amp GO SLEEP amp GO may be necessary b Above the frequen ange from 150 kHz to 80 MHz the field intensi 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Recommended separation distances between mobile and portable RF communications units and the SCREEN amp GO SLEEP amp GO The SCREEN amp GO SLEEP
53. nd the environment The general technical verification of safety systems settings and features being part of the device must be made according to the Procedure of Verification and Adjustment for the Sleep amp 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 responsible for malfunction or damage to the equipment resulting from poor maintenance done by personnel not certified in writing or belonging to SIBEL S A Accessories and spare parts should always be original and requested to the manufacturer or authorized dealer to ensure the proper functioning of the polygraph Periodic functional and metrological verification is necessary to ensure the operation of equipment over the life of the product The manufacturer recommends annual inspections by an authorized service center and in any case not exceeding two years according to the verification and adjustment procedures specified by the manufacturer and applied during the manufacture of the equipment 534 7AB MU2 e REV 1 07 Annex 1 Electromagnetic compatibility Sleep amp Go User s Manual 5 3 CORRECTIVE MAINTENANCE Corrective maintenance is the process of leaving the device
54. operation of the oximeter sensor may be affected by the presence of strong room lighting If necessary the sensor area must be protected e g with surgical tape The oximeter may not be capable of detecting minimal values of saturation with the same degree of accuracy and precision as the maximum values of saturation It is also possible that it can 534 7AB MU2 e REV 1 07 5 195 doo S ydveasdAjod User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual not quantify the degree of existing hyperoxemia Interferences such as movements abnormal hemoglobins intravascular contrasts states of low perfusion and skin pigmentation may affect the operation of the pulse oximeter It is unlikely that organisms are transmitted via pulse oximetry However we recommend washing the pulse oximetry sensor for each change of patient with soapy water or disinfectant solution as specified by the manufacturer The pulse oximetry module and the pulse oximetry probe is CE marked The temperature of the area of the probe in contact with the finger will not reach temperatures 42 9 See the instructions for use before use Strictly follow the manufacturer 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
55. ories for proper operation of the equipment see section 1 2 PACKING LIST The sensors used by other manufacturers are User s Manual Cardiorespiratory polygraph Sleep amp Go Accessory SIBEL Manufacturer reference reference THERMOCOUPLE SENSOR S L P INC 06309 1401S BI SOFT PULSE OXIMETRY SPO UNIMED MEDICAL 08013 U101S 08 SENSOR SUPPLIES INC SOFT PULSE OXIMETRY SPO UNIMED MEDICAL 08012 U401S 08 SENSOR SUPPLIES INC DISPOSABLE NASSAL CANNULA S L P INC 08049 15805 2 FT DISPOSABLE PROTECH NASAL PRO TECH 07679 P1328 60 CANNULA PACKAGE 60PC DISPOSABLE PROTECH ORO NASAL PRO TECH 07680 P1343 CANNULA PACKAGE 30PC DISPOSABLE SLEEPSENSE ORO S L P INC 07681 14802 2 FT NASAL CANNULA PACKAGE 5PC DISPOSABLE SLEEPSENSE NASAL S L P INC 08049 15805 2 FT CANNULAR THORAX EFFORT INDUCTIVE BAND S L P INC 06314 9102S BI AMPLIFICATION INTERFACE ABDOMINAL EFFORT INDUCTIVE S L P INC 06308 9101S BI BAND AMPLIFICATION INTERFACE FASTENING BELT SMALL SIZE S S L P INC 06311 1348B FASTENING BELT LARGE SIZE L S L P INC 06312 1341 FASTENING BELT EXTRA LARGE S L P INC 06313 1340 SIZE XL ELASTIC INDUCTIVE BAND SMALL S L P INC 01425 9002 L40 SIZE S ELASTIC INDUCTIVE BAND MEDIUM S L P INC 01424 9002 L60 SIZE M ELASTIC INDUCTIVE BAND LARGE S L P INC 01421 9002 L90 SIZE L ELASTIC INDUCTIVE BAND XTRA S L P INC 01420 9002 L120 LARGE SIZE XL 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual Accessory
56. repare the area where the electrodes are to be placed The skin must be cleaned adequately using abrasive paste This allows a good contact impedance typically less than 10K Fix the electrode to the patient s skin by filling the cup with conductive paste and fixing it in place with colodion A hair dryer can be used to speed up the drying process When the test is over the electrodes are easyly removed with acetone Use a wire adaptor with 2 1 5mm TouchProof connectors to imm key connector ref 01644 for connecting the couple of electrodes to the appropriate channel In order to acquire the EMG EOG or EEG signals you must have the ExG module optional ref 08022 Connect the adapter to any of the three ExG channels included 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 together the electrode wires Place a third electrode on the patient s forehead and connect it to the neutral input N in the ExG module The EEG EOG and EMG signals 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 i
57. s Manual a Manual start and stop the patient starts and stops manually the recording of the test through the color screen and joystick in the Sleep amp Go b Automatic start and stop health personnel program the Sleep amp Go to start and stop automatically the test at a certain date and time The device s batteries last up to 24 hours in holter mode with a single charge Online mode in this mode the test data are sent in real time to the PC via Bluetooth the transfer from the memory card not being necessary 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 amp 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 enter to the setup menu of the Sleep amp Go do the following e Switch on the Sleep amp Go and make the following keystrokes on the joystick one after another and leaving a short interval of time between each of them y 4 e The screen changes and a new icon is displayed SYSTEM CONFIG A Select the SYSTEM CONFIG icon and press the joystick to move to the setup screen e Select OPTIONS B e Select CUSTOMIZE C 534 7AB MU2 e REV 1 07 0x pdoo S ydevasdAjod
58. s 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 labelling and packaging of substances and mixtures REACH INTENDED USE Acquisition storage and display of biomedical signals for the simplified diagnosis and control of sleep related breathing disorders mainly Sleep Apnea and Hypopnea Syndrome being anyone or any combination of the following signals respiratory airflow snore CPAP pressure measurement thoracic effort abdominal effort SpO beats per minute perfusion wave body position body activity extremity limb movement and EEG EMG EKG signals Next conditions must be taken into account e Usein a health center patient s home or similar indoor use not for outdoor use e Not intended for use in moving transport vehicles 534 7AB MU2 e REV 1 07 Jo uonere oe IO JIULIOJU Safety Sleep amp Go User s Manual e Not intended for monitoring vital signals e EKG signal can not be used for heart diagnosis purpose It s only intended for bradycardia and tachycardia detection during sleep analysis INDICATIONS FOR USE The Sleep amp Go has been designed for maximum safety All of the operating instructions should been read before proceeding to operate with the system Failure to do so may result in injuries to the user orthe patient
59. sation EXG silver cup electrodes 20 80 without to 50 G Ref 08701 condensation Cable for button stud type electrodes Ref 10 to 509C 29 000 el condensation 08093 3 4 APPLICABLE STANDARDS The Sleep amp Go has the CE Marking CE 0197 The CE mark is a statement that the Sleep amp Go fulfills the guidelines established by the EU for medical devices The Sleep amp Go is manufactured by SIBEL and the system including the software meets the following standards and regulations 534 7AB MU2 e REV 1 07 0x pdoo S ydevasdAjod enuen Jos User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual Recommendations e National consensus document on the apnea hypopnea syndrome SAHS Spanish Sleep Group GES September 2005 e The AASM Manual for the Scoring of Sleep and Associated Events 2007 European Directive 93 42 EEC R D 1591 2009 e EC marking Class II a Safety e EN 60601 1 2006 AC 2010 Electrical safety 3rd edition 60601 1 1990 1 1993 2 1995 11 1993 12 1993 A13 1996 e EN 60601 2 26 2003 Electromedical Devices Part 2 Special Safety Requirements for Electroencephalographs EN60601 2 40 1998 Safety requirements for Electromyographs e EN 60601 1 11 2010 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and m
60. teries The SCREEN amp GO SLEEP amp GO runs batteries The magnetic field in the room must be low enough to ensure the performance of the test REV 1 07 Sleep amp Go User s Manual Manufacturer s guide and statement electromagnetic immunity The SCREEN amp GO SLEEP amp GO is designed to be used in the electromagnetic environment specified below The customer or user of the SCREEN amp GO SLEEP amp GO must ensure that it is used in this environment Test Level EN IEC Compliance Immunity Test Guide Electromagnetic environment 60601 level Portable and mobile RF Communications units must be used no closer to any part of the SCREEN amp GO SLEEP amp GO including cables than the recommended separation distance calculated for the equation opina Sunoouso qnoa 7 xouuy applicable to the transmitter frequency Recommended separation distance Conducted RF 15 dx ES P EN IEC 61000 4 6 from 150KHz to 80 MHz from 80 MHz to 800 MHz 3 5 cf P from 80 MHz to 800 MHz 3 55 TR E 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 Radiated RF Field intensities from permanent RF transmitters EN IEC 61000 4 3 from 80 MHz to 2 5 GHz determined by an electromagnetic measurement of the place a must be less than the level of compliance i
61. terpretation of the tests and any ensuing treatment must be carried out by a doctor The acceptability of a test is the responsibility of the health personnel The symptoms presented by the patient before starting any test should be considered by the health personnel The Sleep amp Go should not be used when it is likely that the validity of the results may be compromised due to external factors Electro Magnetic interference see section EMC WARNINGS AND PRECAUTIONS The Sleep amp Go IS NOT CERTIFIED FOR USE IN CONTINUOUS MONITORING where a failure in operation 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 amp 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 display functional oxygen saturation and requires no calibration The pulse oximeter waveform is not standarized The Sleep amp Go is not intended for monitoring vital signals There are no applicable parts to the patient which produce stimulation The system has no user serviceable parts Use only authorized service and spare parts supplied by the manufacturer Contact of liquids with the internal parts of the device and the connectors must always be avoided 534 7A
62. tient If necessary adjust the tubes under the chin e Insert the cannula connector in the Luer connector of the Sleep amp Go labeled as Nassal cannula and turn it until secured 1 4 4 3 THERMOCOUPLE AIRFLOW SENSOR In addition to the nasal cannula the Sleep amp Go may also 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 but they can also add distortion to the signal if used in excess Filters are applied in the BitmedLab software Read that software s manual if you need to modify them The placement of the thermocouple sensor has a significant impact in obtaining high quality signals Follow these steps to place it properly e Place the thermocouple on the upper lip Bend the nasal tips softly until the ends of the sensor are exposed to the maximum possible air flow The tips should not get in contact with the 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual skin or penetrate the nasal orifice e Wrap the cable around the ears and place it under the chin Surgical tape can be used to fasten the cables to the cheeks of the patient If necessary adjust the
63. tional NiMh battery For devices commercialised before July 22th 2014 The SleepSense sensor for limb movement contain mercury All Sleepsense sensors except the cannulas contain Pb in the solderings All Sleepsense sensors except the cannulas may also contain PBB and PBDE The cables for electrodes Ref 08093 contain Pb in the soldering 534 7AB MU2 e REV 1 07 om doo S ydeasdAjod enuen s sN User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual The interconnection bridge Ref 02741 and the cable adapter Ref 01644 contain Cadmium e Materials according to the Medical Device Directive two of the sensors that may be used in combination with the device contains phtalates Sleepsense cannulas and Pro Tech cannulas The device and all the accesories are latex free e Materials according to the REACH regulation neither the device nor its accessories use any hazardous substance according to REACH regulation e 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 disposal of infected products Information on proper disposal is available from your dealer or from Technical Support at SIBEL S A 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual 1 INSTRUCTIONS OF INSTALLATION AND USE 1 1 MODELS The
64. ty The SCREEN amp GO SLEEP amp GO is designed to be used in the electromagnetic environment specified below The customer or user of the SCREEN amp GO SLEEP amp GO must ensure that it is used in this environment Immunity Test Electrostatic ESD discharge EN IEC 61000 4 2 Electrical fast transient burst EN IEC 61000 4 4 Surge EN IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines EN IEC 61000 4 11 Magnetic field 50 60 Hz EN IEC 61000 4 8 Test level EN IEC 60601 6 kV in contact 8 kV in air 2 kV feeder cables and earth lines 1 kV for input output lines 1 kV in differential mode 2 kVin common mode lt 5 Ut gt 95 drop of Ut for 0 5 cycles 40 Ut 60 drop of Ut for 5 cycles 70 Ut 30 drop of Ut for 25 cycles lt 95 Ut gt 5 drop of Ut for 5 seconds Compliance level 6 kV in contact 8 kV in air Not applicable Not applicable Not applicable Not applicable Not applicable Note Ut is the alternating current power tension prior to the application of the test 534 7AB MU2 e Guide Electromagnetic The floor must be made of wood cement or ceramic If the floor is covered with synthetic material the relative humidity must be at least 30 The SCREEN amp GO SLEEP amp GO runs on batteries The length of the E S lines is less than 3 m The SCREEN amp GO SLEEP amp GO runs bat
65. ystem allows the patient to wear it comfortably fastened with a strap Follow these steps to fasten the device to the patient e Insert the strap between the two guides in the rear side of the Sleep amp Go e Place the device on the patient s chest in a comfortable position midway between the thoracic effort band which should be on top and the abdominal effort band which should be below e Secure the strap by means of the Velcro so that the device stands firm 534 7AB MU2 e REV 1 07 Sleep amp Go User s Manual General placement schema 1 4 4 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 534 7AB MU2 e REV 1 07 6 udeiS od enuen ssn User s Manual Cardiorespiratory polygraph Sleep amp Go Sleep amp Go User s Manual e Place the cannula over the upper lip Bend the nasal probes softly until the tips are exposed to the maximum possible air flow The tips should not get in contact with the skin or penetrate the nasal orifice e Wrap the tube around the ears and place it under the chin Surgical tape can be used to fasten the tubes to the cheeks of the pa

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