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1. lt Screen amp GO Manual Revisi n 534 70S MU2 Rev 1 06 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 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 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 0S MU2
2. DESCRIPCI N DESCRIPTION SCREEN amp GO n CANAL AUXILIAR MOVIMIENTO EXTREMIDADES a 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 CANAL AUXILIAR SNORING PARA SLEEP amp GO INCLUYE 1 ACTIVACI N DEL CANAL AUXILIARY CHANNEL SNORING FOR SLEEP amp GO INCLUDES CHANNEL ACTIVATION SENSOR RONQUIDO PIEZOEL CTRICO PIEZOELECTRIC SNORE SENSOR TARJETA DE MEMORIA MICROSD CON ADAPTADOR SD MICROSD MEMORY CARD WITH SD ADAPTER 03673 2 PILAS ALCALINAS AA 1 5V AA 1 5V ALKALINE BATTERY MALETIN TRANSPORTE SCREEN amp GO CARRYING CASE SCREEN amp GO MALET N TRANSPORTE SLEEP amp GO CARRYING CASE BITMEDLAB CON CD BITMEDLAB SOFTWARE WITH LICENSE LICENCIA MANUAL DE USO USER S MANUAL Doc 534 74A MU M DULO BASE DE DATOS DATABASE MODULE M DULO ANALISIS AUTOM TICO EVENTOS AUTOMATIC EVENTS DETECTION MODULE SCREEN amp GO MANUAL DE USO SCREEN amp GO USER S MANUAL Doc 534 70S MU _ SLEEP amp GO MANUAL DE USO SLEEP amp GO USER S MANUAL Doc 534 7AB MU GUIA RAPIDA SLEEP amp GO QUICK GUIDE Doc 534 7AB GR Accesorios Opcionales Optional Accessories LECTOR TARJETAS MEMORIA USB PARA PC USB MEMORY CARD READER FOR PC SLEEP amp GO ADULT PULSE
3. 2 OPERATION The Screen 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 00 2010 10 7 23 Free Battery memory status This is the screen displayed when the Screen amp Go is switched on 29 02 114 397 41 44 ee Re MEMORY 1880HB 2 38h 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 4 while pressing it is used to click an option 2 1 WORKING MODES The Screen amp Go works always in holter mode In this mode the Screen 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 a Manual start and stop the patient starts and stops manually the recording of the test through the color 534 70S MU2 e REV 1 06 Screen amp Go User s Manual screen and joystick in the Screen amp Go b Automatic start and stop health personnel program the Screen amp Go to start and stop a
4. 18 1 2 2 REAR vasis ioni il ROO ORO V a GR iln 19 1 4 INSTALLATION AND 5 19 1 4 1 BATTERY PLALEMENT Ed MEER 19 1 4 2 POWER SAVING MODE TIT et 20 1 4 3 PLACEMENT OF SENSORS 20 1 4 3 1 PLACEMENT OF THE SCREEN amp GO POLYGRAPH 20 1 4 3 2 NASAL CANNULA 21 1 4 3 3 THERMOCOUPLE AIRFLOW 5 50 22 1 4 3 4 RESPIRATORY EFFORT BAND p TUN 23 1 4 3 5 PULSE OXIMETERH RA RIRERAREE ROCA PRIMER ADU 24 1 4 3 6 BODY POSITION AND ACTIVITY 26 1 4 3 7 EVENT MARKER 27 2 OPERATION RAM dads Gesadaeeapanacen 28 2 1 WORKING MODES T eer 28 2 2 SYSTEM CONFIGURATION 29 2 3 INITIAL DEVICE 5 30 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 2 3 1 SETTING THE DATE AND TIME 30 2 3 2 SETTING THE 30 2 3 3 SETTING THE TYPE OF BATTERIES 31 2 4 MAKING POLYGRAPHY TESTS M M 31 2 4 1 STARTING AND ENDING A TEST M
5. REV 1 06 PRODUCT IN COMPLIANCE WITH MEDICAL DEVICE DIRECTIVE 93 42 EEC CLASS 0197 Thank you for choosing this product SCREEN amp GO system is designed and manufactured with the best guarantees of quality Applications SCREEN 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 2013 11 Date 2013 11 Technical Director Sales Director 534 0S MU2 REV 1 06 Index Screen amp Go User s Manual TABLE OF CONTENTS SAFETY Pr e 6 INTENDED 5 om 6 INDICATIONS FOR USE Mad iu is 7 LIMITATIONS IN USE CONTRAINDICATION 7 WARNINGS AND PRECAUTIONS DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION d 1 INSTRUCTIONS OF INSTALLATION AND USE 13 PES Rit nr 13 1 2 PACKING LIST 14 1 3 LAYOUT OF CONTROLS INDICATORS AND CONNECTORS E 18 1 3 1 FRONT TOP RIGHT 18 LEFT PANNEL
6. Temperature 209C to 602C Relative humidity lt 93 without condensation 534 70S MU2 e REV 1 06 Screen 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 Pulse rate Accuracy Precision SpO 70 100 105 2 Pulse rate Measuring wavelength power Maximum application time Biocompatibility and toxicity 0 10096 196 18 321 1 pulse erroneous value No movement Finger clip sensor adults paediatric 2 digits 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 neonates 4 digits Low perfusion All sensors adults paediatric 2d gitos neonates 3 digits No movement 18 300 BPM Finger clip sensor flexible paediatric neonates 3 digits sensor adults Movement 40 240 BPM Finger clip sensor flexible paediatric neonates 5 digits sensor adults Low perfusion 40 240 BPM Finger clip sensor flexible paediatric neonates 3 digits sensor adults Red 660nm 0 8W Infrared 910nm 1 2mW Consult the operating instructions of the pulsioximetric sensor Sensor 534 70S MU2 e Consult the operating instructions of the puls
7. YES BACK MOVEMENT 1 2 4 2 3 CHANNEL CONFIGURATIONS The Screen 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 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 534 70S MU2 e REV 1 06 User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual memory card See the software s manual for more information on this point 2 5 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 Screen amp Go before transferring 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 Screen 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 downlo
8. 60 drop of Ut for The SCREEN amp GO Screen amp Go Not applicable variations on power supply 065 runs on batteries input lines 70 96 Ut 30 96 drop of Ut for 25 cycles EN IEC 61000 4 11 95 Ut gt 5 96 drop of Ut for 5 seconds Magnetic field 50 60 Hz The magnetic field in the room must be low enough to ensure the EN IEC 61000 4 8 performance of the test Note Ut is the alternating current power tension prior to the application of the test 534 70S MU2 e REV 1 06 Screen amp Go User s Manual Manufacturer s guide and statement electromagnetic immunity The SCREEN amp GO Screen amp Go is designed to be used in the electromagnetic environment specified below The customer or user of the SCREEN amp GO Screen amp Go must ensure that it is used in this environment Test Level EN IEC Compliance Immunity Test Guide Electroma ronment 60601 level Portable and mobile R be used no closer to any part of the SCREEN amp GO Screen amp Go including cables than the recommended separation distance calculated for the equation Annex 2 Troubleshooting guide applicable to the transmitter frequency Recommended separation distance Conducted RF P from 150KHz to 80 4 from 80 MHz to 800 MHz MHz EN IEC 61000 4 6 P from 80 MHz to 800 MHz 25 p 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
9. 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 contact the manufacturer Patients must be insistently warned that they must not open the Screen amp Go or attempt to adjust it Sensors or accessories in bad condition should not be used Use only the Screen amp Go with accessories and sensors provided by the manufacturer or dealer or those that meet the specifications of this manual The use of other sensors with the Screen 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 534 70S MU2 REV 1 06 Screen amp Go User s Manual 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
10. 2006 AC 2010 Electrical safety 3rd edition e 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 534 70S MU2 REV 1 06 Screen amp Go User s Manual 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 Biocompatibility 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 Symbols to be used with medical device labels labelling andi nformation to be suplplied Packaging and labelling e Packagin
11. 70S MU2 e REV 1 06 Screen amp Go User s Manual 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 Screen amp Go A 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 Screen amp Go prior to cleaning or disinfection The 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 det
12. cover The service and repair of the device should be carried out only by trained personnel The Screen 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 534 70S MU2 e REV 1 06 alety Screen amp Go User s Manual 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 10 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 The system shall be stored and used within the temperature ranges pressure and humidity specified in section number 3 Artifacts in the signal may be produced as a result of ESD A trained operator should be able to recognize these artifacts 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 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 Screen amp Go system does not increase the safety risk for patients
13. is specified in regulation EN60601 1 The Screen 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 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 534 70S MU2 REV 1 06 Screen amp Go User s Manual 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 Du
14. of the transmitter and d is the recommended separation distance in metres m EN IEC 61000 4 3 from 80 MHz to 2 5 Field intensities from permanent RF transmitters GHz determined by an electromagnetic measurement of the place a must be less than the level of compliance in each margin of frequency b Interferences may appear in the vicinity of units marked with this symbol 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 534 70S MU2 REV 1 06 Screen amp Go User s Manual The 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 Screen amp Go is normal Otherwise additional measurements such as the reorientation or change in placement of the SCREEN amp GO Screen amp Go may be necessary Above the frequency range f
15. the Screen amp Go labeled as Nassal cannula and turn it until secured 1 4 3 3 THERMOCOUPLE AIRFLOW SENSOR In addition to the nasal cannula the Screen amp Go may also use the thermocouple sensor ref 06309 in order to measure the respiratory airflow Both the thermocouple airflow sensor and the effort band are to be connected to the connector labeled as Aux and therefore both can not be used at the same time The quality of the registered signal depends on variables such as the filters selected in the software the sensor placement the patient s respiration and room temperature 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 70S MU2 e REV 1 06 Screen amp Go User s Manual skin or penetrate the nasal orifice 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 sensor cable on the chin Bend the
16. 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 Screen 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 about 24 hours The battery compartment is located on the rear panel protected by a cap that needs to be removed to proceed to change the batteries 534 70S MU2 REV 1 06 YdvasAjod enuen 5 1957 User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual Before opening the battery compartment to replace the batteries please switch off the Screen 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 PLACEMENT OF SENSORS 1 4 3 1 PLACEMENT OF THE SCREEN amp GO POLYGRAPH The small size and weight of the Screen amp Go system allows the patient to wear it comfortably fastened with a strap Follow these s
17. 5 samples s 1 sample s 1 sample s Selectable 10 25 50 samples s Event marker Resolution Resp airflow pressure 12 bits transducer snore pressure transducer polygraphic aux actimetry Pulse rate oxygen saturation Body position Event marker Sample storage size Input range 5 mVpp 4 cmH 20 3 9 hPa over the cannula aprox 0 5 cmH 20 0 49 hPa over the cannula aprox 18 300 BPM 1 min 0 100 96 aprox 30 mg 300 m s Supine prone left right seated Polygraphic aux Airflow pressure transducer Snoring pressure transducer Pulse Oxygen saturation Actimetry Body position Linearity Resp airflow pressure transducer snore pressure transducer Polygraphic aux actimetry Accuracy Pulseoximeter See pulseoximeter table 534 70S MU2 REV 1 06 YdvasAjod enue 5 1957 User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual Fixed hardware filters Polygraphic aux 0 05 10 Hz Airflow pressure transducer 0 05 50 Hz Snoring pressure transducer 30 250 Hz Pulse Oxygen saturation R Actimetry 0 5 25 Hz In operation Transportation and storage Body position Temperature 59C to 409C Relative humidity Environmental conditions 15 9396 without condensation Barometric pressure 700hPa to 1060hPa approx 2950 to 350m
18. 6309 1401S BI SOF PUESE OXIMETRY SPO UNIMED MEDICAL 08013 01015 08 SENSOR SUPPLIES INC SOFT PULSE OXIMETRY SPO UNIMED MEDICAL 08012 U401S 08 SENSOR SUPPLIES ING DISPOSABLE NASSAL CANNULA SEPANG 08049 15805223H 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 SIE PINE 08049 1580552 1 CANNULAR THORAX EFFORT INDUCTIVE BAND 06314 9102S BI 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 ELASTIC INDUCTIVE BAND XTRA S PING 01417 9002 L150 XTRA LARGE SIZE XXL 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 5 CLEANING AND MAINTENANCE The Screen amp Go polygraph requires like any electronic equipment a maintenance in order to Ensure the safety of the patient the operator and its environment Ensure the reliability and accuracy of the functions for which the Screen amp Go was dev
19. ANUALLY Ec 2 4 2 SCHEDULED TESTS CHR ENS ER EARN ER A READ 32 2 4 2 1 SCHEDULING A TEST IN THE SCREEN amp GO 2 4 2 2 DISPLAYING THE SCHEDULED 34 2 4 2 3 CHANNEL CONFIGURATIONS 35 2 5 TRANSFER AND REVIEW OF THE TESTS 36 2 0 NAME 36 2 7 DEVICE OPTIONS UPDATE 37 3 TECHNICAL SPECIFICATIONS pinus nis 38 3 1 GENERAL ER re ere ON 38 3 2 PULSE OXIMETER TECHNICAL SPECIFICATIONS 41 3 3 CONDITIONS OF OPERATION AND STORAGE OF ACCESSORIES 42 3 4 APPLICABLE STANDARDS 42 SYMBOLOGY rr rer err re rer rr ee 45 4 1 SYMBOLOGY OF THE SCREENG amp GO aaa 45 4 2 SYMBOLOGY OF THE ACCESSORIES T 46 4 3 VALIDATED 55 6 48 5 CLEANING AND r 49 5 1 CLEANING 49 5 2 PREVENTIVE 49 5 2 1 ACTIONS TO BE TAKEN BY THE USER 49 5 2 2 ACTIONS TO BE TAKEN BY QUALIFIED PERS
20. BLUETOOTH 08084 MODULE FIRMWARE OPTION EXG SENSOR MODULE MODULO DE SENSORES EXG KIT FOR SLEEP amp GO ELECTRODO CUCHARA PLATA EXG PAQUETE 10U EXG SILVER CUP ELECTRODES PACKAGE 10PC CABLE ADAPTADOR 1MM A 1 5MM CABLE ADAPTER 1MM TO 1 5MM 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 25U EKG ELECTRODE PACKAGE 25PC CABLE ADAPTADOR 1MM A 1 5MM CABLE ADAPTER 1MM TO 1 5MM 534 70S MU2 REV 1 06 Screen amp Go User s Manual C DIGO CANT SLEEP amp GO DESCRIPCI N DESCRIPTION SCREEN amp GO CODE QTY B SENSOR RONQUIDO PIEZOEL CTRICO PIEZOELECTRIC 06346 SNORE SENSOR CANULA NASAL DESECHABLE PROTECH PAQUETE 60U 1 07679 DISPOSABLE PROTECH NASAL CANNULA PACKAGE 60PC ORO NASAL DESECHABLE PROTECH PAQUETE 07680 30U DISPOSABLE PROTECH ORO NASAL CANNULA C NULA ORO NASAL DESECHABLE SLEEPSENSE PAQUETE 07681 5U DISPOSABLE SLEEPSENSE ORO NASAL CANNULA PACKAGE 5PC C NULA NASAL DESECHABLE SLEEPSENSE DISPOSABLE 08049 SLEEPSENSE NASAL CANNULAR _ BANDA DE SUJECI N TAMANO PEQUENO S FASTENING BELT SMALL SIZE S BANDA DE SUJECI N TAMANO EXTRA GRANDE XL FASTENING BELT EXTRA LARGE SIZE XL BANDA INDUCTIVA EL STICA TAMANO PEQUENA S ELASTI
21. C INDUCTIVE BAND SMALL SIZE S BANDA INDUCTIVA ELASTICA TAMANO MEDIANA M 01424 ELASTIC INDUCTIVE BAND MEDIUM SIZE M BANDA INDUCTIVA EL STICA TAMANO GRANDE L 01421 1 ELASTIC INDUCTIVE BAND LARGE SIZE L BANDA INDUCTIVA EL STICA TAMANO EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL BANDA INDUCTIVA EL STICA TAMANO EXTRA EXTRA ELECTRODO DE ECG PAQUETE 25U EKG ELECTRODE 02646 1 P PACKAGE 25PC STANDARD OPCIONAL OPTIONAL 1 NO DISPONIBLE NOT AVAILABLE EL SLEEP amp GO A S LO INCLUYE UNA UNIDAD DE ESTA REFERENCIA THE SLEEP amp GO A ONLY INCLUDES ONE PIECE OF THIS REFERENCE NOTA LOS ARTICULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS EN CASO DE FALTAS O DESPERFECTOS PROCEDAN A COMUNICARNOSLO LO MAS PRONTO POSIBLE NO SE DEBE DESPRENDER DE LOS EMBALAJES 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 A LA REPARACI N O REPOSICI N NOTE 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 DISTRIBUT
22. EST MANUALLY In this mode either the patient or the technician will start and end the test e Switch on the device by pressing for 3 seconds the ON OFF button e Once in the main screen press the joystick A to select the MANUAL START icon e 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 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 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 stop the test just select the STOP imr option or hold down the ON OFF button for 3 seconds B EE ee a PRESSURE AIRFLOW MANUAL SYSTEM START CONF MEET Nd 2 4 2 SCHEDULED TESTS The Screen 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 the patient does not have to interact at all with the Screen amp Go for starting or ending the test You can schedule up to 5 consecutive tests These tests may be scheduled right from the Screen amp Go device or by using the BitmedLab software in the PC This manual describes the programming procedure in the Screen
23. ONNEL 50 5 3 CORRECTIVE RN 50 ANNEX 1 ELECTROMAGNETIC COMPATIBILITY 52 ANNEX 2 TROUBLESHOOTING GUIDE 56 534 70S MU2 REV 1 06 xopu Declaration of conformity Screen amp Go User s Manual SAFETY The Screen amp Go respiratory 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 Screen amp Go respiratory 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 Screen 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 Screen amp 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 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 bre
24. OR 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 534 70S MU2 e REV 1 06 1 Ydvasdjod enuen 5 1957 Screen amp Go User s Manual 1 3 LAYOUT OF CONTROLS INDICATORS AND CONNECTORS 1 3 1 FRONT TOP RIGHT PANNELS SpO XPod pulse oximeter connector Nasal cannula nasal QUT nua connector Cannula Aux auxiliary channel ScreengGo connector suitable for both thermocouple Ke airflow sensor and the CH respiratory effort band Joystick Status LED 1 3 2 LEFT PANNEL MicroSD memory card slot ON OFF button 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 1 3 3 REAR PANNEL Battery compartment 2x AA alkaline or 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
25. OXIMETRY KIT FOR SCREEN amp GO SLEEP amp GO MODULO PULSIOXIMETRIA XPOD MODELO 3012 XPOD 3012 PULSEOXIMETRY MODULE SENSOR PULSIOXIMETRIA SOFT SOFT PULSE OXIMETRY SPO SENSOR MUNEQUERA DE SUJECI N FASTENING CUFF 534 70S MU2 REV 1 06 YdvasdAjod enuen 5 1957 User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual CODIGO CANT SLEEP amp GO DESCRIPCI N DESCRIPTION SCREEN amp GO CODE A KIT DE PULSIOXIMETRIA PEDIATRICO PARA SCREEN amp GO SLEEP amp GO PEDIATRIC PULSEOXIMETRY KIT FOR SCREEN amp GO SLEEP amp GO MODULO PULSIOXIMETRIA XPOD MODELO 3012 XPOD 3012 PULSEOXIMETRY MODULE SENSOR PULSIOXIMETRIA SOFT SOFT PULSE OXIMETRY SPO SENSOR MUNEQUERA DE SUJECI N FASTENING CUFF OPCION DE FIRMWARE CANAL DE RONQUIDO POR PRESION 08078 PRESSURE SNORING CHANNEL FIRMWARE OPTION OPCION DE FIRMWARE CANAL DE POSICION CORPORAL 08079 BODY POSITION CHANNEL FIRMWARE OPTION OPCION DE FIRMWARE CANAL DE 08080 ACTIGRAPHY CHANNEL FIRMWARE OPTION OPCION DE FIRMWARE CANAL DE MARCAS DEL PACIENTE 08081 PATIENT S MARKS CHANNEL FIRMWARE OPTION OPCI N DE FIRMWARE CANAL DE PRESI N CPAP CPAP 08082 PRESSURE CHANNEL FIRMWARE OPTION OPCION DE FIRMWARE CANAL DE ONDA DE PULSO PULSE 08083 WAVE CHANNEL FIRMWARE OPTION OPCI N DE FIRMWARE MODULO BLUETOOTH
26. VACI N DEL CANAL 08049 08087 06309 THERMOCOUPLE MODULE INCLUDES CHANNEL ACTIVATION SENSOR TERMOPAR THERMOCOUPLE SENSOR User s Manual Respiratory pol ACTIVACION DEL CANAL INDUCTIVE THORACIC EFFORT MODULE INCLUDES CHANNEL ACTIVATION INTERFAZ DE AMPLIFICACION BANDA INDUCTIVA ESFUERZO TORACICO THORAX EFFORT INDUCTIVE BAND AMPLIFICATION INTERFACE BANDA INDUCTIVA ELASTICA TAMANO EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL SLEEP amp GO INCLUYE ACTIVACION DEL CANAL INDUCTIVE ABDOMINAL EFFORT MODULE FOR SLEEP amp GO INCLUDES CHANNEL ACTIVATION INTERFAZ DE AMPLIFICACION BANDA INDUCTIVA ESFUERZO ABDOMINAL ABDOMINAL EFFORT INDUCTIVE BAND AMPLIFICATION INTERFACE BANDA INDUCTIVA ELASTICA TAMANO EXTRA GRANDE XL ELASTIC INDUCTIVE BAND XTRA LARGE SIZE XL CUANDO SE ENTREGA LA REFERENCIA 08089 JUNTO CON UN SCREEN SLEEP amp GO NO SE INCLUYE LA REFERENCIA 01421 PAQUETE DE 2 BANDAS INDUCTIVAS TAMANO L PUESTO QUE YA ESTA INCLUIDA EN LA REFERENCIA 08088 LA REFERENCIA 01421 SE INCLUIRA SOLO SI EL MODULO 08089 SE SUMINISTRA POR SEPARADO WHEN THE REFERENCE 08089 IS SUPPLIED WITH A SCREEN SLEEP amp GO DOES NOT INCLUDE REFERENCE 01421 PACK OF 2 BAND INDUCTIVE SIZE L SINCE IT IS ALREADY INCLUDED IN THE REFERENCE 08088 THE REFERENCE 01421 IS INCLUDED ONLY IF THE MODULE 08089 IS DELIVERED SEPARATELY 534 70S MU2 REV 1 06 Screen amp Go User s Manual C DIGO
27. ad 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 6 FIRMWARE UPDATE Over time new versions of the program managing the Screen amp Go firmware might be released either to improve the operation of the equipment or to add new features Technical Service will provide one or several files to be copied to the MicroSD memory card of the Screen amp Go e Insert the memory card in the Screen 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 Screen amp Go switches off automatically Your device is already updated 534 70S MU2 e REV 1 06 Screen amp Go User s Manual In case you are provided with several files the process will be repeated as many times as needed 2 7 DEVICE OPTIONS UPDATE As mentioned in paragraphs 1 2 and 1 3 the Screen amp Go is delivered with just the airflow channel enabled The available channels may be expanded though In case new features are 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 Screen amp Go Insert the memory card in the Screen amp Go and switch it on The update starts autom
28. amp Go Refer to the software manual for information on the programming process in BitmedLab 2 4 2 1 SCHEDULING A TEST IN THE SCREEN amp GO e Switch on the Screen 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 V 4 4 e Select the SYSTEM CONFIG icon and press the joystick to move to the setup screen 534 70S MU2 e REV 1 06 Screen amp Go User s Manual Select SCHEDULED TESTS A Select NEW TEST B Select the DATE field and set the starting date for the test Select OK when finished C D 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 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 Screen amp Go The device will start automatically the test at the designated date and
29. athing disorders mainly Sleep Apnea and Hypopnea Syndrome being anyone or any combination of the following signals respiratory airflow snore thoracic effort SpO beats per minute body position and body activity 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 e Not intended for monitoring vital signals 534 70S MU2 e REV 1 06 Screen amp Go User s Manual INDICATIONS FOR USE The Screen 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 or the patient and damage to the device and or accessories The Screen amp Go has been designed for being used by a doctor or a technician trained in the acquisition of respiratory 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 I
30. atically When prompted confirm that you want to update the device s features When the update is complete the Screen amp Go switches off automatically Your device is already updated and the new channels are available from now on 534 70S MU2 REV 1 06 YdvasAjod enuen 5 4957 Screen amp Go User s Manual 3 TECHNICAL SPECIFICATIONS 3 1 GENERAL DATA Useful life for Xpod pulseoximeter 5 years module 2x AA alkaline batteries or AA NiMh rechargeable Battery type battery life batteries 2450mAh minimum 24h in holter mode Enclosure protection degree IP22 Device classification EN60601 1 Class internally powered User s Manual Respiratory polygraph Screen amp Go Type BF applied parts not protected against defibrillator Input impedance 20MW CMRR common mode rejection ratio Signal input connectors Pressure transducer respiratory LUER connector airflow snore Polygraphic aux 1 mm key connector Pulse oximeter Specific 3 pin connector Actimetry Internal Body position Internal Event marker Joystick 534 70S MU2 e REV 1 06 Screen amp Go User s Manual Storage sampling rate software selectable Airflow pressure transducer Snore pressure transducer Polygraphic aux Pulse rate Oxygen saturation Actimetry Body position Selectable 25 50 100 samples s Selectable 50 100 250 samples s Selectable 10 2
31. e 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 and 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 Screen 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 serv
32. ecting 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 not quantify the degree of existing hyperoxemia 534 70S MU2 e REV 1 06 5 495 9 Ajod 0 oYU ydg User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual e Interferences such as movements abnormal hemoglobins intravascular contrasts states of low perfusion skin pigmentation may affect the operation of the pulse oximeter e Itis 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 e 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 gt 42 9 e See the instructions for use before use Strictly follow the manufacturer s safety instructions as well as those specified in this manual e 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
33. eloped 5 1 CLEANING To clean the unit and its accessories excluding the sensors 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 immediately after use Nasal cannulas are single use and must be replaced with each patient For the cleaning and disinfection of reusable sensors please refer to the information provided by its manufacturer The device can not be sterilized For the cleaning and disinfection of sensors 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 items are in perfect condition not broken and with no external damage Pay special attention to the cables and connectors 534 70S MU2 REV 1 06 Ayyiqneduros xouuy Annex 2 Troubleshooting guide Screen amp Go User s Manual 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 solv
34. g and packaging waste directive 94 62 EC e Regulation EC 1272 2008 on classification labelling and packaging of substances and mixtures REACH 534 70S MU2 REV 1 06 26 YdvasdAjod enuen 5 1957 User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual Information supplied by the manufacturer e 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 The user should follow e Data protection Directive 95 46 EC 2002 96 EC 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 4 SYMBOLOGY 4 1 SYMBOLOGY OF THE SCREEN amp GO SERIAL NUMBER MANUFACTURER manufacture date name and address of the manufacturer REFERENCE CONSULT INSTRUCTIONS FOR USE WARNING START UP STANDBY BF APPLIED PARTS NO SPO ALARMS IP22 see section WARNINGS AND PRECAUTIONS DISPOSAL OF WASTE ELECTRICAL ELECTRONIC ACORDING TO THE RAEE DIRECTIVE BATTERIES 534 70S MU2 e REV 1 06 YdvasdAjod enuen 5 sN Annex 1 Electromagnetic compatibility Sc
35. he values in each field PE e Once you have set the date and F time select OK To cancel setting the date and time select CANCEL oo oo CANCEL 2 3 2 SETTING THE LANGUAGE Once in the CUSTOMIZE screen follow these steps in order to change the language the Screen amp Go Select LANGUAGES ENGLISH Use move along the different available languages The selected language is marked with the symbol CANCEL 534 70S MU2 e REV 1 06 Screen amp Go User s Manual e When you have set the desired language select OK If you want to cancel the language settings then 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 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 BATTERIES e Use and to select the type of 05 02711994 42 Be batteries used in the device The 2 of batteries is marked with the NiMH mark e When you have set the desired language select OK If you want to cancel the language settings then CANCEL select CANCEL 2 4 MAKING POLYGRAPHY TESTS There are two different ways to start and stop the tests either manually or automatically scheduled 2 4 1 STARTING AND ENDING A T
36. ice 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 5 3 CORRECTIVE MAINTENANCE Corrective maintenance is the process of leaving the device in 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 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 70S MU2 REV 1 06 opina Sunoouso qnoa 7 xouuy Screen amp Go User s Manual Annex 1 ELECTROMAGNETIC COMPATIBILITY Manufacturer s guide and statement electromagnetic emissions The SCREEN amp GO Screen 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 Guide Electromagnetic environment The SCREEN amp GO Screen amp Go uses RF energy only for internal use Therefore its emissions are Annex 2 Troubleshooting guide Radiated RF Emissions Group 1 very low and unlikely to cause any interference to CISPR 11 EN 55011 Class B nearby electronic devices Conducted RF Emissions Not applicable The SCREEN amp GO Screen amp Go runs on batteries CISPR 11 EN 55011 Harmonic Emission
37. ioximetric REV 1 06 YdvasAjod enuen s sN User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual 1 precision specifications were determined from studies of hypoxia induced in healthy adult volunteers of both sexes from Caucasian Indian and African ethnic groups 2 Standard Deviation Due to the statistic distribution of the pulse oximeter measurements only about two thirds of the pulse oximeter measurements be expected to be found within x Arms of the value measured by CO oximeter 3 3 CONDITIONS OF OPERATION AND STORAGE OF ACCESSORIES Although the device 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 all accessories 3 4 APPLICABLE STANDARDS The Screen amp Go has the CE Marking CE 0197 The CE mark is a statement that the Screen amp Go fulfills the guidelines established by the EU for medical devices The Screen amp Go is manufactured by SIBEL and the system including the software meets the following standards and regulations 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
38. ith the device contains phtalates Sleepsense nasal cannula and Pro Tech nasal cannula 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 70S MU2 e REV 1 06 Screen amp Go User s Manual 1 INSTRUCTIONS OF INSTALLATION AND USE 1 1 OPTIONS The Screen amp Go screening polygraph is available with the the following features Screen amp Go _ Nasal cannula pec Default Option 534 70S MU2 REV 1 06 YdvasAjod enuen 5 sN Screen amp Go User s Manual 1 2 PACKING LIST RELACI N DE CONTENIDI PACKING LIST 534 708 110 REV 2 CODIGO SLEEP amp GO DESCRIPCION DESCRIPTION SCREEN amp GO CODE raph Screen amp Go y POL GRAFO POLYGRAPH m T Accesorios Est ndar Standard Accessories BANDA DE SUJECI N TAMANO GRANDE L FASTENING BELT LARGE SIZE L CANULA DESECHABLE NASAL DISPOSABLE NASSAL CANNULA M DULO TERMOPAR INCLUYE ACTI
39. n 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 e The adult sensor is for people over 12 years of age 40Kg The pediatric sensor is for children aged between 5 and 12 years of age 15 40 kg e 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 e Do not use blood flow restrictors because they can lead to loss of signal 1 4 3 6 BODY POSITION AND ACTIVITY The Screen amp Go records information about the patient s body 534 70S MU2 REV 1 06 Screen amp Go User s Manual position and actigraphy Both sensors are place inside the Screen amp Go device so no external accessory is needed 1 4 3 7 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 medication and so on 534 70S MU2 REV 1 06 YdvasAjod enuen 5 sN anual User s M R 3 Y roa 4 1 D Iiratory e Screen amp Go User s Manual
40. ooting guide Screen amp Go User s Manual Annex 2 TROUBLESHOOTING GUIDE The Screen amp Go does not start e Make sure the batteries are placed according to the polarity in the battery compartment 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 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 Pulse oximetry signals are null e Make sure the pulse oximeter sensor is correctly connected to the patient as indicated the PLACEMENT OF SENSORS section e Make sure the pulse oximetry sensor connector is properly plugged into the top panel of the Screen amp Go e sure the red light the pulse oximetry sensor switches on when connected to the Screen amp Go 534 70S MU2 e REV 1 06
41. 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 Insert the sensor connector in the connector of the Screen 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 1 4 3 4 RESPIRATORY EFFORT BAND The inductive plethysmography belt refs 01425 01424 01421 01420 01417 supplied with the Screen amp Go is based in the RIP technology Respiratory Inductive Plethysmography Strap the sensor band around the patient s chest or abdomen over any clothing Attach the first wire of the interfaze box ref 06314 to the snap that is on the same side of the band as the Velcro patch While holding this end to the left of the patient s center line wrap the band around the patient s chest or abdomen 534 70S MU2 REV 1 06 26 Ydvasdjod enuen 5 1957 User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual e Pull the other end over the first end and secure the band on the right side of the center line The band sh
42. ould 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 Both the thermocouple airflow sensor and the effort band are to be connected to the connector labeled as Aux and therefore both can not be used at the same time e Fix each of the little boxes to the corresponding belt with the aid of the provided strips 1 4 3 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 In adults the ideal point for the application of the oximeter sensor is the index finger However it may also be placed in other fingers when the thickness is between 5mm and 21mm 0 2 and 0 87 dimension H in the figure To place pulse oximeter sensor follow these steps e Place the wristband provided in the patient s wrist and insert the XPod module into the socket e Insert a finger preferably the index finger the sensor until the finger tip reaches the stop It is not recommended to place 534
43. reen 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 70S MU2 e REV 1 06 Screen amp Go User s Manual LE go m 79 OAH gt I 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 70S MU2 REV 1 06 Ayyiqneduros onouSgeuiogoo q xouuy Annex 1 Electromagnetic compatibility Screen 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 accessories for proper operation of the equipment see section 1 2 PACKING LIST The sensors used by other manufacturers are Accesory SIBEL Manufacturer reference reference THERMOCOUPLE SENSOR Se PING 0
44. ring 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 Screen amp Go is not protected against defibrillation shocks Therefore never use a defibrillator on a patient connected to a Screen amp Go system Do not use an electric scalpel or a high frequency surgical device while the patient is connected to any sensors of the Screen 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 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
45. rom 150 kHz to 80 MHz the field intensity must be less than 3 V m Recommended separation distances between mobile and portable RF communications units and the SCREEN amp GO Screen amp Go The SCREEN amp GO Screen 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 Screen 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 Screen amp Go as recommended below according to the power output of the communications unit Viaximum power output o the transmitter Separation distance depending on the transmitter frequency m From 150 kHz to 80 MHz From 80 MHz to 800 From 800 MHz to 5 3 5 4 9 E 2 a 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 70S MU2 e REV 1 06 opina Sunoouso qnoa 7 xouuy Annex 2 Troublesh
46. s Not applicable The SCREEN amp GO Screen amp Go runs on batteries EN IEC 61000 3 2 Flicker and tension fluctuations Not applicable The SCREEN amp GO Screen amp Go runs on batteries EN IEC 61000 3 3 534 70S MU2 e REV 1 06 Screen amp Go User s Manual Manufacturer s guide and statement electromagnetic immunity The SCREEN amp GO Screen amp Go is designed to be used in the electromagnetic environment specified below The customer or user of the SCREEN amp GO Screen amp Go must ensure that it is used in this environment Guide Electromagnetic Immunity Test Test level EN IEC 60601 Compliance level environment The floor must be made of wood Electrostatic discharge 6 kV in contact ESD 6 kV in contact cement or ceramic If the floor is covered with synthetic material opina Sunoouso qnoa 7 xouuy 8 kV in air the relative humidity must be at least 30 EN IEC 61000 4 2 8 kV in air 2 kV feeder cables and earth Not applicable The SCREEN amp GO Screen amp Go Electrical fast transient burst lines runs on batteries EN IEC 61000 4 4 The length of the E S lines is less 1 kV for input output lines Not applicable than 3 m 1 in differential mode Not applicable The SCREEN amp GO Screen amp Go urge runs on batteries EN IEC 61000 4 5 2 kVin common mode Not applicable lt 5 Ut gt 95 drop of Ut for 0 5 cycles Voltage dips short interruptions and voltage 40 Ut
47. 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 environment that allows the patient to sleeping normally DISPOSAL OF ELECTRICAL AND ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION Never dispose of the Screen 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 the device contains lead for the electric soldering and PBB in the plastic cover It uses a lithium battery and could use an optional NiMh battery Sleepsense sensors may contain PBB and PBDE 534 70S MU2 REV 1 06 Ayayes User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual e Materials according to the Medical Device Directive two of the sensors that may be used in combination w
48. t 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 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 Screen amp Go is not designed to be used outdoors nor in other conditions or with energy sources not covered in this manual Using the Screen amp Go systems does not involve any monitoring or diagnosis of the patient LIMITATIONS IN USE CONTRAINDICATION The interpretation 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 Screen amp Go should not be used when it is likely that the validity 534 70S MU2 REV 1 06 Ayayes Safety Screen amp Go User s Manual of the results may be compromised due to external factors Electro Magnetic interference see section EMC WARNINGS AND PRECAUTIONS The Screen 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
49. teps to fasten the device to the patient e Insert the strap between the two guides in the rear side of the Screen 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 70S MU2 e REV 1 06 Screen amp Go User s Manual General placement schema 1 4 3 2 NASAL CANNULA The nasal airflow cannula refs 07679 07680 07681 08049 is used to acquire the airflow and snoring 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 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 534 70S MU2 e REV 1 06 YdvasAjod enuen 5 sN User s Manual Respiratory polygraph Screen amp Go Screen amp Go User s Manual 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 patient If necessary adjust the tubes under the chin e Insert the cannula connector in the Luer connector of
50. 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 11 46 29 92 4114 99 12 e CHANNELS CONF SHOW TEST 47 DELETE TEST BACK cy MORE OPTIONS BACK 534 70S MU2 e REV 1 06 Loox TI HE DURATION CHANNELS CONF SAVE E G SCREENIN x OK CANCEL You can see the scheduled tests in the Screen amp Go up to a maximum of 5 tests Switch on the Screen amp Go and enter the setup mode by making the following keystrokes with the joystick 4 Select the SYSTEM CONFIG icon and press the joystick to move to the setup screen Select SCHEDULED TEST Select SHOW TEST A 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 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 channel configuration C To view the channel configuration enabled channels and sampling frequencies select CHANNELS CONF D A 8 E Bees NEU TEST 02132200 p BACK DELETE TEST BACH C qs 02 114 984 12 22 02152300 DATE 02 18 2111 PRESSURE 100 2 TES TIME 23 00 DURATION 08 OOmin THERMOC 25Hz YES E THORA 75Hz DELETE E ABDOM
51. utomatically the test at a certain date and time The device s batteries last up to 24 hours with a single charge 2 2 SYSTEM CONFIGURATION The setup mode in the Screen 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 Screen amp Go do the following Switch on the Screen amp Go and make the following keystrokes on the joystick one after another and leaving a short interval of time between each of them 4 4 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 Select MORE OPTIONS B Select CUSTOMIZE C E B 03027 11698 42 SCHEDULED TEST F CHANNELS CONF MANUAL SYSTEM START 534 70S MU2 e REV 1 06 Screen amp Go User s Manual 29 02 11 4397 12 04 MAINTENANCE BLUETOOTH BACK 2 3 INITIAL DEVICE SETUP 2 3 1 SETTING THE DATE AND TIME Once in the CUSTOMIZE screen follow these steps in order to change the date and time the Screen amp Go a LANGUAGES e Select DATE AND TIME E BATTERY e Use to access each INTERNAL CONF of the options to set the date and time in the device Use and to modify t

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