Porti 8 user manual
Contents
1. A Warning Applying the device to more than one patient at any one time is not allowed A Warning When applying sensors to the patient please ensure that no electrical line of the device is in contact with any other electrical conductive parts including ground A Warning Avoid placing this instrument in direct sunlight or in close proximity to intense heat Prevent also the contact with dust lint dirt moisture and liquids A Warning Children or incompetent persons should not use this device unattended without first having obtained ins tructions for the safe use of the device Ensure that infants children and animals cannot touch the device unattended 2 2 General information This instruction manual should be regarded as a component of the device It should be kept on hand somewhere near the device at all times Reading and understanding the instruction manual is a prerequi site for proper use and correct handling of the device in order to maintain the safety of the patient and operator The guarantee is valid for a period of 24 months for the device and 6 months for the equipment from the date of sale Only accessories which are listed in this instruction manual should be used with the device We cannot guarantee the safe operation and function of the device if unknown proprietary accessories consum ables are used that have not been tested E g Patient leads Sensors Consumables Memory cards etc Dama2. PORTI S SLEEP DOC Description and instructions for use Specialist Sleep Solutions Niis E Dr Fenyves und Gut Deutschland GmbH PORTI S SLEEP DOC Table of Contents 1 Introduction uuennsserennnnennnnnnnennnnnnnennnnnnnennnnnnnnnn 2 1 1 Assigned Purpose uunssnsssnsssnnnnsnnnnnnnnnnnnen 2 1 2 Accessofi 8 a nun naked 2 2 Information uneeresnnneennnnnnnennnnnnnnnnnnnnnnnnnnn nn 3 2 1 Safety related information 3 2 2 General information 3 2 3 Technical inspection u e nennen 4 2 4 Liability for functioning or damage 4 3 Recording measurement data using the Porti An 4 ES A seen san niania 4 3 1 1 Sensors for flow and snoring NoiSes 4 3 1 2 Thermistor sensor for breathing 4 3 1 3 Sensor for CPAP Bilevel pressure 4 3 1 4 Sensor for oxygen saturation and pulse frequency en A ET RT er ee ET DE i 5 3 1 5 Sensor for thorax and abdominal movement 5 3 1 6 Sensor for body position uesseenennenennn gt 5 3 1 7 Sensor for leg movement u seeneenennnnnn 5 3 1 8 Sensor for ECG sir aiioa aeni 5 3 1 9 Sensor for Neuropott unnseenssenssnensnennnnnnnnennnn 5 3 1 10 Sensors for EEG EOG EMG 6 3 2 Preparing for measurement Ambulatory 6 3 3 Attaching the Porti unit and starting the meas rement
3. sissors nian 6 3 4 Online Measurements Inpatient 7 4 Service and Maintaining the device 7 4 1 Charging the battery ennnnen 7 4 2 Cleaning instructions 7 4 3 Maintenant Ossona 7 4 4 Transport and storage conditions 7 5 Evaluation software for PC unueeesenennnnnennenenn 7 5 1 Installing the software 7 5 2 Selecting a printer neennnenneneennnnennnnenn 8 6 Troubleshooting urreennnennnnnnnennnnnnnnnnnnnnnnnnnn 8 7 Ordering informations neuunnsnnnnennnnnnnnnnnnnnnnn 9 8 Technical specifications uneennneenennnnnnnnnn 10 9 Used Symbols u 2 10 10 Index 2 2 een a 11 11 EC Declaration of conformity unsseen 12 REV 2014 11 17 Dr Fenyves und Gut Deutschland GmbH G PORTI 8 SLEEP DOC 1 Introduction 1 1 Assigned Purpose The Porti 8 Sleep Diagnosis System is a recording system for outpatient and clinical use It serves as a differentiated diagnosis for the sleep apnea syn drome The Porti unit enables continuous recording of up to 40 channels for at least 15 hours without loss of data lt records signals for the following physiological variables Flow Oxygen saturation SpO2 Pulse frequency Pulse wave Body position Respiratory and snoring sounds CPAP pressure Ambient Light Thorax effort Abdomen effort optional e Thermisto
4. DSUB connector has to be extended with Lemo DSUB extension infants 15 50kg Extension Lemo DSUB for Porti and infant sensor Dr Fenyves und Gut Deutschland GmbH PORTI S SLEEP DOC 8 Technical specifications e Dimensions 35mm x 75mm x 168mm H x W x L without bag e Weight 260 g including storage battery without bag e Housing metallized plastic polystyrol UL 94HB e Temperature range 5 0 45 C e Moisture 25 95 e Storage media Internal flash memory e Storage capacity min 24 hours e Registered parameters Respiratory activity Differential pressure measurement via flow prong with adaptor also during CPAP therapy alternative or additional measurement by means of thermistor possible option Thoracic effort Differential pressure measurement by means of rubber cuffs built into chest strap Abdominal effort Differential pressure measurement by means of rubber cuffs built into abdomen strap Breathing sounds Phonometric transducer via flow prong SpO Pulse Built in pulsoximeter SpO measurement range 80 99 2 SpO2 60 79 4 SpO Pulse measurement range 50 1 min 150 1 min 2 Finger sensor special rubber coated thimble finger sensor Pulse wave Plethysmogramm display measurement via fingersensor Position Acceleration sensor for position recording 5 positions Ambient Light Photometric measurement and light Intensity display CPAP Bi level Differential pressure m
5. Ensure the battery is fully charged see Page 7 2 Apply the device and connect all sensors to the patient see Page 6 3 Connect the Porti unit switched off to your PC using the USB interface cable 4 Start the Porti software on your PC 5 Complete the Patient data fields in the menu item Porti Online Record and start the trans fer 6 Switch on the Porti unit by sliding the switch to the right position The device can be switched on also direct after attaching the device to the patient 7 Perform impedance test and biosignal calibra tion see the online help of the software 8 Once the test is complete the following mor ning click the stop button stor to end the mea surement 9 Switch the Porti device off by sliding the switch to the left position 4 Service and Maintaining the device 4 1 Charging the battery The Porti 8 unit is equipped with a special fast charge Li lon battery The battery charging adaptor included with your device is specially designed for this type of battery and should only be used with your Porti 8 unit A full charge allows one measurements of 15 hours to be performed Caution It is not allowed to use a different battery charger than the one provided Battery charging procedure e Connect the battery charger adaptor to the Porti device e Plug the charger into a power outlet e The charger LED will illuminate white As soon as the battery is charged the LED wi
6. Rx Council Directive 93 42 EEC concerning m medical devices in 14th June 1993 Protection class II gt O hb Type BF um Protect the device from moisture and liquids Online operations In online operation with a patient an optical waveguide to the PC is Meaning Electrical and electronic devices may not be disposed of with domestic waste Consumers are obliged by law to return electrical and electronic devices at the end of their service lives to the public collection points set up for this purpose or point of sale Details to this are defined by the national law of the respective country This symbol on the product the instruction manual or the package indicates that a product is subject to these regulations By recycling reusing the materials or other forms of utilising old devices you are making an important contribution to protecting our environment 10 Dr Fenyves und Gut Deutschland GmbH PORTI S SLEEP DOC 10 Index Abdominal SENSO sssrin 5 ACCOSSOM OS ieia een 2f Assigned PUTOS ccoooocccoccncoccccnononcnononnnnnanonanncanannnos 2 Attaching the PoOrbli o oooonnocccnninicicinnnccccnnnnnnccninnnnnnnn 6 Attaching the SenSOFS oococcinncccccnononccononananancnnnnnnnnn 5 Battery CharQing cccecessccceeeseccceeseeeneeeseeeneeeeneees 6 Charging the battery nnnennnnnnennnnn 7 Cleaning instructions nunsseenssneennnenennnnnnennnn 7 CPAP SONS Ol
7. attach the ECG electrodes 2 Secure the Porti unit to the thorax using the elasticated thorax belt with the two built in pockets Apply the belt whilst in the standing position and exhale A correctly fitted belt should not slip up or down once fastened To record abdominal breathing attach the abdominal belt with the single built in pocket around the stomach in the same way Always ensure the belts are fitted over the night clothes and not directly onto bare skin 3 Check the position of the pressure transducers black rubber pads The sensors should be fully inserted into the built in pockets sewn onto the belt Never pull on the tubing connected to the pressure pads 4 Apply the flow prong and or respiratory ther mistor to the nose or fix the adapter hose to the CPAP mask 5 If applicable attach the leg sensor the Neuro Port electrode and the neurological splitter box 6 Apply the finger sensor SpO2 to a finger and secure the cable to the wrist using the velcro armband Whilst doing so ensure that you do not apply pressure to the finger thereby disturbing the blood flow 7 If no automatic start was predefined the Porti unit has to be switched on using the slider towards the right Otherwise the Porti unit will automatically switch itself on at the predeter mined time Both LEDs light up briefly for testing purposes If all sensors have been connected correctly the red LED will go out The green LED blink
8. once a month Upon reaching the end of its service life the device and its accessories should be disposed of in accordance with the WEEE Directives or relevant Electronic Disposal protocol For further details please contact Dr Fenyves and Gut 2 3 Technical inspection Only devices that are regularly checked and main tained are deemed safe to use It is recommended that units are subject to a test protocol and the battery is replaced every 24 months For more details on servicing and service contracts please contact the F amp G Customer Service Depart ment or your service provider The following tests need to be carried out by the operator before each measurement e Visual inspection of the device and accessories for obvious damage which could result in mechanical failure e Testing all hose connections are air tight e Testing the thorax and abdominal sensors for leaks e Checking the display LEDs e Testing the pulse and SpO2 finger sensors and carrying out a plausibility test timed pulse test using e Checking the CPAP pressure e Testing the battery capacity 2 4 Liability for functioning or damage In the event of improper use or repair by the owner or operator the liability for the device will be transferred to those parties F amp G shall not be liable for damages arising from non observance of this instruction manual The actual guarantee and warranty condi tions in the F amp G terms of sale delive
9. C Pulse oximeters not responding The channels for oxygen saturation and pulse frequency are registering 50 and 30 P min respec tively despite the patient being connected First check that the finger sensor is seated correctly on the patient and remove any nail polish that may be present A small red light should be present in the sensor when the finger is inserted If the light doesn t switch on when the sensor is applied to the finger then you need to check the connection at the Porti unit and any intermediate extensions Printout not working The printer prints characters on the page but in no apparent format The wrong printer or printer driver has been installed The printer is not responding to the print command Check the printer cable and the connections to the printer and PC The printer should be switched on and operational i e the control LED s on the printer should be lit Cannot establish connection to the Porti unit The USB cable is not connected correctly Check the connection of the USB cable to the Porti unit and the PC USB interface was deactivated The USB interface can be activated in the Porti device software Select the Porti tab followed by menu Settings Battery is discharged Charge the battery correctly For clarification and in case of problems during the installation maintenance or use please refer to your local distribution partner or directly to the manufacturer 8 Dr F
10. art The QM system according to EC Directive app Il 3 is controlled by notified body no 0483 Medical Device Certification Verantwortlich f r die Bereithaltung der Technischen Dokumentation ist der Gesch ftsf hrer Herr Andreas Faulhaber The responsible person for the supply of the technical documentation is the General Manager Mr Andreas Faulhaber Diese Konformit tserkl rung ist g ltig bis 2019 01 03 This declaration of conformity is valid until 2019 01 03 U kolky Andreas Faulhaber Gesch ftsf hrung Hechingen 2014 05 19 f2 DeVilbiss Healthcare Ltd Unit 3 Bloomfield Park Bloomfield Road Tipton West Midlands DY4 9AP Tel 44 0 121 521 3140 Fax 44 0 121 521 3141 enquiries devilbisshc com www devilbisshc com
11. de during the study The blue marked connecting plug of the EEG electrode cable needs to be plugged into the blue socket on the Porti unit 5 Dr Fenyves und Gut Deutschland GmbH RG PORTI S SLEEP DOC 3 1 10 Sensors for EEG EOG EMG For the neurological channels EEG EOG EMG all commonly available types of electrodes with 1 5mm safety plugs can be used To connect the electrodes to the device the splitter box is required The green plug of the splitter box has to be connected to the green socket of the device For application and cleaning of the electrodes please refer to the manufacturers instructions Note In order to guarantee good adhesion of the electrodes and strong frequency signals clean the desired skin area with a sterile solution and apply a good quality conductive cream 3 2 Preparing for measurement Ambulatory In preparation of an ambulatory study where the patient will use the device at home please ensure the following 1 Charge the battery see Page 7 2 Connect the Porti unit with the USB interface cable 3 Start the Porti software on the PC 4 Fill out the fields relating to personal data of the patient in the menu item Porti Porti Initia lisation or select the following tab button D and start the transfer 5 Switch on the Porti unit by sliding the switch to the right For self testing purposes both LEDs will light up initially The red LED w
12. dominal movement The sensors used for recording thorax and abdomi nal movement consists of small rubber pressure pads that are connected to the Porti device via mea suring hoses The sensor for recording thorax move ment comprises of two pressure pads whereas the sensor for abdominal movement contains only one The sensors are inserted into the pockets of the elas ticated effort belts The thorax belt is applied at the height of the sternum the abdominal belt in the stomach region For hygiene reasons and to avoid allergic reactions the belts should be worn over clothes The red connector of the thorax sensor needs to be attached to the red connector and the black connector of the abdominal sensor needs to be attached to the black connecor of the device The effort belts are adjustable in size due to the Velcro fasteners and should be suitable for most patients These belts are however also available in special sizes Note Overstretching of the belts may result in poor signals and possible loss of data 3 1 6 Sensor for body position The position sensor integrated in the Porti unit displays information related to the patient s body position during the study For accurate determination of body position ensure the Porti device is applied to the patient correctly The body positions detected are Supine Prone Left side Right side Upright 3 1 7 Sensor for leg movement To diagnose restless or periodic leg mov
13. e can result in cross infection 3 1 2 Thermistor sensor for breathing Additional to the flow prong a Thermistor can be used to measure the breathing Please also observe the instructions accompanying the sensor The brown connector of the Thermistor needs to be attached to the brown connector on the Porti unit 3 1 3 Sensor for CPAP Bilevel pressure When performing measurements on a patient under going CPAP therapy an adapter hose is used instead of the flow prong 4 Dr Fenyves und Gut Deutschland GmbH RG PORTI S SLEEP DOC The blue connector of the CPAP adapter needs to be attached to the blue connector on the Porti unit 3 1 4 Sensor for oxygen saturation and pulse frequency A pulse oximeter has been integrated into the Porti device for the purpose of measuring oxygen saturation and pulse frequency When using a finger sensor please use the Velcro wrist armband to secure the sensor and cable The use of adhesive tape to secure the sensor may result in allergic reactions to the patient adhesive residue damaging the sensor loss of data Please ensure that blood circulation at the point of measurement is not affected by the manner in which the sensor has been secured All nail polish coloured or clear must be removed from the measuring finger to obtain useable data Please read and understand the instructions accom panying the finger sensor 3 1 5 Sensor for thorax and ab
14. e software To install the Porti software program place the CD supplied with your device into the CD ROM drive of your computer The program will automatically run If the program does not run automatically open the Explorer option on your operating system and select the CD ROM drive Once selected double click the Setup exe file from the software es Dr Fenyves und Gut Deutschland GmbH EG PORTI S SLEEP DOC You can check your computer and network if applicable for Porti software versions that may have been previously installed To ensure the correct up to date version is selected open the software installed and click the Search button The program will then automatically find and use the latest version installed Note Alternatively you can update the software by selecting menu item Tools Update from the soft ware Only for updating the software After selecting the target drive the installation pro gram will now automatically create the necessary directories and copy all the required files to the hard drive The installation will automatically insert a new group containing an entry for the new software in the Programs folder of the Start Menu In addition a shortcut on your Windows desktop will be created After successful installation remove the CD and store itin a safe place 5 2 Selecting a printer The measurement curves and reports can be printed on any commonly available type of prin
15. easurement directly on CPAP mask Measurement range OcmH O 45cmH20 5 Neuroport Special electrode for frontal lead option Leg movement Two leg sensors EMG for measurements of muscular actions separate recording for left and right leg connection via 1 5mm safety plug option ECG 6 channel lead via adhesive electrodes option Central heart frequ Measurement range 30 1 min 200 1 min 2 option PTT Measurement range 100 ms 355 ms 4 option Syst blood pressure Measurement range 60 mmHg 315 mmHg 4 option EEG 6 channel lead via adhesive electrodes option connection via 1 5mm safety plug Impedance 10 MO frequency 0 2 Hz 70 Hz EOG 2 channel lead via adhesive electrodes for left and right eye option connection via 1 5mm safety plug EMG Bipolar measurement EMG of muscular actions of the chin via adhesive electrodes option External channels External box with voltage input RJ45 0 2 5 V for up to 8 external channels with galvanic separation and RJ45 jack e Fault indicator 2 LEDs on front of the device e Power supply Rechargeable Li Ion storage battery 3 7 V with built in Semiconductor safety e Charger Plug in power supply with medical approval e Output USB interface with cable for data transmission e Power consumption Approx 160mA indispensable option 9 Used Symbols Symbol Meaning Symbol Pay attention to the instructions for use CE mark This device complies with the
16. ements restless leg the Porti device can be equipped for each leg with a sensor and internal recording soft ware optional The device then enables continuous recording of leg movements and associated analysis results in the report Attaching the leg sensor All commonly available types of electrodes with 1 5mm safety plugs can be used for both bipolar EMG channels To connect the electrodes to the device the splitter box is used The yellow marked connecting plug of the splitter box needs to be plugged into the yellow socket on the Porti unit For application and cleaning of the electrodes please refer to the manual of the manufacturer For long time electrodes a very careful preparation of the skin is necessary 3 1 8 Sensor for ECG The supplied ECG cable optional is compatible with all commonly available adhesive electrodes and can be used as consumables Attaching the ECG electrodes Yellow NN Green Black The red marked connecting plug of the EEG electrode cable needs to be plugged into the red socket on the Porti unit 3 1 9 Sensor for Neuroport The Neuroport signal is obtained via the supplied EEG cable optional We recommend special 3 part EEG electrode strips as consumables The 3 part EEG electrode strip needs to be applied to the forehead Before applying the electrode the forehead must be cleaned with a sterile solution A headband around the forehead will eliminate movement of the electro
17. enyves und Gut Deutschland GmbH G PORTI 8 SLEEP DOC 7 Ordering informations Art No Spare parts consumer material Accessories 920 102 Finger sensor SpO2 HP finger cuff with cable and Lemo plug 925 305 Velco wrist strap to fix finger sensor cable to the wrist 1 PU 5 pieces 920 310 Flow prong nose spectacles for flow measurement PU 10 100 500 920 314 Thermistor for Porti with Lemo connector reusable 920 315 Thermistor for Porti disposable 920 316 Thermistor set for Porti 10 x Thermistor disposable Art No 920 315 connection cable 2m Lemo plug 920 307 Flow pronge with O2 connector nose spectacles for flow measurement during oxygen therapy 920 309 Flow prong Nasal Oral with separate mouth tube 925 241 Adapter hose for flow prong for connection with Porti basic instrument 20cm 925 246 Nipple for flow prong adapter hose blue 925 220 CPAP adapter hose for CPAP mask 920 221 Nipple for CPAP mask 1 PU 10 pieces 925 233 CPAP Adapter hose for CPAP Mask Resmed 925 231 CPAP Adapter hose for CPAP Mask Respironics 925 234 CPAP Adapter hose for CPAP Mask SleepNet Viasys 925 705 Manometer for quick control of CPAP pressure 925 140 Thorax sensor complete 2 pressure pads flexible connection tubes 928 281 Carrying strap for Porti 8 flexible blue with connection to splitter box 928 427 Size S 928 283 Carrying strap for Porti 8 flexible black with connect
18. ges resulting from the use of third party accessories or consumables shall render this warranty void The manufacturer will only assume responsibility for the device in terms of safety reliability and function if 1 assembly add ons reinstallation changes and repairs are carried out by the manufac turer or a qualified agent authorized by the manufacturer to do so 2 The device is used in accordance with the instruction manual Dr Fenyves und Gut Deutschland GmbH RG PORTI S SLEEP DOC All printed material relates to the model of the device and the safety regulations at the time of printing All devices switches processors software programs and names contained herein are subject to copyright law F amp G shall only be liable for the malfunction of the device and its software if used in the normal operating conditions in accordance to this manual If a PC is included in delivery third party software is not allowed to be installed on this PC Medical devices must only be operated by a qualified experienced person s to ensure correct handling of such devices The operator must read and understand the user manual to operate the device correctly The operator must check the functionality of the device before each use to ensure it is in sound condition and in good working order Functional testing of the device must be carried out at regular intervals It is recommended that this is conducted
19. ill then go off The green LED on the Porti unit will remain lit for the duration of the initialization process 6 In the next step of the Initialization process you have the option to choose Timer Controlled or Manual recording Timer controlled recording start A dialogue window will be displayed in order for the operator to determine the start time for recording The Porti unit needs to remain switched on after this time The unit will now rest in stand by mode until the selected Start Time of the recording The unit will then automatically switch on and start recording data Never switch off the Porti sliding switch during use Manual recording start Once the unit has been successfully initialized both LEDs will flash confirming ready for use The Porti unit now needs to be switched off sliding the switch to the left After fitting the device the patient will need to switch the unit on before going to bed by sliding the switch to the right 7 The Porti unit is now ready for use The unit can now be disconnected from the PC Note remove cable by pulling on the plug not on the cable 3 3 Attaching the Porti unit and starting the measurement In order to ensure reliable recording of data you need to observe the following points when attaching the Porti unit and sensors Before ambulatory measurements these steps should be demonstrated and practised with the patient beforehand in the clinic 1 If applicable
20. ion to splitter box 928 427 Size M 928 284 Carrying strap for Porti 8 flexible red with connection to splitter box 928 427 Size L 925 395 Abdomen sensor complete 1 pressure pad connection hose 928 388 Abdomen strap Porti 8 flexible blue with connection to splitter box 928 420 Size S 928 389 Abdomen strap Porti 8 flexible black with connection to splitter box 928 420 Size M 928 390 Abdomen strap Porti 8 flexible red with connection to splitter box 928 420 Size L 928 400 ECG electrode cable Porti 8 to record the ECG signal 925 025 ECG adhesive electrodes PU 500 pieces 928 425 EEG electrode cable for Neuroport module automatic sleeping stage classification 925 046 EEG adhesive electrodes PU 150 pieces 925 052 Headband to fix EEG elecrode cable blue 928 420 Splitter box LEG with cable Porti 8 for connection to leg EMG electrodes 928 421 Cable for splitter box LEG 105 cm length black reusable Art No 928 422 928 427 928 501 928 502 928 160 928 357 928 204 928 302 928 301 925 501 Art No 925 150 928 286 925 396 928 393 920 303 920 114 920 115 920 116 920 112 Spare parts consumer material Accessories Cable for splitter box LEG 105 cm length white reusable Splitter box NEURO with cable Porti 8 for connection to EEG EOG EMG electrodes 14 pol EC2 Grass adhesive electrode cream 100g Skin Pure abrasive skin preparation Gel 2 x 135g USB cab
21. le for data transmission between Porti and PC Electrical isolator USB for galvanic seperation bet ween Porti device and PC during online measurement complete with adapter Power adapter Friwo for Porti with lemo connector medical approval Shoulder bag cloth bag with shoulder strap for carrying Porti Carrying case gray plastic case for unit and accessories 2 Years Inspection for SleepDoc Porti e Check and adjustment of all measurement functions Calibration of CPAP pressure Alignment of all filters e Replacement of the rechargeable battery e Upgrade of firmware in the device e Update of PC software Final inspection European Standard ISO 13485 Extension of the guarantee period for other 2 years Spare Parts Accessories for use with children Thorax sensor complete 2 pressure pads with flexible connection tubes red marked and lengthened tube for positioning Porti near child Thorax strap for children flexible black with connection to splitter box 927 420 Size XS Abdomen sensor complete 1 pressure pad with flexible connection tube black marked and and lengthened tube Abdomen strap for children flexible black Size XS Flow prong for children PU 10 pieces Infant sensor Philips SpO2 with DSUB connector has to be extended with Lemo DSUB extension infants 1 4kg Infant sensor Philips SpO2 with lemo connector no extension required infants 4 15kg Infant sensor Philips SpO2 with
22. ll illuminate blue The device can remain connected to the charging adaptor for a long period of time without suffering any damage 4 2 Cleaning instructions The flow prong is designed for single patient use and should not be used more than once or on different patients The finger sensor thermistor leg movement sensor and the electrodes can be cleaned using a moist cloth or if necessary by using disinfectant You should never however immerse the sensors in liquid Any adhesive residues that may be present should be removed regularly e g using alcohol swabs The RLS sensor wire is very fragile Special care is required when cleaning this sensor The thorax and abdomen belts can be machine washed at temperature of 60 C Please ensure to remove the pressure pads from the belts before placing in the washing machine The bag can be cleaned using moist disinfectant wipes observe the detergent manufacturer s instruc tions 4 3 Maintenance We recommend the device including all accessories is serviced every 2 years The servicing should only be carried out by the manufacturer or by an authorised agent Calibration of the CPAP channel should be carried out once a week by the user 4 4 Transport and storage conditions The ambient temperatures for transport and storage are between 5 C and 45 C The maximal humidity may not exceed 95 condensation has to be avoided 5 Evaluation software for PC 5 1 Installing th
23. nalysed on a standard commercial PC The measurement curves and the analysis results can be printed on all commonly available printers including dot matrix laser or ink jet printers The OR5 Online Recording analysis program has the following minimum configuration requirements PC with Windows operating system e Microsoft Windows XP Windows Windows 7 Windows 8 512 MB of RAM 2 GB recommended 1 GB of disk space on the hard drive CD Rom drive for installation Mouse 128 MByte VGA graphics card with a resolution of at least 1024 x 768 512 MB 1280 x 1024 True Colour recommended e Free USB port Printer with Windows driver Vista This manual is intended to give the operator and user general information on how to safely handle and operate the SleepDoc Porti device It also explains the intended use of the unit the different sensors and connections The next chapter guides you through the PC software installation followed by a trouble shooting guide should you encounter any problems with the SleepDoc Porti device Technical specifi cations spare parts and accessories list and an index complete the manual e Dr Fenyves und Gut Deutschland GmbH G PORTI 8 SLEEP DOC 2 Information 2 1 Safety related information A Observe the instruction manual Every use of the device requires exact knowledge and observance of this instruction manual The device is only intended for the u
24. nnnns 2 11 11 EC Declaration of conformity EG Konformit tserkl rung SleepDoc Porti Dr Fenyves und Gut Deutschland GmbH Anschrift Lotzen cker 9 Address D 72379 Hechingen Medizinprodukt Schlaf Diagnoseger t Medical Device Sjeep Diagnosis Device UMDNS Code Device Group riskclass rule 13 085 Polygraph SleepDoc Porti 7 2a 10 17 458 Polysomnograph SleepDoc Porti 8 2a 10 Wir erkl ren in alleiniger Verantwortung Das oben beschriebene Medizinprodukt ist konform mit We declare under sole responsibility The medical device described above is in conformity with EG Richtlinie 93 42 EWG Anhang II 3 des Rates vom 14 06 1993 ber Medizinprodukte EG Richtlinie 2011 65 EU des Rates vom 08 07 2011 ROHS II Richtlinie Council Directive 93 42 EEC App Il 3 14 06 1993 concerning medical devices Council Directive 2011 65 EU 08 07 2011 ROHS II Directive zus tzliche Angaben Additional information Die Entwicklung Herstellung und der Vertrieb der Produkte wird durch ein QM System gem den Forderungen der ISO 13485 des Medizinproduktegesetzes unterst tzt Development manufacture and distribution of the medical devices are supported by a QM system in accordance with the requirements of ISO 13485 the act on medical devices Das QM System nach EG Richtlinie Anhang 11 3 wird berwacht durch die Benannte Stelle Nr 0483 Medical Device Certification GmbH Kriegerstra e 6 D 70191 Stuttg
25. r e 6x ECG e Central heart Frequency PTT Pulse Transit Time Systolic Blood Pressure 3x EMG Leg movement Chin e Neuroport Frontal EEG 6xEEG 2xEOG 8x Analogue channel 1 2 Accessories The SleepDoc Porti system as a whole contains two components The microprocessor controlled Porti recording device e PC software for measurement data presentation and PC analysis It is also equipped with the following accessories e USB Interface cable for data transfer between the Porti unit and PC e SpO2 finger sensor with cable for obtaining pulse frequency and oxygen saturation values e Velcro strap for securing the finger sensor to the wrist Flow prongs for obtaining the respiratory signal The 20 cm long adapter hose is identified by a blue ring e Adapter hose for measurement during CPAP Therapy e Flexible carry belt with integrated pressure transducers thorax effort to fasten the Porti unit to the patient e Flexible belt with integrated pressure transducer to record abdominal effort e Battery recharger e Shoulder bag for storing the Porti unit e Transport case optional e Splitter box for connecting the Leg sensors e ECG electrode for recording ECG signals e EEG electrode for recording the forehead EEG signals e Splitter box for connecting the EEG EOG EMG signals e Thermistor for additional breathing detection e Analogue Input Connection incl Splitter Box The data can be displayed and a
26. ry are not exten dable 3 Recording measurement data using the Porti unit 3 1 Sensors 3 1 1 Sensors for flow and snoring noises The detection of patient flow is determined by the use of a nasal flow prong that transmits the pressure signal to an internal pressure transducer of the device The flow prong can be easily applied by the user and will have no adverse affect on the quality of sleep The use of a flow prong also eradicates the problem where adhesive sensors cannot be used i e patients with beards In addition the flow prong is an economical choice of sensor as it is commonly available No additional sensor is required for respiratory and snoring detection Respiratory sounds are trans mitted to the Porti unit via the flow prong The built in microphone detects the sounds which are then electronically analysed Therefore additional micro phones are not required Due to the high sensitivity of the internal pressure transducer the Porti device is capable of measuring and recording ultra fine pressure differences associated with patients who mouth breathe In order to connect the flow prong ensure the blue connector of the prong attaches into the blue connector of the device The flow prong should be used in accordance with the manufacturer s instructions A Warning The flow prong is intended for single patient use No attempt should be made to clean or use the flow prong the more than once Multiple us
27. s at regular 4 second intervals The red LED signals a faulty pulse signal Check the finger sensor and cable Once the patient has been educated on fitting the device the device can then be packed into its hard carry case for the patient to take home The patient can refer to the quick reference guide when fitting the device at home When going to bed the patient needs to Attach the Porti unit using the elasticated thorax 6 Dr Fenyves und Gut Deutschland GmbH RG PORTI S SLEEP DOC belt Attach the flow prong and finger sensor e If applicable attach the abdominal belt leg sensor ECG and EEG electrodes e Check that the sensors and their connectors are positioned correctly e If manual recording start was selected Switch on the Porti unit by sliding the switch to the right The next morning Stop the measurement by switching off the Porti e Detach the Porti unit and sensors and return all parts to the case Cleaning of the sensors will be carried out by the technical staff at the clinic or hospital Bring the case back to the clinic or hospital e For automatic evaluation the measurement can be transferred to the PC using the device software Select the Porti tab followed by Read measurement from device or select the following tab button wy 3 4 Online Measurements Inpatient Please adhere to the following steps when perfor ming an online measurement 1
28. se described herein A Patient instruction Patient instruction must only be carried out by the doctor or staff authorized by that person The enclosed quick reference cannot take the place of the manuals instructions and warnings about possible hazards A Do not open the device A Warning For online measuring you must use an electrical or optical isolator for connection of the device to the PC available from your home care provider A connec tion of the device to the PC without electrical or optical isolator is only allowed if all patient connec tions have been removed first Only Physicians or trained staff is allowed to perform online measure ments A Warning Magnetic and electrical fields can impact on the func tioning of the device When operating the device en sure that all third party devices being operated in the vicinity are meeting their relevant EMC requirements X Ray equipment HF surgical devices tomography devices etc can interfere with other devices as they may emit higher levels of electromagnetic interfe rence A Warning The device has no defibrillator protected application parts A direct application of the device to the heart esp ECG is not allowed A Warning Using multiple devices for patient screening could re sult in excessive leakage current above the allowed value A Warning Using the device together with pacemakers can result in disturbances of the pacemaker or the device
29. ter ink jet dot matrix or laser printer that is already installed on your Windows system The correct printer driver can be selected using the Windows Control Panel application 6 Troubleshooting Channels e g CPAP are missing in the display The channels are deactivated and therefore do not appear during Test and Record Check which channels are active for recording using the menu item Options Channel settings Channels are missing after loading a measure ment They were not recorded or have been hidden for measurement data display Flow signal is missing during recording or follows the edge of the range The flow signal follows a straight flat line in the middle of the channel Check the flow prong on the patient and the connec tion on the Porti unit When measuring during CPAP therapy check the connection of the CPAP adapter hose on the CPAP mask and on the Porti unit Signal amplitudes are very small or do not appear Check the corresponding sensors on the patient and their connections to the Porti unit Whilst doing so check that the tube hoses and the black pressure pads of the thorax sensors are intact A leaking sen sor can cause inaccurate readings in the thorax channel The pressure pads should be attached to the patient securely without over tightening the belt and the tube hoses should be routed in such a way that they cannot kink Check all cables and connectors on the Porti unit and the P
30. tigsscessectecaceiessect uel ceieceessectingideesdansueaec 4 Declaration of conformity 12 DISPOSAL E E E E E 4 EEG are A E E E 6 EMG einen 6 Sn 6 EQUIPO 2 PINGO SONS OF evvsrccita carrasco el 5 Flow pfong dit rica 4 Flow sensor 4 Functional testing u 4444enn nennen 4 Information da 3 Installing the software 7 Leg MOVE OMdiecccconncccccnonacccnnononcnnnnnoncnnnnnanccnnnnanennns 5 MaintenanC E sirsenis naaie 7 Neurona da daa 5 Optical iSOlatOr ooooocinnndininininnnconnccnnncccnnnrcnnanarccnno 3 Ordering inforMati0NS concocinncconncccnnnccnoncccnanann nono 9 Pacemaker nee 3 Positi n sensor n enee nahen 5 Preparing for measurement 6 Press re Pads nn 5 Safety related information 3 Selecting a printer 0unennnneennnnnnnnennnnnnnnn 8 A E 4 Starting the measurement ennennenn 6 SYM DOS is au 10 System requireMent cceceeceeeeeeseeeseteeteneeeseaes 2 Technical inspection uusrssnssensennnnnnannnnnnnn 4 Technical specifications u en 10 Thermist r unn aneenaeen ne 4 Third party accessories 3 Third party software unennnnnnnnennnnennennnnnnnnn 4 Thorax sensor een 5 Transport and storage conditions 7 Troubleshooting uu 44444Hnn ernennen nnnnnnennnnnn nn 8 Wananiy nereseno i lla 3 Whole SysteM ooccccconoccccnnooncccnnonncnnonnnnnnnnnnnannnnnn
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