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SOMNO

check

micro

SOMNO

check

micro CARDIO

Sleep apnea diagnosis set

Instructions for Use

Содержание SOMNOcheck micro

Страница 1: ...SOMNOcheck micro SOMNOcheck micro CARDIO Sleep apnea diagnosis set EN Instructions for Use...

Страница 2: ...on to the PC 34 5 Operation 35 5 1 Prepare a recording 35 5 2 Give patient instructions 35 5 3 Perform a recording 36 5 4 Cancel recording 38 5 5 After the recording 39 5 6 Read out results 40 5 7 Ins...

Страница 3: ...verview 1 1 Device 2 Button 3 Connection for pulsoximetry sensor CARDIO Sensor 1 Connection for diagnostic nasal cannula 5 Display 4 Attachment for wristband 6 Wristband 7 USB port 8 Rubber cover 9 Ba...

Страница 4: ...nection for pulsoximetry sensor CARDIO Sensor This is where the pulsoximetry sensor is connected 4 Attachment for wristband You can attach the pulsoximetry sensor or the CARDIO Sensor here 5 Display T...

Страница 5: ...uer lock adapter is used to connect the diagnostic nasal cannula to the device 3 Diagnostic nasal cannula You can use the diagnostic nasal cannula to detect your patient s respiratory flow and snoring...

Страница 6: ...6 Overview EN 1 3 Menu structure for signal control mode recording mode Signalkontrollmodus Aufzeichnungsmodus Signal control mode Recording mode...

Страница 7: ...Overview 7 EN 1 4 Menu structure for results display SOMNOcheck micro...

Страница 8: ...8 Overview EN SOMNOcheck micro CARDIO...

Страница 9: ...gnals Floppy disk symbol with arrow indicates that a recording is in progress Results display if no sensor is connected Name Name Name of patient Page is not shown if neither the name nor the recordin...

Страница 10: ...nts AHI Apnea Hypopnea Index number of apneas and hypopneas per hour within the artifact free evaluation time of the flow signal OAHI Obstructive Apnea Hypopnea Index number of obstructive apneas and...

Страница 11: ...may be less than RDI especially if there has been no differentiation between central and obstructive apneas due to arrhythmias CRDI Central Respiratory Disturbance Index number of central apneas and h...

Страница 12: ...s caused by increased respiratory effort If the warning Check for arrhythmia AFib has been issued the device does not supply a result here O2 saturation Oxygen saturation Drops Desaturation index numb...

Страница 13: ...The device can be configured from SOMNOlab Version 2 11 Analysis time Duration of artifact free recording Flow rate Flow signal Pulse Pulsoximetry signal Erase data Erase measured data To erase press...

Страница 14: ...for sleep disturbance HIGH as the highest individual risk is red AAI Risk level Color Meaning None No data available Green The risk is low LOW if all the values are in the range shown here AHI 10 RDI...

Страница 15: ...me and hypoxemic status These data are used for calculation in a complex algorithm and the final result is a CRI between 0 low risk and 1 high risk Risk level Color Meaning None No data present becaus...

Страница 16: ...16 Overview EN 1 8 Display of charging state Symbol Meaning 100 capacity 75 capacity 50 capacity 25 capacity 10 capacity symbol flashes 0 capacity device switches off after 10 seconds...

Страница 17: ...tion in the instructions for use Do not dispose of the device in domestic waste Protection class BF CE symbol confirms that the product conforms to the applicable European directives Protection agains...

Страница 18: ...s can be used 4 Connection for diagnostic nasal cannula Pulsoximetry sensor Do not dispose of the device in domestic waste Date of manufacture Diagnostic nasal cannula Intended to be used once and the...

Страница 19: ...to avoid the hazard There are three levels of warning instruction depending on the degree of hazard DANGER Indicates an unusually large hazard If you do not follow this instruction severe irreversible...

Страница 20: ...at a patient s home or in hospital The doctor and specialist staff instructed by the doctor provide the patient with instruction in the functions of the device and how to use it The screening results...

Страница 21: ...wards The results are shown in the display after the end of the recording SOMNOcheck micro CARDIO SOMNOcheck micro CARDIO additionally analyzes the signals recorded for parameters which provide inform...

Страница 22: ...ting towards the floppy disk symbol appears at the bottom right of the display During recording the device shows in the display the current oxygen saturation pulse frequency and respiratory flow measu...

Страница 23: ...flow and snoring in combination with the pressure sensor integrated in the device Inspiration is registered by the vacuum generated exhalation by the overpressure generated Snoring generates pressure...

Страница 24: ...eyne Stokes respiration The CARDIO Sensor is color coded to distinguish it from the pulsoximetry sensor SOMNOcheck micro may only be used in conjunction with this pulsoximetry sensor or the CARDIO Sen...

Страница 25: ...ube of the diagnostic nasal cannula may not be pinched during the measurement If the diagnostic nasal cannula is incorrectly attached measurement results may be impaired Significant movements of the t...

Страница 26: ...will significantly falsify the measurement result Normal ambient light is compensated by the sensor Particularly strong or fluctuating ambient light e g as a result of direct sunlight or operating roo...

Страница 27: ...ep apnea diagnosis set may not be used to monitor vital physical functions Do not touch the patient if you have the USB cable connector in your hand and the USB cable is connected to the PC Caution Do...

Страница 28: ...ble version of system standard EN 60601 1 1 In the event of questions contact your local specialist dealer or the manufacurer The device may deliver incorrect measurement results if drugs which change...

Страница 29: ...cannula and the pulsoximetry sensor Do not connect the device to a PC if sensors are attached to the patient Note Plug all sensor connectors into the specified connection points When handling sensors...

Страница 30: ...reased emission or to reduced immunity to interference of the device or system Note Dispose of the components in accordance with the regulations applicable in your medical sphere Have servicing and re...

Страница 31: ...wristband should face the hand 5 Tighten the wristband so that it sits firmly but does not restrict circulation in the arm 6 Do up the buckles 4 2 Put on diagnostic nasal cannula 1 Draw the tube for t...

Страница 32: ...attached sensors and tubes may impede circulation in parts of the body and restrict breathing Ensure that sensors and tubes are not impeding circulation in any part of the body Ensure that your patie...

Страница 33: ...f sensors and tubes are attached too tightly Incorrectly attached sensors and tubes may impede circulation in parts of the body and restrict breathing Ensure that sensors and tubes are not impeding ci...

Страница 34: ...this proceed as follows 1 Install the PC software as described in the User Manual for the PC software The User Manual can be found on the CD ROM supplied 2 If necessary take the device off the wristba...

Страница 35: ...to your patient 6 If you are using the PC software enter the patient data and program an automatic start time if desired 7 Show your patient how to use the sleep apnea diagnosis set 5 2 Give patient i...

Страница 36: ...8 Stow the sleep apnea diagnosis set and the patient s instructions for use in the carrying bag 9 Give your patient the carrying bag 5 3 Perform a recording Manual recording 1 Put on the device see 4...

Страница 37: ...tely after 2 minutes In the first 15 minutes after starting recording the data are saved but not analyzed as it is unlikely the patient has already fallen asleep in this time A manual start is not pos...

Страница 38: ...signals at the start of the recording with a programmed recording time the device switches off automatically after 2 minutes After another 20 minutes the device tries to start another recording The r...

Страница 39: ...ce matches the serial number on the form on the reverse of the patient s instructions for use 2 Check whether the patient s name on the form on the reverse of the patient s instructions for use matche...

Страница 40: ...ene treatment see 6 Hygiene treatment on page 49 5 6 Read out results Read out results using the PC You can use the PC software to read out the results of recording and output the results in the form...

Страница 41: ...f positive findings only the Check for Cheyne Stokes Respiration page is displayed Risk level Color Meaning LOW low Green The risk is low LOW if the CRI is in the range 0 0 33 MODERATE Moderate Yellow...

Страница 42: ...events The Respiratory Disturbance Index RDI is shown in the display in the following cases only the pulsoximetry sensor was attached to the device during the recording the pulsoximetry sensor and the...

Страница 43: ...ic nasal cannula was attached to the device during the recording the pulsoximetry sensor and the diagnostic nasal cannula were attached to the device during the recording The signal for the diagnostic...

Страница 44: ...recording time is not adequate for reliable results A message appears in the display to indicate that the recording time was insufficient Analysis time insufficient Recordings less than two hours long...

Страница 45: ...age 16 and tends to be inaccurate To be on the safe side use new batteries for every recording and always keep spare batteries to hand If the display of charging state is displaying 75 a complete reco...

Страница 46: ...rage and ambient conditions Follow the instructions for use provided by the rechargeable battery manufacturer Rechargeable batteries have a finite service life The typical service life of the recharge...

Страница 47: ...If the display of charging state is displaying at least 75 a complete recording 8 hours is guaranteed Even if the capacity of the rechargeable batteries runs out during a recording the recorded data...

Страница 48: ...48 Operation EN 5 9 Transport device 1 Stow the sleep apnea diagnosis set and the patient s instructions for use in the carrying bag...

Страница 49: ...re cleaning seal the connection for the diagnostic nasal cannula with the Luer lock sealing cap Connect the pulsoximetry sensor to the device Do not immerse the pulsoximetry sensor in liquid Informati...

Страница 50: ...s e g household or disposable gloves when disinfecting 3 Disinfect the individual components as described in the table below Parts Clean SOMNOcheck micro Wipe the component with a damp cloth and mild...

Страница 51: ...em again 6 4 Sterilization Sterilization of the device and its components is not permitted 6 5 Change of patient On a change of patient clean and disinfect the device and its components as described i...

Страница 52: ...k includes 7 2 Perform a visual inspection on page 52 7 3 Perform function check on page 52 7 1 Intervals Perform a function check before each use 7 2 Perform a visual inspection Look carefully at the...

Страница 53: ...e display is working correctly if the signals from the sensor are shown in the display Check sensors 1 Put on the device see 4 1 Put on device on page 31 2 Put on the diagnostic nasal cannula see 4 2...

Страница 54: ...ng the measurement Repeat the recording with clean or new sensors Device displaying no signals Plug connections are not properly connected Ensure the connections are firm Display too dim Display defec...

Страница 55: ...s interrupted Check all cable connections Device has switched off Connection has been inactive for over 5 minutes Switch device back on at the button No manual recording can be started The device has...

Страница 56: ...e under the specified ambient conditions see 11 1 Specifications on page 61 Remove the batteries rechargeable batteries from the device if the device is not to be used for an extended period If rechar...

Страница 57: ...ment Officer or your local authority The device packaging cardboard and inserts can be disposed of in paper recycling facilities Dispose of wristband Dispose of the wristband in domestic waste Dispose...

Страница 58: ...al cannulas and 1 adapter WM 94519 Softtip sensor size L with Minimed connector right angled WM 94595 Carrying bag WM 94055 Wristband WM 94560 Luer lock adapter WM 95221 Luer lock sealing cap WM 94137...

Страница 59: ...5 Wristband WM 94560 Luer lock adapter WM 95221 Luer lock sealing cap WM 94137 Battery 1 5 V AA round cell LR 6 WM 5186 Instructions for use for SOMNOcheck micro EN WM 96621 Patient s instructions for...

Страница 60: ...M 94595 Carrying bag WM 94055 Wristband WM 94560 Luer lock adapter WM 95221 Set 10 Luer lock adapters WM 95224 Luer lock sealing cap WM 94137 Battery 1 5 V AA round cell LR 6 WM 5186 Instructions for...

Страница 61: ...A round cell HR6 min 2500 mAh Operating time Battery approx 15 hours NiMH rechargeable batt 2700 mAh approx 20 h depending on time display is operated Mean power consumption approx 250 mW without disp...

Страница 62: ...r favorable measuring conditions The values may be extended in the event of poor pulse strength or movement artifacts First display after application 3 6 s Measured at default setting The poorer the m...

Страница 63: ...ile HF telecommunication devices e g cellphones and SOMNOcheck micro Nominal power of HF device in W Safety distance depending on transmission frequency in m 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5...

Страница 64: ...laim under warranty contact your specialist dealer 13 Declaration of conformity L wenstein Medical Technology GmbH Co KG Kronsaalsweg 40 22525 Hamburg Germany the manufacturer of the devices described...

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Страница 68: ...WM 96621d 08 2017 EN L wenstein Medical Technology GmbH Co KG Kronsaalsweg 40 22525 Hamburg Germany T 49 40 54702 0 F 49 40 54702 461 www loewensteinmedical de...

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