Lowenstein Medical SOMNOcheck micro Instructions For Use Manual Download Page 6

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Overview

1.3 Menu structure for signal control mode/

recording mode

Signalkontrollmodus

Aufzeichnungsmodus

Signal control mode

Recording mode

Summary of Contents for SOMNOcheck micro

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

Page 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...

Page 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...

Page 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...

Page 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...

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

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

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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Page 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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