A Telozo product. - Home • agentur
Contents
1. transmission VY DOWNLOAD clueTime p gt sae Cc clue lue The enclosed IrDA stick will be connected to the computer using an USB slot Optionally an existing IrDA interface on your computer can be used too To transmit the data position clue medical or clue medical BASIC 10 to 20 cm from the IrDA stick facing it with the Infrared window as shown in the picture Press the operating button twice A window opens up on the computer display which asks to permit data to be received with a mouse click Successful transmission to the computer s desktop is then acknowledged on the screen After this you ll find a pdf file on the desktop with the device name its serial number S N and recording num ber This file can then be opened with the free Acrobat Reader from Adobe and then individually managed This information can be communicated to your physician Only your physician can make a medical interpretation of these results The manufacturer is not responsible for the inter pretation of the recordings performed with clue medical or clue medical BASIC clue medical and clue medical BASIC will confirm successful transmission to the PC with flashing of the yellow LED and with an ascending tone j If you are using clue medical and try to contact the clue medical Server and store the measurement there successful data transfer to the Service Center will also be confirmed with an ascending tone Three tones in a row two short2. and TV broadcasters are theoretically not 100 predictable A site study is recommended to determine the electromagnetic environment as it pertains to the stationary transmitters If the measured field strength at the site where clue medical is used site exceeds the concordance levels listed above the clue medical should be monitored to document proper functionality and operation as intended Additional measures might become necessary g modifying orientation or a different location for the clue medical if unusual performance characteristics are observed Note b The field strength should be less than 3 V m for the frequency range of 150 kHz to 80 MHz Recommended Safety Distances between Portable and Mobile RF Telecommunications Devices For DEVICES or SYSTEMS which are not LIFE SUPPORTING The clue medical is intended for use in an electromagnetic environment where RF interference quantities are controlled The customer operator of the clue medical can contribute to lowering electromagnetic emis sions by complying with the minimum distance between portable and mobile RF telecommunica tions devices transmitters and the clue medicale depending on the output power of the communication device listed below Rated output of the transmitter Safety distance based on the transmitting frequency m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 17xV P d 1 17 xV P d 2 33 xV P 0 01 0 12 0
3. corresponding DIP switches are located inside the battery compartment example transmission to server using Bluetooth i e with a mobile phone Pos Swith1 O O Switch 2 up T Transmission to clue medical Server only clue medical Bluetooth _ down IE Direct Transmission Infrared 12 6 Instructions for Use Power on Before you Start for the first time the protection foil for the battery has to be removed After pressing the operating button once clue medical and clue medical BASIC are immediately ready for use You will know the device is ready for use when the green LED flashes up and you hear one ascending tone The yellow LED flashes when the device memory is full clue medical and clue medical BASIC can store a maximum of 30 recordings If the memory is full you will have to transmit the data before you can record again Changing the battery The orange LED flashes up when the battery power is in sufficient To change the battery the battery compartment must be opened Any commercially available AAA battery is permitted In addition rechargeable 1 2 V NiMH batteries may also be used Deleting device memory To clear the device memory the DIP switch 2 has to be in Infrared position switch 2 down 4 Turn on clue medical or clue medical BASIC and press the operating button again for at least 10 seconds Successful deletion will be confirmed with an ascending tone The yellow LED lights for a
4. 12 Q23 0 1 0 37 0 37 0 73 1 1 17 1 17 250 10 3 70 3 7 0 J37 100 11 70 11 70 23 30 The safety distance d in meters m for transmitters with a max rated output not listed in the table above can be calculated by applying the corresponding formula in the respective column P is the max rated output of the transmitter in watts W as specified by the transmitter manufacturer Note 1 The higher frequency range applies in case of 80 MHz and 800 MHz Note 2 These guidelines might not be applicable in all cases The distribution and spread of electromagnetic quantities differs depending on the absorption and reflection of buildings objects and people 45 15 Analysis notes 1 page measurement values i i cliie ie i Journal Device ID Channel Recorded Transmitted Heart Rate Heart Period HRV SDNN HRV CV Tachogram Spectrum ID on the server count of all measurements count of memory erasure serial number and current Firmware version indicates how recording was performed adhesive or fixed electrodes time of recording time of transmission measured over 2 minutes average Heart Rate Period absolute Heart Rate Variability relative Heart Rate Variability in tachogram of cardiac cycle durations sympathetic and parasympathetic regulations FFT analysis GA_102_E Vers 2 0 47
5. IMMUNITY TEST LEVEL LEVEL ENVIRONMENT guidelines Conducted RF interference 3 VEff 3 VEff Portable and mobile wireless quantities according to IEC 150 kHz to devicesshould not be used in closer 61000 4 6 80 MHz proximity to the clue medical including cables lines than the recommended safety distance calculated based on the transmit ting frequency and the applicable formula Recommended safety distance d 1 2 VP d 1 2v P for 80 MHz to 800 MHz d 2 3 V P for 800 MHz to 2 5 GHz with P as the rated output of the transmitter in watts W Radiated RF interference 3 V m 3 V m according tothe information quantities according to IEC 80 MHz to provided by the manufacturer 61000 4 3 2 5 GHz of the transmitter and d as recom mended safety distance in meters m Field strengths from fixed RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference is possible in the proximity of devices featuring the following pictograph C Note 1 The higher frequency range applies in case of 80 MHz and 800 MHz Note 2 These guidelines may not be applicable in all cases The spread of electromagnetic quantities differs depending on the absorption and reflection of buildings objects and people Note a The field strength of stationary transmitters such as base stations of mobile phones and land mobile devices ham radio stations AM and FM radio
6. and clue medical BASIC also allow measurement and display of autonomic nervous system activities Indications for Use clue medical and clue medical BASIC are handheld bat tery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals Specifically clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm e Skipped beats e Pounding heart palpitations e History of arrhythmia clue medical and clue medical BASIC ECG data is intended to be used by a licensed health care practitioner These measurements are not intended for any specific clinical diagnosis The clinical significance must be determined by the physician 1 Intended use clue medical and clue medical BASIC are systems for one channel recording of application specific ECG sections for the purpose of determining heart rhythm disturbancies heart rate variability HRV as well as the activity of the autonomic nervous system sympathetic parasympathetic regulation as indicators of cardiovascular stress recovery and balance The data can be sent either telemetrically using a computer or a mobi
7. few seconds Normally deletion is not necessary because after a successful trans mission the recordings will be deleted automatically Recording with fixed electrodes Recording using adhesive electrodes Place clue medical or clue medical BASIC on the sternum Connect the electrode cable to clue medical or as shown in the picture When using without the neck clue medical BASIC as shown in the picture Strap the clips for the neck strap should be pointing up The adhesive electrodes are connected to the electrode wards in order to ensure proper recording of the signal cable with the snap fastener Remove the protective Turn on clue medical or clue medical BASIC and press film from the electrodes the device against the chest After being wA E switched on the device automatically Place the adhesive electrodes with the correct polarity A determines if there is a signal coming as shown p from proper skin contact or the adhesive electrodes If clue medical or clue medical BASIC i PA detects a signal the recording starts automatically and the green LED flashes f If skin contact is interrupted or if contact a i OO OM _ pressure is too low then this will be g ma i ae indicated by a continuous warning signal The end of the recording is acoustically 6 confirmed with an ascending tone and i the yellow LED flashes up CAUTION Be sure that all four fixed electrodes are placed on the skin and that there i
8. lla products Class Ila products have to be labeled with the identification number of the inspection authority This device fulfils the requirements of the following Standards e IEC 60601 1 e IEC 60601 1 2 e IEC 60601 2 25 e EC 60601 2 47 0408 4 Packaging and accessories clue medical and clue medical BASIC 1 device 1 instruction manual 2 copies for US market 1 neck strap 1 AAA battery 1 IrDA USB adapter The packaging consists of one carton Optional accessory e electrode cable e package of adhesive electrodes AMBU K041026 carrier belt If one of the components listed is missing please contact your distributor immediately All device components and accessories can be reordered directly from an approved supplier Name clue medical BASIC Product group 102 clue medical Product group 102 Neck strap Three pole electrode cable Blue Sensor adhesive electrodes Carrying belt USB IrDa stick Order Number 102 0 06 04 01 102 0 06 04 02 100 O 06 07 01 100 1 06 03 01 100 O 06 01 O01 102 0 06 06 01 100 O 06 02 01 For ordering replacement parts or technical questions please contact your distributor a 5 Device overview controls Battery compartment cover neck strap clips Operating button Orange LED Green LED Yellow LED Speaker output IR window Fixed electrodes Connection socket for electrode cable Changing modes of transmission
9. spleen lymphnodes and parts of the immune sys tem are sympathetically innervated 36 Parasympathetic nervous system Another component of the autonomic nervous system It is also described as vagus nerve since it serves the metabolism regeneration and build up of the body s own reserves The parasympathetic nervous system takes care of rest recovery and protection and automatically controls most internal organs and circulation It reduces heart rate pulse and blood pressure and is significantly affected by respiration The parasympathetic nervous system controls the smooth muscles and glands of the gastro intestinal tract the excretory organs sexual organs and lungs It also innervates the atria of the heart the lachrymal and salivary glands in the head area and the inner eye muscles In contrast it has no direct impact on the preparatory glands and the entire vascular systems with few exceptions such as the genital organs This is the critical difference between the para sympathetic and sympathetic nervous system the latter of which innervates all vessels Normal range resting heart rate Range 60 80 beats per minute Heart rate bradycardia Slow resting heart rate compared to the normal range fewer than 60 beats a minute Borderline resting heart rate Range 80 100 beats per minute Heart rate tachycardia With sinus tachycardia the resting heart rate originating in the sinus node is over 100 beats per minute
10. your physician clue medical and clue medical BASIC are contra indicat on whether it is possible for you to use the device ed for use during treatment with electrosurgery devices or electrocoagulation WARNINGS e during simultaneous defibrillation e in the presence of overly strong electro Interference magnetic interference fields antennas high 1 clue medical and clue medical BASIC should not be voltage transformers generators MRI s used in intensive care areas in order to rule out confusion e in combination with an external pacemaker with alarms e for recording an intracardiac ECG 2 The fixed electrodes are made of surgical stainless steel e by infants weighing less than 10 kg 22 Ibs and also contain nickel portions If irritation occurs upon skin contact we recommend using the adhesive electrodes WARNINGS Warnings describe potential serious adverse reactions and safety hazards 3 The device including associated parts should be inspected at regular intervals to ensure that it is intact This is done by visual inspection of the appropriate parts 4 In service inspections pursuant to the ordinance on the operation of medical devices MPBV are not necessary PRECAUTIONS CAUTION 5 Due to the signal quality and the frequency response 0 05 40Hz on the adhesive electrodes clue medical and clue medical BASIC is suitable for evaluating ST segments An automatic analysis is not provided for 6 When printing th
11. A Telozo product Telozo GmbH Office Park I Top 4 A 1300 Vienna Airport Austria Phone 43 1 7007 32551 Fax 43 1 7007 32559 e Mail office telozo com www cluemedical com ra E an HI Mobile Cardiac Complex Analyzer Operating Instructions clue medical and clue medical BASIC not available in every country TABLE OF CONTENTS Indications for Use M ei FC US cs cose tpe ce E occurs E E E E 2 Dig SEE By MTOM el LONE aisiara a sencatansnaienes 4 3 Declarato n OF COMMON AICS oiid ena AE EEA 8 4 Packaging and a CCESSON IGS tines asia a oe peared dane 9 5 Device overview controls us sssssssssrrrissssessrrirsessersrrrrsssssssrrrrrrrresrrnnn 11 SECC TIONS Ol USE eraa 13 7 Activating an account on the clue medical Server 29 8o Cleaning SINC Ca sssss ae ee ss tassscesseses bearenstecnsrctaune 30 OD DEVICE SPEC MCAT OMS acid a E E 32 10 Technical requirements for tranSMISSlON ssecccssecssesessseecsseeeseseees 32 Wie EXONS MARION onI SINS aatan nate sata ade atta a esc ta ttt Ge 36 12 SVMOOlS and WHat THe Vs IMEAM ainsi No ccs aves ip scldaa loca dacisluse 40 POAN E E NANN 41 14 Manufacturer s Declaration of Compliance ceccscssecsesseeccesnesseen 42 ISAN ENOTE Se AE EEA 46 As a clue medical or clue medical BASIC user you have decided on a State of the art telemedicine system Thanks to their complex evaluation options in addition to the one channel ECG clue medical
12. INTERFERENCE IMMUNITY for all DEVICES and SYSTEMS clue medical is designed to operate in an electromagnetic environment as described below The clue medical customer or user should make sure that the device is operated in such an environment ELECTRO MAGNETICINTERFERENCE IMMUNITY tests IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTRO MAGNETIC ENVIRONMENT guidelines Discharge of static electricity ESD according to IEC 61000 4 2 Electric fast transients bursts according to IEC 61000 4 4 6 kV contact discharge 8 kV air discharge 2 kV for AC power lines 1 kV for input and 6 kV contact discharge 8 kV air discharge not applicable clue medical has no lines longer than Floors should be made of wood or concrete or feature ceramic tiles If the floor consists of synthetic material the relative humidity should be at least 30 Interference emission measurements Compliance Electromagnetic environment Guidelines output lines 3 meters Surges according to IEC 61000 4 5 1kV not applicable differential mode clue medical is only battery 2kV operated and has no common mode AC supply lines voltage Blackouts lt 5 UT not applicable Brownouts and fluctuations of gt 95 crash of the power supply according to IEC the UT rT 61000 4 11 for 1 2 period cue Una i 40 UT is only battery 60 crash of the UT for 5 periods 70 UT 30 crash
13. Tachogram of cardiac cycle durations If you determine for each heart action u within a given measure ment time e g 2 minutes with clue medical the associated cardiac cycle duration TH p e g the applicable RR interval and plot it as a function of the corresponding heart action you get the tachogram of cardiac cycle durations as a characteristic cardiovascular function oF Consequently the beat to beat variations and thus the heart rate variability are illustrated in such a representation FFT spectrum From the tachogram of cardiac cycle durations a function in the time range an equivalent representation in the frequency range can be derived using a mathematical operation FFT spectrum referred to in literature as the performance spectrum of heart rate variability This soectrum is made up of characteristic frequency ranges in regards to the use of the clue medical family the following ranges serve as a basis Low frequency range LF 0 04 to 0 15 Hz Predominately sympathetic cardiovascular activity can be attributed to this range and with it also physical and psychological stress High Frequency range HF 0 15 to 0 4 Hz Typical for this range is parasympathetic vagal activity and with it breathing synchronous heart rate fluctuations of respiratory sinus arrhythmia Very High Frequency range VHF 0 4 to 0 5 Hz A cardiac risk marker can be attributed to this range which is beyond the activity of the r
14. VE 2002 96 EC This symbol on the product or its packaging indicates that this product Is not to be treated as normal household garbage rather it must be disposed of at an acceptance point for recycling of electrical and electronic equipment You can obtain more information from your local authority the local disposal companies or the company where you purchased the product Lead free pursuant to Directive 2002 95 EC No lead is added to this product in any way The device contains components which are used to produce non ionizing radiation 13 Warranty All systems excluding sensors cables and batteries are covered vis a vis the purchaser by a two year warranty Telozo GmbH undertakes to repair any systems found to be defec tive under this warranty or to replace them with a new device at no charge provided that the defect was communicated to Telozo GmbH by the purchaser along with the serial number within the valid warranty period This warranty is the sole and exclusive form of legal redress to which the pur chaser is entitled for devices or accessories supplied which turn out to be defective in any way All repaired or replaced devices shall be delivered to the customer by Telozo GmbH free of charge Costs for sending complaints to Telozo GmbH are excluded from this warranty These systems are sensitive devices and may only be repaired by experienced and specially trained personnel The warranty shall become void if the devi
15. a transmission Read your mobile phone Instruction manual carefully and or seek advice from your mobile phone provider Computer or notebook system requirements Computer or notebook with Adobe Reader Version 6 0 1 or higher installed Download Adobe Reader free of charge at www adobe com e Available USB port Operating system Windows XP Service Pack 2 or Windows VISTA Read your computer or notebook instruction manual care fully For USB IrDA Bluetooth adapters which are not part of clue medical or clue medical BASIC accessories please follow their installation instructions 33 Troubleshooting 34 Problem Solution Orange LED flashes when device is turned on Replace the AAA battery Item 7 CHANGING THE BATTERY Yellow LED glows when device is turned on Device memory is full Transmit the data in order to delete the memory Item 7 TRANSMITTING A continuous tone sounds during recording Device has lost skin contact and indicates this until it regains skin contact Press the device more firmly against the skin during recordings If the patient has a lot of chest hair move the device gently back and forth in order to ensure that there is sufficient skin contact during the recording When recording with adhesive electrodes attach the electrode cable to the skin with common bandages a few cm below each of the connection points of the adhesive electrodes Data printout is not to s
16. cale On the printer turn off automatic scaling and set zoom to 100 The display is correct if the total length of a 10 second ECG is exactly 25 cm Problem Solution Transmission via mobile phone is not possible orange LED flashes with acoustic signaling The IrDA or Bluetooth interface on your mobile phone may not be activated Follow the instructions for your mobile phone The distance between the interfaces may be too large or too small or the interfaces are not parallel to each other Reposition the devices Transmission via IrDA stick is not possible orange LED flashes with acoustic signaling Check the system requirements of the Computer Make sure the USB IrDA stick is properly installed Check the distance and position of the IrDA interfaces You ve forgotten your login data Call your vendor IrDA transmission ok PDF is not on the desktop Under settings go to your computer s control panel and make sure that under wireless connections the desktop is set as the standard folder for data received Symbol A on my PDF printout next to date and time It is a note that time and date of your clue medical or clue medical BASIC should be updated with a special program clueTime Please follow the instructions on the homepage www cluemedical com 35 11 Explanation of terms Heart rate variability HRV Heart rate variability HRV refers to va
17. ce has been opened maintenance work has been performed by personnel other than Telozo personnel tampering or any forms of misuse or improper use of the device have occurred All work not covered by the provisions of the warranty shall be performed according to Telozo GmbH prices and charges appli cable at the time the device is returned to Telozo GmbH WARRANTY EXCLUSION THE WARRANTY STATEMENTS ESTABLISHED IN THIS MANUAL ARE EXCLUSIVE NO OTHER WARRANTIES OF ANY NATURE WHETHER LEGAL WRITTEN VERBAL OR TACIT INCLUDING ANY GUARANTEE OF SUITABILITY FOR A PARTICULAR PURPOSE OR MARKETABILITY SHALL APPLY 41 14 Manufacturer s Declaration of Compliance The following table contains specific information on the conformity of this device with IEC Standard 60601 1 2 clue medical uses RF energy for its functions Result of the EMC tests according to IEC 60601 1 2 clue medical meets all the requirements Fur further informations regarding EMC testing please contact Telozo GmbH Telemedizin Guidelines and Manufacturer s Statement ELECTROMAGNETIC EMISSIONS For all DEVICES and SYS TEMS Guidelines and Manufacturer s Statement ELECTRO MAGNETIC INTERFERENCE EMISSIONS clue medical is designed to operate in an electromagnetic environment as described below The clue medical customer or user should make sure that the device is operated in such an environment Guidelines and Manufacturer s Statement Electromagnetic
18. dical device once on www cluemedical com under 365 24 clue central login see also Chapter 7 You will also need to ensure that in case of using your mobile phone it is set up with an Internet gateway In case of using a computer with Internet connection to transmit the recorded data to the clue medical Server it is essential that a small program clueSync is running which can be downloaded and installed prior to trans mitting data If running you can see the clueSync symbol at the task bar of your PC You ll find the download sign below on our homepage www cluemedical com SOFTWARE DOWNLOAD NZ ronson clue clue For support contact your mobile phone service provider To send data via computer or mobile phone plug in and activate the enclosed IrDA stick or pair clue medical with the receiving Bluetooth device In case of using IrDA Infrared connection position the interfaces in a direct line of sight 10 to 20 cm apart as shown in the picture below i By me i ay ail a IF ioe a In case of using Bluetooth a successful pairing between your device and the receiving mobile phone is needed before transmitting data For details of how to pair see page 22 to 26 For more information read the instruction manual of your mobile phone computer respectively contact your vendor 19 Press the button twice clue medical or clue medical BASIC will acknowl
19. e pdf analysis please ensure that automatic scaling is off and that zoom is set to 100 The representation is correct if the total length of a 10 second ECG section is exactly 25 cm Due to display problems with some printers correct resolution cannot be guaranteed 7 clue medical and clue medical BASIC are battery operated devices The included standard AAA battery is replaceable and may only be disposed of in refuse con tainers provided for that purpose Batteries do not belong in household garbage As a consumer you are legally obligated to return used batteries You can discard your old batteries at public collection points or anywhere where batteries of the same type are sold 8 In case of prolonged periods of disuse the battery should be removed from the device 9 No devices which have not been inspected pursuant to EN 60601 1 may be located in the patient s surroundings The standard for general requirements for safety includ ing the essential performance characteristics of medical devices must be followed 10 clue medical and clue medical BASIC work in a temperature range of 10 C to 45 C To ensure safe opera tion it must be free of condensation Any large change in the surrounding temperature should therefore be avoided 11 The device should be protected from mechanical strains such as blows shocks and scratches 12 clue medical and clue medical BASIC are not de Signed for emergency situations In acute em
20. edge successful transmission with flashing of the yellow LED and confirming successful data transfer to the clue medical Server with an ascending tone Three tones in a row two short one long signify that transmission was unsuccessful and the orange LED flashes up In this case transmit the data again With each transmission all new recordings are transferred approx 25 Kbytes of data are transmitted per recording The memory Is only deleted automatically if the trans mission was successful IF THE YELLOW LED FLASHES Data transmission is in progress After a successful transmission a positive confirmation tone sounds for each recording to confirm successful transmission IF THE ORANGE LED FLASHES If the transmission was not successful then a negative confirmation tone sounds and the orange LED flashes The data are still stored in the device and the transmission can be reattempted at any time again Transmitting via USB IrDA stick Infrared directly to a computer clue medical and clue medical BASIC 20 Before data can be directly transmitted to a computer the specific settings for the USB IrDA adapter must be configured as indicated by the manufacturer and the clueTime program which can be downloaded from www cluemedical com has to be installed and started cluelime is needed for date and time synchronisation between clue medical or clue medical BASIC and the computer The actual synchronisation will happen during
21. ergencies please contact an emergency medical service immediately 13 clue medical and clue medical BASIC are not water proof and must therefore remain protected from water They may not be operated in water or in the rain If the device has become wet inside it can no longer be used and must be replaced 14 When transmitting with a mobile phone a safety distance of at least 30 cm 12 should be kept between the user s patient s sternum heart and the mobile phone electromagnetic radiation 15 clue medical and clue medical BASIC may only be repaired by the manufacturer or authorized repair persons 16 Before giving the clue medical or clue medical BASIC to a second user delete the memory of the device before passing it on see Chapter 6 17 Do not use any accessories that have not been provided other than adhesive electrodes bearing the CE label or batteries meeting the technical specs indicated see Chapter 9 technical data 18 All conductive parts of the electrodes and attached plug connections Including neutral electrodes must not come in contact with any other conductive parts including the ground 19 If more than one device is used on a patient at one time the sum of the leakage currents should be monitored 3 Declaration of compliance This product complies with directive 93 42 EEC on medical devices clue medical and clue medical BASIC are approved pursuant to directive 93 42 EEC for medical devices as class
22. esting components of the cardiovascular system Spectral measures By determining applicable integral surface area measurements for the frequency ranges 0 04 0 15 Hz and 0 15 0 4 Hz for a derived FFI spectrum and division with applicable normal values absolute spectral measures M in percent can be introduced M 0 weighted measure for sympathetic activity stress and strain Mu o Measure for parasympathetic activity relaxation and recovery M represents the measure M multiplied by the Square of the average heart rate which the above standardized Surface area measurement It follows from the above that higher heart rates significantly raise this weighted measure M whereas a rates lower than the normal heart rate value of approx fH 70 1 min considerably reduce it This completely corresponds to physiological behavior since higher heart rates activate the sympathetic nervous system whereas heart rates below the normal value activate the parasympathetic nervous system Weighted balance We know from physiology that in the LF range of the FFT spectrum derived from the cardiac cycle duration tachogram predominately the sympathetic nervous system is illustrated although vagal parasympathetic portions may also be included Consequently the balance determined from the straight LF and HF ratio can only be quantified to a limited extent Applying the above spectral measures M as a weighted measure and M p a
23. le phone network to a defined recipient clue medical BASIC With clue medical BASIC recorded data are sent directly to a computer PC Notebook via an USB IrDA adapter or Bluetooth interface Transmission and display depend on the technical parameters of your computer see Chapter 10 clue medical In addition to the BASIC functions recorded data can be sent telemetrically to the clue medical Server using a mobile phone as modem or a computer PC Notebook with Internet connection by using the enclosed USB IrDA stick Please pay attention to the technical requirements see Chapter 10 Description A recording time of 2 minutes and a sampling rate of 1 KHz enable clue medical and clue medical BASIC to provide diagnostic quality information on heart rate variability HRV and the effect of the autonomic nervous system on heart activity and the cardiovascular system This is accom plished by intelligent signal processing namely through highprecision determination and evalution of RR intervals beat to beat taking into account stationarity requirements The following information is provided by the 2 minute recording 1 a complete one channel ECG over a period of 2 minutes 2 a Signal averaged ECG with the characteristic time values 3 average cardiac cycle and heart frequency absolute SDNN and relative CV heart rate variability 4 a tachogram of cardiac cycle durations including cardio vascular divisions 5 a s
24. llowing instructions at regular monthly intervals and each time the device is given to a patient o The device and the cable should be cleaned with a damp soft lint free cloth Warm water mild soap pH neutral or a commercial cleaning product suitable for plastic can also be used o Commercially available aldehyde free surface disinfectants must be used for this purpose e g Gigasept Dentalrapid AF o No liquid may get inside of the device while disinfecting it o Ether benzene and acetone may not be used 30 When cleaning please be sure that no liquid gets inside the device as this could place the user patient in danger and destroy the device If this nonetheless does happen please contact the clue medical hotline under 43 0 1 7007 32551 In case of damage the device may no longer be used and must be replaced In order to protect the environment we ask that you dispose of and use all materials and cleaning products properly The device does not cause any environmental pollution either in or out of operation The adhesive electrodes should be properly disposed of according to the indications of the electrode manufacturer and may not be reused 31 9 Device Specifications Measurements L D W Weight with battery Weight without battery Operating temperature range Storage temperature range Transport temperature range Relative humidity Operating time w o change of battery Risk class Degree of protectio
25. n ECG lead ECG recording Input voltage DC offset correction Frequency range adhesive electrodes3 Frequency range fixed electrodes Scanning rate Resolution of AD conversion Memory Battery type Battery display Electrode monitoring IrDA Transmission IrDA Transmission Method of heart rate measurement Bluetooth module 32 AS T alae Ass Taallan 56 g 49 9 10 C to 45 C 20 C to 60 C 20 C to 60 C 10 to 95 non condensed gt 400 measurements lla BF IP 20 gt echianie bipolar and neutral electrodes 10 mV p p lt 300 mV 0 05 40 Hz 3dB 0 1 40Hz 3dB 1000 Hz 12 Bit 30 recordings max AAA alkaline 1 5V Rechargeable types allowed NiMh 1 2V Optical MES Modem IrComm to central server over Internet connection Obex push PDF file directly to recipient Average ECG over 2 minutes LMX9838 10 Technical requirements for transmission With clue medical or clue medical BASIC you have purchased a high quality medical device Because the device is designed to be used with other devices you may experience technical issues unrelated to the clue medical or clue medical BASIC We are happy to assist you in configuring your computer systems but you may need to contact the manufacturer of your other devices if the problem persists Mobile telephone requirements Your mobile telephone must have an IrDA or Bluetooth interface and be Internet capable in order to carry out a dat
26. n order to transmit data from the clue medical device to the clue medical Server you will need to set up an account on www cluemedical com note this feature is not avail able for clue medical BASIC Procedure 1 Visit the clue medical website www cluemedical com 2 Go to 365 24 clue central login 3 Go to create a new account 4 Enter a personal user name 5 Enter a personal password that contains at least 8 characters at least one capital letter and one number have to be contained e g Testpass1 6 Re enter the password to confirm 7 Go to create account After this procedure a personal account exists and you can activate your clue medical 1 Login on www cluemedical com on our clue medical Server 2 Under my devices you will find a button add device 3 Here you have to enter the serial number and the activation code of the clue medical You can find the serial number and activation code on the backside of your user manual 4 Once your clue medical has been activated you can find it under my devices and you can see all following transmitted measurements 29 8 Cleaning and care of your clue medical or clue medical BASIC e The device and the electrode cable should be cleaned as needed with a damp soft lint free cloth Warm water mild soap pH neutral or a commercial cleaning product suitable for plastic can also be used e The device should be disinfected according to the fo
27. o the clue medical Server via computer or mobile phone is not possible Transmission and display depend on the technical parameters of your computer see Chapter 10 If you have a clue medical recorded data can be sent telemetrically directly to a computer in form of a odf visualization see clue medical BASIC or via com puter or mobile phone with Internet connection to the clue medical Server for protected global access The recordings can be viewed and managed 24 hours a day using a defined user ID and password chosen by you via www cluemedical com under 365 24 clue central login Transmitting via mobile phone is besides Infrared or Bluetooth capability only bound to the network requirements of the particular location and if applicable of the technical standards of different mobile phone network providers Note The recording has to be completed first before the transmission can be started Transmitting via computer or mobile phone clue medical The recorded data can be transmitted via computer or mobile phone with Internet connection to the clue medical Server In this case the computer or mobile phone act as a modem and allows an automatic connection to the clue medical Server to transmit the recorded data from your clue medical device for visualization and storage You do not need to dial any numbers for the transmission to occur Before transmitting via computer or mobile phone you need to activate the clue me
28. of the UT for 25 periods lt 5 UT gt 95 crash of the UT for 5s operated and has no AC supply lines RF emissions according to Group 1 clue medical uses RF energy for its functions CISPR 11 Its RF emission is very low and it is unlikely that electronic devices in close proximity will experience interference RF emissions according Class B clue medical is suitable for use in facilities other CISPR 11 than residential ones which are directly connected to the PUBLIC POWER GRID which also provides power to buildings used for residential purposes Emission of harmonic current not according to IEC 61000 3 2 applicable Emission of voltage not fluctuations flicker according applicable to IEC 61000 3 3 Supply frequency magnetic field 50 60 Hz according to IEC 61000 4 8 3 Alm 3 Alm Magnetic fields of the mains power frequency should comply with the typical values of business and hospital environments Note UT is the mains alternating voltage before applying the test levels Guidelines and Manufacturer s Statement ELECTROMAGNETIC INTERFERENCE IMMUNITY For DEVICES or SYSTEMS which are not LIFE SUPPORTING clue medical is designed to operate in an electromagnetic environment as described below The clue medical customer or user should make sure that the device is operated in such an environment ELECTROMAGNETIC IEC 60601 COMPLIANCE ELECTRO MAGNETIC ene
29. one long signify that transmission was unsuccessful the orange LED flashes up In this case transmit the data again With each transmission all recordings are transferred approx 25 Kbytes of data are transmitted per recording The memory Is only deleted automatically if the transmission is successful IF THE YELLOW LED FLASHES Data transmission is in progress After successful transmission a positive confirmation tone sounds for each recording to confirm successful transmission IF THE ORANGE LED FLASHES 22 If the transmission is not successful then a negative confirmation tone sounds and the orange LED flashes The data are automatically stored in the device and the transmission can be repeated CAUTION When transmitting make sure that there are no computing devices i e Laptops printers etc nearby with their infrared or Bluetooth interfaces activated Transmitting via Bluetooth directly to a computer clue medical and clue medical BASIC or via a computer mobile Phone to the clue medical Server clue medical Note Pairing is not possible during measurement Note During pairing don t wear your clue medical or clue medical BASIC on your body because you would start a new recording and will therefore not be able to initi ate pairing If you use adhesive electrodes please discon nect the electrode cable from your clue medical or clue medical BASIC Step Preferences Signal clue medical or receiving de
30. pectral analysis FFT including surface area measurements derived from such for sympathetic and parasympathetic activity as well as their balance To get more information about the scientific background of the measurement of clue medical and clue medical BASIC please visit our website on www cluemedical com 2 Safety information PRECAUTIONS cauriow Precautions are statements of a hazard that warn you of Please pay careful attention to all safety instructions and a potentially hazardous situation or unsafe practice which warning symbols contained in these operating instructions if not avoided may result in minor or moderate injury or Read these instructions thoroughly prior to use of the damage to clue medical and clue medical BASIC product they contain important Information for users of clue medical and clue medical BASIC To ensure safe use of the device you should be able to read Keep these Instructions in a safe and accessible place speak and understand English You must be able to operate the device on your own after reading this manual The operating personnel must be thoroughly acquainted and receiving detailed instructions from your physician with the following symbols for precautions and warnings If you are not comfortable with the instructions for use and instructions from your physician you should not take CONTRA INDICATIONS clue medical and clue medical BASIC home with you o If you are hearing impaired please consult
31. riations in the heart rate over a shorter or longer measurement period in a heart beat to heart beat analysis Accordingly the heart beat is not normally uniform but varies in a characteristic fashion HRV is a parameter of the autonomic function of the heart as well as a measure of the hearts ability to regulate itself Autonomic nervous system The autonomic nervous system consisting of the sympathetic parasympathetic and enteric nervous system innervates the smooth musculature of all organs as well as the heart and glands It regulates the vital functions of breathing circulation digestion metabolism gland secretion body temperature and reproduction It is not arbitrarily controlable it is autonomous In addition to the hormone system it represents one of the two information systems between the individual organs Sympathetic nervous system A component of the autonomic nervous system It regulates the cardiovascular system including organ activity and causes an increase in performance increases among other things heart rate pulse and blood pressure and is also an indicator or measure for Stress The organs controlled by the sympathetic nervous system are the smooth muscle tissues of all organs arteries bowels ex cretory and sexual organs hair pupils cardiac muscle fibers and some glands sweat salivary digestive glands Moreover adipose cells lipocytes hepatocytes renal tubules lymphatic tissues e g thymus
32. s a basis results in the weighted balance B M Mp Cardiovascular stress Stress affects the nervous system by increasing sympathetic nervous system activity and inhibiting the vagus As a result the measure derived from the FFT spectrum M represents a measure for sympathetic activity stress and strain In contrast the measure MHF is an indication of parasympathetic activity relaxation and recovery Since the weighted balance B is derived as a quotient from the two measures M and M an increase in sympathetic activity stress and strain can be inferred from a rise in B If the weighted balance is reduced however a reduction of these sympathetic components a rise in parasympa thetic activity of relaxation or recovery can be inferred As such M and B represent quantitative measures for cardiovascular stress IrDA Infrared Data Association universal wireless 2 way data transmission based on infrared light Sternum breast bone Bone in the anterior centre of the thorax which connects to the ribs or their cartilaginous extensions T 12 Symbols and what they mean CAUTION 2 ELD RoHS 40 2002 5 EC iy Precautions for safe use of the device Failure to heed this warning may result in serious injury to patients or damage to the device Attention see accompanying documents Date of manufacture Manufacturer Serial Number BF type applied part WEEE symbol pursuant to DIRECTI
33. s no clothing between the electrodes and the skin If you have a lot of chest hair move clue medical or clue medical BASIC back and forth gently and then increase the contact pressure in order to make contact with the skin The device will indicate insufficient skin contact with a beep sound clue medical and clue medical BASIC should only be used on healthy intact skin not on wounds scars etc CAUTION In order to prevent tensile stress on the cables particulary during movements attach the electrode cable to the skin with medical bandages a few cm away from each of the connection points of the adhesive electrodes as shown clue medical or clue medical BASIC can also be worn in a carrier belt optionally available over your clothing After being switched on clue medical or clue medical BASIC will automatically detect a proper Signal If clue medical or clue medical BASIC does detects a signal then the recording is started automatically The green LED flashes during measurement If skin contact is interrupted during recording clue medical or clue medical BASIC will emit a continuous warning signal The end of a successful measurement is confirmed with an ascending tone Transmitting data If you have a clue medical BASIC you can transmit the recorded and visualized data only as a pdf file directly to a computer usually to desktop on PC notebook via an IrDA or Bluetooth compatible interface Transmission t
34. sought Receiving Once a Bluetooth device found receiving device is found the green LED flashes along with the yellow Step Preferences Signal clue medical or receiving device clue medical BASIC Short flash of orange green yellow LED then the green LED lights up Descending tone yellow LED flashes Green yellow LED flashes When no device is found orange lights and three successive tones twice short once long Confirm the successful pairing On your receiving device a password Is required Please enter 1111 and confirm Note if you don t have a password call on your receiving device make sure that the device is visible Note If both LEDs flash yellow and green it could be possible that another still activated Bluetooth device near you has received the password call of your clue medical or clue medical BASIC In this case wait for the failure tone and start the procedure again Mostly you get from your device a success report which you have to confirm Note you get also a positive signal from your clue medical or clue medical BASIC Pairing successful Successful green LED lights and ascending tone Failure orange LED lights and three successive tones twice short once long Start To start the Yellow LED transmission transmission press the flashes button twice On your receiving device Yellow LED you will get a message flashes the which yo
35. stored in the memory of both clue medical or clue medical BASIC and the receiving d vice With the next transmission attempt clue medical or clue medical BASIC contacts the most recent Bluetooth partner If you intend to connect a new receiving device you can press the button for more than 8 seconds at the next Bluetooth transmission session and initiate a new pairing session 27 The table below provides a summary of the indicator lights and acoustic signals Spec No Purpose Usage Acoustic signal Optical signal A5 1 Start ECG Press button Increasing tone All LEDs flash recording 1x short green LED lights up A5 2 Recording Recording Yellow LED finished finished lights up for appr 10sec A5 12 Recording Yellow LED not possible lights up for memory full appr 10sec A5 13 ECG Press button Yellow LED transmission 2 x short flashes IrDa A5 14 Transmission Increasing tone Green LED successful Beepbeepbeepbeepbeep lights up for for each ECG min1 appr 10sec max10 A5 15 Reset erase Press button Yellow LED all ECG for 10 sec lights up A5 16 Confirmation Descending tone All LEDs of reset flash all ECG data erased A5 17 Incomplete Descending tone Orange LED transmission Beepbeep beep lights up beepbeep beep A5 18 Start Descending tone Orange LED transmission Beepbeep beep light up with no ECG beepbeep beep in memory 28 7 Activating an account on the clue medical Server I
36. u have to green LED confirm If you have lights if the authorized clue medical tranmission was or clue medical BASIC successful you will not get this Failure orange message lights and three note you can find your successive tones clue medical or clue twice short medical BASIC in a list once long of coupled authorized devices on your receiving device You can change these settings so that you don t have to confirm a message for each transmission 26 Transmission After transmission successful clue medical or clue medical BASIC switch off automatically clue medical or clue medical BASIC are now ready to Start a measurement again If no signal is detected clue medical or clue medical BASIC switch off automatically Note clue medical or clue medical BASIC use RF energy below the internationaly recommended level during Bluetooth transmission If you want to reduce such a RF exposure keep your head and body about 50 cm away from the devices during transmission Note After successful pairing it is possible to set your receiving device back to invisible This means that no third Bluetooth device can find your device to try pairing For further information please read the operating manual of your receiving device or contact your vendor Note After transmission clue medical or clue medical BASIC switches off automatically This ensures that no further transmission may occur The pairing information is
37. vice clue medical BASIC Preparation for pairing Position your device and attempt to deactivate other Bluetooth receivers close by Activate the Bluetooth module and be sure that it can be found by other Bluetooth devices How to make this please read the user manual of the receiving device Note after successful pairing you can change the Bluetooth settings back to invisible Note if you need addi tional information please read the user manual of your receiving device or ask your vendor There should not be any RF active device within 1m of the clue medical or clue medical BASIC to avoid physical interferences and distortion effects to the RF signal If possible please de activate other Bluetooth compatible devices within a radius of 7m to minimize unsuccessful first attempts to pair clue medical or clue medical BASIC with the in tended receiver If there are other active BI devices in range during pairing mode you may need more than one try to pair to the intended receiver device Check Please make sure DIP Switch that the DIP Switches settings settings of your device is correct switch 2 up T Note If switch 2 remains in the down position you may accidentally delete memory Switch on Press the button once your then release clue medical Start pairing Press the button once again and hold it for approx 8 seconds A signal should occur and a Bluetooth compatible device is
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