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91 

 

1 4

 

Appr ova ls a n d EM C in for m a t ion 

 
The CADScor

®

Syst em  is a m edical device 

class I I a, fulfilling t he requirem ent s in 
com pliance wit h t he Council Direct ive 
93/ 42/ EEC, Medical Device Direct ive ( MDD) . 
 
The CADScor

®

Syst em  soft ware is classified 

as safet y class B, according t o I EC/ EN 62304, 
“ Medical device soft ware – Soft ware life- cycle 
processes”  
 
This device com plies wit h part  15 of t he FCC 
Rules. Operat ion is subj ect  t o t he following 
t wo condit ions:  (1)  This device m ay not  
cause harm ful int erference, and ( 2)  t his 
device m ust  accept  any int erference 
received, including int erference t hat  m ay 
cause undesired operat ion.  

CADScor sensor is com pliant  wit h t he 
requirem ent  for RF exposure in US wit h less 
t han  

50 m m  separat ion dist ance bet ween t he user 
and/ or byst ander of t he device. 

CADScor sensor is only com pliant  if no 
changes or m odificat ions are m ade t o t he 
device.  

 
 

CE- m ark 

I ndicat es com pliance 
wit h t he 

Medical Device 

Direct ive

 93/ 42/ EEC 

I EC/ EN 60601 

I n com pliance wit h 
I EC/ EN 60601- 1 

EMC- em ission 

The equipm ent  com plies 
wit h t he em ission 
requirem ent s for Class B 
equipm ent  in I EC/ EN 
60601- 1-2 

EMC- im m unit y 

The equipm ent  com plies 
wit h t he im m unit y 
requirem ent s in I EC/ EN 
60601- 1-2 

FCC I D 

2AYXI -ASE1401 

Содержание CADScor System

Страница 1: ...CADScor System User Manual Rx Only...

Страница 2: ...ssed to Acarix directly or to the Acarix distributor in your country who will initiate replacement or repair of faulty equipment 1 1 Disclaimer The information given in this document is adapted to an...

Страница 3: ...on provided in this printed manual Acarix disclaims any liability for errors and omissions herein The illustrations used in this manual may differ slightly from the appearance of the actual device pac...

Страница 4: ...er manual 15 5 14 Warnings 16 5 15 Precautions 16 5 16 CADScor System unboxing 18 5 17 The CADScor Sensor 20 5 18 CADScor Docking station 22 6 I nstallation of CADScor System 2 3 6 1 Desktop model 23...

Страница 5: ...se Main recording 66 8 10 Recording phase cancelling 67 8 11 Recording phase CAD scoring 68 8 12 Short diastole CAD score 69 8 13 QR code for printing archiving and sending a CADScor patient report 70...

Страница 6: ...his manual carefully and understand the use of the CADScor System before starting to use the system professionally 5 2 The CADScor System and the environment The Acarix CADScor System has been designe...

Страница 7: ...face of the patient and the patient risk factors present The CADScor System consists of two physical units the CADScor Sensor and the CADScor Docking station for charging and qualification of the sens...

Страница 8: ...her testing will reduce un necessary evaluation and risk The CAD score can thus aid the decision to initiate additional evaluations or not or to observe the patient further prior to additional evaluat...

Страница 9: ...t 30 40 prevalence A follow up test based on a CAD score at or below 20 can be done after two to five years if indicated At higher significant CAD prevalence in the investigated population the PPV inc...

Страница 10: ...ized and thus be diagnosed and enter treatment earlier By use of the CADScor System no risks are associated directly from use except in rare cases where a slight transient skin reaction towards the pa...

Страница 11: ...ation The CADScor System is intended to be used in males and females by born gender above 40 years of age Do not use the CADScor System without the necessary qualifications and only after instruction...

Страница 12: ...s Typical angina sym ptom s all three below Sub sternal chest discomfort of characteristic quality and duration Provoked by exertion or emotional stress Relieved by rest and or nitrates within minutes...

Страница 13: ...anical heart pump I mplanted Pacemaker or Cardioverter Defibrillator I CD Other implanted active electronics or active electronic support equipment closer than 50 cm to the CADScor System The CADScor...

Страница 14: ...ion approximately two centimetres of the sternum bone for placement of patch The CADScor Sensor must only be used together with a CADScor Patch Patches are single use only and should not be moved on t...

Страница 15: ...ur to patient or user or damage the equipment or property Symbol Explanation Product code number Serial number Warnings and precautions See description below 5 13 5 15 Instruction to Read user manual...

Страница 16: ...planted electronics like I CD Pacemakers heart pumps closer than 50 cm to similar active electronic support equipment due to risk of equipment failure from CADScor System electromagnetic RFI D impulse...

Страница 17: ...of damage to the CADScor System Do not touch the charge point terminals on the CADScor System due to risk of permanent damage to the electronics inside by electrostatic discharge 5 17 5 18 Do not drop...

Страница 18: ...e CADScor System box one each CADScor Sensor CADScor Docking station A box containing a power adaptor plus country specific plug A box in the lid holding a User Manual a separator tool to separate the...

Страница 19: ...or possible transport damages Take out the box containing the power adaptor and supplied plug Assemble power adaptor unit by pressing the plug firmly onto the power adaptor until clicked securely into...

Страница 20: ...display and a sensor head extending on a flexible arm from the sensor body see figure at right The push button has several functions when pressed or pressed and held for extended time Press Function...

Страница 21: ...a built in speaker that generates auditory cues for guiding the patient to pause breathing The sensor charge contact point terminals are used to re charge the sensor battery when the sensor is placed...

Страница 22: ...e point terminals on the CADScor System due to risk of permanent damage to the electronics inside by electrostatic discharge The Docking station LED shows the current status of the CADScor System when...

Страница 23: ...the Docking station using both hands Make sure that the sensor head is fully inserted into the sensor tester and that the red indicator line on the sensor head is completely hidden A spring action me...

Страница 24: ...drop or exert excessive force to the CADScor System since this may damage the CADScor System permanently LED indicator Sensor status Constant YELLOW Power on docking station Constant GREEN Sensor ful...

Страница 25: ...part of the Docking station hold the Docking station by the aluminium plate one end resting on a table Place the separator tool into the two small holes in the edge and press gently using the index fi...

Страница 26: ...using appropriate screws and plugs Place the top part of the Docking station on the back plate sensor tester placed at upper right corner and click into locking position Ensure that top plate has eng...

Страница 27: ...pouches The pouch is opened at one end by holding and separating the two layers Additionally an assembly tool is provided to ensure the correct alignment and assembly of the patch to the sensor head a...

Страница 28: ...tch has adhesive material on both sides and a coupling ring where the sensor head has to be inserted On the patch is furthermore a numbering sequence to follow when applying the patch and sensor onto...

Страница 29: ...Make sure the coupling ring is situated correctly on top of the hole cut out in the assembly tool See figure at right Place the sensor on top of the patch aligning to the axis of the patch The sensor...

Страница 30: ...e sensor head must now be hidden in the coupling ring when looked from the side Visually confirm the disappearance of the red colored indicator ring all around the sensor head see figure at right From...

Страница 31: ...onnect the power adaptor to the Docking station and turn on supply voltage Place the sensor in the Docking station if not already docked to charge the battery The sensor will automatically detect the...

Страница 32: ...ge will show that qualification is in progress REF 302 Follow the instructions to keep quiet and not touching or removing the sensor from the Docking station After qualification and first time the sen...

Страница 33: ...tment of Date Time and Language REF 500 Follow the instructions below to do the correct adjustments The SERVI CE MODE option is intended for Acarix authorized personnel to e g install new software and...

Страница 34: ...on the Settings display REF 500 to change user interface language The default language is English I n the Set language display REF 501 Press or to select a user interface language Press DONE to save...

Страница 35: ...s and cannot be changed I n the Set time display REF 502 Tap the hours HH or minutes MM fields individually to activate the wanted field Press or to change time HH MM Press DONE to save time setting a...

Страница 36: ...en by three letter abbreviations The date format cannot be changed I n the Set date display REF 503 Tap the month day or year fields individually to activate field Press or to change date M D Y Press...

Страница 37: ...o enter the set up menu directly is available by pushing the push button three times in succession This cannot be done during a recording session This functionality is also enabled while the sensor is...

Страница 38: ...een will go black The sensor will then only perform automatic qualification every 23rd hour The sensor will power on again after pressing the push button or taking the sensor out of the Docking statio...

Страница 39: ...ge the sensor battery when docked Qualify the sensor at regular intervals or on request I ndicate the CADScor System status by LED light Transfer of data from the sensor to a removable memory card onl...

Страница 40: ...n the side of Docking station 7 10 Charging of the sensor battery I n the Docking station charging of the sensor battery is initiated through the charging contact terminals of the Docking station Appr...

Страница 41: ...sensor if turned on in the Docking station LED indicator Sensor status Constant YELLOW Power on docking station Constant GREEN Sensor fully charged ready for use Flashing GREEN Ongoing charging of sen...

Страница 42: ...23 hours if the sensor is placed in the Docking station I f the sensor qualification has expired outside the Docking station a display message will ask for sensor to be placed in the home Docking sta...

Страница 43: ...expiration clock by 23 hours Place the sensor in the home Docking station The sensor will power on automatically in the powered on Docking station Press and hold the push button for 4 seconds a single...

Страница 44: ...on for 8 seconds beyond the 4 seconds single beep until a double beep signal feedback is given to power off the sensor The sensor will automatically turn on again while in the powered Docking station...

Страница 45: ...traffic noise talk construction work and similar Turn off indoor noisy or unused electrical equipment e g noisy PC mobile telephones ventilators fans air condition Unplug power to patient bed if avai...

Страница 46: ...n in the display top right 20 REC Battery level low Charge the battery if the level is below minimum red battery icon Qualification status is shown by circled blue check mark in upper display informat...

Страница 47: ...ir at the I C4 L region has to be removed as well as hair in the area of the applied patch The extended shaving area will ensure better anchoring of the CADScor Sensor and easier removal of patch afte...

Страница 48: ...r Costal space is most reliably identified using a simultaneous four finger palpation on the patient s chest This method is also known as the finger method for I C4 L identification picture at right U...

Страница 49: ...rs against the chest left side and massage the fingers into the intercostal spaces at the sternum border A moderate to high palpation pressure is needed to recognize the costa and the intercostal spac...

Страница 50: ...be able to identify the I C4 L position correctly The I C4 L position is equivalent to the electrode V2 position in a standard 12 lead ECG Train and counsel with a colleague to identify and establish...

Страница 51: ...f the assembly tool as outlined on the tool see figure at right Then place the CADScor Sensor on top of the patch Press sensor head carefully into coupling ring by using the palm of your hand Make sur...

Страница 52: ...e to pause breathing The sound will be demonstrated to the patient before starting I nstruct patient to relax respiration and do belly breathing instead of thorax breathing Show belly breathing by pat...

Страница 53: ...est I dentify the I C4 L region and do hair removal in I C4 L patch region if needed Observe at least 5 minutes of patient resting to ensure hemodynamic balance before doing CAD scoring and blood pres...

Страница 54: ...New examination on the home display REF 102 shown when sensor is un docked Whenever New Examination is chosen a new REC I D will be assigned Four patient specific risk factors are required to initiat...

Страница 55: ...year intervals should be registered as age on the day of the examination on display REF 105 I f the entered data should be corrected press EXI T to return to New Examination display REF 102 Patient sy...

Страница 56: ...nsion a standard blood pressure reading after the resting period and prior to the CADScor measurement should be done to establish hypertension status Observe at least 5 minutes patient rest to ensure...

Страница 57: ...for the CADScor System A warning sign behind the resulting CAD score will indicate the higher uncertainty of the CAD score from this group I f the information of the patient was correct and approved...

Страница 58: ...f the patch pouch I nspect if sensor head is correctly seated in the coupling ring When patch is attached to sensor press DONE The patch production data are checked by the sensor REF 127 Avoid placing...

Страница 59: ...on the patch The part under the sensor microphone is taken of separately divided from the remaining release liner by a pre made cut Keep the remaining release liner part in place until sensor is place...

Страница 60: ...sition orienting the sensor body towards the patient head on the sternum Do not apply strong pressure to the sensor head when applying patch on the patient Ensure proper adherence of sensor head to ch...

Страница 61: ...hor the long part of the patch onto the chest Finally remove release liner marked 3 on the patch and fix the sensor body to the top adhesive on the patch Do not pull the sensor to fix it on the patch...

Страница 62: ...while doing a CADScor recording will increase the chances of a successful recording and subsequent CAD scoring Find a suitable generally relaxing supine position placing arms along the body and restin...

Страница 63: ...tate the display by 180 degrees for better viewing comfort For the patient it is important to become familiar with the sound instructions given during the recording phase Select START SOUND DEMO REF 1...

Страница 64: ...eathing Belly breathing will ensure better recording results Explain belly breathing to patient Show e g belly breathing by patient hand on belly including inhalation exhalation and natural breathing...

Страница 65: ...ress START RECORDI NG REF 112 to begin recording process During Pre recording no talking should take place REF 113 I f external internal and electrical noise conditions during Pre recording are evalua...

Страница 66: ...e During the Main recording each recording phase will be indicated on the display in text as Continue breathing or Pause breathing The time left in each phase of the loop is indicated by a count down...

Страница 67: ...nal noise like patient coughing stomach rumbling increased hall way talk the actual recording can be retried without sacrificing a new patch To cancel the ongoing recording press the push button twice...

Страница 68: ...recording has to be made due to recording errors The calculation time is approximately 1 2 minutes The CAD score will be shown on the display in a colored bar indicating the patient risk group with th...

Страница 69: ...n a short diastole based CAD score is presented a possibility to redo the recording is offered Try to relax lower the heart rate the patient further before attempting a new recording A maximum of four...

Страница 70: ...for the purpose Currently mobile devices running iOS system at least version 13 with a camera can be used The CADScor app can be downloaded from the Apple App Store and should be installed configured...

Страница 71: ...score in the 30 39 year age group The CAD scores from patients in the 30 39 year group are currently outside the intended patient population A warning triangle indicates the higher uncertainty of thei...

Страница 72: ...nd recording will continue I n case of unsuitable recording conditions or other errors a display message will be shown indicating the cause of error Depending on error or message type the CADScor Sens...

Страница 73: ...the LOOK UP I D display REF 504 enter the four digit REC I D number and press the OK button to continue Notice that the REC I D is relating to the specific CADScor Sensor that performed the recording...

Страница 74: ...a to the patient REF 506 I f the REC I D is not found REF 507 check if the entered REC I D number or sensor number is correct I f the LOOK UP function is used on a different sensor than the original r...

Страница 75: ...splashing water to clean the sensor I f the sensor has become accidentally wet wipe it dry and leave to dry out for minimum 24 hours Do not attempt to dry in oven or using dry blower Do not expose th...

Страница 76: ...operation of the CADScor System sounds are indicating the various events Some sounds are related to the timing of breathing pause breathing intervals in the recording sequence and other sounds to con...

Страница 77: ...ystem cannot be machine washed or autoclaved nor heat or radiation sterilized Do not expose the CADScor System to liquids water oils detergents or similar or dust since this may damage the CADScor Sys...

Страница 78: ...irements Please contact your local Acarix distributor for instructions Acarix and its distributors within the European Union and associated states have taken the necessary steps to comply with the dir...

Страница 79: ...03 REF 125 REF 128 REF 506 If a CAD score is calculated from a patient below 40 years outside intended patient group the CAD score is presented with a warning symbol Establish if the entered patient i...

Страница 80: ...rmly into the sensor tester and observe that red indicator ring on the sensor head is not visible and retry qualification Contact local distributor Acarix if sensor will not qualify 6 Ambient noise to...

Страница 81: ...ination room location 8 Internal noise to high REF 207 REF 208 Can be caused by intermittent stomach rumbling Typically stomach rumbling will occur in periods prior to eating as a consequence of air i...

Страница 82: ...Abort if recording is not possible 11 The recording stopped after pre recording REF 203 REF 205 REF 207 REF 209 REF 211 Ambient noise or electrical noise was too high The heartbeat signal was too low...

Страница 83: ...ith proper patch reading Do a retry patch RFID reading away from metal containing surfaces 14 Temperature or pressure out of range REF 304 REF 313 REF 314 The temperature in the room has exceeded the...

Страница 84: ...f persistent failure contact local distributor Acarix service 17 Self test failed REF 315 A technical problem inside the CADScor System has occurred Contact local distributor Acarix service 18 Unexpec...

Страница 85: ...nction was performed on the Sensor that made the original recording Check if the last REC ID number on the Sensor display is lower than the Look up REC ID If the Sensor REC ID number is lower the Look...

Страница 86: ...g into power adaptor by pressing firmly Replace power supply unit if suspected malfunctioning Restore electrical supply Try restart procedure 7 14 Contact local distributor Acarix for available option...

Страница 87: ...ve humidity 20 80 non condensing I ngress Protection I P ratings CADScor Sensor I P44 CADScor Docking station I P22 Power adaptors I P20 Operating noise environm ent External noise level 65dB SPL Exte...

Страница 88: ...ndard I SO14443 Tx power Magnetic field short range device with 0 dB A m 10m Modulation ASK Bandwidth 14 kHz Do not use the CADScor System on patients with implanted electronics like I CD Pacemakers h...

Страница 89: ...ystem Shipper box 1x Outside box made of recyclable corrugated cardboard Approx weight 120 g System Shipper box 6x Outside box made of recyclable corrugated cardboard Approx weight 580 g Patch box 1x...

Страница 90: ...id strong vibrations or shock from dropping or handling Observe storage and operating conditions described in CADScor System requirements for temperature altitude and humidity in section 12 The manufa...

Страница 91: ...is device must accept any interference received including interference that may cause undesired operation CADScor sensor is compliant with the requirement for RF exposure in US with less than 50 mm se...

Страница 92: ...ssions CI SPR 11 Group 1 The CADScor sy st em ACS 1401 m ust em it elect rom agnet ic energy in order t o perform it s int ended funct ion Nearby elect ronic equipm ent m ay be affected RF em issions...

Страница 93: ...4 2 8 kV contact 15 k V air 8 kV contact 15 k V air Floors should be wood concret e or ceram ic t ile I f floors are covered wit h synt het ic m at erial t he relat ive hum idit y should be at least...

Страница 94: ...or 5 sec 0 UT 100 dip in UT for 0 5 cycle 0 UT 100 dip in UT for 1 cycle 70 UT 30 dip in UT for 25 cycles 0 UT 100 dip in UT for 5 sec Mains power qualit y should be t hat of a t ypical com m ercial o...

Страница 95: ...antennas should be used no closer than 30 cm 12 inches to any part of the CADScor system ACS 1401 including cables specified by the manufacturer Otherwise degradation of the performance of this equip...

Страница 96: ...96 Table 3 Radiated I m m unity Test Levels I m m unity to RF W irelss Com m unication Equipm ent...

Страница 97: ...erformed by the sensor I C4 L Left fourth intercostal space Stenosis Narrowing of the coronary arteries Coronary murmurs Heart sounds that are produced as a result of turbulent blood flow that is suff...

Страница 98: ...libpng org libsndfile LGPL 2 1 linux kernel GPL 2 memtester GPL 2 netbase GPL 2 pcre BSD 3 Clause see copyright holders below qt4 embedded LGPL 2 1 u boot GPL 2 wireless tools GPL 2 and LGPL 2 1 zlib...

Страница 99: ...ission is hereby granted free of charge to any person obtaining a copy of this software and associated documentation files the Software to deal in the Software without restriction including without li...

Страница 100: ...is built THE BASIC LI BRARY FUNCTI ONS Written by Philip Hazel Email local part ph10 Email domain cam ac uk University of Cambridge Computing Service Cam bridge England Copyright c 1997 2011 Universi...

Страница 101: ...ARY OR CONSEQUENTI AL DAMAGES INCLUDING BUT NOT LIMI TED TO PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES LOSS OF USE DATA OR PROFITS OR BUSI NESS INTERRUPTION HOWEVER CAUSED AND ON ANY THEORY OF LIABI...

Страница 102: ...e original author s reputation will not be affected by problems that might be introduced by others Finally software patents pose a constant threat to the existence of any free program We wish to make...

Страница 103: ...ch use some of those functions and data to form executables The Library below refers to any such software library or work which has been distributed under these terms A work based on the Library means...

Страница 104: ...of a whole which is a work based on the Library the distribution of the whole must be on the terms of this License whose permissions for other licensees extend to the entire whole and thus to each and...

Страница 105: ...derivative of the Library you may distribute the object code for the work under the term s of Section 6 Any executables containing that work also fall under Section 6 whether or not they are linked di...

Страница 106: ...ion of the work based on the Library and of the other library facilities is otherwise permitted and provided that you do these two things a Accom pany the combined library with a copy of the same work...

Страница 107: ...nsequence of the rest of this License 1 2 If the distribution and or use of the Library is restricted in certain countries either by patents or by copyrighted interfaces the original copyright holder...

Страница 108: ...under the terms of the ordinary General Public License To apply these terms attach the following notices to the library It is safest to attach them to the start of each source file to most effectively...

Страница 109: ...gs To protect your rights we need to make restrictions that forbid anyone to deny you these rights or to ask you to surrender the rights These restrictions translate to certain responsibilities for yo...

Страница 110: ...ify your copy or copies of the Program or any portion of it thus forming a work based on the Program and copy and distribute such modifications or work under the terms of Section 1 above provided that...

Страница 111: ...tains plus any associated interface definition files plus the scripts used to control com pilation and installation of the executable However as a special exception the source code distributed need no...

Страница 112: ...if he or she is willing to distribute software through any other system and a licensee cannot impose that choice This section is intended to make thoroughly clear what is believed to be a consequence...

Страница 113: ...e public the best way to achieve this is to make it free software which everyone can redistribute and change under these terms To do so attach the following notices to the program I t is safest to att...

Страница 114: ...for the program if necessary Here is a sample alter the names Yoyodyne Inc hereby disclaims all copyright interest in the program Gnomovision which makes passes at com pilers written by James Hacker...

Страница 115: ...115 US FDA version CADScor System User Manual English US FDA revision 12 5 Mar 20th 2021 From software version 4 0 US FDA...

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