acarix CADScor System User Manual
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acarix CADScor System User Manual

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CADScor
Syst em
User Manual
Rx On ly

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Summary of Contents for acarix CADScor System

  • Page 1 ® CADScor Syst em User Manual Rx On ly...

  • Page 2: A R R Ant Ies A Nd Discla Im Er

    Any claim s on warrant y should be t o any t hird part y wit hout t he prior writ t en addressed t o Acarix direct ly or t o t he consent of Acarix. Acarix dist ribut or in your count ry, who will init iat e replacem ent or repair of fault y equipm ent .

  • Page 3: Cha Nges

    This docum ent is subj ect t o change wit hout ® not ice and you are urged t o cont act Acarix CADScor is a regist ered t radem ark owned t o verify whet her t he docum ent has been by Acarix.

  • Page 4: Table Of Contents

    ® Ta ble of con te n t 5.17 The CADScor Sensor ....20 ® 5.18 CADScor Docking st at ion ..22 W a r r ant ies a nd discla im er ....2 Disclaim er ........2 ®...
  • Page 5 ® 7.11 Docking stat ion indicat ion LED light 8.15 Possible CADScor Syst em ..........41 m essages during or after recording ..72 7.12 Qualificat ion of sensor ....42 8.16 Recalling a previous recording 7.13 Forced qualificat ion....43 result ..........

  • Page 6: Nt R Oduct Ion

    ® CADScor Syst em before st art ing t o use dist ribut or or shipped back t o Acarix for t he syst em professionally. recycling.

  • Page 7: Product Descript Ion

    Product descript ion ® CADScor Syst em ; Docking st at ion holding ® The CADScor Syst em is a device for Sensor. recording and quant ifying acoust ic noise arising from coronary art ery st enosis m icro-t urbulence and m yocardial m ovem ent .

  • Page 8: I Nt Ended Use

    I nt ended use observe t he pat ient furt her prior t o addit ional evaluat ions. ® The int ended use of t he CADScor Syst em The presence of ot her pat ient risk fact ors is t o record heart sounds, i.e. m urm urs or condit ions m ay influence t his decision.

  • Page 9: Tr Oubleshoot Ing Guide

    81.8 invest igat ed populat ion, t he PPV increases. * m odelled from Acarix clinical dat a for The observed PPV of t he CAD- score above sensit iv it y / specificit y abov e at t hreshold ≤20.

  • Page 10: Risk- Benefit For Use

    Risk- Benefit for use ® By using t he CADScor Syst em for evaluat ing pat ient risk of Coronary Art ery Disease, a CADScor low risk of significant CAD can help t o direct ot her cause evaluat ion decisions and also rem ove unnecessary anxiet y.

  • Page 11: I Nt Ended User Profile

    I nt ended user profile ® The CADScor Syst em is int ended t o be ® Do not use t he CADScor Syst em operat ed only by regist ered nurses, wit hout t he necessary qualificat ions, clinical/ m edical laborat ory t echnicians, and only aft er inst ruct ion and having m edical doct ors/ physicians aft er having read and underst ood t his User- Manual,...

  • Page 12: I Ndicat Ions For Use

    Typica l a n gin a sym pt om s; ( all t hree below) Sub-st ernal chest discom fort of • charact erist ic qualit y and durat ion; Provoked by exert ion or em ot ional • st ress; Relieved by rest and/ or nit rat es wit hin I ndicat ions for use •...

  • Page 13: Cont Ra-Indicat Ions For Use

    5.10 Cont ra-indicat ions for use Asym pt om at ic for angina or chest pain, I m plant ed donor heart , Previous Coronary Art ery Bypass Graft ( CABG) , ® Previous Coronary st ent ing or known CAD The CADScor Syst em has not been Arrhyt hm ia causing non-sinus rhyt hm ,...

  • Page 14: I Nt Ended Condit Ions Of Use

    5.11 I nt ended condit ions of use ® ® The CADScor Syst em is int ended t o be Use t he CADScor Syst em below 2500 used at m edical clinics and hospit als, at m et ers. room t em perat ure and below 2500 m et er above sea level.

  • Page 15: Sym Bols Used

    Sy m bol Ex plana t ion Product code num ber. 5.12 Sym bols used Serial num ber Definit ions: ® The CADScor Syst em user m anual Warnings and precaut ions. cont ains sym bols, operat ional warnings See descript ion below ( 5.13- 5.15). and caut ions, which are im port ant and I nst ruct ion to Read user m anual.

  • Page 16: Warnings

    ® 5.14 Warnings CADScor Syst em elect rom agnet ic RFI D im pulse (5.10; 6.4) . Warnings are alert s described t o alert and reduce t he risk of deat h or serious inj ury Do not at t em pt t o re-use a ®...
  • Page 17 ® CADScor Syst em m ust only be serviced Do not t ouch t he charge- point t erm inals by qualified Acarix personnel (10) . ® on t he CADScor Syst em , due t o risk of perm anent dam age t o t he elect ronics...

  • Page 18: Cadscor Syst Em Unboxing

    ® 5.16 CADScor Syst em unboxing Place t he box on a t able and open it as shown in figure below. Est ablish t he cont ent of t he ® CADScor Syst em box ( one each) : ®...
  • Page 19 ® The CADScor Syst em is pre- assem bled in deskt op posit ion. ® Lift t he CADScor Syst em from t he syst em box by holding t he syst em at t he edges of t he alum inium plat e of t he Docking st at ion. ®...

  • Page 20: The Cadscor Sensor

    ® ® 5.17 The CADScor Sensor Main com ponent s of t he CADScor Sensor, t op/ side view. ® The CADScor Sensor is t he part t o record heart sounds at t he fourt h left I nt er Cost al region and t o calculat e t he CAD- score based on t he acoust ic recording.
  • Page 21 The sensor LCD t ouch display shows a user Charge t erm inals int erface t o guide you t hrough a recording session. Also, t he sensor st at us and t he Heart sound CAD- score are shown on t he display when m icrophone it is calculat ed.

  • Page 22: Cadscor Docking St At Ion

    ® 5.18 CADScor Docking st at ion Parts ident ificat ion Top v iew Bot t om v iew The Docking st at ion serves as a "hom e" for I ndicat or LED Back plate t he sensor t o which t he sensor is m at ed Sensor tester Product inform at ion specifically from t he fact ory.

  • Page 23: I Nst A Lla T Ion Of Cad Scor ® Sy St

    ® I n st a lla t ion of CAD Scor Syst e m Deskt op m odel Place t he Docking st at ion on a st able surface ( deskt op/ t able) . Deskt op posit ion is t he pre- set operat ing m ode of t he Docking st at ion.
  • Page 24 The LED on t he Docking st at ion lower right LED indicat or Sensor st at us corner should light up. Const ant YELLOW Power on docking st at ion Three different colours are used t o indicat e syst em st at us (t able at right ) .

  • Page 25: Cadscor ® Syst Em Wall M Ount Ing

    ® CADScor Syst em wall m ount ing ® The CADScor Syst em can be wall m ount ed t o save deskt op space or for increased general visibilit y. Det erm ine suit abilit y of t he wall m at erial and it em s in t he wall before m ount ing.
  • Page 26 Drill t wo holes ( Ø 4m m ) t hrough t he cent re of m arks and m ount back plat e (t hinner rim facing up) using appropriat e screws and plugs. Place t he t op part of t he Docking st at ion on t he back plat e, sensor t est er placed at upper right corner, and click int o locking posit ion.

  • Page 27: Cadscor ® Pat Ch Box Opening

    ® CADScor Pat ch box opening Pat ch box wit h assem bly t ool and labeling: ® Place t he CADScor Pat ch box on a t able and open along t he perforat ed line at t he box front and t op sides ( see figure at right ) .

  • Page 28: The Cadscor Pat Ch

    ® The CADScor Pat ch The disposable pat ch is used for anchoring t he sensor ont o t he chest of t he pat ient and provides opt im al recording condit ions ( see figures at right ) . ®...

  • Page 29: The Cadscor Pat Ch, Assem Bly

    ® The CADScor Pat ch, assem bly Place t he cardboard assem bly t ool on an even hard surface (e.g. t able t op) . Align t he un- packed pat ch on t op of t he assem bly t ool, so t hat t he pat ch is wit hin t he out line on t he t ool.

  • Page 30: Confirm Ing Correct Sensor- Patch Assem Bly

    Confirm ing correct sensor- pat ch assem bly The red colored assem bly indicat or ring on t he sensor head m ust now be hidden in t he coupling ring, when looked from t he side. Visually confirm t he disappearance of t he red colored indicat or ring all around t he sensor head ( see figure at right ) .

  • Page 31: Se T T Ing Up T He Cad Scor ® Syst E M Prior T O Use

    The sensor will aut om at ically det ect t he Docking st at ion and power on, showing t he Acarix logo ( as shown at right ) .
  • Page 32 As part of t he power- on sequence an inform at ion display will show current soft ware version and user relevant warnings and inst ruct ions ( REF: 101) . Since qualificat ion of t he sensor is needed every 23rd hours, a display m essage will show t hat qualificat ion is in progress 4.
  • Page 33 Follow t he inst ruct ions below t o do t he correct adj ust m ent s. The SERVI CE MODE opt ion is int ended for Acarix aut horized personnel t o e.g. inst all new soft ware and is not accessible in norm al use.

  • Page 34: Set T Ing Language

    Set t ing language Press LANGUAGE on t he Set t ings display ( REF: 500) t o change user int erface language. The default language is English. I n t he "Set language" display ( REF: 501) , Press t o select a user int erface language.

  • Page 35: Set T Ing T Im E

    Set t ing t im e Press "TI ME" t o set t he correct t im e. Tim e form at is int ernat ional 24 hours, and cannot be changed. I n t he "Set t im e" display ( REF: 502) , Tap t he hours (HH) or m inut es ( MM) fields individually t o act ivat e t he want ed field.

  • Page 36: Set T Ing Date

    Set t ing dat e Press "DATE" t o set t he correct dat e. Dat e form at is Mont h: Day: Year, where m ont h is given by t hree let t er abbreviat ions. The dat e form at cannot be changed. I n t he "Set dat e"...

  • Page 37: Finishing Sensor Set- Up

    Finishing Sensor SET- UP Press "DONE" t o exit "Set t ings" display. The sensor will ret urn t o t he "hom e" display ( REF: 102) . The sensor will t urn off aut om at ically aft er five m inut es of inact ivit y.
  • Page 38 While t he sensor is docked, a pause display ( "Last recording") will be shown ( REF: 103) . Aft er a period of inact ivit y, t he sensor will aut om at ically power- down t o save energy and t he screen will go black.

  • Page 39: Cadscor ® Docking St At Ion

    Transfer of dat a from t he sensor t o • a rem ovable m em ory card (only available in clinical t rials t hrough arrangem ent wit h Acarix) . Updat e t he sensor soft ware. •...

  • Page 40: Connect Ing/ Disconnect Ing Power Adapter T O Docking Stat Ion

    Connect ing/ disconnect ing power adapt er t o Docking st at ion ® The CADScor Docking st at ion has a dedicat ed ext ernal universal power adapt or ( 100- 240 VAC/ 50- 60Hz) . To supply t he Docking st at ion, connect t he sm all power adapt or plug int o t he j ack on t he side of Docking st at ion.

  • Page 41: Docking Stat Ion Indicat Ion Led Light

    7.11 Docking st at ion indicat ion LED light LED indicat or Sensor st at us Const ant YELLOW Power on docking When t he sensor is placed in t he Docking st at ion st at ion, an LED on t he alum inium front indicat es t he present st at us of t he Const ant GREEN Sensor fully charged;...

  • Page 42: Qualificat Ion Of Sensor

    7.12 Qualificat ion of sensor ® The CADScor Syst em is qualified at regular int ervals t o ensure safe operat ion. During qualificat ion, a series of t ones are played from t he Docking st at ion t o t he sensor.

  • Page 43: Forced Qualificat Ion

    7.13 Forced qualificat ion ® I f you are bringing t he CADScor Sensor along and suspect qualificat ion will expire before ret urning, a forced qualificat ion can reset expirat ion clock by 23 hours. Place t he sensor in t he hom e Docking st at ion The sensor will power-on aut om at ically in t he powered-on Docking st at ion.

  • Page 44: Re- Set T Ing Sensor

    7.14 Re- set t ing sensor ® The CADScor Sensor operat ing syst em can be reset in t he event of unresponsive soft ware failure. The re-set t ing will force t he sensor t o reload sensor - soft ware and also re- qualify t he sensor.

  • Page 45: Preparing T He Exam Inat Ion Room

    D e t ect ion of h e ar t soun ds Preparing t he exam inat ion room ® The CADScor Syst em records very weak heart m urm urs. Reducing ext ernal or environm ent al noise will increase t he likelihood of a successful recording.

  • Page 46: Preparing T He Sensor

    Preparing t he sensor Press t he push but t on t o t urn on t he sensor in t he Docking st at ion or t ake out t he sensor from t he Docking st at ion. Aft er power-on ( and event ual qualificat ion) t he display will ret urn t o t he "hom e"- display ( REF: 102) if sensor is ready, and...

  • Page 47: Preparing T He Pat Ient

    Preparing t he pat ient Always use a paper/ linen bedcover bet ween pat ient and exam inat ion- bed t o avoid rubbing noise. This will reduce sit uat ions pot ent ially requiring a second recording. H a ir r e m ova l Also, t o obt ain high- qualit y heart sound recordings and t o reduce secondary Always conduct proper skin cleaning and...

  • Page 48: I Dent Ifying T He Fourth Left I Nter Cost Al Space ( I C4- L)

    I dent ifying t he fourt h left I nt er Cost al space (I C4- L) Est ablishing t he correct recording posit ion on t he pat ient is very im port ant for obt aining a valid heart sound recording. The fourt h left I nt er Cost al space is m ost reliably ident ified using a sim ult aneous four- finger palpat ion on t he pat ient ’s...
  • Page 49 St anding on t he pat ient s’ right side, spread your left -hand fingers approxim at ely 1.5 cent im et ers, and place your left -hand lit t le finger up against t he collar bone ( clavicular) . Just under t he collarbone cost a num ber one ( C1) is found.
  • Page 50 Use a clearly visible pen m arker, t o lat er reliably locat e t he est ablished recording posit ion t o avoid reposit ioning t he sensor- pat ch assem bly and t hereby reduce skin adherence. The m arked I C4- L spot indicat es t he cent re of t he recording sit e for t he sensor head.

  • Page 51: At T Achm Ent Of Pat Ch T O Sensor

    At t achm ent of pat ch t o sensor An assem bly t ool is provided wit h t he pat ches t o m ount t he pat ch correct ly t o t he sensor ( see also sect ion ®...

  • Page 52: Explaining Off T He Recofrding Profcedure T Of Pat Ient

    Explaining of t he recording procedure belly, including inhalat ion, exhalat ion and t o pat ient nat ural breat hing pause aft er exhalat ion. Explain t he recording procedure t o pat ient . Pr ocedur e St e p Act ions e ( s) Being generally relaxed and pausing...

  • Page 53: Observe At Least 5 M Inut Es Of Pat Ient

    Before Recording phase Su m m a r y Check exam inat ion room for acoust ic and elect rical noise. Check sensor readiness. Ask pat ient t o rem ove clot hing from t he waist -up and lie on t he back on t he exam inat ion bed ( supine posit ion) and rest .

  • Page 54: Recording Phase, Pat Ient Risk Fact Ors

    I nit iat ing t he recording sequence: I f not already powered- on press push but t on once t o act ivat e sensor. The Acarix st art - up display ( REF: 101) will be shown during sensor self- t est . Choose "New exam inat ion"...
  • Page 55 Pat ient birt h Gender should be ent ered on display ( REF: 104) . I f t he ent ered dat a should be correct ed press EXI T, t o ret urn t o New Exam inat ion display ( REF: 102) .
  • Page 56 Presence (or not ) of Pat ient hypert ension should be ent ered in display ( REF: 107) . Hypert ension is defined as pat ient having syst olic blood pressure equal or above 140 m m Hg or being in m edical t reat m ent for syst olic hypert ension.
  • Page 57 I f t he pat ient age ent ered is wit hin t he pat ient age- group 30-39 years, a not ice display ( REF: 219) is shown t o indicat e t hat t he pat ient age is below t he current int ended pat ient populat ion for t he ®...
  • Page 58 At t a ch in g se nsor/ pa t ch asse m bly t o pa t ie n t I f sensor is ready t o record, t he sensor will ask for new pat ch ( REF: 110) . Mount a new pat ch as described above ( sect ion 8.5) or as described on t he back of t he pat ch pouch.
  • Page 59 When t he pat ch inform at ion has been verified and recognised a confirm at ion is given ( REF: 111) . Proceed t o place sensor on I C4- L. First rem ove t he release liner m arked “1 ” on t he pat ch.

  • Page 60: Pre

    Now, place t he sensor head at t he pre- m arked I C4- L posit ion, orient ing t he sensor body t owards t he pat ient head on t he st ernum . Do not apply st rong pressure t o t he sensor head when applying pat ch on t he pat ient .
  • Page 61 Then, Peel-off release liner m arked “ 2 ” on t he pat ch and anchor t he long part of t he pat ch ont o t he chest . Finally, rem ove release liner m arked “ 3 ” on t he pat ch and fix t he sensor body t o t he t op adhesive on t he pat ch.
  • Page 62 When sensor and pat ch assem bly is securely posit ioned, press DONE t o verify placem ent on I C4- L. When t he adhesive of t he pat ch has been adhered t o t he pat ient , t he Sensor and pat ch should not be m oved.
  • Page 63 Three opt ions will t hen becom e available ( in REF: 112) : START SOUND DEMO t o dem onst rat e recording sounds t o pat ient START RECORDI NG t o init iat e t he act ual recording, or ROTATE DI SPLAY t o rot at e t he display by 180 degrees for bet t er viewing com fort .

  • Page 64: Breat Hing

    Press DONE t o exit SOUND DEMO aft er pat ient has becom e fam iliar wit h t he sounds. Again, inst ruct pat ient t o relax respirat ion and do belly breat hing inst ead of t horax breat hing.

  • Page 65: Recording Phase, St Art

    Recording phase, St art ® The CADScor Sensor will evaluat e current recording condit ions during a Pre- recording, before cont inuing t o t he m ain heart sound recording. Press START RECORDI NG (REF: 112) t o begin recording process. During Pre- recording, no t alking should t ake place ( REF: 113) .

  • Page 66: Recording Phase, Main Recording

    Recording phase, Main recording The Main recording has four recording loops of approxim at e 26 seconds each. Each recording loop has t wo phases, 18 seconds of norm al belly breat hing and eight seconds of breat hing pause. During t he Main recording, each recording phase will be indicat ed on t he display in SCREEN_115_1_recording+4+14.pngSCREE...

  • Page 67: Recording Phase, Cancelling

    8.10 Recording phase, cancelling The ongoing recording can be cancelled if condit ions for recording heart sounds becom e unsuit able. I n case of increased ext ernal noise ( like high t raffic noise, helicopt er landing, high sounding alarm s) or int ernal noise ( like pat ient coughing, st om ach rum bling, increased hall- way t alk) , t he act ual recording can be ret ried wit hout sacrificing...

  • Page 68: Recording Phase, Cad- Scoring

    8.11 Recording phase, CAD- scoring Aft er t he heart sound recording has ended t he sound-file will be evaluat ed for errors like excessive noise, and a CAD-score is calculat ed ( REF: 124) . The sensor/ pat ch should not be rem oved from t he pat ient at t his m om ent , in case of a new recording has t o be m ade due t o recording errors.

  • Page 69: Short Diastole Cad-Score

    8.12 Short diast ole CAD- score I n a few cases a st andard CAD- score cannot be calculat ed based on a m inim um diast olic period lengt h, however an est im at ed CAD- score will be shown. The short diast ole CAD- score is indicat ed by an ast erisk ( * ) in front of t he CAD- score.

  • Page 70: Qr- Code For Print Ing, Archiving And Sending A Cadscor Pat Ient Report

    8.13 QR- code for print ing, archiving and sending a CADScor pat ient report ® A funct ionalit y of t he CADScor Syst em is t he int egrat ion of a QR- code for print ing, archiving and sending a pat ient report from a previous CAD-scoring, using a m obile device like a sm art phone, or a QR code scanner set up for t he purpose.

  • Page 71: Cad- Score In T He 30-39 Year Age Group

    8.14 CAD- score in t he 30-39 year age group The CAD- scores from pat ient s in t he 30- 39- year group are current ly out side t he int ended pat ient populat ion. A warning t riangle indicat es t he higher uncert aint y of t heir CAD-score.

  • Page 72: Possible Cadscor Syst Em M Essages During Or After Recording

    ® 8.15 Possible CADScor Syst em m essages during or aft er recording ® The CADScor Sensor will during a pre- recording, prior t o t he heart sound recording sequence, det erm ine if am bient condit ions are fulfilled. I f recording condit ions are fulfilled t he heart sound recording will cont inue.

  • Page 73: Recalling A Previous Recording Result

    8.16 Recalling a previous recording result From t he Set t ings display ( REF: 500) it is possible t o select a LOOK- UP I D funct ion t o recall dat a from a previous recording session if t he Record- I D ( REC-I D) is known.
  • Page 74 Check in t he LOOK-UP dat a t hat t he LOOK- UP REC-I D recording dat e corresponds t o t he ant icipat ed dat e for t he recording t hat is being ident ified. The ot her pat ient s’ param et ers ( e.g. gender and age- group) , can also be used for est ablishing t he relevance of t he Look- up dat a t o t he pat ient ( REF: 506) .

  • Page 75: Aft Er T He Recording

    8.17 Aft er t he recording Clean t he sensor using 70% et hanol wipes aft er use. The sensor will aut om at ically t urn it self off. ® Do not expose t he CADScor Syst em t o Place t he sensor in t he Docking st at ion for liquids ( wat er, oils, det ergent s or charging and aut om at ic qualificat ion unt il...

  • Page 76: Sound Guida Nce Used In The Int Er Fa Ce

    Sou n d gu ida nce use d in t h e in t e r face During operat ion of t he CADScor® Syst em sounds are indicat ing t he various event s. Som e sounds are relat ed t o t he t im ing of breat hing/ pause breat hing int ervals in t he recording sequence and ot her sounds t o confirm act ions or as a warning of int ended...

  • Page 77: M A Int E Na Nce

    ® use or repair a defect CADScor Syst em , st erilized. due t o risk of m alfunct ioning. The ® CADScor Syst em m ust only be serviced by qualified Acarix personnel.

  • Page 78: Disposal

    Please cont act your local Acarix dist ribut or for inst ruct ions. Acarix and it s dist ribut ors wit hin t he European Union and associat ed st at es have t aken t he necessary st eps t o com ply wit h...
  • Page 79 The sensor bat tery has been day s for recharging aft er deep discharge. Low bat tery power deep discharged. Cont act local dist ribut or/ Acarix for See also # 20. available opt ions if problem persist ing.
  • Page 80 Error in t he Dock ing st at ion. Cont act local dist ribut or/ Acarix if sensor Error in t he sensor. will not qualify.
  • Page 81 Er r or m essage D ispla y Possible ca use Corr e ct ion a ct ion r e fe r e nce REF: 205 The elect rom agnet ic field Unplug power ( if any ) to t he Elect rical noise t oo REF: 206 noise in t he exam inat ion...
  • Page 82 Er r or m essage D ispla y Possible ca use Corr e ct ion a ct ion r e fe r e nce # 10 REF: 211 The sensor head was not Re- ident ify left I C4 space and use a new Heartbeat signal t oo REF: 212 anchored correct ly at t he...
  • Page 83 # 15 REF: 213 A t echnical problem inside Ret ry recording. ® Algorit hm REF: 218 t he CADScor Sensor has I f persistent failure cont act local int eract ion failed occurred. dist ribut or/ Acarix serv ice.
  • Page 84 I f persistent failure cont act local dist ribut or/ Acarix serv ice. # 17 REF: 315 A t echnical problem inside Cont act local dist ribut or/ Acarix serv ice. ® Self- t est failed t he CADScor Sy stem has occurred.
  • Page 85 Er r or m essage D ispla y Possible ca use Corr e ct ion a ct ion r e fe r e nce # 19 REF: 507 The pat ient REC- I D was Check t hat t he REC- I D num ber was t yped REC- I D not found not found on t he Sensor.
  • Page 86 The Dock ing stat ion Try rest art procedure ( 7.14) . contacts interface is not Cont act local dist ribut or/ Acarix for recognizing sensor. available opt ions if problem persist s. # 21 The sensor is in off m ode.

  • Page 87: Cad Scor ® Syst Em R Equir E M Ent S

    ® 1 2 CAD Scor Syst e m re qu ir e m en t s Syst e m a lt it u de cor r ect ion Up t o 2500 m above sea level N or m a l ope r a t in g e n viron m en t : Syst e m pow er sour ce Tem perat ure + 10 t o + 40°...

  • Page 88: System Specificat Ion

    12.1 Syst em specificat ion RFI D : Frequency band: 13.56 MHz I SM band Model: ACS-1401 Com m unicat ion st andard: I SO14443 Dim ensions: Tx power: Magnet ic field short range device ® CADScor Sensor: ASE- 1401 wit h <...

  • Page 89: Packaging M Aterials

    Pat ch box: 1x 12.2 Packaging m at erials Out side box m ade of recyclable cardboard. Syst em Box: 1x I nside pouches m ade from Polyet hylene and Out side box m ade of recyclable corrugat ed paper. cardboard.
  • Page 90 CADScor Syst em m ust only be serviced caused by im proper operat ion. by qualified Acarix personnel (10) . This syst em com prises sensit ive com ponent s Do not drop or exert excessive st ress or and m ust be t reat ed carefully t o avoid st rong ®...

  • Page 91: Appr Ov A Ls A Nd Emc Infor M A Tion

    50 m m separat ion dist ance bet ween t he user 1 4 Appr ova ls a n d EM C in for m a t ion and/ or byst ander of t he device. ® The CADScor Syst em is a m edical device CADScor sensor is only com pliant if no class I I a, fulfilling t he requirem ent s in changes or m odificat ions are m ade t o t he...
  • Page 92 T a b l e 1 : G u id a n ce a n d m a n u f a ct u re r’s d e cla ra t io n – e le ct r o m a g n e t ic e m issio n s Th e CADScor sy st em ACS- 1401 i s i n t en d ed for u se in t h e elect r o m ag n e t i c en v i r o n m e n t sp e cifi ed b elow .
  • Page 93 T a b l e 2 : G u id a n ce a n d m a n u f a ct u re r’s d e cla ra t io n – e le ct r o m a g n e t ic im m u n it y Th e CADScor sy st em ACS- 1401 i s i n t en d ed for u se in t h e elect r o m ag n e t i c en v i r o n m e n t sp e cifi ed b elow .
  • Page 94 T a b l e 2 , con t in u e d: G u id a n ce a n d m a n u f a ct u re r’s d e cla ra t io n – e le ct r o m a g n e t ic im m u n it y Volt age dips, short 0 % UT 0 % UT...
  • Page 95 Ta ble 2 , con t in u e d: Gu id a n ce a n d m a n u f a ct u r e r’s d e cla ra t io n – e le ct r o m a g n e t ic im m u n it y Conduct ed RF 3 Vrm s 3 Vrm s...
  • Page 96 Ta ble 3 : Ra dia t e d I m m un it y Te st Le ve ls ( I m m u n it y t o RF W ir e lss Com m u n ica t ion Equ ipm e n t ) .
  • Page 97 1 5 Acron ym s & De fin it ions in t e x t Acronym s Definit ions Coronary Art ery Disease. Chronic Coronary Syndrom e ® CADScor Syst em Sensor, Docking st at ion and Pat ch. ® ®...
  • Page 98 / / zlib.net • Som e of t he licenses grant t he user full access t o t he source code for t he specific package. To get t his access, please cont act Acarix info@acarix.com .
  • Page 99 < The MI T License, see below> = = = = = LibTom Cr ypt and LibTom Mat h are writ t en by Tom St Denis, and are Public Dom ain. = = = = = sshpt y.c is t aken from OpenSSH 3 .5p1, Copyright ( c) 1995 Tat u Ylonen <...
  • Page 100 Release 8 of PCRE is dist ribut ed under t he t erm s of t he "BSD" licence, as specified below. The docum ent at ion for PCRE, supplied in t he "doc" direct ory , is dist ribut ed under t he sam e t erm s as t he soft ware it self. The basic library funct ions are writ t en in C and are freest anding.
  • Page 101 Neit her t he nam e of t he Universit y of Cam bridge nor t he nam e of Google I nc. nor t he nam es of t heir cont ribut ors m ay be used t o endorse or prom ot e product s derived from t his soft ware wit hout specific prior w rit t en perm ission.
  • Page 102 whet her t his license or t he ordinary General Public License is t he bet t er st rat egy t o use in any part icular case, based on t he explanat ions below. When we speak of free soft ware, we are referring t o freedom of use, not price. Our General Public Licenses are designed t o m ake sure t hat you have t he freedom t o dist ribut e copies of free soft w are ( and charge for t his service if you wish) ;...
  • Page 103 a free library does t he sam e j ob as widely used non- free libraries. I n t his case, t here is lit t le t o gain by lim it ing t he free library t o free soft ware only, so we use t he Lesser General Public License.
  • Page 104 2 . You m ay m odify your copy or copies of t he Library or any por t ion of it , t hus form ing a work based on t he Librar y, and copy an d dist ribut e such m odificat ions or work under t he t erm s of Sect ion 1 above, provided t hat you also m eet all of t hese condit ions: a ) The m odified work m ust it self be a soft ware library.
  • Page 105 I f dist ribut ion of obj ect code is m ade by offering access t o copy f rom a designat ed place, t hen offering equivalent access t o copy t he source code from t he sam e place sat isfies t he requirem ent t o dist ribut e t he source code, even t hough t hird part ies are not com pelled t o copy t he source along wit h t he obj ect code.

  • Page 106: Lice Nses

    ( 2) will operat e properly wit h a m odified version of t he library, if t he user inst alls one, as long as t he m odified version is int erface- com pat ible wit h t he version t hat t he work was m ade wit h. c) Accom pany t he work wit h a writ t en offer, valid for at least t hr ee years, t o give t he sam e user t he m at erials specified in Subsect ion 6a, above, for a char ge no m ore t han t he cost of per form ing t his dist ribut ion.
  • Page 107 1 1 . I f, as a consequence of a court j udgm ent or allegat ion of pat ent infringem ent or for any ot her reason ( not lim it ed t o pat ent issues) , condit ions are im posed on you ( whet her by court order, agreem ent or ot herwise) t hat cont radict t he condit ions of t his License, t hey do not excuse you from t he condit ions of t his License.
  • Page 108 PARTI ES PROVI DE THE LI BRARY "AS I S" WI THOUT WARRANTY OF ANY KI ND, EI THER EXPRESSED OR I MPLI ED, I NCLUDI NG, BUT NOT LI MI TED TO, THE I MPLI ED WARRANTI ES OF MERCHANTABI LI TY AND FI TNESS FOR A PARTI CULAR PURPOSE. THE ENTI RE RI SK AS TO THE QUALI TY AND PERFORMANCE OF THE LI BRARY I S WI TH YOU.
  • Page 109 Ty Coon, President of Vice That 's all t here is t o it ! GPL- 2 GNU GENERAL PUBLI C LI CENSE Version 2, June 1991 Copyright ( C) 1989, 1991 Free Soft ware Foundat ion, I nc. 51 Franklin St reet , Fift h Floor, Bost on, MA 02110- 1301, USA Everyone is perm it t ed t o copy and dist ribut e verbat im copies of t his license docum ent , but changing it is not allowed.
  • Page 110 TERMS AND CONDI TI ONS FOR COPYI NG, DI STRI BUTI ON AND MODI FI CATI ON 0 . This License applies t o any program or ot her work which cont ains a not ice placed by t he copyright holder saying it m ay be dist ribut ed under t he t erm s of t his General Public License.
  • Page 111 Thus, it is not t he int ent of t his sect ion t o claim right s or cont est your right s t o wor k w rit t en ent irely by you; rat her, t h e int ent is t o exercise t he right t o cont rol t he dist ribut ion of derivat ive or collect ive wor ks based on t he Program .
  • Page 112 furt her rest rict ions on t he recipient s' exercise of t he right s grant ed herein. You are not responsible for enforcing com pliance by t hird part ies t o t his License. 7 . I f, as a consequence of a court j udgm ent or allegat ion of pat ent infringem ent or for any ot her reason ( not lim it ed t o pat ent issues) , condit ions are im posed on you ( whet her by court order, agreem ent or ot herwise) t hat cont radict t he condit ions of t his License, t hey do not excuse you from t he condit ions of t his License.
  • Page 113 1 1 . BECAUSE THE PROGRAM I S LI CENSED FREE OF CHARGE, THERE I S NO WARRANTY FOR THE PROGRAM, TO THE EXTENT PERMI TTED BY APPLI CABLE LAW. EXCEPT WHEN OTHERWI SE STATED I N WRI TI NG THE COPYRI GHT HOLDERS AND/ OR OTHER PARTI ES PROVI DE THE PROGRAM "AS I S"...
  • Page 114 The hypot het ical com m ands ` show w' and ` show c' should show t he appropriat e par t s of t he General Public License. Of course, t he com m ands you use m ay be called som et hing ot her t han ` show w' and ` show c'; t hey could even be m ouse- presss or m enu it em s- - what ever suit s your program .
  • Page 115 US- FDA version. ® CADScor Syst em User Manual, English US- FDA revision 12.5, Mar. 20 , 2021. From soft ware version 4.0 US- FDA.

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