User Manual for acarix models including: ASE1401, 2AYXI-ASE1401, 2AYXIASE1401, acarix Handheld CADScor System, Handheld CADScor System, CADScor System
Acarix A/S ASE1401 CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of presence of coronary stenosis, as an aid in cardiac analysis and diagnosis 2AYXI-ASE1401 2AYXIASE1401 ase1401
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DocumentDocumentCADScor® Syst em User Manual Rx Only 1 W arranties and disclaim er The CADScor® Syst em is covered by a general 1- year warranty from dat e of purchase, t hat covers fault y hardware, including t he CADScor® Sensor, t he CADScor® Docking st at ion and t he ext ernal power adaptor. Furt herm ore, Acarix guarant ees t hat t he CADScor® Syst em will be operat ional for at least 1000 recordings in t he warrant y period. I f, however t he CADScor® Syst em does not operat e properly, please first consult t he "Troubleshoot ing guide"- sect ion 11 in t his m anual describing possible errors. Any claim s on warrant y should be addressed to Acarix directly or t o the Acarix dist ribut or in your count ry, who will initiate replacem ent or repair of fault y equipm ent . 1.1 Disclaim er The inform at ion given in t his docum ent is adapt ed to an int ernational m arket of healt hcare professionals, based on illust rations, sym bols and t ext . The docum ent is giving no specific references t o religious preference, ethnic origin, gender or polit ical viewpoint s. Any such relat ion is considered an int erpret at ion of which Acarix cannot be held reliable. The inform at ion is int ended t o ensur e t he safe and accurat e operat ion of t he CADScor ® Syst em . 2 Copyr igh t n ot ice The cont ent s of t his docum ent shall not be reproduced or com m unicat ed in any form t o any t hird party without the prior writt en consent of Acarix. 2 3 Ch a n ge s This docum ent is subj ect t o change wit hout not ice and you are urged t o cont act Acarix t o verify whether the docum ent has been changed. The m anual relevant t o t he specific equipm ent m odel can also be downloaded from t he Acarix websit e. You can locat e t he specific m odel num ber ( REF num ber) on t he back of t he alum inium fram e of t he CADScor® Docking st at ion. While every effort is m ade to ensure t he correct ness of t he inform at ion provided in t his print ed m anual Acarix disclaim s any liabilit y for errors and om issions herein. The illust rat ions used in t his m anual m ay differ slight ly from t he appearance of t he act ual device, packaging m at erials or int erface and reflect s on- going effort s t o im prove safet y, usabilit y and clarify t he overall inst ruct ions given. 4 Tradem arks and Third-party softw are CADScor® is a regist ered t radem ark owned by Acarix. Third part y soft ware license agreem ent s are list ed in t he back of t his m anual. US- FDA revision 12.5, Mar. 20th, 2021. From soft ware version 4.0 US- FDA. Acarix Ryvangs Allé 81-83 DK- 2900 Hellerup Denm ark w w w . acar i x . co m 3 Table of content 1 W arranties and disclaim er ................ 2 1.1 Disclaimer ................................... 2 2 Copyright not ice ............................... 2 3 Changes ........................................... 3 4 Tradem arks and Third-party softw are3 5 I ntroduction..................................... 6 5.1 About this m anual......................... 6 5.2 The CADScor® System and t he environm ent .......................................... 6 5.3 Product descript ion ....................... 7 5.4 I nt ended use ............................... 8 5.5 Use of t he CAD- score .................... 8 5.6 Risk- Benefit for use...................... 10 5.7 I nt ended user profile .................... 11 5.8 I ntended patient population........... 11 5.9 I ndicat ions for use ....................... 12 5.10 Cont ra- indicat ions for use .......... 13 5.11 I nt ended condit ions of use ......... 14 5.12 Sym bols used .......................... 15 5.13 Sym bols on t he CADScor® Syst em and in User m anual................................ 15 5.14 Warnings ................................ 16 5.15 Precaut ions ............................. 16 5.16 CADScor® Syst em unbox ing ........ 18 5.17 5.18 The CADScor® Sensor ............... 20 CADScor® Docking st at ion .......... 22 6 I nst a lla t ion of CAD Scor ® Sy st em ......2 3 6.1 Desktop m odel............................ 23 6.2 CADScor® Syst em wall m ount ing .... 25 6.3 CADScor® Pat ch box opening.......... 27 6.4 The CADScor® Patch ..................... 28 6.5 The CADScor® Patch, assem bly....... 29 6.6 Confirm ing correct sensor- patch assem bly ............................................. 30 7 Se t t ing up t h e CAD Scor ® Syst e m p rior to use ....................................................3 1 7.1 CADScor® Sensor ......................... 31 7.2 First t im e configurat ion of t he CADScor® Sensor ................................... 31 7.3 Set t ing language ......................... 34 7.4 Setting time ............................... 35 7.5 Setting date ............................... 36 7.6 Finishing Sensor SET- UP............... 37 7.7 Universal access.......................... 37 7.8 CADScor® Docking st at ion.............. 39 7.9 Connect ing/ disconnect ing power adapter to Docking station ...................... 40 7.10 Charging of t he sensor bat tery ...... ............................................. 40 4 7.11 7.12 7.13 7.14 Docking stat ion indicat ion LED light ............................................. 41 Qualificat ion of sensor ............... 42 Forced qualificat ion................... 43 Re- set t ing sensor ..................... 44 8.15 Possible CADScor® Syst em m essages during or after recording .......... 72 8.16 Recalling a previous recording result ............................................ 73 8.17 After the recording ................... 75 8 Detection of heart sounds............... 4 5 8.1 Preparing t he exam inat ion room .... 45 8.2 Preparing t he sensor .................... 46 8.3 Preparing t he pat ient ................... 47 8.4 I dent ifying t he fourth left I nter Cost al space ( I C4- L) ....................................... 48 8.5 At t achm ent of pat ch t o sensor ....... 51 8.6 Explaining of t he recording procedure to patient ............................................. 52 8.7 Recording phase, pat ient risk fact ors . ................................................ 54 8.8 Recording phase, St art ................. 65 8.9 Recording phase, 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 print ing, archiving and sending a CADScor pat ient report............. 70 8.14 CAD- score in t he 30- 39 year age group ............................................. 71 9 Sound guidance used in the interface . ......................................................76 1 0 Maintenance ................................ 7 7 10.1 Disposal ................................. 78 1 1 Troubleshooting guide .................7 9 1 2 CAD Scor ® Syst em r eq u ir e m en t s ....... ...................................................87 12.1 System specificat ion ................. 88 12.2 Packaging m aterials ................. 89 13 W arranty .....................................90 1 4 Appr ov a ls a nd EMC infor m a tion ....... ...................................................91 1 5 Acronym s & Definitions in text ........ ...................................................97 1 6 Licenses ...................................... 9 8 5 5 I ntroduction 5.1 About this m anual This user m anual is int ended as a reference guide for t he safe and correct use of t he CADScor® Syst em , aft er having been instruct ed in the proper operat ion of t he CADScor® Syst em . This user m anual cont ains bot h general and specific operat ing instructions, hereunder procedures for recording heart sounds, m aint enance of the CADScor® Syst em , t roubleshoot ing, inst ruct ions and inform at ion of individual com ponents. To ensure optim al safet y in operat ion and service of t he CADScor® Syst em , it is im port ant t o read this m anual carefully and underst and t he use of t he CADScor® Syst em before st art ing t o use t he syst em professionally. 5.2 The CADScor® Syst em and t he environm ent The Acarix CADScor® Syst em has been designed t o m inim ize t he environm ent al im pact from fabricat ion, t ransport and use. The Syst em - and Pat ch boxing and packaging is m ade from light weight recycled paper and cardboard, which can be disposed of as paper- wast e and r ecy cl ed . The used pat ch and pouch can be disposed of as norm al household wast e. The CADScor® Sensor, docking st at ion and power adaptor cont ains elect ronic com ponent s, and should not be discarded in norm al household wast e, but ret urned for recycling at a regulat ed facilit y, local dist ribut or or shipped back t o Acarix for r ecy cl in g . 6 5.3 Product descript ion The CADScor® Syst em is a device for recording and quant ifying acoust ic noise arising from coronary art ery st enosis m icro-t urbulence and m yocardial m ovem ent . These noises are usually described as "coronary m urm urs". CADScor® Syst em ; Docking st at ion holding Sen sor . The CADScor® Syst em calculat es a pat ient specific CAD-score by com put at ional processing of a recording obt ained from t he chest surface of t he pat ient and t he pat ient risk fact ors present . CADScor® Pat ch and power adapt or below. The CADScor® Syst em consist s of t wo physical unit s; t he CADScor® Sensor and t he CADScor® Docking st at ion for charging and qualificat ion of t he sensor. A specific power adapt or powers t he Docking st at ion. The pat ch for anchoring t he sensor t o t he chest of t he pat ient is a necessary accessory for proper funct ioning of t he CADScor® Syst em ( all shown at right ) . The CADScor® Syst em is operat ed by a graphical user t ouch-screen int erface. 7 5.4 I nt ended use observe the pat ient furt her prior to additional evaluations. 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. and vibrat ion for calculat ion of a patient specific score, t he CAD- score, indicat ing Definit ions of CAD: t he risk of coronary st enosis, as an aid in cardiac analysis and diagnosis. 5.5 Use of t he CAD- score The CAD- score is a pat ient specific heart m urm ur score indicat ive of Coronary Art ery Significant CAD I nsignificant CAD Non- CAD 50% lum inal < 50% lum inal Negative ( 0) diam eter diam et er r educt ion calcium by CCT reduct ion by CAG. by CAG or CCT or no evidence calcium > 0, or < 70% of lum inal lum inal area st e n o sis. r ed u ct io n . CAG: Cor onar y Angiogr aphy; CCT: Cor onar y Com put ed Tom ography Disease ( CAD) / Chronic Coronary The CAD- score is t hus indicat ing risk of Syndrom e ( CCS) for im m ediat e risk having significant CAD, defined as having st rat ificat ion, prior t o pot ent ial secondary 50% lum inal diam et er reduct ion. evaluation. Two risk cat egories are defined using t he The CADScor ® Syst em risk st rat ificat ion can CADScor ® Syst em : be applied to pat ient s with sym ptom s suggest ive of CAD/ CCS, in com pliance wit h t he indications for use. Using t he CAD- score t o risk st rat ify CAD- score 20 Low risk CAD- score > 20 Elevat ed risk pat ient s prior t o furt her t est ing will reduce un-necessary evaluat ion and risk. The CAD- score can t hus aid t he decision t o The Negat ive ( NPV) and Posit ive ( PPV) predict ive values vary wit h t he prevalence initiate additional evaluations or not , or to 8 of significant CAD in t he invest igat ed populat ion. At lower significant CAD prevalence ( e.g. 5- 20% ) in the investigated population, the NPV increases. The NPV of t he CAD- score at or below 20, for ruling- out risk of significant CAD in t he pat ient t hus increases by falling prevalence, ranging from approxim at ely 92.3-98.3% at 5-20% p r ev alen ce. At higher significant CAD prevalence ( e.g. 30-40% ) in t he invest igat ed populat ion, t he NPV decreases. The NPV of t he CADscore for ruling out significant CAD t hus decreases by increasing prevalence, ranging from approxim at ely 87.5-81.8% at 30-40% prevalence. A follow- up t est , based on a CAD- score at or below 20, can be done aft er t wo to five years, if indicat ed. At higher significant CAD prevalence in t he invest igat ed populat ion, t he PPV increases. The observed PPV of t he CAD- score above 20 for predict ing significant CAD is 14.4% ( 11.6- 17.5% ) in a 10.7% CAD prevalence populat ion. CAD Scor ® Syst e m per for m a nce : Significant CAD vs Ot her (Significant CAD versus insignificant CAD and non- CAD com bin ed) . Algorit hm ver. 3.2- US: Sensit ivit y: 87.5% (79.2-93.4% ) Specificit y: 37.5% ( 34.2-41% ) Validat ion dat a CAD- prevalence: 10.7% NPV: 96.2% ( 93.4-98% ) PPV: 14.4% ( 11.6-17.5% ) . CAD/ CSS NPV % * Prevalence % CAD- score 20 5 98.3 10 96.4 15 94.4 20 92.3 30 87.5 40 81.8 * m odelled from Acarix clinical data for sensit iv it y / specificit y abov e at t hreshold 20. 9 5.6 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. Pat ient s wit h a CADScor elevat ed risk of significant CAD m ay be earlier recognized and t hus be diagnosed and ent er t reat m ent earlier. By use of t he CADScor ® Syst em no risks are associat ed direct ly from use, except in rare cases where a slight t ransient skin react ion t owards t he pat ch adhesive m ay be observed. I nform pat ient s who have CAD- score 20 t o seek m edical att ention if sym ptom s persist or worsen aft er initial evaluat ion. The risk of a false negat ive result for a t rue pat ient or a false posit ive result for a nonCAD pat ient should be t aken int o considerat ion when evaluat ing t he pat ient . 10 5.7 I nt ended user profile The CADScor® Syst em is int ended t o be operat ed only by regist ered nurses, clinical/ m edical laborat ory t echnicians, m edical doctors/ physicians after having been instruct ed in the proper operat ion of t he CADScor® Syst em . 5.8 I nt ended pat ient populat ion The CADScor® Syst em is int ended t o be used in m ales and fem ales ( by born gender) above 40 years of age. Do not use t he CADScor® Syst em wit hout t he necessary qualificat ions, and only aft er instruction and having read and underst ood t his User- Manual, due t o risk of deat h or serious inj ury. The CAD- scores from pat ient s in t he 3039- year group are current ly out side t he int ended pat ient populat ion. A warning t riangle indicat es the higher uncert ainty of t heir CAD-scores ( 8.14) . 11 5.9 I ndicat ions for use The CADScor® Syst em is indicat ed for use as a diagnost ic aid in sym pt om at ic pat ient s suspect ed of st able Coronary Art ery Disease/ Chronic Coronary Syndrom e. Sym pt om s of CAD/ CCS m ay m anifest as* Typical angina sym ptom s; ( all three 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 m inut es. At ypical angina sym pt om s; ( Two of the above) Non-anginal chest pain; Lacks or m eet s only one or none of t he above charact erist ics. Dyspnea/ breathlessness * as defined by ESC Guidelines 2019 & NI CE UK Guidelines CG95, 2019. 12 5.10 Cont ra-indicat ions for use Asym ptom atic for angina or chest pain, I m planted donor heart, Previous Coronary Art ery Bypass Graft ( CABG) , Previous Coronary st ent ing or known CAD Arrhyt hm ia causing non-sinus rhythm , Fragile or com prom ised skin, or abnorm al anatom y or significant operat ion scars in t he fourt h left I nt er Cost al (I C4- L) -recording area. I m plant ed m echanical heart or m echanical heart pum p, I m plant ed Pacem aker or Cardiovert er Defibrillat or ( I CD) , Ot her im plant ed act ive elect ronics or act ive elect ronic support equipm ent closer t han 50 cm t o t he CADScor® Syst em . The CADScor® Syst em has not been validat ed as a screening t ool for Coronary Art ery Disease/ Chronic Coronary Syndrom e in asym pt om at ic populat ions. Do not use t he CADScor® Syst em on pat ient s wit h im plant ed elect ronics like I CD, Pacem akers, heart - pum ps or closer t han 50 cm t o sim ilar act ive elect ronic support equipm ent , due t o risk of equipm ent failure from CADScor® Syst em elect rom agnet ic RFI D im pulse. 13 5.11 I nt ended condit ions of use The CADScor® Syst em is int ended t o be used at m edical clinics and hospit als, at room t em perat ure and below 2500 m et er above sea level. The patient shall be lying on the back on an exam inat ion bed ( supine posit ion) during ident ificat ion of the fourt h left I nt er Cost al (I C4- L) space and recording of heart sounds. Mark t he I C4- L posit ion aft er location, approxim at ely t wo cent im et res of t he st ernum bone for placem ent of pat ch. The CADScor ® Sensor m ust only be used t oget her wit h a CADScor ® Pat ch. Pat ches are single-use only and should not be m oved on t he body aft er first adherence. I f a pat ch has been m isplaced a new pat ch m ust be used. The applied t im e of t he CADScor® Sensor (including pat ch) is norm ally less than 15 m inut es. Use t he CADScor® Syst em below 2500 m et ers. Train t o ident ify left I C4 locat ion. Wrong posit ion m ay influence result . Do not at tem pt t o re-use a CADScor® Pat ch. The pat ch is single use only for hygienic reasons. 14 5.12 Sym bols used Definit ions: The CADScor® Syst em user m anual cont ains sym bols, operat ional warnings and caut ions, which are im port ant and should be read and understood carefully before perform ing the relat ed procedures. Sym bols and warnings are also found on t he CADScor® Syst em , t he CADScor® Pat ch and t he syst em packaging boxes. 5.13 Sym bols on t he CADScor® Syst em and in User m anual W a r n in gs: Describes a condit ion or a sit uat ion where risk of deat h or serious injury can occur. Pr eca u t ion s: Describes a condit ion or a situat ion where a non- serious injury can occur t o pat ient or user or dam age t he equipm ent or propert y. Sy m b ol Ex p la n a t io n Product code num ber. Serial num ber Warnings and precaut ions. See descript ion below ( 5.13- 5.15). I nst ruct ion to Read user m anual. Rx only * / I PXX I nst ruct ion to Consult user m anual. Caut ion: Federal law rest ricts t his dev ice t o sale by or on t he order of a physician. Magnet ic Resonance I m aging room unsafe I ndicat ion of a short diast ole ( * ) result or a not ice for result ( ) Denot es liquid and dust ingress protect ion levels Defining the Sensor as t he Applied part of CADScor® Sy stem Manufactured by / 15 Expiry date / single use of patches The CADScor® System , when reaching its end of life, must be collected and recy cled separately from other waste according to nat ional requirem ent s ( Direct ive 2012/ 19/ EU, WEEE) . 5.14 Warnings Warnings are alert s described t o alert and reduce t he risk of deat h or serious inj ury from use of t he CADScor® Syst em . Warnings and precaut ions are labelled with a warning t riangle and also refers to t he relevant sect ion in t he User Manual. Pat ient and user risk warnings: Do not use t he CADScor® Syst em wit hout t he necessary qualificat ions, and only aft er instruction and having read and underst ood t his User- Manual, including, sym bols, cont ra- indicat ions, warnings and precaut ions, due to risk of deat h or serious inj ury. Do not use t he CADScor® Syst em on pat ient s wit h im plant ed elect ronics like I CD, Pacem akers, heart - pum ps closer t han 50 cm t o sim ilar act ive elect ronic support equipm ent , due t o risk of equipm ent failure from CADScor® Syst em elect rom agnet ic RFI D im pulse (5.10; 6.4). Do not at tem pt t o re-use a CADScor® Pat ch. The pat ch is single use only for hygienic reasons, to prevent possible cross cont am inat ion/ infect ion bet ween pat ient s (5.11; 8.7) . The CADScor® Syst em and pat ches are MRI - unsafe and should not be operat ed or placed in a Magnet ic Resonance I m aging ( MRI - ) room , due t o risk of skin burns and/ or m agnet ic at t ract ion and im pact (7) . Never use other power adaptor than supplied wit h t he CADScor® Syst em , due t o risk of elect rical shock (5.17) . 5.15 Precaut ions Precaut ions are alert s t o reduce pot ent ially hazards sit uat ions or risks of non- serious 16 injury or reduced effect iveness from use of t he CADScor® Syst em . Risk of incorrect CAD- score: I ncorrect placem ent of t he CADScor® Sensor, out side pat ient I C4- L, m ay result in an incorrect CAD- score (8.4) . I nform pat ient s who have CAD- score 20 t o seek m edical at t ent ion if sym pt om s persist or worsen aft er init ial evaluation", due to t he risk of a false negat ive CADScor result (5.6) . The CAD- scores from pat ient s in t he 3039- year group are current ly out side t he int ended pat ient populat ion. A warning t riangle indicat es the higher uncert ainty of t heir CAD-score ( 8.14) . Risk of dam age t o t he CADScor® Syst em : Do not t ouch t he charge- point t erm inals on t he CADScor® Syst em , due t o risk of perm anent dam age t o t he elect ronics 17 inside by elect rost at ic discharge ( 5.175.18) Do not drop or exert excessive force t o t he CADScor® Syst em since t his m ay dam age t he CADScor® Syst em perm anently (6.1) . Do not expose t he CADScor® Syst em t o liquids ( wat er, oils, detergents or sim ilar) or dust , since t his m ay dam age t he CADScor® Syst em perm anent ly ( 10) . The CADScor® Syst em cannot be heat or radiat ion st erilized, or m achine washed/ cleaned, since t his m ay dam age t he CADScor® Syst em perm anent ly ( 10) . Do not m odify t he CADScor® Syst em or use or repair a defect CADScor® Syst em , due t o risk of m alfunct ioning. The CADScor® Syst em m ust only be serviced by qualified Acarix personnel (10) . 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 the CADScor ® Syst em box ( one each) : · CADScor ® Sen sor . · CADScor® Docking st at ion. · A box cont aining a power adapt or plus count ry specific plug. · A box in the lid holding; · a User Manual, · a separat or tool to separat e the back plat e from the top part of the Docking st at ion and · a drilling tem plate for mounting the Docking st at ion on t he wall. 18 The CADScor® Syst em is pre- assem bled in desktop 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. Place CADScor® Syst em on st eady surface. I nspect t he CADScor® Syst em for possible t ransport dam ages. Take out t he box cont aining t he power adapt or and supplied plug. Assem ble power adaptor unit by pressing the plug firm ly onto the power adapt or unt il clicked securely int o place. No volt age adjustm ent s are needed for the power adapt or . Never use other power adaptor than supplied wit h t he CADScor® Syst em , due t o risk of elect rical shock. Finally t ake out t he lid box cont aining t he user m anual, separat ion key and drill tem plate. 19 5.17 The CADScor® Sensor 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. The sensor has one physical but t on, a t ouch display and a sensor head ext ending on a flexible arm from t he sensor body ( see figure at right) . The push but t on has several funct ions when pressed or pressed and held for ext ended tim e. Pr ess 1x 2x 3x Hold> 4 sec Hold> 8 sec Funct ion Turn sensor on Cancel on- going recording Ent er Set t ings m enu Forced qualificat ion Sensor off and reset Beep Triple beep Single beep Double beep Main com ponent s of t he CADScor® Sensor, t op/ side view. 20 The sensor LCD t ouch display shows a user int erface to guide you through a recording session. Also, t he sensor st at us and t he CAD- score are shown on t he display when it is calculat ed. The flexible sensor arm connect s t he sensor body t o t he sensor head. Wit hin t he sensor head a heart m icrophone and an am bient m icrophone are placed. I nside t he sensor body is a built - in speaker t hat generat es audit ory cues for guiding t he patient to pause breat hing. The sensor charge/ cont act point t erm inals are used t o re-charge t he sensor bat t ery, when t he sensor is placed in t he Docking st at ion ( See figure at right ) . Main com ponent s of t he CADScor® Sensor, bot t om - side view and labelling at right ( SN refers t o CADScor® Sensor serial num ber) . 21 Charge t erm inals Heart sound m icrophone Do not t ouch t he charge- point t erm inals on t he CADScor® Syst em , due t o risk of perm anent dam age t o t he elect ronics inside by elect rost at ic discharge. L0110V5 5.18 CADScor® Docking st at ion The Docking st at ion serves as a "hom e" for t he sensor t o which t he sensor is m at ed specifically from t he fact ory. I n t he Docking st at ion t he sensor is recharged and qualified. A specific sensor can only be qualified in it s hom e Docking st ation. Do not t ouch t he charge- point t erm inals on t he CADScor® Syst em , due t o risk of perm anent dam age t o t he elect ronics inside by elect rost at ic discharge. The Docking st at ion LED shows t he current st at us of t he CADScor® Syst em when t he sensor is docked and powered ( Colour codes in sect ion 6.1) . The Docking st at ion can be wall m ount ed for easy access and saving desk space ( see section 6.2 below) . Parts ident ificat ion Top v iew I ndicat or LED Sensor tester Cont act t erm inals DC- in Bot t om view Back plate Product inform at ion m arking 22 6 I n st a lla t ion of CAD Scor ® Syst e m 6.1 Deskt op m odel Place t he Docking st at ion on a st able surface ( desktop/ t able) . Deskt op position is t he pre- set operat ing m ode of the Docking st at ion. I nsert t he CADScor® Sensor in t he Docking st at ion using bot h hands. Make sure t hat t he sensor head is fully insert ed int o t he sensor t est er and t hat t he red indicat or line on t he sensor head is com plet ely hidden. A spring act ion m echanism will hold t he sensor- body firm ly in t he Docking st ation. I nsert t he sm all power plug t o t he Docking st ation on right hand side and t he power adapt or int o a 100- 240 VAC power out let . Turn on wall outlet power. 23 The LED on t he Docking st at ion lower right corner should light up. Three different colours are used to indicat e syst em st at us (t able at right ) . I f no colour is light ing up t he Docking st at ion LED, wall out let power has not been turned on or the power adaptor is fault y . See t roubleshoot ing guide sect ion 11. Do not drop or exert excessive force t o t he CADScor® Syst em since t his m ay dam age t he CADScor® Syst em perm anently. LED indicat or Const ant YELLOW Sensor st at us Power on docking st ation Const ant GREEN Sensor fully charged; ready for use Flashing GREEN Const ant RED Flashing RED Flashing RED Ongoing charging of sensor bat t ery above m inim um level Error in Sensor or Docking st at ion; Not ready for use (in sensor display) . On- going qualificat ion (in sensor display) Low on Bat t ery (in sensor display) The LED is off Power not applied. 24 6.2 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 the wall m at erial and it em s in t he wall before m ounting. To unlock t he back plat e from t he t op part of t he Docking st at ion, hold t he Docking st ation by the alum inium plat e, one end rest ing on a t able. Place t he separat or t ool int o t he t wo sm all holes in t he edge and press gent ly using t he index fingers of bot h hands and separat e slowly ( see figure at right ) . Do not apply st rong force since slipping grip m ay happen and lead to injury. Use drill t em plat e and a pencil t o m ark up t he wall posit ion. Ensure horizont al level using a spirit level or sim ilar. 25 Drill t wo holes ( Ø 4m m ) t hrough the centre of m arks and m ount back plat e (thinner 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. Ensure t hat t op plat e has engaged at all four corner posit ions. Place CADScor® Sensor in t he Docking st ation and apply power. 26 6.3 CADScor® Pat ch box opening 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). Each CADScor® Pat ch box cont ains 20 pat ches individually packaged in peelpouches. The pouch is opened at one- end, by holding and separat ing t he t wo layers. Addit ionally, an assem bly tool is provided t o ensure t he correct alignm ent and assem bly of t he pat ch t o t he sensor head and body. On t he paper backing of t he pat ch peelpouch, inst ruct ions are given for t he assem bly. Follow t hese inst ruct ions carefully to obt ain high qualit y heart recordings ( see sect ion 6.5-6.6) . Pat ch box wit h assem bly t ool and labeling: 27 6.4 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 optim al recording conditions (see figures at right ). The CADScor® Syst em cannot be operat ed wit hout a valid pat ch. The CADScor® Pat ch has adhesive m at erial on bot h sides and a coupling ring where t he sensor head has t o be insert ed. On t he pat ch is furtherm ore a num bering sequence to follow when applying t he pat ch and sensor ont o t he pat ient 's chest . A Radio-frequency ident ificat ion chip ( RFI D) can be seen under t he t op foil, used t o validat e t he pat ch before use. Upon rem oval of the sensor from t he patch a pull-st ring is drawn t o open t he coupling ring for easier disassem bly. 28 6.5 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. Make sure t he coupling ring is sit uat ed correct ly on t op of t he hole cut -out in the assem bly t ool (See figure at right ) . Place t he sensor on t op of t he pat ch, aligning t o t he axis of t he pat ch. The sensor head shall be placed in t he coupling ring of t he pat ch. Press t he sensor head gent ly and evenly int o t he coupling ring, using t he palm of your hand. The sensor head will t hen correct ly snap int o t he coupling ring. 29 6.6 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 ) . From t he pat ch underside a slight prot rusion of t he sensor head t hrough t he pat ch can be observed. 30 7 Se t t in g u p t h e CAD Scor ® Syst e m prior to use 7.1 CADScor® Sensor The CADScor® Sensor is t he part of t he CADScor® Syst em t o record heart sounds at t he left I C4 region, and t o display t he calculat ed CAD- score. 7.2 First t im e configurat ion of t he CADScor ® Sensor Connect t he power adapt or t o t he Docking st at ion and t urn on supply volt age. Place t he sensor in t he Docking st at ion, if not already docked, to charge t he bat t ery. 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 ). The CADScor® Syst em and pat ches are MRI - unsafe and should not be operat ed or placed in a Magnet ic Resonance I m aging ( MRI - ) room , due t o risk of skin burns and/ or m agnet ic at t ract ion and im pact . 31 As part of the 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 ( REF: 302) . Follow t he inst ruct ions t o keep quiet and not touching or rem oving the sensor from t he Docking st ation. Aft er qualificat ion and first t im e t he sensor is powered- on, configurat ion is needed. While t he sensor is "docked" in t he Docking st at ion, t he "last - recording" display ( REF: 103) is shown. Take out ( "un- dock") the sensor from t he Docking st at ion t o enable configurat ion. 32 4. 0- USFDA The sensor will aut om at ically go t o t he sensor "hom e" display ( REF: 102) . Press "Ent er set up" on t he "hom e" display t o configure t he sensor ( REF: 102) or t riple-click t he push but t on. A sub- m enu will appear, allowing adj ust m ent of Dat e, Tim e and Language ( REF: 500) . 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. Do not m odify t he CADScor® Syst em or use or repair a defect CADScor® Syst em , due t o risk of m alfunct ioning. The CADScor® Syst em m ust only be serviced by qualified Acarix personnel (10) . 33 7.3 Sett 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 or language. t o select a user int erface Press "DONE" t o save language choice and exit "LANGUAGE" m enu. 34 7.4 Sett ing tim e Press "TI ME" t o set t he correct t im e. Tim e form at is int ernational 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. Press or t o change t im e (HH: MM) Press "DONE" t o save t im e set t ing and exit "TI ME" m enu. When TI ME has been changed, a requalificat ion is autom atically required. 35 7.5 Sett ing dat e Press "DATE" t o set t he correct dat e. Dat e form at is Mont h: Day: Year, where m onth is given by three lett er ab b r ev i at i on s. The dat e form at cannot be changed. I n t he "Set dat e" display ( REF: 503) , Tap the m onth, day or year fields individually t o act ivat e field. Press or t o change dat e ( M/ D/ Y) . Press "DONE" t o save and exit "DATE" m enu. When DATE has been changed, a requalificat ion is autom atically required. 36 7.6 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. 7.7 Universal access A functionalit y to ent er the set -up m enu direct ly is available by pushing t he push but t on t hree t im es in succession. This cannot be done during a recording session. This funct ionalit y is also enabled while t he sensor is in t he Docking st at ion. I n case an unknown language has been chosen, t riple- push t he but t on and select t he upper right blue quadrant to ent er language set t ings. Choose relevant language and press "DONE" t o finish language select ion. 37 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 autom atically power- down to save energy and t he screen will go black. The sensor will t hen only perform autom atic qualificat ion, every 23rd hour. The sensor will power-on again aft er pressing t he push but t on or t aking t he sensor out of t he Docking st at ion. When powered on again, t he sensor will ret urn t o it s "last recording" display while in t he Docking st at ion ( REF: 103) or ret urn t o t he "hom e" display out side t he Docking st at ion ( REF: 102) . 38 7.8 CADScor® Docking st at ion The Docking st at ion is used for: · Holding t he sensor and charge t he sensor bat t ery when docked. · Qualify t he sensor at regular int ervals or on request . · I ndicat e t he CADScor ® Syst em st at us by LED light . · 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. 39 7.9 Connect ing/ disconnect ing power adapt er t o Docking st at ion The CADScor® Docking st at ion has a dedicat ed external universal power adaptor ( 100- 240 VAC/ 50- 60Hz) . To supply t he Docking st at ion, connect t he sm all power adaptor plug into t he jack on t he side of Docking st at ion. 7.10 Charging of t he sensor bat t ery I n t he Docking st at ion, charging of t he sensor bat t ery is init iat ed t hrough t he charging cont act t erm inals of t he Docking st ation. Approxim at ely 30 m inut es are needed to charge t he sensor bat t ery allowing for approxim at ely 5-10 st andard recordings and CAD-score calculat ions. Never use other power adaptor than supplied wit h t he CADScor® Syst em , due t o risk of elect rical shock (5.17) . 40 7.11 Docking st at ion indicat ion LED light When t he sensor is placed in t he Docking st at ion, an LED on t he alum inium front indicat es t he present st at us of t he CADScor® Syst em . More inform at ion on t he sensor st at us can be found in t he display of t he sensor if t urned on in t he Docking st ation. LED indicat or Const ant YELLOW Sensor st at us Power on docking st ation Const ant GREEN Sensor fully charged; ready for use Flashing GREEN Const ant RED Flashing RED Flashing RED Ongoing charging of sensor bat t ery above m inim um level Error in Sensor or Docking st at ion; Not ready for use (in sensor display) . On- going qualificat ion (in sensor display) Low on Bat t ery (in sensor display) The LED is off Power not applied. 41 7.12 Qualificat ion of sensor The CADScor® Syst em is qualified at regular int ervals t o ensure safe operation. During qualification, a series of tones are played from t he Docking st at ion t o t he sen so r . The qualification procedure is aut om atically carried out every 23 hours, if t he sensor is placed in t he Docking st at ion. I f t he sensor qualificat ion has expired out side t he Docking st at ion, a display m essage will ask for sensor t o be placed in t he hom e Docking st at ion ( REF: 300) . I t is im port ant t hat t he sensor head is pressed firmly down into t he built -in sensor t est er. The red indicat or ring on t he sensor head should be invisible when insert ed correct ly. When the qualification is on- going a display m essage is shown ( REF: 302) . 42 7.13 Forced qualificat ion I f you are bringing t he CADScor ® Sensor along and suspect qualificat ion will expire before returning, a forced qualification can reset expirat ion clock by 23 hours. Place t he sensor in t he hom e Docking st ation The sensor will power-on aut om at ically in t he powered-on Docking st at ion. Press and hold t he push but t on for 4 seconds ( a single beep feedback will be given) t o act ivat e sensor qualificat ion procedure ( REF: 302) . The sensor display will ret urn t o t he "last recording" display when qualified ( REF: 103) . 43 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-setting will force t he sensor t o reload sensor - soft ware and also re- qualify t he sensor. Pr o cedu r e: Press and hold t he push but t on for 8 seconds ( beyond t he 4 seconds single 3.2 beep, unt il a double beep signal feedback is given) t o power off t he sensor. The sensor will aut om at ically t urn on again while in t he powered Docking st at ion or by but t on press. The sensor will t hen reload operat ing soft ware and qualify aut om atically. The sensor will display t he st art -up display ( REF: 101) followed by t he "last recording" display ( REF: 103) when t he qualificat ion has finished, and sensor is docked. 44 8 Detection of heart sounds 8.1 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. Close doors and windows t o reduce noise from out side sources like t raffic noise, t alk, const ruct ion work and sim ilar. Turn off indoor noisy or unused elect rical equipm ent ( e.g. noisy PC, m obile t elephones, ventilat ors, fans, aircondit ion). Unplug power to patient bed if available. Keep quiet ( bot h user and patient ) during t he heart sound recording. Reduce room noise! The CADScor® Syst em and pat ches are MRI - unsafe and should not be operat ed or placed in a Magnet ic Resonance I m aging ( MRI - ) room , due t o risk of skin burns and/ or m agnet ic at t ract ion and im pact . 45 8.2 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. After power-on ( and eventual qualification) t he display will return to the "hom e"display ( REF: 102) if sensor is ready, and out side Docking st at ion. The sensor bat t ery st at us and t he num ber of rem aining recordings on current bat t ery level is shown in the display, top right ( 20 REC) . Bat t ery level low: Charge t he bat t ery if the level is below m inim um ( red bat t ery icon) . Qualificat ion st at us is shown by circled blue check m ark in upper display inform at ion line. Qualification expired: Qualify t he sensor if t he previous qualificat ion has expired ( red cross in circle) . 46 I con REF: REC- I D: / or / or REC. I con descript ions Display reference num ber Recording ident ificat ion num ber Sensor qualificat ion st at us icon : Qualification valid. : Qualification expired. Batt ery level icon : Full bat t ery level : Low bat t ery level. Rem aining capacit y recording icon 8.3 Preparing t he pat ient Always use a paper/ linen bedcover bet ween pat ient and exam inat ion- bed to avoid rubbing noise. This will reduce sit uat ions pot ent ially requiring a second r ecor d in g . Hair rem oval Also, t o obt ain high- qualit y heart sound recordings and t o reduce secondary recordings, body hair at t he I C4- L region has to be rem oved as well as hair in t he area of t he applied patch. The ext ended shaving area will ensure bet t er anchoring of t he CADScor® Sensor and easier rem oval of pat ch aft er r ecor d in g . Shaving can be done using surgical clipper or st andard single use shaving tool. Greasy or m oist skin should be cleaned using st andard alcohol skin wipes. Always conduct proper skin cleaning and hair rem oval in pat ch area for opt im al pat ch adhesion and high- qualit y heart sound recordings. 47 8.4 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 the patient is very im portant 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 the pat ient 's chest . This m et hod is also known as t he "fingerm et hod" for I C4- L ident ificat ion, pict ure at right. Un- dress the patient in the thorax area. I t is im port ant t hat clot hing will not rub against t he sensor during recording. Place t he pat ient flat on t he exam inat ion bed in supine posit ion (chest facing u pw ar ds) . 48 St anding on t he patients' right side, spread your left -hand fingers approxim at ely 1.5 cent im et ers, and place your left -hand litt le finger up against t he collar bone ( clavicular) . Just under t he collarbone cost a num ber one ( C1) is found. Press t he ot her fingers against t he chest left side and m assage t he fingers int o t he int ercost al spaces at t he st ernum border. A m oderat e t o high palpat ion pressure is needed t o recognize t he cost a and t he int ercost al spaces. When each of t he four fingers has found t heir int ercost al spaces, m ark up t he fourt h left I nt er cost al space under your index finger. Mark t he posit ion of I C4- L, approxim at ely t wo cent im et ers from t he st ernum border int o t he fourt h I nt er Cost al space. 49 Use a clearly visible pen m arker, t o lat er reliably locat e the est ablished recording posit ion t o avoid reposit ioning t he sensorpat ch assem bly and t hereby reduce skin ad h er en ce. The m arked I C4- L spot indicat es t he cent re of t he recording sit e for t he sensor head. The sensor head should rest free of t he st ernum border. Train t o be able t o ident ify t he I C4- L posit ion correct ly. The I C4- L posit ion is equivalent t o t he elect rode V2 posit ion in a st andard 12-lead ECG. Train t o obt ain I C4- L locat ing experience. I ncorrect placem ent of t he CADScor® Sensor, doing recording out side I C4- L on t he pat ient , m ay result in an incorrect CAD- score. Train and counsel wit h a colleague t o ident ify and est ablish t he correct posit ion for t he I C4- L locat ion, using t he finger t echnique. Train on a num ber of pat ient s unt il safe I C4- L locat ing experience has been obtained. 50 8.5 At t achm ent of pat ch t o sensor An assem bly t ool is provided wit h the pat ches t o m ount t he pat ch correct ly t o t he sensor ( see also sect ion CADScor® Pat ch assem bly) . Place t he CADScor® Pat ch on t op of t he assem bly tool as outlined on t he tool ( see figure at right ) . Then place t he CADScor® Sensor on t op of t he patch. Press sensor head carefully int o coupling ring by using t he palm of your hand. Make sure t hat t he sensor head is secured at t he st op posit ion and t hat t he red indicat or ring on the sensor head is now not visible. The sensor and pat ch assem bly is now ready for at t achm ent t o t he pat ient . 51 8.6 Explaining of t he recording procedure t o patient belly, including inhalat ion, exhalat ion and natural breathing pause aft er exhalat ion. Explain t he recording procedure t o pat ient . Being generally relaxed and pausing breat hing at correct int ervals is im port ant P r o ce d u r e Rest ing p h ase St e p Tim e ( s) > 300 Act io n s Pat ient lies in bed. for recording of high- qualit y heart sounds. Observe at least 5 m inutes of patient resting to ensure hem odynam ic balance before doing CAD- scoring and blood pressure readings. Pr e recording Loop Nr. 1 Breat hing Breat hing p a u se 30 Analysing + recording 30 conditions 18 No recording 8 Recording Recording phase The recording sequence is less t han t hree m inut es long and divided into a prerecording and 4 recording loops. During each recording loop, the pat ient should pause his breat h for 8 seconds. Loop Nr. 2 Breat hing Breat hing p a u se Loop Nr.3 Breat hing 18 No recording 8 Recording 18 No recording A sound will be heard when it is t im e t o pause breat hing. The sound will be dem onst rat ed t o t he pat ient before st art ing. Breat hing p a u se Loop Nr. 4 Breat hing Breat hing p a u se 8 Recording 18 No recording 8 Recording I nst ruct pat ient t o relax respirat ion and do belly breathing instead of thorax breathing. Show belly breathing by pat ient hand on Re su l t p h ase App r ox . Post recording 60120 524- Calculat ion of CADscore 52 Tot al t im e 564 Before Recording phase Sum m ary Check exam inat ion room for acoust ic and elect rical noise. Check sensor readiness. Ask patient to rem ove clot hing from t he waist -up and lie on the back on the exam inat ion bed ( supine posit ion) and rest . I dent ify t he I C4- L region and do hair rem oval in I C4- L/ pat ch region if needed. Observe at least 5 m inutes of patient resting to ensure hem odynam ic balance before doing CAD- scoring and blood pressure readings. Assem ble new CADScor® Pat ch and sensor using assem bly t ool. Not e absence of red indicat or ring around sensor head in coupling ring of pat ch. I nst ruct pat ient in recording sequence, breat hing m ode and inst ruct ion sounds. 53 8.7 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" on the "hom e"- display ( REF: 102) , shown when sensor is un- docked. 3.2 Whenever " New Exam inat ion" is chosen a new REC- I D will be assigned. Four pat ient specific risk fact ors are required to initiat e t he recording and are included in t he calculat ion of t he CADscor e: Pat ient Gender Pat ient Age- group Pat ient Sym pt om and Pat ient hypert ension st at us The risk factors are ent ered sequent ially and sum m arized for confirm at ion. 54 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) . Pat ient Age- group, represent ed as 10-year int ervals, should be regist ered as age on t he day of the exam ination on display ( REF: 105) . 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) . Pat ient sym pt om , as defined by ESC and NI CE UK Guidelines ( refer t o sect ion 5.9) should be ent ered in ( REF: 106) . 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) . 55 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. I f syst olic blood pressure is unknown and pat ient is not in m edical t reat m ent for hypert ension, a st andard blood pressure reading aft er t he rest ing period and prior t o t he CADScor m easurem ent , should be done t o est ablish hypert ension st at us. Observe at least 5 m inut es pat ient rest t o ensure hem odynam ic balance before doing CAD- scoring and blood pressure readings. 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) . Aft er ent ering hypert ension st at us, a pat ient dat a sum m ary display ( REF: 108) is shown. Confirm t he pat ient dat a t o cont inue or EXI T t o re- ent er dat a. 56 I f t he pat ient age ent ered is within the pat ient age- group 30-39 years, a notice 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 the CADScor® Syst em . A warning- sign ( ) behind t he result ing CAD- score will indicat e t he higher uncert aint y of t he CAD- score from t his group. I f t he inform ation of t he pat ient was correct and approved, press Cont inue t o acknowledge t he inform at ion and proceed t o Pat ch assem bly and pat ient m urm ur recording or press EXI T t o change t he pat ient det ails or abort the current CADScor m easurem ent . 57 At t aching sensor/ pat ch assem bly t o patient 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. I nspect if sensor head is correct ly seat ed in t he coupling ring. When pat ch is at t ached t o sensor, press DONE. The pat ch product ion dat a are checked by t he sensor ( REF: 127) . Avoid placing t he assem bled sensor and pat ch on a m et al- t able during pat ch checking since t his can int erfere wit h t he sensor reading t he pat ch inform at ion. Always det ect pat ch before pat ch is applied t o patient . 58 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. The part under t he sensor m icrophone is t aken of separat ely, divided from the rem aining release liner by a pre- m ade cut . Keep the rem aining release liner part in place unt il sensor is placed at I C4- L. Do not at tem pt t o re-use a CADScor® Pat ch. The pat ch is single use only for hygienic reasons, to prevent possible cross cont am inat ion/ infect ion bet ween pat ient s. 59 Now, place t he sensor head at t he prem 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 . Ensure proper adherence of sensor head t o chest by pressing on coupling ring around t he sensor head. 60 Then, Peel-off release liner m arked " 2 " on t he patch and anchor the 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 patch. Do not pull t he sensor t o fix it on t he pat ch, but let t he sensor follow t he curvat ure of t he pat ient chest . 61 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. I nst ruct pat ient t o relax t horax by belly breat hing and generally relaxing m uscles: Relaxing while doing a CADScor® recording will increase t he chances of a successful recording and subsequent CAD- scoring. Find a suit able generally relaxing supine posit ion, placing arm s along t he body and rest ing t he head against t he m at t ress. Offer a pillow for increased com fort or elevat ed headrest . Ask and ensure pat ient is com fort able and rest ing wit hout significant m uscle t onus. Observe at least 5 m inut es pat ient rest t o ensure hem odynam ic balance before doing CAD- scoring and blood pressure readings. 62 Three options will then becom e available ( in REF: 112) : START SOUND DEMO t o dem onst rat e recording sounds to 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 . For t he pat ient , it is im port ant t o becom e fam iliar wit h t he sound inst ruct ions given during t he recording phase. Select START SOUND DEMO ( REF: 126) , and dem onst rat e t he PAUSE BREATHI NG ( single beep) , START BREATHI NG ( double beep) , RECORDI NG START ( ascending t ones) and RECORDI NG STOP sounds ( descending tones) . Adj ust speaker volum e if needed. 63 Press DONE t o exit SOUND DEMO aft er pat ient has becom e fam iliar wit h the sounds. Again, inst ruct pat ient t o relax respirat ion and do belly breat hing inst ead of t horax breathing. Belly breat hing will ensure bet t er recording r esul t s. Explain belly breat hing t o pat ient . Show e.g. belly breathing by patient hand on belly, including inhalat ion, exhalat ion and natural breathing pause aft er ex h al at io n . Explain t o t he pat ient t hat he or she will be guided by the operator as well, to pause or st art belly breathing int ervals. I nst ruct belly breat hing 64 8.8 Recording phase, St art The CADScor® Sensor will evaluat e current recording condit ions during a Prerecording, 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) . I f ext ernal, int ernal and elect rical noise condit ions during Pre-recording are evaluat ed accept able by t he sensor, t he sensor will proceed t o heart sound recording autom atically. The Pre- recording and evaluat ion will t ake approxim at ely one m inut e ( REF: 114) . 65 8.9 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 breathing and eight seconds of breat hing pause. During t he Main recording, each recording phase will be indicat ed on t he display in t ext as "Cont inue breat hing" or "Pause breathing". The tim e left in each phase of the loop is indicat ed by a count - down t im er, from 18 t o zero ( breathing phase) , or from eight to zero seconds (pause breat hing) . The m ain heart sound recording phase will last approxim at ely t wo m inut es. SCREEN_115_1_recording+4+14.pngSCREE N_115_1_recording+4+14.png 66 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 a new pat ch. To cancel t he ongoing recording press t he push but t on t wice in quick succession. A triple beep warning will be heard. A display m essage ( REF: 309) will appear asking if cancel is only concerning t he current recording or will be t o exit recording alt oget her. Exit ing recording will invalidat e t he pat ch used. 67 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 patient at this m om ent , in case of a new recording has t o be m ade due t o recording errors. The calculation tim e is approxim at ely 1-2 m inut es. The CAD- score will be shown on t he display in a colored bar indicat ing t he pat ient risk group, wit h the corresponding Record- I D. Not e t he CAD- score result and Record- I D in t he pat ient 's m edical file. The sensor and pat ch can now be gent ly rem oved by pulling pat ch ear ( REF: 125) . The sensor is released by pulling t he st ring of t he coupling ring in t he direct ion of t he arrow. 68 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 diastolic period length, 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. When a short diast ole- based CAD- score is present ed, a possibilit y t o redo t he recording is offered. Try t o relax (lower the heart rat e) the pat ient furt her before at t em pt ing a new recording. A m axim um of four recording at t em pt s are allowed per pat ch. I t is not recom m ended t o pursue recording aft er four at tem pt s on t he sam e pat ient . A short diast ole- based CAD- score is not as precise as t he st andard CAD- score, which is why prom pt ing for a new recording is encouraged ( REF: 128) . 69 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 patient 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. Current ly, m obile devices running iOS syst em , at least version 13, wit h a cam era can be used. The CADScor app can be downloaded from t he Apple App St ore and should be inst alled/ configured prior t o use. On t he result screen of t he CADScor ® Sensor, press t he CAD-score result and t he screen will convert t o a QRcode. Point t he act ivat ed CADScor App in " Scan Report " m ode t o t ransfer t he dat a t o t he mobile device. The QR- code funct ionalit y can be disabled/ enabled by your local sales agent . 70 8.14 CAD- score in t he 30-39 year age group The CAD- scores from pat ient s in t he 3039- year group are current ly out side t he int ended pat ient populat ion. A warning t riangle indicat es the higher uncert ainty of t heir CAD-score. 71 8.15 Possible CADScor® Syst em m essages during or aft er recording The CADScor® Sensor will during a prerecording, 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. I n case of unsuit able recording condit ions or ot her errors, a display m essage will be shown indicating the cause of error. Depending on error or m essage t ype t he CADScor® Sensor m ay prom pt for an addit ional recording or abort ing recording altoget her. I n case of failure t o obt ain a CAD- score result , ot her pat ient evaluat ions should be p u r su ed . A com prehensive list of errors and m essages is list ed in t he t roubleshoot ing section 11. 72 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. Only REC-I Ds wit h a result ing CADscore can be found. Wit hin t he LOOK-UP I D display ( REF: 504) ent er t he four- digit REC- I D num ber and press t he OK but t on t o cont inue. Not ice t hat t he REC-I D is relat ing t o t he specific CADScor® Sensor t hat perform ed t he recording and t he subsequent CADscore calculat ion. REC- I Ds from cancelled recordings cannot be looked up. Also not ice t hat t he REC-I D count er will reset t o 1000 aft er REC-I D 9999. Previous recording REC-I D dat a will t hus be overwritt en with new dat a having the sam e REC- I D num ber. 73 Check in t he LOOK-UP dat a t hat t he LOOKUP REC-I D recording dat e corresponds t o t he ant icipat ed dat e for t he recording t hat is being identified. 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 Lookup dat a t o t he pat ient ( REF: 506) . I f t he REC- I D is not found ( REF: 507) , check if t he ent ered REC-I D num ber or sensor num ber is correct . I f t he LOOK-UP funct ion is used on a different sensor t han t he original recording sensor, t he LOOK- UP can display dat a relat ing t o anot her pat ient , from a different recording session. I f t he CADScor device is used in a blinded clinical invest igat ion, t he CAD- score will not be shown in t he LOOK-UP display. Press EXI T t o ret urn t o set t ings m enu. 74 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. Place t he sensor in t he Docking st at ion for charging and autom at ic qualificat ion unt il next recording session. Do not use running t ap- or splashing wat er t o clean t he sensor. I f t he sensor has becom e accident ally wet , wipe it dry and leave t o dry out for m inim um 24 hours. Do not at tem pt t o dry in oven or using dry b l o w er . Do not expose t he CADScor® Syst em t o liquids ( wat er, oils, detergents or sim ilar) or dust , since t his m ay dam age t he CADScor® Syst em perm anent ly. The CADScor® Syst em cannot be heat or radiat ion st erilized, or m achine washed/ cleaned, since t his m ay dam age t he CADScor® Syst em perm anent ly. 75 9 Sound guidance used in the in t e r f a ce During operat ion of t he CADScor® Syst em sounds are indicating t he various event s. Som e sounds are relat ed t o the tim ing of breathing/ pause breathing int ervals in t he recording sequence and ot her sounds t o confirm actions or as a warning of int ended act ion. 76 1 0 M aint enance There are no user serviceable part s wit hin t he CADScor® Syst em . Maint enance is lim it ed t o cleaning t he ext ernal surfaces of t he sensor and t he Docking st at ion. Only use 70% et hanol wipes for cleaning, do not use running t ap wat er, splashing wat er or wat erjet s, or oils, det ergent s or sim ilar subst ances. The CADScor® Syst em cannot be m achine washed or autoclaved nor heat or radiat ion st erilized. Do not expose t he CADScor® Syst em t o liquids ( wat er, oils, detergents or sim ilar) or dust , since t his m ay dam age t he CADScor® Syst em perm anent ly. The CADScor® Syst em cannot be heat or radiat ion st erilized, or m achine washed/ cleaned, since t his m ay dam age t he CADScor® Syst em perm anent ly. Do not m odify t he CADScor® Syst em or use or repair a defect CADScor® Syst em , due t o risk of m alfunct ioning. The CADScor® Syst em m ust only be serviced by qualified Acarix personnel. 77 10.1 Disposal Pa t ch The pat ch can be disposed of in ordinary wast e. Sensor and Docking st at ion The CADScor® Syst em , when reaching it s end of life, m ust be collect ed and recycled separat ely from ot her wast e according t o nat ional requirem ent s. 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 t he direct ive, 2012/ 19/ EU on wast e elect rical and elect ronic equipm ent (WEEE) Wast e elect rical and Elect ronic Equipm ent environm ent al im plicat ions: WEEE cont ains m at erials t hat are potent ially hazardous t o t he environm ent and to hum an healt h. 78 1 1 Troubleshooting guide Error m essage #1 The CAD- score has a * -symbol in front of it . D isp la y r e fe r e nce REF: 102, REF: 103, REF: 125, REF: 128, REF: 506 Possible cause The diast olic periods in the recorded acoustic patient file are shorter than optim al for precise CAD- score calculat ion, due t o higher heart rate. See sect ion 8.12. Correct ion act ion Try t o relax pat ient t o lower heart rat e below 80- 90 bpm and ret ry recording. Heart rates above 80-90 may result in error m essage " I rregular heart beat " see # 9 ( REF: 209; REF: 210). #2 The CAD- score has a warning sy m bol behind it. REF: 102, REF: 103, REF: 125, REF: 128, REF: 506 I f a CAD-score is calculated from a patient below 40 years (out side intended pat ient group) , t he CADscore is present ed wit h a warning sy m bol. Est ablish if t he ent ered pat ient inform ation was correct. Be aware t hat t he pat ient group below 40 y ears of age is outside current int ended populat ion group, and t herefore conclude caut iously. #3 Sensor restarted due t o bat tery supply error or Low bat tery power REF: 306 REF: 308 Defect in battery. The sensor bat tery power level is too low. The sensor bat tery has been deep discharged. See also # 20. Place t he sensor in t he Dock ing st at ion for charging > 15 REC. Set system for recharging, m ay take 1-2 day s for recharging aft er deep discharge. Cont act local dist ribut or/ Acarix for available opt ions if problem persist ing. 79 Error m essage #4 Qualificat ion expired D isp la y r e fe r e nce REF: 300 Possible cause The prev ious qualificat ion has expired. Correct ion act ion Qualify the sensor in t he Dock ing st at ion. #5 Qualificat ion failed #6 Am bient noise t oo high REF: 301 REF: 303 REF: 203 REF: 204 I ncorrect Dock ing stat ion. Leak between the sensor head and the Dock ing st at ion sensor t ester. Error in t he Dock ing st at ion. Error in t he sensor. The acoust ic noise level in the exam ination room was t oo high, abov e 65 dB SPL. Place sensor in hom e Dock ing st at ion. Place t he sensor head firm ly int o t he sensor test er and observe t hat red indicator ring on the sensor head is not visible and ret ry qualificat ion. Cont act local dist ribut or/ Acarix if sensor will not qualify. Close doors and windows to shield from acoust ic noise com ing from outside recording room. Keep silent during the recording. Turn off running nearby fans, radios or sim ilar. Change exam inat ion room locat ion. Ot her exam ples of noise: Const ruct ion/ building m achinery , road & rail t raffic noise, em ergency helicopter serv ice and sim ilar. 80 Error m essage #7 Elect rical noise t oo high D isp la y r e fe r e nce REF: 205 REF: 206 Possible cause The elect rom agnet ic field noise in the exam ination room was too high. #8 I nt ernal noise t o high REF: 207 REF: 208 Can be caused by interm ittent stom ach rum bling. #9 I rregular heartbeat REF: 209 REF: 210 Pat ient heart rate was t oo irregular or t oo high. Correct ion act ion Unplug power ( if any) to t he examination bed. Turn off unused elect ronic equipm ent in the exam ination room. Turn off wireless elect rical dev ices (e.g. cell phones). Change exam inat ion room locat ion. Ty pically st om ach rum bling will occur in periods prior to eating as a consequence of air in t he int est ines. A m inor meal prior to measurement m ay resolve frequent stomach rumble. Try t o relax pat ient t o lower heart rat e below 80- 90 bpm and ret ry recording. Consider evaluat ing pat ient for arrhy t hm ia. Pat ient m ay already be diagnosed having known arrhyt hm ia. 81 Error m essage # 10 Heartbeat signal t oo low # 11 The recording stopped after prerecording. # 12 I nconsistent data an aly sis D isp la y r e fe r e nce REF: 211 REF: 212 REF: 203 REF: 205 REF: 207 REF: 209 REF: 211 REF: 214 REF: 215 Possible cause The sensor head was not anchored correct ly at t he left I C4 posit ion. The sensor head was incorrect ly placed in coupling ring. Heart action weak. Am bient noise or elect rical noise was too high. The heartbeat signal was too low. The heartbeat signal was irregular. Dat a collect ed outside normal algorithm pattern. Com binat ion of heart related sounds not compatible with current algorit hm . Correct ion act ion Re- ident ify left I C4 space and use a new patch for posit ioning correct ly at left I C4. Secure sensor appropriately in coupling ring using pat ch assem bly tool. Abort if recording is not possible. See all indiv idual causes abov e, # 6- 10. Reduce am bient - and elect rical noise. Guide the pat ient to relax t o lower t he heart rate, below 80-90 bpm . Guide the pat ient to relax t o lower t he heart rate, below 80-90 bpm . 82 Error m essage # 13 The pat ch was not a ccep t e d ; Patch is expired, or has been used p r ev iously , or Patch RFI D reading was disturbed. D isp la y r e fe r e nce REF: 200 REF: 201 REF: 202 Possible cause The pat ch has past expiration date or was used previously. Maxim um st orage period is 48 m onths from production date. Correct ion act ion Use a new non- expired or un- used patch. Reading a pat ch RFI D on a m et al- table ( or close t o m etal) m ay interfere wit h proper patch reading. Do a ret ry patch RFI D reading away from m etal cont aining surfaces. # 14 Tem perat ure or pressure out of range REF: 304 REF: 313 REF: 314 The tem perat ure in t he room has exceeded the operating conditions for t he CADScor® Sy stem . Av oid exposing t he CADScor® System to excessive heat, or direct sunlight . The CADScor® System has been brought out side its height lim itations. Observe m axim um operat ing height 2500 m eters abov e sea lev el. # 15 Alg or it hm interaction failed REF: 213 REF: 218 A t echnical problem inside t he CADScor® Sensor has occurred. Ret ry recording. I f persistent failure cont act local dist ribut or/ Acarix serv ice. 83 Error m essage # 16 Ambient m icrophone error # 17 Self-test failed # 18 Unexpected issue det ected. Rest art required. D isp la y r e fe r e nce REF: 216 REF: 315 REF: 317 Possible cause The test signal received by the ambient m icrophone was lower than ant icipated. Error was t riggered by liquid exposure to sensor. A t echnical problem inside t he CADScor® Sy stem has occurred. An internal error has occurred. Sensor needs t o be restarted. The USB connect ion bet ween Dock ing stat ion and Sensor failed. Correct ion act ion Take care not t o cover sensor or am bient m icrophone during recording. Ensure CADScor® Sensor body is oriented along sternum towards chin. Allow sensor to dry > 24 hours in Dock ing st at ion . I f persistent failure cont act local dist ribut or/ Acarix serv ice. Cont act local dist ribut or/ Acarix serv ice. Place sensor in dock ing st at ion and press " EXI T" . Wait for restart to finish. I nspect charging pins in Dock ing st at ion for free up and down m ov em ent . Exercise pin gent ly t o free up stuck pin. Clean charging pads on sensor using cotton swabs with 70% ethanol. 84 Error m essage # 19 REC- I D not found D isp la y r e fe r e nce REF: 507 Possible cause The pat ient REC- I D was not found on t he Sensor. Correct ion act ion Check t hat t he REC- I D num ber was t yped in correctly. Check t hat t he Look -up funct ion was performed on the Sensor that m ade the original recording. Check if t he last REC- I D num ber on t he Sensor display is lower t han t he Look -up REC- I D. I f t he Sensor REC- I D num ber is lower, the Look - up use- dat a tex t - file m ay have been overwritten by new data. The sensor m ay hav e been m em ory reset as part of serv ice; Recording I D has been erased. Not ice that REC- I D´ s t hat have been cancelled do not appear in REC- I D log. 85 Error m essage # 20 The LED indicat or on Dock ing st at ion is off, or constant y ellow when Sensor is docked. # 21 The display is black . D isp la y r e fe r e nce Possible cause The power adapt or has been turned off at m ains. The power j ack has been d isco n n e ct ed . Plug assem bly not fully inserted into adaptor. The power adapt or is fault y, or elect rical supply is m issing. The Dock ing stat ion contacts interface is not recognizing sensor. The sensor is in off m ode. The sensor bat tery is d i sch a r g ed . See also # 3. # 22 Display cracked # 23 Sensor unresponsive The display is brok en. Software error. Correct ion act ion Turn on power adapt or out let. Apply power j ack supply t o t he dock ing st at ion . Est ablish full insert ion of plug int o power adaptor by pressing firm ly. Replace power supply unit if suspected m alfunctioning. Restore elect rical supply. Try rest art procedure ( 7.14) . Cont act local dist ribut or/ Acarix for available opt ions if problem persist s. Press push butt on t o swit ch on sensor. Charge t he sensor bat tery in t he Dock ing st at ion . For deep discharged bat teries recharging m ay t ake 1- 2 day s. I t is recom m ended t o always k eep power on sy stem , for ease of use and batt ery charging. Cont act local dist ribut or/ Acarix for available opt ions. Sensor needs rest art. See sect ion 7.14 86 1 2 CAD Scor ® Syst e m re qu ir e m en t s Normal operating environm ent: Tem perat ure + 10 t o + 40° C. Relat ive hum idit y 20-80% non- condensing. Below 2500 m above sea level. Short term storage/ transportation environm ent ( up t o 9 6 hours) : I n packaging- box/ shipper- box. Maxim um - 30 t o + 70° C. Maxim um 93% RH condensing, at + 40° C. Minim um am bient pressure 59,7 kPa ( 4.267 m above sea level). Normal storage environm ent: Tem perat ure + 10 t o + 40° C. Relat ive hum idit y 20-80% non- condensing. I ngress Prot ect ion ( I P) rat ings: CADScor ® Sensor I P44 CADScor® Docking st at ion I P22 Power adapt ors I P20 Operating noise environm ent: Ext ernal noise level < 65dB SPL. Ext ernal elect rical noise level < 65dB SPL. Syst em alt it ude correct ion Up to 2500 m above sea level Syst em pow er source Only t he supplied power adapt or m ust be used, identified by a m anufacturer nam e and t ype num ber: XP- Power ACM06US05 ( - XZ1505) Rat ed input volt age: 100-240VAC, 50/ 60 Hz Rat ed out put volt age: 5VDC Max. power: 6.0 W Never use other power adaptor than supplied wit h t he CADScor® Syst em , due t o risk of elect rical shock. 87 12.1 Syst em specificat ion Model: ACS-1401 Dim ensions: CADScor® Sensor: ASE- 1401 75(W) x 160( L) x 26( H) m m Approx. weight : 180 g CADScor® Docking st at ion: ADS- 1401 193(W) x 109(D) x 53(H) m m Approx. weight : 600 g XP Power, Power adapt or: Excl. wire 42(W) x 70(D) x 69(H) m m Approx. weight : 110 g (incl. wire, EU plug) CADScor® Pat ch: ACP-1401 80(W) x 190( L) x 9(H) m m Approx. weight : 10 g RFI D: Frequency band: 13.56 MHz I SM band Com m unicat ion st andard: I SO14443 Tx power: Magnet ic field short range device wit h < 0 dB µA/ m @10m Modulat ion: ASK Bandwidth: 14 kHz Do not use t he CADScor® Syst em on pat ient s wit h im plant ed elect ronics like I CD, Pacem akers, heart - pum ps or closer t han 50 cm t o sim ilar act ive elect ronic support equipm ent , due t o risk of equipm ent failure from CADScor® Syst em elect rom agnet ic RFI D im pulse. Date of m anufacture: The dat e of m anufact ure can be read from t he serial [ SN] num bers on t he sensor or Docking st at ion respect ively, e.g: S14- 020001 is m anufact ured Febr. 2014, and D1404-0001 is m anufact ured April, 2014. The four last digit s are lot num bers. 88 12.2 Packaging m at erials Syst em Box: 1x Out side box m ade of recyclable corrugat ed cardboard. I nternal fixtures m ade from recyclable folded corrugat ed cardboard. I nt ernal boxes m ade from recyclable car d b o ar d . User m anual m ade of 80g/ m 2 paper. Separat or t ool m ade from st ainless st eel. Tot al approx. weight , incl. CADScor® Syst em and power adaptor: 1500 g Syst em Shipper- box: 1x Out side box m ade of recyclable corrugat ed car d b o ar d . Approx. weight : 120 g Syst em Shipper- box: 6x Out side box m ade of recyclable corrugat ed car d b o ar d . Approx. weight : 580 g Pat ch box: 1x Out side box m ade of recyclable cardboard. I nside pouches m ade from Polyet hylene and paper. Assem bly t ool m ade from cardboard. Tot al approx. weight , incl. pat ches: 240 g Pat ch Shipper- box: 1x Out side box m ade of recyclable corrugat ed car d b o ar d . Approx. weight : 100 g Pat ch Shipper- box: 6x Out side box m ade of recyclable corrugat ed car d b o ar d . Approx. weight : 580 g 89 13 Warranty The CADScor® Syst em is covered by a one ( 1) year warrant y (subj ect t o count ry regulat ions) , replacing/ correct ing defect ive part s or syst em part s, or at least 1000 recordings in t he warranty period. Opening of t he CADScor® Sensor or m odifying t he CADScor® Syst em invalidat es t he warrant y. The CADScor® Docking st at ion can only be opened for wall m ount inst allat ion. No serviceable part s inside. The warrant y does not cover any dam ages caused by im proper operation. This syst em com prises sensit ive com ponent s and m ust be t reat ed carefully t o avoid st rong vibrat ions or shock from dropping or handling. Observe st orage and operat ing condit ions described in CADScor® Syst em requirem ent s, for t em perature, altitude and hum idity in section 12. The m anufacturer cannot be held liable for any dam age caused by incorrect applicat ion or operat ion of CADScor® Syst em . The warrant y does not ext end t o int erpret at ion of result s obt ained using t he CADScor® Syst em or use of t he syst em out side it s int ended use. Do not m odify t he CADScor® Syst em or use or repair a defect CADScor® Syst em , due t o risk of m alfunct ioning. The CADScor® Syst em m ust only be serviced by qualified Acarix personnel (10) . Do not drop or exert excessive st ress or force t o t he CADScor® Syst em since t his m ay dam age t he CADScor® Syst em perm anently. 90 1 4 Approvals and EMC inform ation The CADScor® Syst em is a m edical device class I I a, fulfilling t he requirement s in com pliance wit h t he Council Direct ive 93/ 42/ EEC, Medical Device Direct ive ( MDD) . 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 odifications are m ade to the d ev i ce. 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 p r o cesses" 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) this device m ust accept any int erference received, including interference 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 CE- m ark I EC/ EN 60601 EMC- em ission EMC- im m unit y FCC I D I ndicat es com pliance wit h t he Medical Device Direct ive 93/ 42/ EEC I n com pliance wit h I EC/ EN 60601- 1 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 The equipm ent com plies with the im munity requirem ent s in I EC/ EN 60601-1-2 2AYXI -ASE1401 91 T a b le 1 : Gu idan ce an d m an u f a ct u re r's decla rat ion elect r om a gn e t ic em ission 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 . Th e cu st om er or t h e u ser of t h e CADScor sy st em ACS- 1401 sh ou ld assu r e t h at i t is u sed in such an env ir onm ent . Em i ssi on s t e st Com p l i a n ce El e ct rom a gn e t i c e n vi ron m e n t g u i d a n ce RF em issi ons CI SPR 11 Group 1 The CADSco r sy st e m ACS- 1 4 0 1 m ust em it elect rom agnet ic energy in order t o perf orm it s int ended f unct ion. Nearby elect ronic equipm ent m ay be affected. RF em iss ions CI SPR 1 1 Class B Harm onic em issions I EC 61000- 3 - 2 Volt ag e fluct u at ion s/ flicker em ission s Class A Com plies The CADSco r sy st e m ACS- 1 4 0 1 is suit able f or use in all est ablishm ent s, including dom est ic est ablishm ent s and t hose direct ly connect ed t o t he public low -volt age power supply net work t hat supplies buildings used for dom est ic purposes. I EC 61000- 3 - 3 92 T a b le 2 : Gu idan ce an d m an u f a ct u re r's decla rat ion elect r om a gn 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 . Th e cu st om e r or t h e u se r of t h e CADScor sy st em ACS- 1401 sh ou ld assu r e t h at it is u sed in su ch an en v ir on m en t . I m m unit y t est Elect r ost at ic Discharge, (ESD) I EC 61000- 4 - 2 I EC/ EN 6 0 6 0 1 - 1 - 2 test level 8 kV cont act 15 k V air Com p l i a n ce l e ve l 8 kV cont act 15 k V air Ele ct rom agnet ic environm ent g u id a n ce Floor s shou ld be w ood, 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 30 % . Elect r ical fast t r an sient / bu r st I EC 61000- 4 - 4 Surge I EC 61000- 4 - 5 2 k V for power supply lines 1 k V for input / out put lines 1 k V line( s) t o line( s) 2 kV line( s) t o eart h 2 k V for power supply lines N/ A, no input / out put lines 1 k V line( s) t o line( s) 2 kV line( s) t o eart h Mains power qualit y should be t hat of a t ypical com m ercial or hospit al environm ent . Mains power qualit y should be t hat of a t ypical com m ercial or hospit al environm ent . 93 T a b le 2 , cont inued: Gu ida n ce a n d m a n u f act u rer's de cla ra t ion elect r om agn e t ic im m u n it y Volt age dips, short 0 % UT int errupt ions and ( 10 0% dip in UT) f or volt age variat ions on 0.5 cycle power supply input lines 0% UT ( 100% dip in UT) f or 1 I EC 61000- 4 - 11 cycle 0% UT ( 10 0% dip in UT) f or 0.5 cycle 0% UT ( 100% dip in UT) f or 1 cycle Mains power qualit y should be t hat of a t ypical com m ercial or hospit al environm ent . 70 % UT 70 % UT ( 30 % dip in UT) f or 25 ( 30 % dip in UT) f or 25 cycles cycles 0% UT 0% UT ( 10 0% dip in UT) f or 5 ( 10 0% dip in UT) f or 5 sec sec Pow er f requency ( 50/ 60 Hz) m agnet ic field I EC 61000- 4 - 8 30 A/ m 30 A/ m Pow er f requency m agnet ic f ields should be at levels charact erist ic of a t ypical locat ion in a t ypical com m ercial or hospit al environm ent . NOTE UT is t he a. c. m ains v olt age prior t o applicat ion of t he t est lev el. 94 Table 2 , cont inued: Gu idan ce an d m an u f a ct u r er's decla ra t ion ele ct r om agn e t ic im m u n it y Conduct ed RF im m unit y I EC 61000- 4 - 6 Radiat ed RF im m unit y I EC 61000- 4 - 3 3 Vrm s 150 kHz t o 80 MHz. 80 % AM at 1 kHz 3 Vrm s 150 kHz to 80 MHz. 80 % AM at 1 kHz 6 Vrm s in I SM bands 6 Vrm s in I SM bands between 150 kHz and 80 between 150 kHz and 80 MHz ( see note) MHz ( see note) 3 V/ m 80 MHz t o 2.7 GHz 80 % AM at 1 kHz 3 V/ m 80 MHz t o 2.7 GHz 80 % AM at 1 kHz WARNI NG: Port able RF com m unicat ions equipm ent ( including peripherals such as ant enna cables and ext ernal ant ennas) should be used no closer t han 30 cm ( 12 inches) t o any part of t he CADScor sy st em ACS- 1401, including cables specified by t he m anufact urer. Ot herwise, degradat ion of t he perform ance of this equipm ent could result . Plus addit ional t est lev els Plus, addit ional t est lev els according t o t he below according t o t he below table. table. N OTE: The I SM ( indust rial, scient ific and m edical) bands bet ween 0 .15 MHz and 80 MHz are 6.765 MHz t o 6.795 MHz; 13.553 MHz t o 13.567 MHz; 26.957 MHz t o 27.283 MHz; and 40.66 MHz t o 40.70 MHz. 95 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 Equipm ent) . 96 1 5 Acronym s & Definitions in text Acr ony m s CAD CSS CADScor® Syst em CADScor® Sensor CADScor® Docking st ation CADScor® Pat ch Reco r din g I C4- L St enosis Coronary m urm urs CAD- score RFI D- chip Sensor qualificat ion Ext ernal noise I nt ernal noise Elect rom agnet ic noise Defin it ion s Coronary Art ery Disease. Chronic Coronary Syndrom e Sensor, Docking st at ion and Pat ch. Acoust ic recording sensor, part of t he CADScor® Syst em . Docking st at ion for charging and qualificat ion of t he sensor, part of t he CADScor® syst em . Pat ch for anchoring t he sensor ont o t he chest of t he pat ient , part of t he CADScor® Syst em Acoust ic recording perform ed by t he sensor. Left fourt h int ercost al space. Narrowing of t he coronary art eries. Heart sounds t hat are produced as a result of t urbulent blood flow t hat is sufficient t o produce audible noise. Calculat ed heart m urm ur score (of coronary m urm urs) on t he basis of t he acoust ic recording. Radio-frequency ident ificat ion chip A procedure t o ensure sensor operat ional st at us. The am bient noise surrounding t he heart sensor. The sounds arising from inside of hum an body (respirat ory, m uscle, bow el) . Non- acoust ic noise generat ed by elect rom agnet ic fields (EMC) . 97 1 6 Licenses The CADScor® Sy st em ( r) m akes use of several open source packages. Here is a list wit h package nam e, t he nam e and version of t he licenses used and, in som e cases, ot her not es. Aft er wards, t he licenses will be writ t en. · alsa- lib, LGPL- 2.1 · alsa- ut ils, GPL- 2 · busybox, GPL- 2 · dropbear, several licenses, see below · freet ype, GPL- 2 · glib, LGPL- 2 .1 · i2c- t ools, GPL- 2 · j peg, t he j peg library is work of t he I ndependent JPEG Group. · libpng, see http: / / w ww .libpng.org · libsndfile, LGPL- 2.1 · linux kernel, GPL- 2 · m em t est er, GPL- 2 · net base, GPL- 2 · pcre, BSD- 3- Clause, see copyright holders below · qt 4- em bedded, LGPL- 2 .1 · u- boot , GPL- 2 · wireless- t ools, GPL- 2 and LGPL- 2.1 · zlib, http: / / 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 at info@acarix.com . dropbear The m aj orit y of code is writ t en by Mat t Johnst on, under t he MI T license below. Port ions of t he client - m ode work are ( c) 2004 Mihnea St oenescu, under t he sam e license Copyright ( c) 2002- 2008 Mat t Johnst on Port ions copy right ( c) 2004 Mihnea St oenescu. All rights reserved. 98 < 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 taken from OpenSSH 3 .5p1, Copyright ( c) 1995 Tat u Ylonen < ylo@cs.hut .fi> , Espoo, Finland All rights reserved "As far as I am concerned, the code I have writ ten for this soft ware can be used freely for any purpose. Any derived versions of t his soft ware m ust be clearly m arked as su ch, and if t he derived work is incom pat ible wit h t he prot ocol descript ion in t he RFC file, it m ust be called by a nam e other than "ssh" or " Secure Shell". " ===== loginrec.c, loginrec.h, at om icio.h, at om icio.c and st rlcat ( ) ( included in ut il.c) are from OpenSSH 3 .6.1p2, and are licensed under the 2 point BSD license ( see below) . loginrec is writ t en prim arily by Andre Lucas, at om icio.c by Theo de Raadt . st rlcat ( ) is ( c) Todd C. Miller ===== I m por t code in keyim port . c is m odified from PuTTY's im port . c, licensed as follows: PuTTY is copy right 1997- 2003 Sim on Tat ham . 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THE BASI C LI BRARY FUNCTI ONS Written by: Philip Hazel Em ail local part : ph10 Em ail dom ain: cam .ac.uk Universit y of Cam bridge Com put ing Service, Cam bridge, England. Copyright ( c) 1997- 2011 Universit y of Cam bridge All rights reserved. PCRE JUST- I N- TI ME COMPI LATI ON SUPPORT Written by: Zoltan Herczeg Em ail local part : hzm est er Em ain dom ain: freem ail.hu Copyright ( c) 2010- 2011 Zolt an Herczeg All rights reserved. STACK- LESS JUST- I N- TI ME COMPI LER Written by: Zoltan Herczeg Em ail local part : hzm est er Em ain dom ain: freem ail.hu Copyright ( c) 2009- 2011 Zolt an Herczeg All rights reserved. THE C+ + WRAPPER FUNCTI ONS Cont ribut ed by : Google I nc. Copyright ( c) 2007- 2011, Google I nc. 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Such a work , in isolat ion, is not a derivat ive work of t he Library , and t herefore falls out side t he scope of t his License. However, linking a "work t hat uses t he Library " wit h t he Librar y creat es an execut able t hat is a derivat ive of t he Library ( because it cont ains port ions of t he Library ) , rat her t han a "work t hat uses t he library". The execut able is t herefore covered by t his License. Section 6 states term s for distribu tion of such executables. When a "work t hat uses t he Librar y" uses m at erial from a header file t hat is part of t he Library, t he obj ect code for t he wor k m ay be a derivat ive work of t he Library even t hough t he source code is not . Whet her t his is t rue is especially significant if t he work can be linked wit hout t he Library, or if t he work is it self a library. Th e t hreshold for t his t o be t rue is not precisely defined by law. I f such an obj ect file uses only num erical param et ers, dat a st ruct ure layout s and accessors, and sm all m acros and sm all inline functions ( ten lines or less in length) , then the use of the obj ect file is unrestricted, regar dless of whether it is legally a derivative work . ( Execut ables cont aining t his obj ect code plus por t ions of t he Library will st ill fall under Sect ion 6.) Ot herwise, if t he wor k is a derivat ive of t he Library , you m ay dist ribut e t he obj ect code for t he work under t he t erm s of Sect ion 6. Any execut ables cont aining t hat work also fall under Sect ion 6, whet her or not t hey are linked direct ly wit h t he Librar y it self. 6 . As an except ion t o t he Sect ions above, you m ay also com bine or link a "work t hat uses t he Library " wit h t he Librar y t o produce a work cont aining port ions of t he Librar y, and dist ribut e t hat work under t erm s of your choice, provided t hat t he t erm s perm it m odification of the work for the custom er's own use and reverse engineering for debugging such m odifications. You m ust give prom inent not ice wit h each copy of t he work t hat t he Library is used in it and t hat t he Library and it s u se are covered by t his License. You m ust su pply a copy of t his License. I f t he work during execut ion displays copyright not ices, you m ust include t he copyright not ice for t he Library am on g t hem , as well as a reference direct ing t he user t o t he copy of t his License. Also, you m ust do one of these things: a ) Accom pany t he wor k wit h t he com plet e corresponding m achi ne- readable source code for t he Library including what ever changes were used in the work ( which m ust be distribu ted under Sections 1 and 2 above) ; and, if the wor k is an executable linked wit h t he Library , wit h t he com plet e m achine- readable "work t hat uses t he Library" , as obj ect code and/ or source code, so t hat t h e user can m odify t he Librar y and t hen relink t o produce a m odified execut able cont aining t he m odified Library . ( I t is underst ood t hat t he user who changes t he cont ent s of definit ions files in t he Library will not necessarily be able t o recom pile t he applicat ion t o use the m odified definitions.) b) Use a suit able shared library m echanism for linking wit h t he Library . A suit able m echanism is one t hat ( 1) uses at run t im e a copy of the library already present on the user's com puter system , rather than copying library functions into the executable, and 105 ( 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 erfacecom patible with the version that the work was m ade with. c) Accom pany the work with a written offer, valid for at least thr ee years, to give the sam e user the m aterials specified in Subsection 6a, above, for a char ge no m ore than the cost of per form ing this distribution. d) I f distribution of the work is m ade by offering access to copy from a designated place, offer equivalent access to copy the above specified m aterials from the sam e place. e ) Verify that the user has already received a copy of these m at erials or that you have already sent this user a copy . For an execut able, t he required form of t he "work t hat uses t he Library " m ust include any dat a and ut ilit y program s needed for reproducing the executable from it. However , as a special exception, the m aterials to be distributed need not include anything that is norm ally distributed ( in either source or binary form ) with the m aj or com ponents ( com piler, kernel, and so on) of the operating system on which the executable runs, unless that com ponent itself accom panies the executable. I t m ay happen that this requirem ent contradicts the license restrictions of other proprietary libraries that do not norm ally accom pany t he operat ing syst em . Such a cont radict ion m eans you cannot use bot h t hem and t he Library t oget her in an execut able that you distribute. 7 . You m ay place library facilit ies t hat are a work based on t he Library side- by- si de in a single library t oget her wit h ot her library facilit ies not covered by t his License, and dist ribut e such a com bined library, provided t hat t he separat e dist ribut ion of t he work based on t he Library and of t he ot her library facilit ies is ot herwise perm it t ed, and provided t hat you do t hese t wo t hings: a ) Accom pany t he com bined library wit h a copy of t he sam e wor k based on t he Librar y, uncom bined wit h any ot her library facilit ies. This m ust be dist ribut ed under t he t erm s of t he Sect ions above. b) Give prom inent not ice wit h t he com bined library of t he fact t hat part of it is a work based on t he Librar y, and ex plaining where to find the accom panying uncom bined form of the sam e work. 8 . You m ay not copy , m odif y, sublicense, link wit h, or dist ribut e t he Library except as expressly provided under t his License. Any at t em pt ot her wise t o copy, m odify, su blicense, link wit h, or dist r ibut e t he Library is void, and will aut om at ically t erm inat e your right s under t his License. However, par t ies who have received copies, or right s, from you under t his License will not have t heir licenses term inated so long as such parties rem ain in full com pliance. 9 . You are not required t o accept t his License, since you have not signed it . However, not hing else grant s you per m ission t o m odify or dist ribut e t he Library or it s derivat ive works. These act ions are prohibit ed by law if you do not accept t his License. Therefore, by m odifying or dist ribut ing t he Librar y ( or any wor k based on t he Library ) , you indicat e your accept ance of t his License t o do so, and all it s t erm s and condit ions for copying, dist ri but ing or m odifying t he Library or wor ks based on it . 1 0 . Each t im e you redist ribut e t he Library ( or an y wor k based on t he Library) , t he recipient aut om at ically receives a license from t he original licensor t o copy, dist ribut e, link wit h or m odify t he Library subj ect t o t hese t erm s and condit ions. You m ay not im pose any 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 wit h t his License. 106 1 1 . I f, as a consequence of a court j udgm ent or allegation of patent infringem ent or for any other reason ( not lim ited to patent issues) , conditions are im posed on you ( whether by court order, agreem ent or otherwise) that contradict the conditions of this License, t hey do not excuse you from t he condit ions of t his License. I f you cannot dist ribu t e so as t o sat isfy sim ult aneously your obligat ions under t his License and any ot her pert inent obligat ions, t hen as a consequence you m ay not dist ribut e t he Librar y at all. For exam ple, if a pat ent license would not perm it royalt y- free redist ribut ion of t he Library by all t hose who receive copies direct ly or indirect ly t hrough you, t hen t he only way you could sat isfy bot h it and t his License would be t o refrain ent irely from dist ribut ion of t he Library. I f any portion of this section is held invalid or unenforceable under any particular circum stance, the balance of the section is intended to apply, and the section as a whole is intended to apply in other circum stances. I t is not the purpose of this section to induce you to infringe any patents or other propert y right claim s or to contest validity of any such claim s; this section has the sole purpose of protecting the integrity of the free software dist ribution system which is im plem ent ed by public license pract ices. Many people have m ade generous cont ribut ions t o t he wide range of soft ware dist ribut ed through that system in reliance on consistent application of that system ; it is up to the author/ donor to decide if he or she is willing to distribute soft ware through any other system and a licensee cannot im pose that choice. This sect ion is int ended t o m ake t horoughly clear what is believed t o be a consequence of t he rest of t his License. 1 2 . I f t he dist ri but ion and/ or use of t he Library is rest rict ed in cert ain count ries eit her by pat ent s or by copy right ed int erfaces, t he original copyright holder who places t he Librar y under t his License m ay add an explicit geographical dist ribut ion lim it at ion excluding t hose count ries, so t hat dist ribut ion is perm it t ed only in or am ong count ries not t hus excluded. I n such case, t his License incorporat es t he lim it at ion as if writ t en in t he body of t his License. 1 3 . The Free Soft ware Foundat ion m ay publish revised and/ or n ew versions of t he Lesser General Public License from t im e t o t im e. Such new versions will be sim ilar in spirit to the present version, but m ay differ in detail to address new problem s or concerns. Each version is given a dist inguishing version num ber. I f t he Library specifies a version num ber of t his License which applies t o it and "any later version", you have the option of following the term s and conditions either of that version or of any later version published by t he Free Soft ware Foundat ion. I f t he Librar y does n ot specify a license version num ber, you m ay choose any ver sion ever published by t he Free Soft ware Foundat ion. 1 4 . I f you wish t o incorporat e par t s of t he Librar y int o ot her free program s whose dist ribut ion condit ions are incom pat ible wit h t hese, writ e t o t he aut hor t o ask for perm ission. For sof t ware wh ich is copyright ed by t he Free Soft ware Foundat ion, writ e t o t he Free Soft ware Foundat ion; we som et im es m ake except ions for t his. Our decision will be guided by t he t wo goals of preserving t he free status of all derivatives of our free software and of prom oting the sharing and reuse of software generally. NO W ARRANTY 1 5 . BECAUSE THE LI BRARY I S LI CENSED FREE OF CHARGE, THERE I S NO WARRANTY FOR THE LI BRARY, 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 107 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. SHOULD THE LI BRARY PROVE DEFECTI VE, YOU ASSUME THE COST OF ALL NECESSARY SERVI CI NG, REPAI R OR CORRECTI ON. 1 6 . I N NO EVENT UNLESS REQUI RED BY APPLI CABLE LAW OR AGREED TO I N WRI TI NG WI LL ANY COPYRI GHT HOLDER, OR ANY OTHER PARTY WHO MAY MODI FY AND/ OR REDI STRI BUTE THE LI BRARY AS PERMI TTED ABOVE, BE LI ABLE TO YOU FOR DAMAGES, I NCLUDI NG ANY GENERAL, SPECI AL, I NCI DENTAL OR CONSEQUENTI AL DAMAGES ARI SI NG OUT OF THE USE OR I NABI LI TY TO USE THE LI BRARY ( I NCLUDI NG BUT NOT LI MI TED TO LOSS OF DATA OR DATA BEI NG RENDERED I NACCURATE OR LOSSES SUSTAI NED BY YOU OR THI RD PARTI ES OR A FAI LURE OF THE LI BRARY TO OPERATE WI TH ANY OTHER SOFTWARE) , EVEN I F SUCH HOLDER OR OTHER PARTY HAS BEEN ADVI SED OF THE POSSI BI LI TY OF SUCH DAMAGES. END OF TERMS AND CONDI TI ONS How t o Apply These Term s t o You r New Libraries I f you develop a new library, and you want it to be of the greatest possible use to the public, we recom m end m aking it free soft ware t hat everyone can redist ribut e and change. You can do so by perm it t ing redist ribut ion under t hese t erm s ( or , alt ernat ively, under t he t erm s of t he ordinary General Public License) . To apply t hese t erm s, at t ach t he following not ices t o t he library. I t is safest t o at t ach t hem t o t he st art of each source file t o m ost effectively convey the exclusion of warranty; and each file should have at least the "copyright " line and a pointer to where the full notice is found. one line to give the library's nam e and an idea of what it does. Copyright ( C) year nam e of aut hor This library is free soft ware; you can redist ribut e it and/ or m odify it under t he t erm s of t he GNU Lesser General Public License as published by t he Free Soft ware Foundat ion; eit her version 2.1 of t he License, or ( at your opt ion) any lat er version. This library is dist ribut ed in t he hope t hat it will be useful, but WI THOUT ANY WARRANTY; wit hout even t he im plied warrant y of MERCHANTABI LI TY or FI TNESS FOR A PARTI CULAR PURPOSE. See t he GNU Lesser General Public License for m ore det ails. You should have received a copy of t he GNU Lesser General Public License along wit h t his library; if not , w rit e t o t he Free Soft ware Foundat ion, I nc., 51 Franklin St reet , Fift h Floor, Bost on, MA 02110- 1301 USA Also add inform ation on how to contact you by electronic and paper m ail. You should also get your em ployer ( if you wor k as a program m er) or your school, if any, t o sign a "copyrigh t disclaim er" for t he library, if necessary. Here is a sam ple; alter the nam es: Yoyodyne, I nc., hereby disclaim s all copyright int erest in t he library ` Frob' ( a library for t weaking knobs) writ t en by Jam es Random Ha ck e r . signat ure of Ty Coon, 1 April 1990 108 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. Pream ble The licenses for m ost soft ware are designed t o t ake away your f reedom t o share and change it . By cont rast , t he GNU General Public License is int ended t o guarant ee your freedom t o share and change free soft ware- - t o m ake sure t he soft ware is free for all it s users. This General Public License applies t o m ost of t he Free Soft ware Foundat ion's soft ware and t o any ot her program whose aut hors com m it t o using it . ( Som e ot her Free Soft ware Foundat ion soft ware is covered by t he GNU Lesser General Public License inst ead.) You can apply it t o you r program s, t oo. When we speak of free soft ware, we are referring t o freedom , n ot price. Ou r General Public Licenses are designed t o m ake sure that you have the freedom to distribute copies of free software ( and charge for this service if you wish) , that you receive source code or can get it if you want it, that you can change the software or use pieces of it in new free program s; and that you know you can do these things. To prot ect your right s, we need t o m ake rest rict ions t hat for bid anyone t o deny you t hese right s or t o ask you t o sur render t he right s. These rest rict ions t ranslat e t o cert ain responsibilit ies for you if you dist ribut e copies of t he soft ware, or if you m odif y it . For exam ple, if you dist ribut e copies of such a program , whet her grat is or for a fee, you m ust give t he recipient s all t he right s t hat you have. You m ust m ake sure t hat t hey, t oo, receive or can get t he source code. And you m ust show t hem t hese t erm s so t hey know their rights. We protect your rights with two steps: ( 1) copyright the soft war e, and ( 2) offer you this license which gives you legal perm ission to copy, dist ribute and/ or m odify the soft ware. Also, for each author's protection and ours, we want to m ake certain that everyone understands that there is no warranty for this free software. I f the soft ware is m odified by som eone else and passed on, we want its recipients to know that what they have is not the original, so that any problem s introduced by others will not reflect on the original authors' reputations. Finally, any free program is t h reat ened const ant ly by sof t ware pat ent s. We wish t o avoid t he danger t hat redist ribut ors of a free program will individually obt ain pat ent licenses, in effect m aking t he program propriet ary. To prevent t his, we have m ade it clear that any patent m ust be licensed for everyone's free use or not licensed at all. The precise t erm s and condit ions for copying, dist ribut ion and m odificat ion follow. 109 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. The "Program " , below, refers t o any such program or work , and a "work based on t he Program " m eans eit her t he Program or any derivat ive work under copyri ght law: t hat is t o say , a wor k cont aining t he Program or a port ion of it , eit her verbat im or wit h m odificat ions and/ or t ranslat ed int o anot her language. ( Hereinaft er, t ran slat ion is included wit hout lim it at ion in t he t erm "m odificat ion".) Each licensee is addressed as "you" . Act ivit ies ot her t han copying, dist ribut ion and m odificat ion are not covered by t his License; t hey are out side it s scope. The act of running t he Program is not rest rict ed, and t he out put from t he Program is covered only if it s cont ent s const it ut e a wor k based on t he Program ( independent of having been m ade by running t he Program ) . Whet her t hat is t rue depends on what t he Program does. 1 . You m ay copy and dist ribut e ver bat im copies of t he Program 's source code as you receive it , in any m edium , provided t hat you conspicuously and appropriately publish on each copy an appropriate copyright notice and disclaim er of warrant y; keep intact all t he not ices t hat refer t o t his License and t o t he absence of any warrant y ; and give any ot her recipient s of t he Program a copy of t his License along wit h t he Program . You m ay charge a fee for t he physical act of t ransferring a copy, and you m ay at your opt ion offer warrant y prot ect ion in exchange for a fee. 2 . You m ay m odify your copy or copies of t he Program or any port ion of it , t hus form ing a wor k based on t he Program , and copy and distribute such m odifications or work under the term s of Section 1 above, provided that you also m eet all of these condit ions: a ) You m ust cause t he m odified files t o carry prom inent not ices st at ing t hat you changed t he files and t he dat e of any change. b) You m ust cause any wor k t hat you dist ribut e or pu blish, t hat in whole or in part cont ains or is derived from t he Program or an y part t hereof, t o be licensed as a whole at no charge t o all t hird part ies under t he t erm s of t his License. c) I f the m odified program norm ally reads com m ands interactively when run, you m ust cause it, when started running for such interactive use in the m ost ordinary way, to print or display an announcem ent including an appropriate copyright notice and a notice that there is no warranty ( or else, saying that you provide a warranty) and that users m ay redist ribute the program under t hese condit ions, and t elling t he user how t o view a copy of t his License. ( Except ion: if t he Program it self is int eract ive but does not norm ally print such an announcem ent , your wor k based on t he Program is not required t o print an announcem ent .) These requirem ent s apply t o t he m odified wor k as a whole. I f ident ifiable sect ions of t hat work are not derived from t he Program , and can be reasonably considered independent and separat e works in t hem selves, t hen t his License, and it s t erm s, do not apply t o those sections when you distribute them as separate works. But when you distribute the sam e sections as part of a whole which is a work based on t he Program , t he dist ribut ion of t he whole m ust be on t he t erm s of t his License, whose perm issions for ot her licensees extend to the entire whole, and thus to each and every part regar dless of who w rote it. 110 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 he 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 . I n addit ion, m ere aggregat ion of anot her work not based on t he Program wit h t he Program ( or wit h a wor k based on t he Program ) on a volum e of a st orage or dist ribut ion m edium does not bring t he ot her work under t he scope of t his License. 3 . You m ay copy and dist ribut e t he Program ( or a work based on it , under Sect ion 2) in obj ect code or execut able form under t he term s of Sections 1 and 2 above provided that you also do one of the following: a ) Accom pany it with the com plete corresponding m achine- readable source code, which m ust be distributed under the term s of Sections 1 and 2 above on a m edium custom arily used for soft w are interchange; or, b) Accom pany it with a written offer, valid for at least three years, to give any third par ty , for a charge no m ore than your cost of physically perform ing sour ce distribution, a com plete m achine- readable copy of the correspon ding source code, to be dist ributed under the term s of Sections 1 and 2 above on a m edium custom arily used for software interchange; or, c) Accom pany it wit h t he inform at ion you received as t o t he offer t o dist ribut e corresponding source code. ( This alt ernat ive is allowed only for noncom m ercial distribution and only if you received the program in obj ect code or executable form with such an offer, in accord with Subsection b above.) The source code for a wor k m eans t he preferred form of t he wor k for m aking m odificat ions t o it . For an execut able work , com plet e source code m eans all the source code for all m odules it contains, plus any associated interface definition files, plus the scripts used t o cont rol com pilat ion and inst allat ion of t he execut able. However, as a special except ion, t he source code dist ribut ed need not include anything that is norm ally distributed ( in either source or binary form ) with the m aj or com ponents ( com piler, kernel, and so on) of the operating system on which the executable runs, unless that com ponent itself accom panies the executable. I f distribution of executable or obj ect code is m ade by offering access to copy from a designated place, then offering equivalent access to copy the source code from the sam e place counts as distribution of the source code, even though third par ties are not com pelled to copy the source along with the obj ect code. 4 . You m ay not copy , m odif y, sublicense, or dist ribut e t he Progr am except as expressly provided under t his License. Any at t em pt ot herwise t o copy , m odify, su blicense or dist ribut e t he Program i s void, and will aut om at ically t erm inat e your right s under t his License. However, part ies who have received copies, or right s, f r om you under t his License will not have t heir licenses t erm inat ed so long as such parties rem ain in full com pliance. 5 . You are not required t o accept t his License, since you have not signed it . However, not hing else grant s you per m ission t o m odify or dist ribut e t he Program or it s derivat ive wor ks. These act ions are prohibit ed by law if you do not accept t his License. Therefor e, by m odifying or dist ribut ing t he Program ( or any work based on t he Program ) , you indicat e your accept ance of t his License t o do so, and all it s t erm s and condit ions for copying, dist ribut ing or m odifying t he Program or wor ks based on it . 6 . Each t im e you redist ribut e t he Program ( or any work based on t he Program ) , t he recipient aut om at ically receives a license from t he original licensor t o copy, dist ribut e or m odify t he Program su bj ect t o t hese t erm s and con dit ions. You m ay not im pose any 111 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 allegation of patent infringem ent or for any other reason ( not lim ited to patent issues) , conditions are im posed on you ( whether by court order, agreem ent or otherwise) that contradict the conditions of this License, t hey do not excuse you from t he condit ions of t his License. I f you cannot dist ribu t e so as t o sat isfy sim ult aneously your obligat ions under t his License and any ot her pert inent obligat ions, t hen as a consequence you m ay not dist ribut e t he Program at all. For exam ple, if a pat ent license would not perm it royalt y- free redist ribut ion of t he Program by all t hose who receive copies direct ly or indirect ly t hrou gh you, t hen t he only way you could sat isfy bot h it and t his License would be t o refrain ent irely from dist ribut ion of t he Program . I f any portion of this section is held invalid or unenforceable under any particular circum stance, the balance of the section is intended to apply and the section as a whole is intended to apply in other circum stances. I t is not the purpose of this section to induce you to infringe any patents or other propert y right claim s or to contest validity of any such claim s; this section has the sole purpose of protecting the integrity of the free software dist ribution system , which is im plem ent ed by public license pract ices. Many people have m ade generous cont ribut ions t o t he wide range of soft ware dist ribut ed through that system in reliance on consistent application of that system ; it is up to the author/ donor to decide if he or she is willing to distribute soft ware through any other system and a licensee cannot im pose that choice. This sect ion is int ended t o m ake t horoughly clear what is believed t o be a consequence of t he rest of t his License. 8 . I f t he dist ribut ion and/ or use of t he Program is rest rict ed in cert ain count ries eit her by pat ent s or by copy right ed int erfaces, t he original copyright holder who places t he Program under t his License m ay add an explicit geographical dist ribut ion lim it at ion excluding t hose count ries, so t hat dist ribut ion is perm it t ed only in or am ong count ries not t hus excluded. I n such case, t his License incorporat es t he lim it at ion as if writ t en in t he body of t his License. 9 . The Free Soft ware Foundat ion m ay publish revised and/ or new versions of t he General Public License from t im e t o t im e. Such new versions will be sim ilar in spirit to the present version, but m ay differ in detail to address new problem s or concerns. Each version is given a dist inguishing version num ber. I f t he Program specifies a version num ber of t his License which applies t o it and "any later version", you have the option of following the term s and conditions either of that version or of any later version published by t he Free Soft ware Foundat ion. I f t he Program does not specify a version num ber of t his License, you m ay choose any version ever published by t he Free Soft ware Foundat ion. 1 0 . I f you wish t o incorporat e par t s of t he Program int o ot her fr ee program s whose dist ribut ion condit ions are different , writ e t o t he aut hor t o ask for perm ission. For soft ware which is copy right ed by t he Free Soft ware Foundat ion, w rit e t o t he Free Soft ware Foundat ion; we som et im es m ake except ions for t his. Our decision will be guided by t he t wo goals of preserving t he free st at us of all derivatives of our free software and of prom oting the sharing and reuse of software generally. NO W ARRANTY 112 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" 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 PROGRAM I S WI TH YOU. SHOULD THE PROGRAM PROVE DEFECTI VE, YOU ASSUME THE COST OF ALL NECESSARY SERVI CI NG, REPAI R OR CORRECTI ON. 1 2 . I N NO EVENT UNLESS REQUI RED BY APPLI CABLE LAW OR AGREED TO I N WRI TI NG WI LL ANY COPYRI GHT HOLDER, OR ANY OTHER PARTY WHO MAY MODI FY AND/ OR REDI STRI BUTE THE PROGRAM AS PERMI TTED ABOVE, BE LI ABLE TO YOU FOR DAMAGES, I NCLUDI NG ANY GENERAL, SPECI AL, I NCI DENTAL OR CONSEQUENTI AL DAMAGES ARI SI NG OUT OF THE USE OR I NABI LI TY TO USE THE PROGRAM ( I NCLUDI NG BUT NOT LI MI TED TO LOSS OF DATA OR DATA BEI NG RENDERED I NACCURATE OR LOSSES SUSTAI NED BY YOU OR THI RD PARTI ES OR A FAI LURE OF THE PROGRAM TO OPERATE WI TH ANY OTHER PROGRAMS) , EVEN I F SUCH HOLDER OR OTHER PARTY HAS BEEN ADVI SED OF THE POSSI BI LI TY OF SUCH DAMAGES. END OF TERMS AND CONDI TI ONS How t o Apply These Term s t o You r New Program s I f you develop a new program , and you want it to be of the greatest possible use to the public, the best way to achieve this is to m ake it free software which everyone can redistribute and change under these term s. To do so, at t ach t he following not ices t o t he program . I t is safest t o at t ach t hem t o t he st ar t of each source file t o m ost effect ively convey t he exclusion of warrant y; and each file should have at least t he "copy right " line and a point er t o where t he full not ice is found. one line to give the program 's nam e and an idea of what it does. Copyright ( C) yy yy nam e of aut hor This program is free soft ware; you can redist ribut e it and/ or m odify it under t he t erm s of t he GNU General Public License as published by t he Free Soft ware Foundat ion; eit her version 2 of t he License, or ( at your opt ion) any lat er version. This program is dist ribut ed in t he hope t hat it will be useful, but WI THOUT ANY WARRANTY; wit hout even t he im plied warrant y of MERCHANTABI LI TY or FI TNESS FOR A PARTI CULAR PURPOSE. See t he GNU General Public License for m ore det ails. You should have received a copy of t he GNU General Public License along wit h t his program ; if not , writ e t o t he Free Soft ware Foundat ion, I nc., 51 Franklin St reet , Fift h Floor, Bost on, MA 02 110- 1301, USA. Also add inform ation on how to contact you by electronic and paper m ail. I f the program is interactive, m ake it output a short notice like this when it starts in an interactive m ode: Gnom ovision version 69, Copyright ( C) year nam e of aut hor Gnom ovision com es wit h ABSOLUTELY NO WARRANTY; for det ails t y pe ` show w'. This is free soft ware, and you are welcom e t o redist ribut e it under cert ain condit ions; t ype ` show c' for det ails. 113 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 ething other than ` show w' and ` show c'; they could even be m ouse- presss or m enu item s- whatever suits your program . You should also get your em ployer ( if you wor k as a program m er) or your school, if any, t o sign a "copyrigh t disclaim er" for t he program , if necessary. Here is a sam ple; alter the nam es: Yoyodyne, I nc., hereby disclaim s all copyright int erest in t he program ` Gnom ovision' ( which m akes passes at com pilers) writ t en by Jam es Hacker . signat ure of Ty Coon, 1 April 1989 Ty Coon, President of Vice This General Public License does not perm it incorporat ing your program int o propriet ar y program s. I f you r program is a subrou t ine library, you m ay consider it m ore useful to perm it linking proprietary applications with the library. I f this is what you want to do, use t he GNU Lesser General Public License inst ead of t his License. 114 US- FDA version. CADScor® Syst em User Manual, English US- FDA revision 12.5, Mar. 20th, 2021. From soft ware version 4.0 US- FDA. 115macOS Version 10.16 (Build 20D91) Quartz PDFContext Word