acarix CADScor System User manual
2
1 W a r r an t ie s a n d discla im e r
The CADScor ® Sy st em is cover ed by a
general 1- year warranty from dat e of
purchase, that cov ers fault y hardwar e,
including t he CADScor®Sensor, the
CADScor®Do ck in g st at ion and t he ext ernal
power adaptor.
Furt her m or e, Acarix guar ant ees t hat t he
CADScor®System wi ll b e oper at io nal f or at
least 1000 recordings in the warrant y
period.
I f, however t he CADScor®Sy st em does not
operat e properly, please first consult the
"Tr oubleshoot ing guide"- sect ion 11 in t his
m anual describing possible errors.
Any claim s on warrant y shou ld be
addressed t o Acarix directly or t o t he
Acarix dist ributor in your count ry, w ho will
init iat e r eplacem ent or repair of fault y
equipm ent .
1.1 Disclaim er
The inform ation given in this docum ent is
adapt ed to an int ern at ional m ar ket of
healthcare professionals, based on
illust rations, sym bols and t ext . The
docum ent is giving no specific references
to religious preference, ethnic origin,
gender or polit ical v iew point s. Any such
relat ion is consider ed an int er pr et ation of
which Acarix cannot be held reliable. The
inform at ion is int ended to ensure the safe
and accur at e operat ion of t he
CADScor®Syst em .
2 Copyright notice
The cont en t s of t his docum ent shall n ot be
repr odu ced or com m unicat ed in any for m
to any third party without the prior written
consent of Acarix.
3
3 Cha n ges
This document is subject to change without
notice and you are urged to cont act Acarix
t o v erify whet her the docum ent has been
changed. The m anu al r elev an t t o t h e
specific equipm ent m odel can also be
downloaded from the Acarix websit e. You
can locat e t he specific m odel num ber ( REF
num ber) on t h e back of the alum inium
fr am e of t he CADScor ®Docking st at ion.
While every effort is m ade to ensure t he
cor rect n ess of t he inform ation pr ov ided in
this pr in t ed m an u al Acarix disclaim s any
liability for errors and om issions herein.
The illust rat ions u sed in t his m anu al m ay
differ slight ly fr om t he appearance of t he
act ual device, packagin g m at erials or
interface and reflects on-goin g ef fo rt s t o
im prove safety, usabilit y and clarify t he
overall instruct ions given.
4 Trade m arks and Th ir d-pa r t y
soft w ar e
CADScor®is a registered tradem ark owned
by Acarix.
Third part y soft w ar e license agr eem ent s
ar e list ed in t he back of t his m anual.
US-FDA rev ision 12.5, Mar. 20t h, 2021.
From soft w are version 4.0 US-FDA.
Acarix
Ryvangs Allé 81-83
DK- 2900 Hellerup
Denm ark
www.acarix .com
4
Table of content
1W a r ranties and disclaim er ................ 2
1.1 Disclaim er ................................... 2
2Copyright notice ............................... 2
3Changes ........................................... 3
4Tradem ark s a nd Third-party softw are3
5I nt r oduction..................................... 6
5.1 About t his m anual......................... 6
5.2 The CADScor®System and t he
environm ent .......................................... 6
5.3 Product description ....................... 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 nt ended pat ient population...........11
5.9 I ndicat ions for use .......................12
5.10 Contra-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 Precautions .............................16
5.16 CADScor®Syst em unboxing ........18
5.17 The CADScor® Sensor ............... 20
5.18 CADScor®Dockin g st at ion .......... 22
6I nstalla t ion of CAD Scor®Sy st e m ......2 3
6.1 Deskt op m odel ............................ 23
6.2 CADScor®Syst em w all 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-pat ch
assem bly ............................................. 30
7Setting up the CAD Scor ®Sy st e m p ri or
t o u se ....................................................3 1
7.1 CADScor®Sen sor ......................... 31
7.2 First time configurat ion of t he
CADScor®Sensor ................................... 31
7.3 Set ting language ......................... 34
7.4 Set ting t ime ............................... 35
7.5 Set ting 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 t o Docking stat ion ...................... 40
7.10 Charging of the sensor bat tery ......
............................................. 40
5
7.11 Dock ing stat ion indicat ion LED lig ht
............................................. 41
7.12 Qualification of sensor...............42
7.13 Forced qualificat ion................... 43
7.14 Re-set t ing sensor .....................44
8Det ection of hear t sounds............... 4 5
8.1 Pr eparing 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 (IC4-L) .......................................48
8.5 At tachm ent of pat ch t o sensor .......51
8.6 Explaining of t he recording procedure
to pat ient .............................................52
8.7 Record ing p hase, p at ient r isk fact ors .
................................................54
8.8 Recording phase, Start ................. 65
8.9 Recording phase, Main recording .......
................................................66
8.10 Recording phase, cancelling ....... 67
8.11 Recording phase, CAD-scorin g .......
............................................. 68
8.12 Short diastole CAD-score ........... 69
8.13 QR-code for print ing, archiving and
sending a CADScor patient report............. 70
8.14 CAD-score in t he 30-39 y ear age
group .............................................71
8.15 Possible CADScor®Syst em
m essages during or after recording .......... 72
8.16 Recalling a previous recording
result ............................................ 73
8.17 Aft er the recording ................... 75
9Sound gu idance used in th e in t er face .
......................................................7 6
1 0 Main t e nance ................................7 7
10.1 Disposal ................................. 78
1 1 Troubleshoot ing guide .................7 9
1 2 CAD Scor ®Syst em req uirem ents .......
...................................................8 7
12.1 System specificat ion ................. 88
12.2 Packaging m at erials ................. 89
1 3 W arran t y .....................................9 0
1 4 Ap pr ov a ls a n d EM C in fo r m a t ion .......
...................................................9 1
1 5 Acr onym s & Definitions in text ........
...................................................9 7
1 6 Lice nses ......................................9 8
6
5 I nt r oduct ion
5.1 About this m anual
This user m anu al is int en ded as a
reference guide for t he safe and corr ect
use of the CADScor®Syst em , aft er h aving
been instruct ed in t he proper operat ion of
the CADScor®Sy st em .
This user m anual cont ains bot h gener al
and specific operat ing inst r uct ions,
hereunder procedures for recor din g h eart
sou nds, m aint en ance of the
CADScor®Syst em , t roubleshooting,
inst ructions an d in fo r m at i on o f in div i du al
com ponent s.
To ensure optim al safet y in operation and
service of t he CADScor ®System , it is
im port ant t o read t his m anual car efully an d
understand t he use of t he
CADScor®System before st ar t in g t o use
the syst em pr of ession ally .
5.2 The CADScor®Sy st em an d t h e
environm ent
The Acarix CADScor®Syst em h as been
designed to m in im ize t h e env ironm ent al
im pact from fabrication, t r an sport and u se.
The Syst em - and Pat ch boxin g and
packaging is m ade from light weight
recycled paper an d car dbo ar d , w hich can
be disposed of as paper-wast e and
recycled.
The used pat ch and pouch can be disposed
of as nor m al household wast e.
The CADScor ®Sensor, do ck in g 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 returned
for recycling at a regulat ed facilit y, local
distr ibut or or shipped back to Acarix for
recycling.
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5.3 Product description
The CADScor ®System is a device for
recording and quantifying acoust ic noise
arising from coronar y art ery st enosis
m icro-t urbulence an d m y ocardial
m ovem ent . These noises are usually
described as "coron ar y m ur m urs" .
The CADScor®Syst em calculates a patient
specific CAD-scor e by com put at ion al
processing of a recording obt ained from
the chest surface of the patient and the
pat ient risk fact ors pr esent .
The CADScor ®System consists of two
physical unit s; t he CADScor®Sensor an d
the CADScor®Dockin g st at ion for char gin g
and qu alificat ion of the sensor. A specific
power adapt or powers t he Docking st at ion .
The pat ch for anchoring t he sensor to the
chest of the patient is a necessary
accessory for proper fun ct ioning of the
CADScor®System ( all shown at right ) .
The CADScor ®System is operated by a
graphical user t ouch-screen int erface.
CADScor®Syst em ; Dock in g st at i on hol din g
Sensor.
CADScor®Patch and power adaptor below.
8
5.4 Int en ded use
The in t ended use of t he CADSco r ®Syst em
is to record heart sounds, i.e. m u rm ur s
and vibrat ion for calculat ion of a pat ient
specific score, t he CAD-score, indicating
the risk of coronary stenosis, as an aid in
cardiac analysis and diagnosis.
5.5 Use of the CAD-scor e
The CAD-score is a p at ien t specific h ear t
m urm ur score indicative of Coronary Art ery
Disease ( CAD) / Chronic Cor onar y
Syndrom e (CCS) for im m ediat e r isk
st r at ificat ion, prior to pot ent ial secondary
evaluation.
The CADScor ®Syst em risk st r at ification can
be applied t o pat ient s wit h sym ptom s
suggestive of CAD/ CCS, in com plian ce wit h
the indications for use.
Using t he CAD-score t o risk st r at ify
pat ient s prior t o furt her t est ing will r edu ce
un-necessary evaluation and risk.
The CAD-score can t hu s aid the decision t o
initiate additional ev alu at ion s or not , or t o
observe the pat ient fu rt her pr ior t o
addit ional ev alu at ions.
The pr esence of ot her pat ient risk fact or s
or conditions m ay in fluence t his decision.
Definit ions of CAD:
The CAD-score is t hus indicat ing risk of
having significant CAD, defined as having
≥50% lum inal diam et er r educt ion.
Two r isk cat egories ar e defined using t he
CADScor®Syst em :
The Negative ( NPV) and Posit ive ( PPV)
predict ive valu es vary wit h t he prev alen ce
Significant CAD
I nsignificant CAD
Non-CAD
≥50% lum in al
diam et er
redu ct ion by CAG.
< 50% lum i nal
diam et er r edu ction
by CAG or CCT
calcium > 0, or < 70%
lum in al area
redu ct ion.
Negat ive ( 0)
calcium by CCT
or no evidence
of lum inal
st enosis.
CAG: Coronar y An giogr ap hy ; CCT: Cor on ar y Com p ut ed
Tom ography
CAD-score ≤20
CAD-score > 20
Low risk
Elevated risk
9
of significant CAD in the investigat ed
populat ion.
At lower significant CAD prevalence ( e.g.
5- 20% ) in t h e in vest igat ed populat ion , t he
NPV increases. The NPV of t h e CAD-score
at or below 20, for ruling-out risk of
significant CAD in t he patient thus
increases by falling prevalence, r an gin g
from approxim at ely 92.3-98.3% at 5-20%
prevalence.
At higher sign ificant CAD pr evalen ce ( e.g.
30-40% ) in the investigated population,
the NPV decr eases. Th e NPV of the CAD-
score for ruling out significant CAD thus
decreases by increasing pr evalence,
rangin g from approxim at ely 87.5-81.8% at
30-40% prevalence.
A follow-up test, based on a CAD-scor e at
or below 20, can be done aft er t wo to five
years, if indicated.
At higher sign ificant CAD prevalence in t he
investigat ed population, the PPV increases.
The observed PPV of t he CAD-score above
20 for predicting significant CAD is 14.4%
(11.6-17.5% ) in a 1 0 .7% CAD prevalence
populat ion.
CAD Scor ®Syst em per form ance:
Significant CAD v s Ot h er ( Significant CAD
versus insignificant CAD and non -CAD
com bined) .
Algorithm ver. 3.2-US:
Sensit ivit y: 87.5% ( 79.2 -93.4% )
Specificit y: 37.5 % ( 34.2-41% )
Validation data CAD-prevalence: 10.7%
NPV: 96.2% ( 93.4-98% )
PPV: 14.4 % ( 11.6-17.5% ).
CAD/ CSS
Pr evalence %
NPV % *
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 clin ical dat a for
sen sit iv it y / specif icit y ab ov e at t h resh old ≤20.
10
5.6 Risk-Benefit for use
By using the CADScor ®Syst em for
evaluating pat ient risk of Coronary Art ery
Disease, a CADScor low risk of sign ificant
CAD can help to dir ect ot h er cause
evaluation decisions and also rem ove
unnecessary an x iet y .
Pat ien ts w it h a CADScor elev at ed risk of
significant CAD m ay be earlier recognized
and thus be diagnosed and enter
t reat m ent earlier.
By use of t h e CADScor®Syst em no risk s
ar e associat ed dir ect ly from use, ex cept in
rare cases where a slight transient skin
react ion towards the pat ch adhesive m ay
be observed.
I nform pat ient s who have CAD-score ≤20
t o seek m edical at tention if sym ptom s
per sist or worsen aft er init ial ev aluat ion .
The risk of a false negative r esult for a t rue
pat ient or a false positive result for a non-
CAD patient shou ld be t aken into
con siderat ion when ev aluat ing the pat ient .
11
5.7 I nt ended user profile
The CADScor ®System is int ended to be
operat ed only by r egist er ed nur ses,
clinical/ m edical laboratory t echnicians,
m edical doctors/ physicians af t er havin g
been instruct ed in t he proper operat ion of
the CADScor®Sy st em .
5.8 I nt ended pat ient populat ion
The CADScor ®System is int ended to 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 h e necessary qualifications,
and only aft er instr uct ion and having
read and underst ood t his User -Manual,
due to risk of death or serious injury.
The CAD-scores from pat ient s in t he 30-
39-year group are current ly out side t he
intended pat ient population. A warning
triangle indicat es the higher uncertainty
of their CAD-scores ( 8.14) .
12
5.9 I ndicat ions for use
The CADScor®Syst em is indicated for use
as a diagnost ic aid in sym pt om atic pat ient s
su spected of st able Coronary Art ery
Disease/ Chronic Cor onary Syndrom e.
Sym ptom s of CAD/ CCS m ay m anifest as*
Typical angina sym pt om s;
(all thr ee below)
• Sub-st er nal ch est discom fort of
ch ar act erist ic qu alit y and du rat ion;
• Pr ovok ed by ex ert ion or em ot ional
st r ess;
• Relieved by rest and/ or nit rat es wit hin
m in ut es.
At ypical angina sym pt om s;
(Two of the above)
N on-angin al chest pain;
Lacks or m eet s only one or none of t he
abov e charact erist ics.
Dyspnea/ br eathlessness
* as defined by ESC Guidelines 2019 &
NI CE UK Guidelines CG95, 2019.
13
5.10 Cont r a-indications for use
Asym pt om atic for angina or chest pain,
I m plant ed donor heart,
Pr evious Coronar y Art er y By pass Graft
(CABG),
Pr ev ious Coron ary st ent ing or known CAD
Arrhyt hm ia causing non-sinus rh yt h m ,
Fr agile or com prom ised skin,
or abnorm al anat om y or significant
operat ion scars in t he fourth 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 active elect ronics or active
elect ronic support equipm ent closer than
50 cm to t he CADScor ®Syst em .
The CADScor ®System has not been
validat ed as a screenin g t ool for Coronar y
Artery Disease/ Chronic Coronary
Syndrom e in asym ptom at ic populations.
Do not use t he CADScor ®Syst em on
pat ient s wit h im plan t ed elect r onics lik e
I CD, Pacem akers, heart -pum ps or closer
t han 50 cm to sim ilar active electronic
su pport equipm ent , du e t o risk of
equipm ent failure from
CADScor®Syst em electrom agnetic RFI D
im pulse.
14
5.11 I nt ended conditions of use
The CADScor ®System is int ended to be
used at m edical clinics and hospit als, at
room t em per at ur e an d below 2500 m et er
above sea lev el.
The patient shall be lying on the back on
an exam inat ion bed ( su pine posit ion)
during ident ificat ion of t he fou rt 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, appr oxim 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
together with a CADScor®Patch. Pat ches
are single-use only and should not be
m oved on the body aft er fir st adher ence. I f
a pat ch h as been m isplaced a new pat ch
m ust be u sed. The applied tim e of the
CADScor®Sensor (including pat ch) is
norm ally less t han 15 m in ut es.
Use the CADScor ®Syst em below 2500
m et ers.
Train t o ident ify left I C4 locat ion. Wrong
posit ion m ay influence r esult .
Do not at t em pt t o re-use a
CADScor®Pat ch. The pat ch is single use
only for hygienic reasons.
15
5.12 Sym bols used
Definit ions:
The CADScor®Syst em user m anual
con t ains sym bols, operat ional warnings
and caut ions, which ar e im port ant and
should be read and underst ood carefully
befor e per form ing t he r elat ed procedu res.
Sym bols and warnings are also found on
the CADScor®Sy st em , t he CADScor ®Pat ch
and t he syst em packaging boxes.
5.13 Sym bols on t h e CADScor® System
and in User m anual
W ar n ings: Describes a con dit i on or a
sit uat ion w here risk of death or serious
injury can occur.
Preca ut ion s: Describes a con dit ion or a
sit uat ion w here a non -serious injury can
occur to patient or user or dam age the
equipm ent or propert y.
Sym bol
Explan ation
Product code num ber.
Ser ial num ber
Warnings and precaut ions.
See description below (5.13-5.15).
I nstruct ion to Read user m anual.
I nstruct ion to Consult user
m anual.
Rx only
Caution: Federal law restricts t his
device to sale by or on the order of
a physician.
Magnetic Resonance I m aging room
unsafe
* /
I ndicat ion of a short diastole (*)
result or a not ice for result ( )
I PXX
Den ot es liq uid and dust ing ress
protection levels
Defining the Sensor as the Applied
part of CADScor®Sy st em
Manufactured by
/
Expiry date / single use of patches
The CADScor®Sy stem , w hen
reaching it s end of life, m ust be
collected and recycled separately
fr om ot her w ast e accord ing t o
nat ional requirem ent s ( Direct iv e
2012/ 19/ EU, WEEE).
16
5.14 Warnings
Warnings are alert s described t o alert an d
reduce t he risk of death or serious inj ury
from use of t he CADScor®Sy st em .
Warnings and precaut ions are labelled with
a warning triangle and also refers to t he
relevant section in the User Manual.
Pat ien t and user risk warnings:
Do not use t he CADScor ®Syst em
without the necessar y qualificat ions,
and only aft er inst ruction and having
read and underst ood t his User -Manual,
including, sym bols, con t r a-indicat ions,
war nin gs an d pr ecaut ion s, du e t o ri sk of
deat h or serious inj ur y.
Do not use t he CADScor ®Syst em on
pat ient s wit h im plan t ed elect r onics lik e
I CD, Pacem akers, heart -pum ps closer
than 50 cm t o sim ilar act i v e elect r oni c
support equipm ent , du e t o r i sk o f
equipm ent failure from
CADScor®System el ect r om agn et ic RFI D
im pulse (5 .10; 6.4) .
Do not at t em pt t o re-use a
CADScor®Pat ch. The pat ch is single use
only for hygienic reasons, to prevent
possible cross con t am inat ion/infection
bet ween pat ient s (5.11; 8.7) .
The CADScor ®System an d pat ch es ar e
MRI -unsafe an d should not be operat ed
or placed in a Magnetic Resonance
I m aging ( MRI -) r oom , due t o risk of
sk in bu rns and/ or m agnetic att ract ion
and im pact ( 7) .
Never use other po wer ad apt or t han
supplied wit h t he CADScor®Syst em , due
to risk of electrical shock ( 5.17 ) .
5.15 Pr ecaut ions
Pr ecaut ions are alert s t o redu ce pot ent ially
hazards situations or risks of non-serious
17
injury or reduced effect iv eness from use of
the CADScor®Sy st em .
Risk of incorrect CAD-score:
I ncorrect placem ent of the 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
sy m pt om s per sist or worsen aft er in it ial
evaluation” , due to t he risk of a false
negative CADScor result (5.6) .
The CAD-scores from pat ient s in t he 30-
39-year group are current ly out side t he
intended pat ient population. A warning
triangle indicates the higher uncert ainty
of their CAD-score (8.14).
Risk of dam age t o t he CADScor®System :
Do not touch the charge-point t erminals
on the CADScor ®Syst em , due to risk of
per m anent dam age t o t h e elect ronics
inside by elect rostat ic discharge ( 5.17-
5.18)
Do not dr op or exert excessive force t o
the CADScor®Syst em since this m ay
dam age t he CADScor®Syst em
perm anently (6. 1) .
Do not ex pose t h e CADSco r ®Syst em to
liquids (wat er, oils, detergents or
sim ilar) or dust , since this m ay dam age
the CADScor®Sy st em per m anent ly (10) .
The CADScor®Syst em cannot be heat-
or radiation st erilized, or m achine
washed/ cleaned, since this m ay dam age
the CADScor®Sy st em per m anent ly (10) .
Do not m odify t he CADScor ®Sy st em or
use or repair a defect CADScor®Sy st em ,
due to risk of m alfun ct ioning. The
CADScor®System must only be serviced
by qualified Acarix per so nn el ( 10) .
18
5.16 CADScor ®Syst em unboxing
Place t he box on a t able an d open it as
shown in figure below.
Establish t he
con t ent of the
CADScor®System
box ( one each) :
• CADScor ®
Sensor.
• CADScor ®Docking st at ion .
• A box cont aining a power adapt or
plus count r y specific plug.
• A box in the lid holding;
• a User Manual,
• a separat or t ool to separat e t he
back plat e from the top part of t he
Docking st ation and
• a dr illing tem plate for m ount ing t he
Docking st at io n on t h e w all.
19
The CADScor ®System is pre-assem bled in
deskt op posit ion .
Lift the CADScor ®Syst em from the syst em
box by holding t he syst em at t he edges of
the alu m inium plat e of t he Docking st at ion.
Place CADSco r ®System on st eady surface.
I nspect the CADScor®System for possible
t ransport dam ages.
Take ou t t he box cont ainin g the power
adapt or and su pplied plug. Assem ble
power adapt or unit by pressing the plu g
firm ly onto t he power adapt or until clicked
securely into place. No volt age
adj ustm ent s are needed for t he power
adapt or.
Never use other power adapt or t han
su pplied w it h t he CADScor®Syst em , due
to risk of electrical shock.
Finally t ak e out t he lid box cont aining the
user m anual, separ ation key and drill
t em plate.
20
5.17 The CADScor® Sensor
The CADScor®Sensor is the part t o recor d
heart sounds at t he four t h left I nt er Cost al
region and t o calculat e the CAD-score
based on t he acou st ic r ecor din g.
The sensor has one physical but t on, a
touch display and a sensor head ext ending
on a flexible arm from the sensor body
(see figure at right ) .
The push but t on has sev er al fun ct ions
when pressed or pressed an d h eld for
ext en ded tim e.
Press
Function
Beep
1x
Turn sensor on
-
2x
Cancel on-going
recording
Triple beep
3x
Ent er Set tings m enu
-
Hold>
4 sec
Forced qualification
Single beep
Hold>
8 sec
Sensor off and reset
Double beep
Main com ponent s of t he CADScor®Sensor,
top/side view.
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