ADC Diagnostix 2100 Manual

ADC®DiagnostixTM 2100
Fingertip P lse Oximeter
®
Directions
or Use
ADC
55 Commerce Drive
Hauppauge, NY 11788
ADC (UK) Ltd.
Unit 6, PO14 1TH
United Kingdom
Made in China.
tel: [phone]
toll ree: 1-800-232-2670
ax: 631-273-9659
www.adct day.c m
in [e-mail]
IB p/n 93-2100-00 rev 4 Printed in China
Warranty
Am rican Diagnostic Corporation (ADC®) warrants its products against d f cts in ma-
t rials and workmanship und r normal us and s rvic as follows:
1. Warranty s rvic xt nds to th original r tail purchas r only and comm nc s with
th dat of d liv ry.
2. Your Puls Oxim t r is warrant d for two (2) y ars from dat of purchas (all parts).
What is C vered: R plac m nt of parts, and labor.
What is N t C vered: Transportation charg s to and from ADC®. Damag s caus d
by abus , misus , accid nt, or n glig nc . Incid ntal, sp cial, or cons qu ntial dam-
ag s. Som stat s do not allow th xclusion or limitation of incid ntal, sp cial, or
cons qu ntial damag s, so this limitation may not apply to you.
T Obtain Warranty Service: S nd it m(s) postag paid to ADC®, Attn: R pair
D pt., 55 Comm rc Dr., Hauppaug , NY 11788. Pl as includ your nam and ad-
dr ss, phon no., proof of purchas , and a bri f not xplaining th probl m.
Implied Warranty: Any impli d warranty shall b limit d in duration to th t rms of
this warranty and in no cas b yond th original s lling pric ( xc pt wh r prohibit d
by law).
This warranty giv s you sp cific l gal rights and you may hav oth r rights which vary
from stat to stat .
This manual is available online in a variety o
languages, ollow the links or language options.
www.adctoday.com/care
To register your product visit us at
www.adct day.c m/register
FOR QUESTIONS, COMMENTS,
OR SUGGESTIONS CALL TOLL FREE:
1-800-ADC-2670
OR VISIT
www.adctoday.com/feedback
0197
Tr ublesh ting P ssible Pr blems
Pr blem P ssible Reas n S luti n
1. Fing r is not ins rt d corr ctly.
2. Pati nt SpO2 valu is too low to
b m asur d.
1. Fing r might not b ins rt d
d p nough.
2. Exc ssiv pati nt mov m nt.
1. No batt ry or low batt ry pow r.
2. Batt ry not install d corr ctly.
3. Th monitor may b damag d.
1. Th Oxim t r is automatically
pow r d off, wh n no signal
was d t ct d aft r 8 s conds.
2. Th batt ry pow r is too low
to op rat .
1. ERR 3 m ans th r d mission
LED is damag d.
2. Err 4 m ans th infra-r d
mission LED is damag d.
Err 6 m ans crystal damag .
Err 7 m ans all th mission LED
or r c ption dioxid is damag d.
SpO2% or puls
rat do not display
normally.
SpO2% or puls
rat is shown
unstably.
Th monitor cannot
b pow r d on.
Indication is
sudd nly off.
“Err 3” or “Err 4”
“Err 6”
“Err 7”
1. R try ins rting th fing r.
2. Th r is xc ssiv illumination.
3. M asur mor tim s. If you d t rmin th product
is working corr ctly, s your h althcar provid r
for an xact diagnosis.
1. R try ins rting th fing r.
2. Sit calmly and r try.
1. R plac batt ry.
2. R mov and r install batt ry.
3. Contact custom r s rvic c nt r.
1. Normal.
2. R plac batt ri s.
1. Ch ck th r d mission LED.
2. Ch ck th infra-r d mission LED.
3. R turn to S rvic C nt r
1. R turn to S rvic C nt r
1. R turn to S rvic C nt r
Display Typ : OLED Display
SPO2 display rang : 0-100%
PR Display Rang : 30-235 BPM
PR Display Mod : Bargraph
Data Updat Tim : < 15 s
LED Wavelengths
R d: 660nm
Infrar d: 940nm
Measurement range:
SPO2: 70-99% - 100% ±3%; s ≤70%
no d finition
Puls Rat : 30-235 BPM, ±2 bpm during th
puls rat rang of 30-99 bpm
and 2% during th puls rat
rang of 100-235 bpm.
Accuracy: ±2% on th stag of 80%-99%;
±3% on th stag of 70%-80%;
Accuracy: ±2 BPM or ±2% (larg r)
Puls Int nsity: Bargraph Indicator
Pow r R quir m nts: Two AAA alkalin Batt ri s
Pow r consumption: L ss than 40mA
D claration: EMC of this product comply with IEC60601-1-2 standard.
M asur m nt P rformanc in Low P rfusion Condition: r quir d th t st quipm nt (BIO-TEK INDEX Puls Oxim t r
t st r) th puls wav is availabl without failur wh n th simulation puls wav amplitud is at 6%.
Int rf r nc R sistanc Capacity against Ambi nt Light: D vic work normally wh n mix d nois produc d by BIO-TEK
INDEX Puls Oxim t r t st r.
Guidance and Manufacturer’s Declarati n
Electr magnetic Emissi ns
Guidanc and Manufactur r’s d claration - l ctromagn tic nvironm nt sp cifi d b low.
Th custom r or th us r of th PULSE OXIMETER should assur that it is us d in such an nvironm nt.
Emissi n Test C mpliance Level Electr nic Envir nment Guidance
RF Emissions CISPR11 Group 1 Th PULSE OXIMETER us s v ry low RF n rgy
only and is not lik ly to caus int rf r nc
to n arby l ctronic quipm nt.
RF Emissions CISPR11 Class B Th PULSE OXIMETER is suitabl for us
in all stablishm nts,including dom stic and
Harmonic missions Not applicabl thos dir ctly conn ct d to th public
IEC 61000-3-2 low-voltag pow r supply which pow rs
buildings us d for dom stic purpos s.
Voltag fluctuations/
Flick r missions Not applicabl
IEC 61000-3-2
Rec mmended Separati n Distance Between P rtable and M bile RF c mmunicati n equipment
and the Equipment r Systems
F r all equipment and Systems that are n t Life-Supp rting
Rec mmended separati n distances between p rtable and m bile RF c mmunicati ns equipment
and Pulse Oximeter
Th Puls Oxim t r is int nd d for us in l ctromagn tic nvironm nt in which radiat d RF disturbanc s ar controll d. Th
custom r or th us r of th Puls Oxim t r can h lp pr v nt l ctromagn tic int r f r nc by maintaining a minimum distanc
b tw n portabl and r comm nd d b low, according to th maximum output pow r of th communications quipm nt.
Rated maximum Separati n distance acc rding t frequency f transmitter (m)
Output p wer f
transmitter (W) 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.1167 0.2334
0.1 0.3689 0.7378
1 1.1667 2.3334
10 3.6893 7.3786
100 11.6667 23.3334
For transmitt rs rat d at a maximum output pow r not list d abov , th r comm nd d s partaion distanc (d) in m t rs (m) can b stimat d
using th quation applicabl to th fr qu ncy of th transmitt r, wh r (p) is th maximum output pow r rating of th transmitt r in watts (w)
according to th transmitt r manufactur r.
NOTE 1: At 80 MHz and 800 MHz, th s paration distanc for th high r fr qu ncy rang appli s.
NOTE 2: Th s guid lin s may not apply in all situations. El ctromagn tic propagation is aff ct d by absorption and r fl ction from structur s,
obj cts, and p opl .
Guidance and Manufacturer’s Declarati n - Electr magnetic Immunity
F r all Equipment and Systems
Guidanc and Manufactur r’s d claration - l ctromagn tic nvironm nt sp cifi d b low.
Th custom r or th us r of th PULSE OXIMETER should assur that it is us d in such an nvironm nt.
Immunity IEC 60601 C mpliance Electr nic
Test Test Level Level Envir nment Guidance
El ctrostatic Discharg +/- kV contact +/- kV Contact Floors should b wood, concr t , or c ramic til .
(ESD) +/- 8kV air +/- 8kV air If floor is cov r d with synth tic mat rial, th
IEC 61000-4-2 r lativ humidity should b
at l ast 30%.
Pow r Fr qu ncy Pow r fr qu ncy magn tic fi lds should b at
(50/60 Hz) Magn tic Fi ld 3A/m 3A/m l v ls charact ristic of a typical location in a typical
IEC 61000-4-8 comm rcial or hospital nvironm nt.
Guidance and Manufacturer’s Declarati n - Electr magnetic Immunity
F r all Equipment and Systems that are n t Life-Supp rting
Guidanc and Manufactur r’s d claration - l ctromagn tic nvironm nt sp cifi d b low.
Th custom r or th us r of th PULSE OXIMETER should assur that it is us d in such an nvironm nt.
Immunity IEC 60601 C mpliance Electr nic
Test Test Level Level Envir nment Guidance
Radiat d RF 3 V/m 3 V/m Portabl and mobil RF communications quipm nt should not b
IEC 61000-4-3 80 MHz to 2.5 GHz us d clos to any part of th Puls Oxim t r, including cabl s.
Th r comm nd d s paration distanc should b calculat d from
th quation applicabl to th fr qu ncy of th transmitt r.
R comm nd d s paration distanc
80MHZ to 800MHZ
800MHZ to 2.5GHz
Wh r P is maximum output pow r rating of th transmitt r
in watts (W) according to th transmitt r manufactur r
and (d) is th r comm nd d s paration distanc in m t rs (m).
Wh r P is th maximum output pow r rating of th transmitt r
in watts (W) according to th transmitt r manufactur r and d
is th r comm nd d s paration distanc in m t rs (m).
Fi ld str ngths from fix d RF transmitt rs, as d t rmin d by an
l ctromagn tic sit surv y. should b l ss than th complianc
l v l in ach fr qu ncy rang .
NOTE 1: At 80MHz and 800MHz, th high r fr qu ncy rang appli s.
NOTE 2: Th s guid lin s may not apply in all situations. El ctromagn tic propagation is aff ct d by absorption and r fl ction
structur s, obj cts and p opl .
A. Fi ld str ngths from fix d transmitt rs, such as bas stations for radio, (c llular/cordl ss) t l phon s, and land mobil radios,
amat ur radio, AM/FM radio, and TV broadcasts cannot b pr dict d th or tically with accuracy. To ass ss th l ctromagn tic n-
vironm nt du to fix d RF transmitt rs, an l ctromagn tic sit surv y should b consid r d. If m asur d fi ld str ngth in th
location in which th Puls Oxim t r should b obs rv d to v rify normal op ration. If abnormal p rformanc is obs rv d, additional
m asur m nts may b n c ssary, such as r ori nting th location of th Puls Oxim t r.
B.Ov r th fr qu ncy rang 150kHz to 80MHz, fi ld str ngths should b l ss than 3V/m.
Symb l Definiti n
Important Warning/Caution
Lat x-Fr
Equipm nt typ is BF
H moglobin Saturation
H art Rat (BPM)
Low Pow r Indication
Symb l Definiti n
Not for Continuous Monitoring
Conforms to EU Standards
Authoriz d Europ an R pr s nativ ’s
Information
Manufactur r’s Information
S rial Numb r
Symbol De initions
L w p wer indicati n:
Batt ry Lif : (2) ”AAA” 1.5V, 600mAh
alkalin batt ri s Can
op rat as long as
30 hours (continious).
Dimensi n:
L ngth: 2.3” (58mm)
Width: 1.3” (32mm)
H ight: 1.3” (34mm)
W ight: 1.8oz. (50g)
(including two AAA
batt ri s)
Envir nment:
Op ration T mp ratur : 41°F - 104°F (5°C - 40°C)
Storag T mp ratur : 14°F - 104°F (-10°C - 40°C)
R lativ Humidty: 15%-80% in op ration /
10%-80% in storag
Fing r Rang : .31” - .98” (.8cm-2.5cm)
Minimum W ight: 20lbs. (13kg)
Technical Speci ications

ADC®Fingertip Pulse Oximeter
Thank you for purchasing an ADC DiagnostixTM Brand Fing rtip Puls Oxim t r. W ’r
proud of th car and quality that go s into th manufactur of v ry product that b ars
our nam . With prop r car and maint nanc your DiagnostixTM Fing rtip Puls
Oxim t r will provid many y ars of d p ndabl s rvic .
Device Description and Intended Use
This d vic is int nd d for m dical diagnostic purpos s only. It is us d to indir ctly
m asur th functional oxyg n saturation (SpO2) of an adult or p diatric pati nt’s
blood. It is int nd d for us on fing rs with a thickn ss of .3” to .8” (6.6mm to
19.7mm). This is th distanc b tw n th fing rnail (top), and th fing r pad
(bottom). Functional oxyg n saturation r f rs to th ratio of oxyh moglobin to all
h moglobin that is capabl of carrying oxyg n. This oxim t r is not int nd d for
continuous monitoring. Th Puls Oxim t r r quir s no routin calibration or
maint nanc oth r than r plac m nt of batt ri s.
Puls oxim try combin s th principl s of optical pl thysmography and sp ctropho-
tom try to d t rmin art rial oxyg n saturation valu s. Optical pl thysmography us s
light absorbanc t chnology to r produc wav forms produc d by pulsating blood.
Sp ctrophotom try us s various wav l ngths of light to p rform quantitativ m asur -
m nts about light absorption. Photo l ctric Oxyh moglobin Insp ction T chnology is
combin d with Capacity Puls Scanning and R cording T chnology, so that two b ams
of diff r nt wav l ngths of light (660nm glow and 940nm n ar infrar d light) can b
focus d onto th human nail tip through a fing r-tip s nsor. Th s two LED’s ar cho-
s n b caus th light absorption vari s with th oxyg n conc ntration of h moglobin
in th s fr qu nci s. Th puls amplitud s of th r d and n ar infrar d signals ar d -
t ct d using photo l ctric s nsors and run through a microproc ssor which conv rts
th r adings to num rical valu s.
Contraindications:
• Th pati nt suff rs from significant l v ls of dysfunctional h moglobins (such
as carbonxy-h moglobin or m th moglobin).
• Intravascular dy s such as indocyanin gr n or m thyl n blu hav b n
inj ct d into th pati nt.
• Us d in th pr s nc of high ambi nt light (i , dir ct sunlight). Shi ld th
s nsor ar a with a surgical tow l if n c ssary.
• Th r is xc ssiv pati nt mov m nt.
• Th pati nt xp ri nc s v nous pulsations.
• Th pati nt has hypot nsion, s v r vasoconstriction, s v r an mia,
or hypoth rmia.
• Th pati nt is in cardiac arr st or is in shock.
• Pati nts hav fing rnail polish or fals fing rnails as th y may caus inaccurat
SpO2 r adings.
General Warnings
A warning stat m nt in this manual id ntifi s a condition or practic which, if not
corr ct d or discontinu d imm diat ly, could l ad to pati nt injury, illn ss, or d ath.
WARNING: B for us , car fully r ad th manual.
WARNING: Do not us th puls oxim t r in an MRI or CT nvironm nt.
WARNING: Th op ration of Puls Oxim t r may b aff ct d by th us of an
l ctrosurgical unit (ESU).
WARNING: F d ral law r stricts this d vic to sal by or on th ord r of a
physician or lic ns d h althcar practition r.
WARNING: Th puls oxim t r is int nd d only as an adjunct in pati nt
ass ssm nt. It must b us d in conjunction with oth r m thods of ass ssing
clinical signs and symptoms.
WARNING: Follow local ordinanc s and r cycling instructions r garding
disposal or r cycling of th d vic and d vic compon nts, including batt ri s.
CAUTION: D n t use the pulse ximeter in an expl sive atm sphere.
CAUTION: SpO2 and puls rat data is display d for informational purpos s only
and do s not constitut a diagnosis or m dical advic of any kind. Only a
qualifi d h althcar prof ssional should int rpr t th data obtain d on this d vic .
CAUTION: Ch ck th puls oxim t r s nsor application sit fr qu ntly to
d t rmin th positioning of th s nsor and circulation and skin s nsitivity of
th pati nt.
CAUTION: Th puls oxim t r is not for continuous monitoring.
CAUTION: Prolong d us or th pati nt's condition may r quir changing th
s nsor sit p riodically. Chang s nsor sit and ch ck skin int grity, circulatory
status, and corr ct alignm nt at l ast v ry 4 hours.
CAUTION: Inaccurat m asur m nts may b caus d by autoclaving, thyl n
oxid st rilizing, or imm rsing th s nsors in liquid.
CAUTION: Th d vic should not b us d on an xtr mity with a blood pr ssur
cuff, art rial cath t r, or intravascular lin .
Brie Description o Front Panel
Included Pulse Oximeter Accessories
• On (1) lanyard
• Two (2) AAA batt ri s
• On (1) us r manual
Battery Installation
1. R mov batt ry compartm nt cov r
by d pr ssing button on batt ry
cov r top, th n slid cov r in th
dir ction of th arrow, th n tilt
upward on hing .
2. Ins rt two AAA batt ri s into batt ry
compartm nt b ing sur to
obs rv th corr ct polariti s.
3. R plac th batt ry cov r by
r v rsing st p 1. (Figur 1)
N te: Be sure to obser e correct battery polarity. Failure to do so might
damage the de ice. If de ice will not be used for an extended period of time,
remo e batteries. Replace batteries when low battery symbol appears on
display. Always replace BOTH batteries at the same time
Operating Instructions
1. B sur to ins rt two AAA batt ri s b for att mpting to op rat .
2. Cl an insid surfac of oxim t r and pati nt’s fing r with isopropyl alcohol
b for us .
3. Squ z th nd opposit th pow r switch b tw n th thumb and for fing r
in ord r to op n th d vic (th r is a t xtur d surfac on th batt ry cov r
sid to facilitat grip) (Figur 2)
4. Ins rt pati nt’s fing r, nail sid up into th d vic . (b sur to fully ins rt th
pati nt’s fing r so that th s nsors ar compl t ly cov r d by th fing r.) Ind x
or middl fing r is r comm nd d.
5. R l as th d vic allowing it to clamp down on th pati nt’s fing r.
6. Pr ss th pow r switch on th front (top) pan l to activat .
7. Hav pati nt k p still for optimal accuracy
8. D p nding upon nvironm ntal and pati nt conditions, th d vic will b gin
to display r adings in about 4 s conds.
9. Not r adings on th display.
10. R mov th pati nt’s fing r from th d vic by squ zing b tw n for fing r
and thumb as indicat d in Figur 2.
11. Th display will indicat fing r out.
12. Th unit will pow r off approximat ly 10 s conds aft r th pati nt’s fing r is
r mov d from th d vic .
Changing Oximeter Display Mode
Th r ar six diff r nt display mod s. Th display mod s alt r th ori ntation of th
display to facilitat r ading by th obs rv r. Horizontal mod s display th puls wav
form along with SPO2 and puls rat whil v rtical mod s display a puls rat bar
graph along with th SPO2 and puls rat r adings.
To alter the display mode:
1. Aft r th unit is pow r d on ach bri f pr ss of th pow r switch will cycl
through to th n xt display mod in th s qu nc shown.
N te: th d fault s tting is display mod 1.
Display Mode Cycle
Alarm
On mod ls quipp d with an alarm, th alarm condition will app ar wh n:
SPO2 < 90% / PR <60 or >100bpm
If th unit is in display mod 1 (sil nt mod ), th param t r (SPO or PR) flash s and
an audibl b p is h ard if it xc ds th alarm condition. If th unit is in display
mod s 2-6 (audibl mod ), th unit will signal an alarm condition with both visual and
audibl al rts.
To sil nc th alarm ton for 30 s conds pr ss th pow r button twic during th
condition.
Changing the Display Brightness (10 adjustable brightness settings)
To change the brightness setting:
1. Aft r th unit is pow r d on, hold and d pr ss th pow r switch. It will cycl
through from BR4 up to BR10, th n start back at BR1.
N te: Th d fault s tting is l v l 4 (BR4).
Lanyard Attachment
1. Thr ad thinn r nd of th lanyard through th hanging hol at th r ar nd of
th d vic .
2. Thr ad thick r nd of th lanyard through th thr ad d nd b for pulling
it tightly.
Care and Maintenance
1. R plac th batt ri s promptly wh n low voltag indicator app ars.
2. Cl an surfac of th fing rtip and oxim t r with isopropyl alcohol b for it
is us d in diagnosis for pati nts.
3. R mov th batt ri s if unit will not b op rat d for xt nd d p riod of tim .
4. It is b st to stor this product in a plac wh r ambi nt t mp ratur is
-10°C -40°C(14°F -104°F) and humidity is 10%-80%.
5. It is r comm nd d that th product should b k pt in a dry nvironm nt at
all tim s.
6. Pl as follow local ordinanc s wh n disposing of batt ri s.
Cleaning the Pulse Oximeter
Cl an th rubb r touching th fing r insid of th Oxim t r with a soft damp n d cloth
with 70% isopropyl alcohol, and cl an th t st fing r using alcohol b for and aft r
ach t st.
N te: Do not pour or spray any liquids onto th Oxim t r, and do not allow any
liquids to nt r any op nings in th d vic . Allow th Oxim t r to dry thoroughly
b for r using.
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SpO2
Pulse Rate Signal
Intensity Bar Graph
Pulse Rate
Power Switch
Low Power
Indicator
SpO2
Wave orm
(Figur 2)
Handstand Horizontal
(4th click)
Normal V rtical
(5th click) Handstand V rtical
(6th click)
Normal Horizontal
Wav Display
(D fault S tting)
Normal Horizontal
Wir Display
(2nd click)
Normal Horizontal
(3rd click)
1
2
(Figur 1)