Hopkins 594810 Instructions For Use Manual

594810 Hopkins

Handheld Pulse Oximeter

Instructions for Use

Hopk ins Medic al Produc ts

PRODUCT INFO RMATION

Produ ct Name: Hopki ns Han dh eld Pu ls e Ox im eter
Produ ct Model : 5948 10
Manufac tu rer: H opkin s Medi ca l Prod uc ts
Addre ss : 6850 South be lt D ri ve

Ca le donia, M I 49 31 6 US A

REVISION HIS TO RY

This m anual ha s a r evisi on num be r. Th is rev is ion nu mber c hanges
wheneve r the m anual is u pd ated d ue to softwa re or t echni ca l
speci fic at ion ch ange. Conte nt s of th is m an ual ar e su bj ect to chang e
witho ut prior alarm .

■ Re vi sion n um ber: 1 .0

■ Re vi sion D at e: 7 /2 018

PREFACE

MANUAL P UR PO SE

This m anual co ntain s the i nstru ct ions n ec essar y to op erate the pr od uct
safel y and i n acco rd ance w ith it s fu nc ti on a nd int en ded us e.
Obser va nc e of this m anual is a prere qu is ite fo r pr op er p ro duct
perfo rm an ce a nd cor re ct o pe ration a nd e ns ures p atien t and
operato r safe ty.

This m anual is an i ntegr al par t of th e pr od uc t. I t shou ld alw ay s be kept
close to the equip me nt s o that it c an be o btained conve ni ently when
needed.

INTENDED AUDIENCE

This m anual is gea re d fo r clin ic al pro fe ssion al s wh o are e xpected to
have a worki ng kno wl edge o f me di cal pr oc edure s, pra ct ices a nd
termi no lo gy a s requ ir ed f or mon it or ing of cri ti cally ill pa ti ents.

ILLUSTRATIONS

All il lustrat io ns i n this manua l serve a s ex am ples o nly. The y may n ot
necessa ri ly r efl ect th e se tu p or data d is playe d on yo ur p ul se o xi me ter.

CONVENTIONS

■ It al ic t ex t is us ed i n this manua l to qu ote th e refe re nced c hapte rs or
secti on s.

■ [ ] is u sed to enclo se scr ee n te xt s.

■ → i s us ed to i ndicate opera ti onal p rocedur es .

Content s

1 Safe in fo rm ation .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .. ..

2 Symbo ls ....... .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .. ....... .

3 Intro du ction.. .. ..... .. ..... .. .. ..... .. ..... .. ....... .. ..... .. ..... .. .......

3.1 Wor kin g Pr inc ip le... ..... ..... ..... ..... .. ... .. ... .. ... .. ... .. ... .. ...

3.2 Inten ded Use ..... ..... .. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ..

3.3 Inc luded i n Pa cka ge ... .. ... .. ... .. ..... ..... ..... ..... ..... .. ... .. ..

3.4 Pro duct De sc rip ti on. .. ... .. ... .. ..... ..... ..... ..... ..... .. ... .. ...

3.5 Dis play Sc re en El em ent s. ... .. ... .. ..... ..... ..... ..... ..... .. ..

4 Batte ry i ns talla ti on... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .. .

4.1 Bat tery Po we r... .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ..... .. ... ..

4. 2 Lo w ba tte ry i ndica tor... ..... ..... ..... .. ... .. ... .. ... .. ... .. ..... ..

4. 3 In st all t he B atter ies.. ..... ..... ..... .. ... .. ... .. ... .. ... .. ... .. .....

5 59481 0 op er ation .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... ..

5.1 Int roduc ti on. .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ..... .. ... .. ... ..

5.2 Turn o n the 594 81 0.. .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ..... .

5.3 Set up th e 59481 0.... ..... .. ... .. ... .. ... .. ... .. ..... ..... ..... .....

5.3.1 A djust p ul se Be ep Vo lum e. ... .. ..... ..... ..... ..... ..... ..

5.3.2 S elect P at ien t Type.. ..... ..... ..... ..... .. ... .. ... .. ... .. ... .

5.3.3 Set ala rm Limi t. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ...

5.3.3 .1 PR Hig h/ Low a la rm Li mi t.. .. ..... ..... ..... ..... ..... ...

5.3.3 .2 S et SPO2 L ow alar m Li mit .. ... .. ... .. ... .. ..... ..... ...

5.3.3 .3 S witch O N/OFF a larm Vol um e.. .. ... .. ... .. ..... ..... .

5.3.3.4 Alarm Silence Duration.............................................

5.3.4 When an Al arm Occ ur s.. .. ... .. ... .. ... .. ..... ..... ..... ....

5.3.5 RESET TO D EFAULT... ... .. ..... ..... ..... ..... ..... ..... .. .

5.4 SpO2& PR meas ureme nt ... .. ... .. ... .. ... .. ... .. ..... ..... ..... .

5.4.1 P lace se ns or on t he fi nge r of p ati en t.... ..... ..... .....

5.4.2 D ispla y de scr ip tio n. ... .. ..... ..... ..... ..... ..... ..... .. ... ..

5.5 Alarms ..... ..... ..... .. ... .. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ...

5.5.1 Alarm C atego ri es. .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ..

5.5.2 Alarm L evels .. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ..... .....

5.5.3 Alarm I ndica to rs. .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ....

Physi ol og ical Ala rm M essag es .. ... .. ... .. ... .. ... .. ... .. ..... ....

Technical Al ar m Messa ge s.... ..... .. ... .. ... .. ... .. ... .. ..... ..... .

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5.6 Measu remen t Limit at ion s. ... .. ... .. ... .. ..... ..... ..... ..... ...

6 Summa ry o f Sp o2 & puls e ra te accu ra cy testin g. ..... ..

7 Maint en ance... .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .. ...

7.1 Clean ing.. ..... ..... .. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ....

7.2 Safet y Check s.... ..... .. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ...

7.3 Dispo sal.. ..... ..... .. ... .. ... .. ... .. ... .. ..... ..... ..... ..... ..... ....

8 Acc essorie s. ..... .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... ..

9 Speci fic at ions. .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .. ..

10 EMC in fo rm ation .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .

11 War ranty... ..... .. ..... .. ....... .. ..... .. ..... .. ....... .. ..... .. ..... .. ....

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1 Safety information

！

WARNING

WARNIN G: Expl os ion h az ard . Do n ot us e th e 59481 0 in the pr esenc e of

！

flamma ble ane st het ic s mix tu re wi th a ir, oxyg en, or ni trous o xide.

WARNIN G: Chem ic als f ro m a bro ke n LCD d is play pa nel are t oxic wh en

！

inges ted. Us e ca uti on w hen t he 5 948 10 h as a brok en disp lay pan el .
WARNIN G: Puls e ox ime tr y mea su rem en ts and pu lse sig nals ca n be

！

aff ec ted b y ce rta in e nviro nment al cond ition s, S PO2 s en sor a pp lic at ion
error s, and ce rt ain p at ien t co ndi ti ons. Se e the app ropri ate sec ti ons o f
this ma nual fo r sp eci fic s afe ty i nfo rm ation .

WARNIN G: The us e of a cce ss ori es , sen so rs, and c ables o ther th an

！

those s pecifi ed m ay re su lt in i nc rea se d emiss ion and /or cre ate inv al id
readi ngs of th e 59 481 0.
WARNIN G: Fail ur e to co ve r the s en sor s it e with op aque ma teria l in

！

high am bient l ig ht co nd iti on s may r es ult in in accur ate mea surem en ts.
WARNIN G: Do not s il enc e th e aud ib le al ar m funct ion or de creas e the

！

audib le alar m vo lum e if p ati en t saf et y could b e compr omise d.
WARNIN G: Th e 59 481 0 is a p rescr iptio n devic e to be ope ra ted o nl y by

！

train ed pers on nel .
WARNIN G: Disp os e of ba tt eri es i n acc or dance w ith loc al ordi nance s

！

and reg ulati on s
WARNIN G: To ens ur e pat ie nt safe ty, do n ot p lac e th e 594 81 0 in an y

！

posit ion tha t mi ght c au se it t o fa ll on t he p atien t.
WARN ING: As wit h all me dic al equipm ent , car efully ro ute patient ca ble s

！

to re duce the po ssibility of p atient en tan gle ment or str ang ulation.
WARNIN G: Ensu re t hat t he s pea ke r is cl ea r of any ob struc tion an d

！

that th e speak er h ole s ar e not c ov ere d. F ailur e to do so co uld res ult
in an ina udibl ea lar m to ne.
WARNIN G: Disc on nec t th e 594 81 0 and S PO 2 senso r from th e patie nt

！

throu ghout m ag net ic r eso na nce i ma ging (M RI) sca nning . Induc ed
curre nt coul d po ten ti all y ca use b ur ns.

WARNIN G: To ens ur e acc ur ate per forma nce and p reven t de vic e

！

failu re, do no t su bje ct t he 59 48 10 to e xt reme mo istur e, such a s direc t
expos ure to ra in . Suc h ex pos ur e may c au se inac curat e perfo rmanc e or
devic e failu re .
WARNIN G:Do no t us e eit he r the 5 94 810 , SP O2 sens or, or cab les tha t

！

appea r damag ed .

WARNIN G:Do no t li ft th e 59 481 0 by t he se ns or or ext ensio n cable

！

becau se the ca bl e cou ld d isc on nec t fr om the 59 4810 an d the 594 810
may dro p on the
patie nt.

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WARNIN G:The 5 94 810 i s no t defi br ill at or-pr oof. Ho wever, i t may

！

remai n attac he d to th e pa tie nt t hro ug hout de fibril latio n or whil e an
elect rosur gi cal u ni t is in u se , but t he m easur ement s may be in accur at e
throu ghout t he d efib ri lla ti on an d sh ortly t herea fter.

WARNIN G:Use o nl y the S PO 2 sen so r and e xt ensio n cable s uppli ed by

！

Hopki ns Medi ca l Pro du cts . Do n ot co nn ect any d evice o ther th an a
Hopki ns-ap pr ove d SP O2 se ns or to t he s ensor c onnec tor.

WARNIN G: Th e 59 481 0 sh ould no t be used a djace nt to or st ac ked w it h

！

other e quipm en t. If a dj ace nt o r sta ck ed use is n ecess ary, the 5 948 10
shoul d be obse rv ed to v er ify n or mal o pe ratio n using t he confi gurat io n
in whic h it is to be u se d.

The med ical el ec tri ca l equ ip men t ne eds to be i nstal led and p ut into

！

servi ce acco rd ing t o EM C Inf or mat io n

Porta ble and m ob ile R F co mmu ni cat io ns equi pment c an affe ct me di cal

！

elect rical e qu ipm en t, re fe r to th e re comme nded se parat ion dis ta nce s
provi ded in EM C In for ma tio n

The use o f patie nt c abl e an d oth er a cce ss ories n ot supp lied by t he

！

manuf actur er m ay re su lt in i nc rea se d emiss ions or d ecrea sed
immun ity of th e eq uip me nt

The equ ipmen t sh oul d no t be us ed a dja ce nt to or st acked w ith oth er

！

equip ment, r ef er to t he r eco mm end ed s epara tion di stanc es prov id ed in
EMC Inf ormat io n

！

CAUTION

Cauti on:Fe de ral l aw ( U.S .A .) re st ricts t his dev ice to sa le by or on t he

！

order o f a physi ci an.

Cauti on: All c om bin at ion s of e qui pm ent mus t be in com plian ce with

！

IEC Sta ndard 6 06 01- 1- 1 sys te ms re qu ireme nts.

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2 Symbols

SET

IPX1

！

Rx onl y(U.S )

Direct Cur re nt (DC)

Atten ti on : Consul t acc ompan yi ng documen ts (t his manu al ).

Auxil ia ry ou tput con ne ctor

Power supp ly co nnect or

Alarm si le nc e

Setti ng bu tt on

Power butt on

Up butto n

Down butto n

Date of man uf ac ture

Seria l num be r

Safet y Cla ss II eq uipme nt

Type BF applie d par t, defibr il latio n pro tected

Resista nt to li quid ing re ss

Europ ea n com munit y rep resen ta tive

The foll ow in g definit io n of the WEEE lab el ap plies
to EU membe r sta te s only.Th is symbo l ind icates
that thi s pro du ct shoul d not be tr eated as ho us ehold wast e.

Cauti on & war ni ng

Feder al (U .S .) Law rest ri cts this de vi ce to sale by or on the
order of a ph ys ician

Non-ste ri le

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3 Introduction

3.1 Working Principle

The Pul se O xi meter w or ks by app ly ing a senso r to a p ulsat in g
arter io la r vascu la r bed. Th e sensor co nt ains a du al l ight sour ce
and photo d et ector. S ki n,bon e, t issue, an d ve ins nor ma lly absor b
a const an t am ount of l ig ht duri ng s ystole an d di astol e, a s blood
volume in cr eases a nd d ecrea se s. The ra ti o of ligh t ab sorbed at
systo le a nd d iasto le i s trans la ted into an o xy gen sat ur ation
measu re me nt. Thi s measu re ment is ref er red to as S pO 2.

3.2 Intended Use

The pul se o xi meter i s in dicat ed f or contin uo us or spo t ch eck
monitor in g of func ti onal ar te rial oxyg en s atura ti on (SpO2) a nd
pulse rat e of a dult pa ti ents in h os pitals an d cl inics .

WARNING: Do not make any cl in ical judgmen ts ba se d sol el y on

the 5948 10 . The 5948 10 is intend ed only as an adjun ct in patien t

！

asses sm en t. It must be use d in conju nc tion wi th cl in ical si gns and
sympt om s.

3.3 Included in Package

Quant it y Item

1 594810 pu ls e oxime te r

3 Al ka li ne “AA” s iz e, 1.5- vo lt batter ie s

1

1

594301 Y-Pr ob e SPO2 se ns or

Instr uc ti ons for U se

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3.4 Product Description

1

7

9

8

2

3

6

10

5

4

Display s cr een

1

Speak er

4

Lamp

7

10

Batte ry d oo r

High leve l Ala rm : the la mp fl ashes r ed .
Medium le ve l Alarm : th e la mp flash es y ellow.

NOTE

Low level Al ar m : the lam p li ghts ye ll ow w ithou t fla shing .

2

Power o n/ off

Set

5

Senso r co nn ector

8

3.5 Display Screen Elements

1

2

3

5

%SPO2 a re a of d ispla y

1

Pulse b ea ts p er minu te ( BPM)

3

area of dis pl ay
Pulse a mp li tude in de x signa l

5

inten si ty b ar

2

Measu re d %S PO2

Measu re d BP M

4

Perfu si on i ndex si gn al

6

inten si ty b ar

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3

Up/Do wn

Alarm s il en ce

6

Cord hole

9

4
6