Sanitas SPO25 User manual

Contents

1. lncluded

in de|ivery.........................

2.

Intended

use...........................

.

. ....... .. ..

3.

Gertirg To k'ow

your

device

4. Slgns

and symb01s............

5. Warnings

and safety notes

9. Evaluating

measurement

resu|ts................

30

1 0.

Maintenance/ciean

nq ...............................

32

1 1. Storage......................................................32

12. Disposa.....................................................32

'13.

What if there

are

problems?......................

34

1 4. Technical

Data...........................................

gs

1 5. Watranty/Service

centre...................,.......

07

6.

U^it description...

7. Init

al use

.20

.21

.24

.27

.28

.29

8. Operation

Please

read

these lnstructions

carefully

and keep them

for later

use. Be

sure to make

them

ac-

cessibie to

other users

anci observe

the lnformation

thev contain.

l.lncluded

in

delivery

'1x

SPO

?5

pulse

oximeter

2x

1 .5 V AAA

batteries

1

x These

instructions for

use

2.

lntended

use

Only

use the

SPO

25

pulse

oximeter

on humans

to measure

the

arteral oxygen

saturation

(SpOr)

of haemoglobin

and

the heart

rate

(pulse

rate). The

pulse

oxlmeter

isiuitabie

for

private

use

(at

home,

on the

go)

as well

as for use

in the medical

sector

(hospitals,

rnedical

establish-

ments).

3.

Getting to

know

your

device

The

SPO 25

pulse

oximeter

provides

a non-invasive

measurement

of the

arterial oxygen

saturation

(Spor)

and the heart

rate

(pulse

rate).

oxygen

saturation

indicates

the

peic-entage

of

haemoglobin

in

adenal

blood that

is loaded

with oxygen.

Therefore

it is

an important

parair-

eter for

assessing

the

respiratory

{unction.

To take

a measurement,

the

pulse

oximeter

uses

two

rays of light

wlth

differing

wavelengths,

which

strike

the finger

inserted

inside the

housing.

A low

oxygen

saturation

varue

generailt

indicates

underlying

irlriesses (respiratory

diseases,

"

asthma,

heart fai

ure

etc,).

People

with

a low

oxygen

saturation

value are

more likely

to experience

the iollowing

symp_

toms:

shodness

of breath, increased

head rate,

weakness,

neryousness

and

outbreiki

oi

sweating.

lf

oxygen

saturation is

known

to be chronically

drminished,

it requires

monitorlng

us-

ing

the

pulse

oximeter

under

medical

supervision.

rfyou

have

acutery

dimihisned

oxygen

iatu-

ration,

with.or

without the

accompanying

symptoms,

you

must consult

a doctor imme'diatety

as it could

lead to

a life{hreatening

situation. The

pulie

oximeter

is

pafticularly

suitable for

patients

at risk

such as

peopre

witi

head

disease

or asthma,

but

ar;;for

athl6tes

and neitthy

people

who

exercise

at high

altitude

(e.g.

mountaineers,

skiers

or amateur

pilots).

4.

Signs

and

symbols

The following

symbols

are

used in these

lnstructions

for

use,

on the

packaging

and on the

type

plate

for the

device:

WABNING

Warning

instruction

indicating

a risk of injury

or

damage

to health

A

IMPORTANT

Safety note

regarding

potential

for

damage to the

device/accessories

,/a\

U'

Note

on important

information

@

Observe the

instructions

for use

%SpO, Aderial oxygen

saturation

of haemoglobin

(in percent)

-..tr*'*e

Permissible

storage

temperature

and humidity

,,..t-"^9*

Permissible

operating temperature

and humidity

PR bpm Pulse

rate

(beats per

minute)

\€a

/4,

I

Disposal

in accordance

with

EC Directive

WEEE

Waste

Electrical

and Electro"

nic Equipment)

Do

not

dlspose

of

batteries

containing

hazardous

substances

with

household

waste.

nI

[,4

an ufact

u rer

m

Application

pad,

type

BF

N

Serial number

C(

0483

I.-9E^l*:!ilg:.flfies.rhat

the

producr

compties

with the

essentiat

require_

ments

ot ljirective

93/42/EEC

on medical products,

d

Date

of

manufacture

^

Alarm

suppression

tP

22

Device protected

against

foreign

objects

> 12.5

mm

and

against

faltrng

Orops

of water

5. Warnings

and

safety

notes

Read these

instructions

for

use

carefully.

Non-observance

of the following

information

may

result

in

personal

njury

oi

material

damage.

store these

instructions

for

use and

make them

accessible

to

other users,

Make

sure

you

include

these lnstructions

for use when

handing

over the

device io third

parties.

A

/!\

WARNING

'

check

to ensure

that the

packagecontains

all the

parts

that

should

be included

in the

delivery.

'

check the

pulse

oximeter

regularly

before use

to ensure

that there

is no

visible

damage

to

the

device

and the

batteries

are

still sulficienfly

charged.

ln

case of

doubt,

do not use-the

device

and contact

customer

services

or an

authoris;d retailer.

'

Do

not

use any addilional

pads

that

are not recommended

by the manufacturer

or offered

as equipment.

'Undernocircumstancesshouidyouopenorrepairthedeviceyourself,asfaulilessfunc-

tionality

could_no longer

be

guaranteed

thereafter.

Failure

to comply

wlll result

in voiding

of

the

warranty,

For repairs,

please

contact

customer

services

or an authorised

retailer.

Do NOT

use the

pulse

oximeter

-

if

you

are allergic

to rubber

products.

-

if the

device

or the finger

you

are using

is damp.

-

on small

children

or babies.

*

during

an lvlFl

or CT scan.

-

whjlst

taking

a blood

pressure

measurement

on the

same

arm using

a cuff.

-

on fingers

that have

nail varnish

on,

are dirty

or have

a

plaster

or otler

dressing

on them.

-

on large

fingers

that do

not fit into

the

device easily

(fingerlip:

width

approx. , )0

mm,

thickness

>15

mm).

-

on fingers

with

anatomical

changes,

oedemas,

scars

or

burns.

-

on flngers

that

are too

small,

as with

small

ctriloren

tor

eiim[tl

lwidtn

approx,

<

10 mm,

thickness

<

5 mm).

-

on

patients

who

are not

steady

at the

site

of

application

(e.g.

trembling).

-

near

flarnmable

or explosrve

qas

mixtures.

'

usrno the

device

for rono

oeriors

may

cause

parn

for

peopre

witr-

circJratory

oisorders.

There'ore

oo

not

use

tn6 oulse

oxirneter

for Jonger

t6Jn

uioior.'Z

5orrs

on

one t.nger.

.

The putse

o\i.neter

disptays

a cJrren,

;";r;;;.i;illin"J

o.

u."o ror

continuous

rnonitorino

'

The

pulse"oximeter

does

not

have

an

ararm

function

and

is therefore

not suitable

for

evaru-

ating

med

cal results.

'

Do

not

seltdiagnose

or serf-medicate

on

the

basis

of

the

measurements

without

consurtino

your

doctor.

ln

particular,

do

not

start

takjng

"ny

ne*

,"oicii,on;;

;;;il

fliliy#;;i;Y

^

!9Wg

ot,a1y

exist;ng

meoicat,or

w.tnout

[rioi

appiou"r.

*

-

"

'

Do

not look

direcflv

inside

the housing

during

the

irieasurement.

The

red right

and the

invis-

-

rbre

infra

red

tighl

.il

the

purse

oxtmet6r

a,e n"a;;j;

i"

;;r;;;;;.

'

rnrs

devlce

is

not

intended

for

use

by

peopje (incr,Loin[

chirdienl

w,th

.estr;cted

physicar.

sensory

or

mentar

skilrs

or a lack

of experience

and/oia

rack

of

inowredge,

unr.isitnev

lre

supe'v,sed

by

a

person

who

has..esponsio,,rty

ror

1116;..u1.,r;liniy

ra.",ua

instructions

from

this

person

on how

to

use

the

device.

c6',oren

inoJJ,i".up"*i..o

around

tne

de-

v:ce

io

ensure

they

do

not

plav

witn it.

.

Neither

of the

d

splays

for the

pulse

wave

and

pulse

bar

allows

the

strength

of the

pulse

or

crrculation

to

be

evalJated

at the

measurenreni

srte.

Rather.

they

iri

exct-us,vely

udeO

to

drsDlay

the

currenr

vrsuar

signar

variarion

at ,1"

""i.ui"reni

iiiino

oo

not

enabre

.errabre

diagnostics

for

the

pulse,

Non-observance

of

the

foliowing instructions

can

Iead

to incorrect

or failed measuremenls.

.

There must not

be any nail varnish,

artificial

nails or other

cosmetics on the finger

to be

measured.

.

Ensure that

the finger nail

on the finger to

be measured is

short enough that

the fingedip

covers the sensor

element in ihe

housing.

.

Keep

your

hand,

finger and

body steady

dur nq the measurement.

.

Fcr

people

with cardiac

arrhythmia, the

measurement values

of SpO,

and ihe heart rate

may

be

incorrect

or the

measurement

may not

be

possible

at

all.

.

ln cases

of carbon monoxide

poisoning,

the

pulse

oximeter

displays

a measurement value

that

is too high.

.

To avoid falsi{ying

the measuring

result, there

should not

be any strong light

sources

(e.g.

fluorescent

lamps or direct

sunlighl) in

the immediate

vicinity of the

pulse

oximeter.

.

People

with low blood

pressure,

who suffer from

jaundice

or

take

medlcation {or

vascular

contraction,

may experien0e

incorrect

or falslfied measuremenls.

.

lncorreci

measurements

are likely

for

patients

who have been

administered medical

dye in

the

past

or for those who

have abnormal

haemoglobin levels.

This

applies in

particulai

for

cases

of carbon monoxlde

poisoning

and methaemoglobin

poisoning,

which can

occur for

example from

the adminlstration

cf local anaesthetics

or from

an exlsting methaemoglobin

reductase

deficiency.

.

Protect

the

pulse

oximeter

from

dust, shocks,

moisiure, extreme

temperatures

and explosive

materia{s.

Display

description

5

1

?

1

Oxygen

saturation

(vatue

in

percent)

2.

puts"e

rate rviiue

in

oears per

mjnure)

|

f, zspoz

I

PRbpm

I I

i.

Purse

wave (prethvsmographic

wave)

-]r

gg,

6dj

5 Batreryreverindicator

aaaaa&aa

4i

7. lnitial

use

7.1

lnserting

the

batteries

'1.

Slide

the

battery compartment

lid open.

2.

Place the

two

batteries

supplied

in the

pulse

oximeter

as

shown. Ensure

that

the

c0rrect

battery

polarity

is

observed.

3.

Close the

battery compartment

lid again.

When

positioning

the battery

compartment

lid,

ensure that

the

points

of the

arrows

are

pojnting

at

each other.

8.

Operation

'1

, lnsert

one finger

into

the

finger

opening

of the

pulse

oximeter

as shown

an-d

hoid

it stlaOy.

2, Press

the

function

button.

The

pulse

oximeter

Degtns

rts

measurement.

Do rot

move

during

the

measurement.

3.

Your

measurement

values

will

appear

on

the

screen

afier

a tew

seconds.

@*o."

sen

you

remove your

finger from

the

purse

oximeter,

the

device

wiil

automaticaily

switch

off

atter

aoorox,

five seconds

Function

button

The function

button

on the

pulse

oximeter

has a three functions

in total:

.

Switch-on

function: When

the

pulse

oximeter

is

switched off

you

can hold

down the func-

tion

button briefly to

switch

it on.

.

Display

function:

To

select

your

desired display

format

(vertical

format,

horizontal

format),

hold down

the

'function

button

briefly

during operation.

.

Brightness

function:

To

select

your

desired

display brightness,

hold

down the function

but-

ton

for slightly

longer

during operation.

9. Evaluating

measurement

results

A

/I\

WARNING

The

following

table for

evaluating

your

measurements

does Nor

apply to

people

with

certain

pre-existing

conditions (e.9.

asthma, heart

failure, respiratory

diseales)

or whil;t

staying at

al:

titudes

above

1 500 metres.

lf

you

have

a

pre-existing

condition,

always consult

your

oo-ctor

to

evaluate

your

measurements

SpOz

{oxygen

saturati.

on}

measurement in

o/o

Classification/measures

to

be taken

oo o/

Normal range

93-90

Decreased

range: visit to

the doctor

recommended

<90

Critical range

Seek medical

attention

urgently

Decline

in

oxygen

saturation

depending

on

altitude

@*o,"

If P]9]]iglltg,

informs you

of the

effecrs

of various

aititudes

on

oxygen

saturarion

vatue

::^" l1:]T!3:19., lhe

human

body.

The

foilowins

tabte

does

NOT

appty to

peopte

wirh

cerlain

pre-exrslrng

conditions

(e.q.

asthma.

heart

fairure..respiratory

diseases'etc.j.

e,i"pr"

*iil

pie_

existing

conditions

can show

signs

of illness (e.g.

hypoxia)

jt

to*"i

jtitro"s

so-urce:.Hackett

PH,

Roach

Rc:

High-Artitude

i,4edicrne.

rn:

Auerbach

ps

(ed):

wirJerness

r\.4edicine,

3rd

edition;

l\4osby,

Si.Louis,

MO

1995:1-37.

31

Attitude

Expected

SpO,

value

(orygen

saturation)

in %

lmpact

on

human

body

1

500-2500 m

>90

No

altitude

sickness (normally)

2500-3500

m

-90

Altitude

sickness,

acclimatisation

recom-

mended

3500-5800

m

<90

Very

f requent

altit,tde

sickness,

acclimatisa-

tion

absolutely

essential

5800-7500

m

<80

Severe

hypoxia.

onty

l;mited

length

of

stay

possible

7500-8850

m

<70

lmmediate,

acute

danger

to life

1

0.

Maintenance/cleaning

A

rueonmrur,

Do

not

use

high-pressure

sterilisation

on

the

pulse

oximeter!

Under

no

circumstances

should

you

noiO

tne

puLe

oximet-ei

under

water,

as this

can

cause

Iiqurd

to

enter

and

damage

the

pulse

oximetei.

'

c,rean

the-housing

and

the

interior

rubber

sudace

with

a soft

croth

dampened

with

medicar

alcohol

after

each

use.

'

lf

alowbatterystatusappea.sonthedisplayof

thepurseoximeter.cnangethebatteries.

.

lt

y.u

are,not going

to

use

the

pulse

oximeter

for

m.ir"

tnrn

one

,ontn.

remove

both

batter_

res trorn

the

dev;ce

to

avoid

possibte

teaking.

11.

Storage

A

/l\

tMPOBTANT:

Store_the,pulse

oximeter.in

a dry

piace

telative

hunidtty

<95

o/o).

lf rhe

humiditv

is

too

hioh it

may

sh.rten

the

se.vice

rrfe

of

rhe

pulse

oximeter

or damage

it.'stoieine puis;;;

iliJil

;

place

where

the

ambient

temperature

is

between

_+0"C

an"o

60"C.-

-

12.

Disposal

Notes

on handling

batteries

'

lf

your

skin

or

eyes

come

into

contact

with

battery

fluid,

flush

out

the

atfected

areas

with

water

and

seek

medical

assistance.

'

A

crr9r11.g

hazardr

smail

chirdren

may

swailow

and

choke

on batteries.

store the

batte-

ries

out

of the

reach

of small

children.

.

Observe

the

plus

(+)

and minus

(-)

polarity

signs,

.

lf a battery has leaked,

put

on

protective gloves

and clean

the

battery compadment

with

a

dry

cloth.

.

Protect the batteries from excessive heat.

.

I

Risf ot exptosion!

Never throw

batteries

into

a

fire.

.

Do not charge or short-circuit batteries.

.

lf the device

is

not

to

be used for a long

period,

take the batteries out of the battery com-

partment.

.

Use identical or equivalent battery types only.

.

Always replace all batteries at the same time.

.

Do not use rechargeable batteries.

.

Do not disassemble, split

or crush

the

ba'iteries.

Battery disposal

.

The empty, completely flat ba'tteries must be disposed of through

specially designated

collection boxes, recycling

points

or electronics

retailers.

You are legally required to dispose

of the batteries.

o

The codes below are

printed

on

balteries

containing harmful

substances:

Pb

=

Battery

contains

lead,

Cd

=

Battery contains cadmium,

Hg

=

Battery

contains

mercury.

33

General

disposal

For,environmental

reasons,

do

not

dispose

of the

device

in the

housef

66[:$lillil[r:m*[.*ltlt1,,r"',,nrn:E,1.ffi

ilrtli,ilflJ."]tE

Electronic

Equipment)

rf

vou have

any

questi*.,

piii."

.*t"Jiiti'Lcar

aut:orities

respon-

sible

for

waste

disposal.

-

13.

What

if there

are

problems?

Problem

'Fo$sible:crisa

Solution

The

pulse

oximeter

is

not

displaying

measurement

values

The

batteries

in

the

pulse

oximeter

are

empty.

Replace

the

batteries.

Batteries

not

inserted

correctly.

Heinset

the

batteries.

lf

after

reinserting

the

batteries

correcfly

there

are stjlt

no

measurement

values

displayed,

contact

customer

seruices

Problem

Possible cause Solution

The

pulse

oxime-

ter is displaying

measurement in-

terruptions

or high

measurement

value

iumps

lnsuff icient circulation

in

the measurement finger

Observe

the warnings and safety

notes

in chapter 5

Measurement finger is

too large or too small

Fingertip must have

the following

measurements: Width between

1

0

and

22mm

Thickness between 5 and 15 mm

Finger, hand or body

is

movrng

Keep

your

finger, hand and body still

during the measurement.

Cardiac arrhythmia

Seek medical attention

14. Technical

Data

Model no. SPO 25

Measurement

Non-invasive measuremenl of arterial oxygen saturation of

haemoglobin

method and

pulse

rate in finger

Measurement SpOz0-'100%,

ranqe Pulse 0

-

254 beats/minute

Accuracy SpOz 70

-100a/0,

x2%,

Pulse 30-250 bpm, t2 beats/minute

Dimensions

L

61

mm x W 36 mm x H 32 mm

I'tignt

n

3i3*"o

""ut".

nuo

tigrrt

ru::f,i:ffi'

r'ii!.!1J[3ll*iiH;iiiE:H:#t1:*:[t*1Xr,l,r1:xl*.-,r,r.q,*

"urti"..

*-it"r*"riur?tll

i"li#lil

!l"ndard

EN60601-1-2

ano

rs

suojecli

to

ilrtrcurar

pre-

HF

co.nmunicatLi;;t;;#:i"9191c

compatibilitv

Rtease

note

tirii'lo;;1.";;;ft[ii

the

stated

cr.i"r.i's.;rj".

riXll]:'t-"|.9

with

this

unit. l\.4ore

details

."n

o" r"qu".1"jiioi

Ugf

,*f***Hjh11+,3;3pf,*/,,:l+;"If

l.ilH,iltrrifl

'ttj;fi::'-

essent,al

perrorran*

"i

p,r.J

"ij,"t.;;il;ffi1,,,?,?H:[::[,]:ltr.

basic

saretv

and

JO

1 5. Warranty/ Service

centre

We offer a 3-year

product

warranty from the date of

purchase

against

material and

production

faults. The warranty does not cover:

.

Damage due

to improper operation

.

Wearing

pafts

.

Cases of

personal

negligence

on

the

part

of the customer

.

The event that the device

has

been opened

by an unauthorised workshop.

The warranty does

not

affect

the

customer's statutory

rights. To assert a warranty claim within

the warranty

period,

the customer must

provide proof

of

purchase.

The warranty claim must

be submitted within a

period

of 3

years

from the date of

purchase

to Hans

Dinslage

GmbH,

Uttenweiler, Germany.

ln

case of complaints,

please

contact

our service department using the following con-

tact details:

Service

hotline

(free):

r@

Tel.:

0800 931

0319

@@Tel.: 1800939235

r@

Tel.: 800 626 05

lf requested,

please

send the faulty

product

to the following

address:

NU

Service GmbH

LessingstraBe

1

0 b

89231 Neu-Ulm

Germany

E-mail:

[email protected]

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c

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p

c

d

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5

a

37

Sanitas SPO25 User manual

Sanitas SPO25 User manual

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