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
.20
.21
.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

AIMPORTANT
Safety note regarding potential for damage to the device/accessories
,/a\
U' Note
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
mApplication pad, type BF
NSerial 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,
dDate 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
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ru::f,i:ffi'
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"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.: [phone]
@@Tel.: [phone]
r@ Tel.: [phone]
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]
[email protected]
[email protected]
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