Silvercrest SPO 55 Instructions For Use And Safety Notes

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Instructions For Use And Safety Notes
PULSE OXIMETER
IAN 290989
PULSOXIMETER
Gebrauchsanleitung und Sicher-
ПУЛСОКСИМЕТЪР
УУУУУУУУ УУ УУУУУУУУ У УУУУУУУУ УУ 
ΠΑΛΜΙΚΟ ΟΞΥΜΕΤΡΟ
УУУУУУУ УУУУУУ УУУ πУУУУУУπУУУУУУУУ 
PULSOXIMETRU
Instrucţiune de utilizare şi indicaţii 
PULSE OXIMETER
Instructions for Use and Safety Notes
GB / CY Instructions for Use and Safety Notes Page 5
RO Instrucţiune de utilizare şi indicaţii de siguranţă Pagina 49
BG Упътване за употреба и указания за безопасност Cтраница 93
GR / CY Οδηγίε χρήση και προειδοποιητικέ υποδείξει Σελίδα 147
DE / AT / CH Gebrauchsanleitung und Sicherheitshinweise Seite 197
Before reading, unfold both pages containing illustrations and familiarise yourself with all functions of the device.
Înainte de a citi instrucţiunile, priviţi ambele pagini cu imagini şi familiarizaţi-vă cu toate funcţiile aparatului.
Преди да прочетете отворете двете страници с фигурите и след това се запознайте с всички функции на уреда.
Πριν ξεκινήσετε την ανάγνωση, ανοίξτε τι δυο σελίδε ε τι εικόνε και εξοικειωθείτε ε όλε τι λειτουργίε τη συσκευή.
Klappen Sie vor dem Lesen die beiden Seiten mit den Abbildungen aus und machen Sie sich anschließend mit allen Funktionen
des Gerätes vertraut.
98
65
%SpO
2
PRbpm
B
DC
A
1 2
3
4
5 6
7
9
8
FE
98
65
%SpO
2
PRbpm
HG
5 GB/CY
List of pictograms used ............................................................................................................................................................Page 6
Introduction ..................................................................................................................................................................................Page 9
Intended Use .............................................................................................................................................................................. Page 10
Function ......................................................................................................................................................................................Page 10
Improper Use .............................................................................................................................................................................Page 12
Parts Description ........................................................................................................................................................................Page 12
Scope of delivery .......................................................................................................................................................................Page 13
Technical Data ...........................................................................................................................................................................Page 14
Important Safety Notes ........................................................................................................................................................... Page 17
Battery Safety Notes..................................................................................................................................................................Page 21
Initial Use ....................................................................................................................................................................................... Page 23
Inserting / Replacing Batteries ...................................................................................................................................................Page 24
“HealthForYou” App / Web Version ........................................................................................................................................ Page 24
Use .................................................................................................................................................................................................... Page 24
Measurements ............................................................................................................................................................................Page 25
Transferring measurements via Bluetooth
®
...............................................................................................................................Page 26
Analysing Measurements .......................................................................................................................................................... Page 27
Altitude-Related Drop in Oxygen Saturation ...........................................................................................................................Page 28
Cleaning and Care......................................................................................................................................................................Page 29
Storage ...........................................................................................................................................................................................Page 30
Troubleshooting .......................................................................................................................................................................... Page 31
Disposal .......................................................................................................................................................................................... Page 33
Warranty / Service ..................................................................................................................................................................... Page 35
6 GB/CY
List of pictograms used
Warns of risks of injury or health hazards
Safety note related to possible damage to the product /
components
Safety notes
Instructions
Read instructions for use
7 GB/CY
%SpO₂
Arterial oxygen saturation of haemoglobin (in percent)
PR bpm Pulse rate (beats per minute)
Storage &
Transport
Permissible storage and transport temperature and humidity
Operation
Permissible operating temperature and humidity
Permissible storage, transport and operating pressure
Manufacturer
8 GB/CY
Applied part, type BF
Serial number
0483
The CE mark certifies compliance with the basic requirements of
Medical Devices Directive 93/42/EEC.
Improper disposal of batteries can harm the environment!
Mute alarm
IP22
Device protects against foreign matter ≥12.5 mm and against
water falling diagonally
9 GB/CY
b
a
Dispose of the packaging and pulse oximeter in an
environmentally friendly manner!
Pulse Oximeter
Introduction
Familiarise yourself with the pulse oximeter before using it for the first time.
Please carefully read the following instructions for use and the important
safety notes. Failure to observe the notes may result in personal injury or
property damage. Only use the pulse oximeter as described and for the indicated pur-
poses. Keep these instructions for use in a safe place. Include all documentation when
passing the pulse oximeter to third parties.
10 GB/CY
Intended Use
Only use the SPO 55 pulse oximeter on people to measure the arterial oxygen saturation
(SpO₂) of haemoglobin and the heart rate (pulse rate). The pulse oximeter is suitable for
private environments (at home) and healthcare (hospitals, medical facilities).
Any other use not specified above or modification of the pulse oximeter is prohibited and
may result in injuries and / or damage the pulse oximeter. The manufacturer assumes no
liability for damages caused by improper use.
Function
The SPO 55 pulse oximeter serves non-invasive measurement of the arterial oxygen
saturation (SpO₂) and the heart rate (pulse rate). The oxygen saturation indicates the per-
centage of haemoglobin in the arterial blood is loaded with oxygen. The respiratory func-
tion is therefore an important parameter of assessment.
11 GB/CY
The pulse oximeter uses two rays with different wavelengths which strike the finger inside
the housing to take measurements. A low oxygen saturation rate is primarily caused by
illness (respiratory illnesses, asthma, heart failure, etc.).
People with a low oxygen saturation rate often experience the following symptoms: short-
ness of breath, increased heart rate, impaired performance, nervousness and perspira-
tion. Chronic and known low oxygen saturation requires monitoring with your pulse
oximeter under medical supervision.
An acute low oxygen saturation, with or without symptoms, requires immediate medical
attention. This could be a sign of a life-threatening condition. The pulse oximeter is there-
fore particularly suited for high-risk patients such as persons with heart disease, asthma, as
well as for athletes and healthy persons in high altitudes (e.g. mounting climbers, skiers or
amateur pilots).
12 GB/CY
Improper Use
The pulse oximeter shows an instant measurement but cannot be
used for continuous monitoring.
The pulse oximeter does not have an alarm and is therefore not suitable for analysing
medical results.
Do not self-diagnose or self-treat based on the measurements without consulting your at-
tending physician. Do not start new medication without consulting a physician and do not
modify the type and / or dosage of current medications.
The pulse wave and the pulse bar do not allow an assessment of the intensity of the pulse
or circulation at the measured site but solely visualise the current signal visualisation at the
site measured, but does not allow certain pulse diagnosis.
Parts Description
1
Display
2
Function button
13 GB/CY
3
Finger opening
4
Battery cover
Display
5
Oxygen saturation (value in percent)
6
Pulse rate (value in beats per minute)
7
Pulse wave (plethysmographic waveform)
8
Pulse bar
9
Battery level
Scope of delivery
1 SPO 55 pulse oximeter
2 1.5 V AAA batteries
1 Set of instructions for use
14 GB/CY
Technical Data
Model no.: SPO 55
Measuring method: non-invasive measurement of the arterial oxygen saturation of
haemoglobin and pulse frequency of the finger
Measuring range: SpO₂ 0 – 100%,
Pulse 0 – 254 beats/minute
Accuracy: SpO₂ 70 – 100%, ± 2%,
Pulse 30 – 250 bpm, ± 2 beats / minute
Dimensions: 58.5 mm x 31 mm x 32 mm (L x W x H)
Weight: approx. 27 g (without batteries)
Sensor system for
measuring SpO₂: red light (wavelength 660 nm);
infrared (wavelength 905 nm); silicon receiver diode
15 GB/CY
Admissible operating
conditions: +10 °C to +40 °C, ≤ 75 % relative humidity, 700 –1060 hPa
ambient pressure
Admissible storage
conditions: -40 °C to +60 °C, ≤ 95 % relative humidity, 500 –1060 hPa
ambient pressure
Power supply: 2 x 1.5 V
AAA batteries
Battery life: 2 AAA batteries provide approx. 2 years of use at
3 measurements per day (60 seconds each).
Classification: IP22, applied part type BF
Expected service life: 3 years
Memory spaces: 100
16 GB/CY
Data transfer via
Bluetooth
®
wireless
technology: The pulse oximeter uses Bluetooth
®
low energy technology,
frequency band 2.402 – 2.480 GHz, the maximum transmitting
power distributed in the frequency band <20 dBm, compatible
with Bluetooth
®
4.0 smartphones /tablets
For a list of compatible smartphones, information about the
HealthForYou app and software, and further details about the
devices please visit: www.healthforyou.lidl
System requirements of
the „HealthForYou“
web version - MS Internet Explorer
- MS Edge
17 GB/CY
- Mozilla Firefox
- Google Chrome
- Apple Safari
(respective current versions)
System requirements of
the „HealthForYou“ App iOS version 9.0 and up, Android
TM
Version 5.0 and up,
Bluetooth
®
4.0.
The serial number is located inside the battery compartment.
Technical specifications subject to change without notice due to updates.
Important
Safety Notes
This product is not intended to be used by persons (including children)
with physical, sensory or mental impairments or lacking experience and / or knowledge
18 GB/CY
unless supervised or instructed on its use by a person responsible for their safety. Children
should be supervised to ensure they do not play with the device.
Do NOT use the pulse oximeter
- if you are allergic to rubber products.
- if the device or the respective finger is moist.
- on toddlers or infants.
- during an MRI or CT scan.
- on the arm with the cuff whilst measuring the blood pressure.
- on fingers with painted nails, dirt or adhesive bandages.
- very large fingers which cannot easily be inserted in the device without using force
(fingertip: width approx. > 20 mm, thickness approx. >15 mm).
- on fingers with anatomic deformities, oedemas, scars or burns.
- on too small of fingers such as in toddlers (width approx. < 10 mm, thickness approx.
< 5 mm).
- in areas the patient is restless (e.g. trembling).
19 GB/CY
- near flammable or explosive gas mixtures.
Prolonged use of the pulse oximeter may cause pain in persons with circulatory
disorders. Therefore do not use the pulse oximeter on the same finger for longer than
approx. 2 hours.
Do not look directly into the housing during measurement. The red light and the
invisible infrared light of the pulse oximeter is harmful to the eye.
Failure to observe the following instructions may result in faulty or failed measure-
ments:
- Do not use nail polish, artificial nails or other cosmetic on the monitored finger.
- Be sure the fingernail on the monitored finger is short enough
so the finger pad covers
the sensor elements inside the housing.
- Keep the hand, finger and body still during measurement.
- Oxygen saturation and heart rate measurements may be false or impossible in
persons with arrhythmia.
20 GB/CY
- The pulse oximeter will display high measurements when carbon monoxide poison-
ing is present.
- To prevent false readings, keep bright light sources (e. g. fluorescent lamps or direct
sunlight) out of the immediate surroundings of the pulse oximeter.
- Measurements may be faulty or false in persons with low blood pressure, jaundice
or taking vasoconstriction medications.
- False measurements should be expected in patients who have received contrast
agents in the past, and in patients with haemoglobin abnormality. This particularly
applies to carbon monoxide poisoning and methaemoglobin poisoning caused by
e.g. local anaesthetics or due to methemoglobin reductase deficiency.
Protect the pulse oximeter from dust, shock, moisture, and extreme temperatures.
Keep out of areas with explosive substances.
Routinely inspect the pulse oximeter to ensure the device is not visibly damaged be-
fore use and the battery level is sufficient. When in doubt, do not use and contact
service or an authorised retailer.
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Silvercrest SPO 55 Instructions For Use And Safety Notes

Tip
Instructions For Use And Safety Notes