Silvercrest 290989 Instructions For Use And Safety

PULSE OXIMETER
IAN 290989
PULSOXIMETER Brugsvejledning og sikkerhedshenvisninger
PULSE OXIMETER Instructions for Use and Safety
PULSOKSYMETR
Instrukcja obsługi i wskazówki bezpieczeństwa
PULSOXIMETER Gebrauchsanleitung und Sicherheitshinweise
GB / IE / NI Instructions for Use and Safety Notes Page 5 DK Brugsvejledning og sikkerhedshenvisninger Side 49 PL Instrukcja obsługi i wskazówki bezpieczeństwa Strona 91 DE / AT / CH Gebrauchsanleitung und Sicherheitshinweise Seite 139
Before reading, unfold both pages containing illustrations and familiarise yourself with all functions of the device.
Før du læser, vend begge sidene med billeder frem og bliv bekendt med alle apparatets funktioner.
Przed przeczytaniem proszę rozłożyć obie strony z ilustracjami, a następnie proszę zapoznać się z wszystkimi funkcjami urządzenia.
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
%SpO2PRbpm
HG
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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
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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
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%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
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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
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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 pur­poses. Keep these instructions for use in a safe place. Include all documentation when passing the pulse oximeter to third parties.
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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 per­centage of haemoglobin in the arterial blood is loaded with oxygen. The respiratory func­tion is therefore an important parameter of assessment.
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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: short­ness of breath, increased heart rate, impaired performance, nervousness and perspira­tion. 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 there­fore 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).
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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 at­tending 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
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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
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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
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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
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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
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- 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
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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).
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- 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.
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- 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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Do not use additional parts not recommended or sold as accessories by the manu-
facturer.
Never open or repair the device or the proper function cannot be guaranteed.
Non-compliance will void the warranty.
Please contact service or an authorised retailer for repairs.
Battery Safety
Notes
DANGER TO LIFE! Keep batteries out of the reach of children. Seek immediate
medical attention if swallowed!
EXPLOSION HAZARD! Never recharge disposable batteries. Never
short-circuit and /or open batteries. The battery may overheat, ignite or explode.
Never throw batteries into fire or water.
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Never exert mechanical stress on batteries.
Risk of battery leakage
Avoid extreme conditions and temperatures which may affect batteries, e.g. radia-
tors / direct sunlight.
Avoid contact with the eyes, skin and mucous membranes! In the event of contact
with battery acid, flush the affected area with clean water and seek immediate medi­cal attention!
WEAR SAFETY GLOVES! Leaked or damaged batteries can cause
burns on contact with the skin. Therefore wear suitable safety gloves in this case.
In the event of a battery leak, immediately remove the batteries from the product to
prevent damage.
Only use the same type of batteries. Do not mix old and new batteries! Remove the batteries if the product will not be used for an extended period.
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Risk of product damage
Only use the specified battery type!
Insert the batteries according to the polarity marking (+) and (-) on the battery and
the product. Clean the contacts on the battery and inside the battery compartment before insert-
ing! Immediately remove drained batteries from the product. Do not use rechargeable batteries.
Initial Use
Verify the parts listed in the scope of delivery are complete. Remove all packaging material.
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Inserting / Replacing Batteries
Slide the battery cover 4 open (Fig. C). Insert the two included batteries (with the correct polarity) in the pulse oximeter
(Fig. D). Please note the marking inside the battery compartment.
Close the battery compartment 4 (Fig. E).
“HealthForYou” App / Web Version
Download the free app „HealthForYou“ from the Apple App Store and Google Play.
Follow the installation instructions on the screen. Alternatively, you can also visit the website at www.healthforyou.lidl.
Use
The function button 2 on the pulse oximeter has 4 functions:
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On
Press and briefly hold the function key
2
to switch the pulse
oximeter on.
Data, time and date synchronisation
With the product switched off, press and hold the function key
2
at least 5 seconds to transfer the data to the app.
Display function
Briefly press the function key
2
during use to adjust the display
format (portrait, landscape).
Brightness function To select your desired display brightness, hold down the function
button
2
for slightly longer during operation.
Measurements
Slide one finger into the finger opening 3 on the pulse oximeter. Hold the finger
still (Fig. F). Press the function button 2. The pulse oximeter will now begin the measurement.
Do not move during measurement (Fig. G). After a few seconds the display 1 will show your measurements (Fig. H).
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After removing your finger from the pulse oximeter, the device will automatically
switch off after approx. 10 seconds.
Transferring measurements via Bluetooth
®
Note: Bluetooth® turns on automatically. The „HealthForYou“ app must be activated for transfer. The time and date will be synchronised with the smartphone during every data transfer. To synchronise measurements with your smartphone via Bluetooth
®
:
Activate Bluetooth® in your smartphone settings and open the „HealthForYou“ app. Hold the function button 2 for 5 seconds with the device switched off. The display
1
will flash „SYNC“.
The device will attempt to connect to the app for 10 seconds. Once connected, „SYNC“ will stop flashing. The stored measurements will automatically be transferred to the app. The pulse
oximeter will then automatically switch off.
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Analysing Measurements
The following table for assessing measurements does NOT apply to persons with certain pre-existing conditions (e.g. asthma, heart failure, respiratory disor­ders) and in altitudes over 1500 metres. If you have a pre-existing condition, always consult your physician to analyse your measure­ments.
SpO₂ (oxygen saturation) measurement in %
Classification / required action
99 - 94 Normal range
93 - 90 Low range: medical consultation recommended
< 90 Critical range: medical consultation urgently
required
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Altitude-Related Drop in Oxygen Saturation
Note: The following table provides information on how different altitudes affect the oxygen
saturation and how this affects the human organism. The following table does NOT apply to persons with certain pre-existing conditions (e.g. asthma, heart failure, respiratory disorders, etc.). Persons with pre-existing conditions may already experience symptoms (e.g. hypoxia) in low altitudes.
Alti­tudes
Expected SpO₂ value (oxygen saturation) in %
Affects on people
1500– 2500 m
> 90 No anoxia (typically)
2500– 3000 m
~
90 Anoxia, acclimatisation recommended
Source: Hackett PH, Roach RC: High-Altitude Medicine. In: Auerbach PS (ed): Wilderness Medicine, 3rd edition; Mosby, St. Louis, MO 1995; 1-37.
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Cleaning and Care
Attention! Possible property damage! Do not use high pressure sterilisation on the
pulse oximeter!
Never hold the pulse oximeter under water, as liquid may enter and damage the
pulse oximeter.
Clean the housing and the rubberised inner surface of the pulse oximeter with a soft
cloth dampened with surgical spirits after every use.
Replace the batteries if the display 1 on the pulse oximeter shows the battery is low. If the pulse oximeter will not be used for more than one month, remove both batteries
from the device to prevent possible battery leakage.
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Storage
Attention! Possible property damage! Store the pulse oximeter in a dry location
(relative humidity ≤ 95 %). High humidity can shorten the life or damage the pulse oximeter. Store the pulse oximeter in a location with ambient temperatures between
-40 °C and 60 °C.
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