Lepu Medical LOX100A User manual

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Shenzhen LEPU Intelligent Medical
Equipment Co.,Ltd.
Addr.: North side of floor 3, BLD 9, BaiWangxin
High-Tech Industrial Park,Songbai Road,Xili
Street, Nanshan District,Shenzhen,China
Company name:Lepu Medical (Europe)
Cooperatief U.A.
Addr.: Abe Lenstra Boulevard 36, 8448
JB,Heerenveen, The NETHERLANDS

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www.lepucare.com
Fingertip pulse
Oximeter
LOX100A / LOX100B
LOX100C / LOX100D
User's Manual
Heartcare

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Copyright
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd
Statement

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The company owns all the copyrights of this manual, including published and unpublished documents,
and classifies this manual as a classified document. This manual can only be used as a reference by the
user for operation and understanding of the company's product or maintenance policy.Use of the manual
for propaganda or any other misconduct will be considered illegal.
In order to prevent infringement, the company reserves the right to defend its legal rights and interests
through legal means in accordance with the provisions of the Copyright Law. Except authorized in
writing by our company, no partner shall copy, use or disclose the manual information to any other
third party. We are not liable for any illegal events or issues involving the interests of any third party
caused thereof.
All information contained in this manual has been confirmed to be correct. The company is not liable
for any accidental injury or life-threatening event directly or indirectly caused by improper use or
operation of the device. All the information contained in this manual is subject to legal protection.
The contents of this manual are subject to change without notice.
Table of Contents
1．Product Overview----------------------------------------------------------------------------01
1.1 Appearance-----------------------------------------------------------------------------01
1.2 Name and Model -----------------------------------------------------------------------01

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2．Intended Use --------------------------------------------------------------------------------01
3．Measuring Principle -------------------------------------------------------------------------02
4．Warnings ------------------------------------------------------------------------------------02
4.1 Precautions ----------------------------------------------------------------------------02
4.2 Causes of Incorrect Measurements ---------------------------------------------------03
5．Symbol Description --------------------------------------------------------------------------04
6．Battery Installation -------------------------------------------------------------------------06
7．Operating Instructions ----------------------------------------------------------------------06
8. Setting --------------------------------------------------------------------------------------08
9．Lanyard Installation ------------------------------------------------------------------------09
10．Product Accessories------------------------------------------------------------------------09
11．Maintenance, Storage and Transportation -------------------------------------------------10
12．Technical Specifications -------------------------------------------------------------------12
13．Electromagnetic Compatibility Guide-------------------------------------------------------13
14．Warranty Terms ----------------------------------------------------------------------------19
15．Registration Information ------------------------------------------------------------------20
1.Product Overview
Thank you for purchasing LOX100 Fingertip Pulse Oximeter. The product is mainly indicated for measurement of
human Oxygen Saturation (SpO2), Pulse Rate (PR) and PI(Perfusion Index). The product has visual prompts and
verbal prompts , such as finger out and pulse sound (optional). The applied part of this device is silica gel pad.
Please carefully read the User’s Manual before use.
1.1 Appearance

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1.2 Name and Model
Name: Fingertip pulse oximeter
Model: LOX100A/LOX100B/LOX100C/LOX100D
2.Intended Use
The LOX100 Fingertip Oximeter is intended for use in homes or hospitals for noninvasive measurement of oxygen
saturation, pulse rate and perfusion index The device can be used for both children and adults. This device is
intended only for spotchecking.
3. Principles of measurement
The measuring principles of pulse oximeter is based on Lambert-Beer law, The spectrum absorption
characteristics is different of Reductive hemoglobin(RHb) and Oxyhemoglobin(Hbo2) in red light and
nearinfrared light zones. The pulse oximeter calculate Spo2 ,PR and PI from the light intensity absorption
difference by measuring the ratio of absorbed red and infrared light with each pulse.
4.Warnings
4.1 Precautions
1. Please carefully read the User’s Manual before use.
2.The product cannot be used for continuous measurement.
3. Electrosurgical devices and defibrillators will affect the use of this device.

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4. The product shall not be used in combination with MRI or CT equipment.
5. Do not squeeze the silica gel pad with your fingers during use.
6. The product shall not be used in flammable and explosive environment.
7. The product plays a supporting role in the diagnosis of patients only. A diagnosis should be made based on clinical
manifestations and symptoms.
8. Test point should be periodically changed during long-term use or depending on patient's conditions. Test point
should be changed, and patient's skin integrity and circulation condition should be checked to make appropriate
adjustments at least every 2 hours.
9. Autoclaving, vinyl oxide disinfectant, or immersing the sensor in liquid disinfectant can cause erroneous
readings.
10. The device specified in this manual, reusable accessories or parts of accessories including batteries should
comply with local laws and regulations.
11.The device complies with the electromagnetic compatibility requirements for electronic medical products or
systems in IEC60601-1-2. Radio transmission equipment or other electromagnetic interference may affect the
performance of this device.
12. Portable radio communication equipment may affect the performance of this device.
13. The device should not be used in the vicinity of other equipment or stacked on other equipment
14. Use of the device is not recommended during transportation of patients, such as on an ambulance.
15. Do not disassemble, install or repair the device without authorization.
16. The materials in contact with the patient is medical silica gelpad,The material meet the requirements of ISO
10993.
17.Temperature shall not exceed 40℃when in contact with human body. The recommended maximum
application time are 1-2 hours.
18. The device is not indicated for children weighing less than 20 kg, pregnant women or nursing mothers.
19.Do not dispose of batteries in fire.Dispose of batteries in accordance with the local ordinances and
regulations.

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20.This device has no audible alarms.
21. Both the time required for the device to warm from the minimum storage temperature or between uses until
the device is ready for its intend use when the ambient temperature is 40 °C; and the time required for the device
to cool from the maximum storage temperature between uses until the device is ready for its intend use when
the ambient temperature is 40 °C is 15±5mins.
4.2 Causes of Incorrect Measurements
1. Dysfunction of important indicators of hemoglobin (such as carbon-containing hemochrome or
methemoglobin);
2. Excessive intravascular staining agent (such as indocyanine green or methylene blue);
3. Impact of surrounding light; add a protective housing to the sensor if necessary;
4. Excessive patient movement may be erroneously identified as pulse signals and may affect the measurements
of this device.
5. Venous rhythmic beating;
6. Placement of the sensor and blood pressure cuff at the same artery or blood vessel.
7. Excessively low blood pressure, systolic blood pressure, severe anemia or hypothermia;
8. Cardiac arrest or shock;
9. Excessively smooth nails or false nails;
10. Weak pulse or weak perfusion;
11. Low hemoglobin;
12. Excessively long nails or nail polish and other cosmetics on nails.
13. Blood oxygen waveform is not normalized; when the signal is too weak, waveform amplitude decreases;
excessively low waveform amplitude may lead to inaccurate measurement results;
5.Symbol Description
Symbol
Description
Type BF applied part
Pulse oxygen saturation

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PI%
Perfusion index
PR
Pulse Rate
Pulse intensity bargraph
Battery power indication
Attention
Battery orientation
CE marking
Reference instructions for use
Anti-fluid level
Serial number
Manufacturer information
Date of manufacture
European Authorized Representative
The device should be sent to the special agencies according to local
regulations for separate collection after its useful life
Storage temperature
Storage humidity
Storage atmospheric pressure
Not for continuous monitoring(no alarm for Spo2)
6．Battery Installation
1. Open the battery cover according to the direction of arrow on the battery cover, as shown in Figure 4;
2. Place 2 AAA batteries into the battery compartment, and ensure the correct direction, as shown in Figure 4;
3. Cover the battery cover.

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7．Operating Instructions
1. According to instructions in the chapter of Battery Installation, place 2 AAA batteries into the device, and cover the
battery cover;
2. Pinch the pulse oximeter as shown in Figure 5;
3. As shown in Figure 6,fully insert the testing finger into the finger cavity, then release the pulse oximeter;
4. Press the power button of the puise oximeter to boot;
5. The finger and patient’s body shall not move during measure-ment;
6. Read data directly from the screen;
7. When reading the data after the data is stable, quickly pressing the power button will change the data display direction,
so that the user may read data from different angles. As shown in Figure 7:

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8. After you pull out your finger from the finger cavity, the screen will show "Finger out" (Figure 8). If the sign
lasts for more than 8 seconds, the device will shut down automatically.
9. When the battery power is short, The screen will display lowbattery indicator mark(Figure9).Then the device
will shut down automatically after 8 seconds.
Figure 8 Figure 9
8．Setting
Menu
Setting range
Default setting
Spo2 Limit Lo
85%~99%
90%
PR Limit Lo
30bpm~100bpm
50bpm
PR Limit Hi
100bpm~200bpm
120bpm
Sound
VolumeLevel 1~5 and Off can be selected
Exit
Long press to exit
Under non-measuerment conditions as “Finger out”interface.Long time press the button can enter the setting menu
interface as below:
In setting menu as Figure 10, short time press the button to shift cursor circularly;Long time press the button to confirm
the selection,Then short time press the button can adjust the setting data;Finally long time press the button oximeter
will confirm the setting data and exit the selected menu.
In Figure 11,Long time press the button will exit the setting menu.
If We haven’t operate are in setting menu about 30 seconds,The oximeter will exit automatically to measuring screen.
In measuring screen,If SPO2 Value or/and PR value exceeds its/their setting limit value during measuring,the osimeter
will beep periodically and the numerical value will flash.Long time press key can disable the current beep soundfor
Finger out

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about one hundred seconds during measuring.Then the oximeter testorebeep function.
9．Lanyard Installation
1. Pass the thinner end of the lanyard through the hanging hole as shown in Figure12;
2. Pass the thicker end of the lanyard through the thinner end and tighten it, as shown in Figure 13.
Figure 12 Figure 13
Warning!
1. Due to small parts, always keep the device out of reach of children.
2. Never leave the device hanging on its lanyard in reach of small children
10．Product Accessories
No.
Name
Unit
Quantity
1
Lanyard
Piece
1
2
AAA batteries
Piece
2
3
User’s Manual
Piece
1
4
Quality certificate
Piece
1
11．Maintenance, Storage and Transportation
The life cycle of this device is 5 years when used daily for a number of 10 measurements, for periods of 10 minutes
each measurement.. In order to conform to this service life please pay information below:
1. Please replace the batteries immediately when the low battery power symbol is indicated.
2. Wipe the surface of the device before and after use.
3. Remove batteries for extended periods of none use.
4. Expected service life is 5 years.
5. The device has been calibrated before delivery, Therefore there is no need for user calibration.

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6. A packaged device should be stored in a clean and wellventilated environment with an ambient temperature of
-20℃~55℃ with relative humidity≦93% and in the absence of corrosive gases, strong mechanical vibration or
electromagnetic fields.
7. For transportation requirements, devices should be loaded correctly according to the symbols on the outer
packaging and should be protected against collision and impact, severe vibration and severe weather conditions
whilst in transit.
8. The device shall be kept dry at all times ,High moisture environments will affect the service life of the device
and potentially cause damage.
9. Do not attempt to disassemble, repair or service the device.
10.To recycle or dispose of the device and batteries,please comply with local authority regulations.
● If there is dust or dirt on the surface of the oximeter, wipe the device with 70% alcohol. Dip a dry cloth or
alcohol pad in a small amount of alcohol before wiping. Avoid drip or flow of alcohol in the device. Dry the
device in the air after wiping. Avoid permeation of any liquid into the device.
● The device does not need scheduled maintenance or calibration except for battery replacement.
● Please stop using the device and contact your local service center immediately if any of the following
conditions occurs:
1. Abnormal alphabet or number appears on the screen.
2. The device cannot be turned on despite replacement of batteries.
3. The device cannot perform measurement due to squeezing, loose spring, button failure and so on.
● Clinical testing is a commonly used method for determining oxygen saturation accuracy. The arterial
hemoglobin oxygen saturation measured with the device should be compared with the result of sampled
arterial blood analyzed with CO-oximeter.
● The name of the simulator used is Index2 FLUKE simulator, version number: 3.0.0.
● Simulator is used for testing of consistency only; equipment measurement accuracy is tested by clinical
comparisons.
Possible causes
Solutions
Boot failure
Low or dead battery, wrong
Please replace the battery, re-install

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battery installation, device failure
the battery or contact your local
customer service center
Abnormal display
of SpO2 or PR
Shallow placement of finger, hard
ambient light, weak perfusion, or
excessively low oxyhemoglobin
for correct measurement
Correctly put your finger and retry;
avoid use in strong ambient light;
go to the hospital for accurate
diagnosis
Unstable display
of SpO2 or PR
Shallow placement of finger,
shaking finger or patient
movement
Correctly put your finger and retry;
avoid movement
12．Technical Specifications
Display mode
OLED
Oxygen
saturation
Measuring range
70%~99%
Accuracy*
80%~99% ±2%;
70%~79% ±3%;
No requirement for 70% below
Resolution
1%
Pulse rate
Measuring range
30bpm~240bpm
Accuracy
30bpm~240bpm,
±2bpm or ±2% (which is larger)
Resolution
1bpm
Measuring range of blood perfusion
index
0.3%~20%
LED probe wavelength
RED 660 ±3nm
IR 905 ±10nm
Radiation power
RED 2mW
IR 2mW
Battery model
2 AAA batteries
Power consumption
< 30mA
Battery life
Continuous use for 25 hours with 2 AAA1.5V alkaline
batteries
Operating temperature
5℃~40℃
Storage temperature
-20℃~+55℃
Relative humidity
≤80%: No condensation in working status
≤93%: No condensation in storage status
Operating atmospheric pressure
86kPa~106kPa
Storage atmospheric pressure
70kPa~106kPa

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Response time
< 20 s
Anti-shock protection category
Internal power supply
Anti-shock protection measure
Type BF applied part
Waterproof protection measure
IP22
NetWeight
Approx.,60g(including batteries)
Dimensions
69mm(L) X35mm(W) X29mm(H)
Operating mode
Non-continuous operation
Data averaging
Spo2
Average of successive five detected pulses, with
exponential smoothing followed
Pulse rate
Average within 8 seconds
Update time
Spo2
Update per second, the update period is less than 20
seconds.
Pulse rate
Update per second, the update period is less than
12 seconds.
* This graph shows plots of the error (SpO2-SaO2)by SaO2 using the LOX100 series oximeter with a linear
regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject
from a clinical study in non-motion conditions.
13．Electromagnetic Compatibility Guide
Note:
● This device should not be used close to or stacked with other devices. If it must be used close to or stacked with
other devices, care should be taken to verify that it functions properly under its intended use.
● Except for the cables of this product sold by the manufacturer as spare parts for internal components, use of the

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accessories and cables other than those specified may result in increased emission or reduced immunity of this
product.
●Since portable and mobile RF communication equipment may affect the performance of this product, please avoid
strong electromagnetic interference during use, such as mobile phones, microwave ovens and so on.
● The user should install and use the device according to the electromagnetic compatibility information provided in
the random file.
(1)
Guide and manufacturer's statement - Electromagnetic emissions
This product is intended for use in the following electromagnetic environment. The purchaser or user of the
product should ensure that it is used in this electromagnetic environment:
Emission test
Compliance
Electromagnetic environment - Guide
RF emissions
Group 1
This product uses RF energy only for its internal functions.
As a result, its RF emissions are low and there is very little
chance of interference with nearby electronic equipment.
RF emissions
Class B
This product is intended for use in all facilities including
domestic facilities and the facilities connected directly to
public low-voltage power supply network for residential
homes.
Harmonic emissions
Not applicable
Voltage fluctuation /
flickering emissions
Not applicable
(2)
Guide and manufacturer's statement - Electromagnetic immunity
This device is intended for use in the following electromagnetic environment. The purchaser or user of this
device should ensure that it is used in this electromagnetic environment:
Immunity test
IEC60601 test level
Compliance level
Electromagnetic
environment - Guide
Electrostatic discharge
± 8kV contact discharge
± 15kV air discharge
± 8kV contact
discharge
The floor should be wood,
concrete or ceramic tile; if

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± 15kV air
discharge
the floor is covered with
synthetic materials, the
relative humidity should be
at least 30%.
Electrical fast
transient burst
± 2kV for power cord
± 1kV for input/output lines
Not applicable
Not applicable
Surge
± 1kV differential mode voltage
± 2kV common-mode voltage
Not applicable
Not applicable
Voltage dips, short
interruptions and
voltage changes in
power input line
<5% UTfor 0.5 cycle (> 95% dips on
UT)
40% UTfor 5 cycles (60% dips on UT)
70% UTfor 25 cycles (30% dips on
UT)
<5% UTfor 5s (> 95% dips on UT)
Not applicable
Not applicable
Power frequency
magnetic field
(50/60Hz)
3A/m
3A/m,50/
60Hz
The power frequency
magnetic field should
have the horizontal
characteristics of power
frequency magnetic field
of a typical place in a
typical commercial or
hospital environment.
Note: UT refers to the AC voltage before applying the test voltage.
(3)

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Guide and manufacturer's statement - Electromagnetic immunity
This device is intended for use in the following electromagnetic environment. The purchaser or user
of this device should ensure that it is used in this electromagnetic environment:
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment - Guide
RF conduction
3V (effective value)
150kHz~80MHz
Not applicable
Portable and mobile RF communication
equipment should not be used near any part,
including cables, of the product at a distance
shorter than the recommended isolation
distance. This distance should be calculated with
the formula corresponding to the transmitter
frequency.
RF radiation
10V/m
80MHz~2.7GHz
80%AMat 1 kHz
10V/m
80MHz~2.7GHz
80%AMat 1 kHz
Recommended isolation distance
Where:
P - The transmitter's maximum rated output power, in watts (W), provided by the transmitter’s
manufacturer;
d- Recommended isolation distance in meters (m) b.
The field strength of a fixed RF transmitter is determined by a survey of electromagnetic locations c,
which should be lower than the compliance level in each frequency range d.
Interference may occur near equipment marked with the following symbol:
Note 1: The higher frequency band formula is used at the frequency of 80MHz and 800MHz.
Note 2: The guide may not apply to all situations. Electromagnetic propagation is affected by the
absorption and reflection of buildings, objects and the human body.
a. The field strength of a fixed transmitter, such as base stations for wireless (cellular/cordless) phones

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and terrestrial mobile radios, amateur radio, AM and FM radio broadcasts and television broadcasts,
cannot be accurately predicated in theory. Survey of electromagnetic sites should be considered to
assess the electromagnetic environment of fixed RF transmitters. If the measured field strength of the
place where the product is located at is higher than the above applicable RF compliance level, the
product should be observed to verify that it can work properly. If abnormal performance is observed,
additional measures may be necessary, such as readjusting the orientation or location of the product.
b. The field strength should be below 3 V/m over the frequency range of 150KHz ~ 80MHz.
(4)
Recommended isolation distances between portable and mobile RF communication equipment and this
product
This product is intended for use in electromagnetic environments where radio frequency radiation harshness
is controlled. Depending on the maximum rated output power of communication device, the purchaser or user
of this product can prevent electromagnetic interference by maintaining the following recommended
minimum distance between the portable and mobile RF communication equipment (transmitter) and this
product:
Rated maximum
output power of
transmitter/W
Isolation distances corresponding to different transmitter frequencies/m
150kHz
80MHz
d=
80MHz
800MHz
d=
800MHz
2.7GHz
d=
0.01
Not applicable
0.12
0.23
0.1
Not applicable
0.38
0.73
1
Not applicable
1.2
2.3

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10
Not applicable
3.8
7.3
100
Not applicable
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23
For the rated maximum output power of transmitter not listed in the above table, the recommended isolation
distance d in meters can be determined using the formula in the corresponding transmitter frequency column,
where P is the maximum output rated power of transmitter provided by the manufacturer in watts (W).
Note 1: The higher frequency band formula is used at the frequency of 80MHz and 800MHz.
Note 2: The guide may not apply to all situations. Electromagnetic propagation is affected by the absorption
and reflection of buildings, objects and the human body.
14．Warranty Terms
1. The user should guarantee that
(1) The user carefully reads the User’s Manual before use of this device;
(2) The user performs operation and routine maintenance according to the requirements in the User’s Manual, and
ensure that the requirements for power supply and environment are met.
2. Maintenance regulations
(1) If the product is within the scope of free maintenance in the maintenance regulations, you may enjoy free
maintenance with the warranty card. If the product is beyond the scope of free maintenance, you may receive paid
maintenance.
(2) With the warranty card and shopping invoice, you may enjoy free maintenance services for the host for 1 year
and for accessories for three months since the date of purchase.
(3) The following situations are beyond the scope of free maintenance: Failure or damage caused by human factors;
damage caused by disassembly or repair by the people not authorized by our company; damage caused by the
operating environment not in compliance with our company's provisions; damage caused by test power; products
beyond the warranty period.
15．Registration Information