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The company owns all the copyrights of this manual, including published and unpublished documents,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: