CONCORD 85101 User Manual

Thank you very much for purchasing a Concord Pulse Oximeter.
This Manual describes the Pulse Oximeter's features and requirements, functions, specifications, correct methods for transportation, installation, usage,
operation, repair, maintenance and storage, as well as the safety procedures to protect both the user and equipment. Please read and follow the User Manual
carefully before using this product. Failure to follow the User Manual may cause measuring abnormality, equipment damage and human injury. The
manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, human injury and equipment damage
due to improper use. The specific products you received may not be exactly as described in this User Manual. This product can be used repeatedly. If you
have any questions regarding to the use of this product, please call us at 888-970-2999 Monday-Friday from 8:00 AM to 5:00 PM Central Time.
WARNING:
 Uncomfortable or painful feelings can occur when using this product continuously. Typically, the sensor should not be applied to the s
same finger for over 2 hours.
 The device should not be clipped on swollen, damaged or tender tissue.
 The infrared light is harmful to eyes, do not stare at the light part of the SpO2 probe, the infrared is invisible.
 Use of Fingernail polish, fake nails or other makeup can cause the oximeter not to get a reading or get unreliable readings.
 The fingernails of the User should not be too long, preventing insertion of the finger into the oximeter.
 This device is not intended for treatment.
1 Safety The User Manual is published by our company. All rights reserved.
1.1 Instructions for Safe Operations
 ● Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect user's safety and monitoring
performance. It is recommended that the device should be inspected once a week at least. Please stop using the device if there is obvious damage.
 ● Necessary maintenance must be performed by qualified technicians only. Users are not permitted to open or maintain it by themselves.
 ● This product is calibrated before leaving factory

1.2 Warnings
 ● Explosive hazard—DO NOT use the oximeter in environment with flammable gas such as some ignitable gases.
 ● The person who is allergic to rubber cannot use this device.
 ● Disposal of oximeter, accessories and packing should follow local laws and regulations.
 ● No modification of this equipment is allowed.

1.3 Precautions
 Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
 If the oximeter gets wet, please stop operating it.
 When it is moved from cold environment to warm or humid environment, please allow a few minutes to acclimate.
 DO NOT operate the button on front panel with sharp materials.
 High temperature or high pressure steam disinfection of the oximeter is not permitted.
 Do not have the oximeter immersed in liquid. When it needs cleaning, please wipe its surface with medical alcohol.
 Do not spray any liquid on the device directly.
 For fingers which are too thin or too cold, improved readings can be achieved by placing on a thick finger such as thumb or middle finger in the
oximeter.
 Do not use the device on infant or neonatal users.
 The product is suitable for pediatric and adults (Weight should be between 15kg/ 33lbs to 110kg/243lbs).
 The data refresh is less than 5 seconds, If abnormal results appear on the screen during testing process, pull out the finger and reinsert to restore normal
use.
 The device shows the low-voltage indicator when the battery is low, requiring a battery replacement.
 Batteries must be removed if the device is going to be stored for more than one month, or else batteries may leak.
1.4.Indication for Use
The Pulse Oximeter is a non-invasive device intended for the spot-checking of saturation of arterial hemoglobin(SpO2) and the pulse rate of adult in home use
environments. This device is not intended for continuous monitoring. Intended for use with sporting and aviation activities. Intended to monitor heart rate during
exercise.
2 Overview
The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood. It is an important bio-
parameter for the respiration. At the same time, the device can measure the pulse rate
The Pulse Oximeter features small size, low power consumption, convenient operation and being portable. It is only necessary for a user to put one finger
into the device to quickly get a reading.
2.1 Features
 Operation of the product is simple and convenient.
 Power consumption of the product is low and two AAA batteries can be operated continuously for about 24 hours.
 The product will automatically be powered off when no signal is received after 5 seconds.
 Low‐battery indicator
2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used for measuring oxygen saturation and pulse rate through the finger.
Do not use if suffering from toxicosis caused by carbon monoxide, the device is not recommended to be used under this circumstance.
2.3 Environment Requirements
Storage Environment
a) Temperature :- 40ºC/32ºF to 60ºC/140ºF
b) Relative humidity :≤95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temperature: :10℃~40℃
b) Relative Humidity :≤75%
c) Atmospheric pressure:700hPa~1060hPa
3 Principle and Caution
3.1 Principle of Measurement
Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum
Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow & near-infrared zones. Operation principle of the
instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so
that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal
can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and
microprocessor.
Instructions to User
3.2 Caution
1. The finger should be placed properly (see the attached illustration of this manual ,Figure 7), or else it may cause inaccurate measurement.
2. The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject's arteriole in a position there between．
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3. The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection.
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4. Make sure the optical path is free from any optical obstacles like rubberized fabric.
5. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc.
6. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
7. User can not use enamel or other makeup.
3.3 Clinical Restrictions
1. 1. As the measurement is taken on the basis of arteriole pulse, substantial pulsating blood flow is required. For a subject with a weak pulse due to
shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case,
the measurement will be more sensitive to interference.
2. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or carbon monoxide
hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problems, the SpO2 determination by this monitor
may be inaccurate.
3. Drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor for errors in SpO2 measurement.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some users with serious anemia may also report
good SpO2 measurement.
4 Technical Specifications
5.
1) Display Format: Digital tube Display;
SpO Measuring Range: 0% - 100%;
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Pulse Rate Measuring Range: 30 bpm - 250 bpm;
Pulse Intensity Display: columniation display
2) Power Requirements: 2 ×1.5V AAA alkaline battery, adaptable range: 2.6V-3.6V.
3) Power Consumption: Less than 25 mA.
4) Resolution: 1% for SpO and 1 bpm for Pulse Rate.
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5) Measurement Accuracy: ±2% in stage of 70%-100% SpO
Pulse Rate. Clinical Trial :SpO regression plot & Bland–Altman plot,Refer to Figure 2 & Figure 3.
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6) Measurement Performance in Weak Filling Condition: SpO
±4%, pulse rate error is ±2 bpm or ±2% (select larger).
7) Resistance to surrounding light: The deviation between the value measured in the condition of man-made light, indoor natural light and that of
darkroom is less than ±1%.
8) It is equipped with a automatic switch function. The Oximeter can be powered off when the finger is off the oximeter within 5 seconds.
9) Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
Figure 2 SpO regression plot
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5 Accessories
 One Lanyard
,
 Two batteries carrying case and rubber boot coverOne User Manual.
6 Installation
6.1 View of the Front Panel
Figure 4. Front View
6.2 Battery
Step 1. Refer to Figure 5. and insert the two AAA size batteries according to the diagram on the unit.
Step 2. Install the battery compartment cover, by sliding the cover back onto the unit. Follow the tabs on the inside of the cover.
Please take care when you insert the batteries for the improper insertion may damage the device.
6.3 Installing the Lanyard
Step 1. Put the end of the lanyard through the hole.
Step 2. Put another end of the lanyard through the first one and then tighten it.
Figure 6. Mounting the hanging rope
7 Operating Instructions
7.1 Insert the two batteries in the proper direction as shown on the diagram on the bottom of the unit
7.2 Open the clip as shown in Figure 7.
7.3 Place finger onto the rubber cushions of the clip (make sure the finger is in the right position), and then clip the finger.
7.4 Press the power button once on front panel to turn the unit on.
7.5 Minimize motion of the finger during the reading. Movement is not recommended while taking a reading.
7.6 Get the information directly from screen display.
7.7 When the device is powered on, press power button once and the device will reset itself.
Fingernails and the luminescent tube should be on the same side.
8 Repairing and Maintenance
 Please change the batteries when the low-voltage is displayed on the screen.
 Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then air dry or clean it with a dry clean towel.
 Using the medical alcohol to disinfect the product after use, prevents from cross infection for next use.
 Please remove the batteries if the oximeter is not in use for a long time.
 The best storage environment of the device is - 40ºC/32ºF to 60ºC/140ºF temperature and not higher than 95% relative humidity.
High-pressure sterilization cannot be used on the device.
Do not immerse the device in liquid.
It is recommended that the device should be kept in a dry environment. Humidity may reduce the useful life of the device, or even damage
it.
Figure 1. Operating Principle
, and meaningless when stage being smaller than 70%. ±2 bpm or±2% (select larger) for
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and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO
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Figure 3 Bland–Altman plot
Figure 5. Batteries Installation
Figure 7. Put finger in position
,
and then put the cover.
error is
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