CONCORD 85301 User Manual

Instructions to User
Dear Users, thank you very much for purchasing our product.
The Manual describes, in accordance with the Pulse Oximeter's features and requirements, main structure,
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. Refer to the respective
chapters for details.
Please read the Manual very carefully before using this equipment. These instructions describe the operating
procedures to be followed strictly, failure to follow these instructions can cause measuring abnormality,
equipment damage and personal injury. The manufacturer is NOT responsible for the safety, reliability and
performance issues and any monitoring abnormality, personal injury and equipment damage due to user's
negligence of the operation instructions. The manufacturer's warranty service does not cover such faults.
The specific products you received may not be exactly as described in this User Manual. If you have any
questions regarding to the use of this product, please call us at 888-970-2999 M-F from 8:00 AM to 5:00 PM CST
WARNING:
 The uncomfortable or painful feeling may appear if using the device ceaselessly. It is
recommended that the sensor should not be applied to the same finger for over 2 hours.
 For the individual user there should be a more prudent inspecting in the placing process. The
device can not be clipped on swollen or tender tissue.
 The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and the
maintenance man, can not stare at the light.
 User can not use fingernail polish, fake nails or other makeup.
 User fingernails can not be too long.
 Please peruse the relative content about the clinical restrictions and cautions.
 This device is not intended for treatment.
1 Safety
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 users safety and monitoring performance about cables and transducers. It is recommended that the
device should be inspected once a week at least. When there is obvious damage, stop using the monitor.
 Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted
to maintain it by themselves.
 The oximeter cannot be used together with devices not specified in User's Manual. Only the accessory
that appointed or recommendatory by manufacture can be used with this device.
 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
anesthetic agents.
 The person who is allergic to rubber can not use this device
 The disposal of scrap instrument and its accessories and packing(including battery, plastic bags, foam and
paper boxes) should follow the local laws and regulations.
 Please check the packing before use to make sure the device and accessories are totally in accordance with
the packing list, or else the device may have the possibility of working abnormally.
1.3 Attentions
 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 carried from cold environment to warm or humid environment, please do not use it immediately.
 DO NOT operate keys on front panel with sharp materials.
 High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User Manual
in the relative chapter for instructions of cleaning and disinfection.
 Do not have the oximeter immersed in liquid. When it needs cleaning, please wipe its surface with medical
alcohol by soft material. 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 and middle finger .
 Do not use the device on infant or neonatal users.
 The product is suitable for children above four years old and adults (Weight should be between 15kg/
33lbs to 110kg/243lbs).
 The device may not work for all users. If you are unable to achieve stable readings, discontinue use.
 The data refresh is less than 5 seconds.
 The waveform is normalized. Please read the measured value when the waveform on screen is
steady-going, this measured value is the optimal value. And the waveform at the moment is the standard
one.
 If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to
restore normal use.
 The instrument 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.
 A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.
1.4 Indication for Use
The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial
hemoglobin(SpO2) and the pulse rate of adult in home use environments.This device is not intended for
continuous monitoring.The device can be multi-used. Solely for use with sporting and aviation activities.
2 Overview
The pulse oxygen saturation is the percentage of HbO
in the blood. It is an important bio-parameter for respiration. For the purpose of measuring the SpO
and accurately, our company developed the Pulse Oximeter. 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 users to put one finger into the device to quickly get a reading.
2.1 Features
 Operation of the product is simple and convenient.
 The product is small in volume, light in weight (total weight is about 50 g including batteries) and
convenient to carry.
 Power consumption of the product is low and the two originally equipped AAA batteries can be operated
continuously for 20 hours.
 The product will enter standby mode when no signal is in the product within 5 seconds.
 Display direction can be changed automatically,easy to view.
in the total Hb in the blood, so-called the O
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2.2 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through finger, and
indicate the pulse intensity by the bar-display.
The product is not suitable for use in continuous monitoring of home users
The problem of overrating would emerge occur when the user is suffering from toxicities caused by
carbon monoxide, the device is not recommended to be used under this circumstance.
2.3 Environment Requirements
Storage Environment
a) Temperature: -40℃~+60℃
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
(HbO ) in glow & near-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin
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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.
3.2 Caution
1. The finger should be placed properly (see the attached illustration of this manual, Figure 5), 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
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position there between.
3. The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or
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receiving intravenous injection.
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 etc.
6. Strenuous action of the subject or extreme electro interference may also affect the accuracy.
7. User can not use fingernail polish, fake nails or other makeup.
3.3 Clinical Restrictions
1. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required.
For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular
contracting drug, the SpO
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 problem, the SpO
3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for
serious error of SpO measure.
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4. As the SpO value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some users
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with serious anemia may also report good SpO
4 Technical Specifications
1) Display Format: OLED Display;
SpO Measuring Range: 0% ~ 100%;
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Pulse Rate Measuring Range: 30bpm ~ 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
PI Measuring Range: 0 ~ 20％
2) Power Requirements: 2×1.5V AAA alkaline battery (or using the rechargeable battery instead), adaptable
range: 2.6V~3.6V.
3) Power Consumption: less than 80mA.
4) Resolution: 1% for SpO
5) Measurement Accuracy: ±2% in stage of 70%-100% SpO
70%. ±2 bpm during the pulse rate range of 30-99 bpm and ±2% during the pulse rate range of 100~250 bpm.
6) Measurement Performance in Weak Filling Condition: SpO
when pulse-filling ratio is 0.4%. SpO
30~99 bpm and ±2% during the pulse rate range of 100~250 bpm .
7) Resistance to surrounding light: The deviation between the value measured in the condition of man-made
light or indoor natural light and that of darkroom is less than ±1%.
8) It is equipped with a function switch. The product will enter standby mode when no signal is in the product
within 5 seconds.
9) Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
wavelength range.
5 Accessories
 One lanyard ;
 Two batteries,carrying case and rubber boot cover
 One User Manual.
concentration
6 Installation
more easily
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6.1 View of the Front Panel
Figure 1 Operating principle
waveform (PLETH) will decrease. In this case, the measurement will be more
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determination by this monitor may be inaccurate.
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measurement.
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, 1 bpm for Pulse Rate and 0.1% for PI.
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, and meaningless when stage being smaller than
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and pulse rate can be shown correctly
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error is ±4%, pulse rate error is ± 2 bpm during the pulse rate range of
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Figure 2 Front view