CONCORD Emerald User manual

OPERATOR’S
MANUAL
Fingertip Pulse Oximeter
General Description
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 for sports
and aviation use. 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.
Measurement Principle
Principle of the oximeter is as follows: A mathematical formula is established making use of Lambert Beer Law according to
Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO
2) in red and near-infrared zones.
Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity
Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near
infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a
photosensitive element, will be shown on the oximeter’s display through process in electronic circuits and microprocessor.
Diagram of Operation Principle
1. Red and Infrared-ray Emission Tube
2. Red and Infrared-ray Receipt Tube
Precautions For Use
1. Before use, carefully read the manual.
2. 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.
3. The fingertip pulse oximeter must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify
that nothing is hindering the pulse measurement before relying on the SpO2 measurement.
4. Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
5. Do not use the fingertip pulse oximeter in an explosive atmosphere.
6. Not intended for Continuous monitoring
7. The fingertip pulse oximeter is intended only for sports and aviation monitoring
8. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not
intended for sterilization.
9. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components,
including batteries.
10. This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility for electrical equipment and/or systems.
However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise
the environment, it is possible that high levels of such interference due to close proximity or strength of a source might
disrupt the performance of this device.
11. Portable and mobile RF communications equipment can affect electrical equipment.
12. This equipment should not be used adjacent to or stacked with other equipment.
13. It may be unsafe to：
—use accessories 、detachable parts and materials not described in the instructions for use
—interconnect this equipment with other equipment not described in the instructions for use
—disassemble, repair or modify the equipment.
14. These materials that contact with the users skin contain medical silicone and ABS plastic enclosure all pass the ISO10993-5
Tests for invitro cytotoxicity and ISO10993-10 Tests for irritation and delayed-type hypersensitivity.
Contraindication
It is not for continuous monitoring.
Inaccurate measurements may be caused by
1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin).
2. High ambient light. Shield the sensor area if necessary.
3. Excessive patient movement.
4. High-frequency interference.
5. Poor blood perfusion.
6. Placement of a sensor on an extremity with a blood pressure cuff.
7. Fingernail polish or false fingernails.
8. Weak pulse quality.
9. Low hemoglobin.
Product Features
1 Brightness LED display SpO2, PR, and Pulse bar.
2 Two display modes.
3 2 pcs AAA-size alkaline batteries; battery-low indicator.
4 When no operation or low signal is detected, the pulse oximeter will power off automatically in 8 seconds.
Intended Use
Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglob
in (SpO2) and pulse rate of adult and pediatric users in sports and aviation.
Operation Instructions
1． Install two AAA batteries according to the Battery Installation instructions.
2． Place one of your fingers into the rubber opening of the pulse oximeter.
3． Press the switch button one time on front panel to turn the pulse oximeter on.
4． Keep your hands still for the reading. Do not shake your finger during the test. It is recommended
that you do not move your body while taking a reading.
5． Read the data from the display screen. There are two display modes. After turning on the pulse oximeter, each time you
press the power switch, the pulse oximeter will switch to another display mode.
Front Panel
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2 and pulse rate value is potentially incorrect.
Battery Installation
1. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the
compartment. If the polarities are not matched, damage may be caused to the oximeter.
2. Slide the battery door cover horizontally along the arrow shown as the picture.
Note:
 Please remove the batteries if the pulse oximeter will not be used for long periods of time.
 Please replace the battery when the power indicator start flickering.
Using the Lanyard
1. Thread thinner end of the lanyard through the loop.
2. Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
 Please notice that the lanyard which is tied to the oximeter may cause strangulation due to excessive length.
Maintenance and Storage
1. Replace the batteries in a timely manner when low voltage lamp is lighted.
2. Clean surface of the fingertip oximeter before it is used in diagnosis for patients.
3. Remove the batteries if the oximeter is not operated for a long time.
4. It is best to store the product in -4°F～+131°F and ≤93% humidity.
5. Keep in a dry place. Extreme moisture may affect oximeter lifetime and may cause damage.
6. Dispose of battery properly; follow any applicable local battery disposal laws.
Cleaning the fingertip pulse oximeter
Please use medical alcohol to clean the silicone touching the finger inside of oximeter with a soft cloth dampened with 70
% isopropyl alcohol. Also clean the finger being tested using alcohol before and after each test.
Do not pour or spray liquids onto the oximeter, and do not allow any liquid to enter any openings in the device. Allow the oximeter
to dry thoroughly before reuse.
The fingertip pulse oximeter requires no routine calibration or maintenance other than replacement of batteries.
The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one
measurement. Stop using and contact local service center if one of the following cases occurs:
 An error in the Possible Problems and solutions is displayed on screen.
 The oximeter cannot be powered on in any case and not the reasons of battery.
 There is a crack on the oximeter or damage on the display resulting readings cannot be identified; the spring is invalid; or
the key is unresponsive or unavailable.
Specifications
1. Display Type
LED/LCD display
2. SpO2
Display range: 0%~100%
Measurement range: 70%~100%
Accuracy: 70%~100%±2digits; 0%~69% no definition
Resolution: 1%
ARMS Value Analysis
Item 70--100 90--100 80--<90 70--<80
#pts 231 82 89 60
Bias 1.10 0.49 1.35 1.62
ARMS 1.68 1.09 1.77 2.14
Bland-Altman plot analysis of sampled data points on all subjects as below
Note: A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. Clinical testing is used to
establish the SpO2 accuracy. The measured arterial hemoglobin saturation value (SpO2) of the sensors is compared to arterial
hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in
comparison to the CO-oximeter samples measured over the SpO2 range of 70%~100%. Accuracy data is calculated using the
root-mean-squared (Arms value) for all subjects, per ISO 9919:2005, Medical Electrical Equipment–Particular requirements for the
basic safety and essential performance of pulse oximeter.
A functional tester is used to measure how accurately Fingertip Pulse Oximeter is reproducing the specified calibration curve
and the PR accuracy.
The model of functional tester is Index2 FLUKE simulator and the version is 2.1.3.
3. Pulse Rate
Display range: 0bpm~250bpm
Measure range: 30bpm~250bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~250bpm, ±2%
Resolution: 1bpm
4. Probe LED Specifications
Wavelength Radiant Power
RED 660 ±2nm 3.2mW
IR 905 ±10nm 2.4mW
NOTE: The information about wavelength range can be especially useful to clinicians.
5. Power Requirements
Two AAA alkaline Batteries
Power consumption: Less than 25mA
Battery Life: Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as 16 hours.
6. Environment Requirements
Operation Temperature: 5℃～ 40℃
Concord Oximeter
Concord Emerald CCI-300-OG
Concord Sapphire CCI-300C3-BLUE
Concord Topaz
CCI-300C
Concord Pink CCI-300-PINK

Storage/ Transport Temperature: -20℃～+55℃
Ambient Humidity: ≤80% no condensation in operation; ≤93% no condensation in storage/transport
Atmosphere pressure: 86kPa～106kPa
7. Equipment data update period
As shown in the following figure. Data update period of slower average is 8s.
8. Classification
According to the type of protection against electric shock: INTERNALLY POWERED EQUIPMENT;
According to the degree of protection against electric shock: TYPE BF APPLIED PART, (applied part: the rubber hole of the device);
According to the degree of protection against ingress of water: IPX1
According to the mode of operation: CONTINUOUS OPERATION
Possible Problems and Solutions
noituloS nosaer elbissoP smelborP
SpO2 or PR can not
be shown normally
1. Finger is not inserted correctly
2. Patient’s Oxyhemoglobin value is too low to be
measured
1.Retry by inserting the finge
r
2. Try some more times. If you can make sure no
problem exist in the product, please go to a
hospital timely for exact diagnosis.
SpO2 or PR is shown
unstably
1. Finger might not be inserted deep enough.
2. Finger is trembling or patient’s body is in movement
status.
1. Retry by inserting the finge
r
2. Try not to move
The oximeter can not
be powered on
1. Power of batteries might be inadequate or not be
there at all.
2. Batteries might be installed incorrectly.
3. The oximeter might be damaged.
1. Please replace batteries
2. Please reinstall the batteries
3. Please contact with local customer service
centre
Indication lamps are
suddenly off
1. The product is automatically powered off when no
signal is detected longer than 8 seconds
2. Power quantity of the batteries is started being
inadequate
1. Normal
2. Replace the batteries
“Error3” or
“Error4” is displayed
on screen
1. Low power
2. Receiving tube being shielded or damaged together
with broken connector.
3. Mechanical Misplace for receive-emission tube.
4. Amp circuit malfunctions.
1. Change batte
r
ies
2. Please contact local customer service center
3. Please contact local customer service center
4. Please contact local customer service center
retnec ecivres remotsuc lacol tc atnoc esaelP eruliaf si neercs eht snaem 6 rrE 6 rorrE
“Error7” is displayed
on screen
1. Low power
2. Emission tube damaged.
3. Current control circuit malfunctions.
1 Please change battery
2 Please contact local customer service center
3 Please contact local customer service center
Symbol Definitions
noitinifeD lobmyS noitinifeD lobmyS
Type BF applied part. Attention.
Protected against dripping water. ﹪SpO2 Oxygen saturation
Pulse rate (BPM) Low power indication
No SpO 2 Alarm Power switch
Storage temperature and relative
humidity Follow instruction for use
Date of Manufacture SN Serial No.
Waste electrical and electronic
equipment Manufacturer’s information
Box Content
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
Notes:
1. The illustrations used in this manual may differ slightly from the appearance of the actual product.
2. The specifications are subject to change without prior notice.
Concord Health Supply, Inc.
Off: 888-970-2999
Fax: [phone]
www.ConcordHealthSupply.com
Version:Ver4.0
ALL RIGHTS RESERVED
Issue date: September 24, 2019