Maintenance and Storage
1.
Replace the batteries in a timely manner when low voltage lamp is lighted.
2.
Clean surface of the 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 -25
℃
~
+
70
℃
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 and disinfecting the device
＊
It is recommended to clean and disinfect the silicone touching the finger inside of device with a soft cloth
dampened with recommended alcohol of 70% isopropyl or 70% ethanol before and after each use.
＊
Excessive disinfection may cause damage to the device and is therefore not recommended for this device
unless oth
erwise indicated in your hospital’s servicing schedule.
＊
Do not pour or spray liquids onto the device and do not allow any liquid to enter any openings in the device.
Allow the device to dry thoroughly before reuse.
Caution:
Never use EtO (ethylene oxide) or formaldehyde for disinfection.
The use life of the device is five years when it is used for 15 measurements every day and 10 minutes per one
measurement. The Oximeter requires no routine calibration or maintenance other than replacement of batteries.
Specifications
1. Display Type
LCD display
2. SpO
2
Measurement range: 70%~100%
Accuracy: 70%~100%: ±2%;
≤69% no definition
Resolution: 1%
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 SpO
2
accuracy. The measured arterial hemoglobin saturation value (SpO
2
) of the
sensors is compared to arterial hemoglobin oxygen (SaO
2
) 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 SpO
2
range of 70%~100%. Accuracy data is calculated using the root-mean-squared (Arms value) for all
subjects, per ISO 80601-2-61, Medical Electrical Equipment
–
Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use.
A functional tester is used to measure how accurately 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
Measure range: 30bpm~250bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100~250bpm, ±2%
Resolution: 1bpm
4. Perfusion Index
Measure range: 0.3%~20.0%
5. Probe LED Specifications
RED Wavelength: 660±3nm Radiant Power: 3.2mw
IR Wavelength: 905±10nm Radiant Power: 2.4mw
(NOTE:
The information about wavelength range can be especially useful to clinicians).
6. Power Requirements
Two AAA alkaline Batteries
Power consumption: Less than 40mA
7. Environment Requirements
Operation Temperature: 5
℃
~40
℃
Storage Temperature: -25
℃
~+70
℃
Ambient Humidity: 15%~93% no condensation in operation;
≤93% no condensation in storage/transport
Atmosphere pressure: 70kPa~106kPa
Notes: When the ambient temperature is 20°C, it is required 6 hours for the equipment to warm from the minimum storage
temperature or 4 hours to cool from the maximum storage temperature between uses until it is ready for its intended use.
8. Equipment Response Time: a
s shown in the following figure, average data update period is 8s.
9. 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: IP22
According to the mode of operation: continuous operation
Clinical Study Summary
The following details are provided to disclose actual performance observed in the clinical validation study of healthy
adult volunteers. The ARMS value analysis statement and Bland-Altman plot of data are shown as follows:
ARMS Value Analysis Statement
Item
70--100
90--100
80--<90
70--<80
70-<90
#pts
227
91
81
55
136.00
Bias
0.99
0.73
1.44
0.74
1.16
ARMS
1.80
1.16
2.04
2.21
2.11
Bland-Altman Plot Graphic
Possible Problems and Solutions
Problems
Possible reason
Solution
SpO
2
or PR cannot
be shown normally.
1. Finger is not inserted correctly.
2.
Patient’s SpO
2
value is too low to be
measured.
1. Retry by inserting the finger.
2. There is excessive illumination.
3. Try some more times. If you can make sure
no problem exist in the product, please go to a
hospital timely for exact diagnosis.
SpO
2
or PR is
shown unstably.
1. Finger might not be inserted deep enough.
2. Excessive patient movement.
1. Retry by inserting the finger.
2. Be calm.
The oximeter
cannot be powered
on.
1. No battery or low power of battery.
2. Batteries might be installed incorrectly.
3. The oximeter might be damaged.
1. Please replace batteries.
2. Please reinstall the batteries.
3. Please contact local customer service center.
Indication lamps
are suddenly off.
1. The product is automatically powered off
when no signal is detected longer than 8s.
2. The battery power is too low to work.
1. Normal.
2. Replace the batteries.
“Err 7” is displayed
on screen.
Err 7 means all the emission LED or
reception diode is damaged.
Please contact local customer service center.
Symbol Definitions
Symbol
Definition
Symbol
Definition
Type BF applied part
Attention
IP22
Protected against dripping water
%SpO
2
Oxygen saturation
PR bpm
Pulse rate (BPM)
Low power indication
No SpO
2
Alarm
Serial No.
Storage temperature and relative
humidity
Follow instruction for use
Manufacturer’s information
Date of Manufacture
Bluetooth indication
?
Indicate the signal is not stable
Waste electrical and electronic
equipment
Medical device
Electromagnetic Compatibility
The device conforms to IEC60601-1-2:2014 Electromagnetic Compatibility (EMC) standard.
Essential performance is defined as SpO
2
accuracy and pulse rate accuracy or an indication of abnormal operation.
Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments
listed in the intended use. If issues are experienced, move the device away from the source of electromagnetic disturbances.
Table 1: Electromagnetic Emissions Limits and Compliance
Emissions Test
Compliance
RF Emissions
CISPR 11
Group 1, Class B
Note: Harmonic Emissions (IEC 61000-3-2), Voltage Flicker Emissions (IEC 61000-3-3) are not applicable.
Table 2: Electromagnetic Immunity
Immunity Test
Compliance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Rated power Frequency Magnetic Fields
IEC 61000-4-8
30 A/m
50Hz and 60 Hz
Radiated RF
IEC 61000-4-3
80 MHz
– 2.7 GHz
10 V/m 80% AM 1kHz
380
– 390 MHz
27 V/m Pulse mod. 18Hz
430
– 470 MHz
28 V/m FM±5Hz deviation 1kHz sine
704
– 787 MHz
9 V/m Pulse mod. 217Hz
800
– 960 MHz
28 V/m Pulse mod. 18Hz
1.7
– 1.99 GHz
28 V/m Pulse mod. 217Hz
2.4
– 2.57 GHz
28 V/m Pulse mod. 217Hz
5.1
– 5.8 GHz
9 V/m Pulse mod. 217Hz
Note: Electrical Fast Transients (IEC 61000-4-4), Surge (IEC 61000-4-5), Voltage dips (IEC 61000-4-11), Conducted Immunity
(IEC 61000-4-6) are not applicable.
FCC Declaration
FCC ID: WWIMD300C228
Please take attention that changes or modification not expressly approved by the party responsible for compliance could
void the user’s authority to operate
the equipment.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may
cause undesired operation.
Box Content
1. One pulse oximeter 2. One lanyard 3. Two AAA batteries 4. One instruction manual
Applicable Models
MD300C208 MD300C228
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.