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SAFETY INFORMATION
• Carefully read all the provided information before use.
• Operation of the ngertip pulse oximeter may be aected by
the use of an electrosurgical unit (ESU).
• The ngertip pulse oximeter must be able to measure the pulse
properly to obtain an accurate SpO
2
measurement. Make sure
that nothing is hindering the pulse measurement before relying
on the SpO
2
measurement.
• Do not use the ngertip pulse oximeter in an MRI or CT
environment.
• Do not use the ngertip pulse oximeter in situations where
alarms are required. The device has no alarms. It is not for
continuous monitoring.
• Do not use the ngertip pulse oximeter in an explosive
atmosphere.
• The ngertip pulse oximeter is intended only as an adjunct in
patient assessment. It must be used in conjunction with other
methods of assessing clinical signs and symptoms.
• In order to ensure correct sensor alignment and skin integrity,
the maximum application time at a single site for our device
should be less than half an hour.
• Do not sterilize the device using autoclaving, ethylene oxide
sterilizing, or immersing the device in liquid. The device is not
intended for sterilization.
• Follow local ordinances and recycling instructions regarding
disposal or recycling of the device and device components,
including batteries.
• This equipment complies with IEC 60601 1 2:2014 for
electromagnetic compatibility for medical electrical equipment
and/or systems. However, because of the proliferation of radio
frequency transmitting equipment and other sources of
electrical noise in healthcare and other environments, 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.
• Portable and mobile RF communications equipment can aect
medical electrical equipment.
• This equipment is not intended for use during patient transport
outside the healthcare facility.
• This equipment should not be used adjacent to or stacked with
other equipment.
• 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.
• These materials that contact with the patient’s skin contain
medical silicone and ABS plastic enclosure and all pass the
ISO10993 5 Tests for invitro cytotoxicity and ISO10993 10 Tests
for irritation and delayed type hypersensitivity.
• When the signal is not stable, the reading may inaccurate.
Please do not reference.
MAINTENANCE & STORAGE
• Replace the batteries in a timely manner when the battery
indicator is blinking.
• Clean the surface of the ngertip oximeter before it is used in
diagnosis for patients.
• Remove the batteries if the oximeter is not used for a long time.
• It is best to store the product in -13°~158°F (-25°~70°C) and ≤
93% humidity.
• Keep in a dry place. Extreme moisture may aect oximeter
lifetime and may cause damage.
• Dispose of the batteries properly. Follow any applicable local
battery disposal laws.
Cleaning the ngertip pulse oximeter
• Disinfection may cause damage to the equipment and is therefore
not recommended for this pulse oximeter. If you do need to
disinfect the oximeter, clean it before disinfection.
CAUTION: Never use EtO or Formaldehyde for disinfection.
• Use medical alcohol to clean the silicone touching the nger inside
the oximeter with a soft cloth dampened with 70% isopropyl
alcohol.
Note: Do not immerse the oximeter in disinfectant or sterilizer.
• Clean the nger being tested with alcohol before and after each
test. The recommended disinfectants include: ethanol 70%,
isopropanol 70%, and glutaraldehyde type 2% liquid disinfectants.
• 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 pulse oximeter requires no routine calibration or maintenance
other than replacement of batteries.
The use life of the device is ve years when it is used for 15
measurements every day and 10 minutes per one
measurement. Stop using and contact customer service if any
of the following occurs:
• "Err7" (indicating the emission LED or reception diode is damaged)
is displayed on screen.
• The oximeter won't turn on after replacing the batteries.
• There is a crack on the oximeter or damage on the display resulting
in reading that cannot be identied, the spring is invalid, or the key
is unresponsive or unavailable.
SPECIFICATIONS
Dimensions (H × W × D): 1.3 × 1.4 × 2.3 in. (34 × 36 × 58 mm)
Weight (with batteries): 0.1 lbs. (50 g)
Display Type: OLED display
SpO
2
:
• Display range: 0%~100%
• Measurement range: 70%~100%
• Accuracy: 70%~100% ±2 %; 0%~69% no denition
• Resolution: 1%
Note:
A functional tester can't 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 9919:2005, 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 Fingertip Pulse
Oximeter is reproducing the specied calibration curve and the PR
accuracy.
The model of functional tester is Index2 FLUKE simulator and the
version is 2.1.3.
Pulse Rate
• Display range: 0 bpm~250 bpm
• Measure range: 30 bpm~250 bpm
• Accuracy: 30 bpm~99bpm, ±2 bpm;
100 bpm ~250 bpm, ±2%
• Resolution: 1bpm
Probe LED
• 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.
Power Requirements
• Two AAA alkaline batteries
• Power consumption: Less than 40 mA
Environment Requirements
• Operation Temperature: 41˚F~104˚F (5˚C~40˚C)
• Storage Temperature: -13˚F~+158˚F (-25˚C~+70˚C)
• Ambient Humidity: 15%~93%
no condensation in operation; ≤93% no condensation in
storage/transport
• Atmosphere pressure: 70 kPa~106 kPa
Inaccurate measurements may be caused by:
• Signicant levels of dysfunctional hemoglobin (such as carbonyl
hemoglobin or methemoglobin).
• Intravascular dyes such as indocyanine green or methylene blue.
• High ambient light. Shield the sensor area if necessary.
• Excessive patient movement.
• High frequency electrosurgical interference and debrillators.
• Venous pulsations.
• Placement of a sensor on an extremity with a blood pressure cu,
arterial catheter, or intravascular line.
• The patient has hypotension, severe vasoconstriction, severe
anemia, or hypothermia.
• The patient is in cardiac arrest or is in shock.
• Fingernail polish or false ngernails.
• Weak pulse quality (low perfusion).
• Low hemoglobin.
TROUBLESHOOTING
SYMBOL DEFINITIONS
ONEYEAR LIMITED
WARRANTY
Visit www.insigniaproducts.com for details.
CONTACT INSIGNIA:
1-877-467-4289 (U.S. and Canada)
1-800-926-3000 (Mexico)
www.insigniaproducts.com
INSIGNIA is a trademark of Best Buy and its aliated companies
Distributed by Best Buy Purchasing, LLC
7601 Penn Ave South, Richeld, MN 55423 U.S.A.
©2020 Best Buy. All rights reserved.
Oxygen saturation
(SpO
2
) or pulse
rate (PR) is not
normal.
Oxygen saturation
(SpO
2
) or pulse
rate (PR) is not
stable.
The oximeter
cannot
be turned on.
The screen
suddenly turned
o.
“Err7” is displayed
on screen.
• Finger is not inserted
correctly.
• Patient’s SpO
2
value is
too low to be
measured.
• Finger might not be
inserted deep enough.
• Excessive patient
movement.
• The battery power is
low.
• Batteries are installed
incorrectly.
• The oximeter is
damaged.
• The oximeter
automatically turns o
when no signal is
detected for longer
than eight seconds.
• The battery power is
low.
The emission LED or
reception diode is
damaged.
• Remove your finger and
reinsert it. Try a few times to
make sure your finger is
correctly positioned.
• Exposed to direct sunlight
• Insert a different finger into
the oximeter.
• If your numbers are not
normal, see your doctor for
an exact diagnosis.
• Remove your finger and
reinsert it. Try a few times to
make sure your finger is
correctly positioned.
• Make sure that your nger,
hand, and body are still while
taking a reading.
• Replace batteries
• Make sure that the batteries
are positioned correctly.
• Contact Customer Service.
• This is normal behavior.
• Replace the batteries.
Contact Customer Service.
PROBLEM
POSSIBLE REASONS SOLUTION
V2 English 21-0073
Type BF applied part.
Protected against dripping
water
Pulse rate (BPM)
No SpO2 Alarm
Storage temperature and
relative humidity
Date of Manufacture
Conformity to WEEE
Directive
DEFINITION
SYMBOL
DEFINITION
SYMBOL
Attention
Oxygen saturation
Low power
indication
Serial No
Follow instruction
for use
Manufacturer’s
information
NS-PSOXMW1_21-0073_QSG_V2_EN.ai 2 1/13/2021 12:36:24 PM