Medline HCSM70P User manual

PULSE OXIMETER
GENERAL DESCRIPTION FRONT PANEL
BATTERY INSTALLATION
USING THE LANYARD
MAINTENANCE AND STORAGE
SPECIFICATIONS
MEASUREMENT PRINCIPLE
PRECAUTIONS FOR USE
CONTRAINDICATION
INACCURATE MEASUREMENTS MAY BE CAUSED BY
PRODUCT FEATURES
INTENDED USE
OPERATION INSTRUCTIONS
Oxygen Saturation is a percentage of Oxyhemoglobin (HbO2) capacity, compounded with oxygen, by all combinative hemoglobin (Hb)
capacity in blood. In other words, it is consistency of Oxyhemoglobin in blood. It is a very important parameter for the Respiratory
Circulation System. Many respiratory diseases can result in oxygen saturation being lowered in human blood. Additionally, the following
factors can reduce oxygen saturation: Automatic regulation of organ dysfunction caused by Anesthesia, Intensive Postoperative Trauma,
injuries caused by some medical examinations. That situation might result in light-headedness, asthenia, and vomiting. Therefore, it is
very important to know the oxygen saturation of a patient so that doctors can find problems in a timely manner.
The fingertip pulse oximeter features low power consumption, convenient operation and portability. Place one fingertip into the
photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display. It has been proven in clinical
experiments that it also features high precision and repeatability.
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 (HbO2) 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 Tub
1. Before use, carefully read the manual.
2. Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
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. Do not use the fingertip pulse oximeter in an MRI or CT environment.
5. Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms. It is not for continuous
monitoring.
6. Do not use the fingertip pulse oximeter in an explosive atmosphere.
7. The fingertip 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.
8. 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.
9. Do not sterilize the device using autoclaving, ethylene oxide sterilizing, or immersing the device in liquid. The device is not intended
for sterilization.
10. Follow local ordinances and recycling instructions regarding disposal or recycling of the device and device components, including
batteries.
11. This equipment complies with IEC 60601-1-2:2007 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.
12. Portable and mobile RF communications equipment can affect medical electrical equipment.
13. This equipment is not intended for use during patient transport outside the healthcare facility.
14. This equipment should not be used adjacent to or stacked with other equipment.
15. Do not disassemble, repair or modify the equipment without authority.
16. 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.
17. These materials that contact with the patient’s 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.
Rx only: “Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.”
It is not for continuous monitoring.
1. Significant levels of dysfunctional hemoglobin (such as carbonyl - hemoglobin or methemoglobin).
2. Intravascular dyes such as indocyanine green or methylene blue.
3. High ambient light. Shield the sensor area if necessary.
4. Excessive patient movement.
5. High-frequency electrosurgical interference and defibrillators.
6. Venous pulsations.
7. Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.
8. The patient has hypotension, severe vasoconstriction, severe anemia, or hypothermia.
9. The patient is in cardiac arrest or is in shock.
10. Fingernail polish or false fingernails.
11. Weak pulse quality (low perfusion).
12. Low hemoglobin.
1. Simple to operate and convenient to carry.
2. Small volume, light weight and low power consumption.
3. OLED display SpO2, PR, and Pulse bar.
4. Level 1-10 adjustable brightness.
5. 6 display modes.
6. 2pcs AAA-size alkaline batteries; battery-low indicator.
7. When no or low signal is detected, the pulse oximeter will power off automatically in 8 seconds.
Fingertip pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate of adult and pediatric patients in hospitals, hospital-type facilities.
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.
6. Press the button again to toggle between six display modes.
After turning on the Oximeter, each time you press the power switch, the Oximeter will switch to another display mode.
There are 6 display modes shown as follows:
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2 and pulse rate value is potentially incorrect.
1. Open the battery door cover shown as the picture.
2. 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.
3. Close the battery door cover.
Note:
¤Please remove the batteries if the pulse oximeter will not be used for long periods of time.
¤Please replace the battery when the low battery power indicator.
1. Thread thinner end of the lanyard through the hanging hole.
2. Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
¤Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.
¤Do not hang the lanyard from the device’s electrical wire.
¤Please notice that the lanyard which is tied to the oximeter may cause strangulation due to excessive length.
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 -20°C~+55°C 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 being tested finger 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 ofthe 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.
1. Display Type
OLED display
2. SpO2
Display range: 0%~99%
Measurement range: 70%~99%
Accuracy: 70%~99%: ±3%; 0%~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
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 equipment for medical use.
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~235bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100bpm~235bpm, ±2%
Resolution: 1bpm
4. Probe LED Specifications
Wavelength Radiant Power
RED 660±2nm 1.8mW
IR 940±10nm 2.0mW
NOTE: The information about wavelength range can be especially useful to clinicians.
5. Power Requirements
Two AAA alkaline Batteries
Power consumption: Less than 30mA
Battery Life: Two AAA 1.5V, 600mAh alkaline batteries could be continuously operated as long as 30 hours.
HCSM70P
Holding the power switch for longer than one second, will adjust the brightness of the oximeter. There are 10 levels of brightness.
The default is level four.

DECLARATION
POSSIBLE PROBLEMS AND SOLUTIONS
SYMBOL DEFINITIONS
BOX CONTENT
Guidance and Manufacturer’s declaration-electromagnetic emissions-
For all EQUIPMENT and SYSTEMS
Guidance and Manufacturer’s declaration-electromagnetic immunity-
For all EQUIPMENT and SYSTEMS
Recommended separation distances between portable and mobile RF communications equipment and
the EQUIPMENT or SYSTEMS - For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacturer’s declaration-electromagnetic immunity-
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacturer’s declaration - electromagnetic emission
The HCSM70P Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of
HCSM70P Pulse Oximeter should assure that it is used in such an environment.
Emission test Compliance Electromagnetic Environment - guidance
RF emissions CISPR 11 Group 1 The HCSM70P Pulse Oximeter uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emission CISPR 11 Group B The Pulse Oximeter HCSM70P is suitable for use in all establishments,
including domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions IEC
61000-3-2
Not Applicable
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Not Applicable
Problems Possible reason Solution
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 finger
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 finger
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 center
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
“Error 3” or “Error 4” 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 batteries
2.Please contact local customer service center
3.Please contact local customer service center
4. Please contact local customer service center
Error 6 Err 6 means the screen is failure Please contact local customer service center
“Error 7” 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
Guidance and Manufacturer’s declaration - electromagnetic immunity
The HCSM70P Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of
the HCSM70P Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Level Electromagnetic Environment – guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
+/- 6kV contact
+/- 8kV air
+/- 6kV contact
+/- 8kV air
Floors should be wood, concrete or ceramic tile.
If floor are covered with synthetic material, the
relative humidity should be at least 30%.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be at levels
characteristics of a typical location in a typical
commercial or hospital environment.
Recommended separation distances between
portable and mobile RF communications equipment and Pulse Oximeter (HCSM70P)
The Pulse Oximeter (HCSM70P) is intended for use in electromagnetic environment in which radiated RF disturbances are con-
trolled. The customer or the user of the Pulse Oximeter (HCSM70P) can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter (HCSM70P)
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.1167 0.2334
0.1 0.3689 0.7378
1 1.1667 2.3334
10 3.6893 7.3786
100 11.6667 23.3334
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Guidance and Manufacturer’s declaration - electromagnetic immunity
The HCSM70P Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of
the HCSM70P Pulse Oximeter should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Level Electromagnetic Environment – guidance
Radiated
RF
IEC
61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m Portable and mobile RF communications equipment should be
used no closer to any part of the Pulse Oximeter (HCSM70B),
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in meters (m). Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a, should be less
than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment marked
with following symbol:
NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations, Electromagnetic propagation is affected by absorption and reflection
structures, objects and people.
a. Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Pulse Oximeter (HCSM70P) should be observed to verify normal operation. If abnormal
performance is observed, additional measurements may be necessary, such as reorienting of the relocating the Pulse Oximeter
(HCSM70P).
b. Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/m
Symbol Definition Symbol Definition
Type BF applied part. Serial No.
Caution Follow instruction for use
Protected against dripping
water. PR bpm Pulse rate (BPM)
Oxygen saturation Low power indication
No SpO2 Alarm Storage temperature and
relative humidity
Manufacturer’s information Date of Manufacture
Waste electrical and
electronic equipment
SN
SpO2
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
5. One silicone case
6. One carrying bag
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.
www.medline.com Made in China.
Manufactured for Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA.
1.800.MEDLINE V3 RC22BCE
ALL RIGHTS RESERVED
6. Environment Requirements
Operation Temperature: 5°C~40°C
Storage/ Transport Temperature: -20°C~+55°C
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 12.4s.
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