Medline HCSM70S User manual

LANYARD USE
MAINTENANCE AND STORAGE
SPECIFICATIONS
BATTERY INSTALLATION
SOFT-TOUCH
FINGER PULSE OXIMETER
This manual describes the Pulse Oximeter’s operation, features, functions, specifications, usage, repair,
maintenance and storage; as well as warnings and safety procedures to protect the user and equipment.
INDICATIONS FOR USE
The Fingertip Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen
saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals,
hospital-type facilities and homecare.
CONTRAINDICATIONS
This device is not intended for continuous monitoring.
PRECAUTIONS FOR USE
Please read the User Manual carefully before using this product. The User Manual describes operating proce-
dures that should be strictly followed. 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 users'
negligence of the operation instructions. The manufacturer’s warranty service does not cover such faults.
This product is designed for ongoing, multiple-patient usage with an operating life of 5 years.
If you have any questions regarding to the use of this product, please call 1-800-MEDLINE.
CAUTIONS
Before use, carefully read the manual.
Operation of the fingertip pulse oximeter may be affected by the use of an electrosurgical unit (ESU).
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 mea-
surement.
Do not use the fingertip pulse oximeter in an MRI or CT environment.
Do not use the fingertip pulse oximeter in situations where alarms are required. The device has no alarms.
It is not for continuous monitoring.
Do not use the fingertip pulse oximeter in an explosive atmosphere.
The fingertip pulse oximeter is intended only as an adjunct in patient assessment. It must be used in con-
junction 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 equip-
ment 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 affect 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
are all pass the ISO10993-5 Tests for in vitro cytotoxicity and ISO10993-10 Tests for irritation and de-
layed-type hypersensitivity.
Rx only: Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed
practitioner.
PRODUCT FEATURES
1. Simple to operate and convenient to carry.
2. Small volume, light weight and low power consumption.
3. Dual color OLED displays SpO2, PR, PI (Perfusion Index), Pulse bar, and waveform.
4. Seven display modes
5. Level 1-10 adjustable brightness.
6. Two pcs AAA-size alkaline batteries; real-time battery status indication.
7. The device automatically shuts off after no operation in 8 seconds when “finger out" displays.
8. Multiple-patient reusability.
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.
6. The display modes are as follows.
HCSM70S
Notes:
The pulse bar less than 30% indicates signal inadequacy and the displayed SpO2 or pulse rate value is
potentially incorrect.
If the screen displays “?”, it means the signal is unstable, please keep your hands still and retry.
PI means Perfusion Index.
1. Slide the battery door cover horizontally along the arrow shown as the picture.
2. Install two AAA batteries into the battery compartment. Match the plus (+) and minus (-) signs in the com-
partment. If the polarities are not matched, damage may be caused to the oximeter.
3. Close the battery door cover.
Notes:
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 starts flickering.
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!
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 -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 the fingertip pulse oximeter
Please use medical alcohol to clean the silicone that touches 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 due to low battery power.
There is a crack on the oximeter or damage to the display resulting in readings that cannot be identified; the
spring fails to hold the device in place; or the key is unresponsive or unavailable.
Disinfecting
The applied parts touching the patient’s body are required to be disinfected once after each use. The recom-
mended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehyde-type 2% liquid disinfectants.
Disinfection may cause damage to the equipment and is therefore not recommended for this pulse oximeter
unless otherwise indicated in your hospital’s servicing schedule. Clean the pulse oximeter before disinfecting it.
CAUTION: Never use EtO or formaldehyde for disinfection.
1. Display Type
OLED display
2. SpO2
Display range: 0%~100%
Measurement range: 70%~100%
Accuracy: 70%~100%±2%; 0%~69% no definition
Resolution: 1%
3. Pulse Rate
Display range: 30bpm~250bpm

SYMBOL DEFINITIONS
WARRANTY
POSSIBLE PROBLEMS AND RESOLUTIONS
CLINICAL SUMMARY STUDY
BOX CONTENTS
www.medline.com
Manufactured in China for Medline Industries, Inc.
Three Lakes Drive, Northfield, IL 60093 USA.
1.800.MEDLINE V1 RA20BCE ALL RIGHTS RESERVED
Measure range: 30bpm~250bpm
Accuracy: 30bpm~99bpm, ±2bpm; 100~250bpm, ±2%
Resolution: 1bpm
4. Perfusion Index
Display range: 0.1%~20.0%
Measure range: 0.2%~20.0%
Accuracy: 0.2%~1.0%, ±0.2digits; 1.1%~20.0%, ±20%
Resolution: 0.1%
5. Probe LED Specifications
Measuring Range Wavelength Radiant Power
RED 660±3nm 3.2mW
IR 905±10nm 2.4mW
6. Power Requirements
Two AAA alkaline Batteries
Power consumption: Less than 40mA
Battery Life: Two AAA 1.5V, 1200mAh alkaline batteries could be continuously operated as long as 24 hours.
7. Environment Requirements
Operation Temperature: 5°C~40°C
Storage Temperature: -25°C~+70°C
Ambient Humidity: 15%~93% no condensation in operation; ≤93% no condensation in storage/transport
Atmosphere pressure: 70kPa~106kPa
8. Equipment Response Time
As shown in the following figure.
Response time of slower average is 8 seconds.
9. Equipment Response Time
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 (The application part is
rubber inside of the Pulse Oximeter);
According to the degree of protection against ingress of water: IP22
According to the mode of operation: CONTINUOUS OPERATION
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 for HCSM70S is
shown as following:
ARMS Value Analysis Statement
Item 90--100 80--<90 70--<80
#pts 78 66 63
Bias 1.02 0.40 -0.48
ARMS 1.66 1.46 1.93
Problems Possible causes Solution
SpO2 or PR
cannot be
shown nor-
mally
1. Finger is not inserted
correctly
2. Patient’s SpO2 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 exists 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. 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 Medline customer
service at 1-800-MEDLINE
Indication
lamps are
suddenly off
1. The product is automatically
powered off when no signal
is detected longer than 8
seconds
2. The battery power is too
low to work
1. Normal
2. Replace the batteries
“Error 7” is
displayed on
screen
Err 7 means all the emission
LED or reception diode is
damaged
Please contact Medline customer
service at 1-800-MEDLINE
Symbol Definition
Type BF equipment (Refer to IEC 60601-1)
IP22 Protected against dripping water
PR bpm Pulse rate (BPM)
Attention
SpO2﹪ Oxygen saturation
Low power indication
No SpO2 Alarm
Storage temperature and relative humidity
Manufacturer’s information
Power Switch
SN Serial No.
Follow instruction for use
Date of Manufacture
? Indicate the signal is not stable
Waste electrical and electronic equipment
+70°C
max
-25°C
min RH 93%
non-condensing
1. Fingertip pulse oximeter
2. One lanyard
3. Two AAA batteries
4. One instruction manual
Warranty Length: 1 year