Drive Medical 18715 User manual

HANDY OX
HAND HELD
PULSE OXIMETER
INSTRUCTION
MANUAL
Model # 18715

Oximeter Series PULSE OXIMETER INSTRUCTION MANUAL
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Contents
1 Introduction ................................................ 3
1.1 Brief Introduction ................................. 3
1.2 Safety Information................................. 3
1.3 Equipment symbols ............................... 8
1.4 Electromagnetism interference...................... 9
1.5 Equipment classification ........................... 9
1.6 Accessory....................................... 10
2 General Descriptions ....................................... 11
2.1 Front panel ...................................... 11
2.2 Rear panel....................................... 13
2.3 Right-side panel.................................. 16
2.4 Product features ................................. 16
2.5 Intended use..................................... 16
3. Getting started ............................................ 16

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4 .Take a measurement ....................................... 19
5. Maintain and Cleaning...................................... 25
5.1 Safety Checks ................................... 26
5.2 Calibration and Verification........................ 28
5.3 Warranty ........................................ 27
APPENDIX A Specifications ................................... 30
APPENDIX B ................................................ 34

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1 Introduction
1.1 Brief Introduction
Thank you for purchasing this handheld pulse oximeter. The
device is designed to measure oxygen saturation (SpO2) and
Pulse Rate (PR), delivering visual and audio alarm. Please read
this manual carefully before using it.
1.2 Safety Information
Concepts of Warning, Caution and Notice
The Warning, Caution and Notice labels in this document are
intended to facilitate safe user operation of this product.
Warning - Indicates a potential hazard or unsafe practice
that, if not avoided, will result in death or serious injury.
Caution - Indicates a potential hazard or unsafe practice
that, if not avoided, could result in minor personal injury or
product/property damage.
Notice: - Provides application tips or other useful
information to ensure that you get the most from your
product.
WARNINGS
Before putting the system into operation, verify that the
equipment, connecting cables and accessories are in correct
working order and operating condition.
Do not use the oximeter in the presence of flammable
anesthetics, vapors or liquids.

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Do not use the oximeter in an MRI or CT environment.
Do not open the equipment housings; electric shock hazard
may exist. All servicing and future upgrades must be carried
out by the personnel trained and authorized by our company
only.
The pulse oximeter is specified for use by medical
professionals only.
Prolonged use of the probe/sensor or the patient’s condition
may require changing the sensor site periodically. Change the
sensor site and check skin integrity, circulatory status, and
correct alignment at least every 4 hours. Prolonged use may
cause blisters, skin deterioration, and discomfort.
When connecting this oximeter to any instrument, verify
proper operation before clinical use. Refer to the instrument’s
user manual for full instructions. The equipment connected to
the pulse oximeter’s data interface must be certified
according to the respective IEC standards, i.e., IEC950 for
data processing equipment or IEC 601-1 for medical electrical
equipment. All combinations of equipment must be in
compliance with IEC601-1-1 systems requirements.
Sensor malfunction may cause inaccurate data possibly
resulting in patient injury or death, so pay close attention to
the sensor and inspect it often.
The physiological data and alarm messages displayed on the
equipment are for reference only and cannot be directly used

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for diagnostic interpretation.
Do not rely exclusively on the audible alarm system for patient
monitoring. Adjustment of alarm volume to “off”may result in
a hazard to the patient. Remember that alarm settings should
be customized according to different patient situations and
always keeping the patient under close surveillance is the
most reliable way for safe patient monitoring.
Worn-out data cables may also cause inaccurate data, so if
the data is used as a reference to treat a patient, pay special
attention to data cable and check it more frequently.
When using the equipment with electrosurgical units (ESU),
make sure the patient is safe.
Do not come into contact with the patient during defibrillation.
Otherwise serious injury or death could result.
Single-use accessories should never be reused.
To avoid inadvertent disconnection, route all cables in a way
to prevent a stumbling hazard. Wrap and secure excess
cabling to avoid risk of entanglement or strangulation by
patients or personnel.
CAUTIONS
Autoclaving, ethylene oxide sterilizing, or immersing the
sensors in liquid may cause inaccurate readings.
To ensure patient safety, use only parts and accessories
specified in this manual.

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The operator must be thoroughly familiar with the information
in this manual before using the device.
Unplug the sensor from the oximeter before cleaning or
disinfecting it.
If liquid is accidentally spilled on the unit, clean and dry
thoroughly before reuse.
Do not try to use the SpO2and NIBP measurement on the
same arm at the same time. This could potentially affect
measurement accuracy.
At the end of its service life, the equipment, as well as its
accessories, must be disposed of in compliance with the
guidelines regulating the disposal of such products.
Always install or carry the equipment properly to avoid
damage caused by drop, impact, strong vibration or other
mechanical force.
NOTES
Put the equipment in a location where you can easily see the
screen and access the operating controls.
Keep this manual in the vicinity of the equipment so that it can
be obtained conveniently when needed.
The software was developed in compliance with
IEC60601-1-4. The possibility of hazards arising from
software errors is minimized.
SpO2measurements may be influenced by high ambient light,

Oximeter Series PULSE OXIMETER INSTRUCTION
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especially sunlight. Shield the sensor area if necessary.
Dyes introduced into the bloodstream, such as methylene
blue, indocyanine green, indigo carmine, and fluorescein,
may influence the accuracy of the SpO2reading.
Any condition that restricts blood flow, such as use of a blood
pressure cuff or extremes in systemic vascular resistance,
may cause a failure to determine accurate pulse rate and
SpO2readings.
Remove fingernail polish or artificial fingernails before
applying SpO2sensors. Fingernail polish or artificial
fingernails may cause inaccurate SpO2readings.
Optical cross-talk can occur when two or more sensors are
located in adjoining areas. It can be eliminated by covering
each site with opaque material. Optical cross-talk may
adversely affect the accuracy of the SpO2readings.
Obstructions or dirt on the sensor’s red light or detector may
cause a sensor failure. Make sure there are no obstructions
and the sensor is clean.
For routine equipment maintenance, please refer to the
service procedures at the associated section as indicated in
the manual.
As to the other concerns for attention, please carefully look
through the specific chapter in this instruction.

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This manual describes all features and options. Your
equipment may not have all of them.
Federal Law restricts this device to sale by or on the order of
a physician.
1.3 Equipment symbols
Symbol
s
Definitions
Attention！Read the operator’s manual carefully before
using the oximeter.
Type BF applied part
Production date
Manufacturer’s address.
Low power indicator
European union approval

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SN
Serial number
1.4 Electromagnetism interference
This oximeter is designed and tested in compliance with the EMC
standard, complying with the international standard for the EMC of
the electronic medical device - IEC 60601-1-2. However, because of
the proliferation of radio frequency transmitting equipment and other
sources of electrical noise in the health-care and home
environments (e.g. cellular phones, mobile two-way radios, electrical
appliances) it is possible that high levels of such interference due to
close proximity or strength of a source, may result in disruption of
performance of this device.
This apparatus complies with the IEC 60601-1-2 international
standard. The requirements of this international standard are:
CISPR11, GROP1, and CLASS B.
1.5 Equipment classification
Classification according to IEC-60601
According to the type of
protection against
Electrical shock:
Internal electrical power
source equipment
According to the degree of
protection against
Type B equipment

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Electrical shock:
According to the degree of
protection against harmful
ingress of water.
Ordinary equipment (enclosed
equipment without protection
against ingress of water)
According to the methods
of sterilization or
disinfection
Non-sterilizable: Use of Liquid
surface disinfectants only.
According to the mode of
operation:
continuous operation
Equipment not suitable for use in the presence of a flammable
anesthetic mixture air or with oxygen or nitrous oxide.
1.6 Accessory
Standard accessories:
1. Two AA-Size Alkaline batteries
2. Operator’s manual
3. One finger sensor
4. One bind
Specification for SpO2Sensor

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2 General Descriptions
The handheld pulse oximeter adapts 8-segment digital LED for
displaying data. It can display the SpO2and pulse rate value
pulse bar as well as battery status etc.
2.1 Front panel
Please refer to Fig 1. The display in fig.1 is normal screen.

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Fig1 Front panel
Instruction of figure 1：
1, SpO2：SpO2value
2, PR：Pulse rate
3, ：Low power indicator. When the power is lower than 2.4V,
the lamp indicated by it will be lighted. And the oximeter will

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power off automatically when the power is lower than 2.3V.
4, Alarm Indicator：When technical alarm or physiological
alarm occurs, the lamp indicated by it will turn red.
5, Power button
6. Pulse bar：The pulse bar is in proportion to the Pulse
volume.
Note: This manual describes all features and options. Your
equipment may not have all of them.
2.2 Rear panel

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Fig.2 Rear panel
Rear panel introduction:
1: Batteries
2: Fixing hole
3: Fixing screw
4: Battery Wharf cover
Batteries Installation :
1) Open the battery cover: Rotate the fixing screw slightly in the
rear panel to the up position which is marked with “ ” and then
open the cover.
2) Install 2 batteries lightly as indicated by the polarity sign.
Note: Be sure to insert the batteries in the correct polarity, as
indicated by polarity markings (+ and -) inside the battery wharf.

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3) Close battery cover: Close the battery cover and rotate the
screw to the position. And the batteries are locked.
Make sure that the polarity of the batteries is
correct. Otherwise the unit cannot operate normally.
Battery life and replacement
When the low-power indication lamp is lighted, please replace
the batteries with new ones timely.
Always turn the unit off before replacing the batteries.
Dispose of the used batteries according to the applicable local
regulations.
Warnings!
If battery fluid should get into your eyes, immediately rinse with
plenty of clean water. Consult a doctor immediately.
Cautions!
Do not use batteries not specified for this unit. Do not insert
the batteries with the polarities in the wrong direction.
Do not dispose of batteries in fire.
If battery fluid should get on your skin or clothing, immediately
rinse with plenty of clean water.
Remove the batteries from this unit when you are not going to
use it for a long period of time (approximately three months or

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more).
Do not use batteries of a different type together.
Do not use new and used batteries together.
2.3 Right-side panel
A band delivered together with the oximeter can be inserted into
the 8-shape hole on the right side of the oximeter,. The band
can help with continuous operation.
2.4 Product features
Rubber grip design offers special protection
Compact, light-weight design for simple, one-hand operation
High brightness LED displays SpO2, pulse rate and pulse bar.
Visual & audio alarm, low battery alarm
Convenient 2 AA-size alkaline batteries
2.5 Intended use
The handheld pulse oximeter is intended for continuous
monitoring, spot-checking of functional pulse oxygen saturation
(%SpO2) and pulse rate (PR) of single adult, pediatric patients in
hospitals and home care.
3. Getting started
3.1 Unpacking and Checking
Before unpacking, examine the packing case carefully for
damage. If any damage is detected, contact the carrier. If the

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packing case is intact, open the package and remove the
equipment and accessories carefully. Check all materials as per
the packing list and check for any mechanical damage.
WARNINGS
Keep the packing material out of children’s reach. Disposal
of the packaging material should observe the applicable
waste control regulations.
The equipment might be contaminated during storage and
transport. Before use, please verify whether the packages,
especially the packages of the single use accessories, are
intact. In case of any damage, do not apply it to the patient.
3.2 Environmental Requirements
The operating environment of the equipment must meet the
requirements specified in this manual.
When the equipment is moved from one place to another,
condensation may occur as a result of temperature or humidity
difference. In this case, never start the system before the
condensation disappears.
Warning: Make sure that the operating environment of the
equipment meets the specific requirements. Otherwise the
equipment may not meet the specifications defined in this manual
and unexpected consequences, e.g. damage to the equipment, may
result.

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3.3 Connect the sensor
1. Before use, check the pulse oximeter for mechanical damage.
2. Install the alkaline batteries and ensure that the batteries
have sufficient power.
3. Plug the SpO2extension cable in the multifunctional
connector on top of the oximeter, as shown in figure 3. Ensure
that the sensor is firmly plugged in.
Fig.3
3.4. Starting or shutting off the oximeter
To start the pulse oximeter,
1. Press and hold the Power button for about 3 seconds. The LED
and alarm indicating lamp flashes, and then goes out. The system
gives a beep and displays the startup screen. The startup screen
displays the version no. of software.
2. The startup screen disappears and the pulse oximeter enters the

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normal screen.
To shut off the pulse oximeter,
1. Confirm that the patient measurement is finished.
2. Disconnect the SpO2extension cable from the pulse oximeter.
3. Press and hold the Power button for 4 seconds.
WARNING
Do not use the pulse oximeter if you suspect it is not working
properly, or if it is mechanically damaged. Contact the carrier or our
service department immediately.
5 Take a measurement
SpO2measuring is a non-invasive technique used to measure
the amount of oxygenated hemoglobin and pulse rate by
measuring the absorption of selected wavelengths of light. The
light emitted by a red and infrared light-emitting diodes passes
through the tissue and is converted into electrical signals by a
photodiode.