Hopkins 594810 User manual

594810 Hopkins
Handheld Pulse Oximeter
Instructions for Use
Hopkins Medical Products

Product Name: Hopkins Handheld Pulse Oximeter
Product Model: 594810
Manufacturer: Hopkins Medical Products
Address: 6850 Southbelt Drive
This manual has a revision number. This revision number changes
whenever the manual is updated due to software or technical
specification change. Contents of this manual are subject to change
without prior alarm.
■ Revision number: 1.0
■ Revision Date: 7/2018
REVISION HISTORY
PRODUCT INFORMATION
Caledonia, MI 49316 USA

PREFACE
MANUAL PURPOSE
This manual contains the instructions necessary to operate the product
safely and in accordance with its function and intended use.
Observance of this manual is a prerequisite for proper product
performance and correct operation and ensures patient and
operator safety.
This manual is an integral part of the product. It should always be kept
close to the equipment so that it can be obtained conveniently when
needed.
INTENDED AUDIENCE
This manual is geared for clinical professionals who are expected to
have a working knowledge of medical procedures, practices and
terminology as required for monitoring of critically ill patients.
ILLUSTRATIONS
All illustrations in this manual serve as examples only. They may not
necessarily reflect the setup or data displayed on your pulse oximeter.
CONVENTIONS
■ Italic text is used in this manual to quote the referenced chapters or
sections.
■ [ ] is used to enclose screen texts.
■ → is used to indicate operational procedures.

1 Safe information.........................................................
2 Symbols......................................................................
3 Introduction................................................................
4 Battery installation....................................................
5 594810 operation.......................................................
3.1 Working Principle.....................................................
3.2 Intended Use...........................................................
3.3 Included in Package.................................................
3.4 Product Description................................................
3.5 Display Screen Elements........................................
4.1 Battery Power.........................................................
4.2 Low battery indicator...............................................
4.3 Install the Batteries.................................................
5.1 Introduction............................................................
5.2 Turn on the 594810..................................................
5.3 Set up the 594810...................................................
5.3.1 Adjust pulse Beep Volume.................................
5.3.2 Select Patient Type...........................................
5.3.3 Set alarm Limit.................................................
5.3.3.1 PR High/Low alarm Limit................................
5.3.3.2 Set SPO2 Low alarm Limit..............................
5.3.4 When an Alarm Occurs......................................
5.3.5 RESET TO DEFAULT.........................................
5.4 SpO2&PR measurement.........................................
5.4.1 Place sensor on the finger of patient...................
5.4.2 Display description...........................................
5.5 Alarms.................................................................
5.5.1 Alarm Categories.............................................
5.5.2 Alarm Levels....................................................
5.5.3 Alarm Indicators...............................................
Physiological Alarm Messages....................................
Technical Alarm Messages..........................................
Contents
5.3.3.3 Switch ON/OFF alarm Volume.........................
5.3.3.4 Alarm Silence Duration.............................................
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10
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7.1 Cleaning...............................................................
7 Maintenance.............................................................
7.3 Disposal...............................................................
9 Specifications..........................................................
10 EMC information......................................................
7.2 Safety Checks......................................................
8 Accessories.............................................................
6 Summary of Spo2 & pulse rate accuracy testing........
5.6 Measurement Limitations.......................................
11 Warranty...................................................................30
20

！
1 Safety information
WARNING
WARNING: Explosion hazard. Do not use the 594810 in the presence of
flammable anesthetics mixture with air, oxygen, or nitrous oxide.
！WARNING: Chemicals from a broken LCD display panel are toxic when
ingested. Use caution when the 594810 has a broken display panel.
！WARNING: Pulse oximetry measurements and pulse signals can be
affected by certain environmental conditions, SPO2 sensor application
errors, and certain patient conditions. See the appropriate sections of
this manual for specific safety information.
！WARNING: The use of accessories, sensors, and cables other than
those specified may result in increased emission and/or create invalid
readings of the 594810.
！WARNING: Failure to cover the sensor site with opaque material in
high ambient light conditions may result in inaccurate measurements.
！WARNING: Do not silence the audible alarm function or decrease the
audible alarm volume if patient safety could be compromised.
！WARNING: The 594810 is a prescription device to be operated only by
trained personnel.
！WARNING: Dispose of batteries in accordance with local ordinances
and regulations
！WARNING: To ensure patient safety, do not place the 594810 in any
position that might cause it to fall on the patient.
！WARNING: As with all medical equipment, carefully route patient cables
to reduce the possibility of patient entanglement or strangulation.
！WARNING: Ensure that the speaker is clear of any obstruction and
that the speaker holes are not covered. Failure to do so could result
in an inaudiblealarm tone.
！WARNING: Disconnect the 594810 and SPO2 sensor from the patient
throughout magnetic resonance imaging (MRI) scanning. Induced
current could potentially cause burns.
！WARNING: To ensure accurate performance and prevent device
failure, do not subject the 594810 to extreme moisture, such as direct
exposure to rain. Such exposure may cause inaccurate performance or
device failure.
！
！WARNING:Do not use either the 594810, SPO2 sensor, or cables that
appear damaged.
！WARNING:Do not lift the 594810 by the sensor or extension cable
because the cable could disconnect from the 594810 and the 594810
may drop on the
patient.
-6-

！WARNING:The 594810 is not defibrillator-proof. However, it may
remain attached to the patient throughout defibrillation or while an
electrosurgical unit is in use, but the measurements may be inaccurate
throughout the defibrillation and shortly thereafter.
！WARNING:Use only the SPO2 sensor and extension cable supplied by
Hopkins Medical Products. Do not connect any device other than a
Hopkins-approved SPO2 sensor to the sensor connector.
！WARNING: The 594810 should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the 594810
should be observed to verify normal operation using the configuration
in which it is to be used.
！The medical electrical equipment needs to be installed and put into
service according to EMC Information
！The use of patient cable and other accessories not supplied by the
manufacturer may result in increased emissions or decreased
immunity of the equipment
！The equipment should not be used adjacent to or stacked with other
equipment, refer to the recommended separation distances provided in
EMC Information
CAUTION
！
！Caution:Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
！Caution: All combinations of equipment must be in compliance with
IEC Standard 60601-1-1 systems requirements.
！Portable and mobile RF communications equipment can affect medical
electrical equipment, refer to the recommended separation distances
provided in EMC Information
-7-

2 Symbols
！
SET
IPX1
Direct Current (DC)
Attention: Consult accompanying documents (this manual).
Auxiliary output connector
Alarm silence
Setting button
Power button
Up button
Down button
Date of manufacture
Serial number
Safety Class II equipment
Type BF applied part, defibrillation protected
European community representative
The following definition of the WEEE label applies
to EU member states only.This symbol indicates
that this product should not be treated as household waste.
Resistant to liquid ingress
Power supply connector
Caution & warning
Federal (U.S.) Law restricts this device to sale by or on the
order of a physician
Rx only(U.S)
Non-sterile
-8-

3 Introduction
3.1 Working Principle
The Pulse Oximeter works by applying a sensor to a pulsating
arteriolar vascular bed. The sensor contains a dual light source
and photo detector. Skin,bone, tissue, and veins normally absorb
a constant amount of light during systole and diastole, as blood
volume increases and decreases. The ratio of light absorbed at
systole and diastole is translated into an oxygen saturation
measurement. This measurement is referred to as SpO2.
3.2 Intended Use
The pulse oximeter is indicated for continuous or spot check
monitoring of functional arterial oxygen saturation (SpO2) and
pulse rate of adult patients in hospitals and clinics.
3.3 Included in Package
Quantity Item
1594810 pulse oximeter
3Alkaline “AA” size, 1.5-volt batteries
1594301 Y-Probe SPO2 sensor
1Instructions for Use
！
WARNING: Do not make any clinical judgments based solely on
the 594810. The 594810 is intended only as an adjunct in patient
assessment. It must be used in conjunction with clinical signs and
symptoms.
-9-

3.4 Product Description
Display screen
Speaker
Lamp
Battery door
High level Alarm : the lamp flashes red.
Medium level Alarm : the lamp flashes yellow.
Low level Alarm : the lamp lights yellow without flashing.
1
4
7
10
NOTE
2
5
8
Power on/off
Set
Sensor connector
3
6
9
Up/Down
Alarm silence
Cord hole
3.5 Display Screen Elements
%SPO2 area of display
Pulse beats per minute (BPM)
area of display
1
3
Pulse amplitude index signal
intensity bar
5
2
4
6
Measured %SPO2
Measured BPM
Perfusion index signal
intensity bar
1
2
3
4
5
6
78
9
10
1
2
3
4
56
-10-

4 Battery installation
4.1 Battery Power
The pulse oximeter is designed to operate on three 1.5V alkaline AA
batteries.A new set of batteries will provide at least 22 hours of
operation.
4.2 Low battery indicator
The Low Battery indicator displays and flashes on the information area,
and a low priority alarm begins to sound when approximately 15 minutes
of operation is available. The batteries should be replaced.
4.3 Install the Batteries
1) Turn off power. Pull the battery cover downward, toward the bottom
of the 594810, and then remove the battery access door.
2) Install three “AA” size batteries.make sure to put the correct
orientation.
3) Replace the battery cover.
！Caution: If the 594810 is to be stored for a period of three
months or longer, remove the batteries from the device before
storage.Warranty is void if batteries are stored in the device.
-11-

！WARNING: Dispose of battery in accordance with local
ordinances and regulations.
！WARNING: Explosion hazard. Do not use the 594810 in the presence
of flammable anesthetics mixed with air, oxygen, or nitrous oxide.
！WARNING: To ensure patient safety, do not place the 594810 in any
position that might cause it to fall on the patient.
！WARNING: As with all medical equipment, carefully route patient cables
to reduce the possibility of patient entanglement or strangulation.
！WARNING: To ensure accurate performance and prevent device failure,
do not expose the 594810 to extreme moisture such as rain.
5 594810 operation
5.1 Introduction
The parameters of the 594810 are preset to factory default values. See
Table 2.Table 2 lists the parameters, ranges available, and the factory
default values. The parameters may be set on an individual basis, by the
clinician, and will remain in effect until the 594810 is turned off.
Table 2: Parameter Ranges
Parameter Range/selections Factory defaults
%SpO2 Upper Alarm
Limit
Lower Alarm Limit plus 1 to100% 100%
%SpO2 Lower Alarm
Limit
20% to Upper Alarm Limit minus 1 90%
Pulse Rate Upper
Alarm Limit
Lower Alarm Limit plus 1 to 250 bpm 90 bpm
ON/OFF Alarm
30 bpm to Upper Alarm Limit minus 1 40bpm
Pulse Rate Lower
Alarm Limit
ON or OFF ON
Patient type ADU(adult) Adult
Alarm Volume 1 to 10 5
Pulse Beep Volume 0 to 10 5
Shelf life 5 Years
-12-

2) Press power button to return to the main screen.
5.3.2 Select Patient Type
！WARNING：Be sure to select correct patient category setting for your
patient before measurement. Wrong patient category may result in
patient hazard due to pulse rate alarm limits.
1) Press button [SET]→[PA] and Press the Up/Down button, select
patient type value: ADU(adult), PED(pediatric), NEO(neonate).
2) Press power button to return to the main screen.
5.3.3 Set alarm Limit
5.3.3.1 PR High/Low alarm Limit
5.2 Turn on the 594810
1) Press and hold the Power button to turn on the 594810.
2) The alarm lamp flashes, and then goes out.
3) The system gives a beep and displays the startup screen.
4) The startup screen disappears and the pulse oximeter enters the
main screen.
5.3 Set up the 594810
5.3.1 Adjust pulse Beep Volume
1) Press button [SET]→[VOL] and press Up/Down button to increase or
decrease the pulse beep volume, then set the volume between 0 and 10.
Note：When the pulse beep volume display is shown, the user is able to
adjust the volume of the pulse beep tone. Each press of an Up or
Down button increases or decr eases the pulse beep volume and
increments or decrements by one level.
Press button [SET]→[BPM H] or [BPM L]and press the Up/Down button,
set the PR value between 30 and 250.
Patient type weight ranges:
Adult, over + 88lb (40Kg)
Pediatric between 33-88lb (15-40Kg)
Neonatal/Infant 2-33lb (1-15Kg)
-13-

Select [SET]→[ALn], and press the Up/Down button, to turn on/off the
alarm tone
5.3.3.3 Switch ON/OFF alarm Volume
！WARNING：When the alarm sound is switched off, the pulse oximeter
will give no audible alarm tones even if a new alarm occurs. Therefore
the user should be very careful about whether to switch off the alarm
sound or not.
！WARNING：Do not rely exclusively on the audible alarm system for
patient monitoring. Adjusting volume to a low level may result in a
hazard to the patient. Always keep the patient under close surveillance.
Press the key for 1 second，the key will light and the alarm
messages remain displayed. The alarm will stay silent for 60 seconds.
5.3.3.4 Alarm Silence Duration
！WARNING：The 594810 will only keep the last setting. When the
594810 is turned on, user should check whether the current setting
meet conditions of patient.
5.3.4 When an Alarm Occurs
When an alarm occurs, observe the following steps to take proper actions:
1) Check the patient's condition.
2) Confirm the alarm parameter or alarm category.
3) Identify the source of the alarm.
4) Take proper action to eliminate the alarm condition.
Note: The pulse rate alarm limit range is 25 to 250.The upper value of the
pulse rate low alarm limit is limited one number lower than the pulse rate
upper alarm limit. The pulse rate low alarm limit cannot be set equal to or
higher than the pulse rate upper alarm limit. In the same way, the pulse
rate upper alarm limit cannot be set equal to or lower than the pulse rate
low alarm limit.
Press button [SET]→[SPO2 L] and Press the Up/Down button, set the
SPO2 value between 20 and 100.
Note:The %SpO2 alarm limit range is 20% to 100%. The upper value of
the %SpO2 low alarm limit is limited to the %SpO2 upper alarm limit. The
%SpO2 low alarm limit cannot be set equal to or higher than the %SpO2
upper alarm limit. In the same way,the lower value of the %SpO2 upper
alarmlimit is limited to the %SpO2 low alarm limit. The %SpO2 upper
alarm limit cannot be set equal to or lower than the %SpO2 low alarm limit.
5.3.3.2 Set SPO2 Low alarm Limit
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4) The default values are defined beleow
VOL： 05
ALM：on
PA: ADU
BMP H: 90
BMP L: 40
%SPo2: L 90
5.4 SpO2&PR measurement
1) Select an appropriate SpO2 sensor according to the person
category and weight.
2) Wear the sensor into the measurement part of patient.
3) Connect an approved SpO2 sensor or extension cable to the 594810
SpO2 sensor port.
5.4.1 Place sensor on the finger of patient
5.4.2 Display description
perfusion index signal
intensity bar
Measured %SPO2
1
2
Measured BPM
3
4Pulse amplitude index signal
intensity bar
2
4
5
1
5.3.5 RESET TO DEFAULT
1) Press button [SET]→[CON] and Press the Up/Down button, set the
value to“SET”.
2) Press button [SET].
3) Reset to default value
5) Make sure the alarm condition is corrected.
For troubleshooting specific alarms, see 5.5.3.
-15-

！Use only SpO2 sensors specified in this manual. Follow the SpO2
sensor's instructions for use and adhere to all warnings and cautions.
！When a trend toward deoxygenation is indicated, blood samples should
be analyzed by a laboratory co-oximeter to completely understand the
person's condition.
！Do not use the pulse oximeter and the SpO2 sensor during magnetic
resonance imaging (MRI). Induced current could cause burns.
WARNING
！
！Reusable sensor must be moved to new site at least every four hours.
Because individual skin condition affects the ability of skin to tolerate
sensor placement, it may be necessary to change the sensor site more
frequently with some patients. If skin integrity changes, move the
sensor to another site.
！Do not apply tape to secure the sensor in place or to tape it shut;
venous pulsations may lead to inaccurate saturation measurements.
！As with any electrosurgical unit, carefully route patient cabling to avoid
entanglement.
！Do not use the SpO2 sensor on a limb with an intravenous infusion or
arterial catheter in place.
！Do not use the SpO2 sensor on a limb where the NIBP cuff is applied.
This may result in inaccurate SpO2 reading due to blocked blood
flow during cuff inflation.
！WARNING: Pulse oximetry readings and pulse signals can be affected
by certain ambient environmental conditions, sensor application
errors, and certain patient conditions. See the appropriate sections of
the manual for specific safety information.
！Caution: Use only Hopkins-approved sensors and extension cables
Note: Physiological conditions, medical procedures, or external
agents that may interfere with the 594810's ability to detect and
display measurements include:
Inaccurate measurements can be caused by:
Arterial dyes
Dysfunctional hemoglobin
Low perfusion
Dark pigment
Externally applied coloring agents, such as nail polish, dye, or
pigmented cream.
Incorrect application of the sensor
Placement of the sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line
Ambient light
-16-

Prolonged and/or excessive patient movement
Intravascular dyes or externally applied coloring, such as nail polish
or pigmented cream
failure to cover the sensor site with opaque material in high ambient
light conditions
Loss-of-pulse signal can occur for the following reasons:
The sensor is applied too tightly
A blood pressure cuff is inflated on the same extremity as the one
with the sensor attached
There is arterial occlusion proximal to the sensor
Poor peripheral perfusion
5.5 Alarms
Alarms triggered by a vital sign that appears abnormal or by technical problems
of the Pulse Oximeter, are presented to the user by visual and audible alarm
indications.
By nature, the pulse oximeter's alarms can be classified into three
categories: physiological alarms, technical alarms and prompt messages.
1) Physiological alarms
Physiological alarms, also called patient status alarm, are triggered
by a monitored parameter value that violates set alarm limits or an
abnormal patient condition.
2) Technical alarms
Technical alarms, also called system status alarms, are triggered by
a device malfunction or a patient data distortion due to improper
operation or system problems.
3) Prompt messages
In fact, prompt messages are not alarm messages, which are
displayed in the technical alarm area. Apart from the physiological
and technical messages, the pulse oximeter will show some
messages which indicate the system status.
5.5.1 Alarm Categories
By severity, the pulse oximeter's physiological alarms can be classified
into three categories: high level alarms, medium level alarms and low
level alarms.
1) High level alarms
Indicate that the patient is in a life threatening situation and an
emergency treatment is demanded.
5.5.2 Alarm Levels
2) Medium level alarms
Indicate that the patient's vital signs appear abnormal and an
immediate treatment is required.
-17-

Alarm tone
Alarm message
For different alarm levels, the alarm lamp, alarm tone and alarm messages
presented are different.
1) Alarm Lamp
If a technical or a physiological alarm occurs, the alarm lamp will
flash. The flashing color and frequency match the alarm level as
follows:
High level alarms: the lamp quickly flashes red.
Medium level alarms the lamp slowly flashes yellow.
Low level alarms: the lamp turns yellow without flashing.
2) Alarm Tones
When a technical or a physiological alarm occurs, the pulse
oximeter presents different alarm tone patterns to match the
alarm level:
High level alarms: triple + double + triple + double beep.
Medium level alarms: triple beep.
Low level alarms: single beep.
3) Alarm Messages
When an alarm occurs, an alarm message will appear in the
technical or physiological alarm area. This time lists only the most
important physiological and technical alarm messages. In the
tables below, “H” means high, “M” means medium and “L” means
low. The “Cause and actions” column gives recommendations to
instruct you to troubleshoot the problems. If the problem persists,
contact your service personnel.
3) Low level alarms
Indicate that the patient's vital signs appear abnormal and an
immediate treatment may be required.
When an alarm occurs, the pulse oximeter will indicate it through the
following indications:
5.5.3 Alarm Indicators
Alarm lamp
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Physiological Alarm Messages
Alarm Message Cause and actions
SPO2 reading will flash.
Alarm lamp is red and
flashing.
A measurement has risen
above the high alarm limit or
fallen below the low alarm
limit. Check the patient's
condition and check if the
appropriate patient type
setting is selected.
Alarm
Level
H
SPO2 reading will flash.
Alarm lamp is red and
flashing.
H
PR reading will flash.
Alarm lamp is red and
flashing.
H
PR reading will flash.
Alarm lamp is red and
flashing.
H
PR and SPO2 reading is
“ - - ”.
Alarm lamp is red and
flashing.
H The pulse signal was too
weak to be analyzed. Check
the patient's condition,
SpO2 sensor and
measurement site.
Alarm lamp stays
yellow.The screen will
show “Low Perfusion”
The pulse signal was weak
and please pay attention to
sensor location and patient
status.
L
Alarm
SpO2 Too High
SpO2 Too Low
PR Too High
PR Too Low
No Pulse
Low Perfusion
Low signal
Quality
Alarm lamp is yellow
and flashing.The
screen will show “Low
Signal Quality”
M The pulse signal was too
weak , Check the patient's
condition condition, SpO2
sensor and measurement
site.
Technical Alarm Messages
Alarm Alarm Message Cause and actions
Sensor Off
Alarm lamp is yellow
and flashing.The
screen will show
“OFF”
The SpO2 sensor is not applied
to the patient or not connected
to the pulse oximeter, or there
was a fault with the SpO2
sensor, or non-compatibl SpO2
sensor was used. Check that the
sensor application site and the
sensor type are correct, and
make sure that the sensor is
undamaged. Reconnect the
sensor if the sensor is
disconnected or use a new
sensor if the sensor is damaged,
for example, the sensor cable is
broken.
Alarm
Level
M
-19-

NOTE:When multiple alarms of different levels occur simultaneously, the
pulse oximeter will select the alarm of the highest level and give visual
and audible alarm indications accordingly.
5.6 Measurement Limitations
If you doubt the SpO2 measurements, check the patient's vital signs
first. Then check the pulse oximeter and SpO2 sensor. The following
factors may influence the accuracy of measurements:
6 Summary of Spo2 & pulse rate accuracy testing
1) According to ISO80601-2-61, the 300 data pairs (SPO2 VS SaO2)
were obtained throughout the hypoxia breathe-down trials in all 12
volunteers.The SpO2 accuracy specification in the range of 70% to
100%,70% to 80%, 80% to 90%, and 90% to 100% is as the
following table:
Pulse
Oximeter
SPO2
Sensor
Arms
100%-70% 100% – 90% 90% - 80% 80% - 70%
2) The data from the hypoxia breathe-down trials for each of the 12
volunteers is summarized in Figures 1&2:
594810 Adult 1.3910 1.2555 1.3774 1.5687
Ambient light
Physical movement (person or imposed motion)
Diagnostic testing
Low perfusion
Electromagnetic interference, such as MRI environment
Electrosurgical units
Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and
methemoglobin (MetHb)
Presence of certain dyes, such as methylene and indigo carmine
Drop of arterial blood flow to unmeasurable level due to shock, anemia, low
temperature or vasoconstrictor.
Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2
-20-