Hopkins 594030 User manual

Hopkins Wave Plus Fingertip
Oximeter
594030
User Manual

I
Instructions to User
Dear Customers,
Thank you for purchasing this quality pulse
Oximeter from Hopkins Medical Products. Please
read the manual very carefully before using this
device. Failure to follow these instructions can
cause measuring abnormality or damage to the
Oximeter.
Version of the Manual: Ver 1.0
Revised date: August 1st, 2019
All rights reserved. 3502-1290169
Note:
The contents contained in this manual are
subject to change without notice.
Information furnished by our company is
believed to be accurate and reliable. However,
no responsibility is assumed by us for its use, or
any infringements of patients or other rights of
third parties that may result from its use.

II
Instructions for Safe Operation
Check the device to make sure that there is no
visible damage that may affect user’s safety or
measurement performance with regard to sensors
and clips. It is recommended that the device
should be inspected before each use. If there is
obvious damage, stop using the device.
Special attention should be paid while the
Oximeter is used constantly at ambient
temperature above 98°F, burns may occur because
of over-heating of the sensor at this situation.
Necessary maintenance must be performed
only by qualified service technicians. Users are not
permitted to service this device.
The Oximeter must not be used with devices
and accessories not specified in User Manual.

III
Caution:
DO NOT use the Oximeter while the patient is
under MRI or CT scanning. This device is NOT MRI
Compatible.
Explosive hazard—DO NOT use the Oximeter
in environment with inflammable gas such as
some ignitable anesthetic agents.
Discomfort or pain may appear if using the
Oximeter continuously on the same location for a
long time, especially for patient with poor
microcirculation. It is recommended that the
Oximeter should not be applied to the same
location for longer than 2 hours. If any abnormal
condition is found, please change the position of
Oximeter.
DO NOT clip this device on edema or tender
tissue.

IV
The light (the infrared light is invisible)
emitted from the device is harmful to the eyes. Do
not stare at the light.
The Oximeter is not a treatment device.
Local laws and Regulations must be followed
when disposing of the device.
Attention:
Keep the Oximeter away from dust, vibration,
corrosive substances, explosive materials, high
temperature and moisture.
The device should be kept out of the reach of
children.
If the Oximeter gets wet, please stop using it
and do not resume operation until it is dry and
checked for correct operation. When it is
carried from a cold environment to a warm and
humid environment, please do not use it
immediately. Allow at least 15 minutes for
Oximeter to reach ambient temperature.
DO NOT operate the button on the front panel
with sharp materials or sharp point.
DO NOT use high temperature or high pressure

V
steam disinfection on the Oximeter. Refer to
Chapter 7 for instructions regarding cleaning
and disinfection.
The equipment is IP32 with protection against
harmful solid foreign objects and ingress of
liquid. So that means the equipment is
protected against solid foreign objects of
12.5mm and greater, and protected against
vertically falling water drops when enclosure
tilted up to 15°.
Please pay attention to the effects of lint, dust,
light (including sunlight), etc.

VI
Declaration of Conformity
The manufacturer hereby declares that this device
complies with the following standards:
IEC 60601-1: 2005 Medical electrical
equipment-Part 1: General requirements for basic
safety and essential performance;
BS/EN/ISO 9919:2009 or the equivalent ISO
80601-2-61:2011 - Medical electrical equipment --
Part 2-61: Particular requirements for basic safety
and essential performance of pulse Oximeter
equipment.
And it also follows the provisions of the council
directive MDD 93/42/EEC.

VII
Table of Contents
1 OVERVIEW............................................................... 1
1.1 APPEARANCE.........................................................1
1.2 NAME AND MODEL............................................... 2
1.3 INTENDED USE...................................................... 2
1.4 FEATURE LIST.........................................................2
2 BATTERY INSTALLATION......................................... 5
3 OPERATION.............................................................. 6
4 TECHNICAL SPECIFICATIONS................................ 11
5 PACKING LIST.........................................................14
6 REPAIR AND MAINTENANCE............................... 14
6.1 MAINTENANCE....................................................14
6.2 CLEANING AND DISINFECTING INSTRUCTION.......... 17

VIII
7 TROUBLESHOOTING............................................. 17
8 KEY OF SYMBOLS.................................................. 18
9 FREQUENTLY ASKED QUESTIONS........................ 19
10 WARRANTY..........................................................22
APPENDIX I RESULT DESCRIPTION..........................26
APPENDIX II EMC..................................................... 26

1
1 Overview
1.1 Appearance
Figure 1 Front View
Figure 2 Rear View
Display Key
Nameplate
Lanyard Hole
Battery Cover
Display Screen

2
Note: the appearance is for demonstration only,
please refer to the Oximeter you purchased.
1.2 Name and Model
Name: Hopkins Wave Plus Fingertip Oximeter
Model: 594030
1.3 Intended Use
This Fingertip Oximeter is intended for measuring
the pulse rate and functional oxygen saturation
(SpO2) through a patient’s finger. It is applicable for
spot-checking SpO2and pulse rate of adult and
pediatric patients in homes and medical clinics.
1.4 Feature List
Explanation of abbreviations:
"√" this function is available, "-" without this
function.
Model Function
594030
Display type
OLED
SpO2, PR, PI
√

3
Plethysmogram
√
Auto on/off
√
PR and PI shifts
√
Over-limits indication
√
Over-limits indication sound
√
Indication sound mute
Manual
Four direction display
√
Setting menu
√
Over-limits setting
√
Pulse beep
√
Wireless function
-
Measuring mode
Continuous,
Spot check
Record list
√
Description:
Indication sound mute
For the model with both over-limits indication function and
pulse beep function, when beep is on and over-limits
indication sound is activated, then the Display Key will work
as the Mute Key, pressing the key can mute the over-limits
indication sound and pulse beep for 90 seconds.

4
Measuring mode

Spot check mode: the measurement starts
automatically when the finger is inserted into the
finger clip properly, the measuring time lasts 30
seconds with a countdown indication. The SpO2and
PR readings will freeze at the end of 30 seconds,
the analysis result for the pulse rhythm will be
displayed on the screen as well. Once the finger is
out, the display will be cleared and the Oximeter
shuts down automatically.

Continuous mode: measurement will start
automatically when finger is inserted into the
Oximeter, SpO2and PR readings will be displayed
until the finger is removed from the Oximeter. Once
finger is removed the Oximeter will automatically
turn off.
Record list

A single group of stable readings will be
recorded in the record list each time when the
Oximeter shuts down regardless of spot-check or
continuous mode. However, if the time from
displaying valid readings to the end of

5
measurement is less than 5 seconds, then no
recording will be created.

Up to 12 groups of records can be stored in the
record list, the newest record is marked as M1, and
the oldest record is marked as M12. The new record
will override the previous record.

When batteries are removed from the device all
readings will be deleted.
④ When the Oximeter is powered off, press and
hold the Display keep to bring up the record recall
screen. On the record recall screen, press and hold
the Display key to shift the records display. The
Oximeter will automatically power off after 6
seconds.
2 Battery Installation
1. Refer to Figure 3, insert two AAA size batteries
into the battery compartment properly, and note
the polarity markings.

6
Figure 3 Battery Installation
2. Replace the cover.
Please make sure that the batteries are correctly
installed. Incorrect installation may cause the
device not to work.
Please remove batteries if the device is not
being used for more than 7 days to prevent and
avoid potential damage from the battery leaking.
Any such damage is not covered under the product
warranty.
3 Operation
1. Open the clip and put finger inside the clip
(make sure the finger is in the correct position),
and then clip the finger, as shown in figure 4.

7
Figure 4
2. Next enter into data display screen:
Press the Display Key to change display
direction, the four display directions are as
shown in figure 5A, 5B, 5C, & 5D. For display
screens of figure 5B and 5D, the PI% display
value will be replaced with PR display value
after 20 seconds if the Display Key is not
pressed again.
Figure 5A Figure 5B
Figure 5C Figure 5D

8
Icon “ ” on display screen is the countdown
timer if the Oximeter is operating in Spot check
mode. The total measuring time for Spot check
mode is 30 seconds.
Figure 5E Figure 6
When the measurement ends up for Spot check
mode, the measured SpO2, PR value and the
analysis result of pulse rhythm will be displayed
on the screen, as shown in figure 5E.
Other result descriptions see Appendix I.
Recording & recall functions are available when
the Oximeter is off. At power off status, press
and hold the Display key can bring up the record
list display screen, as shown in figure 6. In
record list screen, short time press Display key
to shift the records page.
Menu
While the Oximeter is on, press and hold the

9
Display Key to enter the setup menu screen.
“Beep”：Pulse beep option. If it is set to on, every
pulse beat makes a beep.
“Mode”: to set the measuring mode. “Continuous”
and “Spot check” for optional, the default is “Spot
check”.
Menu setup
Press the Display Key to choose the setting item;
press and hold the Display Key to activate the
setting item, then press it to modify the setting
parameter; Next, press and hold the Display Key to
confirm the modification and exit from this setting
item. At last, move the setting item to “Save, exit
menu”, and press and hold the Display Key to store
the modification and exit from the setup menu.

10
Using the Oximeter
The finger should be put into the sensor
correctly.
Do not shake the finger and relax during
measurement.
Do not put a wet finger directly into sensor.
Avoid placing the device on the same limb
which is wrapped with a cuff for blood pressure
measurement or during venous infusion.
Do not let anything block the emitting light
from device, i.e. do not use finger nail
polish/paints.
Vigorous exercise and electrosurgical device
interference may affect the measuring
accuracy.
Nail polish may affect the measuring accuracy,
and too long fingernail may cause failure of
measurement or inaccurate result.
Existence of high intensive light sources, such
as fluorescent light, infrared heater or strong

11
sunshine, etc. may cause inaccuracy of
measurement result. Please put an opaque
cover on the sensor or change the measuring
site if necessary.
If the first reading appears with poor waveform
(irregular or not smooth), then the reading is
unlikely accurate, the more stable value is
expected by waiting for a while, or a restart
and select another finger if needed.
4 Technical Specifications
A. SpO2Measurement
Transducer: dual-wavelength LED sensor with
wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maximal average optical output power:
≤2mW
SpO2display range: 35%~100%
SpO2measuring accuracy:
≤ 2% for SpO2range from 70% to 100%
B. Pulse Rate measurement