Fingertip Pulse Oximeter
User Manual
(Model: PC-60F, PC-60FW)
Importer: Pacific Medical Australia
www.pacificmedical.com.au
Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road,
Xili Street, Nanshan District, 518110 Shenzhen, P. R. China
Tel: +86-755-2643 3514 Fax: +86-755-2643 0930
E-mail: [email protected] Website: www.creative-sz.com
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg Germany
Manufacture date: See the label on the product
Revision Date
：
May 9,2021
Manual Version
：
V1.0 PN
：
3502-2290123
Instructions for Safe Operation
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 minimally
before each use. If there is obvious damage, stop using the device.
Special attention should be paid while the oximeter is used
constantly under the ambient temperature over 37°C, burning hurt
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.
Warnings and Cautions
Explosive hazard—
DO NOT
use the Oximeter in environment with
inflammable gas such as some ignitable anesthetic agents.
DO
NOT
use the Oximeter while the patient is under MRI or CT
scanning. This device is NOT MRI Compatible.
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.
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.
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 steam disinfection
on the Oximeter. Refer to Chapter 8 for instructions regarding
cleaning and disinfection.
Pay attention to the effects of lint, dust, light (including sunlight),
etc.
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.
Follow the provisions of the council directive MDD 93/42/EEC.
FCC Rules (only for PC-60FW)
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
1 Overview
1.1 Intended Use
This Fingertip Oximeter is intended for measuring the pulse rate and
functional oxygen saturation (SpO
2
) through a patient’s finger. It is
applicable for spot-checking SpO
2
and pulse rate of adult and pediatric
patients in homes and medical clinics.
1.2 Views
Figure 1 Front and Rear Views
1.3 Features
Display SpO
2
, PR, PI, and Plethysmogram
Auto power On/Off
Change between PR and PI
Over-limit indication and sound
Mute sound
Four direction display
Setting menu (including over-limit setting)
Pulse beep
Wireless function (PC-60FW only)
Continuous or spot check measuring mode
Record list
2 Battery Installation
1. Refer to Figure 2, insert two AAA
size batteries into the battery
compartment properly, and note
the polarity markings.
2. Replace the cover.
Attentions:
•
Make sure that the batteries are correctly installed. Incorrect
installation may cause the device not to work.
•
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 Start/Stop Measuring
1. Open the clip and put finger inside the clip (make sure the finger is
in the correct position), and then release the clip.
2. Wait for 2 seconds, the
oximeter will power on
and start to measure.
3. The display screen shows
the measurement.
4. Get the finger out, and the device will automatically power off.
Attentions for measuring:
Do not shake the finger and relax during measurement.
Do not put 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.
Existence of high intensive light sources, such as fluorescence light,
ruby lamb, infrared heater or strong sunshine, etc. may cause
inaccuracy of measurement result. Please put an opaque cover on
the sensor or change the measuring site if necessary.
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.
If the first reading appears with poor waveform (irregular or not
smooth), then the reading is unlikely true, the more stable value is
expected by waiting for a while, or a restart is needed when
necessary.
If the measurements over the limits, there is a reminder sound. You
can press the Display key to mute it, or wait for 10 seconds till the
sound disappears by itself.
4 Screen
4.1 Indications and Icons
Figure 4 (a) Measuring Screen with PR
Figure 4 (b) Measuring Screen with PI
Icon
: inidicates the wireless connection is set up between
the mobile device and oximeter. Only PC-60FW has this function.
Status of
Definition
Flashing in blue
The oximeter is connecting with the mobile devices.
Blue on
The connection between the oximeter and mobile
devices is established.
No display of
“ ” icon
1. The oximeter fails to set up wireless connection
with mobile device within 3 minutes.
2. Hardware failure of wireless function.
Icon
: indicates the counting-down time if the oximeter
works at Spot check mode. The total measuring time for Spot
check mode is 30 seconds.
Icon
/
: low battery voltage.
Flashing value: indicates the value is over the defined limits.
There also accompanies the reminding sound.
4.2 Four Directions of the Screen
Figure 5 (a) Figure 5 (b)
Figure 5 (c) Figure 5 (d)
The oximeter supports to show the screen in four directions. The four
display directions are as shown in figure 5 (a), 5 (b), 5 (c), & 5 (d).
The display direction is remembered at each startup, it will display the
screen layout (display direction) from the last time it was used.
Change screen direction
and
PR/PI
:
A short pressing of the Display Key can change display direction by
90
°
, and change PR/PI at the same time. For display screens of
figure 5 (b) and 5 (d), the PI% display value will be replaced with PR
display value after 20 seconds if no key operation.
4.3 Measurement End Screen (Spot Check Mode)
When the measurement ends up for Spot check mode, the measured
SpO
2
, PR value and the analysis result of pulse rhythm will be displayed
on the screen, as shown in figure 6.
5 Menu Setup
During measuring, long pressing Display key can enter the setup
menu screen.
Figure 7 Menu
Menu operating procedures:
1.
Shortly press Display Key to choose the setting item;
2.
Long press Display Key to active the setting item, then shortly
press it to modify the setting parameter;
3.
Long press Display Key to confirm the modification and exit from
this setting item.
4.
Move the setting item to “Exit”, and long pressing Display Key to
store the modification and exit from the setup menu.
“Beep”
：
Pulse beep option. If it is set to on, every pulse beat makes a
beep.
“Mode”:
Set the measuring mode. “Continuous” and “Spot check” for
Nameplate
Battery cover
Display key
Display screen
Perfusion index
Perfusion
symbol
Figure 6 Results
Figure 3 Finger Placement
Figure 2 Battery Installation
Pulse symbol
SpO
2
value
PR label
Pulse strength
bar
PR value
Pleth wave
SpO
2
symbol
Wireless icon (PC-60FW only)
Time
countdown
Battery voltage
