Creative Medical PC-60F User manual

Fingertip Oximeter
User Manual
Shenzhen Creative Industry Co., Ltd.

I
Instructions to User
Dear Customers,
Thank you for purchasing this quality product. Please read
the manual very carefully before using this device. Failure
to follow these instructions can cause measuring
abnormality or damage to the Oximeter.
The manual is published in English and we have the
ultimate right to explain the Manual. No part of this
manual may be photocopied, reproduced or translated
into another language without the prior written consent.
We reserve the right to improve and amend it at any time
without prior notice.

II
For user's convenience, we share the latest version
analysis software of the Oximeter on our website, the user
can enter into our website (www.creative-sz.com) to
download the corresponding latest version data manager
software. Please contact the manufacturer or your local
distributor if anything about software downloading.
Version of the Manual: Ver 1.3
Revised date: April 13th, 2020
All rights reserved. 3502-1290163

III
Notes
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.
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

IV
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 at ambient temperature above 37°C,
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.

V
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.
Warnings
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

VI
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.
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.
Attentions

VII
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.

VIII
DO NOT use high temperature or high pressure steam
disinfection on the Oximeter. Refer to Chapter 7 for
instructions regarding cleaning and disinfection.
The equipment is IP22 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.

IX
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.

X
Caution: U.S. federal law restricts this device to sale or use by
or on the order of a physician.
FCC Rules are specifically 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.

XI
Table of Contents
1 OVERVIEW....................................................................... 1
1.1 APPEARANCE................................................................. 1
1.2 NAME AND MODEL........................................................ 3
1.3 INTENDED USE............................................................... 3
1.4 FEATURE LIST................................................................. 3
2 BATTERY INSTALLATION..................................................9
3 OPERATION....................................................................10
4 DOWNLOAD THE APP SOFTWARE............................... 22

XII
5 TECHNICAL SPECIFICATIONS.........................................24
6 PACKING LIST................................................................. 29
7 REPAIR AND MAINTENANCE........................................29
7.1 MAINTENANCE.............................................................30
7.2 CLEANING AND DISINFECTING INSTRUCTION.................... 33
8 TROUBLESHOOTING......................................................34
9 KEY OF SYMBOLS...........................................................35
10 FREQUENTLY ASKED QUESTIONS.............................. 37
APPENDIX I RESULT DESCRIPTION.................................. 42
APPENDIX II EMC..............................................................43

1
1 Overview
1.1 Appearance
Figure 1 Front View
Display Key
Display Screen

2
Figure 2 Rear View
Note: the appearance is for demonstration only, please
refer to the oximeter you purchased.
Nameplate
Battery Cover

3
1.2 Name and Model
Name: Fingertip Oximeter
Model: PC-60F/PC-60FW/PC-60A
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:

4
"√" this function is available, " × " without this function.
Display type: D-O-D means dot-matrix dual color OLED
Model
Function
PC-60F
PC-60FW
PC-60A
Display type
OLED
OLED
LCD
SpO2, PR, PI
√
√
√
Plethysmogram
√
√
×
Auto on/off
√
√
√
Pulse bar graph
√
√
√
PR and PI shifts
√
√
√
Over-limits indication
√
√
√

5
Over-limits indication
sound
√
√
×
Indication sound mute
Manual
Manual
Manual
Four directions display
√
√
Two
Setting menu
√
√
×
Over-limits setting
√
√
×
Pulse beep
√
√
×
Wireless function
×
√
×
Measuring mode
Continuous,
Spot check
Continuous,
Spot check
×
Record list
√
√
×
Description:

6
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 Display key will work as the Mute key, and short
time pressing it can mute the over-limits indication sound and pulse
beep for 90 seconds.
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
counting-down indication. The SpO2and PR readings will
freeze at the end of 30 seconds, the analysis result for the

7
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