Creative Medical POD-2a, POD-3, PC-60A, POD-1W, PC-60B User Manual

I

II

Fingertip Oximeter

User Manual

Shenzhen Creative Industry Co., Ltd.

III

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.

Version of the Manual: Ver 1.4

Revised date: February 9th, 2015

All rights reserved.

Notes

z The contents contained in this manual are subject to

change without notice.

z 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. 3502-2290065

IV

Instructions for Safe Operation

0 Chec

k

thedevicetomakesurethatthereisno

visible damage that may affect user’s safety o

r

measurement

p

erformance with regar

d

to sensors

and clips. It is recommended that the device shoul

d

b

e inspected minimallybefore each use. If there is

obvious damage, stop using the device.

0 Special attention shouldbepaid while the oximete

r

is used constantly underthe ambient temperature
over37°C,

b

urning hurt may occu

r

b

ecause of

over-heating of the sensorat this situation.

0 Necessary maintenance mustbeperformed onlyby

qualified service technicians. Users are not

p

ermitted to service this device.

0 The Oximeter must not be used with devices and

accessories not specified in User Manual.

Cautions

0 Explosive hazard—DO NOT use the Oximeter in

environment with inflammable gas such as some
ignitable anesthetic agents.

0

DO NOT use the Oximeter while the patient

is under MRI or CT scanning. This device is
NOT MRI Compatible.

V

Warnings

0 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.

0 DO NOT clip this device on edema or tender tissue.

0 The light (the infrared light is invisible) emitted

from the device is harmful to the eyes. Do not stare
at the light.

0 The oximeteris not a treatment device.

0 Local laws and Regulations must be followed when

disposing of the device.

Attentions

 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

VI

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 7 for instructions regarding cleaning and
disinfection.

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.

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

VII

FCC Rules are specifically for PC-60NW

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.

Table of Contents

1 OVERVIEW....................................................................1

1.1APPEARANCE...............................................................1

1.2 NAME AND MODEL.....................................................2

1.3 INTENDED USE............................................................2

1.4 FEATURE LIST.............................................................2

2 BATTERYINSTALLATION.........................................7

3 EXTERNAL SPO2PROBE CONNECTION...............8

4 OPERATION...................................................................9

5. TECHNICAL SPECIFICATIONS.............................18

6 REPAIR AND MAINTENANCE................................21

6.1 MAINTENANCE..........................................................21

6.2 CLEANING AND DISINFECTING INSTRUCTION........22

7 TROUBLESHOOTING................................................23

8 PACKING LIST............................................................23

9 KEY OF SYMBOLS.....................................................24

-1-

1 Overview

1.1 Appearance

Figure 1 Front View

Rubber
Cushions

Display
Screen

Display Key

Nameplate

Battery Cover

Lanyard Hole

Figure 2 Rear View

-2-

1.2 Name and Model

Name: Fingertip Oximeter
Model:

POD-1a/POD-2a/POD-3a/POD-1/POD-2/POD-

3/PC-60A/POD-1W/PC-60B/PC-60B1/PC-60B

2/PC-60B3/

PC-60B5/PC-60C/PC-60C1/PC-60C2/
PC-60D/PC-60D2/PC-60E/PC-60N/PC-60NW

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 SpO

2

and pulse rate of adult and pediatric patients in homes and
medical clinics. Models with external sensor options and
over-limit Indication may be used for longer periods of
time dependent on the suitability of the sensor selected.

1.4 Feature List
Explanation of abbreviations:

"√” this function is available, “-” without this function.
Display type: X-Y-Z

M=monochrome, D=dual color, C=full color
L=LCD, O=OLED.

S=segment, D=dot-matrix.

Note: The finger clip of PC-60D & 60D2 are suitable for

small fingers, especially for pediatric patients. The only

-3-

difference between these two oximeters is battery type.
PC-60D installs rechargeable button cell battery which
could use many times after being charged by the charger.

Configuration of PC-XXXX Fingertip Oximeters

Model

Function

POD-1a POD-2a POD-3a POD-1 POD-2 POD-3

Display type S-L-M S-L-D S-L-C S-L-M S-L-D S-L-C

SpO

2

√√ √ √ √√

PR √√ √ √ √√

PI (Perfusion

index)

-- - - --

Plethysmogram -- - - --

Auto on √√ √ √ √√

Auto off √√ √ √ √√

Low voltage

indication

√√ √ √ √√

Two

directions

dis

play

√√ √ √ √√

Wireless
function

-

--Option

al

-

-

-4-

Model

Function

60A 60B 60B1 60B2 60B3 60B5

Display type S-L-M S-L-M D-O-D D-O-M D-O-D D-L-D

SpO

2

√√ √ √ √ √

PR √√ √ √ √ √

PI(Perfusion

index)

- √√ √ √ √

Plethysmogram --√√√√

Auto on - √√ √ √ √

Auto off √√ √ √ √ √

Over-limit

indication

- √√ √ √ √

Low voltage

indication

√√ √ √ √ √

Two

directions

dis

play

-- 4√ 4 √

Waterproof &
dro

p

resistant

--√ ---

Bignumerical

dis

play

-- - - -√

-5-

Model

Function 60C 60C1 60C2 60D 60D2 60E

Display type D-O-C D-O-C D-O-C D-O-C D-O-C D-O-C

SpO

2,

PR, PI √√ √√√ √

Plethysmogram √√√√√ √

Auto on & off √√ √√√ √

Over-limit

indication

√√ √ √√ √

Setting menu - √ ----

Pulse beep - √ ---√

Low voltage

indication

√√ √ √√ √

Four directions

dis

play

√√ √ √√ √

Orientation-sensor

- √ ---√

Externalprobe

connection

--- --√

Bignumerical

dis

play

√√ ----

-6-

Model

Function

POD-1

W

60N 60NW

(Color)

60NW
(Dual)

60NW

(Monochrome)

Display type S-L-M D-O-

C

D-O-

C

D-O-

D

S-L-M

SpO

2,

PR, PI SpO

2,

PR,

√√√ √

Plethysmogram - √√√ -

Auto on √ √√√ -
Auto off √ √√√ √

Setting menu - √√√ -

Pulse beep - √√ --

Low voltage

indication

√ √√√ √

Four directions

dis

play

2 √√√ -

Orientation-

sensor

--√ --

Externalprobe

connection

- √√ --

Wireless
function

√ - √√ √

-7-

2 Battery Installation

Figure 3 Battery Installation

1. Refer to Figure 3, insert two AAA size batteries into the

battery compartment properly, and note the polarity
markings.

2. Replace the cover.

•

Please make sure that the

b

atteries 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.

-8-

3 External SpO2Probe Connection

Connect the external SpO2probe to SpO2sensor connector
as shown below. Ensure the “Arrow” faces upwards.

Figure 4 Probe Connection（For PC-60E, 60N, 60NW）

Note: When the external SpO

2

probe is connected, the
built-in finger clip sensor will be disabled. The
measurement is detected from the external SpO2probe.
Default over-limit indication settings for SpO2and PR will
change to: SpO2Low limit: 95%

Pulse Rate high limit: 160bpm

Low limit: 60bpm

-9-

4 Operation

1. Open the clip and put finger inside the rubber cushions
of the clip (make sure the finger is in the correct position),
and then clip the finger, as shown in figure 5.

Figure 5 Put finger into the Oximeter

0 ① For PC-60A, press the display key to start the
measurement.
② For other modules (except for PC-60A), wait 2 seconds,
the oximeter will power on automatically and start to
measure;

2. Next enter into data display screen:
① POD-1, POD-2 & POD-3 display screen are as shown
in figure 6

Figure 6

Note: the display direction of POD-1a, POD-2a &POD-3a

-10-

is up and down.
② PC-60A & 60B display screen are as shown in figure
7A

Figure 7A

③ For PC-60B, short time press Display

Key to turn on/off the backlight. Longtime

press Display Key to display PI as shown

in figure 7B, after 8 seconds, the screen

will return to the screen as shown in figure

7A. Figure 7B PI display screen(for PC-60B)

④ For other type oximeter PC-60B1, PC-60B2, PC-60B3,
PC-60B5, PC-60C, PC-60C1, PC-60C2, PC-60D and
PC-60D2, short time press Display Key to change display
direction(Note: 60C1 changes direction automatically ) As
shown in figure 8A& 8B; Longtime press Display Key to
shift the parameter display between PR and PI. Please refer
to figure 8C.

-11-

⑤ For POD-1W, the display screen is as shown in figure
8G.

Figure 8A Figure 8B Figure 8C

Figure 8D Figure 8E Figure 8F Figure 8G

Note:

¾ The PI% display will be shifted back to PR display
automatically after 20 seconds even if no button operation.
¾ For the model PC-60B3, there is no plethysmogram
display while the display direction is shifted to the right or
left direction, as shown in figure 8D; To the opposite,
PC-60B1 has no plethysmogram on default measuring
screen as shown in figure 8E, while the display direction is
shifted to left side direction, there will be displayed
plethysmogram please refer to figure 8F.
¾ For the model of PC-60B2 & 60B5, only has two
change directions: up and down.

-12-

¾ The model PC-60B3 may have different options for
manual switching display direction by button or automatic
changing display direction by o rientation sensor (similar to
the model PC-60C1).
¾ For PC-60E, PC-60N and PC-60NW, when change
display direction, PI value will automatically display on
the device instead of PR value, PR value will restore after
20 seconds.
¾ For PC-60E, upward/downward shift the Oximeter
quickly can turn on/off the pulse beep. The default pulse
beep is OFF.

⑥ Menu (60C1, 60N, 60NW Dual & 60NWColor)

PC-60 C1& 60N PC-60NW Dual PC-60NW Color

Long time pressing display key could enter the setup menu screen.

“Wireless”：the wireless on-off button. Transmitting data

to PC when it is on. “on” and “off” can be optional. The
factory default is “on”.

“Pulse beep”： Pulse beep option. If it is set to on, every

pulse beat makes a beep. Only for model PC-60NW, the
pitch tone of this beep changes according to SpO2value
(within 90~99%).

-13-

Menu setup: Short time press Display Key to choose the

setting item;Longtime press Display Key to active the
setting item, then short time press it to modify the setting
parameter; Next, longtime press Display Key to confirm
the modification and exit from this setting item. At last,
move the setting item to “Save, exit menu”, and long time
pressing Display Key to store the modification and exit
from the setup menu.

Note: if wireless connection is setup, the icon " " will be

displayed on the screen.

4.Wireless icon“ ”/" ":

The icon of
“ ”

Definition

“ ”flashes
blue

The device is being to establish a
wireless connection with the surrounding
host.

“ ” long lights
blue

Successful wireless connection between
the device and a host is established.

No display“ ”
icon

1."Wireless" function is disabled;

2. The device fails to setup a wireless
connection with the surrounding host
within 3 minutes;

3.Hardware failure of wireless
transmission function while the

-14-

Data transmission

The user could effectively transmit the data to computer
through the wireless function. Refer to the “Oximeter Data
Manager” for detailed information.

Attention to the operation

y The fingershouldbeput into the sensorcorrectly.
y Do not shake the finge

r

an

d

relax during

measurement.

y Do notput wet fingerdirectly into sensor.
y Avoi

d

p

lacing the device on the same limb which is

wrapped with a cuff fo

r

b

loo

d

p

ressure measurement

orduring venous infusion.

y Do not let anything

b

loc

k

the emitting light fro

m

device, i.e. do not use fingernailpolish/paints.

y Vigorous exercise and electrosurgical device

interference may affect the measuring accuracy.

y The orientation-sensorworks on the

b

asis of the

gravity.

A

small movable metal

b

all is

b

uilt in the
orientation-sensorfordetecting the orientation of the
oximeter. When you want to change the oximeter’s
display direction, if you move the Oximetertoo
slowly, the movable metalball will also move slowly

“Wireless” function is enabled.

Wireless icon of POD-1W (the number
of lines indicates signal intensity )

-15-

b

ecause of not enough acceleration. Consequently

the response of orientation detection would

b

e

delayed. Acceleration needs to

bep

rovided to the

orientation-sensorforquic

k

sensing the orientation

change.

y Nail polish may affect the measuring accuracy , and

too long fingernail may cause failure of measurement
or inaccurate result.

y 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.

y 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.

Note: Due to the working principle of orientation sensor
used in the Oximeters, such as the model PC-60B3, there is
a small metal ball which is movable within its
compartment of the orientation-sensor. Therefore you may
hear a slight “clatter” sound when you wave or shake the
Oximeter, this is normal!

-16-

Downloading the APP software for Android smart
phone

The terminal devices such as Android smart phone can be
used to receive data from the Oximeter in real-time, and
store the received data, review the stored data as well. You
have to download the corresponding APP software on the
smart phone. Please follow the procedure to download:

1. Scan below QR code.

2. Open the link from the QR code.

3. Download the software “PC-60NW.apk” and install.

4. Run the software to connect the Oximeter for real-time
data transfer.
The below QR Code is appliable to the Fingertip Oximeter
with wireless function.

Instruction for Measurement

☞ Make sure the APP software is successful to connect with

the Oximeter.

☞ Refer to the manual of this APP software for detail

operation.

 Note: APP software for PC and Android smart phone is

also available for download from below link:
http://www.creative-sz.com/software/

NOTES:

① The two-dimensional barcode QR code shown in

-17-

Figure 9A is for Oximeter with bluetooth V2.x and Figure
9B is for Oximeter with bluetooth V4.0. That's to say, if
your Oximeter is PC-60NW or PC-60B5, you need to scan
at Figure 9A to downl oad the corresponding APP software,
while for POD-1W, you need to scan at Figure 9B.

②Please make sure the version of Android system for

your smart phone should be V4.3 or higher, and include
the bluetooth module of V4.0, otherwise, the downloaded
APP s oftware will not be compatible with the Oximeter.

③ Please make sure the APP software performs successful

bluetooth connection with the Oximeter.

Figure 9A

(QR code for Oximeter

with and bluetooth V2.0 )

Figure 9B

(QR code for Oximeter

with and bluetooth V4.0 )

-18-

5. Technical Specifications

A. SpO2Measurement

Transducer: d ual-wavelength LED sensor with
wavelength:

Red light: 663 nm, Infrared light: 890 nm.

Maximal average optical output power: ≤1.5mW
SpO2measuring range: 35%~100%
SpO2measuring accuracy:

≤ 2% forSpO2range fro

m

70% to 100%

B. PulseRatemeasurement

PR measuring range: 30bpm~240bpm

PR measuring accuracy: ±2bpm or ±2% (whichever is
greater)

C. Perfusion Index(PI) Display range

0%~20%

D. Preset over-limits

SpO2low limit: 90%
Pulse Rate: high limit: 120bp

m

low limit: 50bp

m

E. Over-limit indication settings for PC-60C1,N,NW:

SpO2:

low limit setting range: 85%~95%

-19-

Default setting: 85%

Pulse Rate:

Low limit setting range: 30~60bpm;
High limit setting range: 100~240bpm;

Default setting: high: 120bpm; low: 50bpm

F. Over-limit settings for PC-60E

SpO2:

default low over-limit:

For internal sensor: 90%

For external sensor: 95%

Pulse Rate:

For internal sensor:

High limit: 120bpm; Low limit: 50bpm

For external sensor:

High limit: 160bpm; Low limit: 60bpm

G. Audible & visual alert function

When measuring, if SpO2value or pulse rate value
exceeds the preset limit, the device will alert with
beep automatically and the value which exceeds limit
will flash on the screen.

H. Power supply requirement:

2 x LR03 (AAA) alkaline batteries

Supply voltage: 3.0VDC

Operating current: ≤40mA

-20-

I. Environmental Conditions:

Operating Temperature: 5°C ~40°C
Operating Humidity: 30%~80%
Atmospheric pressure: 70kPa~106kPa

J. Low Perfusion Performance:

The accuracy of SpO2and PR measurement still meet
the precision described above when the modulation
amplitude is as low as 0.6%.

K. Ambient Light Interference:

The difference between the SpO2value measured in the
condition of indoor natural light and that of darkroom
is less than ±1%.

L. Dimensions: 66 mm (L) × 36 mm (W) × 33 mm (H)

Net Weight: approx. 60g

M. Classification

The type of protection against electric shock:

Internally powered equipment.

The degree of protection against electric shock:

Type BF applied parts.

Electro-Magnetic Compatibility: Group I, Class B

-21-

6 Repair and Maintenance

6.1 Maintenance

The expected service life (not a warranty) of this device is
5 years. In order to ensure its long service life, please pay
attention to the maintenance.

y Please change the batteries when the low-voltage

indicator lightens.

y Please clean the surface of the device before using,

with 75% alcohol wipes, then let it air dry o r wipe it dry.
Do not allow liquid to enter the device.

y Please take out the batteries if the oximeter will not be

used any more than 7 days.

y The recommended storage environment of the device:

ambient temperature: -20ºC ~60ºC, relative humidity
10%~95%, atmospheric pressure: 50kPa~107.4kPa.

y The oximeter is calibrated in the factory before sale, so

there is no need to calibrate it during its life cycle. Any
SpO2simulators should not be used to validate the
accuracy of the oximeter, they can only be used as
functional testers to verify its precision. The SpO

2

accuracy claimed in this manual is supported by the
clinical study conducted by inducing hypoxia on
healthy, non-smoking, light-to-dark skinned subjects in
an independent research laboratory

.

-22-

y If it is necessary to verify the precision of the oximeter

routinely, the user can do the verification by means of
SpO2simulator, or it can be done by the local third
party test house. Please note that the specific calibration
curve (so called R-curve) should be selected when use
of SpO

2

simulator, e.g. for Index 2 series SpO

2

simulator from Fluke Biomedical Corporation, please
set "Make" to "DownLoadMake: KRK", then the user
can use this particular R-curve to test the oximeter. If
the SpO2 simulator does not contain "KRK" R-curve,
please ask the manufacturer for helping to download
the given R-curve into the SpO2 simulator.

High-pressure sterilization cannot be used on the

device.

Do not immerse the device in liquid.

It is recommended that the device should be kept in

a dry environment. Humidity may reduce the life of
the device, or even damage it.

6.2 Cleaning and Disinfecting Instruction

y Surface-clean sensor with a soft cloth damped with a

solution such as 75% isopropyl alcohol, if low-level
disinfection is required, use a mild bleach solution.

y Then surface-clean with a cloth damped ONLY with

clean water and dry with a clean, soft cloth.

Caution: Do not sterilize by irradiation steam, or ethylene oxide.

Do not use the Oximeter if it is damaged.

-23-

7 Troubleshooting

Problem:

1. The SpO2and Pulse Rate display instable

2. Can not turn on the device

3. No display

4. Display direction doesn’t change or changes insensitively.

5. No display of the wireless icon “ ”

Solution

1. Place the finger correctly inside and try again.

2. Let the patient keep calm.

3. Changing batteries

4. Please shake the oximeter with a certain force to make
the movable metal ball move freely. If the problem still
exists, maybe the orientation-sensor is not working
properly.

5. Hardware failure of wireless transmission function.

6. If the above problem still exists please contact the local
service center.

8 Packing List

1) Fingertip Oximete

r

2) UserManual

3) Batteries

4) External SpO

2

p

robe (Optional)

Note: the items an

d

its quantity are subject to

change,

p

lease referto yoursubject in hand.

-24-

9 Key of Symbols

Symbol Description

Pulse oxygen saturation

/PR P ulse rate (beats per minute)

PI% Perfusion Index (%)

/

Pulse Strength Bar Graph

/ Low battery voltage

CE mark

Serial number

Date of manufacture

Authorised representative in the
European community

Manufacturer (including address)

BF type applied part

Attention ─ refer to User Manual

Follow WEEE regulations for
disposal

Wireless icon

-25-

Shenzhen Creative Industry Co., Ltd.

Tel: [phone]
Fax: [phone]
E-mail: [email protected]

Website: www.creative-sz.com

Address: 2/F, Block 3, Nanyou Tian'an

Industry Town, 518054 Shenzhen,
GD, P.R. China