Creative Medical AP-20 User manual

Sleep Screener
AP-20
User Manual
Shenzhen Creative Industry Co., Ltd

2021
User Manual for Sleep Screener
[I]
Instructions to User
Dear Customer,
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
Sleep Screener.
No part of this manual may be
photocopied, reproduced or translated
into another language without the prior
written consent. We reserve the right to
revise and amend it at any time without
prior notice.
Version of the Manual: Ver 1.
Issued Date: 10th,
All rights reserved.
3502-2640001
2
March

User Manual for Sleep Screener
[II ]
Notes:
The contents contained in this manual
are subject to change without prior
notice.
Information furnished by Creative is
believed to be accurate and reliable.
However, no responsibility is assumed
by Creative for its use, or any
infringements of patents 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 and measurement
performance. It is recommended that
the device should be inspected
minimally before each use. If there is
obvious damage, stop using the
device.

User Manual for Sleep Screener
[III ]
Necessary service must be
performed only by qualified
technicians. Users are not permitted
to service this device.
The Sleep Screener must not be
used with the devices and
accessories not specified in User
Manual.
Cautions
Explosive hazard—DO NOT use the
Sleep Screener in environment with
inflammable gas such as some
ignitable anesthetic agents.
DO NOT use the Sleep Screener
while the Patient is under MRI or CT
scanning. This device is NOT MRI
Compatible.
Warnings
Discomfort or pain may occur if
using the sensor of this device

User Manual for Sleep Screener
[IV ]
continuously on the same location
for a long time, especially for the
patients with poor microcirculation.
Misapplication of a SpO2probe with
excessive pressure for prolonged
periods can induce pressure injury.
Place the SpO2probe on the finger
tightly will cause venous pulse and
effect blood circulation, and lead to
interstitial edema, hypoxia and
inaccurate measurement.
Biocompatibility tests have been
performed on all the applied parts,
some exceptional allergic patients
may still have anaphylaxis. Do not
apply to those who have
anaphylaxis.
For the individual patients, there
should be a more prudent
inspecting in the placing process.

User Manual for Sleep Screener
[V]
The sensor can not be placed on the
edema and tender tissue.
The local law should be followed
when disposing of the expired
device or its accessories.
DO NOT operate in the environment
where strong electro-magnetic
interference exists, such as
radiogram, television, radiophone,
etc.
Please pay attention to the SpO2
probe cable and oral-nasal cannula
while using to avoid strangulating
patient.
Attentions
Keep the Screener away from dust,
vibration, corrosive substances,
explosive materials, high
temperature and moisture.
If the Screener gets wet, please stop
operating it and do not resume

User Manual for Sleep Screener
[VI ]
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 the
Screener 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 Screener and probes. Refer to
related chapter for instructions
regarding cleaning and disinfection.
The intended use of this device is
not for therapy purpose.
The equipment is IP22 with
protection against harmful solid
foreign objects and ingress of liquid.

17
User Manual for Sleep Screener
[VII ]
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.
Declaration of Conformity
The manufacturer hereby declares that
this device complies with the following
standards:
IEC 60601-1:2005+A1: 2012,
IEC60601-1-2:2014, IEC60601-1-11:2010,
ISO 80601-2-61:20 and follows the
provisions of the council directive
MDD93/42/EEC.

User Manual for Sleep Screener
[VIII ]
Table of Contents
1 Overview................................................................ 1
1.1 Appearance...................................................... 1
1.2 Product Name and Model...............................3
1.3 Structure...........................................................3
1.4 Features............................................................3
1.5 Intended Use....................................................4
1.6 Working Environment......................................5
2 Preparation.............................................................5
2.1 Power Supply................................................... 5
2.2 Connection.......................................................6
3 Make measurement.............................................. 9
3.1 SpO2Measurement......................................... 9
3.2 Oral-nasal Air Flow Monitoring.................... 14
3.3 Setting Menu................................................. 17
3.4 Body Movement Detection...........................21
3.5 Additional Information..................................22

User Manual for Sleep Screener
[IX ]
4 Technical Specification........................................23
5 Classification........................................................ 26
6 Packing List...........................................................27
7 Repair and Maintenance.....................................28
7.1 Maintenance..................................................28
7.2 Cleaning and Disinfection............................. 29
7.3 Storage and Transportation.......................... 30
8 Troubleshooting...................................................31
Appendix................................................................. 32
A Common Knowledge for SpO2Measurement 32
B Knowledge for Oral-nasal Air flow and Snoring
detection.............................................................. 37
C Wristband Installation and Disassembly.........38
D Key of Symbol................................................... 41

User Manual for Sleep Screener
1
1 Overview
1.1 Appearance
1. Working status indicator.
2. LCD display screen: Display measurement result,
waveform.
Note: Two kinds of appearance for optional, please
refer to the device you’ve purchased.
Figure 1A Front view
1
2

User Manual for Sleep Screener
2
Figure 2 Right side view
3. Power on/off key: Power on/off the device by
3
4
5
1
2
Figure 1B Front view
Figure 3 Left side view

User Manual for Sleep Screener
3
long pressing.
4. SpO2probe connector.
5. Data interface: For charging, data
uploading and connecting air-flow measuring
module.
1.2 Product Name and Model
Name: Sleep Screener
Model: AP-20
1.3 Structure
It consists of main unit, SpO2probe, air-flow
module, acceleration sensor, oral-nasal cannula,
data interface as well as the bluetooth module
(optional).
1.4 Features
It’s a smart wearable Sleep Screener,
lightweight, small in size and easy to wear;
1.44 inch color LCD to display parameters,
plethysmogram, oral/nasal air flow and

User Manual for Sleep Screener
4
snore waveform;
Body activity recording and analysis
function is available;
Setting menu is available;
Over-limit alert by vibration of the device.
The over limits can be adjusted via the
provided PC software .
Convenient to measure and record SpO2,
pulse rate, respiration rate, oral/nasal air
flow and snore signals in long-term while
sleeping;
Up to 72 hours data storage (500 pieces of
record at most).
Data can be uploaded to PC for review and
analysis.
1.5 Intended Use
This Sleep Screener is intended for measuring and
recording the functional oxygen saturation (SpO2),
pulse rate (PR), respiration rate (RR), oral/nasal air
flow, snoring and so on. It’s applicable for

User Manual for Sleep Screener
5
long-term tracking of SpO2, PR, RR, oral/nasal air
flow and snoring of adult or pediatric while
sleeping in hospital, clinics or home. This device is
not intended for continuous monitoring.
1.6 Working Environment
Operating temperature: 0~40℃
Operating humidity:
10%~90% (non-condensing)
Atmospheric pressure: 70kPa~106kPa
2 Preparation
2.1 Power Supply
Internal power supply: built-in lithium
battery 3.7V/500mAh.
External power supply for charging via USB
cable: the power source from USB cable
should produce the capacity of 5V DC/1.2A.

User Manual for Sleep Screener
6
2.2 Connection
The illustration of connection among SpO2probe,
oral-nasal cannula, air-flow module and Sleep
Screener is shown in figure 2.1.
Note: Two kinds of SpO2probes are for optional
(L-type with wrapper and finger rubber), please
refer to the probe you’ve optioned.

User Manual for Sleep Screener
7
Figure 2.1A Device and accessories connection
----- L-type SpO2sensor with wrapper
Open-ended
branches for nostrils
Oral mask
Sleep Screener
SpO2sensor
(L-type with
wrapper )
Air-flow
module
Oral-nasal cannula

User Manual for Sleep Screener
8
Figure 2.1B Device and accessories connection
----- Finger rubber SpO2sensor
SpO2sensor
(finger rubber)

User Manual for Sleep Screener
9
3 Make measurement
3.1 SpO2Measurement
1. Long press power on/off key to turn on the
device.
2. Connect the SpO2probe to the connector “ ”
on the side of the device, the red blinking light
from the probe indicates a successful
connection. (Note: When disconnecting the
connector, be sure to hold the head of the
connector firmly and pull).
SpO2probe connector
L-type SpO2sensor with wrapper
Finger rubber SpO2sensor

User Manual for Sleep Screener
10
Figure 3.1 SpO2probe connection
3. Wear the Screener on your left hand.
4.
For L-type SpO2sensor with wrapper: Wrap it
upon the finger (index finger is preferred) with
the disposable wrapper (the light emitter
should aim at the light receiver), refer to figure
3.2A for placement illustration.
Figure 3.2A Placement illustration
--- For L-type SpO2sensor with wrapper
For Finger rubber SpO2sensor: Insert the finger
(index finger is preferred, the nail should be not
too long) into the probe until the fingernail tip
rests against the stop at the end of the probe
(figure3.2B). Adjust the finger to be placed evenly
on the middle base of the sensor (make sure the
finger is in the right position).
Table of contents
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