BMC YH-600A Pro User manual

Sleep Apnea Diagnosis Device and Accessories
Sleep Screener
YH-600A Pro
User Manual

YH-600A Pro User Manual V3.0
Table of Contents
CHAPTER 1: DEVICE INTRODUCTION AND OPERATION .......1
1. Symbols.....................................................................................1
1.1 Control Buttons................................................................1
1.2 Device Symbols...............................................................1
2. Warnings, Cautions and Important Tips....................................2
3. Contraindications ......................................................................2
4. Specifications............................................................................3
5. Intended Use.............................................................................5
6. Glossary....................................................................................7
7. Model.........................................................................................9
8. Package Contents...................................................................10
9. System Features.....................................................................12
9.1 General Introduction......................................................12
9.2 Main Device Structure...................................................13
10. Instructions for Use ...............................................................14
10.1 Setting up and Wearing the Device.............................14
10.1.1 Installing the TF Card and Battery...........14
10.1.2 Wearing the Main Device ........................16
10.1.3 Wearing the Airflow Cannula ...................17
10.1.4 Wearing the Pulse Oximeter Sensor .......18
10.1.5 Connecting the Main Device with the
Airflow Kit.....................................................................19
10.2 Operation.....................................................................19
10.2.1 Accessing the Initial Interface..................20
10.2.2 Accessing the Standby Interface .............20
10.2.3 Accessing the “Record”Interface ............21
10.2.3.1 Wearing Alert Messages.................21
10.2.3.2 “Record”Interface...........................23
10.2.4 Accessing the “Setup”Interface...............24
10.2.5 Accessing the “Data”Interface ................26
10.2.6 Accessing the “Tools”Interface................27
10.2.7 Turning Off the Device.............................29
11. Troubleshooting.....................................................................30
12. Cleaning and Disinfection .....................................................31
12.1 Cleaning.......................................................................31
12.2 Disinfection..................................................................33

YH-600A Pro User Manual V3.0
13. Disposal.................................................................................35
14. EMC Requirements...............................................................36
CHAPTER 2: ANALYSIS SOFTWARE FOR SLEEP SCREENER
....................................................................................................41
1. Software Installation................................................................41
2. Co-use of the Software with Sleep Diagnostic Device............41
2.1 Run the Software...........................................................41
2.2 Data Management Application ......................................42
2.2.1 Data Unfolding...........................................42
2.2.2 Data Download ..........................................48
2.2.2.1 Poly Watch........................................48
2.2.2.2 TF Card Data Transmission..............52
2.2.2.3 Bluetooth data transmission .............53
2.2.3 Data Import................................................59
2.3 Help ...............................................................................59
2.3.1 View Help...................................................59
2.3.2 Language...................................................59
2.3.3 About..........................................................59
2.4 Analysis Application.......................................................60
2.4.1 File.............................................................60
2.4.1.1 Data Management............................60
2.4.1.2 Patient...............................................61
2.4.1.3 Read Only.........................................62
2.4.1.4 Report...............................................62
2.4.1.5 Print...................................................63
2.4.2 Review.......................................................63
2.4.2.1 Sleep Staging ...................................63
2.4.2.2 Skip...................................................65
2.4.2.3 Left Actual Time................................65
2.4.2.4 Left Offset Time ................................65
2.4.2.5 Auto Play...........................................66
2.4.2.6 Tool ...................................................67
2.4.2.7 Default Event ....................................68
2.4.3 Analysis......................................................69
2.4.3.1 analysis rules....................................69
2.4.3.2 Automatic Analysis............................75
2.4.4 Settings......................................................75
2.4.5 Window......................................................76

YH-600A Pro User Manual V3.0
2.4.5.1 View..................................................76
2.4.5.2 Help...................................................81
2.5 Data Manual Analysis....................................................81
2.5.1 Technician Annotation................................81
2.5.2 Add, Delete, and Move Channels..............82
2.5.3 Add and Delete Events..............................83
3. Exit Program............................................................................85
4. Software Uninstall ...................................................................85
CHAPTER 3: SERVICE ..............................................................86
1. Technical Support....................................................................86
2. Limited Warranty.....................................................................86

YH-600A Pro User Manual V3.0
1 / 87
CHAPTER 1: DEVICE INTRODUCTION AND
OPERATION
The information in this manual has been carefully checked and is
believed to be accurate. In the interest of continued product
development, BMC Medical Co., Ltd. reserves the right to make
changes and improvements to this manual and the products it
describes at any time, without notice or obligation.
Images shown here are indicative only. If there is inconsistency
between the image and actual product, the actual product shall
govern.
1. Symbols
1.1 Control Buttons
On-Off / OK Button
Shift Button
1.2 Device Symbols
Type BF Applied Part
Follow Instructions for Use
IP22
≥ 12.5 mm Diameter, Dripping (15º tilted)
Serial Number of the Product

YH-600A Pro User Manual V3.0
2 / 87
Lot number
Manufacturer
EC REP
Authorized Representative in the European
Community
European Union Approval
No SpO2Alarms
2. Warnings, Cautions and Important Tips
WARNING!
Indicate the possibility of injury to the user or operator.
CAUTION!
Indicate the possibility of damage to the device.
IMPORTANT TIP!
Place emphasis on an operating characteristic.
Warnings, Cautions, and Important Tips appear throughout this
manual as they apply.
3. Contraindications
Depending on the skin condition or general state of health, the
patient may experience sensitivity to the wrist belt or the
self-adhesive pulse oximeter sensor. Discontinue use if an allergic
reaction to the skin-contact materials occurs.

YH-600A Pro User Manual V3.0
3 / 87
4. Specifications
SpO2
Range
Accuracy
0% ~ 100%
≤±3% (70% ~ 85%), ≤ ±2% (85% ~ 100%)
Pulse rate
Range
Accuracy
30 ~ 250 bpm
≤2 bpm (30 ~ 100 bpm)
≤2% (100 ~ 250 bpm)
Wavelengths
Red
Infrared
660 nanometers
905 nanometers
Maximal Optical
Output Power
Less than 2 mw maximum average
Airflow waveform
Frequency
Margin of error
10 ~ 40 times per minute
≤±1 time
CPAP pressure
Range
Margin of error
4 ~ 20 hPa
≤±1 hPa
Snore
150 ~ 300 Hz
Wrist movement
(sleep / wake)
Automatic sleep-wake identification from
wrist movement
Temperature
Operation
Storage /
Transportation
5°C ~ 35°C
-20°C ~ 55°C
Humidity
Operation
Storage /
Transportation
≤80% (non-condensing)
≤93% (non-condensing)

YH-600A Pro User Manual V3.0
4 / 87
Atmospheric
pressure
Operation
Storage /
Transportation
860 ~ 1060 hPa
700 ~ 1060 hPa
Power supply
DC 1.5 V ±0.15 V (1 ×1.5 V LR6AA)
Minimum record
duration
No less than 8 hours
Data storage
64 records can be stored on TF card
Dimensions
78 mm ×60 mm ×21 mm (main device)
Weight
75 g (main device with battery)
Type of protection
against electrical
shocks
Internal power supply
Classification of
protection against
electrical shocks
Type BF applied part
Waterproof rating
IP22
Working mode
Continuous operation

YH-600A Pro User Manual V3.0
5 / 87
5. Intended Use
YH-600A Pro records the following data: patient respiratory nasal
airflow, snoring, blood oxygen saturation, pulse and wrist
movement during sleep. It can also be connected to a CPAP
system to record and display continuous positive airway pressure.
The device uses these recordings to produce a report that may
aid in the screening of sleep disordered breathing or for further
clinical investigation. The device is intended for the hospital /
institutional environment (supervised) and the home environment
(unsupervised) for adult.
WARNINGS!
•When using consumables and accessories, please read the
manufacturer’s information supplied with the products.
•This device is intended for adult use only. Do not use the
device on infant or neonatal patients.
•Do not use the device in situations where alarms are required.
The device has no audible alarms.
•Keep all parts away from children.
•YH-600A Pro and its accessories are for the specified
intended use only.
•Do not smoke while wearing YH-600A Pro.
•Risk of explosion. Never use the device in the vicinity of
flammable gases (e.g. anesthetics).
•No modification of this equipment is allowed.
CAUTIONS!
•YH-600A Pro cannot be used on a water bed or a bed with an
electric blanket, because these electrical equipments will
disturb the operation of YH-600A Pro.
•Federal law restricts these devices to sale by or on the order
of a physician.
•YH-600A Pro meets requirements of electromagnetic
compatibility. If you doubt YH-600A Pro may disturb the

YH-600A Pro User Manual V3.0
6 / 87
operation of other electrical equipments, such as television,
radio and mobile phone, or if YH-600A Pro does disturb the
operation, you should move YH-600A Pro far away from
these equipments.
•YH-600A Pro must be able to measure the pulse properly to
obtain accurate SpO2measurement. Make sure that nothing
is hindering the pulse measurement before relying on the
SpO2measurement.
•YH-600A Pro measures the percentage of arterial oxygen
saturation of functional hemoglobin. Significant levels of
dysfunctional hemoglobin such as carboxyhemoglobin or
methemoglobin may affect the accuracy of the measurement.
•FCC Caution: Any changes or modifications not expressly
approved by the party responsible for compliance could void
the user’s authority to operate this device.

YH-600A Pro User Manual V3.0
7 / 87
6. Glossary
Snore
Because of the respiratory tract’s airway
limitation, sound is made when respiratory
airflow gets through the narrow respiratory
tract, which usually indicates that the patient is
likely to have suffered in years from sleep
apnea syndrome along with the increase of
age.
Apnea
The performance of respiratory intermission
during sleep is that the respiratory airflow drops
to lower than 10% of the normal range and lasts
for at least 10 seconds. The recurrent
intermission during sleep is easy to cause
severe oxygen-deficit to brain and blood, form
hypoxemia and induce hypertension,
brain-heart disease, arrhythmia, myocardial
infarction and angina, which then can induce
multi-system diseases of the human body.
Hypopnea
The reduction range of respiratory airflow is
more than 50% of the normal, accompanied
with more than 4% of oxyhemoglobin saturation
reduction.
SAHS
The SAHS means at least 30 times of apnea in
7 hours of nightly sleep time of adults and each
apnea lasts for more than 10 seconds. Or the
apnea hypopnea index AHI (the number of
apneas and hypopneas per hour) is greater
than 5.
OSAHS
The OSAHS means the sleep apnea hypopnea
syndrome caused by obstruction of the upper
respiratory tract (including the collapse of
pharyngeal mucosa).

YH-600A Pro User Manual V3.0
8 / 87
AI
The AI means the number of apneas per hour,
which is equal to the number of times apnea
has occurred the whole night divided by the
sleep time of whole night (awakening and
invalid time are not contained), and the unit of
time is hour.
HI
The HI means the average number of times the
hypopnea has occurred every hour which is
equal to the number of times hypopnea has
occurred the whole night divided by the sleep
time of whole night (awakening and ineffective
time are not contained). The unit of time is
hour.
AHI
The AHI means the number of apneas and
hypopneas per hour which is equal to the total
times of apneas and hypopneas during the
whole night divided by the sleep time of whole
night (awakening and invalid time are not
contained), and the unit of time is hour.
SNI
The SNI means the average number of times
the snore has occurred every hour which is
equal to the number of times snore has
occurred the whole night divided by the sleep
time of whole night (awakening and invalid time
are not contained). The unit of time is hour.
ODI
The ODI means the number of times when the
oxyhemoglobin saturation reduction is more
than 3% or 4% every hour.
CPAP
The CPAP means feeding continuous positive
airflow into air passage by face mask.

YH-600A Pro User Manual V3.0
9 / 87
7. Model
Table 1-1 Monitoring Parameters and Components
Model
Monitoring
Parameters
Components
YH-600A Pro
SpO2, pulse rate,
airflow waveform,
snore, wrist movement
(sleep / wake), CPAP
pressure
Main Device, Airflow Kit,
USB Data Cable and
Bluetooth Data
Transmission, TF Card,
Pulse Oximeter Sensor,
CPAP Pressure Tube,
Airflow Cannula, Wrist Belt,
Computer Software

YH-600A Pro User Manual V3.0
10 / 87
8. Package Contents
Table 1-2 shows package contents.
Table 1-2 Package Contents
Main Device
Pulse
Oximeter
Sensor
USB Data
Cable
Airflow Kit
Airflow
Cannula
CPAP
Pressure
Tube
TF Card
User Manual
Quick
Operation
Manual
Quick
Operation
Manual
Computer
Software
Disk
Carrying
Case
Tweezers
TF card
reader
Medical tape
All parts and accessories are not made with natural rubber latex.
The product’s service life shall be five years if the use,

YH-600A Pro User Manual V3.0
11 / 87
maintenance, cleaning and disinfection are in strict accordance
with the User Manual.
WARNING!
•This device should only be used with the tube and
accessories manufactured or recommended by BMC or with
those recommended by your prescribing physician. The use
of inappropriate tubes and accessories may affect the
performance of the device and impair monitoring effects.
CAUTIONS!
•The use of non BMC-certified accessories may undermine
system security, so it is recommended that users only use the
pulse oximeter sensor and other accessories provided by
BMC.
•It is recommended to use Airflow Cannula with the registration
certification for medical device. The Airflow Cannula fitting is a
male Luer-taper fitting with a diameter of 4 mm.
•The tweezers are usedfor putting in or taking out theTF card.
•Different types of products shall contain different parts. Please
always follow the package list enclosed with the product.
•This device and its accessories are for intended use only.
Note:
① The belt on the main device is in accordance with the
biological evaluation of medical devices.
② The finger sheath and cannula are CE marking approved,
indicating compliance to the Medical Device Directive.
③ Several accessories are available for using YH-600A Pro. To
ensure a safe and effective therapy, adopt only BMC accessories.

YH-600A Pro User Manual V3.0
12 / 87
9. System Features
9.1 General Introduction
The performance and functional characteristics of YH-600A Pro
include all the user-friendly features of the predicate device.
YH-600A Pro is powered by one 1.5 V AA battery. Testing was
performed to demonstrate that the performance of YH-600A Pro
in its intended environment is as safe and effective as that of the
legally marketed predicate devices. The safety and effectiveness
of the YH-600A Pro were verified through performance-related
testing that consisted of Electrical Safety, Electromagnetic
Compatibility, Mechanical and Environment Testing.
The recorded data, such as SpO2, pulse rate, airflow waveform,
snore and CPAP pressure, can be replayed on a computer via the
PolyLogic Analysis Software which is provided with YH-600A Pro.
The Sleep Screener can be used as a standalone unit for
recording data. It can also interact with a commercially available
IEC60950-1 compliant computer, which can be used to review
data. The Sleep Screener does not have any audible alarms, and
therefore, should not be used for continuous monitoring.
The patient is an intended operator, who can safely use all
functions and can perform all maintenances mentioned in the
User Manual.
All parts of the device are applied parts.

YH-600A Pro User Manual V3.0
13 / 87
9.2 Main Device Structure
Display Screen Shift Button
On-Off / OK Button
Flow / COM Port
SpO2 Port
Fig 1-1 Main device structure
Table 1-3 shows Component and Function.
Table 1-3 Component and Function
Component
Function
Display Screen
Display the menu, alerts and data
monitored
Shift Button
Switch interfaces and options
On-Off / OK Button
Turn on / off the device, and confirm
adjustment
SpO2Port
Connect to the pulse oximeter sensor to
collect data on SpO2and pulse rate
Flow / COM Port
Connect to the airflow kit to collect data
on the airflow waveform and snore;
connects to the computer with a USB
data cable to transfer data

YH-600A Pro User Manual V3.0
14 / 87
10. Instructions for Use
CAUTIONS!
•Avoid exposure to sources of direct airflow, such as fans
during recording.
•Avoid using this device in an MRI environment or in close
proximity to a high EMI emission source.
•Do not attempt to take the main device apart. No
user-serviceable parts are inside.
•If any unexplained changes are noticed in the performance of
this device, if the device is dropped or mishandled, if water is
spilled into the enclosure, or if the enclosure is broken,
discontinue use and contact BMC.
10.1 Setting up and Wearing the Device
See sections 10.1.1 ~ 10.1.5 for detailed wearing instructions.
10.1.1 Installing the TF Card and Battery
Push and pull the battery door according to Step 1. Insert the TF
card into the slot and put a new AA battery with the positive and
negative terminals on the correct sides according to Step 2. Close
the battery door according to Step 3 (Fig 1-2).
Step 1: Opening battery door

YH-600A Pro User Manual V3.0
15 / 87
Step 2: Inserting TF card and battery
TF Card
Main Device
Battery Compartment
Battery Door
TF Card Port
Step 3: Closing battery door
Fig 1-2 Inserting the TF card and battery
WARNING!
•The battery may leak or explode if used or disposed of
improperly.
When the TF card and battery are correctly inserted into the
device, a symbol indicating correct insertion of the TF card will
appear in the standby interface, as shown in Fig 1-3.
TF Card Symbol
Setup
Data Tools
Record
Fig 1-3 Symbol indicating correct insertion of TF card

YH-600A Pro User Manual V3.0
16 / 87
If the TF card is inserted incorrectly or not inserted, a red “X”
symbol will appear on the “TF card”icon in the standby interface,
as shown in Fig1-4, indicating “incorrect insertion or absence of
TF card”.
Setup
Tools
Record
TF Card Symbol
Data
Fig 1-4 Symbol indicating incorrect insertion or absence of TF card
CAUTIONS!
•When there is a red “X”symbol on the “TF card”icon in the
standby interface, the user should check whether the TF card
is inserted incorrectly or not inserted. If it is inserted correctly,
the TF card may be broken.
•Please place a fully charged or new AA battery every time
before recording. Use only the specified types of battery or
rechargeable battery.
•Replace the battery when the battery quantity drops below
1.2 V, as the icon shows or when the screen flickers.
•If the device has not been used for a long time, remove and
put away the battery to prevent electrolyte leakage from
damaging the device.
10.1.2 Wearing the Main Device
Wear the main device on the wrist as a watch, and fasten the wrist
belt when the device is properly positioned, as shown in Fig 1-5.