BMC YH-600B Pro User manual

Sleep Apnea Diagnosis Device and Accessories
Portable Sleep Diagnostic System
YH-600B Pro
User Manual

YH-600B 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...........15
10.1.2 Wearing the Main Device ........................17
10.1.3 Connecting the Respiration Kit................17
10.1.4 Wearing the Airflow Cannula ...................18
10.1.5 Wearing the Pulse Oximeter Sensor .......19
10.1.6 Connecting the Main Device with the
Respiration Kit..............................................................21
10.2 Operation.....................................................................21
10.2.1 Accessing the Initial Interface..................21
10.2.2 Accessing the Standby Interface .............22
10.2.3 Accessing the “Record”Interface ............23
10.2.3.1 Wearing Alert Messages.................23
10.2.3.2 “Record”Interface...........................25
10.2.4 Accessing the “Setup”Interface...............26
10.2.5 Accessing the “Data”Interface ................28
10.2.6 Accessing the “Tools”Interface................29
10.2.7 Turning Off the Device.............................31
11. Troubleshooting ....................................................................32
12. Cleaning and Disinfection .....................................................33
12.1 Cleaning.......................................................................33
12.2 Disinfection..................................................................35
13. Disposal.................................................................................37
14. EMC Requirements...............................................................38
CHAPTER 2: ANALYSIS SOFTWARE FOR PORTABLE SLEEP
DIAGNOSTIC SYSTEM..............................................................43
1. Software Installation................................................................43

YH-600B Pro User Manual V3.0
2. Co-use of the Software with Sleep Diagnostic Device............43
2.1 Run the Software...........................................................43
2.2 Data Management Application ......................................44
2.2.1 Data Unfolding...........................................44
2.2.2 Data Download ..........................................50
2.2.2.1 Poly Watch........................................50
2.2.2.2 TF Card Data Transmission..............54
2.2.2.3 Bluetooth data transmission .............55
2.2.3 Data Import................................................61
2.3 Help ...............................................................................61
2.3.1 View Help...................................................61
2.3.2 Language...................................................61
2.3.3 About..........................................................61
2.4 Analysis Application.......................................................62
2.4.1 File.............................................................62
2.4.1.1 Data Management............................62
2.4.1.2 Patient...............................................63
2.4.1.3 Read Only.........................................64
2.4.1.4 Report...............................................64
2.4.1.5 Print...................................................65
2.4.2 Review.......................................................65
2.4.2.1 Sleep Staging ...................................65
2.4.2.2 Skip...................................................66
2.4.2.3 Left Actual Time................................67
2.4.2.4 Left Offset Time ................................67
2.4.2.5 Auto Play...........................................68
2.4.2.6 Tool ...................................................69
2.4.2.7 Default Event ....................................70
2.4.3 Analysis......................................................71
2.4.3.1 analysis rules....................................71
2.4.3.2 Automatic Analysis............................76
2.4.4 Settings......................................................76
2.4.5 Window......................................................77
2.4.5.1 View..................................................77
2.4.5.2 Help...................................................82
2.5 Data Manual Analysis....................................................82
2.5.1 Technician Annotation................................82
2.5.2 Add, Delete, and Move Channels..............83
2.5.3 Add and Delete Events..............................84
3. Exit Program............................................................................86
4. Software Uninstall ...................................................................86
CHAPTER 3: SERVICE ..............................................................87
1. Technical Support ...................................................................87
2. Limited Warranty.....................................................................87

YH-600B Pro User Manual V3.0
1 / 88
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-600B Pro User Manual V3.0
2 / 88
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-600B Pro User Manual V3.0
3 / 88
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
Thorax / Abdomen
effort
Range
Margin of error
10 ~ 40 times per minute
≤±3 times per minute
Body position
Supine position, sleep on left or right side,
and prone positons can be detected
Wrist movement
(sleep / awake)
Automatic sleep-awake identification
from wrist movement

YH-600B Pro User Manual V3.0
4 / 88
Temperature
Operation
Storage /
Transportation
5°C ~ 35°C
-20°C ~ 55°C
Humidity
Operation
Storage /
Transportation
≤80% (non-condensing)
≤93% (non-condensing)
Atmospheric
pressure
Operation
Storage /
Transportation
860 ~ 1,060 hPa
700 ~ 1,060 hPa
Power supply
DC 1.5 V ±0.15 V (1 ×1.5 V LR6 AA)
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-600B Pro User Manual V3.0
5 / 88
5. Intended Use
YH-600B Pro records the following data: patient respiratory nasal
airflow, snoring, blood oxygen saturation, pulse, respiratory effort,
body position 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 diagnosis 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 adults.
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-600B Pro and its accessories are for the specified
intended use only.
•Do not smoke while wearing YH-600B 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-600B Pro cannot be used on a water bed or a bed with an
electric blanket, because these electrical equipment will
disturb the operation of YH-600B Pro.
•Federal law restricts these devices to sale by or on the order
of a physician.
•YH-600B Pro meets requirements of electromagnetic
compatibility. If you doubt YH-600B Pro may disturb the

YH-600B Pro User Manual V3.0
6 / 88
operation of other electrical equipments, such as televisions,
radios and mobile phones, or if YH-600B Pro does disturb the
operation, you should move YH-600B Pro far away from
these equipment.
•YH-600B 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-600B 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-600B Pro User Manual V3.0
7 / 88
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-600B Pro User Manual V3.0
8 / 88
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). The unit of
time is hour.
HI
The HI means the number of hypopneas per
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 invalid 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-600B Pro User Manual V3.0
9 / 88
7. Model
Table 1-1 Monitoring Parameters and Components
Model
Monitoring
Parameters
Components
YH-600B Pro
SpO2, pulse rate, airflow
waveform, thorax /
abdomen effort, body
position, snore, wrist
movement (sleep /
wake), CPAP pressure
Main Device, Respiration
Kit, Respiration Effort Belt,
Effort Lead Cable, USB
Data Cable and Bluetooth
Data Transmission, TF
Card, Pulse Oximeter
Sensor, CPAP Pressure
Tube, Airflow Cannula, Wrist
Belt, Computer Software

YH-600B Pro User Manual V3.0
10 / 88
8. Package Contents
Table 1-2 shows package contents.
Table 1-2 Package Contents
Main
Device
Pulse
Oximeter
Sensor
USB Data
Cable
Respiration
Kit
Airflow
Cannula
Respiration
Effort Belt
CPAP
Pressure
Tube
Effort Lead
Cable
Quick
Operation
Manual
Quick
Operation
Manual
TF Card
User
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,
maintenance, cleaning and disinfection are in strict accordance
with the User Manual.

YH-600B Pro User Manual V3.0
11 / 88
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 used for putting in or taking out the TF
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-600B Pro. To
ensure a safe and effective therapy, adopt only BMC accessories.

YH-600B Pro User Manual V3.0
12 / 88
9. System Features
9.1 General Introduction
The performance and functional characteristics of YH-600B Pro
include all the user-friendly features of the predicate device.
YH-600B Pro is powered by one 1.5 V AA battery. Testing was
performed to demonstrate that the performance of YH-600B Pro
in its intended environment is as safe and effective as that of the
legally marketed predicate devices. The safety and effectiveness
of YH-600B Pro have been 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-600B Pro.
The device 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
device does not have any audible alarms, and, therefore, should
not be used for continuous monitoring.
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-600B Pro User Manual V3.0
13 / 88
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 respiration kit to collect
data on the airflow waveform and
snore; connect to the computer with a
USB data cable to transfer data

YH-600B Pro User Manual V3.0
14 / 88
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
Fig 1-2 shows a user wearing YH-600B Pro. Please don’t directly
expose the patient’s skin to the device, which had better been
placed outside the patient’s pajama. See sections 10.1.1 ~ 10.1.6
for detailed wearing instructions.
Airflow Cannula
Respiration Effort Belt
Pulse Oximeter Sensor Main Device
Respiration Kit
Effort Lead Cable
Fig 1-2 Wearing YH-600B Pro

YH-600B Pro User Manual V3.0
15 / 88
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 1-3).
Step 1: Opening battery door
Step 2: Inserting TF card and battery
TF Card
Main Device
Battery Compartment
Battery Door
TF Card Port
Step 3: Closing battery door
Fig 1-3 Inserting the TF card and battery

YH-600B Pro User Manual V3.0
16 / 88
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 1-4.
TF Card Symbol
Setup
Data Tools
Record
Fig 1-4 Symbol indicating correct insertion of TF card
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 Fig 1-5, indicating “incorrect insertion or absence of
TF card”.
Setup
Tools
Record
TF Card Symbol
Data
Fig 1-5 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

YH-600B Pro User Manual V3.0
17 / 88
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 1-6.
Fig 1-6 Wearing the main device
CAUTION!
•Make sure the wrist belt is neither too loose nor too tight;
otherwise normal device operation will be affected.
10.1.3 Connecting the Respiration Kit
Connect the respiration kit according to steps 1 ~ 3, as shown in
Fig 1-7.