Please do not translate those in yellow color.

1.  
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 in 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 the actual product, the actual product shall govern.
2.  
• YH-300 and the accessories are to be used for the specified intended use only.
3.  
• When using consumables and accessories, please read the manufacturer’s information supplied with the products.
4.  
• The oral and nasal airflow cannula is single use only. Only use the original oral and nasal airflow cannula supplies in the original, unopened pack.
5.  
• Apply the oral and nasal airflow cannula and the finger pulse oximeter sensor correctly to avoid the unlikely risk of strangulation.
6.  
• Blood flow must not be impeded during the recording process. The pulse oximeter sensor should be applied snug and comfortable, but not too tight.
7.  
• Excessive ambient light and excessive motion may degrade pulse oximeter performance or affect the accuracy of the measurement.
8.  
• The pulse oximeter sensor may not work on cold extremities due to reduced circulation. Warm or rub the finger to increase circulation, or reposition the sensor.
9.  
• Nail polish or false nails should be removed before using the finger sensor.
10.  
• Keep all parts away from children.
11.  
• Risk of explosion. Never use the device in the vicinity of flammable gases (e.g. anesthetics).
12.  
• The device shall not be serviced or maintained while in use with a patient.
13.  
• Federal law restricts these devices to sale by or on the order of a physician.
14.  
• Never use abrasive agents, alcohol, chlorine-containing substances, acetone, or other solvents to clean the device.
15.  
• Do not immerse the device, the airflow unit, or the pulse oximeter sensor in fluids, and ensure that no fluids penetrate into the products. Do not immerse the main device in water.
16  
• The oral and nasal airflow cannula is non-reusable, dispose of it in accordance with local regulations.
17.  
• Do not use different types of batteries at the same time. Do not mix fully charged and partially charged cells at the same time. These actions may cause the batteries to leak.
18.  
• Insert freshly charged batteries or new batteries into the device before EACH recording. Use only the specified types of battery or rechargeable battery.
19.  
• Heavy smokers, with high carbon monoxide (CO) blood content can not use YH-300.
20.  
• YH-300 meets requirements of electromagnetic compatibility. If you doubt YH-300 may disturb the operation of other electrical equipments, such as television, radio and mobile phone, or if YH-300 does disturb the operation, you should move YH-300 far away from these equipments.
21.  
• YH-300 cannot be used on water bed or a bed with electric blanket, because these electrical equipments will disturb the operation of YH-300.
22.  
• YH-300 determines 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.
23.  
• Cardiogreen and other intravascular dyes, depending on the concentration, may affect SpO₂ accuracy.
24.  
• YH-300 must be able to measure the pulse properly to obtain accurate SpO₂ measurement. Verify that nothing is hindering the pulse measurement before relying on the SpO₂ measurement.
25.  
Do not use YH-300 in an MRI environment.
26.  
Do not operate YH-300 in an explosive atmosphere.
27.  
Do not use YH-300 on infant or neonatal patients.
28.  
Discontinue use if skin reddening or inflammation appears.
29.  
2. Do not use YH-300 device in situation where alarms are required. The YH-300 device has no audible alarms.
30.  
5. Do not smoke while wearing YH-300.
31.  

4. Device description

The performance and functional characteristics of YH-300 includes all the user-friendly features of the predicate device.
With two channels of monitoring and powered by two 1.5 V AAA batteries, YH-300 device is intended to help doctors for sleep apnea screening and is a type 4 sleep monitoring devices. YH-300 is intended for the hospital/institutional environment (supervised) and the home (unsupervised) environment for adult.
Testing was performed to demonstrate that the performance of YH-300 in its intended environment is as safe and effective as that of the legally marketed predicate devices. The safety and effectiveness of YH-300 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, snore and CPAP pressure, can be replayed on a PC via the PolyLogic^® Sleep Analysis Software which is provided with YH-300.
32.  
Note: The indicative icon of battery  in the main interface will blink when the battery voltage is lower than 2.3V.
33.  
Note: Oral and airflow unit is optional.
34.  
Warning!
A flexible circuit connects the two halves of YH-300. Do not twist or pull on the connection.
35.  
Note 2: If the present time displayed on the device is later than the preset record starting time, the device will immediately begin to record.
36.  
 “About” shows device and patient information such as the version, battery power, patient name, ID and the current time, see figure 1-12. Press any key to quit.
37.  
Note: YH-300 has a circulatory data store function. Users needn’t to erase the records manually; the new record will cover the earliest record when the store memory is full. Thus, in order to avoid the data being covered unintended, users need to transfer the data to PC in time to backup after each recording.

38.   • inadequate perfusion

39.   • excessive patient movement

40.   • pulse oximeter and blood pressure measurement on the same limb, etc.

 

41.  The icon of battery blinking	Battery voltage is lower than 2.3V.	Replace the batteries or rechargeable batteries in the device.
42.  Can’t replay the data on computer	Incorrect USB connection between computer and recorder.	Check that the USB cable connection between the recorder and the computer is correct, paying particular attention to the plug contacts.
	43.   USB cable defective.	Contact BMC or an authorized BMC distributor to request a new USB cable.

44.  
SpO₂ < 70 % not validated
45.  
YH-300 was designed to be simple and easy-to-use. Your YH-300 will operate reliably with good care and regular maintenance.
Cleaning instruction:
Clean YH-300 main device
1. Turn off YH-300 and take battery out of YH-300 main device.
2. Scrub YH-300 main device gently with a damp gauze pad.
3. Dry YH-300 main device with a dry soft gauze pad.
Clean the Airflow Unit
1. Detach the Airflow Unit and the pressure cannula.
2. Wipe the Airflow Unit gently with a damp gauze pad.
3. Dry the Airflow Unit with a dry soft gauze pad.
Clean the USB data cable
1. Disconnect the USB data cable from YH-300 main device.
2. Scrub the USB data cable gently with a damp gauze pad.
3. Dry the USB data cable with a dry soft gauze pad.
Clean the Pulse Oximeter Sensor
The Pulse Oximeter Sensor may be surface cleaned by wiping it with a solution such as 70% isopropyl alcohol. If low level disinfection is required, use a 1:10 bleach solution. DO not use undiluted bleach (5%-5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent damage to the sensor could occur.
1. Detach the pulse oximeter sensor from YH-300 main device.
2. Saturate a clean, dry gauze pad with the cleaning solution. Wipe all surfaces of the Pulse Oximeter Sensor with this gauze pad.
3. Saturate another clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the Pulse Oximeter Sensor with this gauze pad.
4. Dry the Pulse Oximeter Sensor by wiping all surfaces with a clean, dry gauze pad.
Caution!
Do not sterile by irradiation or steam.
Cleaning the wrist belt 
1. Wash the wrist belt before first time use, as the dye may run.
2. Detach the wirst belt from the main device.
3. İt is important to always handwash the wrist belt.
4. Wash the wirst belt in warm, (approx. 40°C) and soapy water. Use pure soap.
5. Rinse the wrist belt well and allow it to air dry out of direct sunlight.
46.  
• If necessary, i.e. after infectious diseases or if parts have become unusually dirty, you can disinfect certain parts by wiping them.
Follow the instructions for the disinfectant used. We recommend TERRALIN^® for disinfecting by wiping. Take a disposable gauze pad and spray it with disinfectant. Then wipe the relevant part with it.
We recommend you to wear suitable gloves (e.g. house-hold or disposable gloves) during disinfection procedures.
Leave the disinfected components to dry fully in air before using them again.
• Sterilization of the device and its components is not permitted.
Note: On a change of patient, clean and disinfect the device and its components as described in above clause “Cleaning” and “Disinfect”.
47.  
Do not dispose device as household waste. To ensure proper disposal of the device, consult an authorized and certified electronic scrap recovery firm. You can find out their address from your environmental officer or your municipal authorities.
48.  

2. Patient Information Setup

Before recording, YH-300 allows setting the patient Information on a PC via the PolyLogic^® Sleep Analysis Software, and displaying the patient name and ID in the About interface(Figure1-12) of YH-300 main device.
a) Start Software
Firstly double-click shortcut of the analysis software icon on the desktop, the system will enter YH-300 system main window.
b) Connection of YH-300 and Computer
In the power off status of YH-300, connect one end of the USB data cable to the computer USB port, and the other end to YH-300 Flow/COM socket and then turn on YH-300. The patient information can be set on a computer in all interfaces except About Interface (Figure1-12).
c) Run the software and choose the “File” from the main menu, select "New" to enter the communication interface. Select USB port and click “Connect”.

Figure 2-1 SleepView Online
d) If connection succeeds, the "Connect" button will be grayed. And other originally grayed unavailable buttons will be available now. After online with the computer (see "connection of YH-300 and computer"), YH-300 will automatically enter the communication status.
e) After the success of online, click "Login" button in “SleepView Online” dialog box and the patient information dialog box pops up (Figure 2-2).

Figure 2-2 Patient Information
f) Enter patient information one by one. When the login information input is finished, select “OK”. There will be a dialogue box indicating “Login OK”, press “OK” to confirm the operation. At this time select "Exit" in the dialog box, then YH-300 will automatically exit from the communications status.
g) Exit Program
To back to Windows desktop, just click “File” in the menu and click “Exit” or  at the top right corner.
49.  
Note:
1. Do not connect YH-300 to a USB hub.
2. Only one YH-300 can be connected to the computer at any time.
50.  

7. Help

To show Software Version and Service Email just click “Help” button in the menu bar, then click “About” button.
To alter report title just click “Help” button in the menu bar, then select “Report Title”. The “Report Title” dialog box will pop up (Figure 2-14).
Enter report title, then click “OK” button.

Figure 2-14 Alter Report Title
A.  
• Batteries may leak or explode if used or disposed of improperly.
B.
Wrist Belt
PC Software CD
Software Installation
Driver Installation上海翻譯公司完成醫(yī)療器械類英文翻譯

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