Polymate YH-1000C Polysomnograph. User Manual

Transcription

1 Polymate YH-1000C Polysomnograph User Manual 0123

2 Table of Contents CHAPTER 1: OVERVIEW Package Contents Recorder Profile Symbols... 3 CHAPTER 2: INTRODUCTION Intended Use Warnings Cautions Contraindications Electromagnetic Compatibility... 7 CHAPTER 3: CONTROL PANEL... 8 CHAPTER 4: INSTALLATION AND SETUP Installation Installation the Battery Connecting of the Sensors to the Recorder Applying the Sensors to Patient Instructions for Recorder Turn on/off the Recorder Recorder Information Stop Record CHAPTER 5: CLEANING AND MAINTENANCE Cleaning and Maintenance Disinfect/ Sterilization Disposal CHAPTER 6: TROUBLESHOOTING CHAPTER 7: SPECIFICATION Physical Specifications Features Specifications Condition of Operating, Transport and Storage CHAPTER 8: EMC REQUIREMENTS CHAPTER 9: LIMITED WARRANTY CHAPTER 10: POLYLOGIC ANALYSIS SOFTWARE FOR POLYSOMNOGRAPH Software Installation... 28

3 Install Analysis Software Install the USB driver Collaborated Work and Analysis Data Data reception Data file management Data playback Print preview and output Help Exit program... 52

4 About This manual offers the instructions for installation, using and maintenance of YH-1000C Polysomnograph. This manual is only used by professional sleep lab or physician. Please read this manual before using the device, to make sure operating safely. Copyright The copyright of this manual is belongs to BMC Medical Co., Ltd. Only BMC Medical Co., Ltd. has the explanation right of this manual. Issue date:nov 30,2012

5 Product Name: Model: CHAPTER 1: OVERVIEW Polysomnograph YH-1000C 1.1 Package Contents Your Polymate System should include the following articles. If any of these items are not included, contact a BMC representative. No. Articles Num. N/O 1 Recorder Host 1 N 2 Oral and Nasal Airflow Cannula 1 N 3 SpO 2 Sensor 1 N 4 Body Position, Snoring, Chest and Abdomen effort 1 N Cable 5 CPAP Pressure Cannula 1 O 6 USB Data Cable 1 N 7 Body Position Belt 1 N 8 User Manual 1 N 9 Sheath 1 N 10 Software CD 1 N 11 Tape 1 N Note: O=Optional; N=Normal 1

6 1.2 Recorder Profile The recorder is a small, lightweight diagnostic sleep recorder. The unit measures 140mm x 80mm x 32mm and weighs 360 grams (with battery). Front Side Bottom The Polymate uses sensors to record oxygen saturation, pulse rate, airflow, respiratory effort, snore, and body position in a supervised (hospital/institutional) or unsupervised (home) environment. It is capable of recording at least 8 consecutive hours of patient data. Serial cables allow the Polymate to transfer the data from Polymate to the hose PC. CPAP pressure cannula allow the Ploysomnograph to record data from these pressure therapy device: RESmart CPAP or APAP. Oxygen saturation and pulse measurements are made by a SpO 2 sensor with two light-emitting diodes (LEDs) that send red and infrared light through tissue containing an arterial pulse. The light is received by a photo detector that is located directly opposite the LEDs. Respiratory effort measurements are made by a chest and abdomen effort sensor attached to electrodes on the patient s chest and abdomen area. Airflow measurements are made by an Oral and Nasal airflow Cannula that is placed just inside the patient s nose or a CPAP pressure cannula that is used in conjunction with a nasal mask during CPAP therapy. 2

7 Snoring is also detected by a microphone sensor. Body position is measured by a piezoelectric sensor attached to a fabric package on the patient s abdomen or chest area. The data collected by the recorder is analyzed using the PolyLogic Analysis software for Polysomnograph. 1.3 Symbols Type BF Applied part Operating Instructions IPX1 SN IPX1 Drip-Proof, Vertical Serial Number of the product Manufacturer Authorized Representative in the European Community European union approval 3

8 2.1 Intended Use CHAPTER 2: INTRODUCTION The Polymate is a multi-function recording device intended to be used to collect and store physiological signals related to sleep disorders and generate a report for screening to aid in the diagnosis of related respiratory sleep disorders. The Polymate is only to be used under the direction and supervision of a physician, technologist or clinician. The Polymate records oral and nasal airflow, chest and abdomen effort, pulse oximetry (% SpO 2 and pulse rate), snore, and body position. The recorded information is analyzed by a trained health care professional to identify and report respiratory events via the PolyLogic Analysis Software for Polysomnograph. The analysis software system which has the following functions: Patient archive Sleep apnea and snoring event auto analysis Editing Reporting and printing 2.2 Warnings A Warning indicates the possibility of injury to the patient or operator. Do not use the Polymate recorder for continuous monitoring of oxygen saturation or as a replacement for pulse oximeter monitors. The Polymate recorder does not contain any alarms and is not intended for this application. Do not use this device in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Use only sensors and accessories that are specified by BMC for the Polymate recorder. Non-approved BMC sensors and accessories can compromise the safety, performance, and certification of the Polymate recorder. To avoid electric shock hazard, disconnect the Polymate recorder from the computer before changing the battery. Secure the sensor cord to the patient s body using medical tape to avoid entanglement or the remote possibility of strangulation from the cord. To avoid electric shock, do not allow the patient to shower or bathe while wearing the 4

9 sensors or the Polymate recorder. To ensure the Polymate recorder records throughout the entire sleep session, replace the 1.5V battery in the Polymate recorder prior to each new session. The Polymate recorder needs to be installed and put into service according to the EMC information provided in the Chapter 8. Inaccurate measurements may be caused by: - Incorrectly using the sensor - Using the Polymate recorder in the presence of high levels of carbon monoxide (e.g., on people who are heavy smokers) - Using intravascular dyes (e.g., methylene blue and/or indocyanine green) - Optical interference, such as excessive illumination from surgical lamps, bilirubin lamps, direct sunlight, heat lamps, ambient light, or light from the oximeter sensor`s LED that has not passed through the tissue - Low perfusion caused by blood pressure cuff, arterial or intravascular catheter, or poor blood flow - Portable and mobile Radio Frequency communications equipment. - Electromagnetic interference - Excessive movement - Venous pulsation - Electrosurgical interference - Nail polish - Skin pigmentation - Anemia During downloading patient data, the Polymate recorder must be separate from the patient. This operation is required to ensure that the operator does not accidentally touch the computer and the patient simultaneously possibly exceeding the enclosure leakage current limit of 100µA. All connectors between the sensors and the recorder have been designed to prevent their insertion into any other outlets or orifices. However, it is the user s responsibility to read and understand the instructions in this manual before using this device to prevent any electrical shock hazard. If liquid is spilled on the Polymate, if it is dropped or immersed in liquid, discontinue use and contact BMC. 5

10 Do not use while bathing, shock hazard may occur. Inspect cords periodically for signs of wear. Operation of the Polymate may be adversely affected by: - electromagnetic fields exceeding the level of 10 V/m in the test conditions of EN the operation of high frequency (diathermy) equipment - defibrillators, or short wave therapy equipment - radiation (e.g., x-ray, CT) - magnetic fields (e.g., MRI) The microphone of the snore sensor registers not only the snoring made by your patient, but also nearby noises that have frequencies typical of snoring. Make sure that the surrounding noise level is considerably lower than the volume of the snoring. Do not open the cap of battery compartment while the sensor and patient are connected. User must not touch the metal foils contacting the positive and negative poles as well as the recorder data interface to get rid of the potential safety hazard. The oral and nasal airflow cannula is a disposable component and designed for single patient use only. The pulse oximeter probe which is used for adult(> 40kg)only may be used on the same location for a maximum of 8 hours provided the location is inspected routinely to ensure skin integrity and correct positioning. Because individual skin condition affects the ability of the skin to tolerate probe placement, it may be necessary to change the probe location more frequently with some patients. No modification of this equipment is allowed. 2.3 Cautions A caution indicates the possibility of damage to the device. Read the accompanying manual before using this device to ensure a correct operation. Please put the batteries out of the device when not using it for a long time to prevent it from damaging by the battery liquid. 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. Patient should stop taking any central nervous system stimulant and tranquilizer 3 days 6

11 before recording. And no alcohol is allowed on the recording day. During recording, DO NOT use mobile phone and wireless phone. Otherwise, may result in abnormal and failure record. Do not allow detergent solution or cold sterilization agents to leak into the electronic components. Use extra caution around connectors and panel edges. Do not use abrasive cleaners. To minimize toxic hazards to the environment, dispose of the 1.5V alkaline battery according to the manufacturer s instructions and in accordance with local regulations. BMC is not responsible for the disposal of the 1.5V alkaline battery. 2.4 Contraindications Users allergic to the device Users planted with cardiac pacemaker Pregnant woman 2.5 Electromagnetic Compatibility The Polymate complies with Electromagnetic Compatibility standards for medical devices. If you suspect that the Polymate is interfering with the operation of other appliances (television, radio, cell phone, etc.) or if they are interfering with the operation of the Polymate, move the Polymate away from the appliance. The Polymate is not intended for use while sleeping in a waterbed or with an electric blanket. These devices may interfere with the operation of the Polymate. 7

12 CHAPTER 3: CONTROL PANEL Structure and function are described in figure 1. On/Off Reset USB Data Port LCD Display Shield Button 1 Shift/Cancel Button 2 OK/Event Flow SpO2 Snore/BPI/Res. Figure 1 Control Panel There are two buttons on the panel, each button has multiple functions. Button 1 is for switch between multi options, or in some cases used as "Cancel". Button 2 is normally used for "confirmation", or used to trigger "Event" during record process. Combined with the use of two buttons, you can choose a variety of functions on the LCD screen to achieve the various operations. See the following "Instructions" for details. There are three sensor inputs at the recorder bottom. The flow input is used to connect the oral and nasal airflow cannula. SpO 2 input (Five cores) is to connect the SpO 2 sensor. Snore/BPI/Res. Input (Seven cores) is to connect the snore, chest and abdomen effort and body position sensors. There is a USB data port on the top of recorder. It is used to connect with the computer to playback the recorded data through USB data cable. There are two buttons on the left side of the recorder. The big one is to turn on or off the recorder. In order to prevent misuse, the button is designed to be concave and will not be pressed by 8

13 normal touch. Pressing the big button for more than 1 second can turn on/off the recorder which will not respond to a short-time click. The small button is used to reset the recorder in unusual situation. Usually, it is unnecessary to be used, so it only can be triggered by a special tool. LCD screen is for displaying recorded waveforms, parameters and user s operation. 9

14 CHAPTER 4: INSTALLATION AND SETUP Observe the outer package to check whether there is an obvious transport damage traces before opening the package. Open the packaging carefully to check whether there is damage on device, missing screws or components during transport. 4.1 Installation Installation the Battery Install two new standard AA batteries before each new patient. Check the positive (+) and negative (-) polarity indicated on the bottom of the battery compartment before inserting the battery. The recorder may be damaged if the battery is inserted incorrectly. When the battery voltage is lower than 2.3 volts, the recorder can t work Connecting of the Sensors to the Recorder Check out whether the lead wires and electronic cables are worn out or broken before use. If so, do not use them. Insert cable of the chest and abdomen effort, snore, body position into the Snore/BPI/Res. (seven cores) input on the bottom of recorder. Ensure the red spots on both connectors are aligned. Insert SpO 2 /pulse rate sensor into SpO 2 (five cores) input on bottom of the recorder. Ensure the red spots on both connectors are aligned. Insert airflow cannula into the Flow input on the bottom of recorder. 10

15 4.1.3 Applying the Sensors to Patient To Apply the Chest and abdomen effort, Snore, Body Position Sensor Chest and abdomen effort through the four button cables connect to the body chest and abdominal electrode. Before sticking the electrode to the patient, skin should be cleaned by 95% medical alcohol to erase skin oils for a good contact. The connection of the electrode is in Figure 2. The two buttons of the same color, regardless of positive or negative electrode, can be swapped each other. To obtain the accurate data, BMC suggest using single use ECG electrode. Green: Right axilla central 5 th rib Green: Left axilla central 5 th rib White: One palm distance right from navel White: One palm distance left from navel Figure 2 Fixed position of the Chest and abdomen effort electrode The body position sensor is fixed in front of the patient s chest. See figure 3. The snoring sensor is fixed near the neck and larynx, by the side of Adam's apple. See figure 3. Both the body position sensor and snoring sensor should be fixed onto the clothes without direct skin contact. 11

16 Figure 3 Fixed positions of body position sensor and snore sensor To Apply the SpO 2 Sensor Contact the nail cover with flashing red light, the signal receiver attached to the other side of the finger opposite the red light. Observe SpO 2 and pulse rate value on the LCD screen, if fixed correctly, about 10 seconds later, the patient's current value of SpO 2 and pulse rate will be shown. Then fix sensor with plaster, as shown in Figure 4. In order not to affect the patient's action, it is suggested that the sensor fixed on the patient's forefinger, at the same time the sensor cable should be set aside a certain amount of scope, and fixed well in the hand and wrist. NOTE: When the SpO 2 sensor probe is to be removed from patients and cleaned-up, be careful not to directly pull cable, which will have an impact on sensor life. The performance of the SpO 2 sensor probe is compromised by motion; use of SpO 2 sensor probe is contraindicated for active patients. The SpO2 Sensor model is S0044D-S. Figure 4 Fixed Position of SpO 2 Sensor 12

17 To Apply the Oral and Nasal Airflow Cannula Cannula is fixed on the upper lip, see Figure 5. Cannula Figure 5 Fixed Position of Oral and Nasal Airway Cannula To Apply the CPAP Pressure Cannula (Option) CPAP pressure cannula is intended to connect the recorder to the pressure therapy device. See Figure 6. For the purpose of pressure therapy with the Polymate, please select the therapy device specified by BMC. Figure 6 Fixed Position of CPAP Pressure Cannula 4.2 Instructions for Recorder Explanation: the replay and analysis work of this device is implemented by host analysis software. For detailed operation instructions, see PolyLogic Analysis Software for Polysomnograph. This recorder can be completed most functions except of data playback without of a computer, including: data record, time starting record, data erase and recorder settings. 13

18 4.2.1 Turn on/off the Recorder There are two ways to turn on the recorder: First, press and hold the On/Off button on the left side of the recorder for more than one second until the LCD displays. Second is to load batteries, recorder will automatically boot. Generally no operation is needed to turn off the recorder, because in the default setting, if more than 1 minute recorder is idle (no records and communications, no button operation), recorder will automatically shut down. You can also press the key to shut down; the operation is same as turn on the recorder Recorder Information After turn on, the main interface appears as follows: Figure 7 Recorder main interface Recorder operations and functions choose can achieve through the two buttons on the panel. Press "Shift/Cancel" button allows the cursor to switch in the three functions icon. When the cursor moved to the function you want, press "OK/Event "button to enter the selected function modules. Three icons represented functions are: 1) Record: access to recording status, see "Data Record". 2) Erase: erase the data in recorder memory, each time before the new data records, data already in the recorder must be erased, see "Data Erase". 3) Status: display registered patient information in the recorder, record status and the battery voltage. 14

19 Recorder Status After turn on the recorder, selection Status in the main interface to check the recorder information. The interface is shown as below: Figure 8 Recorder Status Interface In this function you can view the serial number of the recorder motherboard, software version and the precise battery voltage. Because of the different type of batteries, when the left battery power is the same, the battery voltage may be different. If replacement of other type batteries, within this function, by several trials you can determine the minimum battery voltage value for record one more data. So take full usage of each battery for saving money and also conducive to environment protection. Data Erase Each time before the new data record, the data stored in the recorder must be erased. The interface is shown as below: Figure 9 Data Erase Interface 15

20 Once the data is erased, it is impossible to restore. Therefore, before erasing data please keep in mind to transmit the previously recorded data to computer, transfer method as detailed in "Data Transfer". In order to prevent mis-operation from erasing data accidentally, twice prompts will appear to confirm erasing before starting the erase operation. After starting to erase, the erase progress will show on the LCD, please do not remove the battery or press the switch key prior to the completion of the erase. Note: Electric current when erase is much larger than normal status. Low battery can lead to the failure of data erase, please notice the tips on the LCD for the erase operation. Data Record Before recording new data, please ensure that the previous data has been erased. About the data erase, see "Data erase". Turn on the recorder, select function 1 "Record in the main interface to record the data. 1. Record In the main interface, select function 1 "Record", enter records screen, as shown below. Figure 10 Data Record Interface The abbreviations on the interface and their meanings are shown as below: SpO 2 : Oxygen Saturation HR: Heart Rate (Pulse Rate) BPI: Body Position Indicator FL: Flow 16

21 CR: Chest Effort AR: Abdomen Effort SN: Snoring Rcrd Time: Record Time On the recorder screen, you can observe whether all sensors and electrode wire leads on normal working. Oral and nasal airflow, chest and abdomen effort and snoring waveform are displayed on the center of LCD respectively. On the upper LCD, the SpO 2 value, heart rate (pulse rate) and body position are displayed. Below the LCD, the record time is displayed. It has not yet started record when the record time displays the flashing " " with waveforms and parameters displayed. The time record will be enabled by pressing the "OK/Event" button for more than five seconds. Then the duration of record can be observed in ever-changing. Before the start of record, pressing "Shift/Cancel" button can withdraw from the record screen, and return to the main interface. Once the record has already begun, you can not withdraw from the record screen by pressing any button. The only way to stop the record at this time is to turn off the recorder by pressing On/Off button. If you are intended to record data in this way, make sure that all sensors and electrodes are fixed normally before pressing "OK/Event" button for more than 5 seconds to start recording. The data will not be recorded unless the time record is enabled. 2. Timer Setup Access the Record interface, and press "Shift/Cancel" button. Select Yes when the setting timer prompt appears to enter the Timer Setup interface, which is shown as below. Timer Setup Hour 21 Minute 0 Length 8 hours ok Cancel Current Time Figure 11 Timer Setup Interface 17

22 Through the two buttons on the operation panel, you can set the timer for timing record. Use "Shift/Cancel" button to move the cursor and "OK/Event" to modify the contents. As shown, move the cursor to "OK" and press "OK/Event" button to confirm timer, then recorder begins to countdown. On the LCD screen the timer is displayed. When Time Left comes to 00:00:00, recorder starts automatically. In timing record status, when the countdown starts, it does not need to operate the recorder. Recorder will automatically begin to record by preset time. In order to save battery power, after the beginning of the countdown you can press the Turn On/Off button to turn off the recorder. Once the recorder turns on, the timer will continue the countdown. If the boot time exceed to the preset time of the timing record, the recorder will immediately begin to record as soon as the recorder is turned on. Note: DO NOT remove the battery after timer is set, otherwise timer information will lose. During the period of countdown, you can suspend record please and exit from the timing status by pressing the "Shift/Cancel" button for more than five seconds, Stop Record When record starts, only the following situations can stop record: a) Press the On/Off button for more than one second; recorder will exit from recording status and be shut off. Then turn on the recorder into the main interface again. This is the normal way to end the record. b) When the battery voltage is not enough, the recorder will end record and automatically shut down. After re-boot, battery power not enough" will display. c) Some abnormal situations will lead to end record, for example, pressing the "Reset" button or removing the battery. 18

23 CHAPTER 5: CLEANING AND MAINTENANCE The Polymate recorder was designed to be simple and easy-to-use. Your Polymate will operate reliably with good care and regular maintenance. Reusable sensors, the pouch, and the Polymate recorder should be cleaned between sleep studies. 5.1 Cleaning and Maintenance Cleaning the SpO 2 Sensor 1) Disconnect the sensor from the recorder. 2) Dampen a soft cloth with a mild non-abrasive cleanser and gently rub the inside of the finger clip probe and LEDs to remove oil and dirt. 3) Wipe the outside of the clip with a damp cloth. 4) Dry the sensor with a dry cloth. Cleaning the Chest and Abdomen Effort Sensor 1) Disconnect the sensors from the patient. 2) Dampen a soft cloth with a mild non-abrasive cleanser and gently rub the effort sensor. 3) Dry the sensors with a dry cloth. 4) Wash the effort belts with a mild laundry detergent. Cleaning the Polymate Pouch 1) Wipe down the Polymate Pouch using a slightly damp cloth and a mild detergent. 2) Allow the Polymate Pouch to air dry only. Cleaning the Polymate Recorder 1) Disconnect all sensors and cables from the recorder. 2) Remove the battery. 3) Dampen a soft cloth with water and gently wipe the recorder. 19

24 4) Wipe the recorder with a dry, soft cloth. Cleaning the Body Position Belt Hand-wash the body position belt with weak soap solution at 40 C. Changing the Recorder Battery The quality of a recording and reliability of data greatly depends on the integrity of the battery. We suggest the user to use the high duration alkaline battery. For best recording results, check the status of batteries at the beginning of each study and replace the battery if the Voltage is smaller than 2.3V. The battery should be taken out when the recorder left unused for a long time in case that the battery flows out and damage the recorder. Batteries used by the recorder may be purchased at a local retail merchandising store or outlet. Note: Do not subject the diagnostic oral and nasal airflow cannula to any treatment. 5.2 Disinfect/ Sterilization 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 cloth and spray it with disinfect-ant. 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. Warning! The device shall not be serviced or maintained while in use with a patient. 5.3 Disposal 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. 20

25 CHAPTER 6: TROUBLESHOOTING Fault Cause of fault Remedy No signal in flow, snore or pulse and SpO 2 channel Results are displaying implausible values Device displaying no signals Display too dim Display dark Batteries/rechargeable batteries supplying no power Diagnostic airflow cannula and/or SpO 2 sensor not put on Plug connections are not properly connected Sensors are dirty or damp Sensors are defective Plug connections are not properly connected Sensors has got dirty or has slipped out of position during the measurement Plug connections are not properly connected Display defective Contact springs have no contact Batteries/rechargeable batteries defective Batteries/rechargeable batteries discharged Put on the missing sensor Ensure the connection are firm Clean the sensors and wipe them dry Use new sensors Ensure the connections are firm. Check the sensors before or during the recording Repeat the recording with clean or new sensors Ensure the connections are firm. Return the device to BMC for repair Insert the batteries /rechargeable batteries again Replace batteries/ rechargeable batteries Replace batteries or charge rechargeable batteries Device does not switch on Batteries/rechargeable discharged batteries Replace batteries or charge rechargeable batteries Insert the batteries /rechargeable batteries with the correct polarity. Internal fuse has tripped Return the device to BMC for repair No connection can be made to the device Cable connection between device and PC is interrupted Device has switched off Check all cable connection Switch device back on at the button 21

26 CHAPTER 7: SPECIFICATION 7.1 Physical Specifications Dimensions: Weight (with batteries): 140mm x 80mm x 32mm 360g 7.2 Features Real-time display and data storage provides: Heart rate SpO 2 value Airflow wave Snoring wave Respiratory Effort wave Body Position Note: The sampling rate of the SpO 2 signal is about 50Hz, and the update rate of the frame is 1Hz. So even there are some filtering methods to process the SpO2 data, it will not delay for a relative long time to the displaying data. Signal Processing: Pulse Oximetry Calculation Pulse Rate Calculation Body Position Calculation Recording time Sufficient memory for up to 8.5 hours of one continuous recording. Power consumption Less than 1 ma in Power-Down mode When device is switched off, all data remains intact. 7.3 Specifications Oxygen Saturation Range: 0~100% Accuracy: ±3 between % Measuring dynamics: First reaction after 3 s Final value reached after 15 s First display after attachment: 10 s 22

27 Pulse rate Range: 30~240BPM Accuracy: ±3% Emitter Light Wavelengths Red: Infrared: 660 3mw nominal 905 3mw nominal Chest and abdomen effort Method: Range: Accuracy: Impedance 10~40BPM ±1 bpm Oral and Nasal Airflow Rate Range: 10~40BPM Body Position Snore 4 Indexes: supine, left, right and prostrate Power: Range: Battery Type: Battery Duration: Type of Protection Against Electric Shock: Degree of Protection Against Electric Shock: Degree of Protection Against Ingress of Water: Mode of Operation: 150Hz~300Hz Internally Powered Equipment 2X1.5V R6 AA 17 hours minimum Class II Equipment Type BF Applied Part Drip-Proof, Vertical (IPX1) Continuous Operation 7.4 Condition of Operating, Transport and Storage Operating Temperature: 5 to 40 (41 to 104 degrees F) Transport and Storage -20 to 55 (-4 to 131 degrees F) Humidity: 80% Non-condensing 93% Non-condensing Atmosphere Pressure: 860hPa~1060hPa 23

28 CHAPTER 8: EMC REQUIREMENTS Guidance and Manufacturer s Declaration Electromagnetic Emissions The Polysomnograph (YH-1000C) is intended for use in the electromagnetic environment specified below. The customer or the user of the Polysomnograph (YH-1000C) should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Harmonic Emissions IEC Voltage Fluctuations/Flicker Emissions IEC Group 1 Class B N/A N/A This Device uses RF energy only for its internal function. Therefore, its RF radiated emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Polysomnograph (YH-1000C) is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 24

29 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Polysomnograph (YH-1000C) is intended for use in the electromagnetic environment specified below. The customer or the user of the Polysomnograph (YH-1000C) should assure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic Discharge (ESD) IEC ±6 kv Contact ±8 kv Air ±6 kv Contact ±8 kv Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power Frequency (50/60 Hz) Magnetic Field IEC A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical home or hospital environment. 25

30 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Polysomnograph (YH-1000C) is intended for use in the electromagnetic environment specified below. The customer or the user of the Polysomnograph (YH-1000C) should assure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Polysomnograph (YH-1000C), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RFIEC Radiated RF IEC Vrms 150 khz to 80 MHz 3V/m 80 MHz to 2.5 GHz 3 V 3 V/m Recommended Separation Distance d = 1.2 P d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a b Field strength from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Device is used exceeds the applicable RF compliance level above, the Device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Device. Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 26

31 CHAPTER 9: LIMITED WARRANTY BMC MEDICAL CO., Ltd. warrants that the YH-1000C Polymate Polysomnograph device shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one (1) year for main unit and 90 days for all accessories from the date of sale by BMC MEDICAL CO., Ltd. to the dealer. If the product fails to perform in accordance with the product specifications, BMC MEDICAL CO., Ltd. will repair or replace, at its option, the defective part. BMC MEDICAL CO., Ltd. will pay customary freight charges from BMC MEDICAL CO., Ltd. to the dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects not related to material or workmanship. Damages owing to improper operations will ask for paying for the cost fee when servicing. BMC MEDICAL CO., LTD. DISCLAIMS ALL LIABILITY FOR ECONOMIC LOSS, LOSS OF PROFITS, OVERHEAD OR CONSEQUENTIAL DAMAGES WHICH MAY BE CLAIMED TO ARISE FROM ANY SALE OR USE OF THIS PRODUCT. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. To exercise your rights under this warranty, contact your local, authorized dealers or: MANUFACTURER: BMC MEDICAL CO., LTD. 5/F Main Building, No.19 Gucheng S treet West, Shijingshan, Beijing , P.R.China Tel: Fax: Ext. 810 EU AUTHORISED REPRESENTATIVE: Shanghai International Holding Corp. GmbH Eiffestraβe 80, Hamburg Germany Tel: Fax:

32 CHAPTER 10: POLYLOGIC ANALYSIS SOFTWARE FOR POLYSOMNOGRAPH System Requirements for Host Software CPU P3 1.0G Memory 512M Display resolution Hard disk software platform 80G Windows XP, Windows 7, Windows Vista 10.1 Software Installation Install Analysis Software Insert Analysis Software disk to your disk drive. The Installation programs will automatically startup within 10 seconds. The executable program "SETUP.exe" inside the installation catalogue on the disk can be operated to start setup. If not, Double click icon under my computer to run the installation program. Note: The installation prompt "USBDXpressInstaller. exe" will appear along with SETUP.exe. It is not necessary to install "USBDXpressInstaller.exe" temporarily. 28

33 a) Click Next to enter the user information input page. b) Input user information, and click Next. 29

34 c) Select the installation location, and click Next. The default directory is C:\BMC\Polysomnograph. d) Check current settings and click Next. 30

35 e) Check current settings and click Next. f) Wait for software installation and icon creation to complete automatically. 31

36 g) Click Finish to complete installation. h) Now there will be a shortcut icon on the desktop. Double-click the new shortcut icon on desktop to start the software Install the USB driver This driver is intended for PC to identify the recorder. You can continue to install it following the above processes. Or, double-click when the installation of USB driver is required. INSTALL USBXpress Installer AUTOMATICALLY a) Select the installation location, and click Install to continue the installation. 32

37 b) Wait while system is scanned and driver files are copied. c)during this process, a prompt box may pop up, and click Continue Anyway. 33

38 d) Click OK to complete the Installation. INSTALL USBXpress Device The device can only be identified by PC after USBXpressInstaller is installed successfully. Make sure that the USB port of PC works well before install the USB device. a) Connect the device to the PC using the USB cable. When the system finds the hardware, the Found New Hardware Wizard pops up to set up the new device. Select the option No, not this time when asked Can Windows connect to Windows Update to search for software?, and click Next. Note: If the dialogue box Found New Hardware Wizard doesn t appear, follow INSTALL USBXpress Device MANUALLY to install the device. b) Select Install from a list or specific location (Advanced) if necessary and then click Next. Or the software will be installed under the default directory. 34

39 c) Set the options according to the figure in the search and installation options page. Click Browse button to add the directory of the driver and click next, 35

40 d) The wizard continues to search for USBXpress Device. e) During this process, a prompt box may pop up, and click Continue Anyway. 36

41 f) Press Finish to quit the driver installation interface after installation. INSTALL USBXpress Device MANUALLY These steps should be followed when USBXpress Device cannot be automatically installed successfully. a) Right-click the shortcut My Computer on the desktop and enter the system properties interface. Click Device Manager in the hardware page to find the under Universal Serial Bus controllers. 37

42 Note: if can be available instead of, it is suggested that the USB driver for YH-1000C has been installed successfully and it can work now. b) Right-click and select the option Update Driver. c) Follow the steps in INSTALL USBXpress Device AUTOMATICALLY to install driver under the direction of the hardware update wizard of the pop-up window Collaborated Work and Analysis Data Data reception Data reception is to transmit the recorded data to computer. Software will analyze the data, and then the operator can edit the results of the analysis to generate analytical reports. Data receiving process is as the following steps: 1) Software initiation Firstly double-click shortcut of the software icon on the desktop; the system will enter the sleep system main window. 2) Connection of recorder and computer In the power off status of the recorder, connect one end of the playback cable with the computer serial port, connect the other end to the recorder playback socket and then turn on the recorder. 3) Data transmission When the recording is ended, transmit the data into computer. Computer software can analyze the data. Then the operator can edit the results of the analysis to generate analytical reports. Run the software and choose the File from the main menu, select "New" to enter the communication interface (see Figure 1). 38

43 Figure 1 Recorder online Select the right serial port connected with the recorder in the communications menu, and then select the "Connect" in the menu. If online succeeds, the "Connect" button will be grayed. And other originally grayed unavailable buttons will be available now. After online with the computer (see "online between recorder and computer"), recorder will automatically enter the communication status. This process will take you a few minutes. After the success of online, click "Replay" button in Polysomnograph Online dialog box and the replay dialog box pops up. Figure 2 Recorder playback 39

44 The first content is data filename. The second is data type. Having the above two contents set up, click "OK" and the pop-up dialog box of patient information (Figure 3) is shown on the display screen. Figure 3 Patient information input Recording start time is set by system at the beginning of the recording time which is confirmed by the internal clock. If the recorder clock is not correct, you can modify it in the above login screen. The recording end time defaults to 12 hours after the record start. In fact, in the process of data transmission, the system can automatically identify the actual end time of record. Recorder will automatically stop after data transmission is finished. So you need not to change the recording end time in normal situation. If the patient information was login in the recorder already, the system will automatically fill in the corresponding content; otherwise you need to enter one by one. When the login information input is finished, select OK. Then computer begins to receive the recorded data. When data transfer is finished, the system returns to communications dialog box. At this time in the dialog box select "disconnect" or "return", recorder will automatically exit from the communications status. 40

45 If you want to connect another recorder with the computer, you can repeat the process of transmission on-line. If you do not need to transmit data from other recorders, you can select "back" button in the communication to return to the main menu Data file management In the main window of sleep system, choose Open File ; system enters into sleep data management interface. The screen shows the saved data in the hard disk and related information (Figure 4). In the page you can quickly search the needed sleep data by different requirements. Figure 4 Open data file dialog box First of all, through the drop-down menu of the window select the menu of sleep data file; you can also click the mouse to select the menu. Selected menu, the data file lists in the middle of the page and at the same time show the data file name, name of patient, number, record date, record length, person on duty, data version and other information. Use the mouse to click on the appropriate classification column, the program can sort by selected classification. In the lower right of the page is operating function keys: open, backup, delete, cancel. With mouse click the file name, you can select the file, and then select the appropriate function key to achievable data playback, data backup, data delete. Selecting the cancel button may return to the main window of the sleep system. 41

46 Data playback Under the sleep data management page, select the sleep data file, system will enter the data playback interface. If the data does not under analyzed yet, the prompt of auto analysis will be shown on the screen. After open the data file, system will enter the data playback window. There are the tendency char, the profile demonstration, the respiration event, the diagnosis result, the analysis graphics and other pages. (1) Open and close the data file Multi data files can be opened simultaneously in the main window of the sleep system. The method to open the data file please see the management of data file. Open the file may be failure if the file is already being used. Chooses the window in the sleep system main window, then chooses some data file, demonstrated then may switch to the different data file window. Chooses in the toolbar or select cancel in the File option in the menu may close the current window of data file. (2) Display of recorded data and analysis result The data recording, analysis result and statistical result are shown in 5 pages. It is in order of trend, raw data, respiration event, diagnosis result, and report. The report includes summary, respiration analysis and SpO 2 analysis. If the data recorded contain the CPAP pressure, and also has the CPAP pressure report. The first page is trend chart when the data file is opened. Other pages can be available through the tab bar above trend chart. 1) Trend The trend chart shows recorded parameter and the analysis result in the whole recorded duration. Simultaneous display of multi-parameters facilitates the user to observe different physiology parameters as well as relationship between them in the identical time. 42

47 Figure 5 Trend chart The basic functions on the page: 1Parameter browse 2Parameter delete 3Event locate 4Print 5Analysis All the operation can be completed through the menu choose. For the commonly used operation, with the exception of menu operation, you can also select the buttons on the toolbar to finish the corresponding operation. 1 Parameter browse The two buttons in the toolbar can extend and shorten the time axis which is favorable to view the trend change of recorded parameters according to the different time resolution. The cursor on the trend chart can be moved around through the button. The button can be used to display assistance window. It is possible for the assistance window to display all parameter values in the current time (cursor position of trend chart). The cursor can be moved to any time on the trend chart by the mouse. The slide ruler underneath the trend chart is intended to change the cursor position on the trend chart. The trend chart of data analysis result is shown in the middle of the window. There are several 43

48 charts varying from SpO 2 trend chart, apnea trend chart, respiration rate trend chart, snore trend chart, pulse rate trend chart, body position trend chart, to mark trend chart displaying in turn from top to bottom. Abscissa axis on Trend chart is intended to indicate recorded time, and abscissa axis above is used to indicate time scale. 2 Parameter delete Parameters that can be deleted in the trend chart include SpO 2, pulse rate, respiration rate. Using the in the toolbar may delete the invalid parameter. If a certain part of the parameters during a period of time is to be deleted, left-click the mouse and drag it to select the intended part in the chart, click the corresponding item from Trend of the menu bar. It can also be done via the icons in the toolbar. If only some points in the chart are to be deleted, stay the cursor at the exact point and click the button directly to erase them. 3 Event location Click on the chart to make the cursor stay anywhere it is wanted to be. Also, clicking on the icon in the parameter page of assistant window can bring the viewer to the very moment when this event took place. For example, clicking the cursor to the moment of the lowest value of oxygen saturation. item is able to point the 4 Print Use to print or print preview the charts or reports. The printing function also goes well in other pages. 5Analysis If the data analysis work has not been done when file is opened or some parameters are not correctly analyzed, a second analysis is necessary after an adjustment to the data. Select the corresponding options to perform the respiratory analysis and/or snoring analysis. The toolbar has provided three commonly used analysis shortcuts. The buttons respiration event analysis process and the snoring analyzing process respectively. call the The analysis function was still effective in other pages. 2) Raw Data 44

49 This page can show all the recorded signals both in waveform and in numeric value. By different walk speeds of paper, this system can display in the current time scope all the recorded features in this page such as the recorded waveforms, the record parameters as well as the corresponding analysis results and events. Other operations in the current window involve: editing analysis result, inserting, changing and deleting all events. Figure 6 Waveform display The following operations may carry out in this page. 1 Print 2 Modify display setup 3 Modify paper speed 4 Modify time display 5 Event browse 6 Event edit 7 Mark function 1 Print Select in the menu or in the toolbar to print the analysis report. 2 Modify display setup Move the cursor to a certain waveform and right-click with mouse to access the pop-up menu, select the correct item to change the gain and color of the waveform. 45

50 3 Modify paper speed This function is aimed at conveniently observing the waveforms of different types. The tool in the toolbar can zoom in and zoom out the time scale to change the speed at which paper walks. The range is from 8s/page to 480 s/page. 4 Modify time display This page provides many kinds of methods for the operator to locate any period of time conveniently to observe the waveform and its parameters. 1) The two buttons are used to slightly adjust the time back and forth as to when the waveform shall be displayed, with five seconds as a pace. 2) The two buttons are used for page turning with each page length depending on the present speed of paper s walking. For example, if the current displaying waveform walks at 1 minute/page, it shows the waveform of either previous or next one minute upon each clicking on the icons. 3) The bar is a time vernier, which could be dragged back and forth or clicked on to show a waveform in varying time ranges. 4) Moving the mouse cursor to the left or right edges of the waveform where the cursor changes to an arrow, can make the waveform walking at the speed of 2 seconds /page automatically. 5) The display contents can be located in accordance with the markings made by the editor or the various events in the analysis. Refer to the event browse function and marking function in the following parts for details. 5 Event browse 1)Respiration event All the Respiration events are lined out with a series of colorful blocks in the graph, with the serial number, the type and the length of each one annotated nearby. These Respiration events are categorized into HYP, OSA, CSA, MSA which means hypopnea, obstructive sleep apnea, central apnea and the mixed type apnea respectively. And a previous event or next event can be easily located by clicking the buttons. 2)Snore 46

51 The symbol indicates a snore. In this operation, evaluations can be made to the sensitivity of snoring threshold and it can be adjusted by modifying the threshold of snoring identification and therefore changing the number of snores. 6 Event edit The type and length of respiration events can be revised and every event can be inserted or deleted in this page. For changing the respiration event type or deleting any event, right-click on the event and select the corresponding item to continue. For changing the length of a respiration event, firstly point the mouse cursor to the beginning or the end of the block of event, when the mouse arrow changes into a draggable state. Then drag the left or right edges to change the time of beginning and end. For event insertion, left-click mouse and drag it to form rectangular block on the waveform, when a menu pops up, demonstrating the length of this block. Select a corresponding event type to generate such an event. 7 Mark function When the operator feels particularly interested in any recorded part and intends to relocate it on his next opening of the file, he may use this marking function, attaching different marks to different areas of interests. Three symbols, A, B, and C are provided in this function. And the texts +A, +B or +C are shown at the bottom of waveform. The in the toolbar is used to make a mark or search for the previous or next mark. These markings can be kept while file-saving, thus can be relocated quickly upon later reopening. 3) Respiration Event This page has listed all respiration events and their correlations with the statistical data by form. The respiration event list may sort according to different statistical items, with just clicking on the corresponding statistical tags. And the list will be shown in the intended manner. Clicking on the list or using the key on keyboard may choose any event in the respiration event 47

52 list. Click the corresponding button from the Respiration Event drop-down menu to change the type of an event. The displaying order of the list of events is not changed at the moment. Above the respiration event list is the corresponding waveforms where all the respiration events are characterized by blocks of different color. Right-click on the event block, select the corresponding option to revise or delete an event. When the mouse arrow becomes draggable at the beginning or end of an event block, drag it back and forth to shorten or lengthen the time of the respiration event. Also, a respiration event can be inserted by dragging a rectangular block in the waveform. The list of respiration events below will make a change to be ordered by serial numbers accordingly. Change the displaying page to a previous or next one, or, magnify and minify the time axis of waveform by using the toolbar If the respiration event or the snore is to be analyzed for a second time, click or in the toolbar. Figure 7 Respiration Event Edit 48

53 Figure 8 Respiration Event 4) Report All analysis results are produced into summary report, respiration analysis report, SpO 2 analysis report after statistical analysis. If the data recording has contained the CPAP pressure, a CPAP pressure report is also included. Figure 9 Report 49

54 5) Diagnosis The conditions and results of examination can be reached by selecting the corresponding items in the drop-down menu. All the above reports can be printed out Print preview and output Figure 10 Diagnosis result When the waveform is in need of printing, the Raw Data page should be activated to display. Press button or click on preview from the File menu under this page to preview the present waveforms. Figure 11 Print and Preview of the Raw Data Waveform 50

55 In other pages, pressing button or clicking on preview from the File menu may generate a window for preview options. Select the intended report and press button, the preview of report will be shown on the screen. Figure 12 Print and preview Similarly, selecting button in the toolbar, or Print from File menu will show up the window for preview options. The print work will be done after selecting the intended reports and pressing the button. Click to change the printer settings Help To show Software Version and Service 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 13). Enter report title, then click OK button. 51

56 Figure 13 Alter Report Title Exit program To back to Windows desktop just click File in the menu and click Exit or click corner. on the top right 52