BMC Polymate YH-1000C User manual

Brand: BMC

Model: Polymate YH-1000C

Type: User manual

Polymate® YH-1000C

Polysomnograph

User Manual

0123

Polymate

YH-1000C Polysomnograph User Manual V3.1

Table of Contents

CHAPTER 1: OVERVIEW ................................................................................................ 1

1.1 Package Contents ......................................................................................................... 1

1.2 Recorder Profile ........................................................................................................... 2

1.3 Symbols ........................................................................................................................ 3

CHAPTER 2: INTRODUCTION ....................................................................................... 4

2.1 Intended Use ................................................................................................................. 4

2.2 Warnings ....................................................................................................................... 4

2.3 Cautions ........................................................................................................................ 6

2.4 Contraindications ......................................................................................................... 7

2.5 Electromagnetic Compatibility .................................................................................... 7

CHAPTER 3: CONTROL PANEL ..................................................................................... 8

CHAPTER 4: INSTALLATION AND SETUP ................................................................ 10

4.1 Installation .................................................................................................................. 10

4.1.1 Installation the Battery .............................................................................. 10

4.1.2 Connecting of the Sensors to the Recorder ............................................. 10

4.1.3 Applying the Sensors to Patient ............................................................... 11

4.2 Instructions for Recorder ............................................................................................ 13

4.2.1 Turn on/off the Recorder .......................................................................... 14

4.2.2 Recorder Information ............................................................................... 14

4.2.3 Stop Record ............................................................................................. 18

CHAPTER 5: CLEANING AND MAINTENANCE ....................................................... 19

5.1 Cleaning and Maintenance ......................................................................................... 19

5.2 Disinfect/ Sterilization ................................................................................................ 20

5.3 Disposal ...................................................................................................................... 20

CHAPTER 6: TROUBLESHOOTING ............................................................................. 21

CHAPTER 7: SPECIFICATION ...................................................................................... 22

7.1 Physical Specifications ............................................................................................... 22

7.2 Features ...................................................................................................................... 22

7.3 Specifications ............................................................................................................. 22

7.4 Condition of Operating, Transport and Storage ......................................................... 23

CHAPTER 8: EMC REQUIREMENTS ........................................................................... 24

CHAPTER 9: LIMITED WARRANTY ........................................................................... 27

CHAPTER 10: POLYLOGIC® ANALYSIS SOFTWARE FOR POLYSOMNOGRAPH 28

10.1 Software Installation ................................................................................................ 28

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YH-1000C Polysomnograph User Manual V3.1

10.1.1. Install Analysis Software ....................................................................... 28

10.1.2. Install the USB driver ............................................................................ 32

10.2 Collaborated Work and Analysis Data ..................................................................... 38

10.2.1. Data reception ....................................................................................... 38

10.2.2. Data file management ........................................................................... 41

10.2.3. Data playback ....................................................................................... 42

10.2.4. Print preview and output ....................................................................... 50

10.2.5. Help ....................................................................................................... 51

10.2.6. Exit program .......................................................................................... 52

Polymate

YH-1000C Polysomnograph User Manual V3.1

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.

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

Polymate

YH-1000C Polysomnograph User Manual V3.1

CHAPTER 1: OVERVIEW

Product Name: Polysomnograph

Model: 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 SpO2 Sensor 1 N

4 Body Position, Snoring, Chest and Abdomen effort

Cable

1 N

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

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YH-1000C Polysomnograph User Manual V3.1

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 SpO2 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.

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YH-1000C Polysomnograph User Manual V3.1

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 IPX1 Drip-Proof, Vertical

SN Serial Number of the product

Manufacturer

Authorized Representative in the European Community

European union approval

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YH-1000C Polysomnograph User Manual V3.1

CHAPTER 2: INTRODUCTION

2.1 Intended Use

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 (% SpO2

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:

z Patient archive

z Sleep apnea and snoring event auto analysis

z Editing

z Reporting and printing

2.2 Warnings

A Warning indicates the possibility of injury to the patient or operator.

z 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.

z Do not use this device in the presence of flammable anesthetic mixture with air or with

oxygen or nitrous oxide.

z 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.

z To avoid electric shock hazard, disconnect the Polymate® recorder from the computer before

changing the battery.

z Secure the sensor cord to the patient’s body using medical tape to avoid entanglement or the

remote possibility of strangulation from the cord.

z To avoid electric shock, do not allow the patient to shower or bathe while wearing the

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YH-1000C Polysomnograph User Manual V3.1

sensors or the Polymate® recorder.

z 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.

z The Polymate® recorder needs to be installed and put into service according to the EMC

information provided in the Chapter 8.

z 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

z 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.

z 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.

z If liquid is spilled on the Polymate®, if it is dropped or immersed in liquid, discontinue use and

contact BMC.

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YH-1000C Polysomnograph User Manual V3.1

z Do not use while bathing, shock hazard may occur.

z Inspect cords periodically for signs of wear.

z Operation of the Polymate® may be adversely affected by:

- electromagnetic fields exceeding the level of 10 V/m in the test conditions of EN

60601-1-2

- the operation of high frequency (diathermy) equipment

- defibrillators, or short wave therapy equipment

- radiation (e.g., x-ray, CT)

- magnetic fields (e.g., MRI)

z 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.

z 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.

z The oral and nasal airflow cannula is a disposable component and designed for single

patient use only.

z 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.

z No modification of this equipment is allowed.

2.3 Cautions

A caution indicates the possibility of damage to the device.

z Read the accompanying manual before using this device to ensure a correct operation.

z 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.

z 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.

z Patient should stop taking any central nervous system stimulant and tranquilizer 3 days

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YH-1000C Polysomnograph User Manual V3.1

before recording. And no alcohol is allowed on the recording day.

z During recording, DO NOT use mobile phone and wireless phone. Otherwise, may result in

abnormal and failure record.

z Do not allow detergent solution or cold sterilization agents to leak into the electronic

components. Use extra caution around connectors and panel edges.

z Do not use abrasive cleaners.

z 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

z Users allergic to the device

z Users planted with cardiac pacemaker

z Pregnant woman

2.5 Electromagnetic Compatibility

z 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.

z 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®.

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YH-1000C Polysomnograph User Manual V3.1

CHAPTER 3: CONTROL PANEL

Structure and function are described in figure 1.

LCD Display

Shield Button 1

Shift/Cancel

Button 2

OK/Event

USB Data Port

Flow

SpO2

Snore/BPI/Res.

On/Off

Reset

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. SpO2 input (Five cores) is to connect the SpO2 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

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YH-1000C Polysomnograph User Manual V3.1

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.

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YH-1000C Polysomnograph User Manual V3.1

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

4.1.1 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.

4.1.2 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.

z 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.

z Insert SpO2/pulse rate sensor into SpO2 (five cores) input on bottom of the recorder. Ensure

the red spots on both connectors are aligned.

z Insert airflow cannula into the Flow input on the bottom of recorder.

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YH-1000C Polysomnograph User Manual V3.1

4.1.3 Applying the Sensors to Patient

z 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.

White: One palm

distance left from

navel

Green: Left axilla

central 5th rib

Green: Right axilla

central 5th rib

White: One palm

distance right 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.

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YH-1000C Polysomnograph User Manual V3.1

Figure 3 Fixed positions of body position sensor and snore sensor

z To Apply the SpO2 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 SpO2 and pulse rate value on the LCD screen, if fixed

correctly, about 10 seconds later, the patient's current value of SpO2 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 SpO2 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 SpO2 sensor probe is compromised by motion; use of SpO2 sensor probe

is contraindicated for active patients. The SpO2 Sensor model is S0044D-S.

Figure 4 Fixed Position of SpO2 Sensor

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YH-1000C Polysomnograph User Manual V3.1

z To Apply the Oral and Nasal Airflow Cannula

Cannula is fixed on the upper lip, see Figure 5.

Figure 5 Fixed Position of Oral and Nasal Airway Cannula

z 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.

Cannula

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YH-1000C Polysomnograph User Manual V3.1

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.

4.2.2 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.

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YH-1000C Polysomnograph User Manual V3.1

z 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.

z 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

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YH-1000C Polysomnograph User Manual V3.1

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.

z 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:

z SpO2: Oxygen Saturation

z HR: Heart Rate (Pulse Rate)

z BPI: Body Position Indicator

z FL: Flow

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BMC Polymate YH-1000C User manual

BMC Polymate YH-1000C User manual

BMC Polymate YH-1000C User manual

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