Checkme Pro User Manual Ver B Sep 2015

1.

The Basics

Caution: Federal law restricts this device to sale by or on the order of a physician. This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration of Checkme Pro health monitor. Some functions may be not available on your model.

1.1 Safety 

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Warnings Before using the device, please ensure that you have read this manual thoroughly and fully understand corresponding precautions and risks. This device has been designed for practical use, but is not a substitute for a visit to the doctor. The data and results displayed on the device are for reference only and cannot be directly used for diagnostic interpretation or treatment. We recommend not to use this device if you have a pacemaker or other implanted devices. Follow the advice given by your doctor, if applicable. Do not use this device with a defibrillator. The Checkme Pro is MR unsafe. Do not use this device in an MR environment as it contains strongly ferromagnetic materials. Do not use the device in a combustible environment (i.e., oxygenenriched environment). Never submerge the device in water or other liquids. Do not clean the device with acetone or other volatile solutions. Do not drop this device or subject it to strong impact. Do not place this device in pressure vessels or gas sterilization device. 1

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Do not dismantle the device, as this could cause damage or malfunctions or impede the operation of the device. This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Children should be supervised around the device to ensure they do not play with it. Do not allow the electrodes of the device to come into contact with other conductive parts (including earth). Do not use the device with persons with sensitive skin or allergies. Do not store the device in the following locations: locations in which the device is exposed to direct sunlight, high temperatures or levels of moisture, or heavy contamination; locations near to sources of water or fire; or locations that are subject to strong electromagnetic influences. Do not swing the device with the strip, which may result in injury. This device displays changes in the heart rhythm and blood oxygenation etc. which may have various different causes. These may be harmless, but may also be triggered by illnesses or diseases of differing degree of severity. Please consult a medical specialist if you believe you may have an illness or disease. Vital signs measurements, such as those taken with this device, cannot identify all diseases. Regardless of the measurement taken using this device, you should consult your doctor immediately if you experience symptoms that could indicate acute disease. Do not self-diagnose or self-medicate on the basis of this device without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval. This device is not a substitute for a medical examination or your heart or other organ function, or for medical electrocardiogram recordings, which require more complex measurements. It is not possible to use this device to diagnose illness or diseases. This is exclusively the responsibility of your doctor. We recommend that you record the ECG curves and other 2

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measurements and provide them to your doctor if required. This product doesn’t provide on-device data backup function.

Introduction

1.1 Intended Use The Checkme Pro Health Monitor is intended to be used for measuring, displaying, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (adults only for continuous data collection and recording, adults and pediatrics for spot checking) and temperature in the home or in healthcare facilities. This device is not intended to substitute for a hospital diagnostic ECG device and also not to be used on patients with implanted cardiac devices, such as pacemakers and/or implanted cardio-defibrillators (ICDs).

1.2 About Checkme

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Touch Screen Use the pad of your finger to tap or swipe on the touch screen. Do not use your fingernail or any other object to tap the screen.

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Infrared temperature sensor Internal SpO2 sensor LED indicator  Off: the monitor is turned off or working in Standby Mode;  Green: the monitor is turned on, and working normally; or when 3

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the battery is fully charged;  Blue: the battery is being charged;  Red and flash: the battery is low; Multi-functional micro D connector It connects with external SpO2 cable, ECG cable, or charging cable. Home, Power On/Off  When the monitor is off, press this button to power it on.  When the monitor is on, press and hold it for 2 seconds to turn it off.  During operation, pressing this button will switch to Main Screen, or Calendar Screen, or return to upper menu. ECG right electrode Use right thumb to press on it. 8

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Speaker ECG left electrode Put it to your left palm, left abdomen or left knee. 10. Neck strip hole (neck strip not provided) 11. ECG back electrode Use right index finger or middle finger to press on it.

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12. ECG cable with 2 lead wires Connect the micro D connector side to the device and the other side to your left/right wrists or right clavicle /left lower abdomen. 13. SpO2 external finger sensor 4

Connect the micro D connector side to the device and put your index finger in with the fingernail facing up.

1.3 Main Screen The Main Screen is shown as below. Swiping your finger from right to left can switch to the second page, and vice versa.

OxiRecorder

Tapping a button in the Main Screen will start a measurement, activate a function, or open corresponding menu.

1.4 Calendar Screen / Standby Mode The device will enter Calendar Screen / Standby Mode when:  No operation is detected for 120 seconds on the screen interface, the device will automatically switch to the Calendar Screen.  Pressing the Home button in the Main Screen. 3

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Current time Current date When a reminder event happens, this area displays the event name, e.g. “Daily Check”. You are allowed to change the current time and date when the device is powered on at the first time. Or you can also go to the Setting menu to change it. Please refer to Section 5.4 for details. 3. This arrow indicates users to press the Home button to exit the 5

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Calendar Screen / Standby Mode. Battery indicator Please refer to Section 7.1 for details. If you failed to respond to the previous reminder event, then that event will be shown in this area. This icon appears when <Quick ECG> is enabled. Please refer to Section 5.4 for details. This icon appears if you have set reminder event.

When the device enters Calendar Screen, it also begins to work in Standby Mode, which is an ultra-low power consumption mode. In Standby Mode, the touch screen operation is invalid.

1.5 Result Screen This device provides powerful measurement functionalities, including Daily Check, ECG Recorder, Pulse Oximeter, Thermometer, Oxi Recorder, and Pedometer. For each measurement, a Result report will be provided after the measurement is finished. An example is shown below.

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Measured parameters and readings Buttons  Select button to start a measurement again.  Press and hold the button to add voice memo. Voice memo is only available for Daily Check and ECG Recorder measurements.  Select button to review previous results.  Press button to open the help information.

In the Result Screen, if there is no operation for 2 minutes, the device will automatically returns to Stand by Screen.

1.6 Symbols Symbol

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Application part type BF Manufacturer

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Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice”. Against ingress of solid foreign objects ≥12.5mm diameter, Against dripping(15° tilted) MRI unsafe, Presents hazards in all MR environments as device contains strongly ferromagnetic materials. Follow operating instructions No alarm system.

2.

Getting Started

2.1 Unpacking Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or us. If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact us in case of any problem.

Warnings 

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Save the packing case and packaging material as they can be used if the device must be reshipped. Keep the warranty card, which is useful within the period of warranty. When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach. 7

The equipment might be contaminated during storage and transport. Before use, please verify whether the packages are intact. In case of any damage, do not apply it to patients.

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2.2 Power On/Off Press the Power On/Off button to power on the device. Press and hold Power On/Off button for 2 seconds to power off the device.

2.3 Initial Settings The first time the Checkme is powered on, you can follow the steps below to set up your Checkme monitor.

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User Interface

Action

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Tap the language you want the device to use. Then tap .

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Tap the “+” or “-” button to change the date, month and year. Then tap .

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Tap the “+” or “-” button to change the time. Then tap .

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The Main Screen shows when you finish the steps as above.

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3.

Using Checkme

3.1 Prior to Use Warnings 

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Use only cables, sensors and other accessories specified in this manual. The device has no alarms and will not sound if the measurement reading is too low or too high.

Before using ECG Before using Daily Check or ECG Recorder function, pay attention to the following points in order to obtain precise measurements.  The ECG electrode must be positioned directly against the skin.  If your skin or hands are dry, moisten them using a damp cloth before taking the measurement.  If the ECG electrodes are dirty, remove the dirt using a soft cloth or cotton bud dampened with disinfectant alcohol.  During the measurement, do not touch your body with the hand with which you are taking the measurement.  Please note that there must be no skin contact between your right and left hand. Otherwise, the measurement cannot be taken correctly.  Stay still during the measurement, do not speak and hold the device still. Movements of any kind will affect the measurements.  If possible, take the measurement when sitting and not when standing.

Warnings 

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When connecting external electrodes and/or patient cables, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth. If using the ECG for long-term monitoring, periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace the electrodes or change the application site. Do not use this device during defibrillation. Interference from a non-grounded instrument near the patient and 9

electro surgery interference can causes problems with the waveform.

Before using Oximeter Before using Daily Check or Oximeter functions, pay attention to the following points in order to obtain precise measurements.  The finger inserted in SpO2 sensor must be clean to ensure proper reading.  Any of the following conditions may cause inaccurate measurements, including but not limited to: - Flickering or very bright light; - Poor blood circulation; - Low hemoglobin; - Hypotension, severe vasoconstriction, severe anemia or hypothermia; - Nail polish, and/or artificial nails; - Any tests recently performed on you that required an injection of intravascular dyes.  The Oximeter may not work if you have poor circulation. Rub your finger to increase circulation, or place the SpO2 sensor on another finger.  The Oximeter measures oxygen saturation of functional hemoglobin. High levels of dysfunctional hemoglobin (caused by sickle cell anemia, carbon monoxide, etc.) could affect the accuracy of the measurements.  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast towers, and TV broadcast towers may affect accuracy.  The pleth waveform displayed on the device is normalized.

Warnings 

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Limit finger movement as much as possible when using the Daily Check or Oximeter, which might result in incorrect reading or measurement result. Do not use the Oximeter on the same hand/arm when using a blood pressure cuff or monitor. Do not use the Oximeter outside the specified operating and storage temperature ranges. The Checkme Pro is MR unsafe. Do not use this device in an MR 10

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environment as it contains strongly ferromagnetic materials. Induced current could potentially cause burns. The SpO2 sensor may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. Prolonged continuous SpO2 recording may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns. Check the SpO2 sensor application site every 2 hours to determine the positioning of the sensor and the circulation and skin sensitivity of the patient. Patient sensitivity varies depending on medical status or skin condition. For patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently.

3.2 Daily Check About Daily Check Warnings  

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Before using this function, please read the Section 4.1. When using Daily Check, please ensure you select the right user. Wrong user will result in incorrect blood pressure readings. The external pulse oximeter feature is only intended for users greater than 12 years of age (adults and adolescents). To ensure better tracking of your health status, it is strongly suggested that every Daily Check measurement is made at the same time period when your body is in the relative same situation. E.g., every morning when get up, or every night before go to bed.

Daily Check measurement is a function that combines the measuring of ECG (Electrocardiograph) waveform, HR (heart rate), Pleth waveform, SpO2 (blood oxygenation). It takes only 20 seconds to collect your vital signs before giving you vital signs readings and your health evaluation. For each individual, the correlation among those parameters measured by Daily Check is different, so when Daily Check function is used by more than one user, you need to create the user profile for each user. Before using Daily Check measurement or reviewing the Daily Check data, ensure that the correct user is selected. Please refer to Section 5.8 to know how to manage users. 11

Setting Daily Check Reminder To better manage your health status, it is recommended to take Daily Check measurement at a regular interval, like once every day or once a week. To ensure that you never forget to take a Daily Check measurement, you can set a Daily Check reminder. When this Daily Check reminder event is triggered, the device gives audio alarm prompt, which will last for one minute if you don’t cancel it manually. To set the Daily Check reminder event, please refer to Section 4.8.

Using Daily Check To start a Daily Check, follow the steps as below. 1. If you have not created user, then please follow the instruction in Section 5.8 to add your user account. 2. Press the Home button to enter the Main Screen. 3. Tap the <Daily Check> icon in the middle of the screen.

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Choose the right user. Hold the device according to the instruction, keep the device at the same level as your heart, and keep stable posture and stay calm. Don’t exert too much pressure on the ECG electrode, which may result in EMG (electromyography) interference. Just hold gently and ensure good contact with the ECG electrode. Do not exert pressure on the finger that put in the SpO2 sensor. Just fit it inside but gently to ensure good blood perfusion.

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(1) Put the right index finger into the built-in SpO2 sensor. Use the finger nail to squeeze the edge of the SpO2 sensor cover, then move in upward to the left to raise it up as shown below.

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(2) Press the right thumb on the right electrode. (3) Press the right middle finger on the back electrode. (4) Press the left electrode to the left palm. Once the device detects stable waveform, it will automatically start the measurement. The countdown bar moves from left to right. When the bar is fully filled, the device will show the measurement result.

Please refer to Section 2.4 to understand the result screen. Daily Check provides the trending graph of heart rate, SpO2. To view the trend, tap the button, then select one record, and then tap the button. For details, please refer to Section 6.1.

3.3 ECG Recorder About ECG Recorder Warnings 

Before using this function, please read the Section 4.1.

Different methods of taking the ECG measurement are available on Checkme. Some methods may not be available on your product model 13

because of different configuration. Please refer to Section 9 for details. The ECG recorder offers four different methods to measuring ECG. Tap the icon to switch between two pages.

As shown above, from left to right, there are:  Method A: Lead I, right hand to left hand  Method B: Lead II, right hand to left abdomen  Method C: Lead I, left wrist to right wrist  Method D: Lead II, right clavicle to left lower abdomen Method C and D require using external ECG cable and electrode, which is a bit more complicated, but offers better measurement. A message of "Note: Use ECG cable to measure for higher accuracy” will be show when chooses the method without the ECG cable. No matter which method you choose to measure ECG, please keep stable posture and stay calm during the measurement. Movements may result in interference and incorrect readings or measurement result. Generally it is recommended to use method A in most situations. If the ECG waveform amplitude is too small, then use method B. Choosing method C or D for better interpret.

Measuring without Cable To start an ECG Recorder measurement without cable, 1. If the device is in Calendar Screen, press the Home button. 2. In the Main Screen, tap the <ECG Recorder> icon. 3. Choose the method A or B. 4. Follow the instruction according to the mode you selected.

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 Press the right thumb on the right electrode;  Press the right index finger on the back electrode;  For method A, press the left electrode to the left palm;  For method B, press the left electrode to the left lower abdomen; It is important to maintain good contact with the ECG electrodes in order to achieve an accurate ECG reading. If the device does not detect good contact between the electrodes and the skin, the warning “Touch electrodes properly” will be displayed. Do not press the device too firmly against your skin, which may result in EMG (electromyograph) interference. After you finish the above steps, hold the device stably and stay calm. Once the device detects stable waveform, it will automatically start the measurement. The countdown bar moves from left to right. When the bar if fully filled, the device will show the measurement result.

Please refer to Section 2.4 to understand the result screen.

Measuring with Cable To start an ECG Recorder measurement with cable, 1. If the device is in Calendar Screen, press the Home button. 2. In the Main Screen, select <ECG Recorder>. 3. Choose the method C or D. 4. Follow the instructions to connect the ECG cable and place the ECG electrodes.

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 Sit down or stand, stay calm;  For method C, palms facing up, place electrodes marked with L/R in the middle of left/right wrist respectively;  For method D, place electrodes marked with R/L in the right clavicle/left lower abdomen respectively;

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The display will then show your ECG waveform.

The device will monitor your ECG continuously, however no data will be saved until you press the button. Press the button to start collecting your ECG data. The countdown bar moves from left to right. When the bar is fully filled, the device will show the measurement result.

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Please refer to Section 2.4 to understand the result screen.

Quick ECG If the <Quick ECG> function is enabled, then you can start an ECG measurement very quickly by picking up the device and hold it according to method A. This saves time and is much easier for use. Especially for some people whose sight is not good, or when you feel a bit abnormal during sleep and don’t want to turn on the lights. To enable this function, please refer to Section 5.5.

3.4 Oximeter About Oximeter Warnings 

Before using this function, please read the Section 4.1.

The Checkme Health Monitor measures the amount of oxygen in your blood, your pulse rate and pulse index. The Checkme works by shining two light beams into the small blood vessels or capillaries of the finger, reflecting the amount of oxygen in the blood and displaying the measurement on the screen. The oxygen saturation (SpO2) is measured and displayed as a percentage of full capacity. Your pulse rate (PR) will also be measured and displayed.

Measuring without Cable To start a Oximeter measurement without cable, 1. If the device is in Calendar Screen, press the Home button. 2. In the Main Screen, tap the “Pulse Oximeter” icon. 3. Insert the index finger into the built-in SpO2 sensor as shown below.

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Relax your index finger and do exert pressure. When the device detects stable waveform, it will automatically start the measurement. The countdown bar moves from left to right. When the bar is fully filled, the device will show the measurement result.

Please refer to Section 2.4 to understand the result screen.

Measuring with Cable 1. 2.

Connect the external SpO2 sensor to the multi-functional connector. Put your index finger into the external SpO2 sensor. Make sure the cable is positioned along the top of the hand, and the finger nail is in the position as shown below.

Finger nail position

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If the device is in Calendar Screen, press the Home button. Tap the <Pulse Oximeter> icon. The display will then show your PLETH waveform, SpO2 and pulse rate.

The device will not save your data until you press the button. Press the button to start collecting your SpO2 data. The countdown bar moves from left to right. When the bar is fully filled, the device will show the measurement result.

Please refer to Section 2.4 to understand the result screen.

3.5 Temperature About thermometer Warnings 

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The thermometer is only designed for the measuring area on the human body stated in this manual. Check before each use that the lens is intact. If it is damaged, please contact your retailer or the service address. The device needs to be in the room which the measurement is taken for at least 30 minutes before use. Holding the device for too long in the hand or within your cloth can cause the device to warm up, which may result in incorrect readings. Physical activity, increased perspiration on the forehead, taking vasoconstictive medication and skin irritations can distort the result. 19