iHealth Track KN-SS0B Manual

Also See for Track:

User manual (125 pages)

Instruction manual (24 pages)

Owner's manual (19 pages)

Table of Contents

Contents

1 INTRODUCTION
2 BOX CONTENTS
3 INTENDED USE
4 CONTRAINDICATION
5 CONTENTS AND DISPLAY INDICATORS
6 IMPORTANT INFORMATION ABOUT BLOOD PRESSURE MEASUREMENT
7 SETUP AND OPERATING PROCEDURES
8 TROUBLESHOOTING
9 MAINTENANCE
10 SPECIFICATIONS
11 EXPLANATION OF SYMBOLS ON UNIT
12 GENERAL SAFETY AND PRECAUTIONS
13 Documents / Resources
- 13.1 References
- 13.2 Download manual

iHealth Track KN-SS0B Manual

INTRODUCTION

The iHealth Track Blood Pressure Monitor is a fully automatic arm-cuff blood pressure monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The monitor works with your mobile devices to track and share vital blood pressure data.

BOX CONTENTS

Track Blood Pressure Monitor •Cuff
Instruction Manual
4 AAA Batteries

INTENDED USE

iHealth Track Blood Pressure Monitor is for medical professionals or individuals (patients) at home. It is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressure, systolic blood pressure, and pulse rate of an adult individual using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to B.6''-18.9" (22-48cm).

CONTRAINDICATION

warning This Blood pressure monitor (Electronic Sphygmomanometer) is unsuitable for people with severe arrhythmia.

CONTENTS AND DISPLAY INDICATORS

The explanation of symbols on display:

	Bluetooth Symbol		Release Air Symbol
	Memory Indicator		Low Battery Indicator
	Irregular Heartbeat Symbol		Blood Pressure Level Classification Indicator

IMPORTANT INFORMATION ABOUT BLOOD PRESSURE MEASUREMENT

NORMAL BLOOD PRESSURE FLUCTUATION
Blood pressure is affected by various factors, including excitement, stress, body position, and physical activities such as eating, drinking, and smoking. As a result, it is unusual to obtain identical blood pressure readings multiple times. Blood pressure constantly fluctuates throughout the day and night. Typically, blood pressure rises during the day and peaks while most people are awake and active. It then drops in the evening, reaching its lowest while most people sleep. Considering the above information, measuring your blood pressure at approximately the same time every day is recommended.

BLOOD PRESSURE CLASSIFICATION FOR ADULTS
WHO Definitions and Classification of Blood Pressure Levels.

BLOOD PRESSURE CLASSIFICATION	Systolic mmHg	Diastolic mmHg	BACKLIGHT INDICATOR
Optimal	<120	<BO	Green
Normal	120-129	orS0-84	Green
High-normal	130-139	or85-89	Yellow
Grade 1 Hypertension	14-0-159	or90-99	Flashing Yellow
Grade 2 Hypertension	160-179	or 100-109	Red
Grade 3 Hypertension	~,so	or: i!:110	Flashing red

SETUP AND OPERATING PROCEDURES

DOWNLOAD THE APP (Recommended)
Before first use, download and install the iHealth Myvitals app from the App Store (iOS device) or Google Play (Android device). Use the search term "Myvitals."

INSTALL BATTERIES

Open the ballery cover on the back of the blood pressure monitor.
Insert four "AAA" balleries as indicated in the battery compartment.
Close Lhe baltery cover.

Note:

When the battery symbol shows on display, replace batteries with new ones.
Rechargeable batteries are not suitable for this blood pressure monitor.
Remove the batteries if the blood pressure monitor will not be used for at least a month to avoid potential damage from battery leakage.

warning Avoid getting the battery fluid in your eyes. If battery fluid gets in your eyes, immediately rinse with clean water and consult with your physician.
warning The negative(-) side of the battery should be touching the spring.
warning Ensure the battery cover is intact and not damaged before installing the battery.
The monitor, the batteries, and the cuff must be disposed of according to local regulations at the end of their usage.

CONNECT THE CUFF TO THE MONITOR
The iHealth Track Blood Pressure Monitor is available in 2 cuff sizes. The standard cuff will fit arm circumferences between 8.6'' to 16.5" (22cm to 42cm), and the XL cuff will fit arm circumferences from 16.5" to 18.9" (42cm to 48cm). To connect the cuff to the monitor, simply insert the cuff connector into the air hole on the monitor's side.
Note:

Make sure that the connector is completely inserted to avoid air leakage.
Avoid compression or restriction of the connection tube during measurement, which may cause inflation error or injury due to continuous cuff pressure.

APPLY THE CUFF

Place a bare arm through the cuff and position the cuff ½"(1-2cm) above the elbow joint with the cuff tube pointing downward. If applied on the left arm: Position the cuff so that the cuff tube is in the middle of your arm and in line with your middle finger. If applied on the right arm: Position the cuff so that the cuff tube is at the side of your elbow and in line with your little finger.

Sit with your feet flat on the floor without crossing your legs. While seated, place your palm on a flat surface, such as a table, in front of you.
Close the cuff with the velcro fastener.
The cuff should fit comfortably around your arm. You should be able to insert one finger between your arm and the cuff.

Note:

Be careful not to rest your arm on the air tube or otherwise restrict air flow to the cuff.

BODY POSTURE DURING MEASUREMENT

Sitting during measurement

Sit with your feet flat on the floor. Do not cross your legs.
Place your elbow on a table, with your palm facing upward in front of you.
Your cuff should be approximately the same level as your heart. If the monitor is too high or too low below your heart, your blood pressure will be artificially low or high.

Lying down during measurement
You can also lie on your back and place your left arm straight along your side with your hand palm up. Position the air tube in the middle of your arm in line with your middle finger.

TAKE A BLOOD PRESSURE MEASUREMENT
1. After applying the cuff and making sure your body is in a proper position, press the"START/STOP" button, and all symbols will show on display. Please contact customer service if some symbols are missing.

The monitor will inflate the cuff and slowly release pressure from the cuff as the blood pressure is measured. When the measurement is finished, the blood pressure and pulse rate will be shown on the display. The blood pressure will be displayed in different colors (green indicates Optimal or Normal, orange indicates Normal-High or Hypertension type 1, and red indicates Hypertension type 2 or 3) according to the recommendations ofthe WHO (World Health Organization). The result will automatically be stored in the memory bank of the monitor.
If an Irregular Heartbeat (IHB) is detected during a measurement, the IHB symbol will be displayed. If an IHB is detected, the blood pressure measurement results may be inaccurate. Please consult your physician for an accurate assessment.
After measurement, the monitor will turn off automatically after 1 minute of no operation. Alternatively, you can press the "START/STOP" button to turn off the monitor manually.
At any time during a measurement, you can interrupt a measurement by pressing the "START/STOP" button.

Note:

Please refer to the measurable arm circumference in "SPECIFICATIONS"to ensure the cuff is suitable for use.
Measure on the same arm each time.
During measurement, do not talk or move your arm, body, or monitor.
Stay still, and rest for 5 minutes before taking the measurement.
Remove the cuff from the monitor and wipe it with a lightly moistened soft cloth if the cuff becomes dirty. Then air dry the cuff. Do not machine wash. Cleaning the cuff after every 200 measurements is recommended.

Do not place the cuff around your arm if your arm has any inflammation, acute diseases, infection, or skin wounds.
Please consult with a healthcare professional for the interpretation of measurements.

VIEW AND DELETE STORED READINGS

Review previous readings by pressing the "M" button twice. The first memory displayed will be the average of the last three measurements. If no readings are stored, the display will show zero.
When the average reading of the last three measurements is displayed, press the "M" button to display the most recent readings. Continue pressing the"M" button to view the next reading.

When a reading is displayed, holding the"M" button for seven seconds will remove all the readings stored on the device.

SYNCHRONIZE STORED RESULTS WITH THE APP

Place your phone next to your blood pressure monitor.
Start the iHealth MyVitals App on your smartphone (ensure that your Bluetooth is activated in your settings).
Press the "M" (Memory) button on the monitor. The Bluetooth symbol will be displayed when the monitor is successfully connected to the iHealth MyVitals app.

After synchronizing the stored results with the app, all stored results on the monitor will be removed automatically.

Note:

The blood pressure monitor can not be connected to the iHealth MyVitals app when the battery is low or the monitor is taking measurements.

TECHNICAL ALARM DESCRIPTION
The monitor will show 'HI' or 'Lo' as a technical alarm on LCD without delay if the determined blood pressure (systolic or diastolic) is outside the rated range specified in part SPECIFICATIONS. In this case, you should consult a physician or check if your operation violated the instructions. The technical alarm condition (outside the rated range) is pre-set in the factory and cannot be adjusted or inactivated. This alarm condition is assigned as a low priority according to IEC 60601- 1-8. The technical alarm is non-latching and needs no reset. The signal displayed on LCD will disappear automatically after about 8 seconds.

TROUBLESHOOTING

Problem	Explanation	Solution
LCD shows a low battery symbol	Low Battery.	Change all the batteries.
LCD shows "Er 0 11	Pressure is unstable before Measurement.	Try again without moving.
LCD shows "Er 1,,	Fail to detect systolic pressure.
LCD shows "Er 2"	Fail to detect diastolic pressure. The pneumatic system is blocked, or the
LCD shows "Er 3"	cuff is too tight during inflation. Pneumatic system leakage or the cuff is too	Apply the cuff correctly and try again.
LCD shows "Er 4"	Pneumatic system leakage or the cuff is too loose during inflation.	Apply the cuff correctly and try again.
LCD shows "Er 5"	Cuff pressure above 300mmHg.	Measure again after 5 minutes. If the error persists, please contact iHealth customer support.
LCD shows "Er 6,,	More than 3 minutes with cuff pressure above 15 mmHg.
LCD shows "Er 7"	Memory accessing error.
LCD shows "Er 8"	Device parameter checking error.
LCD shows "Er A:'	Pressure sensor error.
No response when pressing buttons or after installing batteries	Incorrect operation or strong electromagnetic interference	Take out the batteries, wait for five minutes, and then reinstall the batteries.

Please visit ihealthlabs.com/support for more information and frequently asked questions.

MAINTENANCE

Do not drop the monitor or subject it to strong impacts.
Avoid high temperatures and direct exposure to the sun. Do not immerse the monitor in water.
If this monitor is stored near freezing temperatures, allow it to acclimate to room temperature before use.
Do not attempt to disassemble this monitor.
Please remove the batteries if you do not use the monitor for a long time.
It is recommended that the performance of this monitor be checked every two years.
Please clean the monitor with a soft dry cloth. Do not use any abrasive or volatile cleaners.
The supplier will make available on request the circuit diagrams, part lists, descriptions, calibration instructions, or other information which will assist the user's appropriately qualified technical personnel in repairing those parts of equipment which are designated by the manufacturer as repairable.
lfthe cuff is used in a hospital or a clinic, it is recommended to disinfect it twice a week. Wipe the cuff's inner side (the side that contacts skin) with a soft cloth lightly moistened with Ethyl alcohol (75-90%). Then airdry the cuff.
The monitor can maintain the safety and performance characteristics for a minimum of 10,000 measurements or three years, and the cuff integrity is maintained after 1,000 open-close closure cycles.
No servicing/maintenance while the monitor is in use.
The monitor requires 6 hours to warm from the minimum storage temperature between uses until it is ready for its INTENDED USE when the ambient temperature is 20°C.

The monitor requires 6 hours to cool from the maximum storage temperature between uses until it is ready for its INTENDED USE when the ambient temperature is 20°C.

SPECIFICATIONS

Product name: iHealth Track Connected Blood Pressure Monitor
Model: KN-SS0BT
Classification: Internally powered, Type BF applied part; IP21, No AP or APG; Continuous operation
Device Dimensions: 38.6"x 38.6"x 18.1 "(9.8 x 9.8 x 4.6cm) (not including the cuff)
Cuff circumference: Standard cuff: 8.6'' to 16.5" (22cm to 42cm) XL cuff: 16.5" to 18.9"(42cm to 48cm).
Weight: 348g (batteries and cuff included)
Measuring method: Oscillometric method, automatic inflation, and measurement
Memory storage: 99 measurements
Power source: 4x1.SV SIZE AAA batteries
Measurement range:
Cuff pressure: 0-300mmHg
Systolic: 60-260mmHg
Diastolic: 40- 199mmHg
Pulse rate: 40-180 beats/minute
Wireless communication: Bluetooth 5.2
Frequency Band: 2.400-2.4835 GHz
Precision of the displayed values: 1 mm Hg
Measuring accuracy:
Pressure: ±3mmHg, Pulse rate: ±5%
Operation conditions: S0°F-l 04°F(10°C-40°C), :'>85% RH, 80-1 0SkPa
Storage/Transport condition: -4°F-122°F(-20°C-·S0°C), :'>85% RH, 80-105kPa
Battery life: Approximately 300 measurements
This blood pressure measurement system includes accessories: A pump, valve, cuff, and sensor.
Note: These specifications are subject to change without notice.

EXPLANATION OF SYMBOLS ON UNIT

	THE OPERATION GUIDE MUST BE READ (The background color: blue. The graphical sign symbol: white.)
	WARNING
	TYPE BF APPLIED PARTS (The cuff is type BF applied part)
	MANUFACTURER
	MRUnsafe
	Symbol for"DATE OF MANUFACTURE"
	Recyclable identification
	SERIAL NUMBER

Manufactured for iHealth Labs, Inc. 1 SOC Charcot Ave, San Jose, CA 95131 USA
+ 1-855-816-7705
www.ihealthlabs.com

GENERAL SAFETY AND PRECAUTIONS

The blood pressure monitor is not intended to exposed to the Electromagnetic Interference (EMI) environment, please do not use the blood pressure monitor within the environment of the following device: Magnetic Resonance Imaging (MRI), computerized axial tomography (CT), diathermy, Radio Frequency Identification (RFID), and electromagnetic security systems such as metal detectors.

Read all the information in the Instruction Manual before operating the unit.
Consult your physician for any of the following situations:

Applying the cuff over a wound or inflamed area.
Applying the cuff on any limb with intravascular access or therapy or an arteriovenous(A-V) shunt.
Applying the cuff on the arm on the side of a mastectomy or lymph node clearance.
Simultaneous use of other medical monitoring equipment on the same limb.
The blood circulation of the user needs to be checked.

Do not use this product in a moving vehicle to ensure measurement accuracy.
Blood pressure measurements determined by this product are equivalent to those obtained by professional healthcare practitioners using the cuff/stethoscope auscultation method within limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.
If an Irregular Heartbeat (IHl3) is detected during the measurement procedure, the IHB symbol will be displayed in the measurement result; but the blood pressure measurement results may be inaccurate. Please consult your physician for an accurate assessment. The IHB symbol will be displayed under 2 conditions:
1. The pulse period's coefficient of variation (CV) is>25%.
2. The difference of adjacent pulse period is;:,:Q.14s, and more than 53 percent of the total number of pulse readings falls within this definition.

Please do not use any cuff other than that supplied by the manufacturer, as this may result in inaccurate measurements.
For information regarding potential electromagnetic or other interference between the blood pressure monitor and other devices and advice regarding avoiding such interference, please sec ELECTROMAG- NETIC COMPATIBILITY INFORMATION. It is suggested that the blood pressure monitor be kept 30 cm away from other wireless devices, such as WLAN units, cell phones, microwave ovens, etc.
lfthc blood pressure measurement (systolic or diastolic) is outside the rated range specified in part SPECIFICATIONS, the monitor will immediately display a technical alarm on the LCD screen. In this case, repeat the measurement, ensure that proper measurement procedures are followed, or consult your medical professional. The technical alarm is preset in the factory and cannot be adjusted or inactivated. This technical alarm is assigned as a low priority according to IEC 60601-1-8. The technical alarm does not need to be reset. It can't be used near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magneticresonance imaging, where the intensity of EM DISTURBANCES is high.
Measurements are not possible in patients with a high frequency of arrhythmias.
The device is not intended for infants, children, or pregnant women. (Clinical testing has not been conducted on infants, children, or pregnant women.)
Motion, trembling, and shivering may affect the measurement reading.
The device is not advisable for patients with poor peripheral circulation, noticeably low blood pressure, or low body temperature (there will be low blood flow to the measurement position).
The device would not apply to patients who use an artificial heart and lung (there will be no pulse).
Consult your physician before using the device for any of the following conditions: common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pre eclampsia, and renal diseases.

The patient is an intended operator.
Swallowing batteries or battery fluid is extremely dangerous. Keep the batteries and the unit out of the reach of children and disabled persons.
Too frequent measurements may cause injury due to blood flow interference.
If you arc allergic to plastic/rubber, please don't use this device.

warning This blood pressure monitor is designed for adults and should never be used on infants or young children below 12. Consult with your physician or other health care professionals before use on older children.
warning This product might not meet its performance specifications if stored or used outside the specified temperature and humidity ranges.
warning Please do not share the cuff with any infectious person to avoid cross-infection.