Rossmax Z5 - Blood Pressure Monitor Manual

Introduction

Blood pressure measurements determined with Z5 are equivalent to those obtained by a trained observer using cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.
This unit is to be used by adult consumers in a home environment. The patient is an intended operator. Do not use this device on infants or neonates. Z5 is protected against manufacturing defects by an established International Warranty Program. For warranty information, you can contact the manufacturer, Rossmax International Ltd.
Attention: Consult the accompanying documents. Please read this manual carefully before use. For specific information on your own blood pressure, contact your physician. Please be sure to keep this manual.

PARR(Pulse Arrhythmia) Technology

Pulse Arrhythmia (PARR) technology specifically detects the existence of pulse arrhythmia, including atrial fibrillation (AFib), Atrial and / or Ventricular Premature Contractions (PC). Pulse Arrhythmia may be related to cardiac disorders, needs medical attention and thus early diagnosis is of paramount importance. The PARR technology detects arrhythmia during regular blood pressure checks without any additional user skills, user interaction and measurement prolongation. Beside the blood pressure diagnosis a specific pulse arrhythmia diagnosis is provided with PARR.
Note: The PARR detection of AFib and PC is provided with a clinically proven high detection probability [1]. However, the sensitivity and specificity is limited, thus most, but not all pulse arrhythmia will be detected and displayed. In certain patients with uncommon clinical conditions the PARR technology may not be able to detect pulse arrhythmia. This partly comes from the fact that some arrhythmia can only be found with an ECG diagnosis, but not with a pulse diagnosis. Thus PARR is not meant to replace any medical ECG diagnosis by your doctor. PARR provides an early detection of certain pulse arrhythmia, which inevitably need to be presented to your doctor in charge.
Remark: [1] Clinical Investigation of PARR - A new Oscillometric Pulse Arrhythmia Type Discriminating Detection Technology.

Atrial Fibrillation Detection (AFib)

The upper chambers of the heart (the atria) do not contract, but quiver and thus blood is driven irregularly and with lower efficiency into the ventricles. Subsequently irregular heartbeats occurs, which mostly are associated with a fast, yet highly instable heart rate. This condition is associated with a higher risk for the formation of cardiac blood clots. Amongst others, they may elevate the risk of brain strokes. Beside this atrial fibrillation may contribute to the severity of a chronic or acute heart failure condition and may be associated with other heart-related complications. Age dependent, about 10%- 20% percent of patients who suffer from an ischemic stroke also suffer from atrial fibrillation. Atrial fibrillation most often initially occurs with temporary periods of arrhythmia and may progress to a permanent state of this disorder in the course of time. No matter, whether you intent to safeguard yourself from an undetected AFib state, or you measure during an ongoing period of active atrial fibrillation, or you measure in between periods of AFib, the PARR technology can be applied at any of these conditions. This unit is able to detect Atrial fibrillation (AFib). The ARR and AFib icons () are displayed right after the measurement if Atrial Fibrillation was detected.
Note:It is strongly recommended, that you consult your physician, if either the AFib icon occurs newly for several times, or, if your AFib is known to your doctor, but the incidence of AFib readings changes over time. Your doctor will then be able to provide all required medical test and possible therapeutic procedures.
Note: The presence of a cardiac pacemaker may impair the AFib detection by PARR.

Premature Contraction Detection (PC)

Extra abnormal heartbeats generated in irregular excitation sites of your heart, either in the atria (PAC), the ventricle (PVC) or the cardiac conduction nodes (PNC). These extra beats may disrupt your regular rhythm, they may come in early or cause a significant pauses regarding your perceivable pulse. This is called palpitations, which can be felt in your chest. They may occur as isolated, single events, as a series of irregular pulses or can be distributed all over your pulse beats. If they are not related to mental stress, or acute demanding physical load, they may be a marker for a multitude of cardiac disorders. Some of these disorders go along with an elevated risk profile for ischemic events, either in the heart (e, g, coronary heart disease) or outside the heart, e.g. an elevated risk for a stroke. Some PCs may indicate on valvular or myocardial disorders and become very important if a myocarditis (infection of the heart muscle) is suspected. This unit is able to detect premature contractions. The ARR and PC icons () are displayed right after the measurement if premature contractions have been detected.
Note: It is strongly recommended, that you consult your physician, if either the PC icon occurs newly for several times, or, if your PC is known to your doctor, but the incidence of PC readings changes over time. Your doctor will then be able to provide all required medical test and possible therapeutic procedures.

Pulse Arrhythmia Detection (ARR)

Once the occurrence of pulse arrhythmia has been detected in the course of your blood pressure measurement, the icon ARR is displayed. In the case, that the found pulse arrhythmia can be specified by the PARR technology, the ARR icon is accompanied by the specifically detected type of arrhythmia, e.g. PC or AFib. Once the kind of found pulse arrhythmia cannot be safely determined by PARR, the device is displaying ARR without any additional pulse arrhythmia type icon.
Note: It is strongly recommended, that you consult your physician, if either the ARR icon occurs newly for several times, or, if your ARR is known to your doctor, but the incidence of ARR readings changes over time. This is independent whether the ARR icon is specified by another pulse arrhythmia icon or not. Your doctor will then be able to provide all required medical test and possible therapeutic procedures.
The PARR technology is able to detect and display combined pulse arrhythmia findings.

Real Fuzzy Measuring Technology

This unit uses the oscillometric method to detect your blood pressure. Before the cuff starts inflating, the device will establish a baseline cuff pressure equivalent to the air pressure. This unit will automatically determine the appropriate inflation level based on pressure oscillations, followed by cuff deflation.
During the deflation, the device will detect the amplitude and slope of the pressure oscillations and thereby determine your actual the systolic blood pressure, diastolic blood pressure, and pulse rate.

Preliminary Remarks

This Blood Pressure Monitor complies with the European regulations and bears the CE mark "CE 1639".
The quality of the device has been verified and conforms to the provisions of the EC council directive 93/42/EEC (Medical Device Directive), Annex I essential requirements and applied harmonized standards.
EN 1060-1: 1995/A2: 2009 Non-invasive sphygmomanometers - Part 1 - General requirements
EN 1060-3: 1997/A2: 2009 Non -invasive sphygmomanometers - Part 3 - Supplementary requirements for electro-mechanical blood pressure measuring systems
EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test Procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers.
ISO 81060-2: 2013 Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type.
This blood pressure monitor was designed for long service periods. In order to ensure continued accuracy, it's recommended that all digital blood pressure monitors require re-calibration. This monitor (under normal usage with approx. 3 measurements a day) does not require re-calibration for 2 years. Once the unit should be re-calibrated the device will display . The unit should also be re-calibrated if the monitor sustains damage due to blunt force (such as dropping) or exposure to fluids and / or extreme hot or cold temperature / humidity changes. When appears, simply return your device to your nearest dealer for re-calibration service.

Blood Pressure Standard

Refer to the definitions of the World Health Organization, the blood pressure ranges can be classified into 6 grades. (Ref. 1999 WHO-International Society of Hypertension Guidelines for the management of Hypertension). This blood pressure classification are based on statistical data, and may not be directly applicable to any particular patient. It is important that you consult with your physician regularly. Your physician will tell you your normal blood pressure range as well as the point at which you will be considered at risk. For reliable monitoring and reference of your blood pressure, keeping long-term records is recommended. Please download the blood pressure log at our website www.rossmax.com.

Blood Pressure Standard World Health Organization (WHO): 1999
		Systolic Pressure (mmHg)	Diastolic Pressure (mmHg)
Optimal		<120 and	<80
Normal		120~129 or	80~84
High-normal		130~139 or	85~89
Grade 1 hypertension (mild)		140~159 or	90~99
Grade 2 hypertension (moderate)		160~179 or	100~109
Grade 3 hypertension		≥180 or	≥110

Name/Function of Each Part

1. Arm Cuff
2. LCD Display
3. User-Switching key
4. LED indicator of charging status
5. Memory Key
6. Air Tube and Connector
7. ON/OFF/START key
8. Type C port
9. Reset button
10. Rechargeable Lithium-ion battery (non-detachable)

Loose Cuff Detection

If the cuff was applied too loosely, it may cause unreliable measurement results or measurements can fail to start. The "Loose Cuff Detection" can help to determine if the cuff is wrapped snugly enough. The specified icon appears once a "loosen cuff" has been detected during measurement. Otherwise the specified icon appears if the cuff is wrapped correctly during measurement.

Movement Detection

The "Movement Detection" helps reminding the user to remain still and is indicating any adverse body movement during measurement. The specified icon appears once a "body movement" has been detected during and after such a measurement.
Note: It's highly recommended that you measure again if the icon appears.

Guest Mode

This monitor has a non-stored single measurement function. Press the User-Switching key to select the memory zone of guest , and follow the Measurement Procedure to take a measurement correctly. When the measurement is completed, the measurement value will not be stored in memory zone.

Hypertension Risk Indication (HRI)

The World Health Organization, classifying blood pressure ranges into 6 grades. This unit is equipped with an innovative blood pressure risk indication, which visually indicates the assumed risk level (optimal / normal / high-normal/ grade1 hypertension / grade 2 hypertension / grade 3 hypertension) of your result, making the meaning of your findings comprehensive.

Error Codes for your reference

EE / Measurement Error: Make sure the L-plug is securely connected to the air socket and calmly measure again. Wrap the cuff correctly around your arm and keep arm steady during measurement. If the error keeps occurring, return the device to your local distributor or service centre.
E1 / Air Circuit Abnormality: Make sure the L-Plug is securely connected to the air socket on the side of the unit and calmly measure again. If the errors still occur, return the device to your local distributor or service centre for help.
E2 / Pressure Exceeding 300 mmHg: Switch the unit off and measure again quietly. If the error keeps occurring, return the device to your local distributor or service centre.
E3 / Data Error: Remove the batteries, wait for 60 seconds, and reload. If the error keeps occurring, return the device to your local distributor or service centre.
Er / Exceeding Measurement Range: Measure again quietly. If the error keeps occurring, return the device to your local distributor or service centre.

Charging the battery with authorized AC Adapter (Optional)

The unit is equipped with a non-detachable and high-capacity rechargeable lithium-ion battery and has a LED light for charge indication. We recommend charging the battery to a full capacity for initial use, and it may take about 3 hours to fully charge.

• Do not charge the battery when AC Adapter is wet or with wet hands. You may suffer electric shock.
• If the fluid in the battery gets into your eye, wash the eye with sufficient water without rubbing the eye, then immediately consult the doctor for treatment. There is danger in losing your eyesight.
• Do not throw the battery into fire, or heat, or disassemble it. It may cause heat, ignition, short-circuit, or explode.

• AC Adapter is optional. Please contact the distributor for the compatible AC Adapter.
• Use only the authorized USB Adapter (5V) with this blood pressure monitor that complies with the relevant safety standards for medical devices including EN 60601-1: 2006+A1:2013 and related collateral standards as EN 60601-1-2: 2015.
• USB cable can only be connected with Rossmax blood pressure monitor and AC Adapter. It cannot be used for any other purpose.
• Do not charge the battery in environments where there is high heat or cold temperatures.
• It is not recommended to perform a measurement or operate the device while the battery is being charged to avoid damage to the battery.

Battery life
Once fully charged, you can use the unit for approximately six hundred measurements depending on battery life and storage condition.

Note:

Battery replacement must be performed by your local distributor or authorized Rossmax service center. Disassembling or repairing the unit will void warranty.

Battery low
You need to recharge the battery as soon as possible when

1. The low battery icon appears on the display.
2. The ON/OFF/START key is pressed and nothing appears on the display.

• There are no user serviceable parts inside. Battery or damage from old battery is not covered by warranty.
• Rechargeable battery is hazardous waste. Do not dispose them together with the household garbage.

Applying the Cuff

Measurement Procedures

Here are a few helpful tips to help you obtain more accurate readings:

• Blood pressure changes with every heartbeat and is in constant fluctuation throughout the day.
• Blood pressure recording can be affected by the position of the user, his or her physiological condition and other factors. For greatest accuracy, wait one hour after exercising, bathing, eating, drinking beverages with alcohol or caffeine, or smoking to measure blood pressure.
• Before measurement, it's suggested that you sit quietly for at least 5 minutes as measurement taken during a relaxed state will have greater accuracy. You should not be physically tired or exhausted while taking a measurement.
• Do not take measurements if you are under stress or tension.
• Sit upright in a chair, and take 5-6 deep breaths. Avoid leaning back while the measurement is being taken.
• Do not cross the legs while sitting and keep the feet flat on the floor during measurement.
• During measurement, do not talk or move your arm or hand muscles.
• Take your blood pressure at normal body temperature. If you are feeling cold or hot, wait a while before taking a measurement.
• If the monitor is stored at very low temperature (near freezing), have it placed at a warm location for at least one hour before using it.
• Wait 5 minutes before taking the next measurement.

Recalling Values from Memory

1. The monitor has two memory zones (1 and 2). Each zone can store up to 60 measurements.
2. To read memory values from a selected memory zone, use the User-Switching key to select a memory zone (1 or 2) from which you want to recall values. Press the Memory key. The first reading displayed is the average of all morning readings from the last 7 days.
3. Continue to press the Memory key to view the average of all nighttime readings from the last 7 days.
4. Press the Memory key again to view the average of the last 3 measurements stored in memory, and the last previously stored measurement. Every measurement comes with an assigned memory sequence number.
5. All readings currently saved on the device can be transferred to the App using Bluetooth® after successful completion of the binding process. Select the desired user memory zone and follow App instructions, the Bluetooth® transfer starts automatically. Data transfer will be halted while performing a measurement or operating the device.

Note: The memory bank can store up to 60 readings per memory zone. When the number of readings exceeds 60, the oldest data will be replaced with the new record.
Note: AM is defined as 4:00 AM – 11:59 AM
Note: PM is defined as 6:00 PM – 2:00 AM

Clearing Values from Memory

Time and Bluetooth® Adjustment

Data Transfer via Bluetooth®

Pairing the Blood Pressure Monitor with your Smartphone
To begin using Bluetooth® for the first time, please visit the website at http://www.rossmax.com for the initial set-up instructions.

1. Download and install the applicable APP onto your smartphone.
2. To bind this device with your smartphone, turn on the device, Bluetooth® and the App of smartphone, and follow set-up and binding instructions.
3. If the binding is successful, the Bluetooth® symbol () will appear on the display and keep flashing during data transfer. The current measured value will automatically be transferred to the App when the measurement is completed.
4. If the binding has failed, the Bluetooth® symbol () will not appear on the display and the current measured value will not automatically be transferred to the App. In this case, the value is saved in the selected user memory zone. Please re-bind this device with your smartphone and follow App instructions for Bluetooth® transfer.

Notes:

1. Unbinding your device will not delete the data from the App.
2. If you re-bind your smartphone with your blood pressure monitor, all prior reading history stored on the App will be retained.
3. Bluetooth® data transfer will reduce the battery capacity.

Troubleshooting

If any abnormality will arise during use, please check the following points.

Note: If the device is still not working properly, return it to your dealer. Under no circumstance should you disassemble and repair the unit by yourself.

Cautionary Notes

1. The unit contains high-precision assemblies. Therefore, avoid extreme temperatures, humidity, and direct sunlight. Avoid dropping or strongly shocking the main unit, and protect it from dust.
2. Clean the blood pressure monitor body and the cuff carefully with a slightly damp, soft cloth. Do not press. Do not wash the cuff or use chemical cleaner on it. Never use thinner, alcohol or petrol (gasoline) as cleaner.
3. The unit should not be operated by children so to avoid hazardous situations.
4. If the unit is stored near freezing, allow it to acclimate at room temperature before use.
5. This unit is not field serviceable. You should not use any tool to open the device nor should you attempt to adjust anything inside the device. If you have any problems, please contact the store or the doctor from whom you purchased this unit or please contact Rossmax International Ltd.
6. As a common issue for all blood pressure monitors using the oscillometric measurement function, the device may have difficulty in determining the proper blood pressure for users diagnosed with diabetes, poor circulation of blood, kidney problems, or for users suffered from stroke, or for unconscious users.
7. This unit is able to detect common arrhythmia (atrial or ventricular premature beats or atrial fibrillation). The ARR, AFib and PC icons are displayed after the measurement if Atrial Fibrillation and Premature Contraction was detected during the measurement. If ARR, AFib or PC icons are displayed, you are advised to wait for a while and take another measurement. It is strongly recommended that you consult your physician if the ARR, AFib or PC icons appear often.
8. While the given device is able to detect specific pulse arrhythmia, the measurement accuracy of the blood pressure meter may be impaired with the occurrence of pulse arrhythmia. mmHg
9. To stop operation at any time, press the ON/OFF/START key, and the air in the cuff will be rapidly exhausted.
10. Once the inflation reaches 300 mmHg, the unit will start deflating rapidly for safety reasons.
11. Please note that this unit can be a home healthcare product, but it is not intended to serve as a substitute for the advice of a physician or medical professional.
12. Do not use this device for diagnosis or treatment of any health problem or disease. Measurement results are for reference only. Consult a healthcare professional for interpretation of pressure measurements. Contact your physician if you have or suspect any medical problem. Do not change your medications without the advice of your physician or healthcare professional.
13. Electromagnetic interference: The device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. USB mobile telephones, microwave ovens) or less than 1.5 km from AM, FM or TV broadcast antennas. These may lead to temporary impairment of measurement accuracy.
14. Dispose of device, batteries, components and accessories according to local regulations.
15. This monitor may not meet its performance specification if stored or used outside temperature and humidity ranges specified in Specifications.
16. Please note that when inflating, the functions of the limb in question may be impaired.
17. During the blood pressure measurement, blood circulation must not be stopped for an unnecessarily long time. If the device malfunctions, remove the cuff from the arm.
18. Avoid any mechanical restriction, compression or bending of the cuff line.
19. Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.
20. Ensure that the cuff is not placed on an arm in which the arteries or veins are undergoing medical treatment, e.g. intravascular access or therapy, or an arteriovenous (AV) shunt.
21. Do not apply the cuff on the side, where a mastectomy has been performed in your patient history.
22. Do not place the cuff over wounds as this may cause further injury.
23. Only ever use the cuffs provided with the monitor or original replacement cuffs. Otherwise erroneous results will be recorded.
24. Batteries can be fatal if swallowed. You should therefore store the batteries and products where they are inaccessible to small children. If a battery has been swallowed, call a doctor immediately.
25. Do not use the tubing and/or AC Adapter for any other purpose than those specified, as they can cause risk of strangulation.
26. Do not service or maintain device and cuff while in use.
27. This unit should not be used adjacent to or stacked with other equipment.
28. Please do not use any other cables or accessories not approved by the manufacturer in this manual to avoid negative influence on electromagnetic compatibility.

Specifications

Measurement Method	Oscillometric
Measurement Range	Pressure: 30~260 mmHg; Pulse: 40~199 beats/ minute
Pressure Sensor	Semi conductor
Accuracy	Pressure: ± 3 mmHg; Pulse: ± 5% of reading
Inflation	Pump Driven
Deflation	Automatic Air Release Valve
Memory capacity	60 memories for each zone x 2 zones
Auto-shut-off	1 minute after last key operation
Permissible Operating Temperature and Humidity	10°C~40°C (50°F~104°F); 15%~85% RH; 700~1060 hPa
Permissible Transport and Storage Temperature and Humidity	-10°C~50°C (14°F~122°F); 10%~90% RH; 700~1060 hPa
Adapter Input	100-240V, 50/60 Hz
Adapter Output / USB Input	5V 1A (Type C)
Li-lon Battery	DC 3.7V
Dimensions	120 (L) X 80 (W) X 57 (H) mm
Weight	276.0g (with battery, w/o cuff)
Arm circumference	Adult: 24~40 cm (9.4"~15.7")
Limited Users	Adult users
	Type BF: Device and cuff are designed to provide special protection against electrical shocks.
IP Classification	IP21: Protection against harmful ingress of water and particulate matter
* Specifications are subject to change without notice.

Electromagnetic Compatibility Information

If higher IMMUNITY TEST LEVELS than those specified in Table 9 are used, the minimum separation distance may be lowered. Lower minimum separation distances shall be calculated using the equation specified in 8.10.

Manufacturer's declaration-electromagnetic immunity
The Z5 is intended for use in the electromagnetic environment specified below. The customer orthe user of the Z5 should assure that is used in such and environment.
Immunity test	IEC 60601 test level	Compliance level	Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6	3 Vrms: 0,15 MHz – 80 MHz 6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz	3 Vrms: 0,15 MHz – 80 MHz 6 Vrms: in ISM and amateur radio bands between 0,15 MHz and 80 MHz 80% AM at 1 kHz	Portable and mobile RF communications equipment should be used no closer to any part of the Z5 including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d = 1,2 √P, d = 1,2 √P 80MHz to 800 MHz, d = 2,3 √P 800MHz to 2,7 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 metres (m). Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000- 4-3	10 V/m 80 MHz – 2,7 GHz 80% AM at 1 kHz	10 V/m 80 MHz – 2,7 GHz 80% AM at 1 kHz
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

More information on EMC compliance of the device can be obtained from Rossmax website: www.rossmax.com.

The symbol on this product means that it's an electronic product and following the European directive 2012/19/EU the electronic products have to be disposed on your local recycling centre for safe treatment.

Healthstyle APP

Data Transfer via Bluetooth® Please download and install the free Healthstyle APP onto your smartphone

www.rossmax.com