Rossmax Z1 Automatic Blood Pressure Monitor

Introduction

Blood pressure measurements determined with the Z1 are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard for Electronic or Automated Sphygmomanometers. This unit is intended for use by adult consumers in a home environment. The patient is an intended operator. Do not use this device on infants or neonates. The Z1 is protected against manufacturing defects by an established International Warranty Program. For warranty information, 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.

Real Fuzzy Measuring Technology

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

Preliminary Remarks

This Blood Pressure Monitor complies with 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 is designed for long service time. To ensure continued accuracy, it is 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. When the unit needs re-calibration, 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 temperature/humidity changes. When ☐ appears, return to your nearest dealer for re-calibration service.

Blood Pressure Standard

Refer to the definitions of the World Health Organization (WHO). Blood pressure ranges can be classified into 6 grades (Ref. 1999 WHO-International Society of Hypertension Guidelines for the management of Hypertension). This classification is based on historical data and may not be directly applicable to every patient. It is important to consult your physician regularly. Your physician will inform you about your normal blood pressure range and the point at which you are considered at risk. For reliable monitoring and reference, keeping long-term records is recommended. Download the blood pressure log from www.rossmax.com.

Display Explanations

• EE / Measurement Error: Ensure the L-plug is securely connected to the air socket and measure again. Wrap the cuff correctly and keep the arm steady. If the error persists, return the device to your local distributor or service center.
• E1 / Air Circuit Abnormality: Ensure the L-Plug is securely connected to the air socket on the unit and measure again. If errors persist, return the device to your local distributor or service center.
• E2 / Pressure Exceeding 300 mmHg: Switch the unit off and measure again. If the error persists, return the device to your local distributor or service center.
• E3 / Data Error: Remove batteries, wait 60 seconds, and reload. If the error persists, return the device to your local distributor or service center.
• Er / Exceeding Measurement Range: Measure again. If the error persists, return the device to your local distributor or service center.

Cuff Wrap Detection

If the cuff is wrapped too loosely, it may cause unreliable results. The “Cuff Wrap Detection” helps determine if the cuff is wrapped snugly enough. The □ icon appears for a “loose cuff” during measurement. Otherwise, the ■ icon appears if the cuff is wrapped correctly.

Movement Detection

The “Movement Detection” reminds the user to remain still and indicates any body movement during measurement. The □ icon appears when “body movement” is detected during and after each measurement.

Note: It is highly recommended to measure again if the □ icon appears.

Hypertension Risk Indication (HRI)

The World Health Organization classifies blood pressure into 6 grades. This unit features an innovative blood pressure risk indication that visually shows the assumed risk level (Optimal / Normal / High-Normal / Grade 1 Hypertension / Grade 2 Hypertension / Grade 3 Hypertension) after each measurement.

Irregular Heartbeat (IHB) Detection

This unit is equipped with Irregular Heartbeat (IHB) Detection, allowing users with irregular heartbeats to obtain accurate measurements by alerting the user to the presence of an irregular heartbeat during measurement.

Note: It is strongly recommended to consult your physician if the IHB icon ☻ appears often.

Using the USB Cable with Authorized AC Adapter (Optional)

1. Connect the USB cable to the AC adapter and insert the USB cable into the Type C port on the right side of the unit (or connect the AC adapter to the Type C port on the right side of the unit).
2. Plug the AC adapter into the socket.

Caution:

• 1. Unload batteries when operating with AC mode for extended periods. Leaving batteries in the compartment may cause leakage and damage the unit.
• 2. Batteries are not needed when operating in AC mode.
• 3. AC adapters are optional. Contact your distributor for compatible AC adapters.
• 4. Use only the authorized USB Adapter (5V) with this blood pressure monitor that complies with relevant safety standards for medical devices, including EN 60601-1: 2006 + A1: 2013 and related collateral standards like EN 60601-1-2: 2015.
• 5. The AC adapter cannot be used for charging batteries.
• 6. The USB cable (optional) can only be connected with the Rossmax blood pressure monitor and AC adapter. It cannot be used for any other purpose.

Installing Batteries

1. Press down and lift the battery cover in the direction of the arrow to open the battery compartment.
2. Install or replace 4 “AAA” sized batteries in the battery compartment according to the indications inside.
3. Replace the battery cover by clicking the bottom hooks first, then pushing in the top end of the cover.
4. Replace batteries in pairs. Remove batteries when the unit is not in use for extended periods.

You need to replace the batteries when:

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

Caution:

• 1. Batteries are hazardous waste. Do not dispose of them with household garbage.
• 2. There are no user-serviceable parts inside. Batteries or damage from old batteries are not covered by warranty.
• 3. Use only brand batteries. Always replace all batteries together. Use batteries of the same brand and type.

Applying the Cuff

1. Unwrap the arm cuff, leaving the end through the D-ring.
2. Put your left arm through the cuff loop. The color strip should be closer to you with the tube pointing towards your arm (Fig. ). Turn your left palm upward and place the cuff edge approximately 1.5 to 2.5 cm above the inner elbow joint (Fig. ). Tighten the cuff by pulling the end.
3. Center the tube over the middle of the arm. Secure the hook and loop material. Allow room for 2 fingers between the cuff and your arm. Position the artery mark (Ø) over the main artery (inside your arm) (Fig. ,). Note: Locate the main artery by pressing with 2 fingers about 2 cm above the elbow bend on the inside of your left arm. Identify where the pulse is strongest.
4. Plug the cuff connecting tube into the unit (Fig. ).
5. Lay your arm on a table (palm upward) so the cuff is at heart level. Ensure the tube is not kinked (Fig. ).
6. This cuff is suitable if the arrow falls within the solid color line (Fig. ). If the arrow falls outside the line, you need a cuff with different circumference. Contact your dealer for additional sizes.

Measurement Procedures

For more accurate readings:

• Blood pressure changes with each heartbeat and fluctuates throughout the day.
• Measurement can be affected by user position, physiological state, and other factors. For accuracy, wait one hour after exercise, bathing, eating, consuming alcohol/caffeine, or smoking before measuring.
• Sit quietly for at least 5 minutes before measurement for relaxed state accuracy. Do not be physically tired or exhausted.
• Do not measure under stress or tension.
• Sit upright, take 5-6 deep breaths. Avoid leaning back.
• Do not cross legs; keep feet flat on the floor.
• Do not talk or move arm/hand muscles during measurement.
• Measure at normal body temperature. If feeling cold or hot, wait before measuring.
• If stored at very low temperatures (near freezing), place in a warm location for at least one hour before use.
• Wait 5 minutes before taking the next measurement.

1. Press the ON/OFF/START key. All displays appear briefly before returning to “0”.
2. The unit inflates automatically to the appropriate level based on pulse oscillations. Measurement begins. Remain still and quiet during measurement; significant movement can affect results.
3. After measurement, systolic, diastolic, and pulse are displayed simultaneously and saved automatically. Up to 90 memories can be saved.
4. Measurement is complete. Press ON/OFF/START to turn off. The unit shuts off automatically in 1 minute if no key is pressed.

The monitor will re-inflate automatically if more pressure is needed.

Note:

• 1. The monitor automatically switches off approximately 1 minute after the last key operation.
• 2. To interrupt measurement, press the Memory or ON/OFF/START key; the cuff will deflate immediately.

Recalling Values from Memory

1. Press the Memory key to recall stored readings. The first reading displayed is the average of the last 3 measurements. The last set of readings will then be displayed.
2. Pressing the Memory key again recalls the previous set of readings.
3. All stored readings are displayed with their sequence number.

Clearing Values from Memory

Press and hold the Memory key for approximately 5 seconds to automatically erase data.

Troubleshooting

Note: If the unit still does not work, return it to your dealer. Do not disassemble or repair it yourself.

Cautionary Notes

• 1. The unit contains high-precision assemblies. Avoid extreme temperatures, humidity, and direct sunlight. Avoid dropping, strong shocks, and protect from dust.
• 2. Clean the monitor body and cuff carefully with a slightly damp, soft cloth. Do not press. Do not wash the cuff or use chemical cleaners, thinner, alcohol, or gasoline.
• 3. Leaky batteries can damage the unit. Remove batteries if not in use for extended periods.
• 4. Keep out of reach of children.
• 5. If stored near freezing, acclimate at room temperature before use.
• 6. Unit is not field serviceable. Contact the store, doctor, or Rossmax International Ltd. for problems.
• 7. The device may have difficulty with users diagnosed with arrhythmia, diabetes, poor circulation, kidney problems, stroke, or unconscious users.
• 8. Press ON/OFF/START to stop operation; cuff air exhausts rapidly.
• 9. Inflation reaching 300 mmHg will cause rapid deflation for safety.
• 10. This is a home healthcare product, not a substitute for professional medical advice.
• 11. Do not use for diagnosis or treatment. Consult a healthcare professional for interpretation of results. Do not change medications without medical advice.
• 12. Avoid strong electrical or electromagnetic fields (mobile phones, microwaves) or broadcast antennas within 1.5 km, as they may impair measurement accuracy.
• 13. Dispose of device, batteries, components, and accessories according to local regulations.
• 14. Performance may not meet specifications if stored or used outside specified temperature and humidity ranges.
• 15. Limb function may be impaired during inflation.
• 16. Do not stop blood circulation for unnecessarily long periods during measurement. Remove cuff if device malfunctions.
• 17. Avoid mechanical restriction, compression, or bending of the cuff line.
• 18. Avoid sustained pressure or frequent measurements, as restricted blood flow can cause injury.
• 19. Ensure cuff is not placed on an arm with medical treatment to arteries or veins (e.g., intravascular access, AV shunt).
• 20. Do not use cuff on people who have undergone mastectomy.
• 21. Do not place cuff over wounds, as this may cause further injury.
• 22. Use only provided or original replacement cuffs for accurate results.
• 23. Batteries can be fatal if swallowed. Keep away from children. Seek medical attention immediately if swallowed.
• 24. Do not use tubing/AC adapter for other purposes than specified to avoid strangulation risk.
• 25. Do not service or maintain device/cuff while in use.
• 26. Do not use adjacent to or stacked with other equipment.
• 27. Use only manufacturer-approved cables/accessories to avoid negative electromagnetic compatibility influences.

Specifications

• Measurement Method: Oscillometric
• Measurement Range: Pressure: 30-260 mmHg; Pulse: 40-199 beats/minute
• Pressure Sensor: Semiconductor
• Accuracy: Pressure: ± 3 mmHg; Pulse: ± 5% of reading
• Inflation: Pump Driven
• Deflation: Automatic Air Release Valve
• Memory Capacity: 90 memories
• 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-60°C (14°F-140°F); 10%-90% RH; 700-1060 hPa
• DC Power Source: DC 6V four AAA Batteries
• AC Power Source: DC 5V, ≥1000mA (Type C)
• Dimensions: 100 (L) X 86 (W) X 68 (H) mm
• Weight: 218.0g (G.W.) (w/o Batteries)
• Arm circumference: Adult: 24-40 cm (9.4”-15.7”)
• Limited Users: Adult users
• Type BF: Device and cuff 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

1. This device needs to be installed and put into service according to the user manual.

2. WARNING: Portable RF communications equipment should be used no closer than 30 cm (12 inches) to any part of the Z1, including cables. Otherwise, performance degradation may occur. Recommended separation distance: d = 1.2 √P (for 80MHz to 800MHz) or d = 2.3 √P (for 800MHz to 2.7 GHz), where P is the transmitter's maximum output power in watts (W).

Manufacturer’s declaration-electromagnetic immunity

The Z1 is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

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

Parts Identification

1. Arm Cuff

2. LCD Display

3. Air Tube and Connector

4. Memory Key

5. ON/OFF/START Key

6. Battery Cover

7. Type C port

Indicators

• 1. Hypertension Risk Indication
• 2. Movement Mark
• 3. Cuff Wrap Detection
• 4. Memory Mark
• 5. Memory Average Mark
• 6. Pulse Rate
• 7. Pulse Mark
• 8. Irregular Heartbeat Detection (IHB)
• 9. Systolic Pressure
• 10. Diastolic Pressure
• 11. Weak Battery Mark

Warranty Card

This instrument is covered by a 5-year guarantee from the date of purchase. The guarantee is valid only upon presentation of the warranty card completed or stamped by the seller/dealer confirming the date of purchase or the receipt. Batteries, cuff, and accessories are not included. Opening or altering the instrument invalidates the guarantee. The guarantee does not cover damage, accidents, or non-compliance with the instruction manual. Please contact your local seller/dealer or www.rossmax.com.

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Product Information

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