rossmax Z1 Blood Pressure Monitor User Manual

rossmax Z1 Blood Pressure Monitor

Overview

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

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

Introduction

Blood pressure measurements determined with Z1 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. Z1 is protected against manufacturing defects by an established International Warranty Program. For warranty information, you can contact the manufacturer, Rossman 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 will establish a baseline cuff pressure equivalent to the air pressure. This unit will 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 for you the systolic blood pressure, diastolic blood pressure, and pulse.

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 time. 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 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 historical 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 blood pressure, keeping long- term records is recommended. Please download the blood pressure log at our website www.rossmax.com.

Display Explanations

EE / Measurement Error: Make sure the L-plug is securely connected to the air socket and measure again quietly. Wrap the cuff correctly and keep arm steady during measurement. If the error keeps occurring, return the device to your local distributor or service center.
E1 / Air Circuit Abnormality: Make sure the L-Plug is securely connected to the air socket on the side of the unit and measure again quietly. If the errors still occur, return the device to your local distributor or service center 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 center.
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 center.
Er/ Exceeding Measurement Range: Measure again quietly. If the error keeps occurring, return the device to your local distributor or service center.

Cuff Wrap Detection

If the cuff was wrapped too loosely, it may cause unreliable measurement results. The “Cuff Wrap 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 body movement during measurement. The specified icon appears once a “body movement” has been detected during and after each measurement.
Note: It’s highly recommended that you measure again if the icon appears.

Hypertension Risk Indication (HRI)

The World Health Organization, classifying blood pressure ranges into 6 grades. This unit is equipped with 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 the result after each measurement.

Irregular Heartbeat (IHB) Detection

This unit is equipped with an Irregular Heartbeat (IHB) Detection which allows those who have an irregular heartbeat to obtain accurate measurements alerting the user of the presence of an irregular heart beat during the measurement.
Note: It is strongly recommended that you consult your physician if the IHB icon ( ) appears often

Using the USB cable with authorized AC Adapter (Optional)

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

Caution :

1. Please unload the batteries when operating with the AC mode for a longer period of time. Leaving the batteries in the compartment for a long time may cause leakage, which may lead to damage to the unit.
2. No batteries are needed when operating with the AC mode.
3. AC adapter is optional. Please contact the distributor for the compatible AC adapters.
4. 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.
5. AC adapter cannot be used for charging batteries.
6. USB cable (optional) can only be connected with Rossman 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 the compartment.
3. Replace the battery cover by clicking in the bottom hooks first, then push in the top end of the battery cover.
4. Replace the batteries in pairs. Remove batteries when unit is not in use for extended periods of time.

You need to replace the batteries when

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

Caution:

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

Applying the Cuff

1. Unwrap the arm cuff, leaving the end of the cuff through the D-ring of the cuff.

2. Put your left arm through the cuff loop. The color strip indication should be positioned closer to you with the tube pointing in the direction of your arm (Fig. ①). Turn your left palm upward and place the edge of the arm cuff at approximately 1.5 to 2.5 cm above the inner side of the elbow joint (Fig. ②). Tighten the cuff by pulling the end of the cuff.

3. Center the tube over the middle of the arm. Press the hook and loop material together securely. Allow room for 2 fingers to fit between the cuff and your arm. Position the artery mark (Ø) over the main artery (on the inside of your arm) (Fig. ③,④).

Note: Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery.

4. Plug in the cuff connecting tube into the unit (Fig. ⑤).

5. Lay your arm on a table (palm upward) so the cuff is at the same height as your heart.
   Make sure the tube is not kinked (Fig. ⑥).
   

6. This cuff is suitable for your use if the arrow falls within the solid color line as shown on the right (Fig. ⑦). If the arrow falls outside the solid color line, you will need a cuff with other circumferences. Contact your local dealer for additional size cuffs.
   

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.

1. Press the ON/OFF/START key. All displays will appear for approximately one second before returning to “0”.
2. The unit will automatically inflate to the appropriate inflation level based on the user’s pulse oscillations. Measurement will then begin. It is important to remain still and quiet during measurement. Any significant movement may affect measurement results.
3. When the measurement is completed, systolic, diastolic and pulse will be shown simultaneously and be saved automatically in memory system. Up to 90 memories can be saved.
4. Measurement is now completed. Press the ON/OFF/START key to turn off the power. If no key is pressed, the unit will shut off automatically in 1 minute.

This blood pressure monitor will re-inflate automatically to higher pressure if the system detects that more pressure is needed to take a blood pressure measurement.

Note:

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

Recalling Values from Memory

1. To recall stored blood pressure readings from memory, simply press the Memory key, the first reading displayed is the average of the last 3 measurements stored in memory, and then the last set of memorized readings will be displayed.
2. Another press of the Memory key will recall the previous set of readings.
3. All readings stored in memory will be displayed with its sequence number. Every measurement comes with an assigned memory sequence number.

Clearing Values from Memory

Press and hold the Memory key for approximately 5 seconds, then the data in the memory zone can be erased automatically

Troubleshooting

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

Replace them with four new batteries
Have the batteries’ polarities been positioned incorrectly?| Re-insert the batteries in the correct positions.
EE mark shown on display or the blood pressure value is displayed excessively low (high)| Is the cuff placed correctly?| Wrap the cuff properly so that it is positioned correctly.
Did you talk or move during measurement?| Measure again. Keep arm steady during measurement.
Did you vigorously shake the cuff during measurement?

Note: If the unit still does not work, 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. Leaky batteries can damage the unit. Remove the batteries when the unit is not used for a long time.

4. The unit should not be operated by children so to avoid hazardous situations.

5. If the unit is stored near freezing, allow it to acclimate at room temperature before use.

6. 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 Rossman International Ltd.

7. 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 common arrhythmia (atrial or ventricular premature beats or atrial fibrillation), diabetes, poor circulation of blood, kidney problems, or for users suffered from stroke, or for unconscious users.

8. To stop operation at any time, press the ON/OFF/START key, and the air in the cuff will be rapidly exhausted.

9. Once the inflation reaches 300 mmHg, the unit will start deflating rapidly for safety reasons.

10. Please note that this is a home healthcare product only and it is not intended to serve as a substitute for the advice of a physician or medical professional.

11. 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.

12. Electromagnetic interference: The device contains sensitive electronic components. Avoid strong electrical or electromagnetic fields in the direct vicinity of the device (e.g. 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.

13. Dispose of device, batteries, components and accessories according to local regulations.

14. This monitor may not meet its performance specification if stored or used outside temperature and humidity ranges specified in Specifications.

15. Please note that when inflating, the functions of the limb in question may be impaired.

16. 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.

17. Avoid any mechanical restriction, compression or bending of the cuff line.

18. Do not allow sustained pressure in the cuff or frequent measurements. The resulting restriction of the blood flow may cause injury.

19. 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.

20. Do not use the cuff on people who have undergone a mastectomy.

21. Do not place the cuff over wounds as this may cause further injury.

22. Only ever use the cuffs provided with the monitor or original replacement cuffs. Otherwise erroneous results will be recorded.

23. 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.

24. Do not use the tubing and/or AC adapter for any other purpose than those specified, as they can cause risk of strangulation.

25. Do not service or maintain device and cuff while in use.

26. This unit should not be used adjacent to or stacked with other equipment.

27. 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

15%~85% RH; 700~1060 haps
Permissible Transport and Storage Temperature and Humidity| -10°C~60°C (14°F~140°F); 10%~90% RH; 700~1060 haps
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 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

1. This device needs to be installed and put into service in accordance with the information provided in the user manual.
2. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Z1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this device could result.

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 Z1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Z1 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 Z1 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 transmit- term in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electro- magnetic site survey, a should be less than the compliance level in each frequency range. b 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 Rossman website: www.rossmax.com.

WARNING: 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 dispose on your local recycling center for safe treatment.

References

• Your Total Healthstyle Provider - Rossmax | Your total healthstyle provider
• Your Total Healthstyle Provider - Rossmax | Your total healthstyle provider

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