1

2

1

2

3

4

3

4

5

5

6

6

1

2

9. Back light Control

The default is to have the back light on once the pressure is inflated over 30 mmHg, and throughout the measurement process. To switch the back light off at any time, press the “ ” key.

10. Error Messages

Err

EE

E3

01

Heartbeat rate detection error. The cuff is deflated too rapidly. Please keep the deflation rate among 2-3 mmHg per second.

A pressure of over 15 mmHg remaining for more than 3 minutes is detected. Please press the “ ” key to switch the unit off, or the unit will automatically switch off after 60 seconds.

Data Error. Please remove and reload the batteries. If error keeps occurring, return the device to the local distributor or service center.

The cuff is inflated to a pressure over 299 mmHg. Please open the valve immediately to rapidly exhaust the air in the cuff.

5

If the unit is used for over 10,000 times, the calibration reminding message (CAL) will appear every time the unit is switched on. It is recommended that calibration be completed every two years. Only the manufacturer or an authorized service technician is qualified for the calibration service.

Please contact the manufacturer, Rossmax

International Ltd. or your local distributors. (The PC Link socket for calibration purpose is inside the battery compartment.)

12. Safety Information

1. Rossmax Mandaus II are exclusively designed for blood pressure measurement at the upper arm or thigh on healthy skin.

2. Please do not inflate to more than 300 mmHg.

3. Do not take your blood pressure for more than 3 minutes.

4. Wait for at least 2 minutes before repeated measurements.

13. 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. Mandaus II 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 who you purchased Mandaus II from or please contact Rossmax International Ltd.

7. To stop operation at any time, open the air release valve, and the air in the cuff will be rapidly exhausted.

8. 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.

9. 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.

10. 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). These may lead to temporary impairment of measurement accuracy.

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

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

Specifications.

6

14. Specifications

Power Source : DC 3V Two AAA Batteries

Measurement Range : Pressure: 0-299 mmHg;

Accuracy

Pulse: 30-240 beats/min

: Pressure:

Pressure Sensor

Inflation

Deflation

Auto-shut-off

0°C~17°C, 34°C~46°C: ±6 mmHg

18°C~33°C: ±3 mmHg

Pulse: ±5% of reading

: Semi-conductor

: Manual Inflation

: Manually operated deflation valves

: 1 min. after last key operation

Back light auto-shut-off : 15 sec. after last key operation

Operation environment : 0°C~46°C (32°F~115°F);

85% RH max

Storage environment : -34°C~65°C (-30°F~149°F);

85% RH max

Dimensions

Weight

Limited users

: 78(L) x 63(W) x 48(H) mm

: 90g (Mandaus II)

267g [Mandaus II+Rossmax Gauge

Cuff (M)]

: Adult users

: Type BF

Device and cuff are designed to provide special protection against electrical shocks.

*Specifications are subject to change without notice.

15.

EMC guidance and manufacturer’s declaration

Guidance and manufacturer’s declaration-electromagnetic emissions

The Mandaus II is intended for use in the electromagnetic environment specified below.

The customer or the user of the Mandaus II should assure that it is used in such an environment.

Emission test Compliance

RF emissions CISPR 11 Group 1

Electromagnetic environment-guidance

The Mandaus II uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissions IEC 61000-3-3

Not applicable

The Mandaus II is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Immunity test

Electrostatic discharge (ESD) IEC

61000-4-2

Guidance and manufacturer’s declaration-electromagnetic immunity

The Mandaus II is intended for use in the electromagnetic environment specified below.

The customer or the user of the Mandaus II should assure that it is used in such an environment.

IEC 60601 test level

± 6 kV contact

± 8 kV air

Compliance level

± 6 kV contact

± 8 kV air

Electromagnetic environment-guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

± 2kV for power supply lines

± 1kV for input/output lines

Not applicable

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

Electrical fast transient/burst IEC

61000-4-4

Surge IEC

61000-4-5

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC

61000-4-11

Power frequency

(50/60 Hz) magnetic field IEC

61000-4-8

± 1kV line(s) to line(s)

± 2kV line(s) to earth

<5% UT(>95% dip in UT) for 0,5 cycle

40% UT(60% dip in UT) for 5 cycles

70% UT(30% dip in UT) for 25 cycles

<5% UT(>95% dip in UT) for 5 s

3 A/m

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Mandaus II requires continued operation during power mains interruptions, it is recommended that the Mandaus II be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration-electromagnetic immunity

The Mandaus II is intended for use in the electromagnetic environment specified below.

The customer or the user of the Mandaus II 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

Radiated RF

IEC 61000-4-3

3 Vrms

150 KHz to 80 MHz

3 V/m

80MHz to 2,5 GHz

Not applicable

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Mandaus II, 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 2,5 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).

Field strengths from fixed RF transmitters, as determined by an electromagnetic 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:

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.

a. 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 and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Mandaus II is used exceeds the applicable RF compliance level above, the Mandaus II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Mandaus II.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distance between portable and mobile RF communications equipment and the Mandaus II

The Mandaus II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Mandaus II can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Mandaus II as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter / W

0,01

0,1

1

Separation distance according to frequency of transmitter / m

150 kHz to 80 MHz / d = 1,2 √P

0,12

0,38

1,2

80 MHz to 800 MHz / d = 1,2 √P

0,12

0,38

1,2

800 MHz to 2,5 GHz / d = 2,3 √P

0,23

0,73

2,3

10

100

3,8

12

3,8

12

7,3

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE1: At 80 MHz and 800 MHz, the separation distance for 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.

Model:

GA102

MANDAUS II

EN

Instruction Manual

www.rossmaxhealth.com

neck aipei, 114, T aiwan.

Rossmax Swiss GmbH, Tramstrasse 16 CH-9442 Ber

12F ., No. 189, Kang Chien Rd., T

Rossmax International Ltd.

Switzerland

1. Introduction

Thank you for choosing Rossmax Mandaus II, the shock and splash resistant backlighted digital sphygmomanometer. Blood pressure measurements determined with Mandaus II are equivalent to those obtained by a trained observer using cuff/stethoscope auscultation method.

Mandaus II is protected against manufacturing defects by an established International Warranty Program. For warranty information, you can contact the manufacturer, Rossmax International Ltd. or your local distributors.

Consult the accompanying documents.

Please read this manual carefully before use. Please be sure to keep this manual.

4. Name/Function of Each Part

Back light key

On/Off/Zeroing key

Arm Cuff

Air Tube and

Connector

Inflating

Bulb

6. Installing and Replacing the Batteries

1. Rotate the clip through 90 °.

2. Loosen the screw on the battery cover.

3. Install the batteries with correct polarities.

4. Replace the battery cover and tighten the screw.

5. Rotate the clip back.

3. The edge of the cuff should be at approximately 1.5 to 2.5 cm above the inner side of the elbow joint. If the index line falls within the range of the arm circumference indicator, the cuff circumference is suitable, otherwise you may need a cuff with a different circumference.

4. Using the correct cuff size is important for an accurate reading.

Applicable cuff circumferences

Rossmax Gauge Cuffs

Young Adult (S) 18 - 26 cm (7.0”-10.3”)

Adult (M) 24 - 36 cm (9.5” – 14.2”)

Large Adult (L) 34 - 46 cm (13.4”-18.1”)

2. Preliminary Remarks

Mandaus II complies with the European regulations and bears the CE mark "CE 0366". 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/A1: 2002 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

Artery Mark

Arm Circumference Indicator

Index Line

Air

Release

Valve

3. Blood Pressure Standard

The National High Blood Pressure Education Program

Coordinating Committee has developed a blood pressure standard, classifying blood pressure ranges into 4 stages.

(Ref. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure-Complete Report

JNC-7, 2004).

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 before making any healthcare decision based on the device's readings.

For reliable monitoring and reference of blood pressure, keeping long- term records is recommended. Please download the blood pressure log

(chart for recording and tracking crucial info: date, time, blood pressure, pulse rate and body condition) at www.rossmaxhealth.com.

1 1

2 2

3

4

3

4

Stethoscope

5. Display Explanations

1. Blood Pressure

2. Deflation Rate (During Measurement)/

Heartbeat Rate (After Measurement)

3. Heartbeat Mark

4. Weak Battery Mark

5. Error Mark

6. Calibration Reminder

1

2

5 5

Carrying Case

6

3

4

6

5. To stop operation at any time, open the air release valve,

1 1

1

5

3

4

You need to replace the batteries when:

1. low battery icon appears on display.

2. the On/Off/Zeroing key is pressed and nothing appears on display.

1

1 together with the household garbage.

2. There are no user serviceable parts inside. Batteries or damage from old batteries are not covered by warranty.

2

3

4

3

4

3. Use exclusively brand batteries. Always replace with new batteries together. Use batteries of the same brand and same type.

8. Measurement Procedures

1. Place the stethoscope head over the main artery, underneath the artery

Press the “ ” key. After zeroing,

Mandaus II is ready to measure. (Fig.

2)

1

2

5

3

4

6

Fig. 2

5

5

7. Applying the Cuff

1. Plug the connector into the gauge and twist clockwise to secure the connection.

2. Place the cuff over the bare upper arm, wrap it with the tube point-

5

over your main artery.

6

3. With the valve closed, press the bulb and continue pumping to a value 30-40 mmHg above your normal blood pressure. (Fig. 3)

Open the valve to deflate the cuff gradually at a rate of 2-3 mmHg per second. (The deflation rate is displayed on

LCD.) (Fig. 4)

Fig. 3 Fig. 4

5. Record the onset of Korotkoff sound as the sys-

Fig. 5 tolic pressure, and the disappearance of these sounds as diastolic pressure.

6. After measurement is completed, fully open the valve to release any remaining air in the cuff. The heartbeat rate is displayed on the LCD. (Fig. 5)

6

6

6