Rossmax MANDAUS II, GA102 Instruction Manual

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 techni-

cian is qualied 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.)

IN0GA1020000000XX

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

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

2. Please do not inate 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.

12. Safety Information

1. The unit contains high-precision assemblies. Therefore, avoid ex-

treme 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.

13. Cautionary Notes

14. Specications

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

Emission test Compliance Electromagnetic environment-guidance

RF emissions CISPR 11 Group 1 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 The Mandaus II is suitable for use in all establishments, including domestic establish-

ments and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.

Harmonic emissions
IEC 61000-3-2

Not applicable

Voltage uctuations/icker

emissions IEC 61000-3-3

Not applicable

Guidance and manufacturer’s declaration-electromagnetic immunity

The Mandaus II is intended for use in the electromagnetic environment specied below.

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

Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance

Electrostatic dis­charge (ESD) IEC
61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV contact
± 8 kV air

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

Electrical fast

transient/burst IEC

61000-4-4

± 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.

Surge IEC
61000-4-5

± 1kV line(s) to line(s)
± 2kV line(s) to earth

Not applicable
Not applicable

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

Voltage Dips, short

interruptions and
voltage variations

on power supply

input lines IEC
61000-4-11

<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

Not applicable

Not applicable

Not applicable

Not applicable

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
(50/60 Hz) mag­netic eld IEC

61000-4-8

3 A/m 3 A/m Power frequency magnetic elds should be at levels

characteristics of a typical location in a typical com-

mercial 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 specied 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 xed 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 reection from

structures, objects and people.

a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, ama-

teur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromag­netic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld 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, eld 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

Separation distance according to frequency of transmitter / m

150 kHz to 80 MHz / d = 1,2 √P 80 MHz to 800 MHz / d = 1,2 √P 800 MHz to 2,5 GHz / d = 2,3 √P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73

1 1,2

1,2 2,3

10 3,8 3,8 7,3

100 12 12 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 reection from

structures, objects and people.

Power Source : DC 3V Two AAA Batteries
Measurement Range : Pressure: 0-299 mmHg;

Pulse: 30-240 beats/min

Accuracy : Pressure:

0°C~17°C, 34°C~46°C: ±6 mmHg
18°C~33°C: ±3 mmHg
Pulse: ±5% of reading

Pressure Sensor : Semi-conductor

Ination : Manual Ination
Deation : Manually operated deation valves

Auto-shut-off : 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 : 78(L) x 63(W) x 48(H) mm

Weight : 90g (Mandaus II)

267g [Mandaus II+Rossmax Gauge

Cuff (M)]

Limited users : Adult users

: Type BF

Device and cuff are designed to pro-

vide special protection against electri­cal shocks.

*Specications are subject to change without notice.

1

2

4

3

5 6

5 6

9. Back light Control

Err

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

EE

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.

E3

Data Error. Please remove and reload the batteries. If

error keeps occurring, return the device to the local
distributor or service center.

01

The cuff is inflated to a pressure over 299 mmHg. Please

open the valve immediately to rapidly exhaust the air in
the cuff.

10. Error Messages

11. Maintenance

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 eld 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 elec-

tronic components. Avoid strong electrical or electromagnetic

elds 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 accord-

ing to local regulations.

12. This monitor may not meet its performance specication if stored

or used outside temperature and humidity ranges specied in
Specications.

www.rossmaxhealth.com

Instruction Manual

Model: GA102

MANDAUS II

EN

Edition: V-3-PA01-3310

Issue Date: 2011/05/13

Rossmax International Ltd.

12F., No. 189, Kang Chien Rd., Taipei, 114, Taiwan.

Rossmax Swiss GmbH, Tramstrasse 16 CH-9442 Berneck

Switzerland

3. With the valve closed,

press the bulb and con­tinue pumping to a val-

ue 30-40 mmHg above

your normal blood pres-

sure. (Fig. 3)

4. 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)

5. Record the onset of Ko-

rotkoff sound as the sys­tolic 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)

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

5. Display Explanations

7. Applying the Cuff

3. Blood Pressure Standard

1. Introduction

4. Name/Function of Each Part

2. Preliminary Remarks

Attention: Consult the accompanying documents.

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

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

8. Measurement Procedures

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

mark of the cuff. (Fig. 1)

2. Press the “ ” key. After zeroing,
Mandaus II is ready to measure. (Fig.

2)

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.

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.

Arm Cuff

Air Tube and

Connector

Inflating

Bulb

Air
Release

Valve

Back light key

On/Off/Zeroing key

Carrying Case

Stethoscope

Index Line

Artery Mark

Arm Circumference Indicator

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

4

3

5 6

5

6

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.

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.

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.

6

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 point­ing your palm, and the artery mark
over your main artery.

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”)

3. The edge of the cuff

should be at approximate-

ly 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.

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

and the air in the cuff will be rapidly exhausted.

4

3

5 6

Fig. 1

Fig. 2

Fig. 3 Fig. 4

5 6

Fig. 5

4

3

5 6

5 6