AXIOMTEK MBOX600 Bedienungsanleitung

mBOX600

Medical Embedded System

User’s Manual

Disclaimers

This manual has been carefully checked and believed to contain accurate information.

Axiomtek Co., Ltd. assumes no responsibility for any infringements of patents or any third

party’s rights, and any liability arising from such use.

Axiomtek does not warrant or assume any legal liability or responsibility for the accuracy,

completeness or usefulness of any information in this document. Axiomtek does not make any

commitment to update the information in this manual.

Axiomtek reserves the right to change or revise this document and/or product at any time

without notice.

No part of this document may be reproduced, stored in a retrieval system, or transmitted, in any

form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without

the prior written permission of Axiomtek Co., Ltd.

August 2023, Version A1

Printed in Taiwan

iii

Safety Precautions

Before getting started, please read the following important safety precautions.

1. The mBOX600 does not come with an operating system which must be loaded first before

installation of any software into the computer.

2. Use a wrist grounding strap and place all electronic components in any static-shielded

devices. Most electronic components are sensitive to a static electrical charge.

3. A sudden surge of power could ruin sensitive components. Make sure the mBOX600 is

properly grounded.

4. Make sure the voltage of the power source is correct before connecting it to any power

outlet.

5. Turn Off system power before cleaning. Clean the system with an antistatic cloth only.

6. Do not leave equipment in an uncontrolled environment where the storage temperature is

below 0°C or above 40°C as it may damage the equipment.

7. Do not open the system’s back cover. For safety reasons, the equipment shall be opened

only by qualified service person.

8. WARNING: Do not modify this equipment without the authorization of Axiomtek Co., Ltd.

Please go to "Support (axiomtek.com) ". Use this site to resolve a hardware problem

and get more information about your product. You can also find information on how to

contact AXIOMTEK and open a support case.

9. WARNING! Danger of an unacceptable high leakage current for the patient may be

caused by insufficient system configuration: Accessories being connected to analog or

digital interfaces must comply with the respective European or international standards (e.g.

EN 60601–1 for medical devices). Furthermore, all configurations building an ME system

must comply with the European or international standard 60601–1. Every person

connecting additional devices to a signal input or output is configuring a medical system

and is therefore responsible for the ME system complying with the applicable version of

the European or international standard 60601–1. If you have questions, please contact

customer support or your local representative.

10. WARNING! To avoid the risk of electric shock, this equipment must only be connected to

supply mains with protective earth.

11. Disconnect device: Appliance inlet of Power Adapter, please do not to position the Power

Adapter too far to difficultly operate the disconnection device.

12. External surfaces of ME EQUIPMENT that are likely to be touched for a time “t”

Time

ME EQUIPMENT and its parts

1s ≤ t < 10s

Outer metal enclosure surface

Outer surface of Power Adapter

Plastic panel near standby switch

13. Environmental Conditions

Operation

Temperature (C)

0 ºC to +40 ºC

Relative Humidity (%)

10 to 90%RH

Atmospheric Pressure (kPa)

106 to 80 kPa

Storage / Transportation

Temperature (C)

0°C to +40°C

Relative Humidity (%)

10 to 90%RH

Atmospheric Pressure (kPa)

106 to 80 kPa

14. If one of the following situations arises, get the equipment checked by service

personnel:

a. The power cord or plug is damaged.

b. Liquid has penetrated into the equipment.

c. The equipment has been exposed to moisture.

d. The equipment does not work well, or you cannot get it to work according to

the user's manual.

e. The equipment has been dropped and damaged.

f. The equipment has obvious signs of breakage.

15. If your computer is losing dramatic time or the BIOS configuration reset to default, the

RTC battery has no power.

Caution

1. Do not replace battery yourself. Please contact a qualified technician

or your retail.

2 .The Computer is provided with a battery-powered real-time clock

circuit. There is a danger of explosion if battery is incorrectly

replaced. Replace only with same or equivalent type recommended

by the manufacture. Discard used batteries according to the

manufacturer’s instructions.

Caution

1. Ne pas remplacer vous-même. Veuillez contacter un technicien

qualifié ou votre commerce de détail.

2 . L'ordinateur est fourni avec une pile de l'horloge en temps réel du

circuit. Il y a un risque d'explosion si la batterie est remplacée de

manière incorrecte. Remplacez-la uniquement par une batterie de

type identique ou équivalent recommandé par le fabricant. Jetez les

piles usées conformément aux instructions du fabricant.

Explanation of Graphical Symbols

Symbol

Description

Follow the national requirement to dispose unit.

European Conformance

US Conformance

On ME EQUIPMENT "Follow instructions for use”

ISO 15223-1

Indicates the medical device manufacturer

IEC 60417-5031: Direct current.

IEC 60417-5032: AC

Stand-by

Equipotentiality

Intended User Profile

1. Education: Medical Experts

2. User group: Medical Professionals

3. Knowledge base: User should possess medical professional knowledge

CAUTION: Medical electrical equipment needs special precautions regarding electromagnetic

compatibility (EMC) and needs to be installed and put into service according to the EMC

information in the XXX sections of this document. Portable and mobile RF communications

equipment can affect medical electrical equipment.

Medical Electrical Equipment needs special precautions regarding EMC and needs to be

installed and put into service according to the EMC information provided in the following.

Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical

Electrical Equipment.

The use of accessories and cables other than those specified may result in increased emissions

or decreased immunity of the unit.

Guidance and manufacturer’s declaration –electromagnetic emissions

The A&D unit is intended for use in the electromagnetic environment specified below. The

customer or the user of the A&D unit should assure that it is used in such an

environment.

Emissions test

Compliance

Electromagnetic environment –

guidance

emissions

CISPR 11

Group 1

The A&D unit uses RF energy only for its

internal function. Therefore, its RF

emissions are very low and are not

likely to cause anyinterference in nearby

electronic equipment.

emissions

CISPR 11

Class B

The A&D unit is suitable for use in all

establishments, including domestic

establishments and those directly

connectedto the public low-voltage power

supply network that supplies buildings

used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations

/flicker emissions

IEC 61000-3-3

Complies

vii

Recommended separation distances between portable and mobile RF communications

equipmentandthe A&D unit

The A&D unit is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the A&D unit can help prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the A&D unit as recommended

below, according to the maximum output power of the communications equipment.

Rated

maximum

output

power of

transmitter

Separation distance according to frequency of transmitterm

150kHzto80MHz

d = 1.2 P

80 MHz to 800 MHz

d = 1.2 P

800MHzto2.5GHz

d = 2.3 P

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in metres (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.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range

applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is

affectedby absorptionandreflectionfromstructures,objects andpeople.

viii

Guidance and manufacturer’s declaration –electromagnetic immunity

The A&D unit is intended for use in the electromagnetic environment specified below. The

customer or the user of the A&D unit should assure that it is used in such an environment.

Immunity

test

IEC 60601

test level

Compliance

level

Electromagnetic

environment –guidance

Portable and mobile RF

communications equipment

shouldbe used no closer to

any part of theA&D unit,

including cables, than the

recommended separation

distance calculated from the

equation applicable to the

frequency of the transmitter.

Recommendedseparation

distance:

Conducted RFIEC

61000-4-6

3 V rms

150 kHz to 80 MHz

3 V rms

d = 1.2 P

Radiated RF IEC

61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

d = 1.2 P80 MHz to 800

MHz

d = 2.3 P800 MHz 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 isthe

recommended separation

distance in meters (m).

Field strengths from fixed RF

transmitters, as determined by

an electromagnetic site

survey, ashouldbe less than

the compliancelevelin each

frequencyrange.b

Interference may occur inthe

vicinity of equipment marked

with the followingsymbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 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. Toassess

the electromagnetic environment due to fixed RF transmitters, an electromagnetic site

survey should be considered. If the measured field strength in thelocation in which the

A&D unit is used exceeds the applicable RF compliance level above, the A&D unit

should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as

re-orienting or relocating the A&D unit.

b Overthe frequencyrange150 kHzto 80 MHz, fieldstrengths should belessthan 3 V/m.

Guidance and manufacturer’s declaration –electromagnetic immunity

The A&D unit is intended for use in the electromagnetic environment specified below. The

customeror the userof the A&Dunit shouldassurethat it is usedinsuch an environment.

Immunit

ytest

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

floors are covered

withsynthetic

material, the

Relative humidity

should beat least

30%.

Electrical fast

transient/burstIEC

61000-4-4

± 2 kV for power

supply lines

± 1 kV

for input/outputlines

± 2 kV for power

supply lines

± 1 kV

for input/output

lines

Mains power

quality should be

that of a typical

commercial or

hospital

environment.

Surge

IEC 61000-4-5

± 1 kV

line to line

±2 kV

line to earth

± 1 kV

line to line

±2 kV

line to earth

Mains power

quality should be

that of a typical

commercial or

hospital

environment.

Voltage dips, short

interruptions and

voltage variationson

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

< 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

Mains power quality

should be that of a

typical commercial

or hospital

environment. If the

user of the A&D

unit requires

continued

operation during

power mains

interruptions, itis

recommended

that theA&D unit

be powered from

an uninterruptible

powersupplyor a

battery.

Power frequency

(50/60 Hz)

magnetic field IEC

61000-4-8

3 A/m

Power frequency

magneticfields

should be at levels

characteristic of a

typical location in a

typical commercial

or hospital

environment.

NOTE: UTis the AC mains voltage prior to application of the test level.

Classifications

1. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air,

oxygen or nitrous oxide.

2. Mode of operation: Continuous.

3. Supply CLASS I Power Adapter see “1.5 Packing List” for power adapter detail

information.

4. No Applied Part

5. IPX0

6. Pollution degree of equipment: Pollution Degree 2

7. Operation altitude of equipment: 0-5000m

8. Material group IIIb

9. Two MOPP insulations were provided between primary and secondary. One

MOPP insulation was provided between primary and earth.

10. Two MOPP insulations were provided between primary and secondary. One

MOPP insulation was provided between primary and earth.

11. ISOLATION ports provide one MOOP 1.5 kVac against other secondary circuits.

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