LPG HUBER 360 MD Operator's Manual

2

Registered trademark

OPERATOR’S MANUAL HUBER

®

360 MD

Please read this entire manual carefully before using your device.

Keep this manual and the separate installation instructions for future reference

© LPG Systems 2014. LPG and HUBER are registered trademarks.

Reproduction, even in part, is strictly prohibited.

GU1306 - GB

Indice A of 10/14

Congratulations on the purchase of your HUBER 360 MD device.

This model represents the culmination of many years of research, combining the latest technologies with LPG’s expertise.

You can fully appreciate the technical perfection and reliability that have made

LPG Systems the leader in this field.

This operator’s manual describes how to operate the device, instructions for periodic maintenance, and safety guidelines.

Your device should be used only by a professional who has completed the manufacturer’s training provided by LPG Systems or an approved provider, if you live outside of France, it’s not suitable for home use.

If you have any questions about operating or maintaining your device, please contact LPG Systems Customer Service:

+33 (0)4 75 78 69 89

≥ W A R N I N G

To better respond to customer requirements and expectations, LPG Systems is constantly looking for ways to improve the design and quality of its products. For this reason, there may be minor differences between your equipment and the unit described in this manual.

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CONTENTS

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One

HUBER ® 360 MD

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One set of guardrails

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One stability test chock

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One articulated stool

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Two pads

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One tablet

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One operator’s manual

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One power cable

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One set of quick unpacking and set-up instructions

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One POS display

Depending on the version you have, basic version or full version (see serial number on the nameplate), some protocols are not activated and their accessories are not provided. Therefore, the paragraphs describing them do not apply to the basic version (see the Table below).

Accordingly, the paragraphs describing them do not concern this version (see table on the next page).

Guardrails

Stability test chock

Articulated stool

Pads

Tablet

Accessories

√

√

√

√

√

≥ W A R N I N G

The manufacturer reserves the right to modify the product’s technical specifications without prior notice. Any reproduction, even in part, is prohibited. All the illustrations in this Operator’s Manual are non-binding.

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CONTENTS

1.

DEVICE DESCRIPTION

..............................................................

7

1.1 Intended use

........................................................ ...........

7

1.2 Presentation

................................................. ..................

8

2.

CONTROLS AND ACCESSORIES

.....................................................

9

2.1 Control Screen

........................................................... ......

9

2.2 Handle

...................................................................... ..

10

2.3 Platform

...................................................................... 10

2.4 Pads

.......................................................................... 11

2.5 Articulated stool (Hu-seat)

....................................................

14

2.6 Tablet

.........................................................................

17

2.7 Guardrails

.................................................................... 18

2.8 Stability test chock

........................................................ ....

19

3.

IMPORTANT SAFETY INFORMATION

...............................................

21

3.1 Installation

.............................................................. ......

21

3.2 Warning

................................................. ......................

23

3.3 Precautions

........................................................ ...........

24

3.4 Warnings

......................................................................

25

3.5 Electromagnetic Compatibility

............................................ ....

26

4.

MAINTENANCE

....................................................................

27

4.1 Cleaning the device

........................................................ ...

27

4.2 Identification nameplate

........................................... ...........

27

4.3 Power cord

............................................................... .... 29

5.

TROUBLESHOOTING

...............................................................

30

6.

TECHNICAL SPECIFICATIONS

.....................................................

31

7.

WARRANTY

........................................................................

33

8.

APPENDIX: ELECTROMAGNETIC COMPATIBILITY

.................................

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DEVICE DESCRIPTION

The HUBER 360 MD is intended for therapeutic use. It can be used for:

1. The muscle reinforcment

2. The joint mobility recovery

3. The additional therapy treatment for obesity

The machine can be used in hospitals and rehabilitation clinics by specialists and physiotherapists.

It is an independent device that cannot be combined with other machines. It should only be used by professionals who have been specially trained by LPG Systems in its use. It is not meant to be used at home.

HANDLE

TOUCHSCREEN

INTERFACE

1

MEASURING

SYSTEM

EMERGENCY

STOP BUTTON

MEASURING

SYSTEM

PLATFORM

BASE

BLOWER

≥ W A R N I N G

The unit can only operate if its power cable is connected to the power outlet and if the on/off switch is turned on.

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DEVICE DESCRIPTION

INDICATOR

POWER ON

CIRCUIT BREAKER

POWER SWITCH NO. 1

TURN ON

FIRST

CIRCUIT BREAKER

POWER SWITCH NO. 2

TURN ON

SECOND

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CONTROL SCREEN

ETHERNET JACK

USB PORT

AUDIO PORT

POWER INDICATOR

TOUCHSCREEN

2

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2

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HANDLE

1 0

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PLATFORM

POSITIONING

MARKERS

PLATFORM LEVEL RECESSED FOR POSITIONING ACCESSORIES

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PADS

The HUBER 360 MD may come with two Pads that can be positioned on the platform.

Overview

FOOT ORIENTATION ANGLE

MARKER

ORIENTATION MARKER ON

THE UPPER MOVEABLE SIDE

2

PAD ROTATION ANGLE

MARKER

POSITIONING

PINS

Underside

1 1

2

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PADS

(CONT.)

POSITIONING THE PADS:

The Pads can be positioned on the platform in the positioning holes.

POSITIONING HOLE

To position the Pads on the platform, you will need to align the positioning pins on the Pads with the suitable positioning holes.

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≥ W A R N I N G

All operations in this section should be performed when the device is powered off.

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PADS

(CONT.)

ORIENTATION OF FOOTINGS ON THE PAD:

The orientation of the footing can vary 0 to 90° with respect to the inclination of the Pad. To do this, simply position the footing to the desired angle.

2

FOOTING

DIRECTION

ORIENTATION OF THE PADS:

The orientation of the Pads with respect to the platform can be adjusted in

15° increments. To adjust the orientation of the Pads, you will need to unlock the locking ring by pushing it downwards (photo 1), and then rotate the upper part of the

Pads so that the marker lines up with the proper degree of tilt (photo 2).

PAD ROTATION

> PICTURE 1 > PICTURE 2

DIRECTION MARKER ON

THE MOVEABLE TOP SECTION

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ARTICULATED STOOL

Your HUBER 360 MD may come with an articulated stool that can be positioned on the platform

Overview

SEAT

HEIGHT ADJUSTMENT

HANDLE

PNEUMATIC

JACK

ARTICULATED

STOOL TILT

ANGLE MARKER

TILT WHEEL

ADJUSTMENT

BASE

LOCK NUTS

1 4

Underside

POSITIONING

PINS

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ARTICULATED STOOL

(CONT.)

POSITIONING THE ARTICULATED STOOL

To position the articulated stool on the platform, you will need to align the positioning pins on the articulated stool with the suitable positioning holes.

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ARTICULATED STOOL

(CONT.)

LOCKING THE ARTICULATED STOOL ONTO THE PLATFORM

Before use, the articulated stool must be locked onto the platform. To do this, press the middle button until the tool is lodged into the recess, as shown in the photos below:

TILTING THE STOOL

The articulated stool can tilt from 0 to 15°.

To do this, turn the articulated stool’s adjustment knob to set the marker to the desired tilt.

TILT ANGLE

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≥ W A R N I N G

Ensure that the articulated stool is properly locked before use.

All operations in this section should be performed when the device is powered off.

TILT MARKER

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TABLET

Your HUBER 360 MD may come with a tablet that lets you access the HUBER 360 application.

This application will allow you to create user profiles and download exercises to the machine. It also allows you to control certain settings remotely.

Details about how to use the application are provided when you open it.

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GUARDRAILS

The HUBER 360 MD may come with two guardrails attached to the machine. These guardrails are meant to make the machine easier to use:

Overview

GUARDRAILS

ATTACHMENT MECHANISMS

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STABILITY TEST CHOCK

The HUBER 360 MD comes with a stability test chock that can be positioned on the platform:

Overview:

2

Underside:

POSITIONING

PINS

POSITIONING

PINS

1 9

2

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STABILITY TEST CHOCK

(CONT.)

POSITIONING THE STABILITY TEST CHOCK

The stability test chock can be positioned on the platform using the positioning holes shown in the photo below:

POSITIONING HOLE

To position the stability test chock, align the positioning pins on the chock with the positioning holes in the platform.

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IMPORTANT SAFETY INFORMATION

The following safety precautions must always be observed when using an electrical device. Read all instructions before using the device.

DANGER - TO MINIMIZE THE RISK OF ELECTRIC SHOCK:

• Ensure that the circuit breakers are tripped and make sure the voltage is off after its use and before its cleaning.

• Check that the voltage indicated on the nameplate matches the voltage of the power outlet.

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INSTALLATION

CLEARANCE: provide a clearance of 1 meter all the way around the device, keeping the area free of any objects or people.

1 meter

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INSTALLATION

(CONT.)

The installation of your HUBER 360 MD machine must respect the instructions given in the unpacking notice (to be found in the pocket affixed to the box). The HUBER 360 MD is a nonmobile device and must be connected by an approved installation expert in accordance with all local/national regulations.

• Before any electrical installation work is undertaken, the electrical current must be disconnected.

• Ensure that a differential device (detecting the DC and AC components from a frequency inverter) is installed on the circuit upstream from the machine.This must comply strictly with all appropriate safety regulations and restrictions.

• Ensure that the circuit-breaker rating is in correct correspondence to the HUBER 360 MD

(the upstream circuit breaker must be rated higher than the machine).

Place the wall connection box (with isolating cover) as close to the main electrical supply as possible for a permanent connection to the HUBER 360 MD. Do not connect with a standard removable plug and socket.

• Locate the electrical system neutral, ensuring that the voltage on the neutral to ground is close to 0 V.

• Ensure the correct wiring of the phase, earth and neutral in the HUBER 360 MD.

• When the connection is completed, re-connect the electrical current and start the

HUBER 360 MD by activating the on/off circuit breaker.

• Ensure that the HUBER 360 MD is activated and functioning correctly.

• The unit must be connected to a dedicated single power line.

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HUBER 360 MD

CABLE

FIXED

CONNECTION

STANDARD

CONNECTION

FIXED CONNECTION (HUBER360 MD)

ET STANDARD CONNECTION (PROHIBITED)

INSTALLATION

COMPLETED

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WARNING

TO>MINIMIZE>THE>RISK>OF>BURNS,>FIRE,

ELECTRIC>SHOCK,>OR>PERSONAL>INJURY:

• The device should never be left unattended while plugged in.

• Unplug the device when not in use for a long period of time or before installing or removing parts.

• Carefully monitor the device when it is used by, on, or around children or disabled individuals.

• Never use this device if the power cord 1 or outlet is damaged, if it is not working properly, if it has been dropped, or if it has been exposed to excessive moisture.

• Return the device to the LPG Systems service center for examination and repair.

• Do not move the device by pulling on its power cord.

• Never use the device if the vents are blocked. Keep openings free of dust and other contaminants.

• Do not drop or insert any objects into any of the openings. This could damage the machine.

• Do not use the device on a dirt or uneven floor or in a humid or salty environment, and do not expose it to bad weather.

• Do not use the device around aerosol (sprays) or oxygen products.

• Never touch the patient and the unprotected connection cables at the same time.

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≥ W A R N I N G

1 Provided power cord information:

Europe H05VVF3G1,50

Japan VCTF3×2,00

USA, Canada, Mexico SJT3×14AWG1,5

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PRECAUTIONS

WARNING>:>KEEP>THESE>INSTRUCTIONS

• As with any physical training, a medical examination should be performed before using the equipment.

• The professional should ensure that the settings (platform oscillation speed, amplitude, activity/rest duration, etc.) are correct for the user’s morphology and physical condition.

• The equipment should be used under careful supervision by a trained professional.

• Users should warm up properly before using the equipment for exercise.

• Users should breathe regularly while exercising.

• Using this equipment with maximum effort is not recommended while the platform is moving.

• The user should stop immediately if experiencing any discomfort during exercise.

• Do not operate the unit in unsuitable environmental conditions (see technical specifications).

• When using the articulated stool, the user’s feet should rest on the wooden platform, not on the base of the articulated stool.

• As its name implies, the emergency shutoff button should be used only in emergencies.

• The tablet should only be used by a trained professional near the machine.

• This symbol means “High Voltage”:

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WARNINGS

• The equipment should not be used by anyone with heart, respiratory, neurological, or rheumatic disease who is advised against physical activity.

• In the case of regaining fitness, maintenance and preventative activity, the patient should be medically certified to undertake physical activity.

• Due to the risk of possible interference, it is important that the professional ensure that the patient is not fitted with a personal medical equipment, such as a pacemaker or a hearing aid.

• If this is the case, determine with certainty whether the equipment in question emits a signal that may interfere with the functioning of the unit.

• The unit must not be used by someone with a medical condition unless accompanied at all times by a qualified professional certified to the standards of the country of use.

• In the case of therapy, a diagnostic assessment performed prior to using the unit provides the following indications and contraindications:

- Swollen joints

- Acute rheumatism

- Recent trauma

- Musculoskeletal infection

- Fever

- Vein thrombosis

- Acute discopathy

- Neuropsychological problems that prevent an understanding of the instructions

or other serious psychological problems

- Cardiovascular disease or any progressive or chronic condition that

contraindicates exercise

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≥ W A R N I N G

This machine contains programs meant to guide the user in order for them to obtain the best possible results that can be expected in their case. This in no way guarantees that the therapy will be successful. Success varies according to each user’s morphology and physiology.

It is strictly prohibited to modify your unit without the authorization of LPG.

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ELECTROMAGNETIC COMPATIBILTY

For more information on electromagnetic compatibility, refer to “Electromagnetic

Compatibility” in the appendix.

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CLEANING THE DEVICE

You should clean your device as often as possible, not only for hygienic purposes and attractiveness, but also because cleaning helps maintaining it in good working order and prolong its life:

• Use a damp sponge to clean the outside of all covers.

• Use a wipe impregnated with cleansing and disinfectant solution to clean the handles and the platform.

• Use a screen wipe impregnated with bactericide and antistatic solution to clean the dashboard.

• Use a vacuum cleaner with a narrow attachment to clean the platform and the inside of the accessory positioning recesses.

• For technical problems, please refer to Chapter 5 “Troubleshooting”

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IDENTIFICATION NAMEPLATE

SERIAL NUMBER

VOLTAGE AND FREQUENCY

≥ W A R N I N G

The identification plate could be modified. The identification plate apposed under your device is the approved identification plate.

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IDENTIFICATION NAMEPLATE

(CONT.)

The identification nameplate is located on the back of your device.

The nameplate indicates the voltage of the device and the serial number to identify your device. When contacting LPG Systems customer service for a technical problem, please provide the serial number of your HUBER 360 MD.

This serial number gives you the year and month of manufacture of your device.

The letter indicates the year of manufacture: A=2010, B=2011…, E=2014,…

The two digits indicate the production month: 01=January, 02=February,

03=March…

This symbol means that the unit was sold after August 13, 2006. In conformity with the 2002/96/EC directive, it cannot be thrown away with standard household waste but must be disposed of in an appropriate sorted collection. When your device reaches the end of its useful life, it must be brought to an appropriate recycling center or returned to your dealer. By doing so, you help the environment by contributing to the conservation of natural resources and the protection of human health.

This symbol means that some specific warnings or precautions associated with this device are not on the label.

allowed weight of the operator of the device is 140 kg.

This symbol indicates the name and address of the manufacturer

This symbol means that your unit has BF parts that come into contact with the patient. They are electrically isolated from all other parts of the unit.

These parts are the handlebars and the platform.

This symbol means store the device somewhere protected from inclement weather.

This symbol indicates temperature limits.

This symbol means carefully read the accompanying document before using the device.

This symbol indicates relative humidity limits.

This symbol means that the maximum

This symbol means ”Danger: High

Voltage”

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POWER CORD

If the power cord of your device is damaged, please contact LPG Systems

Customer Service for a replacement:

LPG Systems Customer Service

+33 (0)4 75 78 69 89

NOTES

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TROUBLESHOOTING

If your unit is not working properly, please run through the following checklist before calling LPG Systems Customer Service:

• Is the unit properly connected to a power outlet?

• Is the power outlet live?

• Is the power switch in the ON position?

• Is the emergency stop button pressed? If so, turn off the power, release the emergency stop button, and then restart the machine.

• For the symptoms listed below, stop the machine and wait 60 seconds before restarting:

- Error message displayed on the screen;

- Screen not working;

- Excessive weight applied to the platform during exercise;

- Fault on the sensor.

Once these checks have been completed and if the problem persists, please contact LPG Systems Customer Service or the nearest authorized dealer, indicating the model of your unit and its serial number.

LPG Systems Customer Service

+33 (0)4 75 78 69 89

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TECHNICAL SPECIFICATIONS

• General Features

Dimensions l x w x h . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 cm x 105 cm x 210 cm

(133 cm with the guardrails)

Net weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285 kg

Maximum weight allowed on the platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 kg

• Electrical Features

Voltage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200 - 240V

Rated frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 Hz / 60 Hz

Power consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . Long-time : 750VA - Momentary : 1800VA

• Platform Movement

Maximum oscillation frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 tr/sec

Maximum amplitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10°

• Force Measurement

Handle measurement scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0 to 85 kg

• Weight measurement

Measurement range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0 to 165 kg

• User Replaceable Batteries

Heart rate monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 pile 3V CR2032

• Surrounding environment restrictions

Operating temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . + 10°C to + 30°C

Storage temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - 20°C to + 70°C

Ambient relative humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 to 75% without condensation

Atmospheric pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .no significant influence for operation

Max altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2500 m

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TECHNICAL SPECIFICATIONS

(CONT.)

Device designed for uninterrupted use.

Huber 360 MD is marked as a medical device under appendix II of the 93/42/

EC directive (consolidated version including the 2007/47/EC Directive).

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TERMS AND CONDITIONS OF THE WARRANTY

You have just purchased a device distributed by LPG Systems or an LPG Systems authorized distributor. The purchaser/operator is responsible for checking with the local government to ensure that all professional qualifications and conditions have been met for using this device.

The purchase of this unit implies full legal acceptance of these general terms and conditions of the warranty by the purchaser/ professional operator.

If the unit was sold by an authorized agent of LPG Systems, the purchaser must refer to the supplier’s general warranty conditions, which will in no circumstances increase the commitment made under this warranty. It is the purchaser’s responsibility to return the properly filled out warranty voucher to LPG SYSTEMS. This will facilitate faster repairs. Any warranty vouchers that have not been completely filled out will be returned by LPG SYSTEMS.

This device is guaranteed against any manufacturing defect. Beyond the legal warranty, the commercial warranty lasts as long as the shorter of the two following periods: one (1) year OR two thousand (2000) hours of use since the billing date.

During this period, we undertake to exchange or repair, free of charge and as quickly as possible, any part acknowledged by us as being defective, without necessarily replacing the entire unit.

Exchanges or repairs covered by the warranty that lead to the machine being out of service will cause the warranty to be extended in proportion to the length of time that it is out of service. The replaced parts become the property of LPG Systems or the authorized dealer. No compensation can be awarded for loss of use.

The purchaser/operator is obliged to give us the time and means required to proceed with any repairs and/or deliveries to replace spare parts, failing which we are released from our warranty obligations. Only the courts located in the area of the LPG Systems registered head office have jurisdiction in the event of disagreement, despite any clause allocating a different jurisdiction that may appear on any document to the contrary.

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The warranty is also suspended in the event of:

• Damage occurring during transport. The device and/or parts are shipped at the recipient’s risk.

• Before accepting the delivery, the recipient is responsible for checking the condition of the device and/or parts and, if necessary, stating any claims using the applicable forms and deadlines for the country of delivery.

• Non-compliance with the rules of installation and use, improper maintenance, and/ or failure to carry out maintenance of the unit, or connection to an electric supply line which is faulty, ungrounded, or of a different voltage than that indicated on the unit.

• If a device is sold before the end of the warranty, the remainder of the warranty will be transferred to the new owner, provided that:

1. The original invoice is transferred to the new owner.

2. The original seller is informed of the sale.

• Modification, fitting accessories, or dismantling the unit.

• Any use and/or intervention not provided for in this LPG Systems Operator’s Manual, carried out by the purchaser/operator and/or a third party not authorized by LPG

Systems.

• The use of inappropriate components, consumables, or parts not supplied by LPG

Systems.

• Normal wear and tear of one or more parts of the device resulting from normal operation.

• Being dropped, suffering an impact, lightning, fire, an act of God, water damage, and natural disaster.

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LIMITATIONS AND EXCLUSIONS

Non-compliance with the general warranty conditions during the term of the warranty and following its expiry can exonerate LPG Systems of any responsibility in the event of damage attributable to the products supplied.

LPG Systems cannot be held responsible for any property damage or consequential loss, of any nature whatsoever, or for any losses suffered of any kind (financial, commercial, image, etc.) that are the direct or indirect consequence of a malfunction and/or non-conforming use of the device.

In any event, if LPG Systems is found to be responsible for a device that is sold and/or services that are performed, the maximum amount of damages and interest for which either or both party may be liable will not exceed the price that the purchaser paid for the device and/or service.

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WARRANTY FORM

YOU CAN ACTIVATE YOUR WARRANTY ONLINE AT : http://warranty.lpgsystems.com

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OR FILL IN THE FORM AND RETURN TO LPG SYSTEMS

®

Name * : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Address * : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Country * : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Phone * : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

E-mail: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Type of establishment: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Profession: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Type of unit: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Serial number HUBER 360 MD * : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Date: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The personal data collected in this form are sent to LPG Systems, which is responsible for processing it in order to manage customers relations, including after-sales service and warranties. Information with an asterisk must be provided in order for this form to be processed. According to modified French law 78-17 from January 6, 1978 relating to computers, digital files, and freedoms, also known as the “Informatique et Libertes” law, you have a right of access, rectify, and remove personal data about you by contacting LPG

Systems in writing at the following address:

LPG SYSTEMS – 30, rue Dr Abel – CS90035 - Technoparc de la Plaine – 26000 VALENCE

(FRANCE).

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APPENDIX: ELECTROMAGNETIC COMPATIBILITY

TABLE 1: DIRECTIVES AND MANUFACTURER DECLARATION – ELECTROMAGNETIC EMISSIONS

HUBER 360 MD is intended for use in the electromagnetic environment specified below. The HUBER 360 MD customer or patient should ensure that it is used in such an environment.

Emissions test Conformity Electromagnetic Environment - Directives

RF emissions CISPR 11 Group 1

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations and flicker IEC 61000-3-3

Class B

Class A

Conforms

HUBER 360 MD uses RF energy only for its internal functions.

Therefore, its RF emissions are very low and unlikely to cause interference in nearby electronic devices.

HUBER 360 MD may be used in all establishments, including domestic sites and sites that are directly connected to the low voltage public power grid, which supplies domestic buildings.

TABLE 2: DIRECTIVES AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY – EMISSIONS TESTS

HUBER 360 MD is intended for use in the electromagnetic environment specified below. The HUBER 360 MD customer or patient should ensure that it is used in such an environment.

Emissions test Conformity Conformity Electromagnetic Environment - Directives

Electrostatic discharge (ESD)

IEC 61000-4-2

Fast transient/burst

IEC 61000-4-4

± 6 kV on contact

± 8 kV in the air

± 6 kV on contact

± 8 kV in the air

Flooring should be made of wood, concrete, or ceramic tile.

If the floor is covered with synthetic material, relative humidity should be at least 30%.

The quality of the electrical power network should be equivalent to that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

± 2 kV for electrical power lines

± 1 kV for input/output lines

± 1 kV between phases

± 2 kV between phase and earth

± 2 kV for electrical power lines

± 1 kV for input/ output lines

± 1 kV between phases

± 2 kV between phase and earth

The quality of the electrical power network should be equivalent to that of a typical commercial or hospital environment.

The quality of the electrical power network should be equivalent to that of a typical commercial or hospital environment. If the HUBER

360 MD patient requires operation to continue during power outages, the HUBER 360 MD should be powered through an uninterruptible power supply or a battery.

Voltage dips, short interruptions, and voltage variations

IEC 61000-4-11

<5% UT

(>95% voltage dip) during 0.5 cycle

40% UT

(60% UT voltage dip) during 5 cycles

70% UT

(30 % UT voltage dip) during 25 cycles

<5% UT

(>95% voltage dip) during 5s

<5% UT

(>95% voltage dip) during 0.5 cycle

40 % UT

(60% UT voltage dip) during 5 cycles

70% UT

(30 % UT voltage dip) during 25 cycles

<5% UT

(>95% voltage dip) during 5s

Power frequency magnetic field

IEC 61000-4-8

3 A/m 3 A/m

NOTE: UT is the AC voltage prior to the application of the test level.

Power frequency magnetic fields should have levels that are characteristic of a typical hospital or commercial environment.

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APPENDIX: ELECTROMAGNETIC COMPATIBILITY

TABLE 3: DIRECTIVES AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY – IMMUNITY TESTS

HUBER 360 MD is intended for use in the electromagnetic environment specified below. The HUBER 360 MD customer or patient should ensure that it is used in such an environment.

Immunity

Test

Test level according to IEC

60601

Conformity level

Electromagnetic environment - directives

Conducted RF disturbances

IEC 61000-4-6

Perturbations

RF rayonnées

CEI 61000-4-3

3 Veff

150 kHz to 80 MHz

3 V/m

De 80 MHz to 2,5 GHz

3V

3 V/m

Portable and mobile RF communications devices should not be used closer to any part of the HUBER 360 MD, including its cables, than the recommended separation distance, calculated from the applicable equation on transmitter frequency.

Recommended separation distance: d = 1.2√P d = 1.2√P 80 MHz at 800MHz d = 2.3√P 800 MHz at 2.5 GHz where P is the transmitter’s maximum power output in watts (W), according to the transmitter’s manufacturer, and d is the recommended separation distance in meters (m).

The field strength for fixed RF transmitters, as determined by an electromagnetic survey at site a , should be less than the conformity level for each range of frequencies b .

Interference may be produced near the device marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the highest frequency range applies. NOTE 2: These directives may not apply in all situations.

Electromagnetic propagation is affected by absorption and by reflections of structures, objects, and people.

a The field strength of fixed transmitters, such as radio/telephone (cellular/wireless) base stations and land mobile radios, amateur radios,

AM and FM radio broadcasting, and TV broadcasting cannot be theoretically predicted with accuracy. To measure the electromagnetic environment due to fixed RF transmitters, consider performing an electromagnetic survey of the site. If the field strength, measured where the HUBER 360 MD is used, exceeds the applicable RF conformity level above, watch the HUBER 360 MD to ensure that it is operating as normal.

If there is any abnormal performance, additional measures may be necessary, such as reorienting or repositioning b the HUBER 360 MD.

For the frequency range of 150 kHz to 80 MHz, field strength should be less than 3 V/m.

TABLE 4: RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION DEVICES

AND HUBER 360 MD

HUBER 360 MD is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The HUBER 360

MD patient or customer can prevent electromagnetic interference by maintaining a minimal distance between the portable or mobile RF communications device (transmitter) and the HUBER 360 MD, as recommended below, based on the maximum transmission power of the communication device.

Maximum rated output of the transmitter W

0,01 d=1,2√P

0,12

Separation distance according to the transmitter frequency m d=1,2√P

0,12 d = 2,3√P

0,23

0,1

1

10

100

0,38

1,2

3,8

12

0,38

1,2

3,8

12

0,73

2,3

7,3

23

For transmitters whose maximum rated output is not shown above, the recommended separation distance d in meters (m) can be estimated using the applicable equation for the transmitter frequency, where P is the transmitter’s maximum output in watts (W), according to its manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the highest frequency range applies.

NOTE 2: These directives may not apply in all situations.

Electromagnetic propagation is affected by absorption and by reflections of structures, objects, and people.

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HEADQUARTERS LPG SYSTEMS S.A.

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