Lode Valiant 2 Pediatric Manual de usuario

Manual - Valiant 2

Pediatric

Lode BV

Zernikepark 16

NL 9747 AN

Groningen

The Netherlands

t: +31 50 571 28 11

f: +31 50 571 67 46

@: ask@lode.nl

www.lode.nl

M938904_MANUAL VALIANT 2 PEDIATRIC / VERSION: V1.1 - 2016-08-25

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Table of contents
1 - Intended Use1 - Intended Use
2 - Precautions2 - Precautions
3 - Contra Indication3 - Contra Indication
4 - Definition of parts4 - Definition of parts
5 - Validity5 - Validity
6 - Install your treadmill6 - Install your treadmill
7 - Maintenance7 - Maintenance
7.1 - Emergency stop installation
8 - Troubleshooting8 - Troubleshooting
8.1 - Belt alignment
9 - Cleaning9 - Cleaning
10 - Control with an External Device10 - Control with an External Device
11 - Control with the Lode Ergometry Manager (LEM)11 - Control with the Lode Ergometry Manager (LEM)
12 - List of symbols used12 - List of symbols used
13 - Electromagnetic Compatibility (EMC)13 - Electromagnetic Compatibility (EMC)
14 - Specification remarks14 - Specification remarks
15 - Accessories15 - Accessories
16 - Specifications16 - Specifications

1 - Intended Use

This device is intended to be used as a stress test device in a medical environment. The main goal of

the use of the devices is to create reproducible stress tests. With cycling ergometers typically workload

(watt) is imposed. With treadmills typically speed (km/h) and inclination (% grade) are imposed. This

product is designed both for manual operation and for control by external ECG-, pulmonary

equipment. Most likely this device will be used in conjunction with another medical device to obtain

other important physiological data, allowing a physician to evaluate a test subjects physical status.

The product may also be used for rehabilitation or active aging therapy.

As such the intended use of the device solely cannot be defined specifically.

The device has to be operated under the supervision of well-trained medical specialists in the field of

use.

The ultimate judgment whether a test subject should undertake a stress test with the device must be

made by the responsible medical specialist, based on the limitations of each individual, the medical

history and all other applicable circumstances. Neither the manufacturer nor its distributors assume

any responsibility for the final use of its equipment.

2 - Precautions

Read this manual before using the device and follow it

carefully.

The operator should instruct the test subject prior to

performing an exercise protocol. If, at any time during

exercise, the test subject feels faint, dizzy, or experiences

pain, stop the test and he or she should be consulted by the

physician.

Care should be taken in mounting or dismounting the

ergometer. Be aware of feet when replacing the ergometer.

The operator should not touch accessible parts and the

patient simultaneously.

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The test subject should always wear the belt of the lanyard

safety belt.

Replacement of the power supply cord should be installed by

authorised service personnel, instructions for correct

connection and anchoring must be ensured, securing that

the requirements of clause 8.11.3 of IEC 60601 1:2005 are

met.

Set up and operate the device on a solid level surface.

The test subject should not wear loose or dangling clothing

while using the device.

Service of this device is restricted to factory trained

personnel only.

Do not jump onto the rotating belt. Do not jump off the

rotating belt (not even to the front). Do not stop moving on

the running belt. Do not turn around on the running belt. Do

not move sideways or backwards. Do not make movement

that could get you out of balance.

The test subject shall wear clothes when using the harness or

the lanyard belt to prevent skin irritation.

Replacement of parts can only be done by the manufacturer

or designated service personnel.

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Read all warnings posted on the device.

Inspect the device for worn or loose components prior to

use. Tighten / replace any loose or worn components prior to

use.

Do not place any loose parts or objects on the device before

and during use.

The equipment has a safety earth (ground) connection and

must be connected to a (grounded) wall socket with

protective earth to avoid the risk of electric shock. The

functional earth connection is for potential equalisation only.

The operator must keep away from the footrail while

lowering.

The test subject should wear proper sports or running shoes

(no spikes).

If this equipment is modified, appropriate inspection and

testing must be conducted to ensure continued safe use of

the equipment.

Cleaning and user maintenance shall not be made by

children without supervision.

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Children being supervised are not to play with the appliance.

Children shall not play with the appliance.

Heart rate monitoring systems may be inaccurate. Over

exercise may result in serious injury or death. If the test

person feels faint stop exercising immediately.

Keep away from the rollers.

No modification of this equipment is allowed.

Not suitable for use in the presence of flammable

anaesthetics.

The appliance is not to be used by persons (including

children) with reduced physical, sensory or mental

capabilities, or lack of experience and knowledge.

The test subject should wear proper sports clothing. The

operator should check possible entrapment of clothing,

fingers or feet, before the start of an exercise test.

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This appliance can be used by children aged from 8 years

and above and persons with reduced physical, sensory or

mental capabilities or lack of experience and knowledge if

they have been given supervision or instruction concerning

use of the appliance in a safe way and understand the

hazards involved.

This device should only be sold by, or under the supervision

of authorized persons.

Your device may be executed with heart rate measurement,

blood pressure measurement, and / or SpO2 (blood

saturation) measurement. These measurements may be

inaccurate, depending on use circumstances. These

measurements are indicative and cannot be used for

diagnostic purposes.

3 - Contra Indication

The device is to be operated by classified personnel only. As stated in the intended use, the device is

intended to be used in a medical environment. During the intended use the test subject will deliver

energy. Application of the wrong dosis of energy could lead to permanent damage of the test subject

health. Only use this device under supervision of a medical physician.

4 - Definition of parts

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1. Service Connector

2. Communication Interface

Module (CIM)

3. On/Off switch

4. Equipotential bonding plug

5. Safety symbols tag

6. Serial number tag

7. Motor compartment for

height adjustment and drive

8. Height adjustment (optional)

9. Walking surface (APPLIED

PART)

10. Front bar

11. Connector for external

emergency stop

12. Magnetic contact for safety

belt

5 - Validity

This manual covers all VaIiant 2 Pediatric versions starting with the following serial number:

938904 Valiant Pediatric: S/N 20140001

Date of issue: June 14

6 - Install your treadmill

1. While unpacking the Lode treadmill ergometer, leave the transport straps on both ends in place.

2. Place the treadmill in the location where it will be used.

3. Remove Both transport straps and remaining packaging materials.

4. The power supply cord should be installed by authorised service personnel and instructions for

correct connection and anchoring must be ensured, securing that the requirements of clause 8.11.3 of

IEC 60601-1:2005 are met.

5. Remove all objects from the walking surface.

6. Switch on the unit with the on/off button and wait until the self-test is carried out. The product is

ready for use after you have heard a series of “beeps”.

8/21M938904_MANUAL VALIANT 2 PEDIATRIC / VERSION: V1.1 - 2016-08-25

7 - Maintenance

7.1 - Emergency stop installation

When your treadmill is delivered with an emergency stop, please note

the following:

The plug of the emergency stop button needs to be placed in the back

connector of the console on the front handrail.

Some emergency stop buttons have a connector for another emergency

stop. You can place the spare dummy there in case you have one

button.

Also make sure that the magnet of the emergency lanyard is connected to the console.Otherwise the

treadmill will not operate.

Maintenance should be carried out on a regular and planned basis. We recommend to check the unit

annually. This may be done by your local dealer. It is also recommended that a record of the service

history is kept for all activities relating to service and maintenance.

Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will

not be held responsible for the results of maintenance or repairs by unauthorized persons.

The check up and/or technical maintenance must be carried out conform the procedure described in

the service manual of the unit.

Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to

warranty.

Lode will make available on request circuit diagrams, component part lists, descriptions, calibration

instructions, or other information that will assist authorized service personnel to repair those parts of

the ergometer that are designated by Lode as repairable by authorized service personnel.

8 - Troubleshooting

For a complete overview of possible error message and the solutions belonging to these messages,

please consult the service manual of the ergometer.

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8.1 - Belt alignment

Place the allen key on the left

bolt while standing behind the

treadmill as shown on the

picture.

Adjusting the belt tension is

very easy with the key on the

left side. Turning the key

clockwise will make the belt

move to the right side of the

treadmill. Turning the key

counterclockwise will make the

belt go left.

The red marked area shows where you can check the belt alignment. The goal is to align the belt edge

exactly in the center of the hole.

10/21M938904_MANUAL VALIANT 2 PEDIATRIC / VERSION: V1.1 - 2016-08-25

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