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1 - Intended Use

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

Lode 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. A Lode 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. 

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 Lode BV nor its distributors assume any responsibility for the final use of its

equipment.

2 - Precautions

2 - Precautions

 

 

 

 

 

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.

Before each use, inspect the vest for damage. Do not use if the integrity is questionable.

The test subject should not wear loose or dangling clothing while using the device.

The test subject should always wear the belt of the lanyard safety belt.

Read all warnings posted on the device.

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M938925 / VERSION: 1.0 - 2015-01-09

Содержание 938925

Страница 1: ...Manual Valiant Ultra Sports Medicine 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 M938925 VERSION 1 0 2015 01 09...

Страница 2: ...cation 4 Validity 5 Definition of parts 6 Installation 6 1 Emergency stop installation 7 Control with an External Device 8 Control with Control Unit 9 Control with the Lode Ergometry Manager LEM 10 Ma...

Страница 3: ...ialists 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 e...

Страница 4: ...device is restricted to factory trained personnel only If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of the equipment Set up and oper...

Страница 5: ...prevent skin irritation This device should only be sold by or on the order of authorized persons No modification of this equipment is allowed The physician should instruct the test subject prior to p...

Страница 6: ...treadmill the subject needs to be instructed never to use the brake It is advised to disable brakes on the bike When using skates or skeelers subjects must be instructed not to assume the braking pos...

Страница 7: ...e 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 e...

Страница 8: ...Height adjustment positive 25 optional 21 Height adjustment negative 25 optional 22 Wheelchair guidance optional 23 Side bar optional 24 Network module optional 25 Floor protection frame optional 6 In...

Страница 9: ...it select Terminal mode to allow external commands When the device does not have a control unit the terminal mode is automatically selected See for detailed instructions the user manual of your extern...

Страница 10: ...inate 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 per...

Страница 11: ...ants concerned Class I MEDICAL EQUIPMENT Type B Electrical Safety IEC 60601 1 Trapping zone Warning do not jump onto the rotating belt Do not jump off the rotating belt not even to the front Do not st...

Страница 12: ...art rate for treadmills Partnumber 945820 Heart rate in beats per minute Heart rate for treadmills Programmable Control Unit with 7 touch screen for Partnumber 945815 Programmable Programmable Control...

Страница 13: ...ce yes Readout Speed yes Readout Energy yes Readout Time yes Set Display yes Customized Screenviews yes Manual operation mode yes Quick start operation mode yes Touchscreen yes Connectivity Lode 38K4...

Страница 14: ...tional non condensing humidity 90 Minimum operational non condensing humidity 30 Maximum storage transport temperature 70 C Minimum storage transport temperature 25 C Maximum storage transport air pre...

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