Enraf-Nonius Cardio Bike Reha User manual

EN109-1413760-45

BIKE REHA

Instructions for Use

EN109-1413760-45

Copyright:

Enraf-Nonius B.V.

Vareseweg 127

3047 AT Rotterdam

The Netherlands

Tel: +31 (0)10 – 20 30 600

Fax: +31 (0)10 – 20 30 699

[email protected]l

www.enraf-nonius.com

Part number: EN109-1413760-45

August 21, 2018

 
EN109-1413760-45 
 
 
TABLE OF CONTENTS 
 
INTRODUCTION ............................................................................................................................................................. 1 
SYMBOLS .......................................................................................................................................................................... 2 
PACKAGE CONTENTS .................................................................................................................................................. 3 
SETUP ................................................................................................................................................................................. 4 
USING THE DEVICE ....................................................................................................................................................... 5 
OPERATION ................................................................................................................................................................... 10 
MAINTENANCE ............................................................................................................................................................ 23 
ORDERING INFORMATION ..................................................................................................................................... 24 
SPECIFICATIONS .......................................................................................................................................................... 25 
PRODUCT LIABILITY ................................................................................................................................................... 26 
 
 

1 of 26

EN109-1413760-45

1 INTRODUCTION

Thank you for purchasing the Enraf-Nonius Bike Reha.

This bicycle ergometer is intended for stationary cycling and to help you treat patients in the field of

physical medicine and rehabilitation.

We hope that this will be a valuable device in the execution of your profession and that it will improve

the health and quality of life of many people.

It is important to read the Instructions for Use carefully before using your Bike Reha.

The manufacturer cannot be held responsible for the results of using this device

for any purposes other than described in the Instructions for Use.

If any serious event occurs in relation to this device, this event should be reported to

Enraf-Nonius and to your local Competent Authority!

2 of 26

EN109-1413760-45

2 SYMBOLS

Follow the instructions in the Instructions for Use.

It is important that you read, understand and observe the precautionary and operating

instructions

Warning:

Indicates that there is a certain form of danger.

Describes the dangers that can lead to personal injury or death.

Caution:

Indicates that there is a certain form of danger.

Describes the dangers that can lead to damage to a product, including the chance of data

loss.

Product is in conformity with European Council of Medical Device Directive (93/42/EEC).

Name and contact information of the manufacturer and production date.

Reference or model number

Serial number, used for identification of the device.

Indicates Type B applied parts.

No electrical contact with Patient and may be earthed.

Indicates the range of atmospheric pressure to which the medical device can be safely

exposed.

Indicates the range of humidity to which the medical device can be safely exposed.

Indicates the temperature limits to which the medical device can be safely exposed.

This is an electronic or electrical device. Dispose of this product according to local

regulations. This will help to recycle

Fuse properties

Emergency stop button

2x T6.3 250VAH

3 of 26

EN109-1413760-45

3 PACKAGE CONTENTS

With your Bike Reha (art.nr. 1413921) or Bike Reha with adjustable cranks (art.nr. 1413922) you will

find enclosed:

1x 1413768 Instructions for Use (PDF on CD)

1x 1413764 Information Booklet

1x 3444298 Power cord

Use of accessories and cables other than those specified or provided by the manufacturer of

this equipment is NOT allowed.

4 of 26

EN109-1413760-45

4 SETUP

No specific installation activities are required that would require the assistance of a technician

authorized by Enraf-Nonius.

UNPACKING

The unit weighs approximately 55 kg.

We advise you to unpack the device with at least 2 persons.

INSPECTION

Immediately upon unpacking the unit, check if the package contains all items listed above in the

package contents and check the device for any damage.

SETUP

Level the device by adjusting the rubber feet for optimal stability.

The connection for the mains cable is located at the rear, on the underside of the frame.

After the mains cable has been connected, switch on the device by using the switch located next to

the mains cable connection.

The Bike Reha is now ready for use.

In case of damage, contact your local distributor. Do NOT use the device!

To avoid the risk of electric shock, this equipment must only be connected to a mains supply

with protective earth.

No unauthorized modification of this equipment is allowed.

Check the technical data section to make sure the mains supply complies with the technical

specifications of the device.

Check the technical data section to make sure the environment complies with the

environmental conditions for use of the device.

Do not install the device next to a heat source or in “wet-rooms” or hydrotherapy rooms

Avoid exposure to direct sunlight.

5 of 26

EN109-1413760-45

5 USING THE DEVICE

INTENDED USER AND INTENDED USE

This Bike Reha is intended for stationary cycling and to help you treat patients in the field of physical

medicine and rehabilitation. It is up to you as the professional user to consider the possible benefits

and potential hazards of providing such treatment to the individual patient.

INDICATIONS

The Bike Reha, for example, can be used for patients that need improving or maintaining

cardiovascular and respiratory capacity / fitness or regain or maintain muscle strength.

It is the professional user who shall decide for which indications the device is used.

CONTRA-INDICATIONS

You, as the professional user, shall decide for which indications the devices can and cannot be used.

Every patient shall be screened by a self-reported medical history or health risk appraisal

questionnaire. The need and degree of follow-up is determined by the answers to these self-guided

methods.

Patients diagnosed with the following disease, should consult with their physician prior to initiating a

physical activity program. Therefore these are considered to be contraindications for using the cardio

device;

• Cardiovascular disease: Cardiac, peripheral vascular, or cerebrovascular disease.

• Pulmonary: COPD, asthma, interstitial lung disease, or cystic fibrosis.

• Metabolic: Diabetes mellitus (Types 1 and 2) or renal disease.

The Bike Reha is intended to be used, and shall ONLY be used, by or under the supervision of

professional users in the field of physical medicine and rehabilitation.

When using this product, always bear in mind the possible hazards of the treatment you are

providing.

6 of 26

EN109-1413760-45

Patients reporting or showing the following symptoms, should consult with their physician prior to

initiating a physical activity program and are therefore considered to be contraindications for using

the cardio device;

• Pain, discomfort in the chest, neck, jaw, arms or other areas that may result from ischemia

• Shortness of breath at rest or with mild exertion

• Dizziness or syncope

• Orthopnea or paroxysmal nocturnal dyspnea

• Ankle edema

• Palpitations or tachycardia

• Intermittent claudication

• Known heart murmur

• Unusual fatigue or shortness of breath with usual activities

Individuals at moderate risk with two or more CVD risk factors from the list below, should be

encouraged to consult with their physician prior to initiating a vigorous intensity, physical activity

program. These risk factors include:

• You are a man ≥45 yr

• You are a woman ≥55 yr

• You smoke or quit smoking within the previous 6 months

• Your blood pressure is ≥140/90 mm Hg

• You do not know your blood pressure

• You take blood pressure medication

• Your blood cholesterol level is ≥200 mg ∙ dL -1

• You do not know your cholesterol level

• You have a close blood relative who had a heart attack or heart surgery before age 55 (father

or brother) or age 65 (mother or sister)

• You are physically inactive (i.e., you get <30 min of physical activity on at least 3 d per week)

You have a body mass index 30 kg ∙m-2

• You have prediabetes

• You do not know if you have prediabetes

7 of 26

EN109-1413760-45

When performing exercise testing with the device, consider all the information above and moreover

consider absolute and relative contraindications for exercise testing like;

Absolute

• A recent significant change in the resting electrocardiogram (ECG) suggesting significant

ischemia, recent myocardial infarction (within 2 d), or other acute cardiac event

• Unstable angina

• Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise

• Symptomatic severe aortic stenosis

• Uncontrolled symptomatic heart failure

• Acute pulmonary embolus or pulmonary infarction

• Acute myocarditis or pericarditis

• Suspected or known dissecting aneurysm

• Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands

Relative

• Left main coronary stenosis

• Moderate stenotic valvular heart disease

• Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia)

• Severe arterial hypertension (i.e., systolic blood pressure [SBP] of >200 mm Hg and/or a

diastolic BP [DBP] of >110 mm Hg) at rest

• Tachydysrhythmia or brady dysrhythmia

• Hypertrophic cardiomyopathy and other forms of outflow tract obstruction

• Neuromotor, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise

• High-degree atrioventricular block

• Ventricular aneurysm

• Uncontrolled metabolic disease (e.g., diabetes, thyrotoxicosis, or myxedema)

• Chronic infectious disease (e.g., HIV)

• Mental or physical impairment leading to inability to exercise adequately

Source: American College of Sports Medicine. ACSM's guidelines for exercise testing and prescription. 9th edition.

Philadelphia :Lippincott Williams & Wilkins.

8 of 26

EN109-1413760-45

GETTING STARTED

1 Saddle height adjustment

2 Horizontal adjustment - saddle

3 Horizontal adjustment – handle bar

4 Vertical adjustment – handle bar

HEART RATE REGISTRATION

Heart rate registration or training is only possible with the optional Polar chest belt.

The belt works best if the transmitter is worn against the bare skin and slightly moistened.

Allow sufficient distance (at least 1.5 m.) between users.

Adjust the saddle and handle bar to position the patient in the right way to avoid injuries.

9 of 26

EN109-1413760-45

PRECAUTIONS

Do not remove any parts of the device as this might result in exposing internal parts and

introducing the risk of electric shock.

Never insert your hand under the cover!

In the event that an error message or warning appears or other obvious defects arise

immediately stop all use of the unit and contact the supplier or Enraf-Nonius B.V. for service.

Before starting any training or test, please make sure the patient is screened thoroughly and

you are sure there will be no adverse effects for the health of your patient.

Always provide the patient with clear information about the training or test. State the purpose

of the training or test, what is going to happen and what is expected of the person concerned.

When you want the patient to operate the device (under your supervision), always provide

sufficient instructions for correct operation.

Make sure that the various adjustable parts (saddle, handlebar) are firm and tight.

If general faults, fluctuations in resistance or faults in the control panel occur then stop the

training immediately and switch off the device.

Use of accessories and cables other than those specified or provided by the manufacturer of

this equipment is not allowed.

Keep unsupervised children away from the training equipment at all times.

The apparatus should only be used by patients within the permissible weight range as

indicated in the technical specifications (see chapter 9).

10 of 26

EN109-1413760-45

6 OPERATION

The bike is equipped with a touchscreen and a rotary knob. Touch the buttons on the screen to

navigate through the menu. When an arc is displayed above a parameter, this means its value can be

adjusted by turning the rotary knob. If you want to adjust another parameter, touch the screen to

activate that parameter. If no arc appears above this parameter, it means it cannot be adjusted.

HOME MENU

After switching on the device, a welcome screen will

be displayed while the device performs a self-test.

At the end of the self-test the unit enters the

“Home Menu” and is ready for use.

Before starting any training or test, please

make sure the patient is screened

thoroughly and that there will be no adverse

effects for the health of your patient.

11 of 26

EN109-1413760-45

QUICK START

Selecting Quick Start is the fastest way to start a

training. The resistance of the training ranges from

level 1 to 12. These levels correspond to

preprogrammed levels of power. (Please note that

manual operation will allow for smaller steps in

increasing the power or to choose different modes

of training (like using constant torque or heart rate).

The arc above the displayed level indicates that the

rotary knob can be used to adjust the level.

By default the elapsed time will be displayed. When

pressing the “show more” tab on the right side,

more parameters will appear.

The screen will show:

- Elapsed time (min : sec)

- Speed (km/h)

- Cadence (rpm)

- Distance covered (km)

- Heart rate (bpm) (when the Polar® chest

belt is used)

- Energy used (kJ)

The training will start automatically when the

patient starts pedaling.

The green play symbol will appear to indicate the

training is in progress.

The training can be stopped at any moment by

touching the stop button.

12 of 26

EN109-1413760-45

MANUAL OPERATION

Select the info button in the top right corner to

display information to help you select the right

mode of training.

Levels

The resistance of the training can be set from level

1 to 12, just like when using the Quick start. These

levels are preprogrammed levels of power.

Power

Choose Power to accurately set the power in Watts.

The power will be kept at the selected level

independent of the cadence. Please note: The

slower the cadence (rpm), the higher the force for

each rotation will be.

Torque

Choose training on torque when you want to control the amount of force on the pedals. The

advantage of this training method is that when due to fatigue the cadence drops, the amount of

force required to ped will not increase. This can be very convenient when you don`t want the force

to become too high on an injured joint.

13 of 26

EN109-1413760-45

HEART RATE

Choose heartrate training when you like to relate

the intensity of the training to the heart rate of the

patient. The power that needs to be delivered by

the patient will automatically be adjusted

depending on the targeted heart rate.

Note: For this mode of training the patient needs

to wear a Polar® chest belt and some basic

knowledge of heart rate training is required to set

the right target heart rate for your patient.

When the “arc” is displayed over the Target hear

rate, this can be set by turning the rotary knob.

Select the max heart rate to set this value in the

same way.

HILL PROFILES

This menu includes 12 set training programs.

Profiles 1-6 are displayed. Use the rotary knob to go

to page 2 (profile 7-12). The power you need to set,

is the maximum power for this program. Depending

on the profile, the power will vary between 50% and

100% of this value. Apart from the profile and its

maximum power, you can also set the total time for

the training.

During the hill training, the actual power will be

displayed. Please note that when you increase the

power for the actual stage of the training, the

power for the other stages in the training will

increase too.

A countdown timer is displayed below the power to

indicate when the next stage will start.

14 of 26

EN109-1413760-45

TRAINING GOALS

In this menu you can set a specific training goal.

This can be a certain time or distance you want the

patient to cover or a certain amount of energy to

be burned. It is also possible to be guided by a

certain heart rate target, based on patient data and

the purpose of the training (e.g. warming up,

endurance training, etc.). The device will help you

set the applicable target heart rate by means of

several training zones.

Time

Choose Time if the goal is to, for instance, train for

10 minutes.

Use the rotary knob to set the time.

Select the mode of training by touching the

applicable button on the right and adjust to the

desired value by using the rotary knob.

The intensity can still be changed during training.

The goal cannot be changed.

15 of 26

EN109-1413760-45

Distance

Choose this option if the goal is to cover a certain

distance. Again choose a training mode. The

intensity can be adjusted during training.

Energy

Choose energy when your goal is to burn a specific

amount of energy. This might be relevant when

weight control is important.

16 of 26

EN109-1413760-45

Heart rate

Set a certain heart rate target, based on patient

data and the purpose of the training (e.g. warming

up, endurance training, etc.). The device will help

you set the applicable target heart rate by means of

several training zones.

When selecting heart rate as the training goal, the

training zones are displayed:

Before starting any training or test, please

make sure the patient is screened

thoroughly and you are sure there will be no

adverse effects for the health of your

patient.

To define the right heart rate for the selected

training zone, we need to know the maximum heart

rate.

First select male or female.

17 of 26

EN109-1413760-45

Then enter age and bodyweight

Please note that the max heart rate will

automatically be calculated based on the formula

HRmax =220-age. If you would like to set a

different max heart rate, simply press the max HR

and overwrite the value by using the rotary knob.

If sufficient data are entered, the OK button will be

active and you can continue by pressing OK.

Before training starts, the screen will display the

target heart rate that was selected based on the

training zone and patient’s max heart rate.

TESTING

The Bike Reha offers you various physical exercise

tests.

With the exception of the Steep ramp test, these

tests require the use of a Polar chest belt.

Like with the heart rate goal training, the device will

first ask you to enter the patient data.

When all personal data are entered, a screen will

give a brief explanation on the test procedure

before starting the test.

Before starting any training or test, please

make sure the patient is screened

thoroughly and that there will be no adverse

effects for the health of your patient.

Page is loading ...

Enraf-Nonius Cardio Bike Reha User manual

Enraf-Nonius Cardio Bike Reha User manual

Related papers