Enraf-Nonius Cardio Total Body Bike User manual

Brand: Enraf-Nonius

Model: Cardio Total Body Bike

Type: User manual

Enraf-Nonius Cardio Total Body Bike

The Enraf-Nonius Cardio Total Body Bike is a versatile and innovative piece of equipment designed to provide users with a comprehensive cardiovascular and rehabilitation workout. With its unique features and advanced technology, the Cardio Total Body Bike offers a wide range of benefits and use cases, making it an ideal choice for individuals looking to improve their overall fitness, mobility, and well-being.

Key Features:

Adjustable Resistance: The Cardio Total Body Bike allows users to customize the resistance levels, making it suitable for individuals of all fitness levels.

Enraf-Nonius Cardio Total Body Bike

Key Features:

Adjustable Resistance: The Cardio Total Body Bike allows users to customize the resistance levels, making it suitable for individuals of all fitness levels.

Total Body Bike

EN109-1413763-40 IFU

November 7, 2022

Instructions for use

Page 2 of 26 EN109-1413763-40 IFU

Table of contents

1 Introduction ...................................................................................................................................................... 3

2 Symbols .............................................................................................................................................................. 4

3 Device components ....................................................................................................................................... 5

4 Package contents ............................................................................................................................................ 6

5 Installation ......................................................................................................................................................... 7

6 Intended use and intended user ............................................................................................................... 8

7 Indications ......................................................................................................................................................... 9

8 Contraindications ......................................................................................................................................... 10

9 Precautionary instructions ........................................................................................................................ 12

10 Operation ........................................................................................................................................................ 13

11 Application information............................................................................................................................. 20

12 Maintenance .................................................................................................................................................. 22

13 Specifications ................................................................................................................................................. 23

14 Contact ............................................................................................................................................................. 24

15 Product liability ............................................................................................................................................. 25

Page 3 of 26 EN109-1413763-40 IFU

1 Introduction

Foreword

Thank you for purchasing the Enraf-Nonius Total Body Bike.

This Total Body ergometer is intended for stationary recumbent 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.

Page 4 of 26 EN109-1413763-40 IFU

2 Symbols

Symbol used

Description

Follow the instructions in the Instructions for Use.

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

operating instructions

Warning or Caution:

Indicates a hazardous situation which, if not avoided, could result in:

a. Death or serious injury to the patient (or)

b. Minor to moderate injury to the patient (or)

c. Damage to the equipment

Product is in conformity with the European Union Medical Device Regulation

(EU) 2017/745.

Name and contact information of the manufacturer and production date.

Reference or model number

Serial number, used for identification of the device.

Indicates that the item is a medical device.

Indicates a carrier that contains Unique Device Identifier information

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

Alternating current

Emergency stop button

Page 5 of 26 EN109-1413763-40 IFU

3 Device components

1 Crank

2 Handle to adjust crank (for version with adjustable cranks)

3 Arm

4 Handle to adjust arm

5 Touchscreen

6 Seat

7 Handle to adjust seat

8 Seat section

9 Handle to unlock/lock seat section

Page 6 of 26 EN109-1413763-40 IFU

4 Package contents

With your Total Body Bike (art.nr. 1413951) or Total Body Bike with adjustable cranks (art.nr. 1413952)

you will find enclosed:

1413763 Instructions for Use (download from our website www.enraf-nonius.com)

1413767 Information Booklet

3444298 Power cord

The following optional accessories for the Total Body Bike are available:

1413800 Pedal adapters with heel support and fixation straps

3496837 Sigma Sport chest belt for heart rate registration

3496838 Elastic strap for Sigma Sport chest belt for heart rate registration

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

this equipment is NOT allowed.

Page 7 of 26 EN109-1413763-40 IFU

5 Installation

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

authorized by Enraf-Nonius.

Unpacking

The unit weighs approximately 150 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 Total Body Bike 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.

Page 8 of 26 EN109-1413763-40 IFU

6 Intended use and intended user

This Total Body Bike 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.

The Total Body Bike 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.

Page 9 of 26 EN109-1413763-40 IFU

7 Indications

The Total Body Bike, 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.

Page 10 of 26 EN109-1413763-40 IFU

8 Contraindications

Use of the Total Body Bike is contraindicated in any circumstance where the healthcare professional

assesses or could have assessed it increases risks for the subject to such an extent that it outweighs

the benefit associated with use of the Total Body Bike.

Following the ACSM* recommendations for preparticipation health screening, the professional user

should screen every subject 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.

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

physical activity program:

• 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.

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

initiating a physical activity program:

• 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

Healthcare professionals should assess the risk for individuals potentially at moderate risk with two or

more CVD risk factors from the list below, in consultation with the patient’s 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

Page 11 of 26 EN109-1413763-40 IFU

The devices can be used for exercise testing. The ACSM states that in those individuals who require

testing, absolute and relative contraindications must be considered.

The contraindications stated by ACSM are as follows:

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

A remark is made that relative contraindications can be superseded if benefits outweigh the risks of

exercise. In some instances, these individuals can be exercised with caution and/or using low-level

endpoints, especially if they are asymptomatic at rest.

* Source: American College of Sports Medicine. ACSM's guidelines for exercise testing and

prescription. 10th edition. Philadelphia: Lippincott Williams & Wilkins.

Page 12 of 26 EN109-1413763-40 IFU

9 Precautionary instructions

If the use of this device may have caused or contributed to an undesirable event such as

death or serious injury to the user, the manufacturer AND the competent authority of the

Member State MUST be notified immediately!

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 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 13).

Page 13 of 26 EN109-1413763-40 IFU

10 Operation

The Total Body 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.

Page 14 of 26 EN109-1413763-40 IFU

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 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.

Page 15 of 26 EN109-1413763-40 IFU

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.

Note: For values lower than 20 W or 6 Nm, the accuracy cannot be guaranteed as required by the

medical device guidelines.

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 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.

Page 16 of 26 EN109-1413763-40 IFU

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.

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.

Page 17 of 26 EN109-1413763-40 IFU

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.

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.

Page 18 of 26 EN109-1413763-40 IFU

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.

Page 19 of 26 EN109-1413763-40 IFU

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.

Gaming

This Total Body Bike includes a gaming option.

We believe the gaming aspect will make it more fun

for patients to work out and therefor easier to

spend a certain amount of time on the bike.

RPM Airlines

Just set the goal time and the difficulty (easy,

medium, hard or expert level) and start the game.

The game is a constant torque protocol and the

challenge is to pedal at the right cadence to avoid

hitting obstacles.

Page 20 of 26 EN109-1413763-40 IFU

11 Application information

To adjust the arm

The arm is adjustable to set the cranks

in the correct ergonomic position for

seated cycling or arm cranking.

Preferably do this without a patient on

the pedals.

• Support the arm.

• Make sure no force is applied to

the arm.

• Move the arm adjustment handle

to unlock the arm.

• Place the arm in the desired

position in a controlled manner.

• Release the handle and make sure

that the arm locks properly again.

For removing the seat section

The seating area can be removed to

accommodate another chair or

wheelchair.

Always do this without a patient on the

chair.

• Move the handle to release the

seat section into the vertical

position.

• Slide the seat section backwards

out of the mounting.

For placing another chair or wheelchair

To attach another chair or wheelchair to the device, a mounting eye is provided.

If required, tension straps (not included) can be used to ensure that it is not pushed away from the

device during training.

Adjust the arm to position the patient in the right way to avoid injuries.

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Enraf-Nonius Cardio Total Body Bike User manual

Brand: Enraf-Nonius

Model: Cardio Total Body Bike

Type: User manual

Enraf-Nonius Cardio Total Body Bike

Key Features:

Adjustable Resistance: The Cardio Total Body Bike allows users to customize the resistance levels, making it suitable for individuals of all fitness levels.

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Enraf-Nonius Cardio Total Body Bike User manual

Enraf-Nonius Cardio Total Body Bike User manual

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