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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.
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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.
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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.
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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.
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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.
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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.
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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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