Enraf Nonius Crosswalker User manual

EN109-1413761-43 IFU
CROSSWALKER
Instructions for Use
Part number: EN109-1413761-43 IFU
January 5, 2021

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TABLE OF CONTENTS
1INTRODUCTION.............................................................................................................................................................3
2SYMBOLS..........................................................................................................................................................................4
3PACKAGE CONTENTS .................................................................................................................................................. 6
4SETUP.................................................................................................................................................................................7
5USING THE DEVICE....................................................................................................................................................... 8
6OPERATION ...................................................................................................................................................................12
7MAINTENANCE ............................................................................................................................................................20
8ORDERING INFORMATION .....................................................................................................................................21
9SPECIFICATIONS..........................................................................................................................................................22
10 PRODUCT LIABILITY ...................................................................................................................................................23

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1INTRODUCTION
Thank you for purchasing the Enraf-Nonius Crosswalker.
This ergometer is intended for stationary training 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.

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2SYMBOLS
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 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

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Emergency stop button
Risk of crushing hands
Risk of crushing feet
Fuse properties
Alternating current
2x T6.3 250VAH

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3PACKAGE CONTENTS
With your Crosswalker (art.nr. 1413931) you will find enclosed:
1x 1413769 Instructions for Use (PDF on CD)
1x 1413765 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.

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4SETUP
No specific installation activities are required that would require the assistance of a technician
authorized by Enraf-Nonius.
UNPACKING
The unit weighs approximately 80 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 Crosswalker 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.

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5USING THE DEVICE
INTENDED USER AND INTENDED USE
This Crosswalker is intended for stationary training 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 Crosswalker, 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
It is up to the professional user to decide for which indications the devices can and can not be used.
Following the ACSM recommendations for preparticipation health screening, the professional user
should screen every patient 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:
•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 Crosswalker 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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Patients 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
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

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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. 9th edition.
Philadelphia :Lippincott Williams & Wilkins.

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HEART RATE MONITORING
Heart rate monitoring or training is only possible with the optional 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.
PRECAUTIONS
If any serious event occurs in relation to this device, this event should be reported to Enraf-
Nonius and to your local Competent Authority!
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!
Never put your hand between the movement mechanism!
Never put your feet between the movement mechanism!
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.
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).

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6OPERATION
The Crosswalker 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: 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 moving.
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 walking
mechanism.
The advantage of this training method is that when due to fatigue the cadence drops, the amount
of force required to keep walking will not increase.
This can be very convenient when you don`t want the force to become too high on an injured joint.

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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.
Please 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 heart
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: 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.

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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.

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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.

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Then enter age and bodyweight.
Please note: The max heart rate will automatically
be calculated based on the formula HR max =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 Crosswalker 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 Crosswalker.
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 walk at the right cadence to avoid
hitting obstacles.

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7MAINTENANCE
The Crosswalker does not require a lot of maintenance. It is important however that you have the
device checked annually by a service technician authorized by Enraf-Nonius.
An annual check by a service technician authorized by Enraf-Nonius is required to determine
whether the device can still be used safely or that it shall be taken out of service.
The manufacturer will not be held responsible for the results of maintenance or repairs by
unauthorized persons.
The use of non-original (replacement) parts and/or auxiliary equipment invalidates the
warranty and can be hazardous.
If the power cord is damaged, remove the power plug from the socket to prevent injury.
CLEANING
Before performing any cleaning, switch off the device and disconnect the plug from the mains
supply.
Clean the device with a damp cloth using a household cleaner.
Do not spray the cleaning agent directly on the glass panel.
Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride or
detergents with ammonia. This may cause damage to the device.
EXPECTED SERVICE LIFE
This device will remain suitable for its intended use as long as it is subjected to yearly maintenance by
a qualified service engineer as described in the service manual.
The service engineer will decide whether the device is suitable for use according to the specifications.
END OF LIFE
Please ensure that you are well informed of the local rules and regulations regarding the
separate disposal of this Device from normal household waste so that they can be recycled.