Lode Valiant 2 Pediatric User manual

Manual - Valiant 2
Pediatric
Pediatric
Lode BV
Zernikepark 16
NL 9747 AN
Groningen
The Netherlands
t: [phone]
f: [phone]
@: [e-mail]
www.lode.nl
M938904_MANUAL VALIANT 2 PEDIATRIC / VERSION: V1.1 - 2016-08-25

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Table of contents
1 - Intended Use1 - Intended Use
2 - Precautions2 - Precautions
3 - Contra Indication3 - Contra Indication
4 - Definition of parts4 - Definition of parts
5 - Validity5 - Validity
6 - Install your treadmill6 - Install your treadmill
7 - Maintenance7 - Maintenance
7.1 - Emergency stop installation
8 - Troubleshooting8 - Troubleshooting
8.1 - Belt alignment
9 - Cleaning9 - Cleaning
10 - Control with an External Device10 - Control with an External Device
11 - Control with the Lode Ergometry Manager (LEM)11 - Control with the Lode Ergometry Manager (LEM)
12 - List of symbols used12 - List of symbols used
13 - Electromagnetic Compatibility (EMC)13 - Electromagnetic Compatibility (EMC)
14 - Specification remarks14 - Specification remarks
15 - Accessories15 - Accessories
16 - Specifications16 - Specifications

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 the 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. This
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.
The product may also be used for rehabilitation or active aging therapy.
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 the manufacturer nor its distributors assume
any responsibility for the final use of its equipment.
2 - Precautions
Read this manual before using the device and follow it
carefully.
The operator should instruct the test subject prior to
performing an exercise protocol. If, at any time during
exercise, the test subject feels faint, dizzy, or experiences
pain, stop the test and he or she should be consulted by the
physician.
Care should be taken in mounting or dismounting the
ergometer. Be aware of feet when replacing the ergometer.
The operator should not touch accessible parts and the
patient simultaneously.
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The test subject should always wear the belt of the lanyard
safety belt.
Replacement of the power supply cord should be installed by
authorised service personnel, instructions for correct
connection and anchoring must be ensured, securing that
the requirements of clause 8.11.3 of IEC 60601 1:2005 are
met.
Set up and operate the device on a solid level surface.
The test subject should not wear loose or dangling clothing
while using the device.
Service of this device is restricted to factory trained
personnel only.
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.
The test subject shall wear clothes when using the harness or
the lanyard belt to prevent skin irritation.
Replacement of parts can only be done by the manufacturer
or designated service personnel.
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Read all warnings posted on the device.
Inspect the device for worn or loose components prior to
use. Tighten / replace any loose or worn components prior to
use.
Do not place any loose parts or objects on the device before
and during use.
The equipment has a safety earth (ground) connection and
must be connected to a (grounded) wall socket with
protective earth to avoid the risk of electric shock. The
functional earth connection is for potential equalisation only.
The operator must keep away from the footrail while
lowering.
The test subject should wear proper sports or running shoes
(no spikes).
If this equipment is modified, appropriate inspection and
testing must be conducted to ensure continued safe use of
the equipment.
Cleaning and user maintenance shall not be made by
children without supervision.
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Children being supervised are not to play with the appliance.
Children shall not play with the appliance.
Heart rate monitoring systems may be inaccurate. Over
exercise may result in serious injury or death. If the test
person feels faint stop exercising immediately.
Keep away from the rollers.
No modification of this equipment is allowed.
Not suitable for use in the presence of flammable
anaesthetics.
The appliance is not to be used by persons (including
children) with reduced physical, sensory or mental
capabilities, or lack of experience and knowledge.
The test subject should wear proper sports clothing. The
operator should check possible entrapment of clothing,
fingers or feet, before the start of an exercise test.
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This appliance can be used by children aged from 8 years
and above and persons with reduced physical, sensory or
mental capabilities or lack of experience and knowledge if
they have been given supervision or instruction concerning
use of the appliance in a safe way and understand the
hazards involved.
This device should only be sold by, or under the supervision
of authorized persons.
Your device may be executed with heart rate measurement,
blood pressure measurement, and / or SpO2 (blood
saturation) measurement. These measurements may be
inaccurate, depending on use circumstances. These
measurements are indicative and cannot be used for
diagnostic purposes.
3 - Contra Indication
The 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
energy. Application of the wrong dosis of energy could lead to permanent damage of the test subject
health. Only use this device under supervision of a medical physician.
4 - Definition of parts
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1. Service Connector
2. Communication Interface
Module (CIM)
3. On/Off switch
4. Equipotential bonding plug
5. Safety symbols tag
6. Serial number tag
7. Motor compartment for
height adjustment and drive
8. Height adjustment (optional)
9. Walking surface (APPLIED
PART)
10. Front bar
11. Connector for external
emergency stop
12. Magnetic contact for safety
belt
5 - Validity
This manual covers all VaIiant 2 Pediatric versions starting with the following serial number:
938904 Valiant Pediatric: S/N 20140001
Date of issue: June 14
6 - Install your treadmill
1. While unpacking the Lode treadmill ergometer, leave the transport straps on both ends in place.
2. Place the treadmill in the location where it will be used.
3. Remove Both transport straps and remaining packaging materials.
4. The power supply cord should be installed by authorised service personnel and instructions for
correct connection and anchoring must be ensured, securing that the requirements of clause 8.11.3 of
IEC 60601-1:2005 are met.
5. Remove all objects from the walking surface.
6. Switch on the unit with the on/off button and wait until the self-test is carried out. The product is
ready for use after you have heard a series of “beeps”.
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7 - Maintenance
7.1 - Emergency stop installation
When your treadmill is delivered with an emergency stop, please note
the following:
The plug of the emergency stop button needs to be placed in the back
connector of the console on the front handrail.
Some emergency stop buttons have a connector for another emergency
stop. You can place the spare dummy there in case you have one
button.
Also make sure that the magnet of the emergency lanyard is connected to the console.Otherwise the
treadmill will not operate.
Maintenance should be carried out on a regular and planned basis. We recommend to check the unit
annually. This may be done by your local dealer. It is also recommended that a record of the service
history is kept for all activities relating to service and maintenance.
Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will
not be held responsible for the results of maintenance or repairs by unauthorized persons.
The check up and/or technical maintenance must be carried out conform the procedure described in
the service manual of the unit.
Opening of the equipment by unauthorized agencies is not allowed and will terminate 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 personnel to repair those parts of
the ergometer that are designated by Lode as repairable by authorized service personnel.
8 - Troubleshooting
For a complete overview of possible error message and the solutions belonging to these messages,
please consult the service manual of the ergometer.
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8.1 - Belt alignment
Place the allen key on the left
bolt while standing behind the
treadmill as shown on the
picture.
Adjusting the belt tension is
very easy with the key on the
left side. Turning the key
clockwise will make the belt
move to the right side of the
treadmill. Turning the key
counterclockwise will make the
belt go left.
The red marked area shows where you can check the belt alignment. The goal is to align the belt edge
exactly in the center of the hole.
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Now start the treadmill with a
speed of 2 km/h. Make
corrections with the allen tool
to the belt alignment so the
edge of the belt stays in the
middle of the hole.
When the belt is properly
aligned you may repeat the
above procedure on higher
speeds. But be cautious; higher
speeds will have a faster
implementation of the belt
alignment when turning the
allen key. Always start with the
2km/h so you can timely intervene is the belt goes to one side quickly.
To finalize the alignment procedure set the treadmill to maximum speed for 2 minutes and check the
alignment of the belt.
Note: NEVER use any lubricants on the walking belt. The belt is self greasing using a wax layer that will
dispose on the deck on high friction points and on higher speeds. The belt does not need to be re-
waxed and runs the complete lifetime of aproximately 10.000km. Incorrect tension, alignment and/or
use can decrease the lifetime of the belt.
9 - Cleaning
The belt can be cleaned with a sponge, with little lukewarm water. Allow the belt to dry thoroughly
after cleaning before re-using the treadmill.
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Before cleaning and other maintenance of any part of the device, first switch off the device and
disconnect it from the mains. The surfaces can be cleaned with a damp cloth and a liquid (non-
abrasive) cleaning product.
General Cleaning
Wipe the device surface down with a cloth moistened with soap water or a disinfectant. The cloth
should not be dripping wet; do not allow liquids to enter the device
Cleaning the Saddle
Clean the saddle with a soft and dry or moist cloth. Disinfectants used should not contain any alcohol.
Cleaning the Upholstery (e.g. couch ergometer)
Wipe the upholstery down with a soft cloth moistened with soap water. The cloth should only be moist
and not dripping wet. If the cleaning agents and disinfectants used are caustic or contain alcohol, they
may damage and/or discolor the upholstery.
If you are not certain about the discolouring effect of a cleaning agent, you may try a little on a part of
the product that is not visible during normal use.
Lode cannot advise a specific cleaning agent, since local recipes may differ.
10 - Control with an External Device
If your device is fitted with a communication card you can connect to many external devices.
1. Connect the device with the supplied cable to the external device. You can control the device with
e.g. an exercise ECG device or Metabolic Card.
2. Download the interfacing instructions from the internet at www.lode.nl after you have registered
your device.
3. If your device has a control unit, 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 external device).
11 - Control with the Lode Ergometry Manager (LEM)
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External Control Connector
Emergency Stop
Network (Proprietary Lode)
Class I MEDICAL EQUIPMENT Type B Electrical Safety IEC 60601-1
Safety notes
Potential Equalization Conductor
RS232
1. If your device has an RS232 or USB port, connect it directly to the PC LEM is installed on. If your
device has a RJ45 connector plug it with an UTP cable to the special interface connector that was
delivered with your device and to a USB port in your PC.
2. Start Lode Ergometry Manager on your PC
3. If your device has a control unit, select “Terminal”- mode to allow external command. If your device
does not have a control unit the terminal mode is automatically selected. (See for detailed instructions
the user manual of LEM).
Trapping zone. Warning: 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. Keep away from rollers. The operator must keep away from
the footrail while lowering.
12 - List of symbols used
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USB
Read manufacturer’s guide, advises and instructions and manual
On-off Switch
The equipment has a safety earth (ground) connection and must be connected to an
earthed (grounded) wall socket.
Tested and certified to U.S. and Canadian National Standards by a NRTL, viz
TÜV Rheinland. Compliance for U.S. and Canadian markets.
FCC 18 RF ISM tested
Symbol for collection, treatment, recycling and disposal of waste electrical and
electronic equipment (WEEE) as set out in Directive 2002/96/EC of 27 January 2003 of
the European Parliament and of the Council on waste electrical an electronic
equipment are necessary to reduce the waste management problems linked to the
heavy metals concerned and the flame retardants concerned
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13 - Electromagnetic Compatibility (EMC)
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14 - Specification remarks
The specification in this manual is of the basic version of the product at the time of the publication of
this manual. The specification of all actual versions can be found on the Lode website. www.lode.nl
Changes to specifications can be made without prior notice.
Mentioned speed at the specifications in this manual is the standard speed supplied on the treadmill.
When optional speed upgrade or speed downgrade is installed on the treadmill, the actual speed of
your treadmill may differ from the speed mentioned at the specifications.
15 -
Accessories
Colour display 3.5" -
single display
Partnumber: 945810Partnumber: 945810
Clear feedback
Colour display 3.5" - single
display
Control Unit with 7"
touch screen for
treadmill
Partnumber: 945814Partnumber: 945814
Multifunctionality
Control Unit with
Touchscreen
Programmable Control
Unit with 7" touch
screen for ...
Partnumber: 945815Partnumber: 945815
Programmable
Programmable Control Unit
Colour Display 3.5" -
2nd screen
Partnumber: 945819Partnumber: 945819
Multifunctionality
Colour Display 3.5"
SpO2 for control unit
with touch panel
(treadmill)
Partnumber: 945822Partnumber: 945822
Oxygen saturation
SpO2 for control unit with
touch panel
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Blood Pressure
Measurement with ECG
trigger for ...
Partnumber: 945824Partnumber: 945824
with ECG trigger
Blood Pressure Measurement
with ECG trigger
Heart rate for
treadmills
Partnumber: 945820Partnumber: 945820
Heart rate in beats per
minute
Heart rate for treadmills
Emergency Stop Button
Partnumber: 945804Partnumber: 945804
Ultimate safety
Emergency Stop Button
Adjustable Acceleration
& Deceleration for
Valiant 2
Partnumber: 945846Partnumber: 945846
Flexibility in exercising
Acceleration & Deceleration
Reverse Walking for
Valiant 2
Partnumber: 938842Partnumber: 938842
Simple switching
between forward and
reverse walking
Switch direction of belt up to
5 km/h
Entrance plate
Partnumber: 938809Partnumber: 938809
Even easier entrance to
the treadmill
Entrance plate
Handrails, Side - Fixed
(yellow), for Valiant 2 ...
Partnumber: 938800Partnumber: 938800
Extra support for the
test subject
Handrails, Side - Fixed, for
Valiant 2 pediatric
Handrails, Side -
Adjustable for Valiant 2
Pediatric (...
Partnumber: 938802Partnumber: 938802
Making your treadmill
suitable for children
Adjustable pediatric side
handrails
Handrail, front
singlesided - Pediatric -
Valiant 2
Partnumber: 938816Partnumber: 938816
Obstacle free
observation of the test
subject
Singlesided Front Handlebar -
Pediatric
Ambient sensor pack
Partnumber: 945826Partnumber: 945826
Check environmental
conditions during test
Ambient sensor pack for
treadmills
Universal treadmill
Arm Support
Partnumber: 945805Partnumber: 945805
Comfort for both test
subject and test
operator
Universal treadmill Arm
Support
Bottle holder
Partnumber: 401200Partnumber: 401200
Convenient beverage
storage
Bottle holder
Extension for
emergency lanyard
Partnumber: 945931Partnumber: 945931
Original Accessory
Extension for emergency
lanyard
Speed upgrade from
0.1-12 to 0.5-20 km/h
for Valiant 2
Partnumber: 945841Partnumber: 945841
Higher speeds
Speed 0.5 – 20 km/h for
Valiant 2
Network Module
Partnumber: 945851Partnumber: 945851
Easy networking with
LEM and LCRM
Network Module
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USB to Serial converter
Partnumber: 226012Partnumber: 226012
Easy connection
USB to Serial converter
RS232 cable
Partnumber: 930911Partnumber: 930911
Easy connection
RS232 cable
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