Lode Katana User manual

m934900 Manual - Katana Sport
Sports Medicine
Lode BV
Zernikepark 16
NL 9747 AN Groningen
The Netherlands
t: [phone]
f: [phone]
@: [e-mail]
www.lode.nl
M934900 - MANUAL KATANA SPORT / VERSION: 1.2 - 2018-10-17

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Table of contentsTable of contents
1 - Intended Use1 - Intended Use
2 - Validity2 - Validity
3 - Precautions3 - Precautions
4 - Contra Indication4 - Contra Indication
5 - Definition of parts5 - Definition of parts
6 - Install your Katana treadmill ergometer6 - Install your Katana treadmill ergometer
6.1 - Emergency stop installation
7 - Control with Control Unit7 - Control with Control Unit
8 - Control with an External Device8 - Control with an External Device
9 - Control with the Lode Ergometry Manager (LEM)9 - Control with the Lode Ergometry Manager (LEM)
10 - Maintenance10 - Maintenance
11 - Troubleshooting11 - Troubleshooting
12 - Cleaning12 - Cleaning
13 - List of symbols used13 - List of symbols used
14 - Electromagnetic Compatibility (EMC)14 - Electromagnetic Compatibility (EMC)
14.1 - Emissions test
14.2 - Immunity test
14.3 - Recommended Separation Distances
15 - Accessories15 - Accessories
16 - Specifications16 - Specifications

1 - Intended Use1 - 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 - Validity2 - Validity
This manual covers all Katana Sport versions starting with the following article numbers:
9349xx | : S/N 20130001 and higher
Date of first issue: October 2015
3 - Precautions3 - Precautions
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.
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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 operator should not touch accessible parts and the
patient simultaneously.
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.
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.
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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 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.
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 test subject should wear proper sports or running shoes
(no spikes).
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If this equipment is modified, appropriate inspection and
testing must be conducted to ensure continued safe use of
the equipment.
No modification of this equipment is allowed.
This device should only be sold by, or under the supervision
of authorized persons.
Make sure you always fix the handrails by tightening the
spanners on the side handrails before anybody starts using
the treadmill.
4 - Contra Indication4 - 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.
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5 - Definition of parts5 - Definition of parts
1. Power cord
2. Connectors, on/off switch
3. Equipotential bonding plug
4. Control Unit (optional)
5. Wheels
6. Walking surface with Slats
7. Motor unit
8. Handrails
9. Elevation frame front
10. Elevation frame rear
(optional)
11. Emergency stop in walking
surface
12. Emergency stop button
(optional)
When no control unit is installed, the safety lanyard will be connected to
the small box on the frontbar (4)
Each treadmill is supplied with a carton box with additional accessories and tools, like the manual, test
certificate, safety lanyard and tools for adjustments.
6 - Install your Katana treadmill ergometer6 - Install your Katana treadmill ergometer
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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”.
6.1 - Emergency stop installation6.1 - 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.
7 - Control with Control Unit7 - Control with Control Unit
You can operate the device as a stand-alone device with the (optional) control unit.
1. After switching on, follow the instructions on the screen for the settings
2. Consult the manual of the control unit for more information
8 - Control with an External Device8 - Control with an External Device
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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).
9 - Control with the Lode Ergometry Manager (LEM)9 - Control with the Lode Ergometry Manager (LEM)
1. If your treadmill ergometer 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 treadmill ergometer and to a USB port in your PC.
2. Start Lode Ergometry Manager on your PC
3. If your treadmill has a control unit, select “Terminal”- mode to allow external command. If your
treadmill does not have a control unit the terminal mode is automatically selected. (See for detailed
instructions the user manual of LEM).
10 - Maintenance10 - Maintenance
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.
11 - Troubleshooting11 - Troubleshooting
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On-off Switch
External Input
External Output
For a complete overview of possible error message and the solutions belonging to these messages,
please consult the service manual of the ergometer.
12 - Cleaning12 - Cleaning
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.
The slats can be cleaned with a dry brush.
13 - List of symbols used13 - List of symbols used
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Read manufacturer’s guide, advises and instructions and manual
Potential Equalization Conductor
Touching with finger prohibited
Class I MEDICAL EQUIPMENT Type B Electrical Safety IEC 60601-1
CE and notified body
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
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.
The equipment has a safety earth (ground) connection and must be connected to an
earthed (grounded) wall socket.
Warning: moving parts, risk of squeeze
Tested and certified to U.S. and Canadian National Standards by a NRTL, viz
TÜV Rheinland. Compliance for U.S. and Canadian markets.
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FCC 18 RF ISM tested
Safety notes
Connector for Control Unit
External Control Connector
Emergency Stop
RS232
USB
Network (Proprietary Lode)
14 - Electromagnetic Compatibility (EMC)14 - Electromagnetic Compatibility (EMC)
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14.1 - Emissions test14.1 - Emissions test
The Lode equipment is intended for use in the electromagnetic environment specified below. It is the
responsibility of the customer or user to ensure that the Lode equipment is used in such an
environment.
Emissions test:Emissions test: RF emissions CISPR11
Compliance:Compliance: Group 1
Electromagnetic Environment – GuidanceElectromagnetic Environment – Guidance:The equipment uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
Emissions test:Emissions test: RF emissions CISPR11
Compliance:Compliance: Class B
Electromagnetic Environment – GuidanceElectromagnetic Environment – Guidance:The equipment is suitable for use in all establishments
including domestic establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Emissions test:Emissions test: Voltage fluctuations / Flicker emissionsIEC 61000-3-3
Compliance:Compliance: Complies
Electromagnetic Environment – GuidanceElectromagnetic Environment – Guidance:The equipment is suitable for use in all establishments
including domestic establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Emissions test:Emissions test: Harmonic Emissions IEC 61000-3-2
Compliance:Compliance: Not applicable
Electromagnetic Environment – GuidanceElectromagnetic Environment – Guidance:Equipment for professional use with a total rated power
greater than 1 kW and is excluded from this requirement
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14.2 - Immunity test14.2 - Immunity test
The Lode equipment is intended for use in the electromagnetic environment specified below. It is the
responsibility of the customer or user to ensure that the Lode equipment is used in such an
environment.
Immunity Test: Immunity Test: Electrostatic discharge (ESD) EN 61000-4-2
IEC 60601-Test Level: IEC 60601-Test Level: ± 6 kV contact
± 8 kV air
Compliance Level: Compliance Level: ± 6 kV contact
± 8 kV air
Electromagnetic Environment - Guidance: Electromagnetic Environment - Guidance: Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity should be at least 30%.
Immunity Test: Immunity Test: Electrical fast transient/burst EN 61000-4-4
IEC 60601-Test Level: IEC 60601-Test Level: Not applicable
Compliance Level: Compliance Level: Not applicable
Electromagnetic Environment - Guidance: Electromagnetic Environment - Guidance: Conducted only on ports interfacing with cables whose
total length, according to the manufacturer’s functional specification, may exceed 3 meters
Immunity Test: Immunity Test: Surge EN 61000-4-5
IEC 60601-Test Level: IEC 60601-Test Level: Not applicable
Compliance Level: Compliance Level: Not applicable
Electromagnetic Environment - Guidance: Electromagnetic Environment - Guidance: Conducted only on ports interfacing with cables whose
total length, according to the manufacturer’s functional specification, may exceed 3 meters
Immunity Test: Immunity Test: Voltage dips, short interruptions and voltage variations on power supply input lines
EN 61000-4-11
IEC 60601-Test Level: IEC 60601-Test Level: Not applicable
Compliance Level: Compliance Level: Not applicable
Electromagnetic Environment - Guidance: Electromagnetic Environment - Guidance: Equipment for professional use with a total rated power
greater than 1 kW and is excluded from this requirement
Immunity Test: Immunity Test: Power frequency (50/60Hz) magnetic field EN 61000-4-8
IEC 60601-Test Level: IEC 60601-Test Level: 3 A/m
Compliance Level: Compliance Level: 3 A/m
Electromagnetic Environment - Guidance: Electromagnetic Environment - Guidance: Power frequency magnetic fields should be at levels
characteristics of a typical location in a typical commercial or hospital environment.
NOTE: NOTE: Ut is the AC mains voltage prior to application of the test level.
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Interference
The Lode equipment is intended for use in the electromagnetic environment specified below. It is the
responsibility of the customer or user to ensure that the Lode equipment is used in such an
environment.
Immunity test: Immunity test: Conducted RF 61000-4-6
IEC 60601-Test Level: IEC 60601-Test Level: 3 Vrms 150kHz to 80MHz
Compliance Level: Compliance Level: 3 Vrms
Immunity test: Immunity test: Radiated RF 61000-4-3
IEC 60601-Test Level: IEC 60601-Test Level: 3 V/m 80MHz to 2,5 GHz
Compliance Level: Compliance Level: 3 V/m
Electromagnetic Environment - Guidance: Electromagnetic Environment - Guidance: Portable and mobile RF communications equipment
should be used no closer to any part of the Lode equipment including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended seperation distance: Recommended seperation distance:
d= 1,2 √ P 80 MHz to 800 MHz
d= 2,3 √ P 800 MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a , should
be less than the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
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NOTE 1: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a.Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radio, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the equipment is used exceeds the applicable RF compliance level above, the
equipment should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the equipment.
b.Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.
14.3 - Recommended Separation Distances14.3 - Recommended Separation Distances
Recommended Separation Distances between Portable and Mobile RF Communication Equipment and
the Lode equipment
The Lode equipment is intended for use in the electromagnetic environment on which radiated RF
disturbances are controlled. The customer or the user of the Lode equipment can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Lode equipment as recommended below, according
to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance [d] in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE:NOTE:
These guidelines may not apply in all instances. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
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15 - Accessories15 - Accessories
Remote Control for
treadmill
Partnumber: 945831Partnumber: 945831
Ease of use
Remote Control for treadmill
Add program function
to 7" touch screen for
Treadmill
Partnumber: U945815Partnumber: U945815
Programmable
Add Program function to
Control Unit
Table foot for Control
Unit with Touchscreen
Partnumber: 945818Partnumber: 945818
Control from any
desired place
Support for Control Unit with
Touchscreen
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
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
Rear Elevation -25%
electrical Katana sport
Partnumber: 934808Partnumber: 934808
Possibility of downhill
walking
Rear Elevation -25% electrical
Katana sport
Emergency Stop
Button
Partnumber: 945804Partnumber: 945804
Ultimate safety
Emergency Stop Button
Autospeed
Partnumber: 945840Partnumber: 945840
Flexibility in exercising
Autospeed
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Adjustable Acceleration
& Deceleration for
Katana & ...
Partnumber: 945847Partnumber: 945847
Flexibility in exercising
Acceleration & Deceleration
Speed 40 km/h
Partnumber: 934840Partnumber: 934840
Extra high speed
Speed 40 km/h
Reverse walking for
Katana
Partnumber: 934842Partnumber: 934842
walking backwards
Reverse walking for Katana
Ambient sensor pack
Partnumber: 945826Partnumber: 945826
Check environmental
conditions during test
Ambient sensor pack for
treadmills
Safety Belt and Fall
stop for Katana sport
Partnumber: 934821Partnumber: 934821
Extra safety
Safety Belt and Fall stop
Extension for
emergency lanyard
Partnumber: 945931Partnumber: 945931
Original Accessory
Extension for emergency
lanyard
Handrail, removable -
for Katana sport
Partnumber: 934811Partnumber: 934811
Convenient removal of
handrail for many
purposes
Removable handrail for
Katana sport
Universal treadmill Arm
Support
Partnumber: 945805Partnumber: 945805
Comfort for both test
subject and test
operator
Universal treadmill Arm
Support
USB to Serial converter
Partnumber: 226012Partnumber: 226012
Easy connection
USB to Serial converter
RS232 cable
Partnumber: 930911Partnumber: 930911
Easy connection
RS232 cable
Network module
connection cable
Partnumber: 930930Partnumber: 930930
Easy connection
Network module connection
cable
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16 - Specifications16 - Specifications
Workload
Maximum speed 30 km/h 18.6 mph
Minimum operational speed 0.1 km/h 0.1 mph
Speed adjustment steps 0.1 km/h 0.1 mph
Positive elevation 25 %
Elevation adjustment steps 0.5 %
Optional negative elevation -25 %
Accuracy
50 Hertz Filter
Elevation readout accuracy 0.3 %
Speed readout accuracy 0.5 km/h 0.3 mph
Comfort
Allowed user weight 225 kg 496 lbs
Connectivity
Lode ERM interface protocol
"HP Cosmos" interface protocol
"Woodway" interface protocol
"Trackmaster" interface protocol
"GE" interface protocol
USB connector
Dimensions
Screen resolution 800 x 400 pixels
Walking surface length 190 cm 74.8 inch
Walking surface width 70 cm 27.6 inch
Step up height 29 cm 11.4 inch
Product length (cm) 250 cm 98.4 inch
Product width (cm) 106 cm 41.7 inch
Product height 145 cm 57.1 inch
Product weight 380 kg 837.8 lbs
Power requirements
Power cord 3L+N+PE
Power cord NEMA
Maximum rated power input 5000 VA
3 x 400 V
Maximum motor power 3.1 kW
Standards & Safety
IEC 60601-1:2005
ISO 13485:2003 compliant
ISO 9001:2008 compliant
Standard emergency lanyard
Step up plate emergency stop
Certification
CE class Im according to MDD93/42/EEC
CE class of product with optional SpO2 IIa
CE class of product with optional BPM IIa
Environmental conditions
Maximum operational temperature 35 °C
Minimum operational temperature 14 °C
Maximum operational air pressure 10 kPa
Minimum operational air pressure 70 kPa
Maximum operational non-condensing
humidity 90 %
Minimum operational non-condensing
humidity 30 %
Maximum storage & transport temperature 70 °C
Minimum storage & transport temperature -25 °C
Maximum storage & transport air pressure 106 kPa
Minimum air pressure storage & transport 50 kPa
Max. humidity storage & transport 95 %
Min. humidity storage & transport 10 %
Order info
Partnumber 934900
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