Lode Corival CPET User manual

M9609XX Manual - Corival 2015
Cardio Pulmonary
Lode BV
Zernikepark 16
NL 9747 AN
Groningen
The Netherlands
t: [phone]
f: [phone]
@: [e-mail]
www.lode.nl
M960900 / VERSION: 1.0 - 2014-09-24

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Table of contents
1 - Intended Use1 - Intended Use
2 - Precautions2 - Precautions
3 - Contra Indication3 - Contra Indication
3.1 - Free area
4 - Validity4 - Validity
4.1 - Description of parts
5 - Installation5 - Installation
5.1 - Install the device
5.2 - Connecting cables
5.3 - Cable Management
6 - Preparation6 - Preparation
6.1 - Adjusting the saddle position
6.2 - Adjust the handlebar
7 - List of symbols used7 - List of symbols used
8 - Control with the Lode Ergometry Manager (LEM)8 - Control with the Lode Ergometry Manager (LEM)
9 - Control with an External Device9 - Control with an External Device
10 - Maintenance10 - Maintenance
11 - Cleaning11 - Cleaning
12 - Calibration12 - Calibration
13 - Electromagnetic Compatibility (EMC)13 - Electromagnetic Compatibility (EMC)
13.1 - Emissions test
13.2 - Immunity test
13.3 - Recommended Separation Distances
13.4 - Errors
14 - Accessories14 - Accessories
15 - Specifications15 - 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.
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If this equipment is modified, appropriate inspection and
testing must be conducted to ensure continued safe use of
the equipment.
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.
The operator should not touch accessible parts and the
patient simultaneously.
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.
Replacement of parts can only be done by the manufacturer
or designated service personnel.
Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
The operator should clean the device (handgrips, cushions)
after each exercise test.
For those test subjects who are not able to use the
handgrips, a handgrip fixation set should be used.
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.
The installation should only be done by authorized persons
who follow the installation instructions.
Do not spill any liquid over the device.
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No modification of this equipment is allowed.
Not suitable for use in the presence of flammable
anaesthetics.
Use of this equipment adjacent to or stacked with other
equipment (other then medical equipment intended to be
used as described in the intended use) should be avoided
because it could result in improper operation.
Make sure the pedal straps are used to keep the feet on the
pedals or in the pedal shoes.
The test subject should keep the feet in the pedals or hold
the hand grips during the total duration of the exercise test.
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the ergometer, including cables specified by the
manufacturer. Otherwise, degradation of the performance of
this equipment could result.
The operator should have knowledge about absolute and
relative contraindications. The operator should have
knowledge about the Warnings and Cautions before using
the device.
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The (support of the) Control Unit can’t be used as handlebar
or support.
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.
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.
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3.1 - Free area
The free area around the
ergometer shall be not less than
0,6 m greater than the training
area in the directions from
which the equipment is
accessed. The free area must
also include the area for
emergency dismount. Where
equipment is positioned
adjacent to each other the
value of the free area may be
shared.
4 - Validity
This manual covers all Corival versions starting with the following serial number:
960900 Corival CPET: S/N 20140001 -
960901 Corival Rehab: S/N 20140001 -
960902 Corival Sport: S/N 20140001 -
960903 Corival Pediatric: S/N 20140001 -
Date of first issue: 2014-12-01
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4.1 - Description of parts
1. Saddle (APPLIED PART)
2. Saddle adjustment release
lever
3. On/off switch
4. Pedal (APPLIED PART)
5. Connections
6. Display (APPLIED PART)
7. Handle bar (APPLIED PART)
8. Handle bar adjustment
release lever
9. Type plate
Note that if the bloodpressure
option is included the cuff is
also an APPLIED PART.
Note that if the SpO2 option is
included the sensor is also an
APPLIED PART
Note that a A USB A-B cable is
standard supplied. For rehab
products this cable can only be
used for service purposes. For
cpet products, it can be used for connection to ECG and pulmonary testing devices as well.
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5 - Installation
5.1 - Install the device
Unpack the device while leaving the transport straps in place.
Place the device in the location where it will be used.
Remove transport straps and remaining packaging materials.
Connect the power cord to the line output at the required voltage (see type plate).
Remove all objects from the device.
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”.
- Use the on/off button in order to switch the ergometer off.
5.2 - Connecting cables
The connection for the power
cord and optional connectors
for external devices are hidden
on the lower side of the device.
Tilt the device carefully to the
side and leave it resting on the
handlebar.
You can now connect the cables
and guide them through the
cable guide.
Place the device upright
carefully again.
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5.3 - Cable Management
To make sure that connectors
are not damaged through
pulling them, you need to use
the strain relief.
1. Place the ergometer on its
side. The handlebar will
support the ergometer on the
ground.
2. Remove the strain relief by
pushing the arms in the cavity
inwards.
3. Lead the wires through the
holes in the strain relief as
shown in the picture and place
it back in the ergometer.
Note. There is place for the thick AC cord in the middle and 2 other thinner cables on the sides.
4. Put the ergometer back in upright position.
To connect cables to the ergometer: tilt the device carefully
to the side and leave it resting on the handlebar. Place both
hands on the handle bar and step aside to prevent trapping
of fingers and toes when putting it back upright.
6 - Preparation
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6.1 - Adjusting the saddle position
Lift the lever under the saddle.
The saddle can now be moved
up and down.
Release the lever to lock the
saddle in position.
Note: the patient should not sit
on the saddle while adjusting it.
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Read manufacturer’s guide, advises and instructions and manual
Potential Equalization Conductor
CE and notified body
6.2 - Adjust the handlebar
Unlock the handlebar by
moving the lever away from the
ergometer.
Position the handlebar in de
preferred position by rotating it.
Lock the handlebar by bringing
the lever back to the original
position.
Note: the patient should not
lean on the handlebar while
adjusting it.
7 - List of symbols used
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FCC 18 RF ISM tested
Tested and certified to U.S. and Canadian National Standards by a NRTL, viz
TÜV Rheinland. Compliance for U.S. and Canadian markets.
"ON" position of the on/off switch: IEC 60417-5007 “ON” (power)
"OFF" position of on/off switch: IEC 60417-5008 “OFF” (power)
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
The equipment has a safety earth (ground) connection and must be connected to an
earthed (grounded) wall socket.
External Input
External Control Connector
Class I MEDICAL EQUIPMENT Type B Electrical Safety IEC 60601-1
USB
General warning
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8 - Control with the Lode Ergometry Manager (LEM)
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).
9 - 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).
10 - 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.
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11 - 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.
12 - Calibration
The ergometer should be calibrated once a year. In case any damage is observed of the ergometer
Lode B.V. or his representative should be informed in order to execute the necessary repair(s). Service
of the ergometer is restricted to factory-trained personnel only.
13 - Electromagnetic Compatibility (EMC)
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13.1 - 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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13.2 - 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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13.3 - 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.
13.4 - Errors
When the device has a display, and certain errors occur, error codes may be displayed. The
explanation of these error codes can be found in the service manual.
14 -
Accessories
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