Lode Corival CPET Manuel utilisateur
M9609XX Manual - Corival 2015
Cardio Pulmonary
Lode BV
Zernikepark 16
NL 9747 AN
Groningen
The Netherlands
t: +31 50 571 28 11
f: +31 50 571 67 46
@: ask@lode.nl
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.
3/24M960900 / VERSION: 1.0 - 2014-09-24
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.
4/24M960900 / VERSION: 1.0 - 2014-09-24
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.
5/24M960900 / VERSION: 1.0 - 2014-09-24
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.
6/24M960900 / VERSION: 1.0 - 2014-09-24
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.
7/24M960900 / VERSION: 1.0 - 2014-09-24
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
8/24M960900 / VERSION: 1.0 - 2014-09-24
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.
9/24M960900 / VERSION: 1.0 - 2014-09-24
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.
10/24M960900 / VERSION: 1.0 - 2014-09-24
Ce manuel convient aux modèles suivants
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