Lode M967900 User manual

M967900 - Manual Angio single
set
Cardio Pulmonary
Lode BV
Zernikepark 16
NL 9747 AN
Groningen
The Netherlands
t: [phone]
f: [phone]
@: [e-mail]
www.lode.nl
M967900 - MANUAL ANGIO SINGLE SET / VERSION: 1.0 - 2017-02-23

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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
4.2 - Angio - description of parts bottom side
5 - Installation5 - Installation
5.1 - General installation of the device
5.2 - Cable Management
6 - Terminal - external control6 - Terminal - external control
6.1 - External control with optional communication card
6.2 - External control with LEM or LCRM
6.3 - Display
7 - List of symbols used7 - List of symbols used
8 - Maintenance8 - Maintenance
9 - Cleaning9 - Cleaning
10 - Calibration10 - Calibration
11 - Accessories11 - Accessories
12 - Specifications12 - 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.
If the device is used as arm ergometer (with hand curbles) it can be combined with various products
(e.g. wall mounts, automatic stand, etc.) to facilitate the stress tests. The device in those situations can
be used for (cardiac) rehabilitation or cardio pulmonary exercise testing with patients who can’t use
their legs (f.i. wheelchair users).
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.
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Care should be taken in mounting or dismounting the
ergometer. Be aware of feet when replacing the ergometer.
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, BP measurements or SpO2
monitoring 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.
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.
The (support of the) Control Unit can’t be used as handlebar
or support.
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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.
Take care that the cable of the control unit cannot get stuck
between the cranks when using the ergometer.
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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.
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.
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4 - Validity
This manual covers all Angio versions starting with the following serial number:
9679xx Angio cpet: S/N 20170001 -
Date of issue: 2017-01-31
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4.1 - Description of parts
1.Handgrips for transport
2.Communication ports
3.Main On/off switch
4.Hand curble or Pedal
(APPLIED PART)
5. Connector - not in use
6.Display
7.Adjustable support control
unit (not for arm ergometers)
8.Type plate
Note that if the SpO2 option is
included, the sensor is also an
APPLIED PART
Note that 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.
Note: check the angle of the
display: the patient must be
able to have a clear view on the
display to see the pedal
revolution (rpm).
Note: be aware of hands near
the display-arm! Tighten the
knobs of the display-arm to
prevent dropping.
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4.2 - Angio - description of parts bottom side
2 - cable connections
6 - Identification plate
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5 - Installation
5.1 - General installation of 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
- Use the on/off button in order to switch the ergometer off.
For a detailed desciption of the installation procedure, we refer to the Installation Instruction available
for authorized service personnel.
5.2 - Cable Management
The connection for the power cord and optional connectors for external devices are placed out of sight
on the bottom side of the device.
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.
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.
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6 - Terminal - external control
6.1 - External control with optional communication card
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 Cart.
2. Download the interfacing instructions from the internet at www.lode.nl after you have registered
your device.
3. Select “Terminal mode” on the control unit to allow external commands. (See for detailed
instructions the user manual of your external device).
6.2 - External control with LEM or LCRM
1. If your device has an optional RS232 or USB port, connect it directly to the PC on which the Lode
software is installed. If your device has a RJ45 connector plug connect 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 Software on your PC.
3. Select “Terminal” mode to allow external command. The terminal mode is automatically recognized
by LEM and LCRM. (See for detailed instructions the user manual of LEM or LCRM).
6.3 - Display
When your device is executed with a single display in display mode, it will only display data. It is not
able to steer the ergometer. It is intended to be used in terminal mode. You can change the settings
for communication and language of the device.
To be able to control the ergometer you will need the optional 945834 Control Unit with touch screen
7" for ergometer or 945835 Programmable Control Unit for ergometer.
For the functioning of the display and/or control units, we refer to the manuals M945810, M945834
and M945835 which can be found on the supplied CD with additional information. The most recent
version in many other languages can always be downloaded from Lode website.
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Read manufacturer’s guide, advises and instructions and manual
Potential Equalization Conductor
CE and notified body
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
7 - List of symbols used
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External Control Connector
Class I MEDICAL EQUIPMENT Type B Electrical Safety IEC 60601-1
USB
General warning
8 - 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.
9 - Cleaning
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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.
The operator should clean the device (handgrips, cushions)
after each exercise test.
Do not spill any liquid over the device.
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10 - 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.
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11 -
Accessories
Control Unit with 7"
touch screen for
ergometer
Partnumber: 945834Partnumber: 945834
Multifunctionality
Control Unit with
Touchscreen
Programmable Control
Unit with 7"
Touchscreen for ...
Partnumber: 945835Partnumber: 945835
Programmable
Programmable Control Unit
Blood Pressure with
ECG trigger for bicycle
ergometer
Partnumber: 945828Partnumber: 945828
with ECG trigger
Blood Pressure Measurement
with ECG trigger
Heart rate for bicycle
ergometers
Partnumber: 945821Partnumber: 945821
Heart rate in beats per
minute
Heart rate for bicycle
ergometers
SpO2 for control unit
with touch panel
(bicycle)
Partnumber: 945823Partnumber: 945823
Saturation and heart
rate
SpO2 for control unit with
touch panel
Pedal shoes (pair)
Partnumber: 917803Partnumber: 917803
Extra stability during
cycling
Pedal shoes for foot fixation
Pedal shoes pediatric
(pair)
Partnumber: 917833Partnumber: 917833
Pedal shoes for childen
Pedal shoes for children
Adjustable cranks
Partnumber: 928804Partnumber: 928804
Optimal force
application
For different leg/arm length
Handgrips (pair)
Partnumber: 917812Partnumber: 917812
Versatile ergometry
Handgrips (pair)
Handgrip fixation set
Partnumber: 917822Partnumber: 917822
Handgrip fixation set
Handgrip fixation set
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USB to Serial converter
Partnumber: 226012Partnumber: 226012
Easy connection
USB to Serial converter
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12 - Specifications
Workload
Minimum load 7 W
Maximum peak load 1000 W
Minimum load increments 1 W
Maximum continuous load 750 W
Hyperbolic workload control
Linear workload control
Fixed torque workload control
Maximum rpm independent constant load 150 rpm
Minimum rpm independent constant load 30 rpm
Optional heart rate controlled workload
Electromagnetic "eddy current" braking system
Accuracy
Workload accuracy from 7 to 100 W 3 W
Workload accuracy from 100 to 500 W 3 %
Workload accuracy from 500 to 1000 W 5 %
User Interface
Readout Distance
Readout RPM
Readout Heartrate
Readout target HR
Readout Energy
Readout Torque
Readout Time
Readout Power
Set Display
Set Resistance
Set P-Slope
Set Mode
Manual operation mode
Preset protocol operation mode
External control unit
Selfdesigned protocol operation mode
Dimensions
Product weight 40 kg 88.2 lbs
Power requirements
V AC 100-240 V
Phases 1
Frequency 50/60 Hz
Power consumption 160 W
Power cord IEC 60320 C13 with CEE 7/7 plug
Power cord NEMA
Standards & Safety
IEC 60601-1:2012
ISO 13485:2016 compliant
ISO 9001:2015 compliant
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
CB according to IECEE CB - pending
Environmental conditions
Maximum operational temperature 35 °C
Minimum operational temperature 14 °C
Maximum operational air pressure 106 kPa
Minimum operational air pressure 80 kPa
Maximum operational non-condensing
humidity 90 %
Minimum operational non-condensing
humidity 30 %
Maximum storage & transport temperature 60 °C
Minimum storage & transport temperature -20 °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 967900
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