h/p/cosmos 150/50 Service manual
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operating and service manual
h/p/cosmos®running machines
N150/50 (mercury®)
N170-190/65 (quasar®/ pulsar®)
N190/65 3p (pulsar®3p)
N200-450/75-300 (venus®/ saturn®)
h/p/cosmos®model names
h/p/cosmos mercury®/ mercury®med
h/p/cosmos stratos® / stratos®med
h/p/cosmos locomotion®150/50 E / DE med
h/p/cosmos gaitway®II F / S
incl. lt-models
h/p/cosmos quasar®/ quasar®med
h/p/cosmos stellar®/ stellar®med
h/p/cosmos pulsar®
h/p/cosmos locomotion®190/65 E / DE med
incl. lt-models
h/p/cosmos pulsar®3p
h/p/cosmos locomotion®190/65 3p E / DE med
incl. lt-models
h/p/cosmos venus®- all sizes
h/p/cosmos saturn®- all sizes
development, production, sales &service
h/p/cosmos®sports &medical gmbh
Am Sportplatz 8
DE 83365 Nussdorf-Traunstein
Germany
phone +49 86 69 86 42 0
fax +49 86 69 86 42 49
www.h-p-cosmos.com
manual-version
firmware MCU5-v1.07, revision 07.02.2013
manual order-no.: [cos14310m5-v1.07hpc-en]
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This user manual / operating instructions / service guide is only valid for the firmware-/software version noted on the first
page of this manual and only for the original configuration of the first delivery of the machine. Firmware updates, software
updates, changes of the system configuration or retrofittings of additional equipment or accessories can result in invalidity of
this manual. In case of alterations of the device or the additional equipment; the latest version of the manual or the
corresponding additional information always should be considered.
The latest manual version is always available in PDF version on the h/p/cosmos website:
http://www.h-p-cosmos.com/en/company/downloads.htm
NIt is strictly forbidden to perform any amendments of the technical design, technical
specifications, labelling and configurations (except allowed programming as described in this
manual) of this machine and the software and accessories connected to this machine.
NAny amendments, unauthorized, poor or lack of service / maintenance will result in loss of
manufacturer’s liability and warranty.
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Dear customer,
We would like to express our gratitude for putting your trust in us, in deciding for this top of the range running machine.
Since 1988 h/p/cosmos®has been developing and manufacturing running machines, systems and accessories for
applications in sports, rehabilitation, medicine, diagnostics and science. When it comes to technology, ergonomy, design and
safety, we have set extremely high standards for ourselves.
Because the running machine is a motor-driven device, you must pay special attention to the mentioned safety regulations.
If proper notice is taken of the safety regulations, the operation of our running machines is nearly without risk.
Neglect of the safety regulations could result in dangerous situations and accidents with serious injury or death. Therefore
please read this operating and service manual and the danger precautions in full before taking the device into operation.
Some simple maintenance and monitoring (no repair work!), as described, can easily be done or even have to be done by
yourself. All kinds of installation and repair work and most maintenance work are to be performed only by trained and
authorized technicians who have been certified by h/p/cosmos. The following symbols will indicate which work can be done
by the customer and which work has to be done only by authorized technicians:
The customer/user should perform this maintenance and monitoring work. Some safety checks or monitoring
(for examples harnesses and ropes, running belt condition and position, etc.) have to be performed on daily
basis. It is not expedient to contract certified technicians for such maintenance work. However, where it is
practical, all maintenance and monitoring work marked with this symbol can also be performed by certified
technicians.
All installation, maintenance, repair and monitoring work marked with this symbol must only be performed by
trained and authorized technicians who have been certified by h/p/cosmos. Customers/users must not
perform these kinds of tasks and work.
We recommend calling our competent service team or entering into a maintenance contract for a routine service at an
interval of 6 or 12 months for standard machines and standard applications. A form for registration of your institution and
device is included in the delivery. In order to be able to supply you with the latest technical information and service, it is
important for you to fill out the form. Therefore please fill out the form for registration immediately and send it back via fax,
email or mail.
This operating and service manual as a firm part of the delivery has to be accessible to the user at any time. It has been
written with great care. Should you, however, still find any details which do not correspond with your device, please notify us
so that we can correct any mistakes as soon as possible. Subject to alterations without prior notice.
Errors and omissions excepted. E & OE.
We wish you a lot of fun and success while exercising and working with your h/p/cosmos running machine.
h
Franz Harrer
President & CEO
h/p/cosmos sports & medical gmbh
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1Model overview...............................................................................................................................................................9
2Introduction ..................................................................................................................................................................11
2.1 Description .....................................................................................................................................................................11
2.2 Device components, including software and accessories..............................................................................................11
2.3 Safety equipment ...........................................................................................................................................................12
3Intended use / indications, contraindications, risks & forbidden use.....................................................................14
3.1 Intended use / indications...............................................................................................................................................14
3.2 Contraindications............................................................................................................................................................15
3.3 Risks...............................................................................................................................................................................16
3.4 Forbidden use ................................................................................................................................................................18
4Safety notes, warnings, precautions..........................................................................................................................19
4.1 General...........................................................................................................................................................................19
4.2 Preparation of the patient / user.....................................................................................................................................20
4.3 Preparation of the running machine...............................................................................................................................20
4.4 During treadmill exercise................................................................................................................................................21
4.5 Machine care..................................................................................................................................................................23
5Operation ......................................................................................................................................................................24
5.1 General...........................................................................................................................................................................24
5.2 Switch on procedure.......................................................................................................................................................26
5.2.1 Switch on procedure model range 150/50 up to 190/65....................................................................................26
5.2.2 Switch on procedure model range 200/75 up to 450/300 (venus/saturn).......................................................... 27
5.3 Switch off procedure.......................................................................................................................................................28
5.3.1 Switch off procedure model range 150/50 up to 190/65....................................................................................28
5.3.2 Switch off procedure model range 200/75 up to 450/300..................................................................................29
5.4 Emergency Stop, stop buttons, stop functions and safety features ...............................................................................30
5.5 UserTerminal / Control Terminal....................................................................................................................................32
5.5.1 The keyboard.....................................................................................................................................................33
5.5.2 The display.........................................................................................................................................................33
5.5.3 External UserTerminal control unit.....................................................................................................................35
5.5.4 TouchPanel........................................................................................................................................................36
5.6 Application: Ergometry / Cardiology ECG treadmill stress test......................................................................................38
5.7 Application: Gait analysis and rehabilitation with neurologic patients ............................................................................38
5.8 Application: Gait analysis and rehabilitation with force measurement plates.................................................................38
5.9 Modes of operation.........................................................................................................................................................40
5.9.1 Acceleration levels.............................................................................................................................................41
5.9.2 Manual mode.....................................................................................................................................................43
5.9.3 Profile mode.......................................................................................................................................................44
5.9.4 Cardio mode ......................................................................................................................................................49
5.9.5 Test mode..........................................................................................................................................................53
5.9.5.1 Standard ergometric tests........................................................................................................................54
5.9.5.2 Additional profiles.....................................................................................................................................59
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5.9.5.3 Programming example: user-defined profile ............................................................................................67
5.10 Optional settings: User Options......................................................................................................................................71
5.10.1 Standard settings for the user options...............................................................................................................77
6Operating manual: running machines for sports andfitness c...........................................................................78
7Service manual.............................................................................................................................................................79
7.1 Safety notes, warnings, precautions ..............................................................................................................................79
7.1.1 Room conditions................................................................................................................................................79
7.1.2 Transport and Installation .......................................................................................................................80
7.1.3 Maintenance and safety inspections ......................................................................................................81
7.2 Electrical safety features................................................................................................................................................82
7.3 Medical device software classification............................................................................................................................83
7.4 Installation & commissioning ..............................................................................................................................84
7.4.1 Unpacking and packaging ......................................................................................................................84
7.4.2 Transport ................................................................................................................................................85
7.4.3 Storage..............................................................................................................................................................87
7.4.4 Environmental requirements / room configuration ..................................................................................87
7.4.5 Mechanical installation ...........................................................................................................................89
7.4.6 Electrical installation ...............................................................................................................................90
7.4.6.1 Electric safety measurements and “First Measured Values“....................................................................92
7.4.6.2 Potential equalization (only for medical treadmills)..................................................................................92
7.4.6.3 General notes and benefits of potential equalization ...............................................................................92
7.4.6.4 Plug assignment at the UserTerminal......................................................................................................93
7.4.7 Cable connections models 200-300/75-125 (venus / saturn) ............................................................................98
7.4.8 Connection of external host and / or auxiliary devices via interface .....................................................100
7.4.9 Programmable, electrical medical systems (PEMS) / In-house production ..........................................101
7.4.10 Installation checklist and instruction of the user ...................................................................................106
8Maintenance and safety inspections........................................................................................................................108
8.1 Preventive maintenance ......................................................................................................................................108
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8.2 Immediate maintenance ...................................................................................................................................108
8.3 Regular inspections / examinations..............................................................................................................................109
8.3.1 Visual inspections .................................................................................................................................109
8.3.2 Protective earth resistance (RPE) measurement ...................................................................................110
8.3.3 Isolation resistance (RISO) measurement .............................................................................................110
8.3.4 Equivalent (alternative) leakage current (IEDL) measurement ...............................................................110
8.3.5 Leakage current measurement ............................................................................................................111
8.3.6 Electric safety tester and measurements .............................................................................................111
8.3.7 Building installation: Electric checks, protective earth function, RCD, leakage current ........................112
8.4 Lubrication of the running belt / running surface .................................................................................................112
8.4.1 Devices with UserTerminal and without automatic oil-pump ...........................................................................113
8.4.2 Lubrication film test .................................................................................................................................114
8.4.3 Devices without UserTerminal and without automatic oil pump .............................................................115
8.4.4 Devices with UserTerminal & automatic oil pump (models "r" for cycle & wheelchair) ...........................116
8.4.5 Refilling oil tank ......................................................................................................................................117
8.4.6 Resetting of oil message ........................................................................................................................118
8.5 Control and tightening of the running belt .........................................................................................................118
8.6 Adjustment (centring) of the running belt ............................................................................................................119
8.7 Control and tightening of the driving belt (poly-V belt system) .........................................................................120
8.7.1 Checking the tension of the driving belt with the “slipping-test“.......................................................................120
8.7.2 Checking the tension of the driving belt with the frequency test......................................................................121
8.8 Driving belt with timing belt system (from running deck size 200/75 upwards) ................................................122
8.9 Side step platforms: check for non-slipping ......................................................................................................122
8.10 Hygiene and cleansing.................................................................................................................................................122
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8.10.1 Cleansing of outside and applied parts ..................................................................................................122
8.10.2 Cleaning of the interior .........................................................................................................................123
8.11 Cleansing and adjustment of the speed sensor / light barrier ...........................................................................123
8.12 Light barrier at belt re-entry zones ...............................................................................................................................124
8.12.1.1 Cleaning of light barriers .............................................................................................................124
8.12.2 Adjustment of light barriers ...................................................................................................................124
8.13 Spare parts & consumables.........................................................................................................................................124
9Trouble shooting ............................................................................................................................................ 125
9.1 Mechanical noise problems..........................................................................................................................................125
9.2 Running belt adjustment problems...............................................................................................................................125
9.3 Fuses............................................................................................................................................................................125
9.4 Electrostatic discharge.................................................................................................................................................126
9.5 Sources of interference................................................................................................................................................126
9.6 Voltage on the device housing / electric shock ............................................................................................................127
9.7 POLAR heart rate measurement system .....................................................................................................................127
9.8 RS232 interface............................................................................................................................................................128
9.8.1 Troubleshooting and testing of the RS232 interface........................................................................................128
9.9 MCU control unit / circuit board, battery.......................................................................................................................128
9.10 Error messages............................................................................................................................................................129
10 Optional settings: administrator options .....................................................................................................135
10.1 List of running machines types.....................................................................................................................................145
11 Technical data ............................................................................................................................................................146
11.1 Running machines, 150/50 (mercury)..........................................................................................................................146
11.2 Running machines, 170-190/65 (quasar / pulsar)........................................................................................................148
11.3 Running machines, 190/65 (pulsar 3p) ........................................................................................................................150
11.4 Running machines, oversize 200-450/75-300 (venus / saturn)....................................................................................152
11.5 Electromagnetic compatibility (EMC) and immunity: Guidance and manufacturer's declaration .................................154
11.6 Compatible devices......................................................................................................................................................156
11.7 Interface protocols........................................................................................................................................................157
11.8 Economic life time........................................................................................................................................................157
12 Accessories and options...........................................................................................................................................158
12.1 Arm support..................................................................................................................................................................158
12.2 Additional keyboard and additional stop button for arm support and remote control...................................................159
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12.3 Special handrails..........................................................................................................................................................160
12.4 Handrails, adjustable with gear tooth locking elements ...............................................................................................161
12.5 Handrails, adjustable: Parallel bars with gas struts and locking lever..........................................................................162
12.6 Therapist’s seat and foot support, adjustable...............................................................................................................164
12.7 Unweighting system h/p/cosmos airwalk se 135..........................................................................................................165
12.8 Unweighting systems airwalk 70/160...........................................................................................................................166
12.9 Vests for subjects for airwalk systems..........................................................................................................................166
12.10 h/p/cosmos robowalk®expander..................................................................................................................................166
12.11 Wheelchair ramp..........................................................................................................................................................167
12.12 Wheelchair stabilizer for oversize running machines...................................................................................................167
12.13 Safety arch with chest belt system...............................................................................................................................167
12.14 Reversible running belt rotation for downhill walk........................................................................................................169
12.15 Pull cord safety stop actuator.......................................................................................................................................170
12.16 Bottle holder, drinking bottle.........................................................................................................................................170
12.17 Retrofitting UserTerminals / laptop for external control unit.........................................................................................171
12.18 Retrofitting emergency stop buttons.............................................................................................................................172
12.19 Safety multiple socket ..................................................................................................................................................172
12.20 RS232 interface / USB converter.................................................................................................................................173
12.21 POLAR heart rate measurement system .....................................................................................................................174
12.22 „Science port“ / raw data of speed sensor....................................................................................................................175
12.23 PC software h/p/cosmos para control®4.1...................................................................................................................176
12.24 PC Software h/p/cosmos para graphics®.....................................................................................................................177
12.25 PC Software h/p/cosmos para analysis®......................................................................................................................178
12.26 PC Software h/p/cosmos para motion®........................................................................................................................179
13 Disposal ......................................................................................................................................................................180
14 Appendix 1: Certificates............................................................................................................................................181
14.1 Certificate of the TSA (TÜV) according to ISO 9001....................................................................................................181
14.2 Certificate of the TSA (TÜV) according to EN ISO 13485............................................................................................182
14.3 EC Certificate of the TSA (TÜV)...................................................................................................................................183
15 Appendix 2..................................................................................................................................................................184
15.1 Calculation of the UKK Fitness Index...........................................................................................................................184
15.2 Instruction protocol, checklist.......................................................................................................................................185
15.3 Instruction protocol, signatures ....................................................................................................................................190
15.4 Service report – [cos15531] .........................................................................................................................................191
15.5 Control protocol – [cos11690en-02].............................................................................................................................192
15.6 Wiring diagram load circuit quasar®med / pulsar®.......................................................................................................193
15.7 Wiring diagram control circuit quasar®med / pulsar®– page 1....................................................................................194
15.8 Wiring diagram control circuit quasar®med / pulsar®– page 2....................................................................................195
16 Appendix 3: Symbols.................................................................................................................................................196
17 Contact........................................................................................................................................................................197
model overview
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1Model overview
n
medical
running machines
c
sports & fitness
running machines
h/p/cosmos locomotion®150/50 E med
h/p/cosmos locomotion®150/50 DE med
h/p/cosmos locomotion®190/65 E med
h/p/cosmos locomotion®190/65 DE med
h/p/cosmos locomotion®190/65-3p E med
h/p/cosmos locomotion®190/65-3p DE med
h/p/cosmos stratos®lt med
h/p/cosmos stratos®med
h/p/cosmos mercury®lt med
h/p/cosmos mercury®med
h/p/cosmos Kistler Gaitway®II F
h/p/cosmos Kistler Gaitway®II S
h/p/cosmos stratos®lt
h/p/cosmos stratos®
h/p/cosmos mercury®lt
h/p/cosmos mercury®
h/p/cosmos stellar®lt med
h/p/cosmos stellar®med
h/p/cosmos quasar®lt med
h/p/cosmos quasar®med
h/p/cosmos pulsar®lt
h/p/cosmos pulsar®
h/p/cosmos pulsar®lt 3p
h/p/cosmos pulsar®3p
h/p/cosmos stellar®lt
h/p/cosmos stellar®
h/p/cosmos quasar®lt
h/p/cosmos quasar®
h/p/cosmos venus®200/75
h/p/cosmos venus®200/75r
h/p/cosmos venus®200/100
h/p/cosmos venus®200/100r
h/p/cosmos saturn®250/75
h/p/cosmos saturn®250/75r
h/p/cosmos saturn®250/100
h/p/cosmos saturn®250/100r
h/p/cosmos saturn®250/125r
h/p/cosmos saturn®300/75
h/p/cosmos saturn®300/75r
h/p/cosmos saturn®300/100
h/p/cosmos saturn®300/100r
h/p/cosmos saturn®300/125r
h/p/cosmos saturn®450/300rs
model overview
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h/p/cosmos saturn®300/125r
h/p/cosmos saturn®450/300rs
introduction
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2Introduction
2.1 Description
A running machine (also called “treadmill ergometer”) is an exercise device for running or walking while staying in one
place. The h/p/cosmos running machines are stationary treadmills which are used for training and testing, simulating
various adjustable speeds and various adjustable elevations (also called “slope” or “inclination”). The medical versions
can also be used for diagnostics and therapy applications. The machine provides a moving platform with a wide
conveyor belt and an electric motor. The belt moves to the rear allowing a person to walk or run an equal, and
necessarily opposite, velocity. The rate at which the belt moves is the rate of walking or running. Thus, the speed of
running may be controlled and measured.
The patient (for sports devices called “subject”)is asked to follow the speed of the belt and keep his position on the deck.
By walking and/or running, the physical condition of the patient can be analysed through a treadmill stress test protocol
and additional ECG or VO2max. (metabolic cart) diagnostic device. In physiotherapy and neurologic application the
patient can be additionally secured and un-weighted with a body weight support system and the gait can be analysed
and corrected under safe and reproducible conditions.
Duration of use of the medical versions is approx. 5 to 25 minutes per patient per day, depending on the prescription of
the doctor, the condition of the patient and depending on the standardized or individual load protocol (for example
BRUCE protocol).
The running surface areas range from 150 x 50 cm (59.0 x 19.7 inches) to 450 x 300 cm (177.2 x 118.1 inches). Max.
allowed subject weight on running deck is 200 kg (440 lbs). Treadmills have handrails on both sides. Technical details
are given in chapter N “Technical data” on page 146.
2.2 Device components, including software and accessories
[1] UserTerminal (cockpit) with displays and keyboard *
[2] pull cord safety stop actuator *
[3] emergency stop button (mushroom style) *
[4] heart rate measurement system (receiver board)
the transmitter with chest belt * is an applied part
[5] handrail crossbar (front) *
[6] handrails (side) *
[7] motor hood/cover
[8] tread plate with slip resistant surface
[9] running surface (gliding plate/deck)
[10] running belt *
[11] rollers (behind the belt)
[12] roller cover
[13] base frame
[14] elevation element
[15] option/accessory: safety arch with fall-stop
prevention
[16] option/accessory: chest-belt/harness * for safety arch
[17] option/accessory: arm support *
[18] option/accessory: keyboard for arm support *
[19] option/accessory: stop button for arm support *
* applied parts based on definition in IEC 60601-1
h/p/cosmos quasar®med treadmill with optional safety arch with chest
belt system for fall stop prevention and optional arm support for
additional stabilization of the patient.
introduction
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h/p/cosmos®treadmills consist of a heavy duty drive system with high capacity and inverter controlled drive motor,
optional elevation system for simulating gradient/elevation (uphill, optional downhill), UserTerminal (models without “lt”)
with clear LCD displays and keyboard including firmware for operation, emergency stop button, interface with coscom
interface protocol for possible connection to ECG or other medical devices, e.g. POLAR heart rate monitor. h/p/cosmos
offers a lot of accessories and options that can be used together with the treadmill. The figure above shows an
h/p/cosmos quasar med treadmill with optional safety arch with chest belt system for fall stop prevention and optional
arm support for additional stabilization of the patient. Adjustable handrails, other different shaped handrails and a
wheelchair ramp are also available. For further details, see chapter N “Technical data”.
The following materials are used: mainly powder coated steel tubes for the frame, conventional rubber or PVC for the
running belt, conventional frequency inverter and drive motor for belt speed control, conventional LCD Display and
keyboard for the UserTerminal, conventional electric and electronic components and conventional plastic parts.
Contact with the body occurs through walking shoes on the running belt, through hand palms on handrail grips when the
patient holds the handrail, through chest belt if the patient wears the chest belt and harness for heart rate detection
and/or for fall stop prevention, on forearms if the patient utilizes the optional arm support and through fingers if the
patient is allowed to press keyboard and/or emergency stop on the UserTerminal of the device. There is no physical
contact to organs, tissues or body fluids.
The h/p/cosmos para control®software is for remote control of the treadmill, loading parameters and for maintenance
issues. Software products such as h/p/cosmos para graphics®, h/p/cosmos para analysis®and h/p/cosmos para motion®
can be optionally applied for further data analysis and documentation, especially to be used for sports and fitness
applications. The h/p/cosmos software is neither intended for medical diagnosis nor medical evaluation. The medical
treadmill can support the doctor and patient when performing stress tests and movement therapy / locomotion therapy of
walking and running.
In medical diagnostics and therapy, the recommended and right endurance dose of the load parameter (speed,
elevation, distance, heart rate, body weight support, motion support, etc.) and specific application is decided and
supervised by the doctor. A number of training profiles and standardized protocols e.g. Bruce, Naughton, Cooper,
Ellestad A, Gardner, etc. are available, but the treadmill does not calculate medical parameters, nor does it perform
medical diagnoses or medical evaluation. Finally, it does not give recommendations for treatment.
2.3 Safety equipment
For any use with patients or other subjects for whom a fall would constitute a serious accident (for example after hip
replacement operations, patients with neurologic problems, patients connected to invasive probes, maximum load tests,
running at high speeds, running side wards, co-ordination training, etc.) or injuries, a fall prevention system such as a
safety arch with chest belt system and stop-function or an unweighting system (for example the h/p/cosmos airwalk) is
obligatory. The chest belt secures the subject and prevents falling forward. The chest belt system is connected via a pull
rope with the emergency stop at the crossbar of the safety arch. If more than approx. 8 kg / 17.6 lbs traction pulls on the
harness, the switch stops the running belt immediately. The length of the harness is individually adjustable. The running
belt is stopped in the moment of falling.
Unweighting systems as an accessory (for example the h/p/cosmos airwalk) can be used for body weight support of the
patient, in case the patient should not bear his full body weight on his legs.
A pull cord safety stop actuator (with magnetic switch) can be attached to the subject.
introduction
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The safety stop cord type and/or the safety arch with chest belt system and stop-function limits the range of motion of
the subject to the front 70% of the running deck length if adjusted properly. The actuator cord should have a suitable
length so that the actuator releases at a position not more than 70% of the length of the running surface. In case the
subject cannot maintain the speed and falls behind to the rear 30% of the running deck length, or in case the subject
falls, the safety stop cord type and/or the safety arch with chest belt system will trigger a stop function of the treadmill
and will stop the running belt.
Caution! The pull cord safety stop actuator cannot prevent the subject from falling and is therefore not as safe as the
safety arch with chest belt system and fall prevention or the unweighting system!
The big and highly visible emergency stop button is standard on all models and is placed on the handrail or
UserTerminal for easy access. An additional emergency stop button can be retro-fitted at all h/p/cosmos running
machines. It can, for example, be duplicated on the opposite handrail.
h/p/cosmos conforms with the norm EN 957-6: “The push-button type or pull cord safety stop actuator shall be in a
reachable position in front of the user and in an area of ± 180 mm parallel to the centre line of the running surface. If the
push-button type safety stop actuator is outside this area, it shall be duplicated on the opposite side except when a pull-
cord actuator is provided.”
h/p/cosmos can supply a second and additional emergency stop button and/or pull cord safety stop actuator and/or a
safety arch with chest belt system fall stop function.
On all medical treadmills the emergency stop push button is simultaneously an emergency off button. That means by
pushing this button the power supply of the device is cut off.
Fall prevention system: safety arch with chest belt
system and stop.
h/p/cosmos arm support with integrated additional
keyboard and integrated additional stop button.
h/p/cosmos airwalk unweighting systems for body weight support, can also be used as fall prevention system.
Emergency stop button on the UserTerminal. Triggers
bi-polar disconnection from the mains (power supply).
Additional emergency stop push button can be
mounted on the opposite handrail of the treadmill.
Safety stop pull cord actuator with waist belt.
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3Intended use / indications, contraindications, risks & forbidden use
The intended application, discussed in the following, can be performed with any h/p/cosmos medical treadmill model,
although there are more or less recommended solutions. Consider obligatory safety accessories (for example unweighting
systems, optional safety arch with chest belt system for fall stop prevention and optional arm support for additional
stabilization of the patient, adjustable handrails, etc.) as described in the respective chapters.
3.1 Intended use / indications
NEndurance training walking and running
NEndurance tests and EMG-measuring (only with safety arch and chest belt system)
NErgometry, exercise-ECG and ergospirometry (only with safety arch and chest belt system)
NGait training
NRecreational fitness training
NDiagnosis and prognosis of cardiovascular disease, specifically coronary artery disease (CAD) by treadmill stress
test (the treadmill is only the stress device, but does not perform diagnosis)
NTherapy of orthopaedic problems, e.g. arthritis in foot ankle, femoropatellar syndrome, knee joint problems,
anterior cruciate ligament plastic
NGait analysis and gait correction for stroke patients
Children are only allowed to use the running machine under constant supervision of a medical
doctor or therapist and only when safeguarded by safety arch with chest belt system.
Additionally, h/p/cosmos recommends the use of adjustable handrails.
The correct loading form of velocity, stride length, kind of course of motion on the treadmill, elevation, duration, total
distance as well as loading / unloading of the patient by an unloading system must be prescribed by a medical doctor.
The treadmill manufacturer cannot make any declaration or recommendation, because the therapy depends on the
patient, the clinical picture, the degree of disability and the progress of rehabilitation.
The medical treadmills may be operated only in medical facilities by medical staff.
The safety requirements in particular requirements for medical electrical equipment and medical electrical systems for
medical care in a home environment (IEC 60601-1-11) - are not considered in the medical device, h/p/cosmos
treadmill ergometer.
An application of the h/p/cosmos medical treadmills in a home or public environment and/or
operation by persons who are not medically trained is not allowed.
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3.2 Contraindications
Contraindications have to be excluded before the treadmill is used.
It makes sense to distinguish between absolute and relative contraindications. In case of relative contraindications, the
application may be started if the possible benefits exceed the risks of application. The decision has to be made by a
medical doctor.
Absolute contraindications:
NAcute myocardial infarction (within 2 d)
NInstable angina pectoris
NCardiac arrhythmia pathology and/or limited hemodynamics
NSymptomatic massive aortic stenosis
NUncompensated / uncontrolled heart insufficiency
NAcute pulmonary embolism or pulmonary infarction
NAcute endocarditis, myocarditis, pericarditis
NAcute aortic dissection
NAcute coronary syndrome
NAcute phlebothrombosis of the lower extremities
NFebrile infections
NPregnancy
NAcute thrombosis
NFresh wounds e.g. after surgery
NAcute fracture
NDamaged disc or traumatic disease of the spine
NEpilepsy
NInflammations
NAcute migraine
Relative contraindications:
NLeft main coronary stenosis
NMain artery disease
NCardiac valve disease of moderate severity
NKnown electrolyte imbalance
NArterial hypertonia (RR > 200 mm Hg syst. > 110 mm Hg diast.)
NTachyarrhythmia or bradyarrhythmia
NHypertrophic cardiomyopathy and other forms of outflow tract obstruction
NHigher degree atrioventricular AV-blocking
NAnemia
NPhysical and/or mental disabilities leading to inability to exercise adequately
Also see following guidelines:
Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e.V. (http://leitlinien.dgk.org).
American College of Cardiology Foundation - www.acc.org
American Heart Association - www.americanheart.org
http://my.americanheart.org/idc/groups/ahaecc-internal/@wcm/@sop/documents/downloadable/ucm_423807.pdf
Further contraindications may occur. This has to be evaluated by the responsible medical doctor.
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3.3 Risks
In the event of overload of the patient due to wrong application and/or wrong assessment and/or unexpected problems,
the following risks, problems and injuries may occur. Risks are reduced by correct load dosing (according to the clinical
picture and condition of the patient). Especially for ergometry (stress-test) application, the patient is subject to additional
risk since the test is designed to stress the patient until cardiovascular problems may occur. The risk remains even in
the presence of trained, medical staff and even when medical equipment and a defibrillator for reanimation are
available. The higher risk cannot be reduced even with the knowledge of contraindications. Neither can loading capacity
nor cognition restrictions be excluded by contraindications.
The risk of falling and consequential injuries is reduced by the safety equipment and application of a fall prevention
system.
Remaining risks in ergometry / stress testing
The following complications are mentioned in the “Praxisleitlinien Ergometrie”:
(Wonisch M, Berent R, Klicpera M, Laimer H, Marko C, Pokan R, Schmid P, Schwann H. [Practice Guidelines for
ExerciseTesting], J Kardiol 2008; 15 (Suppl A): 3-17)
Cardiac complications Frequency
Morbidity < 0.05 %
Lethal complications 0.03 – 0.04 %
Non-lethal complications 0.07 – 0.15 %
Acute MCI 0.035 – 0.1 %
Acute cardiac death < 0.005 %
Ventricular tachyarrhythmia 0.05 % - 2.3 %
Supraventricular tachyarrhythmia
- in case of known paroxysmal
supraventricular arrhythmia
- atrial fibrillation, atrial flutter
3.4 – 15 %
< 1 %
Ventricular extrasystoly 2 – 20 %
Supraventricular extrasystoly 4 – 24 %
Paroxysmal atrial fibrillation 0.8 %
Transient left bundle-branch block 0.4 %
Bradyarrhythmia
Hypotony 3 – 9 %
Hypertensive blood pressure
regulation n.s.
Ventricular rupture n.s.
Papillary muscle rupture n.s.
Non-cardiac complications
Intracranial haemorrhage n.s.
Thromboembolic event n.s.
Transient global amnesia n.s.
Arthralgia n.s.
Myalgia n.s.
Low back pain n.s.
n.s.: not specified
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General Remaining risks
Overload of the patient due to wrong application and/or misinterpretation and/or unexpected problems during correct
application may result in the following risks, problems and/or injuries:
Problem & injury risk Risk control
Due to overloading and/or fall :
NBruises
NSprains and torns
NSkin abrasions
NInjuries of the musculoskeletal system
(joints, tendons, ligaments, muscles,
bones)
NFractures, in worst case (e.g. broken neck)
resulting in death.
NNote in instructions and warning labels on the
UserTerminal that the device may only be used
under supervision by medical or therapeutic staff.
NProper loading dose must be prescribed by doctors
or therapists as qualified personnel only.
NNote in instructions and warning labels on the
UserTerminal that operating personnel must stay in
permanent patient environment of 1.5 m.
NRecommendation and application of weight support
system and/or fall stop device, such as the
h/p/cosmos safety arch with harness and automatic
shut-off of the running belt.
NComprehensive instruction of the patient before the
start of treadmill therapy with an explanation that
the drive of the running belt is very strong and does
not stop automatically when the patient stops.
Overload of the cardiovascular system in extreme
situations with cardiac arrest and death as possible
worst case scenario.
NNote in user’s manual that correct load dosing must
be done by a medical doctor or therapist.
NNote that a defibrillator has to be kept on hand for
reanimation. This is already standard in some
countries.
NIntegrated cardio mode, which reduces the load
after reaching the recommended maximum heart
rate and stops the treadmill in case of overload or
breakdown of the heart rate measurement.
In case of correct load dosing (according to the clinical picture and condition of the patient) and intended use, the risks
are comparable to the risks of walking / running on the ground: falling off the treadmill with skin abrasions, bruises, torn
ligaments, fractures and in worst case fatal injury such as a broken neck.
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3.4 Forbidden use
NAll prohibitions in the chapter entitled "Safety precautions, safety regulations, prohibition and warnings".
NDo not modify the running machines and do not connect them to other equipment which is not explicitly declared
as compatible by all involved manufactures.
NThe running machine must not be used without carefully trained specialist staff and without the staff having been
instructed on the safety regulations.
NThe subject must interrupt the training immediately if he/she starts feeling sick or dizzy and should see a doctor.
NSubject with a cardiac pacemaker or who suffer from any kind of physical restriction must see a doctor before
using the running machine and ask for permission.
NChildren and animals are not allowed to use the running machine without a supervisor (medical doctor or therapist)
and must not get near to it (4 m safety zone) without a supervisor.
NOther use than the explicitly mentioned intended use.
NIn the event of any detected and/or assumed malfunctions and/or defects or unreadable safety warning labels, the
device has to be taken out of operation, clearly marked as such and disabled. The supplier and authorized service
personnel have to be informed in writing.
NUnder no circumstances should a subject/patient or other user be overloaded or overstressed.
NUnder no circumstances should the device be used with increased risk, e.g. sprint or medical application with a
high risk of falling, unless additional safety precautions and safety equipment such as safety arch with fall stop are
used.
NThe device must not be used if one or more of the listed contraindications prevail (see chapter entitled
“Contraindications”).
NThe automatic operation of the running machine (modes profile, cardio, test, remote control via PC and peripheral
devices) is forbidden, if the health and condition of the test person / subject / patient does not permit and if a doctor
has not authorized said operation. Disregarding this provision may lead to injuries, serious health problems and
even death.
NIt is prohibited to use wheels on the standard running machines. Thus, no cycles, wheelchairs, inline skates or
roller skis are to be used. Such applications are only allowed on special running machines marked with „r“ (e.g.
h/p/cosmos saturn®300/100r). Additionally, a safety harness with fall-stop is prescribed. The bike or wheelchair
brakes are to be deactivated (e.g. demount brake suspension) and the skate brakes demounted during the
exercise on the running machine. Remember to reactivate brakes before using this equipment outdoor again.
NNever use running shoes or other shoes with spikes or studs on the standard running surface or running belt.
These applications are only allowed on special running machines with suffix „rs“ which have an extra thick running
belt. A safety arch with chest belt and fall stop is also obligatory in this case.
Nh/p/cosmos devices must not be used in environmental conditions other than those specified in the chapter
„Technical specifications“ and “Environmental conditions” (e.g. in wet and humid areas, swimming pools, sauna,
environmental chambers, high-pressure-, low-pressure, altitude- and oxygen-chambers, etc.).
NDo not jump onto the rotating running belt. Do not jump off the rotating running belt (not even forward). Do not stop
moving or turn around on the rotating running belt. Never run side wards or backwards. Do not do anything which
could interfere with your balance. Do not set too high loads (speed, elevation).
If unauthorized persons are believed to have access to the running machine or if there are other
reasons to lock the device, it has to be blocked for restart. See „option 40“ in chapter 5.10
”Optional settings: User Options”. With option 41 ... 44 separate modes (manual, profile, cardio,
test) can also be locked.
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4Safety notes, warnings, precautions
4.1 General
Important notes, warnings and precautions are marked with this sign. It also reminds you of
concerns which have to be considered for measurements and connection with other devices.
NThese operating instructions are part of the device and must always be accessible for every user.
NExact observance of the operating instructions is required for appropriate operation of the h/p/cosmos device.
NBefore using the running machine, read carefully the operating instructions, especially the safety notes, warnings
and precautions.
NThe safety notes, warnings and precautions have to be pointed out to every user and operator and displayed
within sight of the running machine.
NThe running machine must only be used after careful instruction by authorized field service personnel and after the
user has received the safety notes, warnings and precautions.
NAll regulations and prohibitions are to be followed.
NSafety, reliability, function and accuracy can only be achieved if
Nthe device is used in accordance with the operating instructions, including the use of the described
consumables, sensors and detectors,
NInstallation, commissioning, instruction, extension, alteration, recommended preventive maintenance, safety
checks and repair are performed by authorized staff.
NAny other use than that explicitly listed in the field of application is prohibited.
NUse of the h/p/cosmos medical treadmills in a home environment and/or in public and/or operation by persons who
are not medically trained staff is not allowed.
NIt is prohibited to use the running machine and the accessories without supervisory staff and introduction.
NHolding the handrails during exercise may affect the exercise results (e.g. heart rate, ECG, oxygen uptake, etc.).
Under normal conditions and for healthy subjects we recommend holding the handrails only in case of emergency
or when needed for safety or weight relief.
NUnder no circumstances should the device be used with increased risk, e.g. sprint or medical application with a
high risk of falling, unless additional safety precautions and safety equipment such as safety arch with fall stop are
used.
NDo not deposit any clothes, towels, jewellery, etc. on the running machine. Such objects could be tripped over or
caught in the rotating belt. Make sure that nobody exposes body parts, hair, clothes, ties, towels or other parts to
any dangerous capture areas/gaps at moving parts such as the rollers or elevation system.
NAll lubrication material and all other material or parts of this device are to be kept away from children and animals
and should neither be drunk nor eaten.
NPull the plug before cleaning or disinfecting electric devices.
NPay special attention to all maintenance and service instructions.
NPay special attention to all warnings and precautions in the accessory manuals.
NThe field service personnel are to pay special attention to further safety notes, warnings and precautions in the
service manual (see chapter 7 entitled “Service manual”).
NThe manufacturer has no liability for any injury to persons or damage to property.
NIn the event that a user connects standard components to support, diagnose or appraise in terms of in-house
production according to the MPG (German Medical Devices Act), he creates a system and therefore has to
perform and verify a simplified conformity validation process.
Disregard of intended use, safety notes, warnings and precautions, unauthorized or lack of
maintenance and / or regular safety checks may lead to injuries or even death and / or can damage
the device and will result in loss of any liability and warranty.
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4.2 Preparation of the patient / user
NIt is strongly recommended to consult a doctor before using an exercise device.
NSubjects with a cardiac pacemaker or those who suffer from any kind of physical restriction must see their doctor
and get permission before using the running machine.
NAnimals are not allowed to use the running machine and must not go too near (4 m distance).
NIt is prohibited to use the running machine under the influence of alcohol, drugs and/or anaesthetics.
NTraining or therapy must always be performed with sports or running shoes (no spikes) and sports clothing.
It must never be used with bare feet.
NHarnesses, chest belts, waist belts, patients’ vests, forearm arm rests, leash and cuffs are not designed for direct
skin or mucous membrane contact.
NThere are dangerous capture areas/gaps on the elevation system as well as at the rear end and the sides of the
running belt and rollers. Upon reverse belt rotation, there are dangerous capture areas/gaps at the motor hood and
the front area as well. Make sure that nobody exposes body parts, hair, clothes, ties, towels or other parts to any
dangerous capture areas/gaps.
NSubjects with long hair should use a hairnet and must be made aware of the danger that hair may be caught in the
capture areas/gaps.
Nat the rear end and the sides of the running belt, at the elevation system
Nin case of reverse belt rotation: at the motor hood and the front area.
NValuable articles such as watches, emblazonments, etc. must be removed before using the device, nor should
they be stored in the near vicinity of the device.
NNever use shoes with spikes or studs on the standard running surface or running belt. Spikes and studs are only
allowed on special running machines with suffix „rs“ which have an extra thick running belt. A safety arch with
chest belt system is obligatory in this case.
NIn case of reverse belt rotation, always use the pull cord safety stop actuator or better the safety arch with chest
belt system since the standard safety stop buttons and keyboard as well as standard handrails and front bar
handrail might not be in reach when facing the running deck backwards.
4.3 Preparation of the running machine
NWhen the device is used daily, we recommend switching it on in the morning and leaving it in stand-by mode
during the day.
NIf the running machine is at an angle of elevation > 0 when switched on, it will automatically move to position zero
(display: elevation „INIT“) by switching the device on. Please ensure that while driving down the elevation, no harm
can be done to persons or objects under the running machine.
NThe ON-/OFF intervals must not be shorter than 1-2 minutes (for models with 3-phase connection: 2-3 minutes).
Otherwise it could lead to interferences and/or failure of the backup and/or data loss and/or data corruption. Too
short switch on / switch off intervals lead to a deactivation of the inrush current limiter and result in an overload of
the circuit fuse.
NKeep a safety zone of at least 2 m in length and the treadmills width behind the running machine and
1 x 1 m in front of the running machine. In case of reverse belt rotation, the frontal safety zone should be same
size as the rear. See chapter 5.1 entitled “Operation, General”.
NThe crossbar handrail, safety arch harness and/or safety stop pull cord type should always be positioned in a way
that the subject can walk or run in the first (front) 40% and/or second (middle) 30% of the running surface length.
When the subjects moves to the rear 30% of the running deck length, the safety arch harness and/or safety stop
pull cord type triggers the stop function automatically. See chapter 5.1 entitled “Operation, General”.
NThere must be a gap of at least 4 cm between the crossbar and the UserTerminal due to the danger of bruising.
NIt is not allowed to run with the back to the crossbar.
NThe front handrail crossbar should be dismounted if a safety arch with chest belt system is installed and used.
This manual suits for next models
5
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