h/p/cosmos 170-190/65 Series Service manual

treadmill h/p/cosmos®170-190/65
IMPORTANT! READ CAREFULLY BEFORE USE!
KEEP FOR FUTURE REFERENCE!
date: 22.09.2021
revision: 1.05
article number: cos105000_170-190_65_en
MCU6 rmware version: cos101010fw_1.25.0053*
GUI version: cos101000-v1.4.0206*
Windows 10 Image: cos101000ap (WIN10 2016 INDEX01)*
Inverter Parameter: cos103791-01 (INDEX02)*
ahead of time®
h/p/cosmos sports & medical gmbh
The copyright of this document, media, design, software and intellectual property is owned by
h/p/cosmos sports & medical gmbh, except where explicitly stated differently.
Warning: All rights reserved. Unauthorized copying, reproduction, hiring, lending,
public performance and broadcasting prohibited. E&OE Errors and Omissions Excepted.
*subversions may be included. See screenshots.
❚
170-190/65 MCU6
quasar®
models
❚
quasar® sport
❚
quasar® med
❚
pulsar® sport
❚
pulsar® med
original instructions for use
❚
stellar® sport
❚
stellar® med
❚
stellar® sport 190/65
❚
stellar® med 190/65
incl. OEM Variants
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 1 of 97

These instructions for use are only valid for the original conguration of the rst delivery of the devices pictured below.
Please refer to the latest version of this document, available at: www.hpcosmos.com
These instructions for use are available on request as print version at [email protected]
❚
170-190/65 MCU6
Product family: treadmill h/p/cosmos 170-190/65 (quasar, pulsar)
Manufacturing year: from 2020
Basic UDI-DI: 4050588004002
Models:
sport med
pulsar® sport
UDI-DI: 4050588003074
[cos30004-01va01]
quasar® sport
UDI-DI: 4050588002947
[cos30003-01va01]
quasar®med
UDI-DI: 4050588002954
[cos30003-01va02]
pulsar® med
UDI-DI: 4050588003081
[cos30004-01va02]
stellar®sport
UDI-DI: 4050588002992
[cos30003-01va05]
stellar®med
UDI-DI: 4050588003005
[cos30003-01va06]
stellar®190/65 sport
UDI-DI: 4050588003012
[cos30004-01va05]
stellar®190/65 med
UDI-DI: 4050588003029
[cos30004-01va06]
sport med
quasar® lt
UDI-DI: 4050588003012
[cos30003-01va03]
quasar®lt med
UDI-DI: 4050588003029
[cos30003-01va04]
pulsar® lt
UDI-DI: 4050588003135
[cos30004-01va03]
pulsar®lt med
UDI-DI: 4050588003142
[cos30004-01va04]
pulsar® sport OEM
UDI-DI: 4050588003098
[cos30004-01va07]
pulsar® med OEM
UDI-DI: 4050588003104
[cos30004-01va08]
quasar®sport OEM
UDI-DI: 4050588002961
[cos30003-01va07]
quasar®med OEM
UDI-DI: 4050588002978
[cos30003-01va08]
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 2 of 97

Dear customer,
Thank you for choosing this premium device.
Since its establishment in 1988, h/p/cosmos® has strongly inuenced sports, athletics,
ergometry, rehabilitation, and science through the development and distribution of new
products, software, system solutions, and application methodologies.
During this time the company, based in Traunstein, Germany, has developed into THE
German specialist for manufacturing treadmill ergometers and systems for tness, sports,
sports science, sports medicine, athletics, biomechanics, medicine, rehabilitation, therapy,
ergometry, performance diagnostics, and scientic research.
Many developments and pioneering work from h/p/cosmos® have inuenced not only product
design and functionality but also their usage and methodologies.
Your success with our devices is the primary goal of h/p/cosmos.
This is why we offer individual devices as well as comprehensive system solutions.
You will nd a wide range of options and accessories in these instructions for use and at www.
hpcosmos.com.
At h/p/cosmos, the quality and safety of our products is our highest priority.
These instructions for use include all of the information needed to operate the device correctly
and safely.
Please read them carefully before use and keep them available at all times.
We hope you will have a lot of fun and success as you work with your h/p/cosmos device.
Franz Harrer
President & CEO
h/p/cosmos sports & medical gmbh
Franz Harrer
President & CEO
h/p/cosmos sports & medical gmbh
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 3 of 97

Content
1 Symbols and Labels .......................................................................................................... 7
1.1 Symbols used (general) ............................................................................................................................7
1.2 Symbols used (transport) ..........................................................................................................................8
1.3 Structure....................................................................................................................................................8
1.4 Labels on device .......................................................................................................................................9
2 Description....................................................................................................................... 10
2.1 Illustration................................................................................................................................................10
2.2 Function...................................................................................................................................................10
3 Intended Use (med)......................................................................................................... 11
3.1 Intended use / Indications / Target Population ........................................................................................11
3.2 Intended operator....................................................................................................................................12
3.3 Intended location.....................................................................................................................................12
3.4 Intended duration / exercise stop ............................................................................................................12
3.5 Contraindications.....................................................................................................................................13
4Intended Use (sport)........................................................................................................ 14
4.1 Intended use............................................................................................................................................14
4.2 Intended operator....................................................................................................................................14
4.3 Intended location.....................................................................................................................................14
4.4 Intended duration / exercise stop ............................................................................................................14
4.5 Contraindications.....................................................................................................................................15
5Safety (med).................................................................................................................... 16
5.1 Safety information – Forbidden use ........................................................................................................16
6Safety (sport)................................................................................................................... 18
6.1 Safety information – Forbidden use ........................................................................................................18
7.2 Fall prevention devices............................................................................................................................20
7.3 Emergency dismount...............................................................................................................................22
7.4 Emergency off / safety stop .....................................................................................................................23
7.5 Emergency stop / Quick stop ..................................................................................................................23
7.6 Unauthorized access...............................................................................................................................24
7.7 Residual risk / Side effects (med)............................................................................................................24
7.9 Firefighting...............................................................................................................................................25
7.10 All-pole disconnection............................................................................................................................25
7Safety .............................................................................................................................. 20
7.8 Cybersecurity ..........................................................................................................................................25
7.11 Summary of safety and clinical performance ........................................................................................25
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 4 of 97

8Preparation...................................................................................................................... 26
8.1 Further preparation locomotion ...............................................................................................................27
9UserTerminal ................................................................................................................... 28
9.1 General Description.................................................................................................................................28
9.2 TochScreen ............................................................................................................................................29
9.3 Keys ........................................................................................................................................................30
9.4 Connection of external devices / Interfaces ............................................................................................31
10 Position of Subject and Operator................................................................................... 32
11 Operation ...................................................................................................................... 33
11.1 General application procedure .............................................................................................................33
11.2 Overview of operation modes ...............................................................................................................34
11.3 Manual mode ........................................................................................................................................35
11.4 Profile mode .........................................................................................................................................36
11.5 Cardio mode..........................................................................................................................................38
11.6 Test mode .............................................................................................................................................40
11.7 Interfere with automatic program ..........................................................................................................42
11.8 Pause function.......................................................................................................................................43
11.9 Acceleration levels.................................................................................................................................44
11.10 User Options .......................................................................................................................................45
12 Accessories / compatible devices.................................................................................. 46
12.1 Creating Systems..................................................................................................................................46
12.2 Overview of accessories .......................................................................................................................46
12.3 Compatible devices...............................................................................................................................49
13Disinfection / Cleaning................................................................................................... 50
14Maintenance .................................................................................................................. 51
14.1 Intervals and competences....................................................................................................................51
14.2 Daily inspection .....................................................................................................................................51
14.3 Lubrication.............................................................................................................................................52
14.4 Adjustment of running belt.....................................................................................................................53
14.5 Issues for qualified service personnel ...................................................................................................54
14.6 Safety inspection ...................................................................................................................................54
14.7 Spare parts and consumables...............................................................................................................54
15Troubleshooting............................................................................................................. 55
15.1 General troubleshooting........................................................................................................................55
15.2 RS232 troubleshooting..........................................................................................................................56
15.3 Error messages.....................................................................................................................................56
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 5 of 97

16Technical data (med) ..................................................................................................... 57
16.1 UserTerminal .........................................................................................................................................57
16.2 Dimensions............................................................................................................................................57
16.3 Loads.....................................................................................................................................................57
16.4 Emissions..............................................................................................................................................57
16.5 Essential performance characteristics...................................................................................................58
16.6 Environmental conditions ......................................................................................................................58
16.7 Technical and legal requirements..........................................................................................................59
16.8 EMC tests..............................................................................................................................................59
16.9 Classification .........................................................................................................................................59
16.10 Certificates ..........................................................................................................................................60
16.11 Interfaces (RS232, D-SUB, 9-pole) .....................................................................................................60
16.12 Voltage, Current, Performance............................................................................................................60
16.13 Programs, Software.............................................................................................................................61
16.14 All-pole disconnection..........................................................................................................................61
17Technical data (sport) .................................................................................................... 62
17.1 UserTerminal .........................................................................................................................................62
17.2 Dimensions............................................................................................................................................62
17.3 Loads.....................................................................................................................................................62
17.4 Emissions..............................................................................................................................................62
17.5 Essential performance characteristics...................................................................................................63
17.6 Environmental conditions ......................................................................................................................63
17.7 Technical and legal requirements..........................................................................................................64
17.8 EMC tests..............................................................................................................................................64
17.9 Classification .........................................................................................................................................64
17.10 Certificates ..........................................................................................................................................65
17.11 Interfaces (RS232, D-SUB, 9-pole) .....................................................................................................65
17.12 Voltage, Current, Performance............................................................................................................65
17.13 Programs, Software.............................................................................................................................66
17.14 All-pole disconnection..........................................................................................................................66
18Liability and Warranty .................................................................................................... 67
19Expected Lifetime .......................................................................................................... 67
20 Disposal ......................................................................................................................... 67
21 Annex I .......................................................................................................................... 68
22 Annex II (pre- & self- defined tests)................................................................................ 71
23 Annex III (Accessories)................................................................................................... 77
23 Contact .......................................................................................................................... 98
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 6 of 97

1 Symbols and Labels
1.1 Symbols used (general)
Illustration Description Reference
CE sign, declaration that the essential requirements
(here with number of notied body) were met
(acc. to medical device directive 93/42/EEC
or medical device regulation EU 2017/745)
CE sign, declaration that the essential requirements were met (according to machinery directive 2006/42/EC)
General warning (danger, warning or caution statements) (DIN EN ISO 7010 W001)
Warning of obstacles (stumbling) (DIN EN ISO 7010 W007)
Warning of electrical voltage (DIN EN ISO 7010 W012)
Warning of hot surface (DIN EN ISO 7010 W017)
Warning of counter rotating rollers (trapping zones) (DIN EN ISO 7010 W025)
Follow instructions for use (DIN EN ISO 7010 M002)
Potential equalization (IEC 60445)
Protection ground (IEC 60417-5019)
Chassis ground (IEC 60417-5020)
Alternating current (AC) (IEC 60417-5032)
Applied part of type B (IEC 60417-5840)
Manufacturer (ISO 15223-1)
2018-10-01
Manufacturing date (ISO 15223-1)
Separate collection for electrical and electronic equipment (2012/19/EU)
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 7 of 97

Illustration Description Reference
Fragile, Handle with care (ISO7000-0621)
This way up (ISO7000-0623)
Keep dry (ISO7000-0626)
Centre of gravity (ISO7000-0627)
Temperature limitations (ISO7000-0632)
Do not stack (ISO7000-2402)
1.2 Symbols used (transport, packing & storage)
1.3 Structure
Illustration Description
sport Pages marked with the following symbol are applicable for medical devices, only.
sport Pages marked with the following symbol are applicable for sports devices, only.
med
sport
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
All pages without special marking (med or sport) are applicable for both applications and devices.
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 8 of 97

Illustration Description Order number
name plate -
UDI name plate with serial number,
manufacturer and manufacturing date -
label "caution danger zones" cos10508-03
label "before opening disconnect mains" cos11880
label "follow instructions" cos101380
label "potential equalization" cos101594
label “next inspection 20xx” + base label cos14543-20xx + cos11787
label "adjust running belt" cos10512
label "adjust running belt" cos10512-01
label" lubrication" cos10510
label "safety advice acc. to EN ISO 20957-1" cos103963
label "h/p/cosmos address" cos10144-01
label "NFC sensor" -
marking on running belt -
1.4 Labels and marking on device
In case of any visible or assumed wear and tear (of the device, accessories, labels, etc.), unplug device, exclude reconnection, mark
clearly and inform h/p/cosmos service personnel via telephone and writing. Do not change or remove any labels!
❚
170-190/65 MCU 6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 9 of 97

❚
170-190/65 MCU6
No. Description Illustration
1. UserTerminal
2. Pull cord safety stop
(ripcord / safety lanyard)
3. Emergency stop
4. Crossbar-frontrail
5. Side handrail
6. Motor cover
7. Foot rail
8. Non slip surface
9. Running deck
10. Running belt
11. Rear roller
12. Rear roller protective cover
13. Marking of running belt
14. Safety arch
15. Safety harness / Chest belt
2.1 Illustration
2 Description
2.2 Function
The treadmill has two essential performance characteristics: Speed and elevation.
The rotation of the running belt represents the speed.
The raising of the whole treadmill frame incl. running deck enables the elevation.
Both parameters are manually adjustable on the UserTerminal.
Furthermore, operation is possible via pre- and self-dened modes.
Operation is also possible via external devices (PC, ECG, etc.).
The chapter “operation” gives a detailed description of all functions.
The chapter “technical data” shows technical details.
The treadmill is driven by powerful motors.
For that reason it is very important to follow the safety information, in order to avoid injury or death.
As previously described, the treadmill contains a number of standardized protocols.
Nevertheless, the treadmill does not provide recommendations for treatment.
The decision regarding the correct load is the responsibility of the medical doctor.
Depending on the application, the load includes speed, elevation, distance, heart rate, body weight or motion support, etc..
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 10 of 97

3 Intended Use (med)
3.1 Intended Use / Indications / Target Population
h/p/cosmos medical treadmills are intended for walking or running* in place for
❚
Recreational tness training (incl. athletes)
❚
Gait training (with or without body weight support)
h/p/cosmos medical treadmills can be used in combination with external devices for walking or running* in place as
❚
Stressing devices for neuromuscular and biomechanical measurements (e.g. EEG, EMG, motion analysis)
❚
Stressing devices for cardiovascular measurements (e.g. ECG)
❚
Stressing devices for cardiopulmonary measurements (e.g. ergospirometry)
* Devices marked with an “r” or "rs" like “h/p/cosmos saturn 250/75 r” are intended for applications with wheels as well.
Applications with wheels include cycling, roller skiing, wheelchair applications, etc...
Caution: In which ever mode, function, program, test or feature, the treadmill does not provide any kind of medical treatment
proposal nor medical assessment with analysis. The treadmill is purely used as a stressing device and training equipment.
Prescribed fall prevention device for any application where falling might cause an unacceptable risk such as
❚
while performing sprints, high speed training or max. endurance tests
❚
while training on running surfaces wider than 65 cm
❚
for children (<14 years)
❚
for subjects with all kind of disabilities, impairments (visual, hearing, balance, etc.), activity limitations and participation restrictions
❚
for subjects with recent hip replacement, intracorporal probes, osteoporosis, etc.
❚
during reverse belt rotation at speeds higher than 5 km/h.
❚
It is not allowed to run with the back to the crossbar or to the UserTerminal to prevent from collision.
❚
during all use with wheels (cycling, wheelchair, inline-skating or roller-ski) for the “r” models
The subject of a medical application is not necessarily a patient.
Therefore these instructions for use will use the term “subject” for patients as well as for athletes under test.
h/p/cosmos medical treadmills may be operated with healthy subjects as well.
For applications with healthy subjects, please apply the instructions for use for sports devices, available at www.hpcosmos.com
It is impossible to list all indications, target population (age, gender, weight range, height range) and target user groups for
treadmill training and treadmill testing, since the indications, target population and target user groups most likely correspond to
recommendations for walking and/or running overground.
The treadmill does not provide recommendations for treatment and target population.
It is important to notice that the decision to use the devices with their potential risks and complications for diagnosis, rehabilitation or
therapy of a particular patient is the essential responsibility of the medical operator.
The clinical user’s judgment, on the other hand, must be based on current knowledge in medical science and the specic situation of
the patient.
The indications, target population and target user groups for treadmill testing and treatment have to be decided by the medical doctor
and primarily have to be derived from international accepted guidelines.
Examples:
2020 ESC Guidelines on Sports Cardiology and Exercise in Patients with Cardiovascular Disease
ESC European Society of Cardiology Clinical Practice Guidelines
https://academic.oup.com/eurheartj/article/42/1/17/5898937
ACC/AHA Guidelines for Exercise Testing.
A Report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines (Committee on Exercise Testing)
https://www.jacc.org/doi/pdf/10.1016/s0735-1097%2897%2900150-2
American Academy of Family Physicians Foundation
med
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 11 of 97

Sources:
http://leitlinien.dgk.org (German Cardiac Society)
www.acc.org (American College of Cardiology Foundation)
www.americanheart.org (American Heart Association)
http://my.americanheart.org/idc/groups/ahaecc-internal/@wcm/@sop/documents/downloadable/ucm_423807.pdf
med
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Physical Therapy and Rehabilitation Journal
Robotic-Assisted, Body-Weight–Supported Treadmill Training (BWSTT) in Individuals Following Motor Incomplete Spinal Cord Injury
https://academic.oup.com/ptj/article/85/1/52/2805006
The NEW ENGLAND JOURNAL of MEDICINE
Body-Weight–Supported Treadmill Rehabilitation after Stroke
https://www.ctsi.ucla.edu/education/les/view/training/docs/dobkin-NEJM-BWSTT-after-stroke.pdf
3.2 Intended operator
❚
Medical staff only
❚
that has been carefully trained according to these instructions for use
❚
that is working according to the prescription of the medical doctor, where applicable and necessary
❚
the subject is not the intended operator.
But the intended operator is authorized to allow the subject to control the device according to the instructions and under the
permanent observation of the intended operator. This means the operation of the device remains the responsibility of the intended
operator at all times, taking the physical and mental condition of the subject into account.
The intended operator has to be within permanently reach (patient area = 1.5m radius).
3.3 Intended location
❚
Medical facilities only
❚
no use at home or in home healthcare environments (acc. to IEC 60601-1-11)
❚
no outdoor use
❚
no direct sunlight
❚
Sufciently lighted for proper readability of warning, labels, displays and operation elements
❚
Proper environmental conditions (see “Technical Data”)
❚
Stationary training equipment: Not intended to be moved after installation by professional staff.
3.4 Intended duration / exercise stop criteria
❚
Depending on the prescription of the medical doctor
❚
WARNING! Heart rate monitoring systems may be inaccurate.
❚
Incorrect or over exercising may result in serious injury or death.
❚
If you feel faint or dizzy stop exercising immediately and consult a medical doctor.
❚
Further exercise test stop criteria see guidelines for various treadmill exercise and treadmill tests.
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 12 of 97

3.5 Contraindications
Absolute contraindications
(have to be excluded before the treadmill is used)
❚
Acute myocardial infarction (within 2 days)
❚
Instable angina pectoris
❚
Cardiac arrhythmia pathology and/or limited hemodynamics
❚
Symptomatic massive aortic stenosis
❚
Uncompensated / uncontrolled heart insufciency
❚
Acute pulmonary embolism or pulmonary infarction
❚
Acute endocarditis, myocarditis, pericarditis
❚
Acute aortic dissection
❚
Acute coronary syndrome
❚
Acute phlebothrombosis of the lower extremities
❚
Febrile infections
❚
Pregnancy
❚
Acute thrombosis
❚
Fresh wounds e.g. after surgery
❚
Acute fracture
❚
Damaged disc or traumatic disease of the spine
❚
Epilepsy
❚
Inammations
❚
Acute migraine
❚
uncontrolled heart failure
❚
dissecting aneurysm
❚
recent aortic surgery and ECG abnormalities, such as abnormal ST-segment response (horizontal, planar or
downslopingdepression of >1 mm, T-wave elevation of > 1 mm in leads without Q-waves, and Twavechanges such as inversion
and pseudo-normalization when an inverted T-wave becomes upright.
Relative contraindications
(The application may be started if the possible benets exceed the risks.
The decision has to be made by the medical doctor before the treadmill is used)
❚
Left main coronary stenosis
❚
Main artery disease
❚
Cardiac valve disease of moderate severity
❚
Known electrolyte imbalance
❚
Arterial hypertonia (RR > 200 mm Hg syst. > 110 mm Hg diast.)
❚
Tachyarrhythmia or bradyarrhythmia
❚
Hypertrophic cardiomyopathy and other forms of outow tract obstruction
❚
Higher degree atrioventricular AV-blocking
❚
Anemia
❚
Physical and/or mental disabilities leading to inability to exercise adequately
❚
Partially invasive medical devices (probes, infusions, catheters, external xators, etc.)
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 13 of 97

4Intended Use (sport)
4.1 Intended use / Indications
h/p/cosmos sports treadmills are intended for walking or running* in place.
Do not use h/p/cosmos sports treadmills for medical applications.
* Devices marked with an “r” or "rs" like “h/p/cosmos saturn 250/75 r” are intended for applications with wheels as well.
Applications with wheels include cycling, roller skiing, wheelchair applications, etc...
Caution: In which ever mode, function, program, test or feature, the treadmill does not provide any kind of medical treatment
proposal nor medical assessment with analysis. The treadmill is purely used as a stressing device and training equipment.
Prescribed fall prevention device for any application where falling might cause an unacceptable risk such as
❚ while performing sprints, high speed training or max. endurance tests
❚ while training on running surfaces wider than 65 cm
❚ for children (<14 years)
❚ for subjects with all kind of disabilities, impairments (visual, hearing, balance, etc.), activity limitations and participation restrictions
❚ for subjects with recent hip replacement, intracorporal probes, osteoporosis, etc.
❚ during reverse belt rotation at speeds higher than 5 km/h.
❚ during all use with wheels (cycling, wheelchair, inline-skating or roller-ski) for the “r” models
4.2 Intended operator
❚
Adult persons carefully trained according to these instructions for use.
❚
A professional supervisor has to be in the same room.
4.3 Intended location
❚
No use at home or in home healthcare environments (acc. to IEC 60601-1-11)
❚
No outdoor use
❚
No direct sunlight
❚
Sufciently lighted for proper readability of warning, labels, displays and operation elements
❚
Proper environmental conditions (see “Technical Data”)
❚
Stationary training equipment: Not intended to be moved after installation by professional staff.
4.4 Intended duration / exercise stop criteria
❚
Depending on the condition of the subject
❚
Exclude overloading or overstressing of the subject.
❚
WARNING! Heart rate monitoring systems may be inaccurate.
❚
Incorrect or over exercising may result in serious injury or death.
❚
If you feel faint or dizzy stop exercising immediately and consult a medical doctor.
❚
Further exercise test stop criteria see guidelines for various treadmill exercise and treadmill tests.
sport
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 14 of 97

4.5 Contraindications
(have to be excluded before the treadmill is used)
❚
Acute myocardial infarction (within 2 days)
❚
Instable angina pectoris
❚
Cardiac arrhythmia pathology and/or limited hemodynamics
❚
Symptomatic massive aortic stenosis
❚
Uncompensated / uncontrolled heart insufciency
❚
Acute pulmonary embolism or pulmonary infarction
❚
Acute endocarditis, myocarditis, pericarditis
❚
Acute aortic dissection
❚
Acute coronary syndrome
❚
Acute phlebothrombosis of the lower extremities
❚
Febrile infections
❚
Pregnancy
❚
Acute thrombosis
❚
Fresh wounds e.g. after surgery
❚
Acute fracture
❚
Damaged disc or traumatic disease of the spine
❚
Epilepsy
❚
Inammations
❚
Acute migraine
❚
Left main coronary stenosis
❚
Main artery disease
❚
Cardiac valve disease of moderate severity
❚
Known electrolyte imbalance
❚
Arterial hypertonia (RR > 200 mm Hg syst. > 110 mm Hg diast.)
❚
Tachyarrhythmia or bradyarrhythmia
❚
Hypertrophic cardiomyopathy and other forms of outow tract obstruction
❚
Higher degree atrioventricular AV-blocking
❚
Anemia
❚
Physical and/or mental disabilities leading to inability to exercise adequately
❚
Partially invasive medical devices (probes, infusions, catheters, external xators, etc.)
❚
Cardiac pacemaker
❚
Visual impairment (vision < 30% acc. to WHO)
Sources:
http://leitlinien.dgk.org (German Cardiac Society)
www.acc.org (American College of Cardiology Foundation)
www.americanheart.org (American Heart Association)
http://my.americanheart.org/idc/groups/ahaecc-internal/@wcm/@sop/documents/downloadable/ucm_423807.pdf
Sources:
http://leitlinien.dgk.org (German Cardiac Society)
www.acc.org (American College of Cardiology Foundation)
www.americanheart.org (American Heart Association)
http://my.americanheart.org/idc/groups/ahaecc-internal/@wcm/@sop/documents/downloadable/ucm_423807.pdf
sport
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 15 of 97

5Safety (med)
h/p/cosmos medical treadmills may be operated with healthy subjects as well.
The safety notes, warnings and precautions have to be pointed out to every user and operator and displayed within sight of the
running machine.
Additional and latest safety notes and warnings see: https://www.hpcosmos.com/en/safety
Any serious incident in relation to the device has to be reported to the manufacturer and the competent authority of the EU Member
State in which the user and/or patient is established as well as to EUDAMED database based on MDR.
5.1 Safety information – Forbidden use
Obey the following danger, warning and caution statements stricktly in order to prevent serious injury or death!
❚
Prescribed fall prevention for any application where falling might cause an unacceptable risk (high speed or special applications,
applications with subjects not able to jump off the running belt such as children, physically impaired, etc.)
❚
The automatic modes must only be performed on the prescription of the medical doctor.
❚
During stress tests a medical doctor has to be available at any time.
❚
Do not use the device with children <12 months.
❚
Exclude access of unsupervised children (< 14 years) onto or near any parts of the device (incl. accessories, packaging,
lubrication and service material).
❚
In case of application with children (> 1, < 14 years) permanent observation of the subject by medical staff is obligatory.
❚
Animals must not be in the same room with the device.
❚
Only carefully trained medical staff is allowed to use the device.
❚
Do not use the safety harness on bare skin.
❚
WARNING! Heart rate monitoring systems may be inaccurate.
❚
Incorrect or over exercising may result in serious injury or death.
❚
If you feel faint or dizzy stop exercising immediately and consult a medical doctor.
❚
Further exercise test stop criteria see guidelines for various treadmill exercise and treadmill tests.
❚
Exclude overloading or overstressing of the subject.
❚
The subject has to be checked by a medical doctor before using the device.
❚
A debrillator must be present at any time.
❚
The intended operator has to be in reach of at least one emergency stop/off at any time.
❚
Obey all information given in these instructions for use.
❚
Do not use the device against the intended use.
❚
Do not use the device in case one or more of the listed contraindications prevail.
❚
In case of relative contraindications permanent observation of the subject by medical staff is obligatory.
❚
Neither subject nor operator must be under the inuence of alcohol, drugs or anesthetics.
❚
Start the use of the treadmill with slow walking, especially for beginners.
❚
Make sure the space under the treadmill is free from persons, body parts or objects, especially when switching on (treadmill will
lower during initialization) and when changing the elevation.
❚
Do not enter the device when running belt is rotating.
❚
Do not step on rear roller.
❚
Do not stand on or enter the running deck when device is in elevation (running belt might slip through due to gravity).
❚
Make sure no objects, sand, stones, liquids, towels, jewellery, cell phones, containers with liquid etc. can fall into the device or onto
the running surface or underneath the running belt.
med
* Devices marked with an “r” or “rs” like “h/p/cosmos saturn 250/75 r” are intended for applications with wheels as well. Applications
with wheels include cycling, roller skiing, wheelchair applications, etc.
** Devices supplied with the special “running belt for ski and spike applications” (see “Annex III (Accessories)”) are intended for
application with spikes or studs as well.
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 16 of 97

❚
❚
Do not turn around, walk sideways or backwards; do not jump on or off the running belt while it is in motion.
❚
Do not touch the running belt while it is in motion (besides contact with feet).
❚
Do not lean on the UserTerminal - do not apply pressure to the displays - press keys softly.
❚
Ensure assist mean, accessories, cables etc. do not extend into the running area.
❚
Do not insert any object (especially no metal objects such as a pin or a wire) into any gap or any outlet on the device.
❚
Do not touch the subject and external electrical devices at the same time.
❚
Always the latest command will be executed, regardless of whether it came via interface or from the UserTerminal during one of
the four modes. Only stop command has higher priority and cannot be overwritten.
❚
Be aware that electromagnetic interferences may cause a fail-safe mode, the running belt will stop with a pre-dened deceleration
ramp.
❚
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
❚
WARNING: Do not use portable high frequency communication devices in the subject environment (see “position of subject
and user”). Disregard can cause loss of performance.
❚
Free standing equipment has to be installed on a stable and levelled base.
❚
Choose proper oor, shoes, clothing and humidity, in order to prevent electrostatic charge and discharge (also see technical data).
❚
Do not use the device without instruction by authorized personnel acc. to the instruction protocol.
❚
Regard safety area behind device of 2.0 m x width of treadmill.
❚
Operator and subject have to be aware of automatic load changes during prole, cardio and test mode.
❚
Unmeant trapping hazards: Take off ties, scarfs or other clothes that may be trapped. Secure long hair and ribbons during
maintenance and training in order to prevent being captured in trapping zones.
❚
Perform a daily visual inspection (see chapter “maintenance”).
❚
Obey the maintenance intervals claimed in chapter “maintenance”.
❚
Obey the competences claimed in chapter “maintenance”.
❚
A second person has to be present during maintenance.
❚
In case of any visible or assumed defects or malfunctions (of the device, accessories, software, etc.), unplug device, exclude
reconnection, mark clearly and inform h/p/cosmos service personnel via telephone and writing.
❚
In case of any visible or assumed wear and tear (of the device, accessories, labels, etc.), unplug device, exclude reconnection,
mark clearly and inform h/p/cosmos service personnel via telephone and writing. Do not change or remove any labels!
❚
In case of any uid entering into the device, unplug device, exclude reconnection, mark clearly and inform h/p/cosmos service
personnel via telephone and writing.
❚
Do not modify the device, congurations, accessories or software in any way.
❚
Do not connect any devices, accessories or software, not listed in “accessories / compatible devices”.
❚
Disinfect the device before and after every treatment.
❚
Disconnect the device and all accessories from mains power supply before cleaning or disinfection.
❚
Do not save personal data (names, address, etc.) or patient data (indications, etc.) on the UserTerminal, for example in le names
or prole names.
med
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 17 of 97

6Safety (sport)
h/p/cosmos sports treadmills are intended for walking or running* in place.
Do not use h/p/cosmos sports treadmills for medical applications.
The safety notes, warnings and precautions have to be pointed out to every user and operator and displayed within sight of the
running machine.
Additional and latest safety notes and warnings see: https://www.hpcosmos.com/en/safety
Any serious incident in relation to the device has to be reported to the manufacturer and the competent authority of the EU Member
State in which the user and/or subject is established.
6.1 Safety information – Forbidden use
Obey the following danger, warning and caution statements stricktly in order to prevent serious injury or death!
❚
Prescribed fall prevention for any application where falling might cause an unacceptable risk (high speed or special applications,
applications with subjects not able to jump off the running belt such as children, physically impaired, etc.)
❚
Only carefully trained staff is allowed to use the device.
❚
Do not use the device with children <14 years.
❚
Exclude access of unsupervised children (< 14 years) onto or near any parts of the device (incl. accessories, packaging, lubrication
and service material).
❚
Do not use the safety harness on bare skin.
❚
WARNING! Heart rate monitoring systems may be inaccurate.
❚
Incorrect or over exercising may result in serious injury or death.
❚
If you feel faint or dizzy stop exercising immediately and consult a medical doctor.
❚
Further exercise test stop criteria see guidelines for various treadmill exercise and treadmill tests.
❚
Exclude overloading or overstressing of the subject.
❚
The subject has to be checked by a medical doctor before using the device.
❚
A debrillator must be present at any time.
❚
The intended operator has to be in reach of at least one emergency stop/off at any time.
❚
Obey all information given in these instructions for use.
❚
Do not use the device against the intended use.
❚
Do not use the device in case one or more of the listed contraindications prevail.
❚
Neither subject nor operator must be under the inuence of alcohol, drugs or anesthetics.
❚
Start the use of the treadmill with slow walking, especially for beginners.
❚
Make sure the space under the treadmill is free from persons, body parts or objects, especially when switching on (treadmill will
lower during initialization) and when changing the elevation.
❚
Do not enter the device when running belt is rotating.
❚
Do not step on rear roller.
❚
Do not stand on or enter the running deck when device is in elevation (running belt might slip through due to gravity).
❚
Make sure no objects, sand, stones, liquids, towels, jewellery, cell phones, containers with liquid etc. can fall into the device or onto
the running surface or underneath the running belt
❚
Do not enter the device without athletic or other appropriate shoes. Do not use high heels, spikes, studs, sandals, etc. **
❚
Do not use the device with wheels (bikes, wheelchairs, inline skates, etc.).
❚
Do not turn around, walk sideways or backwards; do not jump on or off the running belt while it is in motion.
❚
Do not touch the running belt while it is in motion (besides contact with feet).
sport
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 18 of 97

❚
Do not insert any object (especially no metal objects such as a pin or a wire) into any gap or any outlet on the device.
❚
Do not touch the subject and external electrical devices at the same time.
❚
Always the latest command will be executed, regardless of whether it came via interface or from the UserTerminal during one of
the four modes. Only stop command has higher priority and cannot be overwritten.
❚
Be aware that electromagnetic interferences may cause a fail-safe mode, the running belt will stop with a pre-dened deceleration
ramp.
❚
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
❚
WARNING: Do not use portable high frequency communication devices in the subject environment (see “position of subject
and user”). Disregard can cause loss of performance.
❚
Free standing equipment has to be installed on a stable and levelled base.
❚
Choose proper oor, shoes, clothing and humidity, in order to prevent electrostatic charge and discharge (also see technical data).
❚
Do not use the device without instruction by authorized personnel acc. to the instruction protocol.
❚
Regard safety area behind device of 2.0 m x width of treadmill.
❚
Animals must not be in the same room with the device.
❚
Operator and subject have to be aware of automatic load changes during prole, cardio and test mode.
❚
Unmeant trapping hazards: Take off ties, scarfs or other clothes that may be trapped. Secure long hair and ribbons during
maintenance and training in order to prevent being captured in trapping zones.
❚
Perform a daily visual inspection (see chapter “maintenance”).
❚
Obey the maintenance intervals claimed in chapter “maintenance”.
❚
Obey the competences claimed in chapter “maintenance”.
❚
A second person has to be present during maintenance.
❚
In case of any visible or assumed defects or malfunctions (of the device, accessories, software, etc.), unplug device, exclude
reconnection, mark clearly and inform h/p/cosmos service personnel via telephone and writing.
❚
In case of any visible or assumed wear and tear (of the device, accessories, labels, etc.), unplug device, exclude reconnection,
mark clearly and inform h/p/cosmos service personnel via telephone and writing. Do not change or remove any labels!
❚
In case of any uid entering into the device, unplug device, exclude reconnection, mark clearly and inform h/p/cosmos service
personnel via telephone and writing.
❚
Do not modify the device, congurations, accessories or software in any way.
❚
Do not connect any devices, accessories or software, not listed in “accessories / compatible devices”.
❚
Disinfect the device before and after every treatment.
❚
Disconnect the device and all accessories from mains power supply before cleaning or disinfection.
❚
Do not save personal data (names, address, etc.) or patient data (indications, etc.) on the UserTerminal, for example in le names
or prole names.
sport
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 19 of 97

7.1Fall prevention devices
A fall prevention device is the only effective way to protect the subject from falling.
Prescribed fall prevention for any application where falling might cause an unacceptable risk (details see chapter 4.1).
h/p/cosmos provides fall prevention devices in the form of a safety arch or a body weight support device (airwalk).
It is up to the operator to use any other certied device that prevents the subject from falling and complies with
IEC 60601-1 and EN 957-6 in combination with this treadmill.
The pull-cord safety stop is not a fall prevention.
Do not use the safety harness on bare skin.
Treadmill with safety arch Body weight support device airwalk®
Further information see “Annex III (accessories)”
Description Illustration
Put on the safety harness so that the h/p/cosmos logo is facing
outside.
The h/p/cosmos logo has to be visible in the back as well.
Close buckles.
Tighten shoulder and chest straps.
Use carabiner to connect safety harness with rope.
select max. patient weight / triggering of STOP function
1.) rope not through upmost eyelet -> max. 250 kg / trigger at 15 kg
2.) rope through upmost eyelet -> max. 300 kg / trigger at 30 kg 1.)
❚
150/50 LC 150/50 150/50 new 170-190/65 200-300/75-125 emotion MCU6
2.)
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 20 of 97
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1
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