Safety is our highest priority
h/p/cosmos only approves the interface protocol „coscom v3“ for medical applications and herewith confirms the -since March 21, 2010 (MDD / Directive 2007/47/EC) mandatory- conformity of coscom v3 according to the norms EN 62304 (Life Cycle Requirements for Medical Device Software; Medical Device Software Life Cycle Processes) and EN 14971 (risk management for medical devices) as well as the compliance to a very high safety standard.
All other interface protocols (older versions coscom v2, coscom v1, coscomekg.dll, Trackmaster, Pacer, etc.) are not validated by h/p/cosmos according to the norms EN 62304 and EN 14971 and must not be used for medical applications (e.g. ergometry, stress-tests, cardiorespiratory diagnostic, performance diagnostic, etc.) since March 21, 2010 in connection with h/p/cosmos treadmills or h/p/cosmos OEM treadmills!
We strongly recommend to update to the latest h/p/cosmos coscom v3 interface protocol. The latest coscom.dll and implementation notes can be found on www.coscom.org. In case you have any questions please contact firstname.lastname@example.org
Pre-cautions, Danger Warnings based on the norms EN 957-1 / EN 957-6 and based on manufacturer's information
- Use at own risk - the manufacturer is not liable for damage.
- Read danger precautions - only use after instruction and under permanent supervision.
- Keep a clear safety area of at least 2 m long and 1 m wide directly behind the machine.
- Only one person at a time to use the treadmill.
- Children and animals are to be kept at a safe distance from treadmill.
- Use only with appropriate clothing and training shoes.
- Max. permissible load on the running deck 200 kg (440 lbs) – see manual.
- Always mount the stationary treadmill from the rear.
- Never jump off backwards or to the front.
- Read the whole manual before use.
- Consult a doctor before using this device.
- WARNING: Heart rate monitoring systems can be inaccurate.
- Incorrect and/or forbidden use and/or overtraining can lead to serious injury or even death.
- If you feel close to fainting, the training has to be stopped immediately.
- If you feel sick or dizzy, stop training immediately and consult a doctor.
- Always warm up fully at walking speed before starting to run.
- End training by pressing the stop button - only use the emergency stop in an emergency.
- To get off the treadmill in an emergency case, press the emergency stop button, hold handrails with both hands and move feet to outside of the running belt.
- For running machines with oversize track (> 160 x 55cm), for children, special applications, for subjects with health and/or other limitations and/or disabilities (e.g. visually impaired, etc.), for high speed running and/or for any application where falling would result in an inacceptable risk and would cause serious injuries and/or even death (e.g. for patients with recent hip replacement operation, probes in the body, etc.), a fall prevention system (e.g. safety arch with harness & chest belt or unweighting system / BWS body weight support device) is obligatory.
- Consulting, sales, installation, commissioning, instruction, inspections, maintenance and service repair works only through trained and by h/p/cosmos certified personnel.
Accidents on running machines in general are very painful especially if a subject is falling.
In general accidents therefore can also lead to serious injuries or death. In many cases apparently unimportant measures, can contribute to more safety in connection with the usage of running machines and therefore reduce risk of injuries or death considerably. Safety for h/p/cosmos starts with the simple danger precaution note in the operation manual, a very professional commissioning and instruction protocol and ends with complex safety systems for sports and medical application.
Warnings include: Always keep away children from running machines and keep a clear safety space of L: 200cm x W: 100cm (or at least the width of the treadmill)
Another very useful safety relevant feature are the Safety-Stop-Buttons, which all h/p/cosmos running machines are equipped with. They are placed on the user terminal in an easy to reach position resp. on running machines without user terminal they are placed directly on the handrail.
Complex h/p/cosmos safety systems ...
- h/p/cosmos airwalk
- h/p/cosmos arm support
- h/p/cosmos safety arch with fallstop
h/p/cosmos running machines are extremely safe: No deadly accident ever has ever been reported in our history. Nor even any accident with injury has been reported to us, where the source of the accident was a technical defect of the running machine.
However, we are aware of accidents due to disregard of safety precautions or due to other reasons while using the machine. In general malfunctions can never be ruled out with a 100% guarantee. Theoretically any treadmill could have a malfunction and accelerate unintentionally and without warning to a high speed for example. Therefore for all risk applications or any use with patients, where falling would lead to very dangerous situations (for example after hip replacement operations, patients with neurologic problems, etc.) a fall prevention system like above listed safety arch is obligatory for such applications.
The potential-isolation-transformers provide excellent safety and additional electrical shielding.
With the help of a metal housing around the frequency inverter and many further technical EMC measures we do more than just fulfill the EMC guidelines. Safety measures that protect humans, machines and peripheral systems.
h/p/cosmos sports devices meet the following technical safety standards and legal demands for sports application: , IEC EN 60335-1, EN 957-1 and EN 957-6 as well as VDE 0700/0701.
h/p/cosmos running machines of the category medical meet the following technical safety standards and legal demands for medical application:
- MDD risk class IIb, ,
- IEC EN 60601-1,
- IEC EN 60601-1-2,
- IEC EN 60601-1-4,
- IEC EN 60601-1-6,
- EN 957-1, EN 957-6,
- 2006/42/EEC + 98/37/EEC,
- EN 14971, EN 62304 and VDE 0750/0751.
Medical devices are equipped with an Emergency-Off-Button instead of a conventional Safety-Stop-Button, which disconnects the device from the power supply when pushing the button in emergency cases.
According to EU-provisions it is prohibited to place on market sports running machines in the medical field.
Preventive maintenance and safety inspections:
Since treadmills are electrically powered devices they can never be maintenance free, especially when they are used for commercial, institutional, scientific or medical use.
Maintenance starts with the regular inspection of the electric safety and should cover a number of important safety and maintenance related electrical and mechanical parts, functions and issues. Also the function check of display for speed, distance, elevation, time, heart rate, energy and other parameter should be checked periodically. For details please refer to the operation manual.
For normal applications h/p/cosmos recommends annual inspection for treadmills. The use of treadmills in special environment (for example in environmental climate chambers, etc.) may require shorter terms and/or additional inspections and preventive maintenance.
All running machines and other machines with moving belts and parts, hold a great potential of danger at the belt re-entry zone on the sides and at the end of the running surface, as the gap between running belt and frame is frequently too wide. To reduce the risk for users, h/p/cosmos running machines have a gap of less than 4 mm and it is marked clearly with additional danger precaution stickers - see below.
Use the safety sticker "Danger Zone" for other danger zones on other machines and order it at h/p/cosmos with the order number cos10508.
Never let children play on, play with or play near a running machine!
Accuracy of displays / data validity:
h/p/cosmos treadmills meet accuracy class A (high accuracy) of treadmill standard EN 957-6. Therefore the values displayed and transferred via interface are very reliable. In order to maintain this accuracy (velocity, inclination, distance, heart rate, etc.) we urgently recommend meeting the regular maintenance intervals. With respect to the validity of your treadmill data we recommend an additional accuracy test immediately prior to very important tests or scientific studies. The test should be double-checked by authorized h/p/cosmos technicians.
We point out that poor voltage power supply with voltage drops, defects, lack of maintenance, etc. may cause accuracy problems.
Medical Device Classification Rules:
A medical treadmill, which is also used for ergometry and cardiopulmonary stress test as well as performance diagnostics is always a risk class IIb medical device either when used as stand alone device in a medical environment or when used in connection with an ECG, EMG, Ergospirometry or blood pressure monitoring device.
Source of above chart: http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf
Immediate danger and additional potential risks during the intended use are involved because:
(1) During various treadmill applications the subject is unable to communicate discomfort or problems and/or may be unable to press the emergency button by himself. This can be for example because the subject is wearing a mask for VO2max measurement, or the subject is disabled or the subject is fixed to special harnesses or the subject has major physical and/or mental limitations or also because of fatigue. Among others, during normal application and/or also in case of falling, fractures, skin-abrasion, bruises, hematoma, traumatic injuries and cardiovascular disorders or even sudden death may occur during this application.
(2) During various applications such as ergometry and cardiopulmonary stress tests as well as performance diagnosticsthe the intended use is to deliver mechanical energy from the treadmill to the subject. It is the intended use to stress the cardiopulmonary system of the patient to an extremely high level, where for examples heart irregularities or even heart failure occur. This is done under controlled and supervised environment. Medical staff and emergency equipment (defibrillator, ECG, etc.) has to be present at any time. Among others, during normal application and/or also in case of falling, fractures, skin-abrasion, bruises, hematoma, traumatic injuries and cardiovascular disorders or even sudden death may occur during this application.
(3) The subject may have problems at any time to catch up with the speed of the moving running belt and therefore is always in the risk of falling. Falling on a treadmill can result in serious injuries (bruises, skin-abrasions, burns, broken bones, etc.) or even death (e.g. through broken neck, cervical dislocation). Some other potential and technical risks, which are not related to the intended use:
(4) Danger of electric shock through isolation malfunction of the treadmill or ECG involved increases when the treadmill is linked via interface to ECG and so indirectly linked with electrodes to the skin of the subject. Treadmills are usually powered with single phase 110 … 240 volts or even 3-phase 3x400 Volts.
(5) Malfunction of heart rate measurement or wrong target heart rate settings may result in overload to the subject through too high loads (speed and elevation) and therefore can lead to serious health conditions or even death.
(6) Malfunction of speed control of the running belt or the interface communication with ECG and ergospirometry device may result in immediate acceleration of the running belt.
(7) Dangerous capture zones mainly at the running belt re-entry zone (gap between belt and frame at the rear roller zone) or through other moving parts and frame of the treadmill when using the elevation system, adjustable handrails, unweighting systems, etc.
(8) A number of deadly accidents are known with treadmills. Luckily there are no known deadly accidents with h/p/cosmos treadmills so far.
(9) Active therapeutic devices intended to administer or exchange energy in potentially hazardous way.
(10) When used to monitor vital processes where variations could result in immediate danger.
Intended use (specific function / purpose) in medical field:
cardiopulmonary stress tests, ergometry, gait analysis, locomotion therapy for neurological patients
Diagnosis and prognosis of cardiovascular disease, specifically coronary artery disease (CAD), Arthritis in foot ankle, Femoropetrellares Syndrom, knee joint problems, anterior cruciate ligament plastic, gait analysis and gait correction for stroke patients.
The following contraindications are from the AHA/ACC guidelines published in 1997.
- Acute myocardial infarction (within 2 d)
- Unstable angina not previously stabilized by medical therapy: Appropriate timing of tests depends on the level of risk of unstable angina as defined by the Agency for Health Care Policy and Research Unstable Angina Guidelines.
- Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
- Symptomatic severe aortic stenosis
- Uncontrolled symptomatic heart failure
- Acute pulmonary embolus or pulmonary infarction
- Acute myocarditis or pericarditis
- Acute aortic dissection
Relative contraindications: Relative contraindications can be superseded if the benefits of exercise outweigh the risks.
- Left main coronary stenosis
- Moderate stenotic valvular heart disease
- Electrolyte abnormalities
- Severe arterial hypertension: In the absence of definite evidence, the committee suggests an SBP of greater than 200 mm Hg
- and/or a DBP of greater than 110 mm Hg.
- Tachyarrhythmias or bradyarrhythmias
- Hypertrophic cardiomyopathy and any other forms of outflow tract obstruction
- Mental or physical impairment leading to an inability to exercise adequately
- High-degree atrioventricular (AV) block
The vast majority of treadmill exercise testing is performed on adults with symptoms of known or probable ischemic heart disease. Candidates for exercise stress testing may have stable symptoms of chest pain, may be stabilized by medical therapy following symptoms of unstable chest pain, or may have already had a myocardial infarction or a vascularization procedure.
The clinical suggestion of CAD based on patient history findings, ECG tracings, and symptoms of chest pain must be established and used as a guide to determine if treadmill exercise testing may be useful according to the Bayes theorem, which states that the diagnostic power of exercise stress testing is maximal when the pretest probability of CAD is intermediate (30-70%) based on age, sex, and the nature of the chest pain.
When the diagnosis of CAD is certain, based on age, sex, description of chest pain, and history of prior myocardial infarction, a clinical need may arise for risk or prognostic assessment to reach a decision regarding possible coronary angiography or revascularization to guide further medical management.
Myocardial infarction is a common first presentation of ischemic heart disease. This subset of patients also may require prognostic and/or risk or assessment.
(source for indications/contraindications for diagnosis and prognosis of cardiovascular disease, specifically coronary artery disease (CAD): http://emedicine.medscape.com/article/1827089-print)
Clinical studies are not required for treadmills, since:
a) performance data are available and fulfilled based on the norms EN 957-1 and EN 957-6 for treadmills;
b) treadmills have been used for more than 50 years worldwide and the clinical benefits are well documented. The clinical benefits exceed the involved risks which are arising in the application. In our risk management system based on EN14971 we have documented the control of all known risks.
Software-Sicherheitsklassifizierung nach EN 62304 Medizingeräte-Software; Software-Lebenszyklus-Prozesse:
Der Hersteller muss jeder Software eine Software-Sicherheitsklasse zuordnen, je nach den möglichen Auswirkungen einer Gefährdung auf den Patienten, den Anwender oder Dritte, zu der die Software beitragen kann.
Die Software-Sicherheitsklassen müssen, basierend auf dem Schweregrad, wie folgt zugeordnet werden:
- Klasse A: Keine Verletzung oder Schädigung der Gesundheit ist möglich
- Klasse B: Keine SCHWERE VERLETZUNG ist möglich
- Klasse C: Tod oder SCHWERE VERLETZUNG ist möglich
Software und Firmware für Laufbänder und Schnittstellenprotokolle sind nach EN 62304 in der Anfangsbetrachtung immer als Klasse C mit höchster Gefährdung und Todesfolge einzustufen, weil bei einem ungewollten und unkontrollierten Durchbeschleunigen eines Laufbandes immer ein Sturz z.B. mit den Folgen eines Genickbruchs passieren kann. Basierend auf oben genannten Klassifizierungsbaum mit Klassifizierungsregeln muss auch immer mit einer technischen Fehlfunktion einer Messfunktion (z.B. Herzfrequenzmessung) gerechnet werden, wodurch dann theoretisch ein Patient überbelastet werden könnte und auch hier mit Todesfolge zu rechnen ist.
Auch seitens besondere Anforderungen an SOUP (Software Of Unknown Provenance) ist festzuhalten, dass medizinische Laufband-Ergometer und deren Software sich SOUP Komponenten bedienen. So sind Frequenzumrichter, Motorregelungen, Firmware und teils PC-Software Bestandteile von medizinischen Laufband-Ergometern und der Laufband-Hersteller hat keinen Zugriff auf Design, Validierung und Wartung solcher Komponenten von Zulieferern.
Auch aus diesem Grund muss immer mit dem Worst-Case einer Fehlfunktion gerechnet werden. Gesunde Menschen im Sportbereich sind in der Regel in der Lage den Not-Aus-Schalter eines Laufbandes zu betätigen und dann bei einer Fehlfunktion das Laufband reaktionsschnell abzuschalten. Der Not-Aus-Schalter muss daher auch völlig ohne Software funktionieren und den Antrieb des Laufbandes stromlos schalten. Bei Patienten und medizinischen Anwendern kann eine schnelle Reaktion des Patienten und ein rechtzeitiges Abschalten nicht gewährleistet werden, weil bei einem Patienten auch eine erste und leichte Geschwindigkeitserhöhung schon zu einem Sturz führen kann.
Um das Risiko auch für Patienten oder Personen mit Behinderungen zu beherrschen, muss bei Anwendungen mit erhöhtem Risiko (z.B. Patienten nach Hüftgelenksoperationen, neurologische Patienten, Herzpatienten, etc.) mit einer Sturzsicherung (z.B. Sicherheitsbügel mit Brustgeschirr und Fallstoppleine) gearbeitet werden, der einen Sturz verhindert (den Patienten auffängt). Darüber hinaus muss der Patient auf dem Laufband permanent beaufsichtigt werden und das Aufsichtspersonal muss sich innerhalb der Patientenumgebung von 1,5m befinden.
Laut EN 957-6 werden als weitere Risiko mindernde Massnahme auf dem Laufband und in der Bedienungsanleitung folgende Warnungen angebracht:
- ACHTUNG — Herzfrequenz-Überwachungssysteme können ungenau sein.
- Übermäßiges Training kann zu ernsthaften Verletzungen oder zum Tod führen.
- Wenn Sie sich einer Ohnmacht nahe fühlen, ist das Training sofort zu unterbrechen.
- h/p/cosmos Laufbänder sind durch die Risikobeherrschung und Risiko mindernden Massnahmen als Klasse B eingestuft.
- Die Risiken und die Risikobeherrschung müssen ins Risikomanagement nach EN 14971 eingebunden sein.
Dear Mr. Harrer
You advise that you place "treadmills" on the market. You asked to re-confirm to which category these treadmills are assigned to. To this end we would like to give the short following legal opinion:
1. Basic product class
Basically once can statue, that there is a type of legal gradation for products of the type into which a treadmill could fall. As a basis, the (German) Product Safety Act (ProdSG) applies to all products that are industrially manufactured and placed on the market. A special class then provides for "Commodities" according to section 2 paragraph 6 of the Food and Feed Code (LFGB). Such commodities are products that come in contact in some way with food or cosmetics (packaging) etc., or in any other way into temporary contact with the human body such as toys and decorations.
Another particular type of product are "medical devices" within the meaning of section 3 of the (German) . These are basically all the items which are used in medical, therapeutic, diagnostic or rehabilitative treatment.
As a crucial demarcation criterion will be seen the intended use (objective purpose) of each product, the special purpose provisions are to be classified with respect to the overall purpose of the product as a priority and classify the total product to an appropriate genre. Thus, a product can only be classified under the Product Safety Act if no intended use (purposes) either in the manufacturers description or the objective expectations of the consumer, for another more specific type of product are met.
The definition of a medical device is in section 3 no. the only relevant alternatives here:
"Medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination intended by the manufacturer to be used for human beings for the purpose of:
a) diagnosis, prevention, monitoring, treatment or alleviation of disease,
b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, or
c) investigation of a physiological process."
Accordingly, it is essential for the assignment of a treadmill to a specific product category, whether at least a purpose that makes reference to a disease or the treatment, alleviation of or compensation of injury or handicap, or simply for the medical examination of a physiological process of the body. The term "disease" is not defined in the Act. While the WHO assumes a much wider concept of disease, the German courts have repeatedly discussed different views on the concept of "disease", especially with respect to the social insurance law. Generally, however, the definition of the Federal Supreme Court should be taken, after which a disease is a disorder of the normal condition or the normal activity of the body which can be eliminated or alleviated. In the social insurance law in this regard it is added that disease is an abnormal state of mind or body, that requires medical treatment and/ or leads to an incapacity for work. A differentiation needs to be made so that the concept of disease symptoms of a particular people, corresponding to a normal life process (especially ageing) are excluded. This can not be described as a disease. On the other hand, agerelated wear and tear (degenerative joint disease), or presbyopics, age-related diabetes etc. despite being related to the ageing process of the body are to be understood as a disease.
Especially in the field of sport, the concept between sporting exercise, wellness, health promotion, disease prevention and disease treatment is fluid. The crucial factor is always that one of the aspects may be due to disease. Next to it is also the further possibility that the purpose of a medical device, is the compensation of an injury or handicap, whether this handicap can be healed through therapy or not, is one possible purpose.
2. Attributable of a treadmill to product category
Under these guidelines, a treadmill is always a medical device if it (or at least also) is used for medical purposes as mentioned above. Here these medical purposes may initially present themselves in the rehabilitative field. If a treadmill was used for rehabilitation after disease, injury or surgery, this treadmill clearly meets the purpose of a medical device. It does not matter whether this rehabilitation is required after a sports injury or due to a medical operation (e. g. replacement of the hip joint). In both cases the implementation of the measures would only be possible with a medical device. Also included in this field is gait therapy, locomotion or other orthopaedic rehabilitation.
In addition diagnostic functions of a treadmill come into consideration. A medical device is used for detection and monitoring of disease and can be used for examining a physiological process of the body. So treadmills used for stress ECGs, ergometry, movement and gait analysis and sports medicine diagnostics of lactate or heart rate analysis or in a study following any disease related state of the body are also medical devices.
If a treadmill is used for at least also one or more of the above purposes, it is mandatory that the product is categorised as a "medical device" according to section 3 no. 1 of the German Medical Devices Act MPG.
In contrast, treadmills that are to be used only in the area of sport training optimization or general performance enhancement and general fitness of users fall within the meaning of the Product Safety Act. However, it should always be borne in mind that whenever such applications, if only as a side effect during use help in recognizing possible problems (particularly circulatory problems, heart problems or similar pathological conditions) of the athlete/user mean that the treadmill is a medical device. Guiding the way in this case is the recent decision of the European Court from 22.11.2012 (Legal Case C 219/11) indicating that an item that was designed for people to use for the purpose of investigation of a physiological process, except when there is no measurement of the function of human organs in any way meaning that it does not fall under the concept of a medical device, is for medical use.
3. Relevance to user
The correct classification of a product is especially necessary for users of a treadmill because the Medical Devices Act and the Medical Devices Directive (MDD) also apply to products that are not placed on the market as medical devices by the manufacturer, but the users and operators have an appropriate purpose use of a medical device according to section 2, paragraph 2 of the German Medical Devices Act. Therefore, it must first be evaluated by the buyer of a treadmill if the proposed use (intended use) is for (or additional to) a medical, rehabilitative or medical diagnostic purpose. In this case, the only legally correct path is the purchase and use of a product classified as medical device.
4. Consequence of the type of product
Medical devices may be placed on the market only if they have undergone a specific conformity assessment procedure. With the CE marking, the manufacturer confirms that all the essential requirements for the specific medical device have been tested and met. The most diverse harmonised standards for the various types medical devices have been adopted and implemented and should be respected by the manufacturer of the product. In particular, the performance and quality characteristics have to meet very high standards, so that a "treadmill" built and classified as a medical device is in no way comparable to a "treadmill" for the pure sportive training.
Medical devices may only be used in accordance with section 6 paragraph 1 of the German Medical Devices Act if they bear the required CE marking.
We hope to have sufficiently and clearly explained the distinctions.
For further requests, please contact us at any time.
Atornery at Law
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