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 service@h-p-cosmos.com

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 limitations, for high speed running and/or for any application where falling can cause serious injuries and/or even death, a fall prevention system (e.g. safety arch with harness & chest belt or unweighting system) 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.

  Warranty

  Safety regulations

  TÜV report "product certification"

  TÜV report "product safety"

  sports vs. medical applications

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!

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/enterprise/sectors/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf

Immediate danger and additional potential risks during the intended use are involved because:

Some other potential and technical risks, which are not related to the intended use:

When used to monitor vital processes where variations could result in immediate danger.

cardiopulmonary stress tests, ergometry, gait analysis, locomotion therapy for neurological patients

Indications:
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.

Contraindications:
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

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

(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.