Safety

Person Responsible for Regulatory Compliance (PRRC)
Nadine Schott

EUDAMED ID Economic Operator Manufacturer: 
SRN: DE-MF-000006147

Addendum to all h/p/cosmos treadmill manuals.

Interface connections, systems and compatibilities:
h/p/cosmos validates and recommends only the coscom v4 interface protocol. See www.coscom.org

TMX 425, TMX428, TMX428CP, TMX58 or T2100 or other interface emulations:
Warning and Disclaimer!
This interface protocol is not validated by h/p/cosmos and not released for medical applications in compliance with standard EN 62304 and regulatory compliance. The system producer / configurator (economic operator) is responsible and liable for sufficient testing, release, validation, regulatory compliance (also MDR (EU) 2017/745 and risk management) and documentation of these combined devices (h/p/cosmos treadmill and external control device, such as ECG, CPET, stress test device, etc.) in case of utilizing this protocol emulation.
h/p/cosmos rejects all claims and all liability for any issues related to the usage of the this interface protocol.

08 Sep 2023

Field Safety Notice FSN: Automatic program/profile modes can cause “unwanted acceleration”

DOWNLOAD the full PDF Dear customers, distributors, field service engineers and...

01 Apr 2023

End-of-life / End-of-support for coscom v3: 31.12.2023

This applies to all h/p/cosmos treadmill families: treadmill h/p/cosmos 150/50 G6 (pluto®, mercury®) treadmill h/p/cosmos 150/50 (locomotion®) treadmill h/p/cosmos...

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25 Nov 2022

Field Safety Notice FSN: remote control of treadmills e.g. during ergometry CPET ECG stress tests

DOWNLOAD the full PDF Dear customers, distributors, field service...

04 Feb 2022

Addendum to all h/p/cosmos treadmill manuals

Dear customers, In order to comply with all regulatory requirements and MDR medical device regulation (EU) 2017/745, h/p/cosmos performs regular PMS Post Market Surveillance,...

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07 Dec 2021

Hints for electrostatic charge and discharge

By moving the user, for example on a treadmill or when walking across the floor, the user's body can charge electrostatically with up to 30,000 volts. If the user then touches a...

21 Oct 2021

Field Safety Notice: safe wiring of frequency inverter connection cables pluto® / mercury® G6

Warning! Improper cable wiring may lead to damage of the cable isolation and can...

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23 Aug 2021

Medical Device Classification Rules

A medical treadmill, which is used for physiotherapy, cardiopulmonary rehabilitation, ergometry, cardiopulmonary stress test and diagostics as well as for performance...

22 Jun 2021

Interface control of treadmills. Risks with non-compliance of safety features

Interface control of treadmills. Risks with non-compliance of safety features DOWNLOAD the full PDF...

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11 May 2021

Important update from coscom v3 to coscom v4

coscom v1 and coscom v2 will be deleted automatically from the MicroControllerUnits MCU5 during the next Firmware Update of the treadmill. MCU6 never included coscom v1, v2 or v3....

19 Apr 2021

Safety Update: for chest belts (cos14903-01-SIZE ... cos14903-04-SIZE)

April 19, 2021 Safety Update: for chest belts (cos14903-01-SIZE ... cos14903-04-SIZE) For almost 15 years, the chest belts (...

19 Feb 2021

Lifetime of a medical device – end of life.

Example: In the case of h/p/cosmos, the intended lifespan of the treadmills, based on the information in the instructions for use, is between 10 and maximum 20 years for normal use,...

08 Feb 2019

Safety Update: for old coscom v1 and coscom v2 interface protocols

Safety Update: for old coscom v1 and coscom v2 interface protocols In the very old coscom v1 and coscom v2 interface protocols the...

10 Dec 2017

Field safety notice to a safety update for the MCU5 to update the firmware to v1.02.2

  Trotz vieler tausend Stunden Tests und trotz mehrmonatiger Testphase im Werk und auch bei ausgesuchten...

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20 Feb 2016

Field safety notice to buckle (fastener) of h/p/cosmos safety harness chest belt

Addressee: Users and operators of h/p/cosmos safety harnesses, used as fall prevention in combination with...

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11 Mar 2005

Field safety notice to the chest belt of the h/p/cosmos safety arch

this letter is a safety warning concerning the chest belt of the h/p/cosmos safety arch. If mistakes occur through neglecting the use...

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11 Mar 2005

Field safety notice to ripcords for treadmills built in 2014/2015

Addressee: Users and operators of h/p/cosmos treadmills built in 2014/2015 Identification of concerned medical devices and equipment:...

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