Discontinuation of support for h/p/cosmos airwalk® 35, 50, 70, 75, 90, 160

Affected devices series:

Manufacturer title: Pneumex Pneu-Lift (manual), Pneumex Pneu-Lift (automatic), Pneumex Pneu-Weight

Legal Manufacturer:
Pneumex Inc.
3115 North Bayer Ave.
US 83864 Sandpoint, ldaho ID / USA
phone 001 / 208 / 265-4105
fax 001 / 208 / 265-9651
pneumex@pneumex.com
www.pneumex.com

Authorised Representative for import to European Union and for Declaration of Conformity and Duties to Council Directive 93142/EEC:
D.R.M. Green Eurolink (Europe) Ltd.
Oakdene, Oak Road, Watchfield, Swindon, Wilts. SN6 8TD / United Kingdom
Tel. +44 1793 784545 Fax +44 1793 784551

We would like to inform you that we must discontinue the technical support for the above listed body weight support devices with immediate effect. The device was marketed as a class I medical device in accordance with Directive 93/42/EEC (MDD) and is used for partial body weight support during treadmill therapy and training.

For safe use, the instructions for use stipulate that the relief cable must be replaced regularly, at least once a year.

This spare part can no longer be supplied by the manufacturer with immediate effect. As h/p/cosmos is not the manufacturer of the product, h/p/cosmos cannot manufacture any spare parts without assuming the manufacturer's responsibility.

For this reason, we can no longer ensure proper maintenance. The discontinuation of support will therefore take immediate effect.

Regulatory information for operators and distributors

Please note the following regulations:

Medical Devices Operator Ordinance: Operators may only operate medical devices in a safe condition. Maintenance must be carried out in accordance with the manufacturer's instructions. If this is not possible, the product must no longer be used.
Product Safety Act: Distributors and operators may only supply safe products.
Product Liability Act: Unauthorised modifications or the manufacture of replacement parts may result in full liability.

Important consequence:

The device must not be operated if the prescribed maintenance cannot be carried out. Dealers who have purchased the product from us must also inform their customers immediately.

We regret this step and thank you for your understanding and cooperation to date. We are of course available to answer any questions or clarify alternatives.

FAQ – Frequently asked questions

Can the device still be used?

The prescribed maintenance (regular replacement of the body weight support cable) can no longer be carried out as the spare part is not available. This means that safety can no longer be fully guaranteed. If nevertheless the use of the device is temporarily to be continued, the responsibility for risk assessment and safe operation lies with the operator.

The following is recommended:

• Visual inspection for wear or damage before and after each use of the rope
• Immediate decommissioning in the event of visible damage
• Documentation of all inspections and measures

Use is at your own risk and outside the scope of service provided by h/p/cosmos.

Is it permissible to replace or reproduce the relief cable yourself?
Unauthorised modifications or reproductions may make the operator legally liable as the manufacturer (in accordance with the Medical Devices Directive 93/42/EEC and the Product Liability Act) and entail considerable liability risks. Such an action is not recommended.

What alternatives are available?

The new weight relief system h/p/cosmos airwalk® ap is being offered at a preferred price as part of a replacement programme.
This system is MDR-compliant and offers additional safety features.

What are the advantages of the new system?

• MDR-compliant and future-proof
• Guaranteed availability of all safety-related spare parts (including cables) throughout the entire product life cycle
• Automatic stop function in critical situations
• Stepless dynamic weight support
• Ergonomic vests for improved comfort
• Compatible with all current h/p/cosmos treadmill models