12-30-102

Organization name

Ganshorn Medizin Electronic GmbH

SRN

DE-MF-000006566

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW273

  Do not use the device if the protective earth is suspect or if the mains lead/power supply unit is damaged or suspected of being damaged. This device may only be connected to a mains supply with protective earth. Prior to initial operation and daily use, the device has to be inspected for external damage. Danger to the patient due to modifications of the electrical system: – Only connect accessories approved by the manufacturer to the device. Danger of electric shock due to ingress of liquid.
• CW999

  Danger of ventricular fibrillation triggered by equalising currents between different device potentials. This may be the case if the device is used together with medical devices for direct cardiac application: – Connect both devices to the building's joint potential equalisation.
• CW999

  The device may only be opened by the manufacturer's customer service. If any ambiguities should arise, promptly contact the manufacturer's customer service.
• CW999

  To change fuses, the device must first be disconnected from the power supply voltage. Fuses must only be replaced by trained electricians. Only replace with fuses with the same electrical specifications –microfuse 5x20mm T 1,25 AH /250 V (for 230 VAC), –microfuse 5x20mm T 2,5 AH / 250 V (for 115 VAC and for variant with E-Saddle).
• CW999

  Danger to the environment due to improper disposal: –Dispose of packaging material, device and accessories according to the country's regulations in which the device is used
• CW999

  Danger to the patient as well as risk of the warranty becoming invalid if accessories or disposables are used that are not approved: – Only use accessories and disposables approved by the manufacturer.
• CW011

  Danger to the patient due to modi fications of the electrical sys- tem: – Only connect accessories approved by the manufacturer to the device.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

07613365500691

Basic UDI-DI

7613365SANABYL

Reference / catalog number

12-30-102

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training and measures this related muscle activity at defined workloads. The Ergometer could be used in exercise testing in combination with stress electrocardiography and/or stress echocardiography device.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z129003CYCLES FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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