Replacement Units (thermode and vibrameter

Organization name

Phi Med Europe

SRN

ES-MF-000029605

Manufacturer status

Active

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

• CW999

  WARNINGS REGARDING EMC The equipment is in conformity with the standards regarding Electromagnetic Compatibility, not causing electromagnetic disturbances, and complying with immunity standards. To prevent adverse events to the patient and Operator due to electromagnetic disturbances, the device requires the following special precautions regarding EMC: - The equipment should not be located close to other devices or stacked with other devices. - The use of accessories, transducers or cables not specified or provided by Phi Med Europe S.L. may negatively affect EMC performance. - “Portable RF communications equipment including antennas should be used no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result” - All the mentioned warnings and instructions must be followed for maintaining basic safety with regard to electromagnetic disturbances for the expected service life. NOTE: “The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment”
• CW999

  Do not use the device on open wounds or mucous membranes.
• CW999

  CONTRAINDICATIONS Do not use the device in patient under psychiatric medical treatment or pathological cognitive status.
• CW999

  CONTRAINDICATIONS Do not use the device on children under the age of 15 years old.
• CW999

  CONTRAINDICATIONS Not indicated for pregnant and nursing women.
• CW999

  CONTRAINDICATIONS • Do not use in people with pacemakers due to electromagnetic disturbances. Likewise, any medical implantation instrument that contains an RF system, if implanted, makes the application of this study not possible and in the case of being external (i.e. insulin pump), the development of the test must be done without the operation of this instrument.
• CW999

  WARNING Side-effect: Possible local erythema of the skin may occur.

Primary placement in Spain; available across 10 countries total.

Trade name

Replacement Units (thermode and vibrameter

UDI-DI code

08437023855034

Basic UDI-DI

B-08437023855034

Reference / catalog number

0110

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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