TOP-X 100LC High frequency X-ray generator

Organization name

Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság

SRN

HU-MF-000017747

Manufacturer status

Active

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

• CW133

  During normal operation the generator does not emit any substance harmful to the environment. The oil in the generator’s high-voltage transformer is harmful to the environment, so it may only be discarded according to effective environment protection regulations. Effective environment protection regulations must be followed when discarding the generator or its parts.
• CW273

  Dangerous voltage is present behind generator covers at all times when generator power is switched on. Dangerous voltage remains behind generator cover even if generator mains voltage is switched off. Wait at least 10 minutes after switching off generator before removing covers. Removal of covers is only allowed to a qualified person.
• CW028

  Generator operation requires thorough preparation in the field of X-ray diagnostics. There is lethal voltage in the high-voltage cables and X-ray tubes within the generator, even after shutdown. During generator operation the X-ray source generates X-ray, so the generator may only be used in work areas designed according to radiation-protection regulations. During operation take the necessary precautions to protect the patient, yourself and the environment from the harmful effects of X-ray.
• CW010

  Disregarding the user manual and installation instructions can result in the generator not performing according to manufacturer’s specifications and can endanger the operator, the patient or the environment. The manufacturer is not responsible for the results of not following the instructions.
• CW023

  Portable and mobile RF communication devices can affect the generator’s operation. The generator requires special EMC related precautions. Installation must be performed according to the EMC instructions in the technical data and installation instructions.

Primary placement in Hungary; available across 1 country total.

Trade name

TOP-X 100LC High frequency X-ray generator

UDI-DI code

D-TOP-X100LCGR

Basic UDI-DI

B-TOP-X100LCGR

Reference / catalog number

R-7333

Issuing entity

EUDAMED

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.innomed.hu/en/#contact

Clinical sizes

• 59 MU10
• 49 MU10
• 39 MU10
• 50–73 MU29
• 32000–50000 MU103
• Output voltage — 40000–150000 MU114
• Current time — 0.5–500 MU999
• Exposure time — 0.001–6 MU81
• 100000 MU27
• Output current — 0.01–0.6 MU107

• Z11039011HIGH VOLTAGE X-RAY GENERATORS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification