TOP-X 100NR 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.

• CW273

  There is dangerous voltage inside the generator and in the high-voltage cables connected to the X-ray tubes, even after it has been turned off.
• CW010

  Not complying with the user manual and the installation related regulations might result in the generator not fulfilling manufacturer specified specifications and endanger the operator, the patient or the environment. The manufacturer is not responsible for results of not complying with the regulations.
• CW028

  The operation of the generator requires extensive preparation in the field of X-ray diagnostics. There is dangerous voltage inside the generator and in the high-voltage cables connected to the X-ray tubes, even after it has been turned off. During the operation of the generator the X-ray source generates X-rays, so the device may only be used in a work area prepared according to X-ray safety regulations. During operation take all necessary precautions to protect the patient, yourself and the environment from the harmful effects of the generated X-ray radiation. During the operation of the generator when selecting the applied examination, treatment or intervention, for the patient’s protection and the accuracy of the diagnostic results, take into consideration the generated X-ray radiation’s physical, chemical and physiological effects, their treatments, interventions and efficiency, and the effects and possible risks on the equipment.
• CW023

  Portable and mobile RF communication equipment may interfere with generator operation. The generator requires special precautions regarding EMC. Installation must be performed according to the EMC information in the technical data and installation manual.
• CW133

  During normal operation the generator does not emit any environmentally dangerous substances. The oil in the generator’s high-voltage transformer is dangerous to the environment so its disposal must be according to the environmental regulations in effect. When rolling out the generator or its parts the operative environmental regulations must be followed.

Primary placement in Hungary; available across 1 country total.

Trade name

TOP-X 100NR High frequency X-ray generator

UDI-DI code

D-TOP-X100NRHV

Basic UDI-DI

B-TOP-X100NRHV

Reference / catalog number

R-7469

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

• 30000–65000 MU103
• Output voltage — 40000–150000 MU114
• 100–120 MU29
• Exposure time — 0.001–6 MU81
• 100000 MU27
• 80 MU10
• 75 MU10
• 42 MU10
• Output current — 0.01–0.82 MU107
• Current time — 0.5–820 MU999

• Z11039011HIGH VOLTAGE X-RAY GENERATORS

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