Spiegelberg HDM 26.1/FV500, HDM 26.1/FV503 Operating Instructions Manual

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Spiegelberg:

ICP-Monitor
HDM 26.1/FV500
HDM 26.1/FV503

Operating Instructions

Monitoring
Technology for
Brains

2

Spiegelberg:

EG-Konformitätserklärung
EC Declaration of Conformity

Die Spiegelberg (GmbH & Co.) KG erklärt als Hersteller in alleiniger Verantwortung,
dass die im folgenden genannten Produkte die Anforderungen der Richtlinie
93/42/EG erfüllen. Das Qualitätsmanagementsystem entspricht den Forderungen
der Norm EN ISO 13485:2003 + AC:2009.

Spiegelberg (GmbH & Co.) confirms as the manufacturer, being solely responsible,
that the following products meet the requirements according to the Medical
Device Directive 93/42/EEC. The Quality Management System is in accordance with
the requirements of the standard EN ISO 13485:2003 + AC:2009.

Produkt: ICP-Monitor
Product:

REF: HDM 26.1/FV500

HDM 26.1/FV503

Gültig ab: SN: 985/10

Angewandte produktspezifische Normen: DIN EN 60601-1:1996
Applied product-specific standards:

Klassifizierung gem. 93/42/EG IIa
Classification acc. 93/42/EC

Zertifikate: 018737 MP29, 018737 MR2
Certificates:

Gültig bis: 2015-10-24
Valid until:

Benannte Stelle: DQS GmbH
Notified Body: August-Schanz-Strasse 21

60433 Frankfurt am Main
Germany

Benannte Stelle Nr.: 0297
Notified Body No.:

Dr. Andreas Spiegelberg
Geschäftsführer

Hamburg, 24.11.2010

Spiegelberg Persönlich haftende
(GmbH & Co.) KG Gesellschafterin:
Tempowerkring 4 Spiegelberg
21079 Hamburg Medizintechnik GmbH
Germany Hamburg

Geschäftsführer:
Dr. A. Spiegelberg

Registergericht Registergericht
Hamburg HRB 81393 Hamburg HRB 46157

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Contents

Safety instructions
Indication and Method
Monitor Operation
Cleaning
Connections
Faults
Technical Specifications
Approved Accessories
Symbols used

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6
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9
10
11
13
15

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Safety Instructions

The ICP-Monitor and the accom­panying probes are designed for the
measurement of intracranial
pressure. The manufacturer accepts
responsibility for the safety,
reliability and performance of the
monitor only if:

- the installation, extensions,
readjustments, modifications and
repairs are performed by
authorized personnel,

- the monitor is used in
accordance with the operating
instructions, and

- the monitor is used with the
approved accessories.

Attention

The device is not intended for use in
areas where there is a danger of
explosion.

Attention

The device may be repaired only by
persons or companies that are
authorized to do so.

Attention

The device is not intended for use
during Electro-Surgery/Diathermy.

Attention

Grounding reliability can only be
achieved if the device is connected
to an equivalent power cord marked
„hospital grade“ or „hospital only“.

Attention

It must be ensured that the
classification of all connected
devices is suitible to the application
with regards to safety against
electric shock. The fact that leakage
currents are amplified if more than
one devices are connected to a
patient must be taken into account.

Attention

It is the sole responsibility of the user
to check that the electric installation
is in compliance with the local and
hospital-specific safety regulations
and that the system is in compliance
with the standard DIN EN 60601-1-1
„General standards, safety
regulations for electro-medical
devices“.