| 12 |
2 Safety
| HCU 40 |
Instructions for Use | 1.0 | EN | 01
Copyright Maquet Cardiopulmonary GmbH
2.1.4 Intended Patient
The device can be used for all patients irrespective of age, body weight and
gender.
2.1.5 Intended Environment
The HCU 40 is used in a clinical environment.
2.1.6 Contraindications
When the heater-cooler unit HCU 40 is used by specially trained personnel under
the supervision of a physician and in compliance with the intended use, no
contradictions are to be expected.
2.2 General Safety Instructions
2.2.1 Precautionary Measures
WARNING!
n
The system must be monitored by a trained member of specialist medical
staff. Clinical procedures and methods are the responsibility of the physician.
n
You should always keep a replacement unit on standby in order to ensure
continuous operation in the event of a complete system failure.
n
Prior to using the system, please read these Instructions for Use and the
Instructions for Use of all the disposables and supplies used.
n
The HCU 40 and all the system components used must comply with the
requirements of IEC 60601-1: 2005, section 16. In case of doubt, contact the
manufacturer of the system components used.
WARNING!
n
It is not permitted to change or modify the device or its accessories.
n
Switch the unit off and disconnect it from the external power supply before
maintenance, cleaning, or storage.
n
n
If a defective warming/cooling blanket is used with an electrosurgical unit
which is either not grounded or incorrectly grounded, this may result in burns
to the patient (⇨ "Connecting a Heat Exchanger", page 52).
Summary of Contents for HCU 40
Page 1: ...INSTRUCTIONS FOR USE HEATER COOLER UNIT HCU 40...
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