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8.5 EMI/EMC Statement and Manufacturer’s Declaration

This equipment has been tested and found to comply with the limits of EN 60601-1-2.

These limits are designed to provide reasonable protection against harmful interference in both a medical and 
residential environment. This equipment generates, uses and can radiate radio frequency energy and, if not used in 
accordance with manufacturer’s instructions, may cause harmful interference to radio communications. However, 
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful 
interference to radio or television reception or other equipment, which can be determined by turning the equipment off 
and on, the user is encouraged to try to correct the interference by one of the following measures:
•  Reorient or relocate the receiving antenna.
•  Increase the separation between the equipment.
•  Connect the equipment to an outlet on a circuit different from that to which the receiver or equipment was 

connected.

The equipment having been tested to operate within the limits of electromagnetic compatibility. (Immunity to 
interference from nearby sources radiating radio frequency energy). Sources exceeding these limits may give rise 
to operation faults. Where possible the system will sense the interference and if it is of short duration transparently 
take countermeasures whilst operating near normally, or failing this will issue a warning and take measures for the 
continued safely of the user. Further increased levels of energy may cause the system to stop operating, continuously 
generate random faults or continuous resets.

Try to ascertain the source of the interference by turning nearby or suspect equipment off, and see if the interference 
effects stop. In any such event the user is encouraged to try to correct the interference by one of the following 
measures:
•  Have the interfering equipment repaired or replaced.
•  Reorient or relocate the interfering equipment.
•  Increase the separation between the equipment and the possible source of the interference.
•  Connect the equipment to an outlet on a circuit different from that to which the interfering equipment was 

connected.

Information regarding Electro Magnetic Compatibility (EMC) according to IEC60601-1-2

With the increased number of electronic devices such as PCs and mobile telephones, medical devices in use may be 
susceptible to electromagnetic interference from other devices. The EMC (Electro Magnetic Compatibility) standard 
IEC60601-1-2 defines the levels of immunity to these electromagnetic interferences. On the other hand, medical 
devices must not interfere with other devices. IEC60601-1-2 also defines the maximum levels of emissions for these 
medical devices. The 

VENTURI

 conforms to this IEC60601-1-2 standard for immunity and emission. Nevertheless, 

special precautions need to be observed:
•  The 

VENTURI

 needs to be installed and put into service according to the EMC information below.

•  The 

VENTURI

 is intended for use in the electromagnetic environment specified in the tables below. The user of 

the 

VENTURI

 should assure that it is used in such environment.

•  In general, although the 

VENTURI

 complies to the EMC standards, it can be affected by portable and mobile RF 

communications equipment (such as mobile telephones).

•  The 

VENTURI

 should not be used adjacent to or stacked with other equipment. In case adjacent or stacked use 

is necessary, the 

VENTURI

 should be observed to verify normal operation.

D H G - H E A LT H C A R E . C O M

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Содержание TG600/08F

Страница 1: ...DHG HE ALTHCAR E C O M VENTURI Compact User Manual...

Страница 2: ...VENTURI COMPACT DHG HEALTHCARE COM...

Страница 3: ...NPWT 5 Getting Started 5 Operating the Vacuum Power Unit 5 5 Operation Guidelines 6 User Information 6 Operation Controls 7 User Selectable Functions 8 Setting Changing Power Unit Display Languages 8...

Страница 4: ...Warning Refer to instruction manual booklet Medical Devices Directive 93 42 EEC Medical Device Regulation 2017 745 North America ETL listed Class II Equipment Double Insulated Do not dispose of with t...

Страница 5: ...for closure by primary intention for wound management odour control exudate management etc Wounds which may benefit from the application of NPWT include pressure ulcers dehisced surgical wounds diabet...

Страница 6: ...acuum power unit or power adapter on or near a heat source Never use the power adapter whilst placed on top of or near to material which is flammable or can be damaged by heat The supplied power adapt...

Страница 7: ...nal s treating the wound must assess how to best use the system for an individual wound 1 Remove all packaging from the power unit and mains adapter NB The power unit internal battery may be mostly di...

Страница 8: ...t and continue NPWT 7 Canisters should be replaced as required or weekly To change canister make sure power unit is in stand by mode if still running press and hold the UNLOCK button followed by the R...

Страница 9: ...ower unit will then power off after 1 minute of inactivity If using mains power switch off by disconnecting power cable from power unit or turning off mains power VACUUM LEVEL Vacuum level can be adju...

Страница 10: ...ey to select this function c To select the required language press and hold the THERAPY MODE button until the language is displayed Releasing the THERAPY MODE button will then set the display for the...

Страница 11: ...s adequately or may interfere with device function Direct Healthcare Group recommends the use of TECcare CONTROL antimicrobial wipes and fluid to clean and decontaminate all products it supplies to he...

Страница 12: ...he canister is removed both of which cancels the message and sounder and returns the power unit to stand by mode Change canister as detailed on page 6 NB The Canister Full sounder can be silenced by p...

Страница 13: ...put Voltage 12V Nominal Vacuum Application Continuous default therapy or intermittent Pressure Range 10 to 180mmHg 0mmHg 20mmHg Fixed Internal Battery 3 7V 10Wh Lithium Ion Rechargeable Cell IP Rating...

Страница 14: ...ion Medical electrical equipment safety and essential performance IEC 60601 1 11 Home healthcare environment 8 4 Manufacturer s Guarantee The VENTURI COMPACT power unit is covered by a 24 month manufa...

Страница 15: ...e source of the interference by turning nearby or suspect equipment off and see if the interference effects stop In any such event the user is encouraged to try to correct the interference by one of t...

Страница 16: ...UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 Mains supply quality for the mains adapter should be that of a typical commercial and or hospital environment In the event of a mains interruption the...

Страница 17: ...in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cell...

Страница 18: ...nual was correct at the time of going to press However Direct Healthcare Group reserves the right to modify the specification of any product without prior notice in line with a policy of continual pro...

Страница 19: ...DHG HEALTHCARE COM USER MANUAL Notes 1 7...

Страница 20: ...et Swatar BKR 4013 Malta Direct Healthcare Group Ltd Withey Court Western Industrial Estate Caerphilly United Kingdom CF83 1BF T 44 0 800 043 0881 F 44 0 845 459 9832 E info directhealthcaregroup com...

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