DeVilbiss Healthcare DV6EB Manual Del Usuario página 8

Additional Specifications
Equipment classification with respect to protection from electric shock .......................................................................................................................................................................... Class II
Degree of protection from electric shock ................................................................................................................................................................................................... Type BF Applied Part
Degree of protection against ingress of liquids ...................... IP21IngressProtection–Protectedagainstfingeraccesstohazardousparts;protectedagainstverticallyfallingwaterdrops
Approvals
Meets RTCA/DO-160 .................................................................................................................................................... DO-160 Section 21 Category M for battery operation only Airline Use
BATTERY OPERATION RUN TIME
Typical battery run times for DV63 Standard Plus and DV64 AutoAdjust/AutoPlus:
Pressure Settings
CPAP (cmH O) Typical Run Time (Hrs)
2
5
10
15
20
• Run times are at a breath rate of 20 breaths per minute and standard mask leak
DEVILBISS GUIDANCE AND MANUFACTURER'S DECLARATION
WARNING
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic Compatibility
[EMC] information provided in the accompanying documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be
observed to verify normal operation in the configuration in which it will be used.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the
Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other
Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer's Declaration – Emissions All Equipment and Systems
Thisdeviceisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeroruserofthisdeviceshouldassurethatitisusedinsuchanenvironment.
Emissions Test
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonics IEC 61000-3-2
Flicker IEC 61000-3-3
Immunity Test
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical Fast Transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5
EN - 8
CPAP Only
Heater Setting = 3
Typical Run Time (Hrs)
17.7
12.5
8.7
5.7
Compliance Electromagnetic Enforcement – Guidance
This equipment must emit electromagnetic energy in order to perform its intended function. Nearby electronic
Group 2
equipment may be affected.
Class B
Radiated and Conducted
Emissions
This equipment is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Class A
Complies
IEC 60601 Test Level Compliance Level
±8kV contact ±8kV contact
±15kV air ±15kV air
±2kV on AC Mains ±2kV on AC Mains
±1kV Differential ±1kV Differential
±2kV Common ±2kV Common
CPAP with Heated Humidifier
Heater Setting = 5
Typical Run Time (Hrs)
4.2 2.7
4.0 2.2
2.6 1.7
2.5 1.6
Electromagnetic Environment - Guidance
Floorsshouldbewood,concreteorceramictile.Iffloorsaresynthetic,therelative
humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Run times shown are Run time is doubled by
DV6EB with one 99.6 adding optional second
wHr battery pack battery pack to DV6EB
A-DV6EB-1