Accessories; Provider's Notes; Devilbiss Guidance And Manufacturer's Declaration; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - DeVilbiss Healthcare iFill PD1000A Serie Guía De Instrucciones

aCCESSORIES

The accessories below are approved for use with the DeVilbiss unit:
Carry Bags
C Cylinder bag ......................................................................................................................................................................................................................................................................EX3000D-651
D Cylinder bag ......................................................................................................................................................................................................................................................................EX3000D-652
M6 Cylinder bag ....................................................................................................................................................................................................................................................................EX3000D-653
ML6 Cylinder bag ..................................................................................................................................................................................................................................................................EX3000D-654
Cylinder cart (E Cylinder) ........................................................................................................................................................................................................................................................................CT001
There are many types of oxygen tubing and cannulas that can be used with this device. Certain accessories may impair the device's performance. Use only standard nasal cannula capable of
supporting a minimum flow rate of 10 LPM with PulseDose delivery. Do not use pediatric (low-flow) nasal cannula or mask with PulseDose delivery. A mask or any nasal cannula can be used with
continuous flow delivery and may be sized according to your prescription as recommended by your homecare provider who should also give you advice on the proper usage, maintenance, and
cleaning.

PROVIDER'S NOTES

No routine calibration or service is required provided the device is used in accordance with the manufacturer's directions. Between patients wipe with a damp cloth having a maximum 5.25%
Sodium Hypochlorite (Bleach) or 3% Hydrogen peroxide solution. Avoid getting fluids or debris such as sand or dirt inside the oxygen connections. Do not immerse in water.

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 and that 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 – Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an
environment.
Emissions Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker emissions
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an
environment.
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Radiated RF IEC 61000-4-3
Conducted RF IEC 61000-4-6
Electrical fast transient
IEC 61000-4-4
Surge IEC 61000-4-5
Power frequency magnetic field
IEC 61000-4-8
Voltage dips, short interrupts and
voltage variations on power supply input
lines IEC 61000-4-11
This device has been tested to and meets the EMC requirements of EN60601-1-2. Do not place the device near other equipment or devices that create or attract electromagnetic fields.
Examples of such equipment are defibrillators, diathermy equipment, CB radios, microwave ovens, etc. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the unit is used exceeds the applicable RF compliance level
above, the unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the unit.
A-535-CYL
Compliance
Group 1
Class B
N/A
N/A
IEC 60601 Test Level
±6kV contact
±8kV air
3 V/m 80MHz to 2.5GHz
3 Vrms 150kHz to 80MHz
±2kV power line
±1kV I/O lines
±1kV differential
±2kV common
3 A/m
>95% dip 0.5 cycle
60% dip 5 cycles
70% dip 25 cycles
95% dip 5 secs.
Electromagnetic Environment – Guidance
This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
This device is suitable for use in all establishments including domestic and those directly connected to the
public low-voltage power supply network that supplies buildings used for domestic purposes.
Compliance
Level Electromagnetic Environment - Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic
Complies
material, the relative humidity should be at least 30%
Field strengths outside the shielded location from fixed RF transmitters, as determined
by an electromagnetic site survey, should be less than 3 V/m. Interference may occur in
Complies
the vicinity of equipment marked with the following symbol:
N/A
N/A
Mains power quality should be that of a typical commercial or hospital environment.
N/A
Power frequency magnetic fields should be at levels characteristic of a typical location in
Complies
a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the
user of this device requires continued operation during power mains interruptions, it is
N/A
recommended that the device be powered from an uninterruptible power supply or
battery.
EN - 9