Poskom Airray 20 User manual
Airray 20 / For Veterinary
Battery Powered Portable X-ray System
Product Manual (Operation & Service)
PART II. SERVICE MANUAL
PART I. OPERATION MANUAL
TABLE OF CONTENTS
1
1. General description
1.1.Overview
Introduction
WARNING
PART 1: OPERATION MANUAL
2
RoHS Compliant
Laser beam
Stand-by
Lithium ion
Battery status
IPX0
No protection of equipment against ingress of water with harmful side effects (non-protected)
3
1.2.Product manual
1.3. Intended use
Indication:
Contraindication:
There are no contraindications for the use of X-radiation for diagnostic purposes provided the
practitioner is able to exercise judgment and justify the use of radiation.
1.4. Safety requirement
4
1.EN 60601-1:2006/A1:2013
2.EN60601-1-2:2015Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and
tests.
3.EN60601-2-54:2009 / A1:2015Medical electrical equipment - Part 2-54: Particular requirements for
the basic safety and essential performance of X-ray equipment for radiography and radioscopy
4.EN60601-1-3:2008/A11:2016
5.EN 60825-1: 2007 Safety of laser products -Part 1: Equipment classification and requirements
1.5. Cautions & Warnings
Possible hazards are associated with the improper operation of x-ray equipment. These hazards are
described on the following warning or caution signs with the appropriate safety precautions.
WARNING
CAUTION
5
1.6. Product life
The Airray X-ray unit is designed for a service life of 7 years.
1.7. Disposal
1) Notice for disposal
1.8. CLASSIFICATION
The X-Ray Unit covered by this Operation Manual is classified as:
Protection against Electric Shock: Class I -- Type B device under IEC 60601-1 standard.
Protection against Harmful Ingress of Water: Ordinary.
Degree of Safety in the presence of Flammable An esthetics Mixture with air or with oxygen or
with nitrous oxide: Not suitable for use in the presence of Flammable Anesthetics Mixture with
air or with oxygen or with nitrous oxide.
Mode of Operation: Continuous with intermittent loading.
1.9. Essential Performance
6
2. Operational safety
2.1. Safe Use
2.2. General Rules for Safe Use
(1) This product should be operated only by or under the supervision of a properly trained and
qualified professional.
(2)
(3)
(4)
(5) Any modification made to this unit without
the express authorization of POSKOM or an authorized dealer will void your warranty.
(6)
(7)
(8)
(9)
(10)
(11) Not to be immersed in water.
(12)
(13) Do not expose the device to strong shocks or vibrations.
CAUTION
7
(14)
Checking before operating
- Due to the essential performance and intended use of the device, testing for immunity to
electromagnetic disturbances was performed. The device may be susceptible at levels
below IEC60601-1--
to EM disturbances.
8
2.3. Electromagnetic compatibility (EMC) information
(1) General
(2)
(3)
(2) Essential Performance
(2) Essential performance
CAUTION
This equipment generates, uses and can radiate radio frequency energy and if not installed and
used in accordance with the instructions, may cause harmful interference to other devices in the
vicinity. However, there is no guarantee that interference will not occur in a particular installation.
WARNING
WARNING
Essential performance (purpose of immunity testing)
Unless the exposure switch is pressed, X-ray is not exposed.
9
(3) Electromagnetic emissions
Table 1 – based on IEC 60601-1-2:2014
Emissions test
Compliance
Electromagnetic environment –guidelines
RF emissions
CISPR 11.
Group 1.
The POSKOM Portable X-ray Unit uses RF energy only for its
internal function. Therefore, its RF emissions are very low and
are not likely to cause interference in nearby electronic
equipment.
RF emissions
CISPR 11.
Class B
The RF emissions characteristic of POSKOM Portable X-ray
Unit make it suitable for use in hospitals, transport and home
healthcare use environments.
Harmonic emissions
IEC 61000-3-2.
Not applicable
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Not applicable
(4) Electromagnetic immunity
Table 4–based on IEC 60601-1-2:2014
Immunity test
EC 60601
test level
Compliance level
Electromagnetic environment-
guidelines
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Radiated RF EM
fields
IEC 61000-4-3
10 V/m
80 MHz 2.7 GHz
80% AM at 1 kHz
10 V/m
80 MHz 2.7 GHz
80% AM at 1 kHz
Recommended separation distance
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meter (m).
Rated power
frequency
magnetic fields
IEC 61000-4-8
30 A/m 50 or 60 Hz
30 A/m 50 Hz or 60 Hz
Power frequency magnetic fields
should be at least characteristic
of a typical location in a typical
commercial or hospital environment.
Enclosure port
immunity
IEC 60601-1-2;2014
Table 9
IEC 60601-1-2;2014
Table 9
Field strengths from fixed RF
transmitters, as determined by an
10
IEC 61000-4-3
electromagnetic site survey, should be
less than the compliance level in each
frequency range. Interference may
occur in the vicinity of equipment
marked with the following symbol:
Recommended separation distances between portable and mobile RF communications equipment and
X-ray Unit. The healthcare professional or the user of X-ray Unit can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and X-ray Unit as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz
d = 1.2√P
80MHz to 800MHz
d = 0.35
800MHz to 2.7GHz
0.01
0.1
1
10
100
N/A
N/A
N/A
N/A
N/A
0.04
0.11
0.35
1.11
3.5
0.07
0.22
0.7
2.21
7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meter (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by adsorption and
reflection from structures, objects and people.
(5) Battery
(1)
(6) IMPORTANT Battery Maintenance and User’s Safety Instructions
CAUTION
11
(1)
(2)
(3)
(4)
(5)
(6)
(Even if the Battery is fully charged, charging for more than an hour and then removing
the charging code helps maintain battery and capacitor charge.)
(7)
(8)
(7) Laser pointer
(1) The laser beam is emitted from the front of Airray
(2) Do not place the laser pointer for direct eye exposure.
(3) Do not stare into the beam.
(4) Do not view directly with optical instruments.
CAUTION
12
3. Operating environment
(1)
(2)
(3)
(4)
(5)
(6)
(7)
°°℉ ℉
°°℉ ℉
℃ ℃
℃ ℃
℃ ℃
℃ ℃
13
4. Radiation safety
(1) Users and operators are required to wear appropriate protective clothing and gear.
(2)
(3)
(4)
(5)
(6)
CAUTION
CAUTION
14
5. System configuration
15
6. Specification
6.1. ELECTRONIC SPECIFICATION
16
6.2. Main Body and Carrying Case
(1) Main Body
(2) Carrying Case
17
3) X-ray Tube Specifications
(1) General details
(2) Filament And Emission characteristics
(3) Rating Charts
18
(4) Anode Heat characteristic curve
(5) Dimension
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