PORTABLE X-RAY UNIT FDR Xair

XD2000

Product Specifications
1st Edition (May 2020)

Marketing authorization holder: FUJIFILM Corporation

Marketer: FUJIFILM Medical Co., Ltd.

Z30N200025
 Contents
1 Overview ........................................................................................................................... 3
2 Features ........................................................................................................................... 3
3 System block diagram ....................................................................................................... 4
4 Composition ...................................................................................................................... 4
4.1 Standard components ................................................................................................ 4
4.2 Options ....................................................................................................................... 4
4.3 Accessories ................................................................................................................ 4
4.4 Devices used in combination ...................................................................................... 5

5 Specifications.................................................................................................................... 5
5.1 X-ray generator .......................................................................................................... 5
5.2 Total filtration .............................................................................................................. 7
5.3 Throughput ................................................................................................................. 7
5.4 EMC ........................................................................................................................... 7
5.5 Essential performance ................................................................................................ 8

6 Basic operation ................................................................................................................. 9

7 Power supply conditions ................................................................................................. 11
8 Maximum power consumption......................................................................................... 11
9 Environment conditions ................................................................................................... 11
10 External dimensions and weight...................................................................................... 12
11 Scattered X-ray distribution ............................................................................................. 14

Z30N200025
2
1 Overview PORTABLE X-RAY UNIT FDR Xair, XD2000, is a portable-type X-ray exposure device
powered by an internal battery.

2 Features (1) Compact and lightweight. Easy to carry around.

(2) Powered by an internal battery. Able to perform 100 radiations per charge.*

(* Under conditions specified by FUJIFILM)

(3) Able to attach a hand switch to the main unit. Convenient for carrying around.

(4) Able to store three exposure conditions.

Z30N200025
3
3 System block
PORTABLE X-RAY UNIT FDR Xair XD2000
diagram Holding device
XD2000 ST
X-ray generator XD2000 PX or
XD2000 ST-M
or
Accessories
XD2000 ST-S
Battery Shoulder strap
Measuring tape

AC adapter
Power supply
cable

* X-ray radiation or exposure condition setting cannot be performed while

charging using an AC adapter.
* Using XD2000 requires combined use with XD2000 ST, XD2000 ST-M, or
XD2000 ST-S.
Wireless

4 Composition
4.1 Standard Trade name: PORTABLE X-RAY UNIT FDR Xair
components
<Constituting units>
(1) X-ray generator (model: XD2000 PX)

(2) Power supply cable

4.2 Options IR remote switch : XD2000 RS

4.3 Accessories (1) X-ray generator: XD2000 PX

 Shoulder strap, measuring tape, AC adapter, hook and loop strip, XD2000 PX
Operation Manual, XD2000 System Operation Manual,

(2) Holding device: XD2000 ST

(3) Holding device: XD2000 ST-M

(4) Holding device: XD2000 ST-S

Z30N200025
4
 4.4 Devices Brand name : Holding device XD2000 ST
used in Notification No. : 14B2X10002000127
combination
Brand name : Holding device XD2000 ST-M
Notification No. : 14B2X10002000128

Brand name : Holding device XD2000 ST-S

Notification No. : 14B2X10002000129

Note: When including Holding devices in a product catalog etc., the brand name under
the Pharmaceutical and Medical Device Act shall be shown along with the trade
name.

5 Specifications  Maximum power: 450 W (90 kV, 5 mA)

 Maximum nominal power: 450 W (90 kV, 5 mA, 0.1 s)
5.1 X-ray
generator (The product of the maximum tube current and voltage that can be applied for 0.1
second at a tube voltage of 90 kV)
 Maximum nominal tube voltage: 90 kV
 Tube voltage range: 50-90 kV 2-kv increment
 Tube voltage accuracy: ±10%
 Tube current: 5 mA (fixed)
 Exposure time range: 0.04-0.5 sec
 Tube current-time product range:
0.20, 0.25, 0.32, 0.40, 0.50, 0.63, 0.80, 1.00, 1.25, 1.60, 2.00, 2.50 mAs
 Tube current-time product accuracy: 0.20-2.50 mAs Error ± (10% + 0.2 mAs)
 Permissible total mAs value in 1 hour: 100 mAs (90 kV)
 Maximum load condition for the number of radiations: 200 shot/h
(at 90 kV and 0.5 mAs, at 18-second intervals)
 Nominal focus value: 0.8
 Target angle: 16°
 Anode type: Fixed anode
 X-ray tube anode heat capacity: 7.0 kJ
 Leakage radiation: 0.14 mGy/h (at a distance of 1 m from the focal point)
* Exposure conditions 90 kV, 100 mAs/h
 Maximum symmetrical exposure field: 43 cm × 43 cm (distance from the focal point:
100 cm) Conforms to JIS Z 4122
 Operation mode: Continuous use by intermittent loading
 Linearity of air kerma over the entire limiting range of X-ray tube loading condition
When the X-ray output under adjacent configurations of tube current-time product is
measured over the specified range during exposure, the measured value in the
adjacent configuration values shall satisfy the formula below.

Where,
K1, K2: Average of measured air kerma
values
Q1, Q2: Displayed value of tube current-time
product

Z30N200025
5
 Exposure field:
0-43 cm × 0～43 cm (SID 100 cm)
 Light exposure field luminance: 120 lx or higher (SID 100 cm)
 Light exposure field lighting time: 30 seconds (can be changed to 10 or 20 seconds
by a service engineer), automatic off timer
Automatically turned off during X-ray radiation

Z30N200025
6
5.2 Total filtration 2.5 mmAl equivalent or higher 70 kV

5.3 Throughput (1) Startup time: Time from turning the power on and becoming ready for exposure is
120 seconds or less

(2) Minimum X-ray radiation interval 8 seconds

(3) Charging time

Charging time from empty to full: 4.5h

Charging time from empty to becoming ready for one exposure: 5 minutes (under
conditions specified by FUJIFILM)
* Exposure conditions 90 kV, 0.5 mAs

(4) Battery duration

100 radiations
* Under conditions specified by FUJIFILM

* Under a state of a new battery being charged for 4.5 hours or longer
* Exposure conditions 90 kV, 0.5 mAs
* Light exposure field time 10 seconds
* Exposure interval 60 seconds

5.4 EMC  IEC 60601-1-2:2014 / EN 60601-1-2:2015

 Class B compliant
(Suitable for use at all facilities including those directly connected to a
low-voltage public mains network supplied to general household facilities
and buildings for general household use purposes.)

Z30N200025
7
5.5 Essential
Specification Remarks
performance Item

The test method is as shown in

Tube voltage 50-90 kV Error within ±10% IEC 60601-2-54
203.6.4.3.104.3

The test method is as shown in

Tube current-time 0.2-2.5 mAs Error within ± (10% +
IEC 60601-2-54
product 0.2 mAs)
203.6.4.3.104.6

The test method is as shown in

X-ray output Coefficient of variation of measured values
IEC 60601-2-54
reproducibility of air kerma 0.05 or less
203.6.3.2.101

When the X-ray output under adjacent The test method is as shown in
configurations of tube current-time product is IEC 60601-2-54
measured for various configurations of tube 203.6.3.2.102 a)
voltage, the measured value in the adjacent
configuration values shall satisfy the formula
below.
K1 K 2
Linearity of X-ray K1 K 2 
output in adjacent   0.2 Q1 Q 2
configuration Q1 Q 2
values Where,
2
K 1, K 2 : Average of X-ray outputs measured
at adjacent configuration values
(mGy)
Q1, Q 2 : Configuration value of adjacent tube
current-time product (mAs)

Z30N200025
8
6 Basic operation
XD2000 PX
1. Charging
Charge the device by connecting an AC adapter to the X-ray generator.
2. Preparation for exposure
(1) Assemble a holding device described on the device to be used in combination
away from the patient.
(2) Place the holding device at a position suitable for exposure.
(3) Press the power button on the operation panel of the X-ray generator to turn it
on.
(4) Operate the operation panel of the X-ray generator to configure X-ray exposure
conditions.
(5) Affix the X-ray generator to the holding device.
3. Exposure field check
(1) Set a receiver. (Separately prepared by the user)
(2) Position the X-ray generator using the adjustment mechanisms of the holding
device.
(3) Adjust the distance between the X-ray generator and receiver using a
measuring tape.
(4) Press the exposure field lamp button on the X-ray generator and configure the
exposure field using the collimator knob.
(The exposure field lamp automatically turns off after 30 seconds or when
preparation for exposure completes.)
4. X-ray exposure
(1) Remove the hand switch from the X-ray generator and move at least 2 m away
from the patient and the X-ray generator.
(2) After ensuring that no person is present within 2 m of the patient and the X-ray
generator and that no person is present in the direction of radiation, operate the
hand switch to radiate X-ray.
* The press button of the hand switch is a dead man’s switch. Do not let it go
until the end of exposure.
5. Shutting down
(1) Turn the X-ray generator off by pressing the power button on the operation panel
of the X-ray generator.
(2) Move the holding device to a suitable location away from the patient.
(3) Remove the X-ray generator from the holding device.
(4) Remove the components of the holding device.

Z30N200025
9
XD2000 ST
1. Assembling
(1) Move to a location away from the patient and other people.
(2) Open the slide arm and fix it.
(3) Open the legs, attach to the slide arm and fix them.
(4) Attach the elevator to the slide.
(5) Affix the platform to the elevator.
(6) Elongate the legs as necessary and fix them.
(7) Move the holder to a position suitable for exposure (to the patient’s position).
(8) Affix the quick shoe to the X-ray generator.
(9) Affix the quick shoe to the platform.
(10) Affix the fall prevention wire to the quick shoe and the slide.
2. Position adjustment
(1) Rotate the crank handle to adjust the position in the up/down direction.
(2) Move the slide to adjust the position in the left/right direction.
(3) Adjust the rotation using the platform.
3. Shutting down (disassembling)
(1) Disassemble by following the assembling procedure in the reverse order.

XD2000 ST-M
1. Assembling
(1) Lock the casters at the base.
(2) Insert the support column to the base and fix using the knob.
(3) Attach the arm to the support column and fix using the knob.
(4) Affix the quick shoe to the X-ray generator.
(5) Affix the quick shoe to the platform.
(6) Affix the fall prevention wire to the quick shoe and the arm.
2. Position adjustment
(1) Unlock the casters and move to the desired location.
(2) Loosen the arm fixing lever and adjust the height of the arm.
(3) Adjust the direction of the X-ray generator using the platform.
3. Shutting down (disassembling)
(1) Disassemble by following the assembling procedure in the reverse order.

XD2000 ST-S
1. Assembling
(1) Move to a location away from the patient and other people.
(2) Attach the legs to the mainstay and fix them.
(3) Elongate the legs as necessary and fix them.
(4) Affix the quick shoe to the X-ray generator.
(5) Affix the quick shoe to the platform.
(6) Affix the fall prevention wire to the quick shoe and the mainstay.
(7) Move the holder to a position suitable for exposure (to the patient’s position).
2. Position adjustment
(1) Adjust the X-ray exposure position using the legs and platform and fix.
3. Shutting down (disassembling)
(1) Disassemble by following the assembling procedure in the reverse order.

Z30N200025
10
7 Power supply X-ray generator: XD2000 PX
conditions (1) Rated supply voltage: 100-240V (AC)
(2) Rated supply frequency: 50-60Hz
(3) Power input: 1.5A
(4) Classification by the type of protection against electric shock:
Class II device (while charging)
Internally powered device (during operating on the battery)

8 Maximum X-ray generator

power 450W
consumption

9 Environment (1) Operating

conditions Temperature: 15°C-30°C
Humidity: 15-80%RH (no dew condensation)
Atmospheric pressure: 700hpa-1,060hPa

(2) Storage/transport environment

Temperature: -10°C-50°C
Humidity: 10-90%RH (no dew condensation)
Atmospheric pressure: 700-1,060hPa

Z30N200025

11
10 External dimensions and weight

X-ray generator
Width (mm) Depth (mm) Height (mm) Weight (kg)
XD2000 PX 301 257 144 3.5
* Agreed tolerance ±10%

Side view Front view

Bottom view X-ray focal point

Z30N200025

12
Holding device

Width Depth Height Weight

(mm, maximum) (mm, maximum) (mm, maximum) (kg)
XD2000 ST 1000 1600 2100 Approx. 7.6
XD2000 ST-M 700 700 1900 Approx. 11.5
XD2000 ST-S 800 950 1600 Approx. 2.8

XD2000 ST

Approx. 700

Front view Side view

XD2000 ST-M XD2000 ST-S

Approx. 510

Front view Side view

Front view Side view

Z30N200025

13
11 Scattered X-ray distribution

[Information]
X-ray Generator Scattered X-ray Beams
Dose Distribution Measurement Diagrams

TYPE: XD2000 PX

Unit: μSv X-ray downward radiation Measuring height: 350 mm

Measurement conditions 90 kV, 2.5 mAs

Unit: μSv X-ray forward radiation Measuring height: 600 mm

Measurement conditions 90 kV, 2.5 mAs
Z30N200025

14