The reproduction, transmission or
use of this document or its contents
is not permitted without express
written authority. Offenders will be
liable for damages. All rights,
including rights created by patent
grant or registration of a utility
model _or_ design,_are_ reserved.
English
Print No.: RXR2-130.101.02.03.02 Doc. Gen. Date:08.97
Replaces: RXR2-130.101.02.01.02
Page 2
0 - 2Revision
ChapterPageRevision
01 to 403
11 to 201
21 to 402
31 to 201
41 to 1002
51 to 202
61 to 201
71 to 202
SIREMOBIL CompactRXR2-130.101.02Page 2 of 4Siemens AG
Rev. 0308.97TD SP 1Medical Engineering
Page 3
Contents0 - 3
Page
1 _______General information and overview_________________________________1 - 1
7 ______ Changes to previous version_____________________________________7 - 1
SIREMOBIL CompactRXR2-130.101.02Page 4 of 4Siemens AG
Rev. 0308.97TD SP 1Medical Engineering
Page 5
General information and overview1
To ensure compliance with the applicable provisio ns of the Federal Performance Standard, the user of the equipment has to ensure that the maintenance procedure described
below is performed at intervals of si x months or less. In case the user does not comply
with these requirements, the manufactu rer can no longer be held liable.
If the results of any of the tests described in this document exceed the tolerances given,
the required adjustments must be performed.
Contact Siemens service.
After performing any adjustment, all appl icable tests must be repeated.
Customer:Customer No.:Room:
BZ-No.:Type No.:Serial No.:
1 - 1
After completion of maintenance:1
I hereby certify t hat all proce dures described i n these main tenance instruc tions have been
completed as specified and that the tolerance values are within the accepted range.
_______________________________
Date Signature
Siemens AGRXR2-130.101.02Page 1 of 2SIREMOBIL Compact
Medical Eng ineeringRev. 0111.96TD SP 1
Page 6
1 - 2General information and overview
CAUTION
WARNING
1 Required reference documents1
- DHHS Test certificate 1a+ and Acceptance Test Prot ocol
(in Register 3 of the Logbook)
2 Required test equipment1
- PTW-NomexSerial-No.: ..........Date of calibration ..........
- FlukeSerial-No.: ..........Date of calibration ..........
-Calculator
3 Safety Notes1
All local safety regulations must be observed.
4 Notes for the Maintenance Instructions1
- Compliance with the applicable s ections of the Federal Performance Standards is
assured when all procedures descri bed in these instructions have been perfo rmed
and tolerance values are within the sp ecified range.
- The unit movements required for thes e procedures must be performed cautio usly to
prevent the unit from being damaged in the event of a malfunction.
Checks or adjustments to be performed with radiation ON are
marked with the radiation warning symbol .
- When performing safety checks or adjus tments with radiation ON, radiati on protection
clothing must be worn.
SIREMOBIL CompactRXR2-130.101.02Page 2 of 2Siemens AG
Rev. 0111.96TD SP 1Medical Engineering
Page 7
Visual checks2
1 Radiation protection2
Make sure that there is no mechanical damage on the SIREPHOS tube housing assembly
and image intensifier which could impair the radiation protection.
SIREPHOS and image intensifier
have been checked for mechanical
damage
Damage present (brief description):
YES
NO
2 - 1
2 Checking the DHHS and Identification Labels2
Confirm that the certificat ion labels as well as serial number and model number labels are
legible. The illustrati on shows the location of the labels.
If labels are required, contact the Regulatory Affairs department in Iselin, N.J.
Tube housing assembly
Image Intensifier
Television receiver
Warning label present and legible YES
Siemens AGRXR2-130.101.02Page 1 of 4SIREMOBIL Compact
Medical EngineeringRev. 0208.97TD SP 1
Page 8
2 - 2Visual checks
2.1 Location of the DHHS and Identification Labels2
Model Nr.
Model Nr.
Serien Nr.
Made in Germany
This product complies with DHHSregulations
21 CFR Subchapter J, applicable at date of
manufacture.
Manufactured:
Siemens Aktiengesellschaft
Wittelsbacherplatz 2, D - 8 München 2
Germany
Image intensifier
cassette
holder
Serien Nr.
Made in Germany
This product complies with DHHSregulations
21 CFR Subchapter J, applicable at date of
manufacture.
Manufactured:
Siemens Aktiengesellschaft
Wittelsbacherplatz 2, D - 8 München 2
Germany
24 x 30 cm
10 x 12 ins.
Safety
instructions
X-Ray control
Model Nr.
Serien N r.
X-Ray Equipment
Classified by
Underwriters Laboratories Inc.
with Respect to Electrical Shock, Fire
and Mechanical Hazards Only.
Sach Nr.
ES 01 02 03 04 05 06 07
08 09 10 11 12 13 14 15
Made in Germany
This product complies with DHHSregulations
21 CFR Subchapter J, applicable at date of
manufacture.
Manufactured:
Siemens Aktiengesellschaft
Wittelsbacherplatz 2, D - 8 München 2
Germany
U
245 B
L
Beam limiting device
Model Nr.
Serien Nr.
*
Made in Germany
This product complies with DHHSregulations
21 CFR Subchapter J, applicable at date of
manufacture.
Manufactured:
Siemens Aktiengesellschaft
Wittelsbacherplatz 2, D - 8 München 2
Germany
Tube Housing assembly
SIREPHOS 110 kV / 5 mA
Model Nr.
11 73 355 X 1988
Serien Nr.
Inherent filtration
added filtration
Röhre/Tube SR 110
Model Nr.
Serien Nr.
This product complies with DHHSregulations
21 CFR Subchapter J, applicable at date of
manufacture.
Manufactured:
Wittelsbacherplatz 2, D 8 München 2
01001
Made in Germany
88 55 199 V 1036
0.6 IEC 336/82
Made in Germany
Siemens Aktiengesellschaft
S01
S06
Germany
**
* Label is not accessible to view.
A duplicate label is visible in the position shown
** minimum filtration: 3.0 mm Al
SIREMOBIL CompactRXR2-130.101.02Page 2 of 4Siemens AG
Rev. 0208.97TD SP 1Medical Engineering
Page 9
Visual checks2 - 3
Model Nr.
WARNING:
This X-Ray Unit may be dangerous to
Patient and Operator unless safe
Exposure factors and Operating
Instructions are observed:
Monitor cart
Television
Receiver
Serien N r.
Model Nr.
Serien Nr.
Made in Germany
This product complies with DHHSregulations
21 CFR Subchapter J, applicable at date of
manufacture.
Manufactured:
Siemens Aktiengesellschaft
Wittelsbacherplatz 2, D - 8 München 2
Germany
Made in Germany
Siemens AGRXR2-130.101.02Page 3 of 4SIREMOBIL Compact
Medical EngineeringRev. 0208.97TD SP 1
Page 10
2 - 4Visual checks
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SIREMOBIL CompactRXR2-130.101.02Page 4 of 4Siemens AG
Rev. 0208.97TD SP 1Medical Engineering
Page 11
Checking the function blocks and displays3
1 Checking the ”deadman” switch function3
1.1 Exposure3
An exposure value is set at the control console.
- Activate the exposure with the exp osure switch and end it immediately by rel easing
the switch.
The exposure must end immediately.
1.2 Fluoroscopy3
Activate fluoroscopy for a short time and release the fluoroscopy switch.
Fluoroscopy must stop immediately.
a) with the fluoroscopic switch at the control console
b) with the foot switch
3 - 1
Deadman’s switch is functi oning YES NO
2 Radiation indicators3
Check that the radiation indicators at the control console and on the monitor cart are visible during radiation and that an audible (whistl ing) signal is sounded after exposure
release for about 1.5 seconds.
Radiation indicators are functioning YES NO
Siemens AGRXR2-130.101.02Page 1 of 2SIREMOBIL Compact
Medical Eng ineeringRev. 0111.96TD SP 1
Page 12
3 - 2Checking the function blocks and displays
3 Fluoroscopy timer3
1.Ensure that the people present are not subj ect to radiation hazard during the t ests
described below.
2.Set the manual fluoroscopy volta ge to the lowest possible kV value .
Close the Iris diaphragm, cover the t ube assembly with a lead apron.
3.Switch on fluoroscopy.
4.Check that the acoustic signal s ounds after a total fluoroscopy time of 4.5 minutes
has elapsed.
5.Reset the buzzer by pressing the button under the symbol in the display.
Fluoroscopy timer functioning correctly YES NO
4 Indication of X-ray tube potential and current3
Confirm that tube potential and current are continuously indicated during fluoroscopy.
Indicators fu n ctioning YES NO
5 Minimum source to skin distance3
Confirm that a spacer limiting the source to skin distance (SSD) to 30 cm is present.
Spacer present YES NO
SIREMOBIL CompactRXR2-130.101.02Page 2 of 2Siemens AG
Rev. 0111.96TD SP 1Medical Engineering
Page 13
Function tests4
1 Checking the accuracy of the tube voltage4
The actual kV value must agree with the indicated value within the limits stated by
4 - 1
Siemens (max. deviation
nected to a power supply corresponding to Siemens specifications.
Tools: PTW-Nomex
Test procedure:
Refer to the information on the Nomex in the operating instructions
Connect the Nomex.
Remove the single-tank cap at the SIREPHOS after removing the two screws.
Select full image intensifier format and open the collimator fully.
Place the measuring detector on the diaphragm.
Set the following values in the operating field and check
Operating modeIndicatedMeasuredTolerance
Fluoroscopy70 kV63 kV to 77 kV
Fluoroscopy101 kV91 kV to 110kV
Fluoroscopy110 kV100 kV to 120 kV
Radiography102 kV92 kV to 110kV
&10 % for the Siremobil Compact), if the X-ray system is con-
2 Reproducibility4
The coefficient of variation must not exceed 0. 05 when the X-ray system is c onnected to a
power supply as specified by Siemens.
The technique factors shoul d be adjus ted to alt ernate sett ings and rese t to t he test set ting
after each measurement.
2.1 Measurement set-up4
Place the dosimeter in the center of the X-ray beam.
Before each new dose measurement, make sure that the indicator is reset to zero.
Siemens AGRXR2-130.101.02Page 1 of 10SIREMOBIL Compact
Medical EngineeringRev. 0212.96TD SP 1
Page 14
4 - 2Function tests
1
2.2 Calculations4
Variation coeffic ient C
For n individual measurements, the coefficient of variation C amounts to:
n
s
C ==
x
x
Σ
i = 1
(xi - x)
n -1
s = calculated standard deviation
= mean value of all individual measurements
x
= measured value of the ith measurements.
x
i
1.To obtain the average x, the 4dose values are added and the sum is divided by 3.
2.T o obtai n the difference, the average value is subtracted from each indi vidual
measured value and entered into the column prov ided
* Disregard the sign if negative numbers are obtained.
Square the differences
2
MeasurementSquare of th e difference (x
- )
i
x
1
2
3
4
3.Add the 4results:
Σ ....................:
4.Divide the sum by 3: ...............
5.Obtain the square root of the ne w result: Square root S: .......... ........
6.Divide the square root S by the average value x determined in step 1:
S
Coefficient of variation C =
x
SIREMOBIL CompactRXR2-130.101.02Page 2 of 10Siemens AG
Rev. 0212.96TD SP 1Medical Engineering
C = . . . . . . . . . . . . . . .(must be
≤ 0.05)
Page 15
Function tests4 - 3
3 Entrance exposure rate4
The legal maximum entrance exposure rate is 87 mGy/min (10 R/min).
For safety reasons, the value has been fixed at < 78 mGy/min (9 R/min) at the factory.
The entrance exposure rate is to be checked by means of a dose rate meter.
In the measurement setup shown, the maximum adjustable values 110 kV and 5 mA yield
an input dose rate of approx. 87mGy/min (10 R/min).
Measurement set-up
Image intensifier
2,1
cm
Fig. 1
30 cm
89,7 cm
Input screen
Ionization
chamber
Focal spot
Position the measurement detector of the dosimeter as shown in the diagram.
Press the " ” button at the operating console.
Select 110 kV. Select full I.I. format, open the collimator to max. aperture, switch fluoroscopy ”ON”. Measure the dose and record.
Siemens AGRXR2-130.101.02Page 3 of 10SIREMOBIL Compact
Medical EngineeringRev. 0212.96TD SP 1
Page 16
4 - 4Function tests
4 Checking the central beam4
REGULATION - Means must be available whereby the radiation field can be centered
in relation to the radiation receiver within a tolerance of less than 2 % of the SID.
4.1 Position of central beam in relation to the I.I. input4
The check is made at the TV monitor.
Determine the central point at the I.I. input. Use adhesive tape to attach center cross
(with lead ruler).
Open the slot collimator, adjust the iris diaphragm to an opening of about 15 cm.
Perform the test in the C-arm position shown.
Fig. 2
Basic position
C-arm to the left
(top view)
C-arm to the right
(top view)
SIREMOBIL CompactRXR2-130.101.02Page 4 of 10Siemens AG
Rev. 0212.96TD SP 1Medical Engineering
Page 17
Function tests4 - 5
x2 + y
2
A = mid-point I.I. input
B = middle of the radiation
field
∆ = deviation of A to B
x = deviation in the x-axis
y
y = deviation in the y-axis
Fig. 3
Work sequence:
1.Select full size (no zoom).
2.Adjust the Iris diaphragm to an opening of about 15 cm.
3.Adjust C-arm (see Fig. 2).
4.Read the evaluation at the TV Monitor ( Fig. 3).
(Use stored image if available).
x
A
B
∆
5.Switch on fluoroscopy
6.Calculate the deviat ion
:
7.Test result (see also Fig. 3):
Average deviation permissible*Average deviationactual
Basic position= must be 17 mm
(2% of the SID)
C-arm to the left= must be 17 mm
(2% of the SID)
C-arm to the right= must be 17 mm
(2% of the SID)
...................... mm
...................... mm
...................... mm
Siemens AGRXR2-130.101.02Page 5 of 10SIREMOBIL Compact
Medical EngineeringRev. 0212.96TD SP 1
Page 18
4 - 6Function tests
5 Check the I.I. format4
TV image
During fluoro, neither the length nor the width of the
radiation field in t he plane of the image receptor may
exceed that of the visible area of the imag e receptor
by more than 3 % of the SID (focus - I.I. distance).
The sum of the longitudinal deviation X and the
Blades, iris diaphragm
Fig. 4
Work sequence:
1.Select the full I.I. input for mat.
width deviation Y shall be no greater t han 4 % of the
2.Set the iris diaphragm to max. apertur e
3.Switch on fluoroscopy
If all eight blades of the ir is diaphragm are still visible at t he edge of the TV monitor
(Fig. 4), no further test s are necessary.
4.Select zoom format (check as in it em 3)..
I.I. format in order YES NO
Zoom format in order YES NO
6 Check the smallest field size4
The smallest field size should be max. 5 cm x 5 cm at the I.I. input.
The check is made at the TV monitor.
1.Select full I.I. view for mat.
2.Close the iris diaphragm and selec t full I.I. view format.
3.Attach a center cross with lead ru ler to the center of the I.I. input screen.
4.Switch on fluoroscopy.
5.Read the size of the X iris on the monitor.
Smallest field size at the I.I. input: ........ cm x ........ cm
SIREMOBIL CompactRXR2-130.101.02Page 6 of 10Siemens AG
Rev. 0212.96TD SP 1Medical Engineering
Page 19
Function tests4 - 7
7 Cassette format4
(Only applicable if cassette holder present)
If no cassette is inserted, continuous fluoroscopy is selected.
Exposure release need not be blocked.
Neither the length nor the width of the X-ray field in t he plane of the image receptor shall
differ from the c orresponding dimensions of the selected portion of the image receptor by
more than 3 percent of the SID when adjusted for full coverage of the sel ected portion of
the image receptor. The sum (disregarding the sign) of the length and width deviations
may not exceed 4 % of the SID.
The cassette format is limited by means of the rectangular diaphragm.
7.1 Cassette to radiation field4
Film 35 cm x 35 cm
Fig. 5
∆B
∆D
∆A
Film(cassette 24 cm x 30 cm
Rad. field
Work sequence:
1.Move the C-arm into the basic position.
2.Attach the cassette holder to t he I.I.
3.Load a 24” x 30” cassette with fi lm and insert into the cassett e holder.
4.Place a 35 cm x 35 cm film in an opaque envelope and attach t he envelope to the
center of the film cassette with adhesive tape.
5.In addition, place three washers on t he opaque envelope and attach them with
adhesive tape.
All three washers must be located wi thin the 24 cm x 30 cm cassette.
∆C
6.Expose both films.
7.Develop the films.
8.Place the films one on top of the other.
9.Calculate the deviat ions.
10.Enter the deviations in the corres ponding table.
11.Repeat items 3 through 8 for the C-arm "lef t" and the C-arm "right" position ( Fig.7).
Siemens AGRXR2-130.101.02Page 7 of 10SIREMOBIL Compact
Medical EngineeringRev. 0212.96TD SP 1
Page 20
4 - 8Function tests
SID’ (source film distance) 85.9 cm
C-arm to the right,
Tube assembly at stop
Basic position
Fig. 6
C-arm to the left,
Tube assembly at stop
(top view)
C-arm basic position
(must be
Shading∆ A ......... + ∆ C ..........= .......... mm
∆ B ......... + ∆ D ..........= .......... mm
∆ A ......... + ∆ B ......... +∆ C ..........+ ∆ D .......= ........ mm (must be < 34 mm)
C-arm to the left, tube assembly at stop
Shading
∆ A ......... + ∆ B ......... +∆ C ..........+ ∆ D .......= ........ mm (must be < 34 mm)
C-arm to the right, tube assembly at stop
Shading
∆ A ......... + ∆ C ..........= .......... mm
∆ B ......... + ∆ D ..........= .......... mm
∆ A ......... + ∆ C ..........= .......... mm
∆ B ......... + ∆ D ..........= .......... mm
(3% of the SID)
(must be
(3% of the SID)
(4% of the SID)
(must be
(3% of the SID)
(must be
(3% of the SID)
(4% of the SID)
(must be
(3% of the SID)
(must be
(3% of the SID)
< 25 mm)
< 25 mm)
< 25 mm)
< 25 mm)
< 25 mm)
< 25 mm)
∆ A ......... + ∆ B ......... +∆ C ..........+ ∆ D .......= ........ mm (must be < 34 mm)
(4% of the SID)
If the deviations are within the given tolerance, no additional tests are necessary.
SIREMOBIL CompactRXR2-130.101.02Page 8 of 10Siemens AG
Rev. 0212.96TD SP 1Medical Engineering
Page 21
Function tests4 - 9
7.2 Center cassette to radiation field4
Film 35 cm x 35 cm
Rad. field
∆A
Film (cassett e 24 cm x 30 cm)
Fig. 7
Work sequence:
1.Use the film pairs already exposed (C-arm in basic position, C-ar m to the right
and C-arm to the left) to evaluate the cente r deviation.
2.Place the film pairs one on top of the other.
3.Mark the geometric center of the 24 cm x 30 cm f ilm.
4.Mark the geometric center of the ra diation field.
5.Calculate the deviat ion.
C-arm basic position:
∆ = .......... mm(must be < 17mm), (2% of the SID)
C-arm to the left, tube assembly at stop
∆ = .......... mm(must be < 17mm), (2% of the SID)
C-arm to the right, tube assembly at stop
∆ = .......... mm(must be < 17mm), (2% of the SID)
If the deviations are within the given tole rance, no additional tests are necessary.
Siemens AGRXR2-130.101.02Page 9 of 10SIREMOBIL Compact
Medical EngineeringRev. 0212.96TD SP 1
Page 22
4 - 10Function tests
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SIREMOBIL CompactRXR2-130.101.02Page 10 of 10Siemens AG
Rev. 0212.96TD SP 1Medical Engineering
Page 23
Technical Data5
Technical data for DHHS components5
In accordance with Federal Radiation Performance
Standards 21 CFR Subchapter J Paragraph 1020.30 (h)
X-Ray Controls and Generators5
5 - 1
Nominal
line voltage:
100 V± 10%12%28 A
120 V± 10%8%24 A
127 V± 10%7%22 A
230 V± 10%5%12 A
240 V± 10%5%12 A
Technique factors for maximum line current:
110 kV
tube voltage, 13 mA tube current
p
Rated line
voltage:
Line-voltageregulation:
Maximum line
current:
Generator ratings:5
Fluoroscopy:110 kVp maximum voltage, 5 mA maximum current
Radiography:Duty cycle:1:60
- 40 kV/20 mA
- 110 kV/13 mA
Maximum deviations 5
Radiography
Tube voltage:± 10 %
accuracy of mAs-product:± 10 % ± 0.2 mAs
Fluoroscopy
Tube voltage:± 10 %
Tube current:± 8 % ± 0.1 mA
Fluoroscopy timer:0 to 5 min. tolerance 1 digit (6 sec)
Definitions of the measurement bases of technique factors5
Exposure time tube current product:
Measured in the mA-measuring pins D1.X39-D1. X40 (x97 opened) in the tube current circuit near ground with an mAs-meter (PTW- Nomex or equivalent).
Peak tube potential:
Measurement of kVp at radiography and at fluoroscopy, using PTW-Nomex (2 filter
method).
Tube current:
As measured in the mA-measuring pins D1.X39- D1.X40 (x97 opened) in the tube current
circuit near ground with an mA-meter (FLUKE 8060 A or equivalent), minus the current
flowing through the built-in high-voltage divider of 0.0025 mA/kV
.
p
SIREMOBIL CompactRXR2-130.101.02Page 2 of 2Siemens AG
Rev. 0211.96TD SP 1Medical Engineering
Page 25
Final steps6
Final visual and function checks6
• After completion of all required operations and c hecks, perform a visual and function
check.
For example, ensure that
- moving parts are freely moving
- there is no danger of collision for movi ng parts
- safety distances are maintain ed
- all parts are p roperly secured
- there is no perceptible damage, et c.
6 - 1
Siemens AGRXR2-130.101.02Page 1 of 2SIREMOBIL Compact
Medical Eng ineeringRev. 0111.96TD SP 1
Page 26
6 - 2Final steps
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SIREMOBIL CompactRXR2-130.101.02Page 2 of 2Siemens AG
Rev. 0111.96TD SP 1Medical Engineering
Page 27
Changes to previous version7
Chapter 0:Cover sheet was adjusted,
Revision level was adjusted accordngly.
Chapter 2:page 2:Part No. of the "Tube Housing assembly" changed
Chapter 7:Content adapted
7 - 1
TD SP 2 / Arnold
TD SP 1 / Schlee
SMS Iselin / O’Donnell
Siemens AGRXR2-130.101.02Page 1 of 2SIREMOBIL Compact
Medical EngineeringRev. 0208.97TD SP 1
Page 28
7 - 2Changes to previous version
This page intentionally left blank.
SIREMOBIL CompactRXR2-130.101.02Page 2 of 2Siemens AG
Rev. 0208.97TD SP 1Medical Engineering
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