SIEMENS SIREMOBIL Compact User manual

SIREMOBIL Compact

SP

DHHS Maintenance Instructions

	© Siemens AG 1996
	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

0 - 2			Revision
Chapter	Page	Revision
0	1 to 4	03
1	1 to 2	01
2	1 to 4	02
3	1 to 2	01
4	1 to 10	02
5	1 to 2	02
6	1 to 2	01
7	1 to 2	02

SIREMOBIL Compact	RXR2-130.101.02	Page 2 of 4	Siemens AG
	Rev. 03 08.97	TD SP 1	Medical Engineering

Contents	0 - 3
	Page

1 _______General information and overview_________________________________ 1 - 1

After completion of maintenance: . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 1 1 Required reference documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2 2 Required test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2 3 Safety Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2 4 Notes for the Maintenance Instructions . . . . . . . . . . . . . . . . . . . . . . . . 1 - 2

2 _______Visual checks__________________________________________________ 2 - 1

1 Radiation protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 - 1 2 Checking the DHHS and Identification Labels . . . . . . . . . . . . . . . . . . . . 2 - 1 2.1 Location of the DHHS and Identification Labels . . . . . . . . . . . . . . . . . 2 - 2

3 _______Checking the function blocks and displays _________________________ 3 - 1

1 Checking the ”deadman” switch function . . . . . . . . . . . . . . . . . . . . . . . 3 - 1

1.1Exposure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1

1.2Fluoroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1

2 Radiation indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 1 3 Fluoroscopy timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 2 4 Indication of X-ray tube potential and current . . . . . . . . . . . . . . . . . . . . . 3 - 2 5 Minimum source to skin distance . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 - 2

4 _______Function tests _________________________________________________ 4 - 1

1 Checking the accuracy of the tube voltage . . . . . . . . . . . . . . . . . . . . . . 4 - 1 2 Reproducibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1

2.1Measurement set-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 1

2.2Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 2

3	Entrance exposure rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 3
4	Checking the central beam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 4
	4.1	Position of central beam in relation to the I.I. input . . . . . . . . . . . . . . . 4 - 4
5	Check the I.I. format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4		- 6
6	Check the smallest field size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 - 6
7	Cassette format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4		- 7
	7.1	Cassette to radiation field . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4	- 7
	7.2	Center cassette to radiation field . . . . . . . . . . . . . . . . . . . . . . . . 4 - 9

5 _______Technical Data _________________________________________________ 5 - 1

Technical data for DHHS components . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 X-Ray Controls and Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Generator ratings: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Maximum deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 1 Tube Housing Assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 - 2 Definitions of the measurement bases of technique factors . . . . . . . . . . . . . 5 - 2

Siemens AG	RXR2-130.101.02	Page 3 of 4	SIREMOBIL Compact
Medical Engineering	Rev. 03 08.97	TD SP 1

0 - 4	Contents
	Page

6 ______ Final steps ____________________________________________________6 - 1

Final visual and function checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 - 1

7 ______ Changes to previous version _____________________________________7 - 1

SIREMOBIL Compact	RXR2-130.101.02	Page 4 of 4	Siemens AG
	Rev. 03 08.97	TD SP 1	Medical Engineering

General information and overview

1 - 1

To ensure compliance with the applicable provisions of the Federal Performance Standard, the user of the equipment has to ensure that the maintenance procedure described below is performed at intervals of six months or less. In case the user does not comply with these requirements, the manufacturer 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 applicable tests must be repeated.

Customer:

Customer No.:

Room:

BZ-No.:

Type No.:

Serial No.:

After completion of maintenance:

I hereby certify that all procedures described in these maintenance instructions have been completed as specified and that the tolerance values are within the accepted range.

_____________ __________________

Date

Signature

Siemens AG	RXR2-130.101.02	Page 1 of 2	SIREMOBIL Compact
Medical Engineering	Rev. 01 11.96	TD SP 1

1 - 2

General information and overview

1 Required reference documents

-DHHS Test certificate 1a+ and Acceptance Test Protocol (in Register 3 of the Logbook)

2 Required test equipment

- PTW-Nomex		Serial-No.: ..........	Date of calibration ..........
-	Fluke	Serial-No.: ..........	Date of calibration ..........
-	Calculator

3 Safety Notes

				All local safety regulations must be observed.
	CAUTION

4 Notes for the Maintenance Instructions

-Compliance with the applicable sections of the Federal Performance Standards is assured when all procedures described in these instructions have been performed and tolerance values are within the specified range.

-The unit movements required for these procedures must be performed cautiously to prevent the unit from being damaged in the event of a malfunction.

WARNING Checks or adjustments to be performed with radiation ON are
marked with the radiation warning symbol	.

-When performing safety checks or adjustments with radiation ON, radiation protection clothing must be worn.

SIREMOBIL Compact	RXR2-130.101.02	Page 2 of 2	Siemens AG
	Rev. 01 11.96	TD SP 1	Medical Engineering

Visual checks

2 - 1

1 Radiation protection

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	YES	NO

Damage present (brief description):

2 Checking the DHHS and Identification Labels

Confirm that the certification labels as well as serial number and model number labels are legible. The illustration shows the location of the labels.

If labels are required, contact the Regulatory Affairs department in Iselin, N.J.

Component certified	Model No.	Serial No.		Date
SIREMOBIL Compact
X-ray control
Beam Limiting device
BLD
Cassette holder
(if present)
SIREPHOS Compact
Tube housing assembly
Image Intensifier
Television receiver
Warning label present and legible					YES

Siemens AG	RXR2-130.101.02	Page 1 of 4	SIREMOBIL Compact
Medical Engineering	Rev. 02 08.97	TD SP 1

2 - 2

Visual checks

2.1 Location of the DHHS and Identification Labels

Model Nr.

Serien Nr.

Model Nr.

Made in Germany

	Serien Nr.						This product complies with DHHSregulations
	Made in Germany						21 CFR Subchapter J, applicable at date of
							manufacture.
							Manufactured:
	This product complies with DHHSregulations
	21 CFR Subchapter J, applicable at date of						Siemens Aktiengesellschaft
	manufacture.						Wittelsbacherplatz 2, D - 8 München 2
	Manufactured:
									Germany
	Siemens Aktiengesellschaft
	Wittelsbacherplatz 2, D - 8 München 2								24 x 30 cm
	Germany
						cassette			10 x 12 ins.
						holder
		Image intensifier
									Safety
									instructions

X-Ray control

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

X-Ray Equipment	UL
Classified by

Underwriters Laboratories Inc.

with Respect to Electrical Shock, Fire and Mechanical Hazards Only.

245 B

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. 01001 S01

Inherent filtration added filtration

Made in Germany

Röhre/Tube SR 110

Model Nr. 88 55 199 V 1036

Serien Nr.

S06

0.6 IEC 336/82

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

Sach Nr.

ES 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15

* Label is not accessible to view.

A duplicate label is visible in the position shown ** minimum filtration: 3.0 mm Al

SIREMOBIL Compact	RXR2-130.101.02	Page 2 of 4	Siemens AG
	Rev. 02 08.97	TD SP 1	Medical Engineering

Visual checks

2 - 3

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

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

Model Nr.

Serien Nr.

Made in Germany

Siemens AG	RXR2-130.101.02	Page 3 of 4	SIREMOBIL Compact
Medical Engineering	Rev. 02 08.97	TD SP 1