Gebrauchsanweisung
Salpingograph
Instructions
Salpingograph
Mode d’emploi
Salpingograph
Instrucciones para el uso
Salpingograf
Инструкция по экс п л у а т а ц и и
Сальпингограф
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salpingograph
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3.5
3.1
3.2
3.3
3.4
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Inhaltsverzeichnis
1. Wichtige Informationen
zur Beachtung vor Inbetriebnahme ............................Seite ............5
2. Zweckbestimmung......................................................Seite ............5
3. Komponenten ............................................................Seite ............5
4. Einleitung ....................................................................Seite ............5
5. Spezielle Vorteile ........................................................Seite ............6
6. Hysterosalpingographie - Pertubation ........................Seite ......6 - 7
7. Durchführung..............................................................Seite ............7
8. Nebenwirkungen und Kontraindikationen ..................Seite ............7
9. Pflegehinweise............................................................Seite ......7 - 8
10. Ersatzteile ..................................................................Seite ............8
11. Technische Daten ......................................................Seite ............8
12. Wartung / Genauigkeitsprüfung..................................Seite ............8
13. Garantie und Reparaturhinweise................................Seite ............9
Contents
1. Important information - read prior to start-up ............page ..........11
2. Purpose ......................................................................page ..........11
3. Components ..............................................................page ..........11
4. Introduction ................................................................page ..........11
5. Special benefits ..........................................................page ..........12
6. Hysterosalpingography - pertubation..........................page ..........12
7. Performance ..............................................................page ..........13
8. Side effects and contra-indications ............................page ..........13
9. Care ............................................................................page ..........13
10. Spare parts ................................................................page ..........14
11. Specification................................................................page ..........14
12. Maintenance / accuracy test ......................................page ..........14
13. Warranty and repair....................................................page ..........15
Sommaire
1. Informations importantes
à lire avant la mise en service....................................page ..........17
2. Utilisation ....................................................................page ..........17
3. Composants................................................................page ..........17
4. Introduction ................................................................page ..........17
5. Avantages spécifiques................................................page ..........18
6. Hystérosalpingographie – Persufflation......................page ..18 - 19
7. Réalisation ..................................................................page ..........19
8. Effets secondaires et contre-indications ....................page ..........19
9. Consignes d'entretien ................................................page ..19 - 20
10. Pièces de rechange....................................................page ..........20
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11. Caractéristiques techniques ......................................page ..........20
12. Maintenance / Contrôle de précision..........................page ..........20
13. Garantie et indications sur les réparations ................page ..........21
Índice
1. Informaciones importantes a tener en cuenta
antes de la puesta en servicio....................................página ........23
2. Aplicación apropiada ..................................................página........23
3. Componentes ............................................................página ........23
4. Introducción ................................................................página........23
5. Ventajas especiales....................................................página........24
6. Histerosalpingografía – Pertubación ..........................página 24 - 25
7. Ejecución ....................................................................página........25
8. Efectos colaterales y contraindicaciones....................página........25
9. Limpieza y conservación del instrumental..................página ........26
10 Piezas de recambio ....................................................página........26
11. Ficha técnica ..............................................................página........26
12. Mantenimiento / Control de la precisión ....................página ........26
13. Garantía e instrucciones de reparación ....................página ........27
Содержание
1. Важная информация
прочтите перед использованием.............................................................. стр. 29
2. Назначение................................................................................................. стр. 29
3. Составные части........................................................................................ стр. 29
4. Общая информация................................................................................... стр. 29
5. Особые преимущества.............................................................................. стр. 29
6. Гистеросальпингография - пертубация.................................................... стр. 30
7. Проведение процедуры.............................................................................. стр. 30
8. Побочные эффекты и противопоказания................................................ стр. 30
9. Рекомендации по уходу.............................................................................. стр. 30
10. Запасные части........................................................................................... стр. 30
11. Технические характеристики......................................................................стр. 31
12. Техническое обслуживание/ проверка точности..................................... стр. 31
13. Гарантия и ремонт....................................................................................... стр. 33
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11
1. Important information read prior to start-up
You have acquired a valuable RIESTER product manufactured in
compliance with Directive 93/42/EEC for medical products and subject
to continuous stringent quality control.
Should you have any queries, please contact the Company or your
RIESTER Agent who will be pleased to assist you. For addresses see
last page of these Operating Instructions. The address of your authorised RIESTER Agent will be supplied to you on request.
Please note that any products described in these Operating Instructions are only suited for application by trained operators.
Please also note that correct and safe operation of products will only
be guaranteed when RIESTER products and accessories are used
throughout.
Significance of symbol on manometer scale:
Caution, observe provided information
2. Purpose
The RIESTER salpingograph is used for diagnosing sterility and
hysterosalpingography after Prof. Dr. Günther K.F. Schultze, for contrast x-ray of the cavum uteri and the (fallopian) tubes and for pertubation, including a bracket for two uterus pick-up forceps.
3. Components
(see diagram)
3.1. 20 cc glass syringe including a Luer lock connector
3.2. Manometer and pressure scale in mmHg
3.3. Centre piece
3.4. Uterus probe
3.5. Three portio adaptors (uterus sealing cone) in the following sizes:
small (base 16 mm dia.), medium (base 24 mm dia.),
large (base 30 mm dia.), height each 25 mm
4. Introduction
The salpingograph after Prof. Dr. Günther K.F. Schultze is well suited
both for hysterosalpingography and pertubation. Its gearing for fixing
the cervix pick-up forceps and metal cones of different sizes will allow
full sealing of the cervix in every case, thus meeting the most important
prerequisites for successful diagnosis.
!
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5. Specific benefits
5.1. The gearing integrated in the uterus probe (3.4) is used for
holding the cervix pick-up forceps. Infinitely variable adjustment
allows accurate dosage tension of the pick-up forceps and therefore the compression of the metal cone to the portio.
5.2. Three metal cones of different sizes (3.5) are used as a portio
adaptor. These are screwed to the tip of the uterus probe (3.4),
projecting the cone by 1-2 cm. The thread of the cones ensures
complete sealing for both contrast media and air.
5.3. A manometer (3.2) may be connected between the uterus probe
(3.4) and the glass syringe (3.1), thus allowing accurate registration of any pressure required for pertubation in mm Hg. During
hysterosalpingography, the instrument may be used without a
connected manometer.
5.4. The scale reading of the manometer is fluorescent, thus
allowing pressure readings to be read in the dark.
6. Hysterosalpingography - pertubation
Hyterosalpingography is used for contrast x-rays of the cervix, the
cavum uteri and the fallopian tube lumen. After injection of a x-ray contrast media into the cervical canal, the x-ray will follow the contrast
media filling the cervical canal and the cavum uteri first, followed by
being discharged retrograde through the three tubes into the free abdominal cavity. Contrast means recesses in the cervical canal or the
cavum uteri are an indication for intra-cavitary or occupation of intracavitary spaces (by polyps, myoma, for instance). Congenital mishapes
of the cervix (i.e. uterus subseptus) are particularly clear to evidence.
Filling the fallopian tubes allows assessment of the patency of the
tubes on the one hand, but may also be used for assessing important
changes in the tube function, such as a variation in thickness, stenoses
or sactosalpingual formations.
Pertubation is used for testing the tube patency. Connection of a
manometer allows testing of the pressure required for pertubation.
Normally, the cavum uteri will widen at a pressure of 40-60 mmHg.
From a pressure of 70 mm Hg, the distension media (liquid and
gaseous) will penetrate into the tube lumen and retrograde into the
abdominal cavity, due to physiological law. During pertubation ensure
that a dispension pressure of 200 mm Hg is not exceeded. Should
pertubation be performed by air or gas, penetration into the free abdominal cavity may be recognised by a typical ”bubble noise” during
abdominal auscultation.
Hysterosalpingography and pertubation have a therapeutic effect in
sterility therapy. One quarter to one third of all cases show that
conception is effected within 4 months after intervention.
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7. Performance
The patient is laid on the x-ray table of the x-raying station. Tables
having a leg bracket at their caudal end have shown to be best, which
support the patient’s legs. This is followed by a speculum examination
and setting of the portio. Injection of a little local anaesthetic into the
front lip of the cervix allows attachment of the portio without causing
any pain. The front cervix lip is positively picked up
in cross direction
after disinfection. Introduction of the salpingograph after selection and
attachment of a suitable cone. Insertion of the ball-shaped forceps into
the hooks of the gearing, followed by slow increase of tension by turning the gearing back. Connection of the filled glass syringe. No the
patient is correctly laid on the x-ray table with her legs stretched out.
The instruments may be positioned on a small sand bag between the
legs. Careful but continuous injection of the contrast media whilst the xray machine is in operation. After termination of x-rays, the instruments
are removed.
8. Side effects and contra-indications
8.1. Side effects
• Distension of the cavum uteri and penetration of x-ray contrast
media through the fallopian tubes may cause pain and peritoneal
irritation.
• Occasionally, vasovagal reactions are observed.
8.2. Contra-indications
An allergy against x-ray contrast media constitutes a contra-indication
against hysterosalpingography.
No pertubation and hysterosalpingography in case of:
• florid cervical and pelvine infections,
• existence during pregnancy.
Test should best be performed during the first half of the cycle and not
during menstruation.
9. Care
Clean instruments under running water. Rinse uterus probe after
each
use. Disinfect instruments with the following infectants: aldehyde,
(formaldehyde, glutaraldehyde, aldehyde separators), tensides or alcohols. Ensure that contact with disinfectants and the glass of the manometer is avoided.
Attention is drawn to the manufacturer’s instructions which must be
complied with at all costs.
Note
Never immerse the manometer in fluid.
Ensure that no fluid penetrates into the interior of the housing.
Sterilisation
According to applicable teaching (Test Centre for Medical Products,
Tübingen), sterilisation is only prescribed during surgery. Nevertheless,
the entire range of instruments (with the exception of the manometer)
may be autoclaved at 130°C.
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10. Spare parts
Item No. 11210 Syringe 20 ml including Luer lock seal
Item No. 11211 Syringe 10 ml including Luer lock seal
Item No. 11212 Uterus probe
Item No. 11213 Sealing cone, small
Item No. 11214 Sealing cone, medium
Item No. 11215 Sealing cone, large
11. Specification
Manometer: Scale: Range 0-200 mm Hg in steps of 10 mmHg
No zero fixation
Pressure increase: Through a syringe including a Luer lock seal
12. Maintenance / accuracy test
The salpingograph and its accessories do not require any special maintenance.
Accuracy test of manometer:
Remove manometer from instrument and hold in horizontal position.
When the pointer stops on zero on the scale, the manometer is accurately set. When the pointer is outside zero, send the instrument to us or
an authorised RIESTER dealer in your vicinity for readjustment. Please
contact us for names.
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G U A R A N T E E
This device was manufactured in accordance with the most
stringent quality requirements. Before leaving the factory, it
underwent extensive final testing.
We are thus in the fortunate position to be able to offer you a
guarantee extending for
2 years starting on the date of purchase
This guarantee covers any defects of the device which are
demonstrably due to material or manufacturing faults. Your
warranty will become null and void under the following circumstances: incorrect handling, non-compliance with Instructions
for Use, use of other manufacturers’ spares and accessories,
unauthorised amendments or repairs and normal wear and
tear.
All defective parts of the device will be repaired or replaced
free of charge within the guarantee period.
Claims made under the guarantee shall be valid only if the
device is accompanied by this Guarantee Card, completely
filled in and stamped by the dealer.
Please note that guarantee claims must be submitted within
the guarantee period.
We will, of course, gladly perform testing or repair work after
the guarantee period as well. Upon request, we will provide
non-binding cost estimates for such work.
Should your device exhibit a defect during the guarantee period or require repair, please send the entire instrument, along
with the filled-in Guarantee Card, to the following address:
Rudolf Riester GmbH & Co. KG
Reparaturen Abt. RR
Bruckstr. 31
D-72417 Jungingen
Germany
Serial number:
(See manometer scale and packaging)
Date
Stamp and signature of the specialized dealer
Please detach this card on the perforated line!
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salpingograph
➔
➔
➔
Rudolf Riester GmbH & Co. K G
Postfach 35 • DE-72417 Jungingen
G e r m a n y
Tel.: +49 (0)74 7 7 /92 7 0-0
Fax: +49 (0)74 7 7 /92 70 7 0
i n f o @ r i e s t e r .de • www. r i e s t e r . d e
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Detailed descriptions of the products can be
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