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FBS Amnioscope and Amnilume™
Single Use Light Source
INSTRUCTIONS FOR USE
Scope: These instructions apply to Rocket Medical Amnioscope and Amnilume™ products, codes R57016-LUME-NS and R57016-PLUS-NS.
R57016-LUME-NS comprises a standard 142mm length amnioscope with Amnilume™. R57016-PLUS-NS comprises a 200mm length amnioscope
with Amnilume™.
Indications: Endoscope with self-contained, battery powered LED light source, for access to and illumination of the fetal scalp during fetal blood
sampling. Sterile, for single patient use.
Contraindications: This procedure is contraindicated with placenta previa, when identification of the
presenting part is uncertain, in the presence of genital infections (e.g. herpes, Group B streptococcus,
gonorrhoea, HIV/AIDS and Hepatitis B), where the mother is a confirmed carrier of haemophilia and the
fetus is either affected or of unknown status, prematurity (less than 34 + 0 weeks) or acute fetal
compromise (for example, fetal bradycardia of >3 minutes).
Procedure:
1.
Using aseptic technique, open the pack and place the device onto a sterile area.
2.
Follow local hospital procedure to prep the perineum and vagina, and complete a vaginal
examination to establish the cervical dilatation and station of the fetal head.
Remove the obturator from the amnioscope. Locate the Amnilume™ light module into the slot in the
3.
amnioscope and push gently to engage. The light will activate when the light source is correctly
fitted. Between samplings, remove the Amnilume™ light source from the endoscope by pushing off
with the thumb.
4.
Insert amnioscope, complete with obturator, into the
vagina against the fetal presentation, ensuring that
the cervix is not trapped.
5.
Remove obturator. Position the bevelled end by
rotating amnioscope to obtain the best possible seal
against the fetal presentation. Rotate to finally
position the light source module in the upper
quadrant.
6.
Maintain close contact between amnioscope and
scalp to prevent leakage of liquor.
7.
Complete the sampling procedure and remove the
amnioscope.
8.
If test results so indicate, repeat the procedure.
IMPORTANT
Ensure the device is turned OFF between samplings.
Duty cycle: 5 x 15 minute ON periods with 10 minutes OFF
between each period.
CAUTION: DO NOT USE ETHYL CHLORIDE SPRAY – this may adversely affect the internal surface of the plastic amnioscope
Disposal:
This device should be handled and disposed of in accordance with local hospital policy and with regard to all applicable regulations, including but
without limitation to, those pertaining to human health & safety and care of the environment. The Rocket Medical Amnilume™ light module contains
lithium-ion based power cells.
This device is
not
manufactured
with natural
rubber latex
ROCKET MEDICAL PLC Sedling Road, Washington,
England, NE38 9BZ
Unless opened or damaged, contents of package are sterile. Store at room temperature. Avoid prolonged exposure to elevated temperatures.
1639
ZDOCK287 2022-02-17 Rev.05
www.rocketmedical.com
Copyright© 2019-22
WARNING: This device contains 2 lithium-based primary cells.
Do NOT attempt to disassemble the device.
Do NOT attempt to recharge or short circuit the batteries.
Lithium cells are suitable for incineration or landfill disposal.
ONLY
ROCKET MEDICAL PLC
Rocket Medical GmbH
Am Rosengarten 48,
15566 Schöneiche.
Germany
.
All Rights Reserved. (GB)
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Table of Contents
Related Manuals for Rocket Medical R57016-LUME-NS
Summary of Contents for Rocket Medical R57016-LUME-NS
- Page 1 This device should be handled and disposed of in accordance with local hospital policy and with regard to all applicable regulations, including but without limitation to, those pertaining to human health & safety and care of the environment. The Rocket Medical Amnilume™ light module contains lithium-ion based power cells.
- Page 2 à usage unique Amnilume™ MODE D’EMPLOI Portée : Ce mode d’emploi s’applique à l’amnioscope Rocket Medical et aux produits Amnilume™, codes R57016-LUME-NS et R57016-PLUS-NS. R57016-LUME-NS comprend un amnioscope standard de 142 mm de longueur avec une source lumineuse Amnilume™.
- Page 3 GEBRUIKSAANWIJZING Betreft: Deze instructies zijn van toepassing op producten van Rocket Medical Amnioscope en Amnilume™, met de codes R57016-LUME-NS en R57016-PLUS-NS. R57016-LUME-NS is een standaard amnioscoop met Amnilume™ van 142 mm lang. R57016-PLUS-NS is een amnioscoop met Amnilume™ van 200 mm lang.
- Page 4 Amnilume™ INSTRUCCIONES DE USO Contenido: Estas instrucciones hacen referencia a los productos Amnioscopio y Amnilume™ de Rocket Medical, códigos R57016-LUME-NS y R57016-PLUS-NS. R57016-LUME-NS consta de un amnioscopio estándar de una longitud de 142 mm con Amnilume™. R57016-PLUS-NS consta de un amnioscopio de una longitud de 200 mm con Amnilume™.
- Page 5 Handhabung und Entsorgung dieses Produkts sollten in Einklang mit den örtlich geltenden Krankenhausrichtlinien sowie den gesetzlichen Vorschriften, unter anderem hinsichtlich des Schutzes von Gesundheit und Sicherheit von Mensch und Umwelt, erfolgen. Das Rocket Medical Amnilume™ Lichtmodul enthält Batterien auf Lithium-Ionen-Basis.
- Page 6 Bortskaffelse: Denne enhed skal håndteres og bortskaffes i overensstemmelse med lokal hospitalspolitik og under hensyntagen til alle gældende forskrifter, herunder men ikke begrænset til dem, der vedrører menneskers sundhed og sikkerhed og miljøhensyn. Rocket Medical Amnilume™ lysmodul indeholder lithiumion-baserede battericeller.
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