1639
ZDOCK287 2022-02-17 Rev.05
Copyright© 2019-22
ROCKET MEDICAL PLC
. All Rights Reserved. (GB)
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 amnios
cope 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.
3.
Remove the obturator from the amnioscope.
Locate the Amnilume™ light module into the slot in the
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.
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
ONLY
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.
IMPORTANT
Ensure the device is turned OFF between samplings.
Duty cycle: 5 x 15 minute ON periods with 10 minutes OFF
between each period.
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.
CAUTION: DO NOT USE ETHYL CHLORIDE SPRAY
– this may adversely affect the internal surface of the plastic amnioscope
Rocket Medical GmbH
Am Rosengarten 48,
15566 Schöneiche.
Germany
