Rocket Medical FBS R57021-55-SW Gebrauchsanweisung

FBS Sampling Wand
INSTRUCTIONS FOR USE
Kit Contents: One sampling wand and five capillary tubes.
Intended Use/Indications: For the puncture of the fetal scalp and collection of fetal blood for the determination of fetal blood gas/pH during labour
in cases of suspected fetal distress. This device should be used by or under the supervision of trained personnel and in conjunction with clinical
practice guidelines. These instructions cover all R57021 series of FBS Sampling Wands, derivatives and kits.
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
example, fetal bradycardia of >3 minutes).
CAUTION: Avoid fetal face, fontanelles and genitalia.
CAUTION: DO NOT USE ETHYL CHLORIDE SPRAY – this may adversely affect the internal surface of the plastic amnioscope.
CAUTION: Failure to use correct blood volume select the correct analysis mode, the use of clotted or paraffin contaminated samples or
the presence of air bubbles in the sample may lead to errors in results or rejection of the whole sample. Carefully follow manufacturer's
instructions.
Capillary Tube Selection:
Rocket Medical supplies a number of FBS Sampling Wand kits with different capillary tubes. Please check your analyser user manual to confirm
capillary tube compatibility. Where in doubt, please contact your analyser manufacturer representative.
Use the lowest volume compatible tube size to minimise the volume of blood required for collection
Product Code Tube Volume /µl
R57021-55-SW 55
R57021-85-SW 85
R57021-10-SW 100
Preparation:
1. Using aseptic technique, remove the device from its outer bag.
2. Select a capillary tube from the pack or kit and load into the holder. Locate the end of
the tube into the holder at  and then advance into the read tube grip at . Ensure the
tube is secure before sampling.
3. 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.
"Rocket Medical recommends the use of Amnilume™ Disposable Light Sources".
4.
Locate the Amnilume™ in the slot in the endoscope 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
5.
by pushing off the with the thumb.
6. Insert the endoscope, complete with obturator, into the vagina up to the fetal
presentation. Ensure that the cervix is not trapped. Remove the obturator.
Position the bevelled end to obtain the best possible seal against fetal
presentation by rotating the endoscope. Maintain close contact between the
amnioscope and the scalp to prevent leakage of liquor.
7. Clean the puncture area using the green, x-ray detectable gauze swabs and
forceps provided.
8. With a clean swab stick, apply a thin layer of white soft paraffin (supplied) to the
puncture area to promote capillary blood aggregation. Remove excess with
one or two dry swab sticks before performing the skin puncture.
9. The sampling wand comes pre-fitted with an FBS blade. Lightly holding the shaft and rear finger grip (A), push the grip forward to expose the
blade (B). Ensure that the blade is locked forward before use.
10. Perform the skin puncture using either technique  make a vertical stab, rotate the blade 90° and make a second stab to form a cross or 
make a vertical stab, then angle the blade upwards and extend using the front edge of the blade to produce a single 4mm incision. Always wait
for a good sized (3-4mm) bead to form on the surface of the paraffin before collection. Never slash at the scalp and avoid multiple small stabs
11. To collect the blood sample, depress the button on the wand shaft to retract the FBS blade, and angle the capillary tube into the bead.
12. Rapidly collect the blood sample, filling the tube completely, without air bubbles. Collection needs to be expedited to avoid blood clotting.
CAUTION: Do NOT use the sample if the blood clots.
13. Remove tube from holder and cap both ends.Take to the analyser immediately. Follow the analyser manufacturer's instructions as regards
sample agitation or mixing. CAUTION: Avoid distributing air through the sample; samples containing air bubbles may be rejected by
the analyser.
14. Always ensure that the clean, non-paraffin exposed end is presented to the analyser. Note: some analysers require a 'clot catcher'.. Please
refer to the manufacturer's instructions for guidance on when a clot catcher is needed.
15. Always ensure that the correct measuring mode is selected before performing the analysis.
16. For repeated samples commence at Step 7.
Post sampling:
17. Haemostasis is accomplished by applying pressure to puncture site with a swab for one full contraction.
18. If indicated, (refer to clinical guidelines) repeat procedure. The kit is for single patient use for the collection of up to 5 individual samples.
if the woman is less than 34+0 weeks pregnant, or acute fetal compromise (for
,
Tube Length Tube OD
59mm +2.0 - 0.0mm 2.05 ± 0.1mm
87.0 ± 0.15mm 2.07 ± 0.06mm
85.0mm 2.3 ± 0.05mm
Tube ID Heparin Type
1.25 ± 0.05mm Na
1.17 ± 0.02mm Na
1.20 ± 0.05 Ca/Na/Li
Concentration
/IU/ml
240
240
200