Rocket Medical R57012 Instructions For Use Manual

®
Rocket Fetal Blood Sampling Kits
INSTRUCTIONS FOR USE
Indications: These instructions apply to Rocket Basic Fetal Blood Sampling Kits and derivatives. Contents of packs will vary. Procedure kit for single
use, to obtain up to 5 fetal blood pH/gas samples in cases of suspected fetal distress during labour. If additional sampling is necessary or if labour is
protracted, a further pack may be required. This device should only be used by or under the supervision of trained personnel and in conjunction with
current clinical practice guidelines such as: NICE Guidelines No. CG190: 12/2014.
'Intrapartum care of healthy women and their babies during childbirth' (as amended).
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) or where the mother is a confirmed carrier of
haemophilia and the fetus is either affected or of unknown status.
FBS Kit Description
R57012 Straight Glass, Heparinised
R57013 Angled Glass, Heparinised
R57012/013 Plastic Capillary, Heparinised
R57018 Plastic Capillary, Heparinised
R57024 Plastic Capillary, Heparinised
R57026 Plastic Capillary, Heparinised
R57027 Plastic Capillary, Heparinised
Rocket Medical supply a range of Rocket

Preparation:

1. Using aseptic technique, remove the kit from outer bag, place onto a suitable surface and unfold outer drape to form a sterile field.
2. Follow local hospital procedure, prep the perineum and vagina and complete a vaginal examination to establish the cervical dilatation and station of
the fetal head.
3. Unpack one FBS blade and using a clockwise rotating action, locate the screw securely into the blade holder.
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
4.
correctly fitted. To turn the light off, withdraw the light module.
5. Insert amnioscope complete with obturator into the vagina against the fetal presentation ensuring that the cervix is not trapped.
6. Remove obturator. Position the bevelled end by rotating endoscope to obtain the best possible seal against the fetal presentation. Maintain close
contact between amnioscope and scalp to prevent leakage of liquor
7. Clean puncture area with the green x-ray detectable gauze swabs and forceps provided.
8. Spray the fetal scalp with ethyl chloride spray or other suitable agent to promote capillary action if required.
9. With a clean swab stick, apply a thin layer of petroleum jelly (supplied) to the puncture area to promote blood aggregation. Always remove excess
petroleum jelly with one or two new, dry swab sticks before performing the skin puncture.
10. Perform skin puncture through the endoscope using the loaded FBS blade holder. Either  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 incision 4-5mm long. Always wait for a good sized (3-4mm) bead to form on the surface before collection. Never slash at the scalp and avoid
multiple small stabs.
CAUTION: Avoid fetal face, fontanels or genitalia. Rocket® FBS blades have a maximum depth of penetration of 2.2mm
11. Where supplied and approved by the analyser manufacturers, use a long glass heparinised tube to collect the bead of aggregated blood.
Collection needs to be expedited rapidly to avoid blood clotting. CAUTION: Do NOT use the sample if the blood clots
12. For micro volume analysers requiring precision volume samples of 170µl or less, use the correct micro-volume capillary tube inserted into the
capillary tube holder. Rapidly collect blood sample, filling the tube completely, without air bubbles.
13. Lightly twist the capillary to remove it from holder and cap both ends with covers supplied. Take to the analyser immediately.
CAUTION: Do not shake the filled collection tube or use wires and magnets to mix heparin.
Use of these techniques may cause air entrainment into the sample. Samples containing air bubbles may be rejected by the analyser.
14. Always ensure the clean, non-fetal exposed end is presented to the analyser. Please refer to the analyser instructions for guidance. Always ensure
that the correct measuring mode is selected before performing analysis.
CAUTION: Failure to use correct blood volume, select correct analysis mode or the use of clotted or contaminated samples may lead to
errors in results or rejection of the whole sample. Carefully follow the analyser manufacturer's instructions.

Post sampling:

15. Haemostasis is accomplished by applying pressure to fetal puncture site with a swab for one full contraction.
16. If test results so indicate, repeat 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.
Unless opened or damaged, contents of package are sterile. Store at room temperature. Avoid prolonged exposure to elevated temperatures.
Manufactured in the UK by: ROCKET MEDICAL PLC Sedling Road, Washington, England, NE38 9BZ
0088 ZDOCK066
Volume
Tube Length
µl
2320 295 ± 5.0mm
2320 295 ± 5.0mm
75 74.85mm
55 59mm +2.0 - 0.0mm
85 87.0 ± 0.15mm
100 85.0mm
170 100.0mm
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FBS Kits suitable for a range of blood gas analysers; contact Customer Services for advice on compatibility.
®
Rocket is a registered trademark of ROCKET MEDICAL PLC.
160517 Rev. 28 Copyright©2010-17 ROCKET MEDICAL PLC.
OD ID
3.0 ± 0.15mm 1.0 ± 0.04mm
3.0 ± 0.15mm 1.0 ± 0.04mm
1.87mm 1.08mm
2.05 ± 0.1mm 1.25 ± 0.05mm
2.02 ± 0.01mm 1.17 ± 0.01mm
2.3 ± 0.05mm 1.20 ± 0.05
2.0 ± 0.05mm 1.55 ± 0.05
Concentration
Heparin type
usp/ml
Na 100
Na 100
Ca/Na/Li 75
Na/Li 240
Na/Li 240
Ca/Na/Li 200
Ca/Na/Li 100
ONLY
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