prompt birthing simulator force monitoring

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PROMPT Birthing Simulator Force Monitoring Designed and manufactured by Limbs & Things Limited, Sussex Street, St. Philips, Bristol, BS2 0RA, UK. Telephone: +44 (0)117 311 0500 Fax: +44 (0)117 311 0501 [email protected] www.limbsandthings.com L85-127 usetvt.qxd Issue 4, March 2007 © 2007 Limbs & Things

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Page 1: PROMPT Birthing Simulator Force Monitoring

PROMPT Birthing SimulatorForce Monitoring

Designed and manufactured by Limbs & Things Limited,Sussex Street, St. Philips, Bristol, BS2 0RA, UK.Telephone: +44 (0)117 311 0500 Fax: +44 (0)117 311 [email protected] www.limbsandthings.com

L85-127usetvt.qxdIssue 4, March 2007© 2007 Limbs & Things

Page 2: PROMPT Birthing Simulator Force Monitoring

General

Declaration of CE conformity 1

Introduction 2

Product information 4

Components 5

Unpacking/packing 6

Training

i Preparing the Birthing Mother 7

ii Accessing the pelvis 10

iii Connecting the Placenta to the Baby 11

iv Setting up for:

Normal delivery 12

Extended breech delivery 14

Shoulder dystocia 16

Instrumental delivery - forceps 18

Instrumental delivery - vacuum delivery 20

Delivery on all fours 21

Management of ‘Third stage’ 23

Changing components

Replacing the Abdomen & Perineum Skin 24

Replacing the Perineal Muscles 26

Force monitoring

Hardware & software quick start guide 28

Contents

In order for this equipment to satisfy CE requirements then this equipment must only be used with CE-marked equipment.

This is NOT a toy and must only be operated by a competent person. It is for professional training purposes only.

Never modify the equipment or an accessory under any circumstances.

Do not operate this equipment in environments containing explosive materials or vapours.

This equipment is designed for indoor use only. Do not expose to rain or moisture.

The affixed manufacturer labels must not be removed, changed or obscured in any way.

Do not remove the cover or disassemble in any way. No user serviceable parts inside. Refer servicing to Limbs & Things Ltd.

Do not use if the equipment appears damaged or faulty. Refer servicing to Limbs & Things Ltd.

If the overload indicator is or has been on then the equipment must be returned to Limbs & Things Ltd for servicing.

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Page 3: PROMPT Birthing Simulator Force Monitoring

Introduction

The PROMPT Birthing Simulator provides a platform for the teaching and acquisition of thepractical skills required for the successful management of childbirth. It has been developed formulti professional training, in conjunction with midwives and obstetricians from SouthmeadHospital, Bristol (UK) and Gloucestershire Royal Hospital (UK). It is an integral part of thePROMPT (PRactical Obstetric Multi-Professional Training) course.

Affectionately known as ‘Nellie’ during its development, the PROMPT Birthing Simulatorincorporates a number of features which enhance training: an anatomically correct bony pelvisin the mother (modelled from CT scan data), silicone pelvic floor musculature and a stretchableperineum. The baby is of newborn size and weight, is fully articulated, and features the correctanatomical landmarks such as fontanelles, clavicles and scapulae.

In addition to being an all-round birthing simulator for all levels of trainee, this product wasspecifically designed to enable doctors and nurses to learn and practise the manoeuvres requiredto manage shoulder dystocia, an unpredictable and largely unpreventable obstetric emergency.Annual drill training for the management of shoulder dystocia is a requirement for the maternityClinical Negligence Scheme for Trusts (CNST) level II in the UK, and is recommended by the JointCommission on Accreditation of Healthcare Organizations (JCAHO) in the USA.

Obstetric brachial plexus injury (OBPI) is a serious neonatal complication of shoulder dystociawhich may be associated with excessive traction applied during delivery1. The unique forcemonitoring baby incorporates a strain gauge linked to a computer for the measurement andrecording of the force applied to the baby by the accoucheur during delivery.

The PROMPT Birthing Simulator, with its force monitoring capability, has been used for a UKDepartment of Health funded study, SaFE (Simulation and Fire-drill Evaluation), to investigatetraining for obstetric emergencies. During the product development stage, midwives andobstetricians, who received training using a prototype, demonstrated a significant objectiveimprovement in the management of simulated shoulder dystocia2.

In addition to training for deliveries complicated by shoulder dystocia, this high fidelity birthingsimulator realistically simulates normal delivery, in semi-recumbent and ‘all fours’ positions, aswell as vaginal breech and instrumental (forceps and ventouse) deliveries.

1 Risk Factors for Shoulder Dystocia: an engineering study of clinician-applied forces Allen R, Sorab J, Gonik

B. Dept of Mechanical Engineering, University of Delaware, Newark. Obstet Gynecol. 191 Mar;77 (3) :352-5

2 Shoulder dystocia training using a new birth training mannequinJoanna F Crofts, Georgios Attilakos, Mike Read, Thabani Sibanda, Timothy J Draycott. RCOG 2005 BJOG: anInternational Journal of Obstetrics and Gynaecology 112, pp. 1-3

2

Normal delivery Delivery of posterior arm withShoulder Dystocia

Forceps delivery

Delivery of placenta Ventouse delivery Breech delivery

Mother on ‘all fours’ delivery

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Page 4: PROMPT Birthing Simulator Force Monitoring

PROMPT Birthing Simulator - Force MonitoringPart No: 80005

This version of the Simulator includes the force monitoring baby which is fitted with anelectronic strain gauge allowing for the measurement of force applied to the baby as it isdelivered.

Skills • Normal delivery• Breech delivery• Delivery on all fours• Shoulder dystocia management• Vacuum delivery• Forceps delivery: traction and rotational deliveries• Delivery of placenta

Features Baby

• Fully articulated body• Force monitoring system including computer software package for simultaneous force display,

measurement and recording of data• Weight 2.3 kg• Palpable fontanelles and suture lines• Palpable clavicles and scapulae• Detachable placenta with cord

Mother• Movable legs: semi-recumbent, lithotomy position, McRoberts’ position and ‘all fours’ position• Realistic pelvis modelled from CT scan data• Detachable abdominal and perineal skin to enable clear view of internal manoeuvres and

foetal positioning during training• Durable, stretchy silicone skin and perineal musculature• Detachable base with securing straps to allow fixing to table or delivery bed• Patient actor can be integrated with birthing mother for training sessions

Package supplied• 1 Lubricant (250ml) Part No: 50181• 1 Birthing Placenta Part No: 80023• 1 Birthing Baby - Force Monitoring Part No: 80022• 1 Birthing Mother Part No: 80020

- 1 Birthing Abdomen & Perineum Skin Part No: 80024- 1 Birthing Perineal Muscles Part No: 80026- 1 lower torso with removable base & straps

• 1 carry case

4

Components

Birthing MotherPart No: 80020

Birthing PerinealMusclesPart No: 80026

Birthing Abdomen &Perineum SkinPart No: 80024

Birthing Baby - Force MonitoringPart No: 80022

Force MonitoringInterface Unit

Computer leads:- PS2 baby lead- USB computer lead

Force MonitoringSoftware CD-ROM

Birthing PlacentaPart No: 80023

Birthing Lubricant(250ml)Part No: 50181

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Page 5: PROMPT Birthing Simulator Force Monitoring

Unpacking/packing

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2

NoteWhen repacking, theBaby case should be putin first: it supports theabdomen of the Mother.

1

To remove the product fromthe case, securely and easily:with one hand grasp thetorso end whilst supportingthe buttocks with the otherhand. Lift the Mother outfrom the case.

The Baby case isunderneath.

Preparing the Birthing Mother

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3

The three holes in the Baseshould line up with those onthe back of the Mother.

2

Remove any other itemsfrom inside the Mother.

Place the Base upside downon the back of the Mother,aligning the holes.

1

Place the Mother on thework surface in the all foursposition.

Use the Baby case as asupport under theabdomen.

Page 6: PROMPT Birthing Simulator Force Monitoring

5

Remove the Baby case fromunder the abdomen.

Tilt the Mother towards tothe edge of the worksurface.

4

Fix the Base in position bytightening the single turnknob.

Secure the Base in place bytightening the remainingtwo. Ensure all three turnknobs are secure.

NoteDo not overtighten theknobs.

6

Turn the Mother over andplace on the work surface.Adjust the position,ensuring that the Mother isclose to the edge for easyaccess whilst training.

Line up the black securingstraps ensuring that theyrun parallel with each otherand that they hang over thesides of the work surface ordelivery bed.

8 9

8

Ensure both sets of strapsare fully tightened.

The Mother should now befirmly secured to the worksurface and ready to use.

7

Draw the ends of one ofthe pair of straps togetherunderneath the worksurface and clip together.

Tighten by pulling the looseend.

Page 7: PROMPT Birthing Simulator Force Monitoring

Accessing the pelvis

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3

Ensure that the perinealmuscles are completelyexposed. The Mother is nowready to be set up for aprocedure.

NoteWhen reattaching theSkin the 2 corner studsshould be engaged.

2

Lift away from hoop.

Pull back over the pubicsymphysis.

1

The Abdomen & PerineumSkin can be removed easilyto facilitate correctpositioning of the Babywithin the pelvis. Ensure thelegs are lying flat.

Peel the Skin away from thesupport hoop. Start at oneend and work along it untilit is completely free.

Connecting the Placenta to the Baby

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1

To identify the type ofBaby:

The Force MonitoringBaby has a serial numberand a red band on theend of the connector.

The Standard Baby has agreen band on theconnector.

1

To attach the Baby to thePlacenta align the ends ofthe leads so that the flatfaces with the doublearrows are towards you.

Gently push together.

Page 8: PROMPT Birthing Simulator Force Monitoring

Normal delivery

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2

Spray the Baby 2 or 3 times.

Spread the lubricant overthe head and upper body.

1

Using the lubricantprovided, spray the perinealmuscles 2 or 3 times.

Spread the lubricant evenlyover the surfaces of themuscles, both front andback.

Remove the Abdomen &Perineum Skin beforecontinuing with thesetup. For fullinstructions on how todo this see the section‘Accessing the pelvis’ onpage 10.

4

Replace the Skin. TheSimulator is now ready foruse. To conduct a normaldelivery the trainer needs topush the Baby through thepelvis, rotating the Baby asappropriate to mimic themechanism of normaldelivery.

3

With the Baby’s arms andlegs fully extended, positionthe Baby face down (OA) inthe pelvis.

Advance the head until it isengaged in the pelvis.Ensure the shoulders are inthe oblique position.

NoteWhen you have finishedwith the Simulator,remove any lubricantfrom the Mother andBaby using the suppliedwipes.

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Page 9: PROMPT Birthing Simulator Force Monitoring

Extended breech delivery

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2

For an extended breechdelivery extend the Baby’slegs and flex the arms.

Spray the Baby’s back andbottom 2 or 3 times.

1

Using the lubricantprovided, spray the perinealmuscles 2 or 3 times.

Spread the lubricant evenlyover the surfaces of themuscles, both front andback.

Remove the Abdomen &Perineum Skin beforecontinuing with thesetup. For fullinstructions on how todo this see the section‘Accessing the pelvis’ onpage 10.

4

Pull the Baby into the pelvisfrom below so the buttockspresent through the perinealmuscles.

Reattach the Skin.

3

Spread the lubricant evenlyover the back and bottom.

Load the Baby, with theBaby’s sacrum in the obliquediameter, into the pelvis.

5

Push on the head fromabove (picture shown withSkin removed) to simulatecontractions and maternaleffort. Ensure the Baby’sarms remain flexed duringthe delivery (unless nuchalarms are required fortraining).

NoteWhen you have finishedwith the Simulator,remove any lubricantfrom the Mother andBaby using the suppliedwipes.

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Page 10: PROMPT Birthing Simulator Force Monitoring

Shoulder dystocia

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2

The Placenta can be placedinside the Mother tocushion the trainer’s handwhilst holding the Baby inposition during training.

Place the Baby’s head intothe pelvis in the OAposition.

1

Using the lubricantprovided, spray the perinealmuscles 2 or 3 times.Spread the lubricant evenlyover the surfaces of themuscles, both front andback.

Spray the Baby’s head 2 or 3times. Spread the lubricantevenly over the head. Anyexcess lubricant can beapplied to the Baby’sshoulders.

Remove the Abdomen &Perineum Skin beforecontinuing with thesetup. For fullinstructions on how todo this see the section‘Accessing the pelvis’ onpage 10.

4

Pull the Skin over the Baby’shead.

Pull the head through thevaginal opening.

3

Deliver the Baby’s headthrough the perinealmuscles by flexion frombelow.

Ensure that the anteriorshoulder of the Baby iswedged behind thesymphysis pubis, the babymust be held in this positionby the trainer when deliverycommences.

5

Fasten the Skin. TheSimulator is ready to use.

NoteThe Baby will need to beheld in the shoulderdystocia position untilthe trainee hasperformed appropriatemanoeuvres to facilitatedelivery. You may decideto hold the Baby inposition only untilMcRoberts or suprapubicpressure has beenperformed, or continueholding until all thecorrect internalmanoeuvres have beenperformed.

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Page 11: PROMPT Birthing Simulator Force Monitoring

Instrumental delivery - forceps

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2

Load the Baby in to thepelvis in the positionrequired for teaching suchas OA, ROT, OP. Reattachthe Skin.

The trainer/patient needs togently hold the first blade inplace from within the pelvisuntil the second blade hasbeen applied and theforceps have been lockedtogether. (Shown with Skinremoved).

1

Using the lubricantprovided, spray the perinealmuscles 2 or 3 times.

Spread the lubricant evenlyover the surfaces of themuscles, both front andback.

NoteDo not lubricate thebaby too much aslubrication may preventthe forceps fromgrasping securely.

Remove the Abdomen &Perineum Skin beforecontinuing with thesetup. For fullinstructions on how todo this see the section‘Accessing the pelvis’ onpage 10.

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NoteWhen you have finishedwith the Simulator,remove any lubricantfrom the Mother andBaby using the suppliedwipes.

3

The placement of theforceps blades can seen bypeeling back the Skin.Whilst the Baby’s head isbeing delivered make surethe shoulders enter theMother’s pelvis in theoblique or AP diameter. If arotational instrumentaldelivery is performed, thetrainer should ensure theappropriate rotation of theBaby’s body in relation tothe Baby’s head within thepelvis.

The Simulator is now readyto use.

Page 12: PROMPT Birthing Simulator Force Monitoring

1

Using the lubricantprovided, spray the perinealmuscles 2 or 3 times.

Spread the lubricant evenlyover the surfaces of themuscles, both front andback.

NoteDo not lubricate theBaby too much aslubrication may preventthe vacuum device fromattaching securely.

Remove the Abdomen &Perineum Skin beforecontinuing with thesetup. For fullinstructions on how todo this see the section‘Accessing the pelvis’ onpage 10.

2

Load the Baby in theMother’s pelvis in theposition required forteaching such as OA, ROT,OP. Reattach the Skin.

Apply vacuum device to theBaby’s head. Whilst theBaby’s head is beingdelivered make sure theBaby’s shoulders enter theMother’s pelvis in theoblique or AP diameter.

NoteWhen you have finishedwith the Simulator,remove any lubricantfrom the Mother andBaby using the suppliedwipes.

Instrumental delivery - vacuum device

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1

Using the lubricantprovided, spray the perinealmuscles 2 or 3 times.

Spread the lubricant evenlyover the surfaces of themuscles, both front andback. Reattach the Skin.

Remove the Abdomen &Perineum Skin beforecontinuing with thesetup. For fullinstructions on how todo this see the section‘Accessing the pelvis’ onpage 10.

2

Place the Mother onto thework surface in the all foursposition.

To support the Mother restthe abdomen on somethingsoft such as the Baby caseor pillows. The angle of theMother’s torso and pelviscan be changed by placing ahigher support under theabdomen.

Delivery on all fours

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Page 13: PROMPT Birthing Simulator Force Monitoring

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5

The Simulator is now readyto use.

NoteWhen you have finishedwith the Simulator,remove any lubricantfrom the Mother andBaby using the suppliedwipes.

4

Position the Baby inside theMother as seen in the‘Normal delivery’ section,stages 3 & 4 (page 12).

To conduct a normal deliverythe trainer should push theBaby through the pelvis,rotating the Baby asappropriate to mimic themechanism of normaldelivery.

3

Spray the Baby’s head 2 or 3times.

Spread the lubricant evenlyover the head.

2

The trainer can hold thePlacenta in situ to representan attached Placenta or itcan be left free to representa placenta that hasseparated.

NoteWhen you have finishedwith the Simulator,remove any lubricantfrom the Mother andPlacenta using thesupplied wipes.

1

Ensure that the umbilicalcord is partially delivered.

Cord traction can bepractised to establish ifseparation of the Placentahas occurred.

Management of ‘Third stage’

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Page 14: PROMPT Birthing Simulator Force Monitoring

Replacing the Abdomen & Perineum Skin

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3

The Perineal Muscle framemust be detached to allowaccess to the perineal end ofthe skin.

Release the frame from thepelvis by turning the fourblack clips.

2

Lift the Skin away from thehoop.

Pull it back over the pubicsymphysis until only theperineal end is attached.

1

Ensure the legs are lyingflat.

Peel the abdominal end ofthe Abdomen & PerineumSkin away from the supporthoop. Start at one end andwork along until it iscompletely free.

5

The studs securing theperineal end of the Skin arenow exposed.

Starting from one end,gently pull the Skin off.

4

Remove the frame.

NoteDuring reassembly, thebottom of the frame isinserted between thelower perineal muscleand the perineal end ofthe skin.

6

The Mother is now ready tohave a new Abdomen &Perineum Skin fitted. Reversethe stages for fitting.

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Page 15: PROMPT Birthing Simulator Force Monitoring

Replacing the Perineal Muscles

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3

The Perineal Muscle framemust be detached to allowaccess to the perineal end ofthe skin.

Release the frame from thepelvis by turning the fourblack clips.

2

Lift the Skin away from thehoop.

Pull it back over the pubicsymphysis until only theperineal end is attached.

1

Ensure the legs are lyingflat.

Peel the abdominal end ofthe Abdomen & PerineumSkin away from the supporthoop. Start at one end andwork along until it iscompletely free.

4

Remove the frame. Reversethe stages for fittingreplacement PerinealMuscles.

NoteDuring reassembly, thebottom of the frame isinserted between thelower perineal muscleand the perineal end ofthe Skin.

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Page 16: PROMPT Birthing Simulator Force Monitoring

Hardware & software quick start guide

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1

If you have a PROMPTBirthing Simulator -Value Set and need toidentify which Baby youare connecting, see thesection ‘Connecting thePlacenta to the Baby’ onpage 11.

Connect the end of the PS2baby lead, with the orangering, to the umbilical cordon the Baby.

Connect the other end ofthe PS2 baby lead to thesocket on the ForceMonitoring Interface Unitmarked ‘baby’.

PS2 baby lead.

USB computer lead.

Ensure that the computermeets the minimum systemrequirements:Operating system:- Windows 2000 / XPHardware:- USB 1.1 port- CD-ROM driveMonitor:- 800 x 600 pixels in 16-bit

(65536 colours)

Start up the computer.

3

Insert the software CD-ROMinto the drive. The CDbrowser program shouldautomatically run. (If it doesnot, use Windows Explorerto navigate to the CD-ROMdrive. Double click cdstart.exe to launch theCD browser program).

To install the ForceMonitoring Software, clickon the install button andfollow the instructions in theinstallation wizard.

2

Connect the ‘square’ end ofthe USB computer lead tothe socket on the InterfaceUnit marked USB.

Connect the ‘flat’ end of theUSB lead to a spare USBsocket on the computer. Thecomputer should report thatit has found the BirthingSimulator, and will installnew hardware for it.(Reboot the computer ifrequested to do so.)

4

Launch the application.

Check that the computerrecognises the attachedhardware: the Status Bar inthe bottom left hand cornerof the program windowdisplays ‘Interface Unit &Baby ready’ and a greenlight.

See the separate user guidesupplied with the ForceMonitoring Baby for detailedinstructions on how to usethe application.

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