Rocket Medical CRAFT Manual

OPERATORS GUIDE
Rocket
®
CRAFT™
and
DUOVAC™
Oocyte Aspiration Pumps

Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
2
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
1. CONTENTS
1. CONTENTS ................................................................................................................................................................2
2. GENERAL ASSEMBLY ..............................................................................................................................................3
2.1. Rocket CRAFT™ DUO-VAC Suction Pump .....................................................................................................3
2.2. Rocket CRAFT™ Suction Pump..........................................................................................................................4
3. GENERAL INSTRUCTIONS.......................................................................................................................................5
3.1. COPYRIGHT........................................................................................................................................................5
3.2. MODEL NUMBERS..............................................................................................................................................5
3.3. MANUAL REVISION:...........................................................................................................................................5
3.4. MANUFACTURER:..............................................................................................................................................6
3.5. SERVICE AGENTS..............................................................................................................................................6
4. SAFETY INSTRUCTIONS..........................................................................................................................................7
4.1. PATIENT PROFILE...........................................................................................................................................7
4.2. MANUAL USAGE..............................................................................................................................................7
4.3. USER TRAINING..............................................................................................................................................8
4.4. SUPPLY VOLTAGE SELECTION....................................................................................................................8
4.5. ELECTROMAGNETIC COMPATIBILITY..........................................................................................................8
4.6. PACKAGING.....................................................................................................................................................8
4.7. POSITIONING and PLACEMENT of the DEVICE............................................................................................8
4.8. WARNINGS.......................................................................................................................................................9
4.9. SYMBOLS USED ON CRAFT SUCTION & DUO-VAC PUMPS.......................................................................10
4.10. SYMBOLS USED ON R57685 SINGE USE WATER TRAP ...........................................................................11
5. GENERAL INFORMATION:......................................................................................................................................12
5.1. GENERAL DESCRIPTION: ...............................................................................................................................12
5.2. INDICATIONS....................................................................................................................................................12
5.3. CONTRAINDICATIONS.....................................................................................................................................12
5.4. REFERENCES...................................................................................................................................................12
6. OPERATING THE PUMP.........................................................................................................................................13
6.1. TABLE 1 RECOMMENDED VACUUM SETTINGS...........................................................................................15
6.2. PROCEDURE ....................................................................................................................................................17
7. CONSUMABLES ......................................................................................................................................................18
8. CLEANING THE PUMP CASING.............................................................................................................................19
9. YEAR OF MANUFACTURE:.....................................................................................................................................19
10. RETURNING THE PUMP FOR SERVICE .............................................................................................................19
11. STORAGE & TRANSPORTATION.........................................................................................................................20
12. OPERATING ENVIRONMENT...............................................................................................................................21
13. WARRANTY............................................................................................................................................................22
14. DISPOSAL:.............................................................................................................................................................22
15. TECHNICAL SPECIFICATIONS ............................................................................................................................23
15.1. CLASSIFICATION............................................................................................................................................23
15.2. SPECIFICATIONS ...........................................................................................................................................23
15.3. EMC Tables......................................................................................................................................................24

Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
3
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
2. GENERALASSEMBLY
2.1. Rocket CRAFT™ DUO-VAC Suction Pump
1. Illuminated O/I Mains Power On/Off
2. Vacuum Control Dial –clockwise to increase, anticlockwise to decrease the setvalue
3. Vacuum Display mmHg-1
4. Footswitch connection ports
5. Water trap connection port for use with R57685 Rocket Craft Pump Water TrapSets
6. R57685 Rocket Craft Pump Water TrapSet
7. Medium Vacuum (Standard) 50-250mmHg-1 & High Vacuum 440mmHg-1 foot-switch

Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
4
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
2.2. Rocket CRAFT™ Suction Pump
1. Illuminated O/I Mains Power On/Off
2. Vacuum Display mmHg-1
3. High Vacuum (440mmHg-1) control button
4. Vacuum Control –clockwise to increase, anticlockwise to decrease the setvalue
5. Patient Connection Port, for use with R57685 or
R57686 Disposable Rocket Craft Pump Water Trap
Sets or Filter Connection Sets
6. R57685 Disposable Rocket Craft Pump Water Trap
Sets
7. Medium Vacuum (Standard) 50-250mmHg-1
footswitch connection port
8. Single foot switch

Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
5
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
READ THIS MANUAL
CAREFULLY: Please
familiarise yourself with
the contents of this
manual before
attempting to use the
device.
Failure to observe
these instructions may
result in damage to the
pump or cause injury to
the patient or user.
This device should only
be used by suitably
qualified personnel.
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
CAUTION:
Any adjustment,
modification or repairs
to the equipment
should be carried out
by authorised service
agents.
Disposal of
this device must be
undertaken with regard
to the WEEE directive
(2002/96/EC).
3. GENERAL INSTRUCTIONS
3.1. COPYRIGHT
This manual contains information that is subject to copyright. All rightsreserved.
This manual should not be photocopied, duplicated or distributed completely or inpart
without the approval of Rocket Medical plc.
3.2. MODEL NUMBERS:
Rocket Craft™ Suction Pump Complete (110v) R29654
Rocket Craft™ Suction Pump Complete (240v) R29655
Rocket Craft™ Duo Vac™ Suction Pump (240v) R29660
Rocket Craft™ Duo Vac™ Suction Pump (110v) R29661
3.3. MANUAL REVISION:
Revision 8: New specification based on Rev 7 25/05/10
Revision 9: Updated CSD address graphics 07/06/10
Revision 10 Symbol tables & storage/transport 28/10/11
Revision 11 CE Mark, manufacturer data 21/11/11
Revision 12 Update to consumables info, voltage 01/12/11
Revision 13 Terminology change Low-Medium 05/12/11
Revision 14 Amend voltage statement in Section 4 07/12/11
Revision 15 CE mark amendment 07/12/11
Revision 16 Symbol correction 30/05/12
Revision 17 Correction to annotated images 29/06/12
Revision 18 Update images with new footswitch 30/09/13
Revision 19 Update to latex statement and symbol 06/11/13
Revision 20 Image to clarify footswitch controls 14/11/13
Revision 21 Amend EMC revision 15/04/14
Revision 22 Update to: YOM, consumption, footer 16/07/14
Revision 23 Update to LRQA CE mark 27/08/14
Revision 24 Gauge images, water trap cleaning ins. 17/12/14
Revision 25 Addition of Portuguese language version 01/08/16
Revision 26 Added EMC Tables, Procedure IFU,
Labelling andadditional warnings 09/05/17
Revision 27 Standards references 23/05/17
Revision 28 Update to Warnings, duty cycle 10/11/17
Revision 29
Update to images, patient profile,training
19/12/17
Revision 30
Amend rating specifications
05/01/18
Revision 31
Amend Warranty period & US address &
EU Rep
25/02/19
Revision 32 Update to Service Agents & CE marks 19/08/20

6
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
3.4. MANUFACTURER:
Rocket Medical plc
Sedling Road
WASHINGTON
Tyne & Wear
NE38 9BZUK.
3.5. SERVICE AGENTS:
Rocket Craft™ Pumps typically require little routine maintenance; however they must be
serviced and calibrated annually at a Rocket Medical plc approved servicefacility.
Failure to service the pump at the indicated intervals may invalidate theWarranty.
UK & European Service Agents:
IVFSynergy Ltd.,
Old School,
Tresillian,
Cornwall
TR2 4BA
Tel: [phone]
Email: [email protected]
Website: www.ivfsynergy.co.uk
UK Customer Services:
Rocket Medical plc. Sedling Road. WASHINGTON. NE38 9BZ.ENGLAND
Tel: [phone]. Fax: [phone]
Email: [e-mail]
Australia Service Agent
DTS Q-Tech,
8/79 Newton Road,
Wetherill Park, NSW 2164
Australia
Tel: [phone]
Email: [email protected]
Website: www.dtsqtech.solutions
US Office:
Email: [email protected]
Rocket Medical
50 Corporate Park Drive.
Suite 890.
PEMBROKE.
MA. 02359. USA
Tel: [phone]
Rocket Medical GmbH
Am Rosengarten 48,
15566 Schöneiche.
Germany

7
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
This manual contains
important information.
Please familiarise
yourself with these
safety instructions
before using the device.
WARNING:
This device should only
be operated by
appropriately qualified
personnel.
WARNING:
This device must only
be operated with
approved consumables.
WARNING:
Protect the device from
ingress of liquid. Should
any liquid enter the
device, discontinue use
immediately and refer
to an authorised service
agent
WARNING:
Ensure the set vacuum
level is appropriate.
WARNING:
No user serviceable
parts inside.
WARNING:
Device can cause
explosion in the
presence of flammable
gases.
4. SAFETY INSTRUCTIONS
This manual describes the operation and intended use of the device and the associated
consumables and it is essential that you use this document to familiarise yourself with the
correct function and operation of the device beforeuse.
Failure to follow these instructions may result in serious injury to the patient or operator and
can lead to damage or breakdown of the device. In case the device fails during an operation,
a replacement device and replacement disposables should be kept within reach so that the
operation maybe completed.
4.1. PATIENT PROFILE
The expected patient profile is:
• Age: Adult, typically between 18-46years.
• Sex: Female
• Weight: Not relevant
• Health: Not relevant
• Nationality: Multiple
• PATIENT state: –Sedated or under GA. PATIENT is not USER: notrelevant
4.2. MANUAL USAGE:
This manual does not provide a detailed description of the oocyte harvesting procedure and
is not intended as a training guide for users inexperienced in thetechnique.
The device must be used with R57685 Rocket CRAFT™ Water Trap (Patient Connection)
Sets. The usage of non-approved tubing or filter sets may impair pump performance, lead
to increased risk to patients and harvested oocytes and will invalidate theWarranty.
The water trap sets are designed to prevent fluid contamination of the vacuum pump. If the
device has been used with a non-approved filter set or there is any evidence or suspicion
that the pump may have been contaminated with fluid during use, it must be removed from
service and returned for examination immediately. Please contact your nearest Service
Centre for advice.
The use of high vacuum levels may lead excessive fluid flow rates which may result in
damage to the oocyte and reduced fertilisation rates. Damage to oocytes inharvesting
systems is principally caused by turbulent flow which can lead to physical shearing
stresses on the cumulus sufficient to denude or damage the fragile zona (Reeves et al
1989). Flow rate is a function needle set configuration and vacuumapplied.
HIGH vacuum setting must only be used to clear blockages from a needleset.
Refer to Table 1 for recommended vacuum setting for given needle setconfigurations.
Refer all servicing to the manufacturer’s authorised service agent.
Do not use in an area where flammable gases are present.
.

8
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
WARNING:
ELECTRIC SHOCK
HAZARD.
Do not immerse the
device.
WARNING:
Device can cause
explosion in the
presence of flammable
gases.
4.3. USER TRAINING:
Rocket Medical or its authorised distributors and agents can provide end-user training on
the preparation, connection, operation and cleaning of thedevice.
Initial end-user training is recommended on installation with refresher training every 3 years
thereafter as required.
Training may include on-site visits, teleconferences, webinars and the provision of training
support materials including thismanual.
Contact your local Rocket Medical sales office or distributor for further training support. See
our website www.rocketmedical.com for details of your localoffice
End User Training includes:
1. Introduction to the product
a. Components
b. Symbols used
2. Setup
a. Mains supply
b. Attachment of footswitches and patient connectionsets
3. Operation
a. Vacuum Settings
b. Footswitch control/operation
4. Contamination control
a. Cleaning
b. Use of approved patient connectionsets
4.4. SUPPLY VOLTAGE SELECTION
The device operates at a voltage 220-240 VAC @ 50Hz.40VA
or 110VAC @ 60Hz as appropriate to themodel.
Ensure that the correct power cord isconnected.
4.5. ELECTROMAGNETIC COMPATIBILITY
Rocket CRAFT™ Oocyte Aspiration Pumps comply with the electromagnetic compatibility
(EMC) limits for medical devices as specified by BS EN60601-1-2:2015.
The device must be operated according to the instructions contained in this manualto
ensure continued electromagnetic compatibility.
4.6. PACKAGING
The packaging has been designed to allow secure transportation of the pump andits
accessories.
After unpacking, re-assemble and retain the packaging for transport for servicingwhen
required.
4.7. POSITIONING and PLACEMENT of the DEVICE
Rocket CRAFT™ Oocyte Aspiration Pumps must be placed on a secure, level surface,
away from sources of heat, water splashes, mists or cooling vents. Do not expose todirect
sunlight.
Do not expose to flammablegases.
Operating temperature Range: +5°C and+35°C

9
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
This device must only
be operated with
approved consumables.
WARNING:
Device can cause
explosion in the
presence of flammable
gases.
WARNING:
Protect the device from
ingress of liquid. Should
any liquid enter the
device, discontinue use
immediately and refer
to an authorised service
agent
WARNING:
Ensure the suction level
is appropriate.
4.8. WARNINGS:
Users should be familiar with and adhere to all warnings, cautions and instructions for use
that are labelled on the device and included in the UserManual.
• This device should only be used by, or under the supervision of, appropriately
trained personnel and in conjunction with current local clinical practiceguidelines.
• Toavoid therisk of electric shock this equipmentmust onlybe connectedto a supply
mains with a protective earth.
• The device can be isolated from the mains supply by removal of the mainssupply
cord from the rear of the equipment.
• The device is not approved for connection to any other device except the Rocket
R57685 or R57686 Water Trap/Filter Sets.
• The Rocket R57685/686 set is single use and its instructions for use must be
followed at all times.
• Do NOT use the Rocket R57685/686 Aspiration set if the packaging isbroken.
• DUTY CYCLE: The pump should be operated for 15 minutes ON with a 15 minute
period OFF prior to re-operation.
• Do not use in an area where flammable gases are present.
• Regular periodic maintenance of the device is recommendedannually.
• Precautions for EMC safety should be observed. The device complies with
EN60601-1-2:2015 for use in a Professional healthcare facilityhowever:
o Electronic equipment in the vicinity of the device may affect its operation
and potentially cause unpredictable operation of thedevice.
o Wherever possible the device should be distanced from surrounding
electromagnetic equipment and cables to this equipment in order to reduce
possible electromagnetic interference.
o The Rocket Craft Pump device power cable should only be connected to a
correctly wired receptacle in order to avoid the risk of electrical shock and
ONLY use the cable supplied by RocketMedical..
• When positioning the unit, ensure that access is available to the AC power cable
located on the rear of theunit.
• Fluids should not be allowed to enter the device as this may result in damage to the
system.
• User should be aware of the status of unit at all times during theprocedure.
• Only qualified personnel should service the device and the device must not be
opened except by these personnel due to the risk of hazardous electrical shock and
premature damage to the device. All service requirements should be referred to a
Rocket Medical authorisedrepresentative.
• All equipment should be thoroughly cleaned after each use (refer to section 6
Cleaning Guidelines).
WARNING: Do not modify this equipment without written authorisation of the
manufacturer.
The use of high suction levels may lead excessive fluid flow rates which may result in
damage to the oocyte and reduced fertilisation rates. Damage to oocytes inharvesting
systems is principally caused by turbulent flow which can lead to physical shearing
stresses on the cumulus sufficient to denude or damage the fragile zona (Reeves et al 1989).
Flow rate is a function needle set configuration and the suctionapplied.
Therefore, the 400mmHg-1 (Max) suction setting must only be used to clear
blockages from a needle set and must NOT be used in contact with the patient. Refer
to Section 6 for recommended suction setting for given needle setconfigurations.

10
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
4.9. SYMBOLS USED ON CRAFT SUCTION & DUO-VAC PUMPS.
These tables describe their respectivemeanings.
Mains Power ON/OFF
This device is Type B
Footswitch connection port
Dispose of this device in accordance with
WEEE directive (2002/96/EC)
Earthed
Read the manual before connection and use
Consult the Instructions for Use
Usage Duty cycle: 15 minutes ON
followed by 15 minutes OFF
CE Mark

11
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
4.10. SYMBOLS USED ON R57685 SINGE USE WATER TRAP
Read the Instruction for Use before connection anduse
Device is for Single Use Only
Device is sterilised by Ethylene Oxide
The device is not manufactured with natural rubelatex
Do not use if pack is opened or damaged
CE Mark

12
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
5. GENERAL INFORMATION:
5.1. GENERAL DESCRIPTION:
The Rocket CRAFT™ Oocyte Aspiration Pumps have been developed to provide smooth,
low volume vacuum at a pre-determined negative pressure. Vacuum is activated by a foot
operated toggle air switch controlled by the surgeon performing the oocytecollection.
The range of vacuum is infinitelyvariable from 10-250mmHg-1 in medium vacuum mode and
at a pre-set 440mmHg-1 in high vacuum mode.
Rocket CRAFT™ Oocyte Aspiration Pumps either a R57685 Disposable Rocket CRAFT™
Water Trap Sets supplied separately, sterile and for singleuse.
5.2. INDICATIONS:
For the generation of medium vacuum between 10-250 mmHg-1 to permit the aspiration of
follicular fluid, oocytes and ovarian fluid as part of the treatment of infertility relating to IVF
and other gynaecologicalprocedures.
This device may only be used by, or under the supervision of, appropriately trained
personnel in conjunction with clinical practice guidelines such as those published by the
National Institute of Clinical Excellence (NICE 2004) and the Human Fertilisation &
Embryology Authority. (HFEA April 2010 –as amended).
5.3. CONTRAINDICATIONS:
Not intended for use where ovarian aspiration or the aspiration of ovarian fluid is
contraindicated. For short term operation only. NOT for continuousdrainage.
5.4. REFERENCES:
Craft I, McLeod F. Edmonds K, ‘Human embryo transfer technique’. Lancet 1961 ii1104-5
Craft I, Diahanbakch O. McLeod F et al ‘Human pregnancy following oocyte and sperm
transfer to the uterus.’ Lancet 1992 i 1031-3
Craft I, (1984) ‘Clinical Methodology’ British Journal of Hospital Medicine90-102
Reeves G, Scott R T, et al (1989) Journal of Assisted Reproduction and GeneticsVolume
6, Number 6 / December, 1989

13
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
This device must only
be operated with
approved consumables.
WARNING:
ingress of liquid. Should
any liquid enter the
device, discontinue use
immediately and refer
to an authorised service
agent
6. OPERATING THE PUMP
Protect the device from
Rocket CRAFT™ Suction Pump:
1. Unwrap the footswitch and attach
the air tubing to the ports on the
front of the pump casing. The
footswitch is normally left
attached to unit in daily use
unless removal for storage is
required.
Rocket CRAFT™ Suction Pump:
2. Unwrap the footswitch and attach
the air tubing to the male/female
ports on the front of the pump
casing. The footswitch is normally
left attached to unit in daily use
unless removal for storage is
required.

14
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
WARNING:
Ensure the set vacuum
level is appropriate to
the patient’s needs
taking into
consideration the
needle and tube set
configuration
1. Connect the correct mains lead to an electrical
supply 110-240VAC 50-60Hz. Modeldependant
2. Turn the power switch 0-I (front panel) to on.
The green light illuminate.
3. Using aseptic technique, un-pack the R57685
Rocket CRAFT™ Water Trap Set and attach the
short tubing length to the water trap connection
point
4. Pass the longer patient connection tube intothe
operative field. The R57685 water trap set is for
single patient use and must be replaced for
each patient.
5. Refer to Table 1 for recommend vacuum values
for various needle and tube setcombinations
6. Occlude the patient tube set, distal to thewater
trap.
7. Activate the foot switch
8. Rotate the control knob clockwise to increase to
the desired value on thegauge
9. To decrease the set value: rotateanticlockwise.
10. When the desired value is reached, release the
footswitch and tubing set occlusion.
11. Repeat from Step 8 to ensure stablevalue.

15
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
Ensure the set vacuum
level is appropriate to
the patient’s needs
taking into
consideration the
needle and tube set
configuration
WARNING:
HIGH VACUUM MODE
must NOT be used to
aspirate oocytes as this
may result in damage
to the oocyte and lead
to reduced fertilisation
rates.
6.1. TABLE 1 RECOMMENDED VACUUM SETTINGS
Single Lumen
Double Lumen
16G
17G
16G
17G
Tube Set Length
Recommended Vacuum -mmHg
55cm
80
110
130
150
70cm
90
130
150
170
90cm
100
150
170
190
12. Connect the patient filter set to a suitable
luer fitting (indicated) such as that found on
the Rocket Oxford Tube Set found on Rocket
Single and Double Lumen Oocyte Aspiration
Needles and attach a collection tube to the
bung.
If vacuum lines become blocked due todebris
or viscous fluids, a temporary high vacuum
(440mmHg-1) can be obtained to unblock the
needle and tubing set by following the
procedures below
Rocket CRAFT™ DUO-VAC
13. To activate the HIGH vacuum, depress
the WHITE HIGH VACUUM Pedal –the
pump will immediately deliver a vacuum
of 440mmHg-1.
Rocket CRAFT™ Suction Pump
14. To activate the HIGH vacuum,occlude
the RED button and depress the
footswitch –the pump will immediately
deliver a vacuum of 440mmHg-1.
15. Removing the occlusion will cause the
vacuum to revert to its previously set
level.

16
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
WARNING:
This device must only
be operated with
approved consumables
which are specifically
designed to provide the
correct flow rates and
vacuum characteristics
Should any liquid
enter the device,
discontinue use
immediately and refer
to an authorised
service agent
1. If water, media or any other material is allowedto
enter the water trap chamber, the pump must be
stopped immediately.
2. Replace with a R57685 Rocket Water TrapSet
3. The pump must NOT be operated if fluid ispresent
in the water trap.
4. Should the water trap become full and there is a
risk that fluid has entered the pump, it must be
withdrawn from service and returned to an
authorised service agent for inspection andrepair.

17
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
6.2. PROCEDURE
Preparation: ROCKET MEDICAL PLC strongly recommend that the position of the uterus
and pelvic organs are confirmed by ultrasonography prior to the procedure. Similarly, the
presence of developed follicles should have been confirmed by serial ultrasound duringthe
10 days prior to the procedure. The procedure is normally be carried out under local
analgesia and/or supplemented light sedation. General anaesthesia may be necessary in
very anxious patients.
Follicular Aspiration: It is essential for a successful outcome that oocytes areharvested
with the least possible trauma to bothpatient
and ova.
Using aseptic technique:
1. Following the manufacturers guidelines,
cover the transvaginal ultrasound probe
with a sterile sheath. A small amount of
ultrasound gel may be added toimprove
picture definition.
2. Select a sterile needle guide approved for
use with the vaginal ultrasound probeand
assemble following the manufacturers
instructions.
3. Open the needle pack carefully, taking
care not to touch or damage the needle
bevel. The use of damaged needles will
cause increased discomfort to thepatient
and may result in loss of theoocyte.
4. Prior to inserting the needle into the
needle guide, attach a syringe offlushing
media to the flushing port, open the tap
and flush the channel with 2ml of media.
Close the 2 way tap.
5. Locate the bung/stopper and attach to a
sterile sample tube.
6. Connect the tubing connector to pateint connection port (see Section4)
7. Aspirate 2-5ml of flushing media into the tube anddiscard.
8. Assemble the needle into the needle guide following the manufacturersinstructions.
The diagram above shows a common probe and needleassembly.
9. Set the vacuum level to your personal preference using the values in Table 1 asa
guide.
10. Ensure all connections are air tight and the tube set is free from any constrictionsas
these cause turbulence which greatly increases the risk of oocytedamage.
11. With the patient in lithotomy, introduce the needle/probe assembly into the vagina,
advancing into the anterior fornix to visualise each ovary. Once the ovaries havebeen
identified, introduced the needle and advance through the vaginal wall and ovarian
stroma into the target follicle.
12. Activate the vacuum pump and aspirate the follicular fluid into the sampling tube.
Check microscopically for the presence of an oocyte. If desired, 2-5ml of media can
be injected via a flushing limb if fitted to distend the follicle prior to subsequent
aspiration. Complete the harvesting from one ovary before commencing theother.

18
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
WARNING:
be operated with
approved consumables
which are specifically
designed to provide the
correct flow rates and
vacuumcharacteristics
Should any liquid
enter the device,
discontinue use
immediately and refer
to an authorised
service agent
7. CONSUMABLES
This device must only
R57685 Rocket CRAFT™ Water Trap
(Patient Connection) Set
glass water trap bottle 2.5m patient connectiontube
with male luer connector. Supplied sterile, for single
use in cartons 10units.

19
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
WARNING:
ELECTRIC SHOCK
HAZARD.
Do not immerse the
device.
WARNING:
Do NOT attempt to
sterilise the device
WARNING:
Protect the device from
ingress of liquid. Should
any liquid enter the
device, discontinue use
immediately and refer
to an authorised service
agent
WARNING:
No user serviceable
parts inside.
HAZARD:
Do NOT include used
consumables as these
pose a significant
contamination risk
IMPORTANT
A decontamination
certificate MUST be
included with every
returned pump.
Repair or servicing
cannot be commenced
unless the service
agent is in possession
of this certificate
8. CLEANING THE PUMP CASING
At the end of each clinical session, turn off the device at the front panel and disconnect the
device from mains power supply
Using an aqueous solution of 70% alcohol (IMS or isopropyl BP), moisten a cloth and wipe
all external surfaces of the device. If the surface has become contaminated with
proteinaceous material, remove with a light detergent solution before surfacing cleaning with
alcohol.
Do NOT use a 100% alcohol or any other solvent to clean the device as this may cause
damage to the casing surface anddisplay.
Prevent any fluid from entering the device.
9. YEAR OF MANUFACTURE:
10. RETURNING THE PUMP FOR SERVICE:
All devices to be returned must be prepared as described below for the protection of the
servicing team and for safety during transport.
1. Surface clean the pump as described in the Sectionabove
2. Seal in a plastic bag and seal within a second plasticbag.
3. Place in the originalpackaging.
4. Enclose the following information:
• Contact name
• Centre address
• Decontamination Certificate
• Description of the fault or servicerequired
• Accompanying Order to authorise servicing –contact your local Customer
Services Team for details
Units manufactured before 2014: The year in which the device was
manufactured is indicated by the first 2 numbers of the serial number.
For example: a serial number starting
11
180776 indicates the device
was manufactured in 2011
For units manufactured after 01/04/14, the year of manufacture is shown
on the rear rating plate label opposite the modelnumber.

Rocket CRAFT™ Oocyte Aspiration Pumps –OperatorsGuide
20
Copyright© 1991-2020
Rocket Medical plc .
All rights reserved.
ZDOCK105
Rev: 32
2020-08-19
11. STORAGE & TRANSPORTATION:
The device must be transported/stored at temperaturesbetween
-10°C to + 50°C
The device must be transported/stored at relative humidity levels
between 20% to 95%
The device must be stored in a clean, dry condition, ideally in its
original packaging which should be retained to return the unitfor
servicing
Protect the device from ingress of liquid. Should any liquid enter the
device, discontinue use immediately and refer to an authorisedservice
agent