Rocket Medical CRAFT Manual

OPERATORS GUIDE
CRAFT™
and
DUO-VAC™
Suction Pumps

CRAFT™ Suction Pumps –OperatorsGuide
2
ZDOCK105 Rev: 34
2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
1. CONTENTS
1.
CONTENTS ................................................................................................................................................................2
2.
GENERAL ASSEMBLY ..............................................................................................................................................3
2.1.
CRAFT™ DUO-VAC™Suction Pump..............................................................................................................3
2.2.
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 & CRAFT DUO-VAC™PUMPS ...................................................10
4.10.
SYMBOLS USED ON R57685 WATER TRAP SET FOR CRAFT™ PUMPS.................................................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

CRAFT™ Suction Pumps –OperatorsGuide
3
ZDOCK105 Rev: 34
2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
2.GENERALASSEMBLY
2.1.
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 connectionports
5.
Water trap connection port for use with R57685 CRAFT™Pump Water TrapSets
6.
R57685 Water TrapSet for CRAFT™Suction Pumps
7.
Medium Vacuum (Standard) 50-250mmHg-1 & High Vacuum 440mmHg-1foot-switch

CRAFT™ Suction Pumps –OperatorsGuide
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ZDOCK105 Rev: 34
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Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
2.2.
CRAFT™ Suction Pump
1.
Illuminated O/I Mains Power On/Off
2.
Vacuum Display mmHg-1
3.
High Vacuum (440mmHg-1) controlbutton
4.
Vacuum Control –clockwise to increase, anticlockwise to decrease the setvalue
5.
Patient Connection Port, for use with R57685
Water Trap Set for CRAFT™Suction Pumps
6.
R57685 Disposable Rocket CRAFT™Pump Water
Trap Sets
7.
Medium Vacuum (Standard) 50-250mmHg-1
footswitch connectionport
8.
Single footswitch

CRAFT™ Suction Pumps –OperatorsGuide
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ZDOCK105 Rev: 34
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Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
3.
GENERAL INSTRUCTIONS
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 oruser.
This device should only
be used by suitably
qualifiedpersonnel.
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only withelectrical
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.
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 Medicalplc.
Revision 32 Update to Service Agents & CE marks 19/08/20
Revision 33 Inclusion of Italian translations 10/02/21
Update to Warnings, Update to
Product Names and section 6.2.
Revision 34 Addition of hyphen in DUO-VAC™ 25/03/21
Disposal of
this device must be
undertaken with regard
to the WEEE directive
(2002/96/EC).
Revision 29
Update to images, patient profile,training
19/12/17
Revision 30
Amend ratingspecifications
05/01/18
Revision 31
Amend Warranty period & US address&
EU Rep
25/02/19
3.2. MODEL NUMBERS:
CRAFT™ Suction Pump (110v)
R29654
CRAFT™ Suction Pump (240v)
R29655
CRAFT™ DUO-VAC™ Suction Pump (240v)
R29660
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 addressgraphics
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 newfootswitch
30/09/13
Revision 19 Update to latex statement andsymbol
06/11/13
Revision 20 Image to clarify footswitchcontrols
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, ProcedureIFU,
Labelling and additionalwarnings
09/05/17
Revision 27 Standards references
23/05/17
Revision 28 Update to Warnings, dutycycle
10/11/17

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ZDOCK105 Rev: 34
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Rocket Medical plc.
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3.4.
MANUFACTURER:
Rocket Medical plc
Sedling Road
WASHINGTON
Tyne & Wear
NE38 9BZ UK.
RocketMedicalGmbH,
AmRosengarten48,
15566Schöneiche.
Germany
3.5.
SERVICE AGENTS:
CRAFT™ Pumps typically require little routine maintenance; however, they mustbe
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:
IVF Synergy Ltd.,
Old School,
Tresillian,
Cornwall
TR2 4BA
Tel: +44 (0) 1872 487224
Email: service@ivfsynergy.com
Website: www.ivfsynergy.co.uk
UK Customer Services:
Rocket Medical plc. Sedling Road. WASHINGTON. NE38 9BZ.ENGLAND
Tel:
+44 (0) 191 419 6988. Fax: +44 (0) 191 419 6989
Email:customerservices@rocketmedical.com
Australia Service Agent:
DTS Q-Tech,
8/79 Newton Road,
Wetherill Park, NSW 2164
Australia
Tel: +61 2 9729 4214
Email: terry@dtsdiagnostics.com.au
Website: www.dtsqtech.solutions
US Office:
Email:usa@rocketmedical.com
Rocket Medical
50 Corporate Park Drive.
Suite 890.
PEMBROKE.
MA. 02359. USA
Tel: +1 781 7496223

7
ZDOCK105 Rev: 34
2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
WARNING:
This manual contains
important information.
Please familiarise
yourself with these
safety instructions
before using thedevice.
WARNING:
This device should only
be operated by
appropriately qualified
personnel.
WARNING:
This device must only
be operated with
approvedconsumables.
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 offlammable
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 may becompleted.
4.1.
PATIENT PROFILE
The expected patient profile is:
•
Age: Adult, typically between 18-46years
•
Sex: Female
•
Weight: Notrelevant
•
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 Water Trap Set for CRAFT™ Suction Pumps. 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 arepresent.

8
ZDOCK105 Rev: 34
2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only withelectrical
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 offlammable
gases.
4.3.
USER TRAINING:
Rocket Medical or its authorised distributors and agents can provide end-user trainingon
the preparation, connection, operation and cleaning of thedevice.
Initial end-user training is recommended on installation with refresher training every 3 years
thereafter asrequired.
Training may include on-site visits, teleconferences, webinars and the provision oftraining
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 Trainingincludes:
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.
Footswitchcontrol/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
CRAFT™ Oocyte Aspiration Pumps comply with the electromagneticcompatibility (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 electromagneticcompatibility.
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
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
ZDOCK105 Rev: 34
2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
WARNING:
This device must only
be operated with
approvedconsumables.
WARNING:
Device can cause
explosion in the
presence offlammable
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 foruse
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.
•
Toavoidthe risk of electric shock this equipmentmustonlybeconnectedto asupply
main with a protectiveearth.
•
The device can be isolated from the mains supply by removal of the mainssupply
cord from the rear of theequipment.
•
The device is not approved for connection to any other device except the
R57685 Water Trap Set for CRAFT™Suction Pumps
•
The R57685 Water Trap Set for CRAFT™Suction Pumps is single use and
its instructions for use mustbe followed at all times.
•
Do NOT use the R57685 Water Trap Set for CRAFT™Suction Pumps if the
packaging isbroken.
•
DUTY CYCLE: The pump should be operated for 15 minutes ON with a 15-minute
period OFF prior tore-operation.
•
Do not use in an area where flammable gases arepresent.
•
Regular periodic maintenance of the device is recommendedannually.
•
Precautions for EMC safety should be observed. The device complieswith
EN60601-1-2:2015 for use in a Professional healthcare facility, however:
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 toreduce
possible electromagnetic interference.
o
The 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 powercable
located on the rear of theunit.
•
Fluids should not be allowed to enter the device as this mayresult 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 bythese 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 section6
CleaningGuidelines).
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
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ZDOCK105
4.9.
SYMBOLS USED ON CRAFT SUCTION & CRAFT™ 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 anduse
Consult the Instructions forUse
Usage Duty cycle: 15 minutes ON
followed by 15 minutes OFF
CE Mark

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ZDOCK105
4.10.
SYMBOLS USED ON R57685 WATERTRAP SET FOR
CRAFT™ PUMPS
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 rubberlatex
Do not use if pack is opened ordamaged
CE Mark

12
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ZDOCK105
5.
GENERAL INFORMATION:
5.1.
GENERAL DESCRIPTION:
The CRAFT™ Suction Pumps 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 vacuummode.
CRAFT™ Oocyte Aspiration Pumps require a R57685 Water Trap Sets for CRAFT™ Suction
Pumps 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 –asamended).
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 i1031-3
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
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ZDOCK105
6.
OPERATING THE PUMP
WARNING:
This device must only
be operated with
approvedconsumables.
WARNING:
ingress of liquid. Should
any liquid enter the
device, discontinue use
immediately and refer
to an authorised service
agent
Protect the devicefrom
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.
CRAFT™ DUO-VAC™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
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ZDOCK105
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
3.
Connect the correct mains lead to an electrical
supply 110-240VAC 50-60Hz. Modeldependent.
4.
Turn the power switch 0-I (front panel) toon.
The green light illuminate.
5.
Using aseptic technique, un-pack the R57685
Water Trap Set for CRAFT™ Suction Pumps and
attachthe short tubing length to the water trap
connection point.
6.
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.
7.
Refer to Table 1 for recommend vacuum values
for various needle and tube setcombinations.
8.
Occlude the patient tube set, distal to thewater
trap.
9.
Activate the footswitch.
10.
Rotate the control knob clockwise to increaseto
the desired value on thegauge.
11.
To decrease the set value: rotateanticlockwise.
12.
When the desired value is reached, release the
footswitch and tubing setocclusion.
13.
Repeat from Step 8 to ensure stablevalue.

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ZDOCK105
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 asthis
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
1. Connect the patient filter set to asuitable luer
fitting (indicated) such as the Oxford Tube Set
found on Rocket Medical Single and Double Lumen
Oocyte Aspiration Needles. 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.
CRAFT™ DUO-VAC™
2. To activate the HIGH vacuum, depress
the WHITE HIGH VACUUM Pedal –the
pump will immediately deliver a vacuum
of 440mmHg-1.
CRAFT™ Suction Pump
3.
To activate the HIGH vacuum,occlude
the RED button and depress the
footswitch –the pump will immediately
deliver a vacuum of 440mmHg-1.
4.
Removing the occlusion will causethe
vacuum to revert to its previously set
level.

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ZDOCK105
WARNING:
This device must only
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
5.
If water, media or any other material is
allowedto enter the water trap chamber, the
pump must be stopped immediately.
6.
Replace with a R57685 Water TrapSet
for CRAFT™Suction Pumps.
7.
The pump must NOT be operated if fluid is
present in the water trap.
8.
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
and repair.

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ZDOCK105
6.2.
PROCEDURE
Preparation: ROCKET MEDICAL PLC strongly recommends confirmation of the position of the uterus and
pelvic organs by ultrasonography prior to the procedure. Similarly, the presence of developed follicles should
be confirmed by serialultrasound during the ten days priorto the procedure.The procedure is normally 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 are harvested with the least
possible trauma to both patient 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 to the sheath to improve
picture definition
2. Select a sterile needle guide approved for use with the
vaginal ultrasound probe and 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 the patient and may result in loss of the oocyte.
4. For double lumen needles/flushing technique: prior to inserting
the needle into the needle guide, attach a syringe of flushing media
to the flushing port, open the tap and flush the channel with 2ml of
media. Close the 2-way tap. For single lumen needles: prime
(if required) using the connection port on the underside of the
bung/stopper.
5. Attach a sterile sample (Falcon) tube to the bung/stopper.
6. Connect the tubing connector to a low power vacuum pump
such as the R29655 CRAFT™ Suction Pump.
7. For double lumen needles/flushing technique: set the pump
to deliver a vacuum of 200mmHg. Aspirate 2-5ml of flushing media
into the Falcon tube and discard.
8. Place the needle into the needle guide following the manufacturer’s instructions. Figure 1 shows a
common probe and needle assembly.
9. Set the aspiration vacuum level to your personal preference using the table as a guide.
10. Ensure all connections are air tight and the tube set is free from any constrictions as these cause
turbulences which greatly increases the risk of oocyte damage.
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 have been identified, introduce 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. For double-lumen needles, if desired, 2-5ml of media can be
injected via the flushing limb (after opening the 2-way tap) to distend the follicle prior to subsequent
aspiration. When using single lumen needles, follicular flushing can be performed via the flushing port on
the underside of the bung/stopper. Complete the harvesting from one ovary before commencing on the
other.
13. If the needle becomes blocked during the procedure, rotate the needle within the follicle to ensure that
the needle is not blocked by follicular wall tissue
Single lumen blockage: if the needle remains blocked, remove the needle from the patient and flush through
with media using the flushing port on the underside of the bung/stopper.
Double lumen blockage: the needle can be flushed without removal from the ovary.
Check that the needle is clear by aspirating media through the needle set. If the blockage is still present,
high vacuum aspiration (400-500mmHg) may be performed with the needle outside the patient. WARNING:
the use of high suction when the needle is inside the ovary should not be performed. This may lead to
turbulent flow, which may damage the oocyte.
14. Flushing may be performed following harvesting to clear the needle prior to oocyte identification.

18
Rev: 34 2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
ZDOCK105
CRAFT™ Suction Pumps –OperatorsGuide
7.
CONSUMABLES
WARNING:
This device mustonly
be operated with
approved consumables
which are specifically
designed to providethe
correct flow rates and
vacuumcharacteristics
Should any liquid
enter the device,
discontinue use
immediately and refer
to an authorised
service agent
R57685 Water Trap Set for CRAFT™
Suction Pumps
glass water trap bottle 2.5m patient connection tube
with male luer connector. Supplied sterile, for single
use in cartons 10units.

19
Rev: 34 2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
ZDOCK105
CRAFT™ Suction Pumps –OperatorsGuide
WARNING:
ELECTRIC SHOCK
HAZARD.
Do not immerse the
device.
WARNING:
Do NOT attempt to
sterilise thedevice
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
contaminationrisk
IMPORTANT
A decontamination
certificate MUST be
included with every
returnedpump.
Repair or servicing
cannot be commenced
unless the service
agent is in possession
of thiscertificate
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 maycause
damage to the casing surface anddisplay.
Prevent any fluid from entering thedevice.
9.
YEAR OF MANUFACTURE:
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 11180776 indicates the device was
manufactured in2011
For units manufactured after 01/04/14, the year of manufacture is shown
on the rear rating plate label opposite the modelnumber.
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 duringtransport.
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 followinginformation:
•
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.

CRAFT™ Suction Pumps –OperatorsGuide
20
2021-03-21
Copyright©1991-2021
Rocket Medical plc.
All rightsreserved.
ZDOCK105
Rev: 34
11.
STORAGE & TRANSPORTATION:
The device must be transported/stored at temperaturesbetween
-10°C to +50°C
The device must be transported/stored at relative humiditylevels
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 unit for
servicing
Protect the device from ingress of liquid. Should any liquid enter the
device, discontinue use immediately and refer to an authorised
service agent
Other manuals for CRAFT
2
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5
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